The History of THE NORWEGIAN SOCIETY FOR AESTHETIC PLASTIC SURGERY From 1983 to 2020

The History of

THE NORWEGIAN SOCIETY FOR AESTHETIC PLASTIC SURGERY

From 1983 to 2020

Editor: Amin Kalaaji, MD, PhD

Editor: Authors:

Amin Kalaaji Gorm Bretteville Frode Samdal Frode Amland Helge Roald Bjørn Rosenberg Amin Kalaaji Kjell Aass Morten Kveim

Contact:

Editor Amin Kalaaji, MD, PhD

President of the Norwegian Society of Aesthetic Plastic Surgery (NSAPS, NFEP)

Phone: +4792062144

E-mail: ami.kal@online.no

Layout:

WebPress, www.webpress.no

Print:

WebPress

Photo cover: Stockphoto Design cover: WebPress

THE FIRST PRESIDENT OF THE SOCIETY, GORM BRETTEVILLE WROTE: «For plastic surgeons, this felt like a group without formal education in plastic surgery was taking over cosmetic surgery, which was perceived as part of the plastic surgery» For this reason, The Norwegian Society for Cosmetic Plastic Surgery was created in 1983, following an initiative from Gorm Bretteville, Roar Rindal, and Morten Kveim; however, the formal founding date in the Brønnøysund Register is 1985, and the society was approved in 1989 as a special section within the Norwegian Plastic Surgery Society (NPF). The society later changed its name to the Norwegian Society for Aesthetic Plastic Surgery (NFEP).

From NAAM October 2, 2017

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CONTENT A. Foreword..........................................................................8 B. Acknowledgment ......................................................... 10 C. 37 Years of activity...................................................... 12 1983-2000: Gorm Bretteville....................................................................... 12 2000-2004: Frode Samdal........................................................................... 17 2004-2008: Petter Frode Amland............................................................. 36 2008-2010: Frode Samdal........................................................................... 40 2010-2012: Helge Einar Roald.................................................................... 53 2012-2014: Ayman Zakaria.......................................................................... 55 2014-2018: Bjørn E. Rosenberg ................................................................. 57 2018-2020: Amin Kalaaji.............................................................................. 60

D. List of presidents and board members......................68 E. plastic surgeons In Norway.........................................70 F. Appendix .......................................................................72 1. Establishment document for NFEP........................................................73 2. Foundation document NFEP....................................................................74 3. NFEP bylaws............................................................................................... 75 4. Ethical rules, revised 2019.......................................................................77 5. Professional rec. for the practice of intimate surgery......................79 6. ALCL Aftenposten debate...................................................................... 80 7. Consultation response NFEP VAT case................................................ 82 8. VAT case Aftenposten.............................................................................. 99 9. NFEP website ...........................................................................................102 10. Regulations concerning cosmetic procedures............................... 103 11. Proposed Norwegian standard for extended infection control by: COVID-19 control...............................................................122

G. Pictures........................................................................ 127 1. Presidents NFEP through 37 years.......................................................128 2. Miscellaneous historical pictures.........................................................129

A. FOREWORD – WHY THIS BOOK? The idea for this book came to me many years ago. It was probably the beginning of the 2000s when the development and activity of the Norwegian Society for Aesthetic Plastic Surgery varied. A society without a focused history always lacks perspective on the future. An important activity of the society has been the planning of professional meetings, which started with Nordic courses organized in the 1980s, progressing to seminars in Austria in the 2000s and Norwegian-American meetings in the 2010s. Over the years, the challenges have varied greatly, from establishment, to relationship with the parent society, administrative measures, patient consent, introduction of VAT in three cases, regulation of aesthetic medicine, and other ethical issues. Other issues include regulation, other specialists, medical tourism, NPE, regulation, ALCL, and the prosthesis register. The society does not lack challenges for the future. This book could not have been possible without the active participation of my co-authors Gorm Bretteville, Frode Samdal, Kjell Aass, Frode Amland, Helge Roald, Bjørn Rosenberg and Morten Kveim, who have written or contributed to their respective periods. The book contains an introduction, descriptions of the time periods, a list of the board through years, lists of current and former members, photos, and attachments for historical reference. Everyone has contributed in their own way to the development of the society and has written their own chapter about their respective periods as managers. Many thanks to all our members who have been loyal and dutiful. We started with about twenty members and are now over sixty. Today, membership in the society is very attractive. I have always believed that we in Norway have great potential in the Nordic region, internationally and in recent years with NAAM 1,2,3, the growth of the society is good proof of this. A big thank you and great appreciation to colleagues and everyone else who has helped define and defend interest in aesthetic plastic surgery. Not least, to setting clear ethical rules to defend the interests of our patients.

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Quality and education are our main motto, and together we build the future of our society and give it a greater place in our professional lives. Much can be reorganized and will improve in the years to come to do the best for our colleagues and patients. The journey has just begun. Our strength is in our agreement to use our personal interest in the plastic surgery community to promote aesthetic plastic surgery as a profession, a profession genuinely accepted and respected, and in taking social responsibility seriously. Congratulations to all our members for the 37 years that have passed. We look forward to continuing work. I thank everyone for the great trust they have put in me as a board member and leader in recent years, which afforded me the opportunity to write this valuable book. Happy reading! Oslo 1st December 2020

Editor and author: Amin Kalaaji, MD, PhD President of the Norwegian Society of Aesthetic Plastic Surgery (NSAPS, NFEP)

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B. ACKNOWLEDGMENT Thanks to everyone who created the society and to all the authors: Gorm Bretteville, Kjell Aass, Morten Kveim, Frode Samdal, Frode Amland, Helge Roald, and Bjørn Rosenberg who contributed to their respective periods. A big thank you to Kjell Aass who contributed photographs from a time from which there are not many photographs. Thanks to John Brataas who helped with publishing-related aspects. Many thanks to board members Bjørn Tvedt and Christian Busch for their support during the 2018-2020 period. Many thanks to all members who have been active in the society during all these years. Editor Amin Kalaaji

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THE HISTORY OF THE NORWEGIAN SOCIETY FOR AESTHETIC PLASTIC SURGERY FROM 1983 TO 2020

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C. 37 YEARS OF ACTIVITY 1983-2000: GORM BRETTEVILLE

Establishment and Beginning: The first Years of Cosmetic Surgery in Norway The transition from general surgery via plastic surgery to cosmetic surgery has taken place gradually over the last 100 years. In Norway, there has been a strong influence from Northern Europe and the United States. Some would say that cosmetic surgery only deals with beautifying surgeries and does not relate to “disease.” However, the border crossing is difficult. Is breast reduction general surgery, cosmetic surgery, or something in between? In Norway, it was approximately 1973 that a report was made (NOU Norwegian Public Report) in which chief physician Henrik Borchgrevink participated. It was to decide what could be operated on in hospitals, what it was the public should pay for and what was considered pure cosmetics and what patients should pay for themselves. The report concluded that much of what “we” thought was purely cosmetic should be covered by the public. Examples of this were prominent ears, excess skin, breast abnormalities, and moles. The waiting lists at the hospitals were long. This created a breeding ground for surgery in private practice. John Wilhelm Loennecken (1907-1973) was a specialist in surgery in 1945. In 1948 he was approved as a specialist in plastic surgery by a specially appointed committee and was our first plastic surgeon. Loennecken served an internship at Wergelandsveien clinic in Oslo and was a consultant at Rikshospitalet in Oslo. When looking for premises for a department of plastic surgery at Rikshospitalet, he was quick to suggest that one could be added to the old military hospital, at the top of Wergelandsveien. This was just a stone’s throw from his own hospital. The ward was located there until it moved into a new building at Rikshospitalet at the turn of the year 1989-1990, about 10 years before the entire hospital was moved to Gaustad. Henrik Borchgrevink (1926-2003), a specialist in plastic surgery in 1967, was hired as assistant doctor in 1963. Eventually he managed the entire department up to 1968, except for a break in 1966-1967 when he had to undergo plastic surgery himself. In 1966, Roar Funder, and later Gunnar Eskeland, was appointed chief of the department. Gunnar Eskeland was appointed head of the department on a permanent basis but after eight months he went to the plastic

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surgery department in Odstock in England in 1967-1968 to become a certified specialist. Meanwhile, Borchgrevink continued as acting departmental chief physician. There was little private practice, but Henrik Borchgrevink and Gunnar Eskeland operated Mondays at Bethany Hospital in Oslo. There they also did some cosmetic surgery. The one who did the most cosmetic surgery before 1970 was Bjarne Grundt (1900-1974). He had an office in Drammensveien and operated with the patients in a dental chair. He was originally a dentist from the NTHL in 1924 and earned a medical degree in Oslo in 1934. He did face lifts and eyelid plastics and was especially known for his rhinoplasties. In 1970, Gorm Bretteville came from Glasgow to Rigshospitalet in Copenhagen. Conditions in Norway and Denmark were similar; permanent plastic surgery hospital positions were few and far between. Most of the more experienced doctors had small private practices next to the hospital. In 1972, younger doctors also began to organize small, private clinics, where they eventually also performed cosmetic surgery. When Gorm Bretteville came to Rikshospitalet in Oslo in 1976, Roar Rindal and Lars Traaholt had already started the Department of Plastic Surgery (1974) in a small apartment in Holtegaten. They invited Gorm Bretteville to join, and soon after they moved to new premises in The Incognito Gate. Roar Rindal acquired premises in Dybwadsgate and left Rikshospitalet in 1976. Thereafter, he was the only privately practicing plastic surgeon in Oslo full time. Demand for him was very large. When he announced that the office was open for appointments, he was filled up for many months to come. Later, he returned to Inkognitogaten, where the three doctors stayed until they moved to Rosenborggaten 8. In this first period, significantly small interventions were made. Everything was done under local anesthesia without sedation. No one had experience making major interventions under local anesthesia. During his time in Copenhagen, Gorm Bretteville had done a great deal of work and concluded that bleeding during and after breast reduction was significantly reduced if local anesthesia was infiltrated with adrenaline in the breasts before the procedure. This was introduced as the default procedure at Rikshospitalet, but the patient still underwent general anesthesia. Bleeding during and after the procedure was significantly reduced. Blood transfusions were no longer necessary, and the patient had a significantly shorter hospital stay than the 10 days that was common at the time. Bretteville began to make maternity plastic surgery private under pure local anesthesia with relatively large amounts of adrenaline to reduce bleeding. He was anxious about the side effects of lidocaine and operated on one breast at a time at one-week intervals after drawing on both. Eventually, valium and leptanal were given intravenously. Anesthesiologist Harald Moen was one day summoned by a less trained colleague who was

1983-2000: Gorm Bretteville

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to insert maternal prostheses. Moen told the colleague how risky and unsafe it was to do intravenous injections without professional monitoring. This was then incorporated into private practice for plastic surgery. Eventually, it led to better medicine and equipment so that the procedures were improved and safer. Easier for the surgeon and far better for the patients. Kjell Aass was Bretteville’s assistant at Rikshospitalet, and he established a private practice in Drammen, where he performed surgery together with Oskar Eikeland. because they had operated on one breast without any problems, they operated on the other as well at the same time. This later became standard. Kjell Aass, Gorm Bretteville, and Oskar Eikeland did one large series of breast reductions at Rikshospitalet, where they used the same amount of xylocaine adrenaline as in private practice. Blood samples were taken from everyone and lidocaine levels in serum were measured during and after the procedure. It was clear that the lidocaine concentration in serum did not reach higher than in one third the levels at risk for toxic effects. Over the years, the methods of general anesthesia have become gentler for the patient and simpler for anesthesia staff and are widely used today. Injection of xylocaine adrenaline nevertheless has its place. In addition to reducing bleeding, the effect of lidocaine makes it possible to make anesthesia lighter and extra gentle for patients. The society for cosmetic/aesthetic plastic surgery was formed from Denmark. Gorm Bretteville was used to the fact that the younger doctors had small informal meetings with each other, where they discussed the job and topics in plastic surgery. When Bretteville came to Oslo, he began immediately doing the same, and it became natural for the younger plastic surgeons to discuss private practice and cosmetic surgery. A new type of doctor emerged during this period. Erik Dillerud (b. 1946) was a specialist in general surgery and had one to two years of practice in plastic surgery with chief physician Ole M. Ugland (1924-2005) at the Red Cross; Jarl Bunæs (b. 1943) was a specialist in ear-nose-throat diseases; and Truls Jørgen Amundsen (b. 1948) was a dermatologist. All three marketed themselves as performing cosmetic surgery. For plastic surgeons, this felt like a group without formal education in plastic surgery was taking over cosmetic surgery, which was perceived as part of the plastic surgeon’s realm. For this reason, the Norwegian Society for Cosmetic Plastic Surgery was founded in 1983 as a subdivision of the Norwegian Plastic Surgery Society (NPF). The society later changed its name to the Norwegian Society for Aesthetic Plastic Surgery (NFEP) and was approved in 1989 as a specialist department within the NPF. The society’s first board consisted of Gorm Bretteville, Roar Rindal, and Morten Kveim. Separate laws were written, and, to become a member, one had to have been a specialist for at least two years and have worked in private practice.

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The NFEP was resolute that patients receive help from qualified plastic surgeons and that not every doctor should be able to offer cosmetic procedures. Eventually, the Medical Society ruled on this and, in 1989, the first regulations were adopted and came into force. These regulations were later replaced by regulations on permission to perform cosmetic plastic surgery from January 1, 2000, and currently not just any doctor is allowed to perform cosmetic intervention in Norway, as it was before 1989. A number of courses and gatherings were held under the auspices of the NFEP, preferably with their lecturers. Next to meetings in Oslo, the society had gatherings in Drammen, Fredrikstad, Geilo, and Vrådal. To present cosmetic surgery as a separate specialty in plastic surgery, the NFEP arranged a course in cosmetic surgery in 1988. The course consisted of two parts and lasted three days in Oslo as university courses 1913 and 1914. The course committee consisted of Gorm Bretteville, Morten Rynning Kveim, and Morten Sandsmark, who was involved as an exceptionally efficient and skilled secretary. This was a trial program to plan a fifth course within a Nordic context with the theme of cosmetic plastic surgery in addition to the four compulsory Nordic courses. The first five courses in plastic surgery were held in Oslo, with 33 participants from all over the Nordic region. For university course 2038 from November 6-9, 1989, course leaders were Gorm Bretteville, Roar Rindal, Hans Petter Gullestad, and Morten Sandsmark. A similar fifth course was held during from November 6-9, 1995, in Oslo: university course 2937. Course leaders were P. Frode Amland and Helge Einar Roald. Here there were 48 participants. The courses were very successful, and the intention was that this would be the fifth course of the Nordic courses. Nevertheless, to avoid too many courses in education, it was later decided that the subjects should only be included in the four ordinary courses. For the new board that was elected in the Norwegian Plastic Surgery Society in 1989, all active members were also in the Norwegian Society for Aesthetic Plastic Surgery. The same was the case for several boards that came later. For a long time, the main society, the NPF, largely took care of its interests in aesthetic plastic surgery. At the same time, annual spring meetings were started in the Norwegian Plastic Surgery Society. Therefore, it was agreed to keep the aesthetic society, but to keep meeting activity low as long as the activity in the Norwegian Plastic Surgery Society was high and covered the fields of interest of the members of the aesthetic society.

1983-2000: Gorm Bretteville

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The book Cosmetic Surgery by Morten Kveim The book Cosmetic Surgery, by Morten Kveim, was published by Cappelens Forlag in 1988 and was intended as a joint reference for plastic surgeons to the public and colleagues. At that time, there were not so many players, and the market was such that it could have been possible to agree on a high-profile and tight framework so that one could build respect in society among colleagues and authorities. The idea was to establish an alliance between the university environments and aesthetic surgery, as in the United States. Simultaneously, could we have prevented distasteful commercialization (too late in the United States due to the market) and taken care of our income base. The book had a preface and postscript that reflects this, and an otherwise easy-tounderstand description of the most common procedures. It was well received and was purchased by the Norwegian Public Library, which had a copy in each and every small town in Norway. It eventually sold out. The book also came with an invitation to the publisher’s annual garden party! It was convenient to be able to refer to the local library when people from Finnmark, for example, called. What joy when a phone call came from the Swedish Plastic Surgery Society! They thought the book was brilliant and asked that it be translated into Swedish. The following year, the book came out at the publishing house Natur og Kultur with a Swedish preface and was called “Beauty Surgery.” Unfortunately, they put a picture of a terrible rhinoplasty on the cover without my consent. A picture of the cover and a copy of four to five pages are attached that may be of interest to read. Still, this was only ten years after the Swedes were completely in the lead with Skoog (for the young reader: who discovered the usefulness of SMAS- without using the term) and Strömbeck (who invented reduction plastic with areola transposition). The attempt to create consensus around attitudes and marketing to build an honorable image around cosmetic surgery was unsuccessful. A lot has gotten better, and a lot has gotten worse, but the issues remain unchanged.

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1983-2000: Gorm Bretteville

2000-2004: FRODE SAMDAL

Resuscitation of the Cosmetic Society In the 1980s and 1990s, there were two plastic surgery societies: the main society, the Norwegian Plastic Surgery Society (NPF), and a subdivision with the name Norwegian Society for Cosmetic Plastic Surgery. Kjell Aass called the latter, “The little society.” The cosmetic society was founded in 1984 and the purpose was to look after the interests of the plastic surgeons who also practiced cosmetic surgery in a rapidly growing and confusing market. Besides Kjell Aass, key members of the small society were Gorm Bretteville, Roar Rindal, Morten Kveim, Lars Traaholt, and Kjell Andenæs. The tiny society set relatively strict requirements for who could become members. To become a full member, one had to hold a Norwegian specialty in plastic surgery, have at least five years in a coherent clinical service in plastic surgery, and have experience and knowledge about cosmetic surgery. In 1990, it was decided to close down the cosmetic society. The main reason for the closure was that the main society NPF would look after the interests of the members who engaged with cosmetic surgery. Contributing to the decision to close the society was that the authorities had made detailed regulations for which medical specialists could perform various types of cosmetic procedures. The board sat for a long time in a relatively passive period. During this period, the board of the main society was largely composed of members of the aesthetic society. There was a lot of activity in the main society, also on the aesthetic side, and little need for its own events. At the beginning of the 2000s, the number of plastic surgeons performing aesthetic plastic surgery full-time was increasing. Several of us, including Frode Amland, Knut Skolleborg, Amin Kalaaji, and Helge Einar Roald, thought it was desirable to breathe life into the old cosmetic society. In addition to safeguarding the purely “trade union” interests, we considered it desirable to have a medical professional forum for aesthetic plastic surgery. At the Autumn Surgical Meeting in 2000, the decision was made to breathe life into the old society. The undersigned took up the position as leader of the society and Ola Evjen became secretary. Kjell Aass, who was the leader of the main society, was persuaded to become treasurer. The criteria for becoming a member were relaxed. Everyone who was a specialist in plastic surgery was welcome, and the number of members of the society grew rapidly.

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The First Meeting The first meeting of the resurrected society was held March 16-17, 2001, in Trondheim. We invited Christer Lindqvist from Gothenburg, the leader of our Swedish sister society the Swedish Society, to the meeting. The professional program on the first day dealt with laser resurfacing, with lectures by Christer Lindqvist and Christer Persson from Coherent. Additionally, we had a session on tissue fillers and a session on quality assurance in plastic surgery private practice. Professor chief physician Tarjei Rygnestad gave a lecture on what was desirable and what should be the minimum standard in a plastic surgery practice from an anesthesiologic point of view. Subsequent panel debate concluded that Tarjei Rygnestad and the undersigned should make a draft anesthesiologic standard and present this at the next ordinary general meeting of the society. The following day, “live surgery” was arranged at Klinikk Stokkan. Laser resurfacing was performed in one operating room and demonstrations with tissue fillers were performed in the other the operating room. Several of the participants and not least the companions appreciated that Q-med posed with free samples of Restylane ad usum proprium. The social program consisted of a revue with Prima Vera followed by dinner in Olavshallen. There was also a separate companion program, with shopping in the city’s malls and a guided tour of Trondheim Kunstforening and Kunstindustrimuseet in Trondheim.

Later Meetings During this period, two more winter meetings were arranged for the society. The first of these was at Oppdal March 8-10, 2002, where social activities were also arranged, including alpine skiing. There was great support, with as many as 70 participants including guests. We invited Colin Rayner from Birmingham as a guest lecturer. The second meeting of the society was in March 2004. This was also arranged in Oppdal with the same social framework as the first meeting and with more than 60 participants. The invited guest lecturer this time was Joseph Hunstad from the United States. In connection with the surgical meeting in October 2004, we arranged a full-day Friday seminar with the main themes of Liposuction and the New Patient Rights Act.

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Matters Dealt With by the Society From 2000-2004 VAT on Plastic Surgery The case in the society’s history that has taken the most time and resources is undoubtedly the VAT case. Kjell Aass and I worked almost around the clock with this case over one intense four- to five-week period. We calculated afterward that together we had spent more than 100 working hours on this. In addition, after the lawyer’s hours and a cost of approximately 65,000, the VAT case came to us like lightning from clear skies. Admittedly, we had heard of the VAT reform already in the spring and that it could have implications for health-related business. But we had the understanding that this would only apply to alternative medicine as was performed by unauthorized healthcare professionals. However, a circular from Ernst and Young dated May 8 explicitly stated that cosmetic surgery would be subject to VAT. The case was completed in the Ministry of Health and Social Affairs and was now with Minister of Finance Karl Eirik Schjøtt-Pedersen and three of his labor state secretaries for effectuation. The Norwegian Plastic Surgery Society was not on the consultation list and when we received the circular from Ernst and Young the consultation deadline had already expired. For us who did plastic surgery in private, the bill appeared completely hopeless. We as plastic surgeons act as a treating physician and look after the interests of the patients, but, at the same time, the bill required that we function as the tax authority’s extended arm, deciding whether our patients should pay VAT. Plastic surgery usually has medical and cosmetic procedure indications. As we saw it, the boundary between what was cosmetic and medically indicated would be virtually impossible to decide in a fair way. A consequence would undoubtedly be discriminatory treatment, with different judgments from doctor to doctor. Kjell Aass and I quickly realized that we needed professional help, and we chose lawyer Harald Ellefsen of the law firm Steenstrup Stordrange in Trondheim. Ellefsen had sat for 12 years in the Storting for the Conservative Party and still had good personal relations with several key Storting politicians. Steenstrup Stordrange had also just hired lawyer Eivind Bryne, who was considered one of Norway’s foremost in the field of VAT. Following advice from the lawyers, we contacted the Ministry of Finance and relevant case officers by phone, fax, and letter. Furthermore, we wrote a formal letter to the Storting’s Finance Committee. Following advice from Ellefsen, Kjell Aass contacted Storting representative Erik Dalheim from Buskerud, who was a member of the Finance Committee and was the Labor Party’s main spokesman in the Storting in tax matters. The undersigned contacted Børge Brende 2000-2004: Frode Samdal

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both by telephone and fax after Ellefsen had first introduced him to the issue. After this, Børge Brende took up the matter in the Storting’s Question Time on May 28, 2001 and was showed the letter we had sent to the Finance Committee. In his reply, Minister of Finance Schjøtt-Pedersen acknowledges that the demarcation between cosmetic and medical indication can be difficult and that the Ministry of Finance is now considering the input from the “competent team.” Børge Brende and we both perceived the answer as quite accommodating, which encouraged us to continue efforts.

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Aass wrote a letter that he sent by fax to John Boorman, head of the plastic surgery section of the UEMS (European Union of Medical Specialists). Boorman sent an e-mail directly to the caseworker at the Ministry of Finance on June 7 and warns against introducing VAT on cosmetic operations in Norway. Boorman states the difficulties in drawing the line between cosmetic and medical indications. Furthermore, no other EU/EEA country has VAT on current services. And that Norwegian VAT decisions will be “very much against the spirit and harmonization within Europe.” The undersigned contacted a journalist in Dagbladet who was stated to be “friendly,” and May 30, we were given a full-page article in Dagbladet where we would be able to present our views. Børge Brende was also interviewed and quoted in the article.

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So that nothing was left untried, Kjell Aass wrote to the Minister of Health Tore Tønne on June 8. On July 1, 2001, the new VAT reform would enter into force, and plastic and cosmetic surgery were still exempt from VAT. The same was true for acupuncture and homeopathy, whereas alternative medicine practiced by unauthorized health professionals

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was subject to VAT. When the storm was over and the dust had settled, we applied to Dnlf for coverage of our legal expenses. There we were rejected.

Other Cases From 2000-2004 New Name: Norwegian Society for Aesthetic Plastic Surgery Following a proposal from Olaf Stangnes, the name of the society was changed on March 17, 2001, from the Norwegian Society for Cosmetic Plastic Surgery to the Norwegian Society for Aesthetic Plastic Surgery (NFEP). The background was a desire to distance themselves from other cosmetic activities, such as skin care salons. The new name was also more in line with the designations at our sister societies in other countries and, not least, the International Society of Aesthetic Plastic Surgery (ISAPS).

Common Form: Consent to Operate The proposal to prepare an informed consent form came after a recommendation from Reidun Førde in connection with the work on NPF’s ethical guidelines. Reidun Førde was, at that time, head of the ethics council of the Norwegian Medical Society. She believed that a written form would help ensure that the patient was well informed about all aspects of an operation. Therefore, the undersigned prepared a draft before the general meeting on October 24, 2002, of the consent form. The draft was thoroughly discussed by the members, and everyone agreed on the value of introducing such a form. However, some members wanted to remove the wording that the patient should also be informed in writing. A vote was held, and the conclusion was that the patient should also be informed in writing (21 to 4 in favor). The draft was adopted in accordance with the submitted proposals and was subsequently printed by Tapir Printing and distributed to members.

Joint Anesthesia Standard At the society’s first meeting, it was decided that the chief physician in anesthesia and professor of pharmacology Tarjei Rygnestad, together with the undersigned, were to draft a standard anesthesiology form for a private plastic surgery practice and present this at the next general meeting of the society. Rygnestad did significant work on the draft, which was based on the Norwegian standard for anesthesia. The proposal was presented at general assembly in October 2002 and led to an engaging debate in which members’ views diverged. Many felt that the standard was too strict, and that special small clinics

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and single practices would have difficulty meeting the minimum requirements. A narrow majority voted not to introduce a common standard of anesthesia.

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Common Websites At GF in 2001, a separate website for the NFEP was desired. Just Omtvedt informed the group that he had bought the domain estetiskkirurgi.no and offered it to the society at price he originally paid. It was agreed that Omtvedt would be responsible for the technical aspect of the website and that the board of the society would be responsible for the content. At the extraordinary GF on March 9, 2002, Just Omtvedt presented the website for the society. All members were listed on the page, with a link to the various clinics’ website. In addition, a discussion page and general information about the most common interventions were created. Omtvedt received much applause for his work, and everyone agreed that this was a very good initiative.

Press Release on Professional Ethics In the early 2000s, media coverage of cosmetic plastic surgery was constant, with a certain ENT doctor in the lead role. Most posts were negatively angled, and the coverage culminated in a report in the magazine KK (“Women and Clothes”) and a subsequent a front-page notice in a large tabloid new paper VG June 21, 2002. The notice stated that plastic surgeon Jarl Bunæs (he was indeed an ENT surgeon and not plastic surgeon) should have offered to fix the nose of the female Somali social debater Kadra, and comments on the appearance of King Harald. It was also claimed that several plastic surgeons had contacted Kadra with an offer of surgery. This negative media coverage of plastic surgery came at a time when both our parent society and the NFEP had spent a lot of time and energy working on ethical issues and the new ethical guidelines. We found it unreasonable and unfair that one bad actor from another specialty should provide plastic surgery and our members repeated and sustained negative press coverage. After putting the matter to the board, the leader of the parent society (NPF) elected Kjartan Arctander and signed up to write a press release. We were advised that the press release should be sent out via the Norwegian Medical Society, which was done. The lack of response from the media was not entirely unexpected. No one wrote as much as a line. We interpreted this as another example of the press having its own agenda and choosing its own angle. Compare the discussion regarding the “Giske case” from 2018 and VG’s role in the case.

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Extreme makeover At the beginning of 2004, it became known that TV Norge was planning to make a Norwegian version of the American reality show “Extreme Makeover,” and the producer announced that they searched for Norwegian clinics that would participate. The matter was discussed in the boards of NPF and NFEP, both of which thought the concept was a bad idea for several reasons. First, there were medical concerns that a patient should be placed under anesthesia for 8 to 12 hours when there was no medical indication for the procedure. Second, we believed that plastic surgery is a part of the specialist health service and is not for entertainment purposes. We were also afraid that participation in such a program, especially for young people, would cause future psychosocial problems. Therefore, the leader of NPF Knut Skolleborg and the undersigned wrote a press release in which we distanced ourselves from the concept. At the same time, we asked our members not to participate in the program. In addition, this time, the press release was sent out via the Norwegian Medical Society’s channels, and the response from the Norwegian press was the same as the last time we sent out a press release: no one wrote so much as a line. However, the press release did not turn out to be a complete waste. Two weeks after it was sent, we received a letter from the Minister of Health Dagfinn Høybråten. He expressed great satisfaction with NPK’s and NFEP’s sending out of the press release, clearly distancing themselves from the reality show. Høybråten concluded by appreciating the positive attitude. All our members loyally followed the call not to participate, and TVNorge’s recording was moved to a Swedish clinic in Stockholm. The case was also dealt with by the Nordic Plastic Surgery Society in Henningsvær on June 12, 2004. The general meeting of the Nordic Plastic Surgery Society unanimously decided to close with the press release sent out by Norwegian plastic surgeons.

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2004-2008: PETTER FRODE AMLAND

I was chairman of the Norwegian Society for Aesthetic Plastic Surgery for 2 terms from 2004 to 2008. In the winter of 2005, a spring-winter meeting was arranged abroad, in Badgastein in Austria, where they wanted to combine professional replenishment with sporting activity with a companion and family (also skiing). The event was over a long weekend, and we flew directly to Salzburg before we were transported in a hired bus to the destination in the Austrian Alps, an approximate 2-hour tour. I put together a reasonably good academic program in which our domestic forces Marius Barstad (moderator), Frode Samdal (a lecture on the position of indication in aesthetics plastic surgery “red flags” and one on complications in plastic surgery), and Amin Kalaaji helped as the leaders of the sessions and with their own lectures. International participation was done with lectures on eyelid surgery and facelift by Professor Hans Holmstrøm at Sahlgrenska Hospital in Gothenburg. The morning was used for lectures, and after lunch we skied until the facilities closed. The congress was hosted by the Salzburger Hof, a 5-star hotel that is especially famous for its good cuisine. No major injuries were recorded on the ski slopes, and I think most found the program good and that the society’s first foreign symposium provided “value for the money.” Towards the end of the first period (2006), 2 issues concerned the society. One was acting as a guard dog with respect to violations of the Marketing Act. We complained to the Norwegian Board of Health about the Ellipseklinikken violating the Marketing Act in October 2006. As so often, the story ended with a response from the Norwegian Board of Health as it did not see that the procedures included surgery. The procedures were seen as cosmetic treatments that were not covered by the “Marketing Regulations” (Our input would be taken into account at a later time.) A nicer story to tell is the inclusion of private plastic surgery in Norwegian Patient Injury Compensation (NPE) Work, which was started in my period but was completed after a lot of tugs of war in 2009 when Frode Samdal was the leader of the society. I, as leader of the society, was summoned to so-called consultation meetings in connection with the regulation. Even with significant input, it was difficult to come to an understanding regarding inclusion of aesthetic surgery in the regulations. An important issue was also to limit the expenses for the individual plastic

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2004-2008: Petter Frode Amland

surgeon. Here got we received help from Bente Openshaw at clinic Stokkan in Tromsø and from FRP politician Harald T. Nesvik. This resulted in a turnaround operation in Health and the Ministry of Care by Bjarne Håkon Hansen. Conference letter attached in Samdal’s statement. Finally, I would like to comment briefly on the work toward the Consumer Ombudsman, which was towards the end of my period (2008). We surprisingly had another very good dialog, which resulted in several information forms for patients approved by the Consumer Ombudsman. These are used to this day in most plastic surgery clinics in Norway.

2004-2008: Petter Frode Amland

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Oslo 5. oktober 2006 Statens Helsetilsyn V/ Avdelingsdirektør Jørgen Holmboe Calmeyers gt. 1 Postboks 8128 0032 Oslo

Ellipseklinikken Spørsmålstilling vedrørende brudd på gjeldende forskrift om markedsføring. Det vises til tidligere korrespondanse fra vår forening, brev datert 06.05. 2006. Vi viser i denne sammenheng også til brev sendt Dere fra tidligere leder i vår forening overlege prof. dr. med. Frode Samdal datert henholdsvis 09.02.2006 og 18.05.2007. Vi registrerer fra dagspressen at Ellipseklinikken per dato fortsatt bedriver aggressiv markedsføring for både fettfjerning med Ultralyd og injeksjoner av reseptbelagte medikamenter (Botox) og injeksjon av Restylane. Våre medlemmer opplever det som provoserende at de seriøse aktørene i markedet og godkjente spesialister i plastisk kirurgi er pålagt noen av verdens strengeste regler når det gjelder markedsføring mens andre aktører (herunder anestesiologer) tilsynelatende fritt kan annonsere uten at tilsynsmyndighetene reagerer. Styret i NFEP vurderer på overnevnte bakgrunn å ta problemstillingen opp med representanter for de politiske myndigheter som stod bak utarbeidelsen av de nye forskriftene også med tanke på offentlig diskusjon i media. Med hensyn på ryddigheten i en slik prosess vil det være ønskelig om å få en rask tilbakemelding fra Helsetilsynet hvorvidt man anser at Ellipseklinikkens virksomhet omfattes av forskriften eller ikke. Vi har forståelse for at Dere prioriterer andre saker av større betydning for liv og helse,-men på den annen side skulle vi tro Helsetilsynets jurister ville kunne svare på denne enkle problemstillingen uten den helt store ressursbruken. Og vi tillater oss således om vår forståelse for vår utålmodighet i aktuelle sak. Med vennlig hilsen: Petter Frode Amland Overlege dr. med. Leder Norsk Forening for Estetisk Plastikkirurgi Postboks 150 Oppsal, 0619 Oslo

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2004-2008: Petter Frode Amland

Vedlegg: 1. Kopi av brev fra Frode Samdal til Fylkeslege Jan Waage av 09.02. 2006 2. Kopi av annonser fra Ellipseklinikken Kopi til: Forbrukerombudet juridisk avdeling ved Janne Kaasin og Professor Frode Samdal Som så ofte endte historien med et «svada»-svar fra Helsetilsynet-idet en ikke kunne se at prosedyrene omfattet kirurgi. Det ble det sett på som kosmetiske» behandlinger som ikke var omfattet av «Forskrift om Markedsføring» (Vi som har levd noen år har dog fått oppleve at våre innspill er blitt tatt til følge på et senere tidspunkt.) En hyggeligere historie å fortelle er inkluderingen av privat plastikkirurgi i Norsk Pasientskade erstatning (NPE) Arbeidet ble påbegynt i min periode, men ble fullført etter mye tautrekking i 2009 når Frode Samdal var leder av foreningen. Undertegnede var som leder i foreningen innkalt til såkalte høringsmøter i forbindelse med forskriften. Selv med betydelige innspill var det vanskelig å møte forståelse for inkludering av estetisk kirurgi i forskriften En viktig sak var også å begrense utgiftene for den enkelte plastikkirurg. Her fikk vi som Samdal skriver hjelp fra Bente Openshaw ved klinikk Stokkan i Tromsø og Frp politiker Harald T Nesvik. Dette resulterte i en snuoperasjon i Helse og Omsorgsdepartementet ved Bjarne Håkon Hansen. Konferer brev vedlagt i Samdals redegjørelse. Til slutt vil jeg også kort kommentere på arbeidet opp mot Forbrukerombudet, som var mot slutten av min periode (2008) Vi fikk forbausende nok en svært god dialog, noe som resulterte i flere informasjonsblanketter til pasienter godkjent av Forbrukerombudet. Disse anvendes den dag i dag ved de fleste plastikkirurgiske klinikker i Norge. Konferer Samdal for vedlegg og ytterligere kommentarer. Snarøya 12.5 2020 Petter Frode Amland

2004-2008: Petter Frode Amland

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2008-2010: FRODE SAMDAL

In 2008, Frode Amland served as chairman for two terms and Amland attended the general meeting albeit somewhat reluctantly as the re-elected leader of the society. This period would fortunately turn out to be considerably calmer and less labor intensive. In connection with the autumn meeting in 2009, we arranged a mini symposium on facial surgery. We invited two foreign guest lecturers: Associate Professor Birgit Stark from Karolinska Stockholm Hospital and Dr. Walther Jungwirth from Salzburg. Stark lectured on the reconstruction of facial paresis and Jungwirth shared his 20 years of experience with face lifts. Ayman Zakaria gave a lecture on composite rhytidectomy and closure of the orbital septum by lower eyelid surgery. The seminar ended with a humorous and entertaining post by Jungwirth with the title, “Is Professional Success a Risk to the Mental Health of the Aesthetic Plastic Surgeon?” The post had examples of colleagues who had been so successful financially that they had lost ground contact.

MATTERS DURING THIS PERIOD New Consent Form in Collaboration With the Consumer Ombudsman The new initiative came about following an inquiry from the Consumer Ombudsman. The starting point was that the Consumer Ombudsman believed that our private patients’ rights as consumers were not clearly defined and, consequently, not good enough. Initially, we were skeptical of this initiative. We argued that private plastic surgery was part of the specialist health service and that we did not engage in regular buying and selling as a business. Warranties such as when selling refrigerators and cars seemed to be of little relevance. We also stated that there were no guarantees in either public or private health services. However, the Consumer Ombudsman made it clear that, if we did not cooperate, it would make regulations without our participation. We concluded that the society was best served by having a constructive dialog and positive collaboration with the Ombud.

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2008-2010: Frode Samdal

2008-2010: Frode Samdal

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Frode Amland, Jarle Kjøsen, and the I had several meetings of the Consumer Ombudsman premises. We managed to promote understanding and acceptance that with cosmetic surgery, as with all other surgical procedures, a specific result is hard to guarantee. Therefore, expectations must be linked to the quality of the performance of the operation, not to the result. We got agreement that, if a patient is not satisfied with the result and wants a correction (“touchup”), the surgeon must have the final say. The prerequisite for making a postsurgical correction is that it is likely it will provide a significant improvement over the first result and that the risk of undergoing a new operation is reasonable proportional to what one expects it to achieve. In June 2008, we agreed with the Consumer Ombudsman on the final version of the form. The form also included the aspects previously discussed in the “Consent to Surgery” form. The new form was reviewed at GF in October of the same year and was ratified by the members. The board of NFEP then had the form printed in 10,000 copies at Tapir Trykkeri and the forms were distributed to all members of the society.

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2008-2010: Frode Samdal

2008-2010: Frode Samdal

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2008-2010: Frode Samdal

2008-2010: Frode Samdal

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2008-2010: Frode Samdal

Young Mothers In February 2009, the society received an unexpected and somewhat delicate case. It proved that one of the largest clinics in Oslo had participated in the recording of an episode of TV Norge’s reality series “Young Mothers.” One of the young mothers whom the series dealt with, got inlaid silicone prostheses and was closely followed by a camera crew. It also emerged that the patient had undergone the operation performed free of charge. When the case became public knowledge in VG, it caused a strong reaction from the press. The criticism was primarily that the TV channel FEM mixed journalism and advertising without viewers being made aware of this. The Secretary General of the Norwegian Press Society Per Edgar Kokkvold stated that this was a clear violation and contrary to the press’ own ethical guidelines. He referred, among other things, to the text advertising poster on which it is stated that text advertising is incompatible with good press practice and that sponsors should not have an influence on editorial content. There were also negative reactions from NFEP’s own members.

2008-2010: Frode Samdal

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The case was considered unfortunate, especially since the society, together with NPF, a few years earlier had closed down much work to introduce new ethical guidelines, and the society had also worked to have a good relationship with both the supervisory authorities and the medical society’s ethical council. Many of our members also had the “Extreme Makeover” case fresh in mind, in which NFEP had taken a clear principled position and received positive feedback for this. The clinic stated that it had initially been perceived that it would be a small part of a documentary and only further into the course did it emerge that the production company did not want to pay for the procedure. The clinic admitted that what had happened was unfortunate and apologized for it all. NFEP informed its members and pointed out that this was an issue to learn from. Furthermore, we chose to be proactive and even inform the Norwegian Medical Society’s ethical council about the case and that we had cleaned our own house. The feedback from the ethics council on this was also unequivocally positive.

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2008-2010: Frode Samdal

2008-2010: Frode Samdal

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Reimbursement Obligation to Norwegian Patient Injury Insurance (NPE) After many years of discussion between the authorities and private insurance companies, in 2008 it was decided that private health services should also be covered through NPE. In the beginning, however, much was unclear about the new insurance scheme. It was especially unclear whether cosmetic surgery was covered as these were surgical procedures that were not medically necessary. After a lot of correspondence via Tere’s clinic lawyer Are Herrem in Selmer, in April 2009, we received an email from department director Jan Storvik of NPE. He stated that cosmetic surgery falls under the scheme. When it comes to aesthetic/cosmetic treatment other than surgery, it will have to be specifically considered whether the treatment falls within the Patient Injuries Act. If such treatment can only be performed by health professionals, the treatment will be covered by NPE. In this context, it is worth noting that a patient who has been injured may choose to direct claims directly to a doctor or clinic according to the usual compensation rules instead of addressing the claim against NPE. However, the conditions for compensation according to normal compensation rules are stricter, so this risk is considered by lawyers to be small. Should a doctor or other health care worker be held responsible by a patient, the physician may file a recovery claim against NPE. NPE will then process the recovery claim in accordance with the rules of the Patient Injuries Act and reimburse the amount normally covered by NPE. The injury cause (surgeon) may risk that part of the claim from the patient is not covered by NPE, but since NPE has comprehensive coverage, the risk is small here too. Financially, the intention was that executive health professionals in the private sector should finance the scheme. In the consultation draft, plastic surgeons and neurosurgeons were placed in the highest risk group with the corresponding highest risk premium. We found this unreasonable as our experience was that the number and size of payouts because of botched operations from our members were few and small. Chairman of the Society from 2004 to 2008, Frode Amland gives a further account of this work. In this context, it is also briefly mentioned that thanks to the general manager of Klinikk Stokkan, Tromsø Bente Openshaw received political support regarding the insurance premium for plastic surgery. Harald T. Nesvik from Frp’s parliamentary group wrote to the Ministry of Health and Care Services and received a positive response from Minister of Health Bjarne Håkon Hansen.

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2008-2010: Frode Samdal

2008-2010: Frode Samdal

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2008-2010: Frode Samdal

2010-2012: HELGE EINAR ROALD

This Board Took Over the Baton at the General Assembly in 2010. Chairman of the board Helge Einar Roald and board members Eystein Hauge and Mette Haga immediately began work establishing an interdisciplinary group together with Norsk Plastic Surgery Society and NBCG to create guidelines for fat transplantation to breast on cosmetic indication. This was groundbreaking work, and, although we initially sat in the driver’s seat, NBCG took over the initiative. Furthermore, we explored the possibility of establishing a breast prosthesis register. The Danes had cleared it, and the Swedes also had plans. After many explorations for which Amin Kalaaji and Christian Busch contributed, the work was eventually put on ice because costs were high, and the society could not own the register itself. From May 2011, we participated in the work on a European standard for aesthetic surgery: European Standard Aesthetic Surgery Services - CEN / TC 403. We got in touch with Standard Norway and the Consumer Council. We had received an inquiry with questions we had about views on the work of designing the standard for aesthetic surgery via the medical society (DnLF). We actively participated in this work and sent out for consultation with our members. Along the way, the medical society changed its view of this work (upon request from UEMS). This would suddenly incorporate standards for specialty education and which groups should be allowed to perform cosmetic procedures. When this came into conflict with Norwegian specialty rules, we were encouraged not to contribute to the further work. In connection with the autumn meeting in 2011, we arranged the seminar “The Hunt for the Perfect Body.” This was a memorable and interesting seminar at which the professor in plastic surgery at St. Olavs Hospital talked about: “The Difficult Patient: Does It Exist?“ He began with the conclusion: “The difficult patient exists, and the solution is not to operate on it!” In 2012, the journal Kirurgen had a special issue on plastic surgery (issue 1, 2012). The chairman of the board wrote several posts, one of which was from his position as a plastic surgeon at Colosseum Clinic. Together with his colleague Knut Christian Skolleborg, they wrote about “the lost generation” about parts of the generation that “fled” to the private sector. This was a direct response to the post of the department head at UNN and the leader in the Specialty Committee in Plastic Surgery Erling Bjordal during the anniversary symposium at the autumn surgical meeting in the autumn of 2011.

2010-2012: Helge Einar Roald

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There he stated, “We have lost an entire generation of plastic surgeons,” after which he referred to the “escape” to the private sector. We also considered arranging a spring meeting on Svalbard in 2012. It had been the chairman’s dream of arranging such a spring meeting. After discussion with the board, we decided not to set up such a comprehensive event. The board chose to request a replacement at the general meeting in the autumn of 2012.

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2010-2012: Helge Einar Roald

2012-2014: AYMAN ZAKARIA

From 2012 to 2014, Ayman Zakaria led the society together with Bjørn Rosenberg and Christian Busch. In addition to normal case follow-up, three activities during this period were the most prominent. (1) The board organized a professional meeting at the autumn meeting in October 2013, where Dr. Patrick Fontet, plastic surgeon in Amiens, France, lectured on new vertical techniques for breast reduction. It was a well-organized meeting with good support. (2) Man announced a scholarship to stimulate international contact (see appendix after this text). (3) During the term of office, a cooperation agreement with ASAPS (American) was proposed, a so-called memorandum of understanding (MOU) in which we collaborate on professional meetings every other year and for which ASAPS provides $6000 USD to a keynote speaker of our choice. In addition, we can subscribe to the Aesthetic Surgery Journal for all our members at a favorable price. The board was positive and gave the go-ahead to sign the agreement. The meeting is called the NorwegianAmerican Aesthetic Meeting (NAAM). Amin Kalaaji fronted the contact with ASAPS. The first NAAM meeting occurred in October 2015.

2012-2014: Ayman Zakaria

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Attachement

Norsk Forening for Estetisk Plastikkirurgis kliniske stipend Bakgrunnen for opprettelsen av et klinisk stipend er at styret i NFEP ønsker å stimulere til internasjonal kontakt og faglig oppdatering uten at det nødvendigvis ligger et forskningsprosjekt i bunnen. Både i klinisk praksis og forskning er det verdifullt å erfare estetisk kirurgi utenfor landets grenser. Nettverk som etableres forsterker båndene til det internasjonale miljøet og vil kunne gi faglig påfyll, større trygghet og bedre vurderingsevne i vår praksis. Målet er at nye kunnskaper ervervet under et studieopphold skal deles i fagmiljøet og være med å heve den nasjonale faglige standard. Stipendet er på 20.000 kr og kan deles ut årlig til et fullverdig medlem av foreningen til bruk ved hospitering eller studiereise i utlandet. Den som får tildelt stipendet må selv dekke utgifter for så å få pengene refundert fra foreningen etter regning. Søknadsfristen er 15.september årlig. Søknaden sendes til leder i Norsk Forening for Estetisk Plastikkirurgi. Søknaden skal inneholde: - Søkerens navn, adresse, fødselsnummer, bankkontonummer og skattekommune - Beskrivelse av planlagt hospitering/studiereise - Det forutsettes at det ikke mottas annen økonomisk støtte til prosjektet Styret i Norsk Forening for Estetisk Plastikkirurgi behandler og avgjør søknadene. Det kliniske stipendet deles ut (dersom det foreligger en verdig søker) på årsmøtet under høstmøtet. Stipendmottakeren presenterer hva stipendet skal benyttes til på årsmøtet under høstmøtet, og fremlegger rapport fra reisen på neste års høstmøte. Stipendmottakeren skal i tillegg sende rapport til styret i foreningen om bruken av midlene innen 25.09 påfølgende år. Det forutsettes at hele eller deler av innholdet i rapporten kan publiseres eller benyttes av medlemmene av Norsk Forening for Estetisk Plastikkirurgi»

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2012-2014: Ayman Zakaria

2014-2018: BJØRN E. ROSENBERG

Members of the new board were voted in during the general meeting at the Holmenkollen Park Hotel on October 23, 2014. The new board consisted of Bjørn E. Rosenberg (chairman), Amin Kalaaji, and Christian Busch. In the second half of the term, Bjørn Tvedt was added as a board member in addition and Amin Kalaaji was a member. During the first year, the board registered the society as a company in the Brønnøysund Register so that it became possible to establish a separate website. The board bought the domains www.nfep.no and www.estetiskforening.no, a custom logo was created. There were rumors that a sketch for the logo already existed from the time of the society’s foundation, but thorough searches in the archives and contact with Gorm did not turn up the original. Therefore, we were free to prepare a new design. The idea was to create a logo that showed that the subject has a long history rooted in medical tradition but at the same time was innovative and forward thinking. The logo became a three-quarter laurel wreath. Honor and tradition rest on such. A mixture of medicine, some tennis, and some Fred Perry. The color was chosen by the design agency. The website eventually fell into place with experimentally neutral patient information on various cosmetic interventions, a searchable overview of all active members, and a news page with current courses. All the society’s laws and rules were intentionally and openly posted on the website for those interested. ALCL became a very hot topic in 2015, and the board was out early with a lecture on the subject at the general meeting that fall. It was decided that the board would prepare guidelines for handling ALCL in Norway. The Norwegian guidelines were based on current guidelines from our European colleagues and DNR was adopted as a central treatment unit of this rare condition. This year also saw the start of work on making the NFEP a partner society with ASAPS. The board had several meetings at Dr. Kalaaji’s clinic in Inkognitogata. A bilateral agreement was reached, and the board agreed to a collective subscription for all members to the Aesthetic Surgery Journal. We wanted this to be the society’s joint trade magazine, something we felt had been missing. The agreement also included a plan for a professional seminar to be arranged every two years in collaboration with ASAPS, the NorwegianAmerican Aesthetic Surgery Meeting, or NAME. The cosmetics field has had expansive growth over the years and has, in many contexts, for better or for worse, been mixed with aesthetic surgery. In 2016, the board of the Aesthetic Society started work on establishing

2014-2018: Bjørn E. Rosenberg

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a so-called injection council in Norway. The background was a desire to regulate the market, and the goal was those national requirements be set for, among other things, education and ethics among therapists in so-called cosmetic medicine. A similar council was already established in Sweden, and various suppliers of medical equipment supported the initiative. The idea was to get the council rooted in the public health sector and they wanted assistance from the Norwegian Medical Society. Here, however, cosmetic medicine was not considered part of the medical field and, therefore, was not considered anything for which the Norwegian Medical Society was responsible. The board had several meetings in Oslo and Bergen. Despite many letters, lobbying, and meetings with various individuals, the initiative died out. In the same year, several clinics were reported to the Medical Ethics Council for violation of regulations on the marketing of cosmetic procedures and the ethical rules for doctors. This led to the council’s coming up with corrections to some clinics and the council’s leader wanted this background a general debate on the topic. I was invited to participate in the panel in the debate “Ethics in Cosmetics,” an open meeting at the House of Literature in Oslo about the doctor’s role in aesthetic treatments based on ethical principles. The debate about aesthetics surgery and medicine was relatively fresh in the media and our field of medicine and our practice of it were partly responsible for the increase in body pressure in society. Part of the criticism turned against intimate surgery and so-called “design vagina”. Intimate surgery became the most talked about cosmetic procedure in the media in 2017 and was highlighted on the TV program “Inside.” Also, on various online forums and social media there was a heated debate about the ethics behind intimate surgery and possible body pressure, in which colleagues from various medical specialties participated. I contacted the board of the Norwegian Gynecological Society to discuss the position and ethics around labiaplasty Based on this, common professional recommendations for the practice of intimate surgery in Norway were suggested. An article was also written in Tidsskrift for the Norwegian Medical Society on the subject. In an article in Aftenposten in 2018, two general practitioners asked questions about whether aesthetic surgery was in line with good medical practice. A complaint of principle was also submitted to the Council for Medical Ethics from the Norwegian Society for General Practice on whether aesthetic activities were compatible with medical practice and whether it was ethically sound. I and president of the Plastic Surgery Society, Kjersti Ausen, wrote a debate article in Aftenposten where we explained the subject of aesthetic surgery, current rules, current research findings, and the distinction between aesthetic

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2014-2018: Bjørn E. Rosenberg

surgery and cosmetic medicine. In addition, The Plastic Surgery Society and the Aesthetic Society agreed to revise the rules for practice of cosmetic plastic surgery in Norway. The goal was to improve its reputation and try to raise the professional standard in aesthetic surgery in Norway. It was especially emphasized that outreach advertising should not occur and that it should end promotions and discounted rates. It was agreed that consultations should be priced at a level equivalent to that of other private colleagues. The wish was that the subject would appear as serious to the outside world as we as colleagues experience it in everyday life, and the new guidelines were adopted at the general meeting in 2018.

English version

Norwegian version

2014-2018: Bjørn E. Rosenberg

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2018-2020: AMIN KALAAJI

In 2018, I led the society, with an active board consisting of Bjørn Tvedt and Christian Busch. The cases came as if on an assembly line. The first case came to the table only a month after the inauguration with the ALCL in November 2018. Media coverage created great unrest among patients and colleagues. The board received many inquiries and wrote a debate article for Aftenposten that explained to the public in laymen’s terms about implants and safe they are and how little risk they pose (see appendix).

Regulation We worked intensely to regulate aesthetic/cosmetic medicine or aesthetic medicine together with the parent society to introduce a new definition of aesthetic/cosmetic treatment. We wanted to include all injections and thread treatments within the definition of aesthetic surgery (see appendix). The case is now with the Ministry of Health and Care Services. We also had various meetings with politicians, including with the Conservative Party’s representative in the Health Committee in the Storting who spoke to the Minister of Health on several occasions about stopping the VAT.

NAAM Meets and Collaborates NAAM 3 in 2019 was successful in attendance and financially. There were 160 participants, for the first time since the meetings have taken place, and several companies with 17 exhibitors also participated (see appendix). The academic program was appealing and included faculty from more than 15 countries and participants from more than 25 countries. NAAM 4 is scheduled for October 29, 2021. The meeting was so profitable that we were able to fund the publication of this book and membership in EASAPS. In memory of NAAM (Norwegian American Aesthetic Meeting) I would like to thank Ayman Zakaria, Bjørn Rosenberg, and Christian Busch for their support in the establishment of a cooperation agreement with ASAPS. I negotiated the agreement in 2013/2014 when a cooperation agreement with ASAPS was proposed (American Society of Aesthetic Plastic Surgery), a so-called memorandum of understanding (MOU). We only needed this for the first two meetings and then we could stand on our own two feet, with NAAM 3 surpassing that financially. The boards that followed since 2014 were very positive and supportive and, as a tradition, have hosted the organizing committee of the NAAM. In addition, Frode Amland was appointed to the Editorial Board of the Aesthetic Surgery Journal.

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2018-2020: Amin Kalaaji

First VAT Case 2019 In the summer of 2019, we unexpectedly received some proposals from the Progress Party to Introduce VAT on aesthetic surgery. We mobilized members from the board and engaged one lobbyist who wrote to politicians and who had various meetings with the Ministry of Finance to prevent the case from reaching the state budget.

Medical Tourism We still work with medical tourism, which is our biggest challenge as many of our patients go abroad, both near and far. A clinic in Vilnius estimated that 400 Norwegians patients are treated with them every year. Clinics in Riga, Tallinn, Turkey, the USA, and Thailand are frequently visited by Norwegian citizens. The board participated in various interviews, including VG to warn against traveling abroad for cosmetic/aesthetic treatments.

Coronavirus COVID-19 appeared at the beginning of March 2020 and the lockdown whole countries. The board decided anonymously to recommend to our members to stop all elective aesthetic surgery and all physical contact with patients as long as the total lockdown was ongoing. We received support from our mother society (the Norwegian society of plastic surgeons) and a week later from both the Norwegian Directorate of Health and the Norwegian Medical Society that this was the proper course of action, this was to our full satisfaction. The number of infected people lessened, and the board defended that we reopen our practice 6 weeks later in April. We have made guidelines for infection control that have gone viral around the world, and Norway is an example of a successful model internationally. We were proud to share this with other colleagues all over the world what our society has worked with. There have been no negative complications that have damaged our reputation of our colleagues; on the contrary, we received positive feedback from the professional and civil community and from patients, and, almost exclusively, everyone has experienced strong progress accordingly. When the second COVID-19 wave came in October 2020, we were better equipped with our guidelines and so, there has been no need for more drastic action as we did the first time.

2018-2020: Amin Kalaaji

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Other activities and cases Nordic Society for Aesthetic Plastic Surgery (NAAPS) The board took the initiative to start a Nordic society for aesthetic plastic surgery and the work with this still going on. In general, there is great acceptance from Denmark and Finland and in principle from Sweden, but who still needs a little more time to organize. Suggestions for bylaws were distributed to all members in October 2020.

First ISAPS Symposium October 2021 The first ISAPS symposium is also planned for October 2021. This is the first time in Norway and in the north. Given the COVID-19 situation, this is planned virtually.

Second VAT case 2020: Establishment of VAT in Cosmetic Surgery: Later came the VAT hearing in June where everyone was taken to bed when we thought the case was over. The board had to work feverishly throughout the summer and had several meetings with politicians from various parties. The board has also written a debate article in Aftenposten. The case came anyway to the Stortinget (Norwegian parliament) with a vote in December. We have collaborated with the parent society for a statement from the medical society that supports our case. We had a hearing in the Stortinget (Norwegian parliament) in October 2021. The outlook this time looks bleak. Although many politicians know our arguments and support them, we are missing political support from an entire party for our cause. Even though the VAT case did not go through, we as a society have received goodwill among politicians and the general public.

NAAM 3 62 //

2018-2020: Amin Kalaaji

2018-2020: Amin Kalaaji

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NAAM 3

NAAM 3 64 //

2018-2020: Amin Kalaaji

NAAM 3

NAAM 3 2018-2020: Amin Kalaaji

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Procedure Statistics for Members 2019 It is worth mentioning that the idea of the procedures statistics started with Bjørn Rosenberg’s time as leader. We have developed this and distributed it anonymously for 2019. Although there only 12 have participated, it was a good start for the next few years by making this a tradition.

Society History Book This book is also a product of our activity. We have been able to finance this from profits of NAAM 3.

Implant Register The Prosthesis Register is being worked on and we have always been in touch with our contact Philip A. Skau at Deputy National Service Environment Health North RHF SKDE National Service Environment for medical quality registers. An initiative has been taken by the Ministry of Health and Care Services about a better overview of implants in Norway. This mission is led by Helse Vest RHF in collaboration with the directorate for health and the Norwegian Medicines Agency. This is an assignment given by the ministry and a possible quality register for breast implants are included in this work. We are now investigating where this work stands and will come back with more info on this. A new regulation for medical quality registers has also been adopted and includes only public institutions (eg, health trusts) that may have data responsibility for a medical quality register. This means that an initiative for a breast implant register must come from a health trust (professional environment or already established quality registers with data responsibility in a health trust), that is to say it is the public sector that must take responsibility. It is now a question of European implant registers being processed. Disclosure and storage of sensitive patient data information is still a challenge.

EASAPS Our society has become a member of EASAPS (European Association of Societies of Aesthetic Plastic Surgery), and this has been paid for from profits of the NAAM 3 meeting.

Digital Voting for the First Time and a Digital GF The board has organized a digital vote for the first time and a GF digital that was successful. The board is very pleased with the many tasks we have performed during these two years.

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2018-2020: Amin Kalaaji

Last: Last, I personally am honored to have been their leader during these years and have had with me two fantastic board members, Bjørn Tvedt and Christian Busch, who have always been available, constructive, and involved in everything we have done. I am very proud that almost everything we have decided has been unanimous. So, thank you Bjørn and Christian! These were sometimes intense times, in fact a full-time job when various current issues required fast action, and there were many of these during these two years. We have not succeeded in everything, but we did everything we could to defend the members’ interest, the society’s name and reputation, and patients. We have had a good dialog with the new board that will take over in 2021, and they were involved in discussion on important issues the past two months, and we wish them good luck.

2018-2020: Amin Kalaaji

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D. LIST OF PRESIDENTS AND BOARD MEMBERS List of presidents and board members in Norwegian society for aesthetic plastic surgery from 1983. 1983-1986 President: Gorm Bretteville Board members: Roar Rindal og Morten Kveim 1986-1988 President: Morten Kveim Board members: Kjell Aass, Roar Rindal 1988-1990 President: Gorm Bretteville Board members: Morten Kveim, Kjell Aass 1990-2000 President: Kjell Aass Board members: Einar Gjessing, Roar Rindal 2000-2004 President: Frode Samdal Board members: Kjell Aass, Frode Amland 2004-2008 President: Frode Amland Board members: Kjell Aass og Kjell Andenæs

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List of presidents and board members

2008-2010 President: Frode Samdal Board members: Jarle Kjøsen, Frode Amland 2010-2012 President: Helge Einar Roald Board members: Eystein Hauge og Mette Haga 2012-2014 President: Ayman Zakaria Board members: Christian Busch, Bjørn Rosenberg 2014-2016 President: Bjørn Rosenberg Board members: Christian Busch, Amin Kalaaji 2016-2018 President: Bjørn Rosenberg Board members: Christian Busch, Bjørn Tvedt Deputy Board Member: Amin Kalaaji 2018-2020 President: Amin Kalaaji Board members: Bjørn Tvedt, Christian Busch

List of presidents and board members

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E. PLASTIC SURGEONS IN NORWAY Active members as of 2020: Aas Kjell Amland Petter Frode Barstad Marius R. Begic Anadi Berg Thomas Berg-Larsen Lars Bjærke Hilde Bjærke Tomm Bjordal Erling Bretteville Gorm Brøndmo Bjørn Christian Bruheim Margareth Bugge Hilde Bugge Øyvind Borch Busch Christian Busic Vanja Cederqvist Bo Charles Phillip Chiu Kenneth Dahl Barbara Hansteen Elvenes Odd Petter Evjen Ola Fiabema Tammy Gudjon Leifur Gunnarsson Gurgia, Layth Haasted Lars Andreas Haga Bjørn Tore Haga Mette Margrethe Hammerstad Margit Haug Morten H. Haukeland Lars Isern Anne Elisabeth Kalaaji Amin

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Kjøsen Jarle Krøger Pål Kveim Morten Lykke Nils Mesic Haris Mørch, Ine Mulk Jamshaid Ul Nordang Bård Nordskar Marit Panczel, Georg Roald Helge Einar Rosenberg Bjørn Samdal Frode A Seland håvard Shahidi Bahram Simensen Halfdan Vier Skolleborg Knut Chr Sneve Kathrin Sørensen Steinbach Frank F. Stubberud Kjetil Sylvester Jensen Hans Christian Tiller Christian Topstad Thom Kåre Tvedt Bjørn Jarle Utvoll Jørgen Vigen Alexander Vindenes Hallvard A. Vindenes Harald Westvik Tormod Wingsternes Tine C.S. Zakaria Ayman Ørner Tom Inge

List of plastic surgeries

Former members: Andenæs Kjell Apelland Leif Arctander Kjartan Buøen Tor Dahl Steinar Diab Lore Eikeland Oscar Frøyen Jan Gjessing Einar Harboe Sverre Hauge Eystein J. Holta Anne Lise Hygen Jan Jan T Røttingen Jorkjend Petter Kleppe Geir

Nordang Erik Nordgard, John Olav Omtvedt Just Rindal Roald Røv Helge Salemeark Lars Ola Sandsmark Morten Schistad Paal Smedhaug Johs Stangnes Olaf Tindholt Tyge Tind Tonvang Gunnar Traaholt Lars Veholmen Øyvind Wessel-Holst Kristian Øgaard Alain

List of plastic surgeries

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F. APPENDIX 1. Establishment

Document for the Norwegian Society for Aesthetic Plastic Surgery

2.

Foundation document NFEP

3.

NFEP bylaws

4.

Ethical rules, revised 2019

5.

Professional recommendations for the Practice of Intimate Surgery in Norway

6.

ALCL Aftenposten debate

7.

Consultation response NFEP VAT case

8.

VAT case Aftenposten

9.

NFEP website

10. Regulations concerning cosmetic procedures authorized by the Health Personnel

Act: Need for amended definitions

11. Proposed Norwegian standard for extended COVID-19 infection-control in

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aesthetic plastic surgery in from 20 April 2020

Appendix

1. ESTABLISHMENT DOCUMENT FOR NFEP

Brønnøysundregistrene REGISTERUTSKRIFT FRA ENHETSREGISTERET Type opplysninger: Registrerte opplysninger: Dato for registr.: Merknad:

Organisasjonsnr.:

914 554 144

PLASTIK KIRURGI

Navn/foretaksnavn: NORSK FORENING FOR ESTETISK Forretningsadr.:

Gamle Kalvedalsveien 25 5019 BERGEN

08.12.2014

Kommune:

1201 BERGEN

Land:

Organisasjonsform: Forening/lag/innretning

Norge

08.12.2014

Stiftelsesdato:

31.10.1985

08.12.2014

Kontaktperson:

Bjørn Erik Rosenberg BERGEN Fødselsdato: 28.05.1969

08.12.2014

Virksomhet/art/ bransje:

Norwegian Society for Aesthetic plastic surgery 08.12.2014 Plastic surgery should work for a high professional standard, professional as well as ethical, within the field of cosmetic surgery. It must take care of the subject area scientific and professional interests and contribute to factual information on the subject. The society is only open to approved specialists in plastic surgery that meet the society’s professional and ethical guidelines, and must therefore be a quality assurance factor for the practice of cosmetic surgery in Norway . Institutional sector code: 7000 Non-profit organizations 08.12.2014

Utskriftsdato 08.12.2014

Organisasjonsnr 914 554 144

1. Establishment document for NFEP

Side l av 2

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2. FOUNDATION DOCUMENT NFEP

Innstiftingsdokument for Norsk Forening for Estetisk Plastikkirurgi Foundation document NFEP Man har i dag kommetfor til the enighet om opprettelse av Aesthetic en egen forening Founding document Norwegian Society for Plastic for kollegerAn somagreement arbeider med estetisk plastikkirurgi Foreningen Surgery. has today been reached oni Norgen. the establishment ofhar fått navnet Norsk Forening for Estetisk Plastikkirurgi. Foreningen utgår a separate society for colleagues who work with aesthetic plastic surgeryfra Norsk Plastikkirurgisk in Norway. The societyforening. has named the Norwegian Society for Aesthetic Plastic Surgery. The society is based on Norwegian Plastic Surgery Society. Foreningen skal arbeide høy faglig og etisk innen within The society shall work forfora en high professional andstandard ethical standard kosmetisk kirurgi.ItDen skal ivareta fagområdets cosmetic surgery. shall take care of the subject vitenskapelige area’s scientific og andfaglige interesser og bidra til saklig informasjon omkring emnet. I tillegg skaltopic. academic interests and contribute to factual information about the foreningen behandle saker som angår kosmetisk kirurgi sammen med Norsk Plastikkirurgisk Forening.

In addition, the society deal with matters relating to cosmetic surgery along with Norwegian Plastic Surgery Society. A separate collection of Det er utarbeidet en egen lovsamling for foreningen. Styret velges i dag laws has been prepared for the society. The board is elected today and sits og sitter frem til ordinær generalforsamling om 2 år. until the annual general meeting in 2 years. Oslo 31 October 1985

Oslo 31.oktober 1985

Gorm Bretteville

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Morten Kveim

2. Foundation document NFEP

3. NFEP BYLAWS

3. NFEP bylaws

// 75

76 //

3. NFEP bylaws

4. ETHICAL RULES, REVISED 2019

Rules for performing aesthetic plastic surgery

Regler for utøvelse av estetisk plastikkirurgi

The members of the Norwegian Plastic Surgery Society are, like all members of the Norwegian Medical Society, bound by ethical rules for physicians. Because the indication for aesthetic (cosmetic) surgery basedav on desire to improve a Norsk plastikkirurgisk forenings medlemmer er, som is alleoften medlemmer Den anorske lægeforening, normal condition, the attending physician show(kosmetisk) special kirurgi caution when assessing forpliktet av etiske regler for leger. Fordi indikasjonenmust for estetisk ofte er begrunnet i et ønske om å forbedre en normaltilstand, må den behandlende lege vise spesiell the indication for intervention. Members are required to familiarize themselves with varsomhet ved vurdering av indikasjon for inngrep. public regulations for the practice of cosmetic surgery as well regulations on the marketing of cosmetic procedures. Medlemmene plikter å gjøre seg kjent med offentlig regelverk for utøvelse av kosmetisk kirurgi samt forskrift om markedsføring av kosmetiske inngrep.

Indications for aesthetic plastic surgery The patient’s total state of health is, as with all health care, the overriding consideration Indikasjoner for estetisk plastikkirurgi for the company. The attending physician must never perform a treatment solely on Pasientens wishes totale helsetilstand somphysician’s ved all helsehjelp det overordnede forassessment virksomheten. believes the patient’s withouterthe assumption an hensyn overall Den behandlende lege må aldri utføre en behandling kun ut fra pasientens ønske uten at legen ut fra that this will be in the patient’s best interests. en helhetsvurdering mener at dette vil være til pasientens beste.

Contraindications Kontraindikasjoner

1. As a general rule, patients under the age of 18 must not be offered aesthetic 1. Pasienter under 18 år må som hovedregel ikke tilbys estetisk kirurgi. surgery. 2. Pasienterwith med kjente alvorlige spiseforstyrrelser må behandles med særskilt aktsomhet tanke care 2. Patients known severe eating disorders should be treated withmed special på kroppsendrende kirurgiske inngrep. on body-modifying surgical procedures. 3. Dersom legen i sine samtaler og undersøkelser får examinations mistanke om at psykiske forstyrrelser påvirker 3. If the doctor in his conversations and suspects that mental pasientens ønske om et spesielt inngrep, må det utøvers særlig aktsomhet. Ved tvil bør det innhentes disorders are affecting the patient’s desire for a special operation, special care vurderinger fra pasientens fastlege eller lege med kompetanse innen psykiske lidelser før inngrep must be exercised. In case of doubt, it should be obtained assessments from foretas. the patient’s GP or doctor with expertise in mental disorders before surgery made. Legens plikt til informasjon og oppfølging 1. Pasienten må informeres grundig om inngrepet. Legen må gjøre sitt beste for å sikre at pasienten forstår informasjonen. Legen må gi en realistisk vurdering av gevinsten ved inngrepet og avdekke urealistiske forventninger.

4. Ethical rules, revised 2019

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The doctor’s duty to provide information and follow up 1. The patient must be thoroughly informed about the procedure. The doctor must do his best to ensure that the patient understand the information. The doctor must give a realistic assessment of the benefit of the procedure and reveal 2. The provider of aesthetic surgery is obliged to follow the current medical guidelines and ensure that all patients are offered adequate medical follow-up after treatment. All patients should be evaluated and examined by a specialist in plastic surgery before surgery. Advertising and marketing 1. Members of the Norwegian Plastic Surgery Society have a special responsibility to ensure that the marketing of own business is not misleading. Marketing must not be given a form that may be offensive or offensive or deliberately playing on people’s flaws or prejudices against normal body phenomena. 2. Advertising that consciously seeks to create new needs for aesthetic surgery in the population must be avoided. Pre- and post-operative images are not permitted for use in advertisements or in publicly available marketing. 3. Active outreach individual marketing must not occur via any kind of communication platform. 4. Free consultations, promotional offers on consultations and surgery, or offers to deduct from consultation rate given that an intervention is carried out shall not occur. Price for consultation shall reflect the work performed and harmonize with the rates of other comparable professional groups. Violation of ethical rules Violations of these rules shall in the first instance be brought before the board of the Norwegian Plastic Surgery Society, which may require that conditions be rectified and issue warnings. The board can also take the matter further The Council for Medical Ethics, which decides whether Ethical Rules for Physicians have been violated. Council for Medical Ethics then has further sanction options in accordance with the Regulations of the Council for Medical Ethics. This includes criticism, an order that conditions worthy of criticism be established, and the Council may send the case to the Central Board recommendation for exclusion from the Norwegian Medical Society. Information about the decision will be passed on international societys.

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4. Ethical rules, revised 2019

5. PROFESSIONAL REC. FOR THE PRACTICE OF INTIMATE SURGERY Professional recommendations for the practice of intimate surgery in Norway, 2016 The Norwegian Society for Aesthetic Plastic Surgery, together with Norsk Gynekologisk Society prepared professional recommendations for the practice of intimate surgery in Norway. Definition Intimate surgery is defined in this context as the reduction of the internal labia (labia minora). The procedure is performed in Norway and internationally both by gynecologists and plastic surgeons. The procedures are mainly performed outside the public health service. Juridisk vurdering Questions have been asked about the intended surgical procedures to reduce the size of the inner labia is in violation of the Genital Mutilation Act. The Norwegian Medical Society at the legal section has at its request taken the case up for consideration and concluded that intimate surgery cannot be compared with traditional circumcision / genital mutilation. This is due to crucial differences in motivation for the procedure and the degree of anatomical changes caused by the procedures. Professional recommendations The board of the Norwegian Society for Aesthetic Plastic Surgery and the board of the Norwegian Gynecological Society agree that the indication for intimate surgery should not be purely cosmetic, but physical ailments related to inner labia. Patients who want surgery should be given detailed information about normal variation in anatomy, risk of complications during surgery and long-term consequences. It is recommended that patients not be set up for any surgery directly after consultation, but to ensure that patients have become thorough reflections on the procedure in that some time elapses from consultation to the time of surgery. There is a special requirement for all treating doctors to deport one a high degree of ethical judgment in dealing with such issues. Younger patients must be handled with special care, and marketing must not play on people’s flaws or prejudices against normal body phenomena.

5. Professional rec. for the practice of intimate surgery

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6. ALCL AFTENPOSTEN DEBATE

80 //

6. ALCL Aftenposten debate

6. ALCL Aftenposten debate

// 81

7. CONSULTATION RESPONSE NFEP VAT CASE

Nettside : www.nfep.no

Org nr : 914 554 144

Oslo, 31. juli 2020

Regarding the Ministry of Finance’s consultation on Vedrørende Finansdepartementets høring om introduction of VAT in aesthetic surgery with case innføring av moms i estetisk kirurgi number 19/2280, deadline 3 August 2020med

saksnummer 19/2280, frist 3. august 2020

The following statement is for made on behalf of the Norwegian Society for Aesthetic Plastic På vegne av Norsk forening estetisk plastikkirurgi avgis følgende uttalelse. Surgery. 1. Sammendrag 2. Innledning 3. 1. Estetisk kirurgi er helsetjeneste Summary 4. Vår forening jobber mot kroppspress Introductionved praktisering av forslaget 5. 2. Utfordringer

3. Aesthetic surgery is health care

5.1 Praktiske utfordringer. Medisinsk vs estetisk og mva avgrensning ved offentlig finansiering 5.24. Avgrensninger mvaagainst body pressure Our societyved works 5.3 Etiske utfordringer Challenges in practicing the proposal 5.45. Administrative utfordringer

5.1 Practical challenges. Medical vs. aesthetic and VAT delimitation by public funding

6. Konsekvenser ved forslaget

5.2 Limitations on VAT og infeksjoner 6.1 Medisinturisme, reoperasjoner

6.2 Bidrag til sosiale forskjeller 5.3 Ethical challenges 6.3 Potensielt tap av viktig kompetanse

5.4 Administrative challenges

7. 6. Konklusjon Consequences of the proposal

6.1 Medical tourism, reoperations and infections

1. Sammendrag

6.2 Contribution to social differences

Forslaget vil utilsiktet avgiftsplikt for medisinsk begrunnede operasjoner som pasienten 6.3 Potential lossmedføre of important competence må betale selv. De avgrensning-, fordelingsvansker, ulikheter og konsekvenser for faget, som et unntak innenfor kirurgisk behandling vil skape, tilsier at all kirurgisk behandling rettmessig 7. Conclusion fortsatt skal anses som helsetjenester. Norsk forening for estetisk kirurgi går inn for en presisering av unntaket til helsehjelp som omfatter kirurgisk behandling.

1. Summary Merverdiavgiftsloven slår fast at «helsetjenester unntattfor fra medically loven, herunder tjenester som such The proposal will unintentionally lead to a taxerliability justified operations omfattes av» a. spesialisthelsetjenesteloven og c. ytes av yrkesgrupper med autorisasjon eller as the etter patient have to pay yourself. Theplastikkirurgi delimitation, distribution difficulties, differences, and lisens helsepersonelloven. Estetisk utøves av autoriserte medisinskfaglig spesialiserte leger. consequences for the subject, as exceptions in surgical treatment will create, dictating that all surgical treatment is legitimate should still be considered health services. Thekirurgi. Norwegian Plastikkirurgi er en spesialitet som innbefatter estetisk (kosmetisk) og rekonstruktiv Overgangen mellom estetisk og generell plastikkirurgi er flytende. Finansiering av operasjon fra

82 // Nettside : www.nfep.no

7. Consultation response NFEP VAT case Org nr : 914 554 144

Nettside : www.nfep.no

Org nr : 914 554 144

Society for Aesthetic Surgery isbegrunnet in favor er ofavgrensningskriterier one clarification of the to health care det offentlige og rent kosmetisk somexception ikke er sammenfallende. Det derfor vanskelig uheldig åThe trekke en grense basert på retningslinjer thaterincludes surgical og treatment. Value Addedfor Taxmerverdiavgift Act states that “health services are for offentlig finansiering som f.eks. ved 5 cm bukfold, eller ved et skjemmende arr som det exempt from the Act, including services such as covered by a. the Specialist Health Services offentlige har ferdigbehandlet, i tillegg til at merverdiavgiftsplikten avgrenses til inngrep som er Act kosmetisk and c. provided by occupational groups with authorization or license under the Health rent begrunnet. Personnel Act. Aesthetic plastic surgery is performed by authorized medical professionals

Verken merverdiavgiftstekniske, helsefaglige eller samfunnsøkonomiske hensyn taler for et specialized doctors. skille innenfor kirurgen. All forskning viser at et godt resultat av merverdiavgiftrettslig plastikkirurgi gir en markant forbedret livskvalitet. Plastikkirurgien gir helsegevinster vi ikke bør blande merverdiavgift inn i. Plastikkirurgi er ikke mote slik som tatovering, som paradoksalt Plasticsom surgery is a specialty that includes aesthetic (cosmetic) and reconstructive surgery. anses kroppskunst i merverdiavgiftslovens forstand. Merverdiavgiftsloven kan forbedres med unntak, men et aesthetic unntak midt i helsetjenesteunntaket på ingen måte veien å gå The færre transition between andinne general plastic surgery is er fluid. Financing of operation dersom man vil forbedre merverdiavgiftssystemet.

from the public and purely cosmetically justified delimitation criteria that do not coincide.

It is therefore difficult and av unfortunate to draw line forhandlekraft VAT basedi on guidelines for Høringsutkastet gir inntrykk at man ønsker å visea politisk forhold til å dempe kroppspress. Vi mener det er feilaktig å framstille estetisk kirurgi som en hovedkilde til public funding such as at 5 cm abdominal fold, or at an unsightly scar like that public has kroppspress. Mote og skjønnhetsindustrien mer generelt er tunge aktører i vårt forbrukssamfunn. completed addition to etter the VAT obligation being limited interventions Dette er ogsåprocessing, aktører sominikke opererer strenge etiske retningslinjer slikto estetisk kirurgi gjør. that are purely cosmetically justified. Neither VAT technical, health professional nor socioEn reduksjon i vår virksomhet vil ikke bidra til reduksjon av kroppspress. Men det vil gjøre det economic considerations one med VATskamfølelse separation over within surgeon.ogAll mer utrygt og mer kostbart åspeak være for pasient egetthe utseende, detresearch vil på sikt kunne tap avresult viktigofkompetanse innenprovides helsevesenet. Moms vil stimulere til showsbidra that til a good Plastic surgery a markedly improved quality of life. medisinturisme som igjen vil belaste helsevesenet grunnet infeksjoner og behov for nye inngrep. Plastic surgery provides health benefits we should not mix VAT into. Plastic surgery is not Covid 19 epidemien har understreket behovet for å unngå unødige belastninger på vårt fashion such as tattooing, which paradoxically is considered body art within the meaning helsevesen. Høringsforslaget uklart ogAct vil på av de ovenfor beskrevne punkterbut bli tilnærmet of the VAT Act.erThe VAT canenkelte be improved with fewer exceptions, an exception umulig å praktisere. Det foreslåtte unntak fra helsetjeneste-unntaket vil dessuten representere en in the middle of forskjellsbehandling. the health service exception by no som means theallerede way to igo if you want betydelig fare for Forslagetisskaper, nevnt 2001, ikke tillit til Regjeringens planer forenkling forvaltningen.draft gives the impression that one wants to improve the VATomsystem. The iconsultation to show political 2. Innledning

action in relation to curbing body pressure. We believe it is wrong to portray aesthetic surgery as a majorhar source fashion and beautyforindustry Regjeringen og Finansdepartementet gått utbody med pressure. en høringThe om innføring av moms kosmetisk kirurgiare (også referert til som estetisk kirurgi) med saksnummer 19/2280 fristdo 3. not more generally heavy players in our consumer society. These are also actorsogwho august. operate according to strict ethical guidelines such as aesthetic surgery does. A reduction in our business not contribute to aNorsk reduction in body pressure. But it will do Forslaget kommerwill ubeleilig midt i ferien. forening for estetisk plastikk-kirurgi er it more overrasket overmore at Regjeringen har fremmet forslag å innføre and insecure and expensive og to Finansdepartementet be a patient with shame over their ownom appearance, merverdiavgiftsplikt på omsetning og formidling av kosmetisk kirurgi “som ikke er medisinsk it will in the longfinansieres run couldhelt contribute to the lossoffentlige”. of important competence infremmet the health begrunnet og ikke eller delvis av det Fremskrittspartiet forslaget i 2019, og will trakkstimulate deretter sitt «kirurgimoms»-forslag. på kirurgi svært care system. VAT medical tourism which inMoms turn will burdenerthe health care vanskelig å praktisere. system due to infections and the need for new interventions. The Covid 19 epidemic has Formålet med the forslaget merverdiavgift-belegge innenfor estetisk underscored need er to åavoid unnecessary strainenkelte on ouroperasjoner health Service. plastikkirurgi, de estetisk plastikkirurgiske inngrep som utelukkende er kosmetisk indisert. Arr-korreksjon i ansiktet som eksempelvis er medisinsk indisert dersom det er «forbedringspotensial ved kirurgi», må vurderes av spesialisten som kan frembringe resultatet, og ikke av et byråkrati som i forslaget:

7. Consultation response NFEP VAT case Nettside : www.nfep.no

// 83 Org nr : 914 554 144

Nettside : www.nfep.no

Org nr : 914 554 144

«All kosmetisk kirurgi og kosmetisk behandling utført i private klinikker uten at det er tatt The consultation proposal isetter unclear andog will be approached on some of thevære points stilling til rett til behandling pasientbrukerrettighetsloven vil dermed avgiftspliktig. Detimpossible må altså foreligge en beslutning fra helsetjenesten/ helsemyndighetene på at described above to practice. The proposed exemption from the health service det konkrete kosmetisk kirurgiske inngrepet eller den kosmetiske behandlingen er medisinsk exemption will also represent one significant risk of discrimination. As already mentioned indisert og dekkes av det offentlige helt eller delvis». in 2001, the proposal does notavgrensningen create confidence The government’s plans for simplification Den eventuelle svært vanskelige blir dermed i tillegg en byråkratisk belastning for alle involverte. of administration.

2. Introduction Høringsnotatet omfatter, utover kirurgi, enkelte kosmetiske behandlinger som ikke er omfattet av den generelt kosmetisk som on f.eks Themerverdiavgiftsplikten Government and the som Ministry of gjelder Financeforhave issued behandling a consultation thefillere, samt «alternativ behandling» som ble generelt unntatt fra merverdiavgift i 2003. introduction of VAT for cosmetic surgery (also referred to as aesthetic surgery) with case

Vi registrerer at vårtand medisinske med operativ kirurgisk pasientbehandling feilaktig number 19/2280 deadlinefagfelt 3 August. sammenblandes med enkelte avgiftsunntatte kosmetiske behandlinger, og også med såkalt «alternativ behandling». Fra vårt ståsted er det uheldig og uriktig å behandle disse ulike The proposal comes in til theoppklaring middle ofdathe Norwegian Society for områdene under ett. Viinconveniently ønsker bidra kort detholiday. synes å herske uklarhet:

Aesthetic Plastic Surgery is surprised that the Government and the Ministry of Finance Estetisk og kosmetisk kirurgi er ikke et eget fagfelt, men hører inn under spesialiteten haveplastikkirugi put forward to medisinsk introduce faglig VAT liability on the sale and distribution of ogproposals fordrer bred kompetanse cosmetic surgery “which is not medical justified and not financed in whole or in part by - Kosmetisk behandling er en samlebetegnelse for hud-/kroppsbehandling, hvor det i dag thegenerelt public sector.” The Progress Party proposal 2019, and then withdrew er merverdiavgiftsplikt, menpromoted hvor det likevel er etinbegrenset avgiftsunntak (etter rettspraksis) for proposal. de tilfellerVAT hvor on det surgery anses nødvendig at to bruk av laser,The fillers o.l. utføres its “surgery VAT” is difficult practice. purpose of theav autorisert helsepersonell. proposal is to tax certain operations within aesthetics plastic surgery, the aesthetic plastic - Alternativ behandling er en samlebetegnelse for behandlingsformer som i hovedsak kun surgery procedures are exclusively cosmetically Scar correction in the eksisterer utenforthat evidensbasert medisin, og hvor detindicated. ikke kreves autorisert helsepersonell. face which, for example, is medically indicated if there is “potential for improvement Norsk forening for estisk plastikkirugi (NFEP) tar ikke stilling til merverdiavgift på verken by kosmetisk behandling eller på alternativ behandling. surgery,” must be considered by the specialist who can produce the result, and not by a bureaucracy as in the proposal: All cosmetic surgery and cosmetic treatmentestetisk performed NFEP har sterke innvendinger mot innføring av merverdiavgift på helsetjenesten plastikkirugi, og anmoder at forslaget tilbake somright ineffektivt og byråkratiserende. in private clinics withoutom it being takentrekkes position on the to treatment according to the Patient and User Rights Act will thus be taxable. There must therefore be a decision 3. Estetisk kirurgi er helsetjeneste from the health service/health authorities that the specific cosmetic surgery or cosmetic Faget plastikkirurgi, innbefattet estetisk plastikkirurgi, er definert som helsetjenester/-hjelp etter treatment is medical pasientskadeloven indicated and covered by the public sector in wholeerorherinatpart. merverdiavgiftsloven, og helsepersonelloven. Konteksten detteThe er en medisinskfaglig yrkesutøvelse i en operasjonsstue eller operasjonssal. Kirurgi burden fordrer etfor høyt possible very difficult delimitation thus becomes in en addition a bureaucratic medisinskfaglig og et høyt håndverksmessig nivå, hvor operatøren i tillegg til medisinsk everyone involved. The consultation memorandum includes, in addition to surgery, certain embetseksamen etter mange års opplæring har en særskilt spesialistautorisasjon, noe som gir den cosmetic treatments that are not covered bygår theetVAT obligation thatskille generally applies nødvendige trygghet for pasientens helse. Det markant helsefaglig mellom kosmetisk behandling, mv. påasden siden, og den klart helsefaglige medisinske to cosmetic treatmenttatovering such as fillers, wellene “Alternative treatment” which was generally operative behandlingen kirurgi. Uansett om et enkeltstående inngrep ikke anses medisinsk exempt from in 2003. We registeranses thatsom our annet medical of surgical patient care begrunnet, kanVAT plastikkkirurgi vanskelig ennfield medisinsk behandling, helsetjeneste og helsehjelp. Helsehjelp-begrepet omfatter estetisk plastikkirurgi i so-called is incorrect mixed with some tax-exempt cosmetic treatments, and also with helsepersonelloven og i pasientskade-loven, og bør også definere helsetjenester i “alternative treatment.” point ofklar view, it is unfortunate and incorrect merverdiavgiftsloven for åFrom sikre our en naturlig avgrensning av helsetjenester som erto liktreat i alle -

sammenhenger, og som dermed naturligvis inkluderer estetisk plastikkirugi også i merverdiavgiftssammenheng. Spesialiteten plastikkirurgi omfatter både rekonstruktive og

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kosmetiske prinisipper, slik at godkjente utøvere skal kunne beherske dette i alle møter med sine these different the areas as a whole. We want to contribute briefly to clarification as there pasienter.

seems to be ambiguity: Aesthetic and cosmetic surgery is not a separate field, but belongs

Norsk forening for estetisk plastikkirurgi imøteser at helsetjenester i mval § 3-2(2) harmoniseres to the specialty til; «helsehjelp, herunder kirurgi, som ytes av yrkesgrupper med autorisasjon eller lisens etter plastic surgery and og requires broad expertise.og helsepersonelloven», «omfattes av medical helse- ogprofessional omsorgstjenesteloven spesialisthelsetjenesteloven».

Cosmetic treatment is a collective term for skin / body treatment, whereskade it is today Norsk pasientskadeerstatning er en offentlig erstatningsordning som omfatter eller in behandlingssvikt helsetjenesten. Deres estetiske plastikkirurgiens general is VAT iliable, but where therepraksis is stillunderbygger a limited taxden exemption (after case law) for plass innen helsehjelp. Plastikkirurgiske inngrep utført i offentlig eller privat regi faller inn under thosepasientskadeerstatning. cases where it is considered necessary that the utført use ofavlasers, fillershelsepersonell etc. performed Norsk Plastikkirurgiske inngrep autorisert er by derfor definerthealth som helsehjelp authorized personnel.uavhengig av om denne helsehjelpen er ansett som nødvendig helsehjelp eller ikke. Alternative treatment isi det a collective forms of treatment mainly only exists Det er flere "helsetilbud" offentligeterm hvorfor helsegevinsten har svak that eller are ingen vitenskapelig dokumentasjon. Et eksempel er kutting av tungebånd hos babyer som ikke ammer godt. Et annet outside of evidence-based medicine, and where no authorized healthcare professional is er operativ behandling av inntåing. I tillegg har man alle behandlingene som gjøres av required. The Norwegian Society for Estonian Plastic Surgery (NFEP) does not take a fysioterapeuter og kiropraktorer. Man kan ikke dokumentere helsegevinst i hvert besøk hos fastlegen Nåron man nå forsøker uavklarteorkriterier å luke uttreatment. et fagfelt fra positionheller. on VAT either cosmeticmed treatment on alternative NFEP has helsebegrepet for å momsbeskatte det, vil alle etablerte helsetjenester måtte gjennomgå samme strong objections to the introduction of VAT on the health service aesthetically plastic vurdering. Man vil da også møte på de samme utfordringene når det gjelder avgrensning «medisinsk/ikke medisinsk». ogsåbehelsetilbud offentlige som all hovedsak virker surgery, and requests that Det the finnes proposal withdrawni det as inefficient andi bureaucratic. gjennom sin estetiske funksjon som for eksempel utstående ører hos barn, brystrekonstruksjon, arrforbedringer, hårtransplantasjoner etter skader, begrensning av lengdevekst hos jenter som 3. Aesthetic surgery is health care ligger an til å bli over 190, samt hormonbehandling for å øke lengdevekst hos kortvokste. The subject plastic surgery, including aesthetic plastic surgery, is defined as health services

Dersom bekjempelse av kroppspress blir brukt som påskudd for å innsnevre helsebegrepet, vil / assistance according to thei Value Added Tax Act,vil theman Patient Injuries and the få Health man måtte "snu hver en stein" det uendelige. I tillegg ganske sikkertAct i fremtiden enda mer vitenskapelig dokumentasjon funksjonens helsen. Når Personnel Act. The context herepåisden thatestetiske this is one medical innvirkning professionalpåpractice in anman da blir nødt til å sammenligne med alle andre helsetilbud når det gjelder effekt, vil det bli en operating room or an operating room. Surgery requires a high medical professional and absurd øvelse og sløsing med ressurser. Via må vårethe pasienter. en sårbartogruppe somthe harofficial behov for highbeholde level ofhelseperspektivet craftsmanship, for where operatorDeineraddition medical, kirurgisk behandling av høy kvalitet. Estetisk kirurgi er kirurgi som uansett er helsetjeneste.

examination after many years of training has a special specialist authorization, which gives itkirurgi necessary security for patient’s health. §There is aledd. marked health er professional Estetisk er helsehjelp etterthe helsepersonelloven 3 tredje Helsehjelp her definert som «enhver handling som har forebyggende, diagnostisk, behandlende, helsebevarende, distinction between cosmetic treatment, tattoo, etc. on the one hand, and the clear health rehabiliterende eller pleie- og omsorgsformål og som utføres av helsepersonell». Det er viktig å medicalatoperative treatment surgery. Regardless of whether a single operation notkan tas presisere estetisk kirurgi er helsetjeneste i enhver relevant sammenheng, og derfor isikke utconsidered av helsetjenestebegrepet i merverdiavgiftsloven uten at det får uoversiktlige uheldige medical justified, plastic surgery can hardly be considered other than medical konsekvenser. Merverdiavgiftsunntaket må være praktikabelt. treatment, health service and health care. The term health care includes aesthetic plastic surgery in the Health Personnel Act and in the Patient Injury Act and should also define 4. Vår forening jobber mot kroppspress health services in the VAT Act to ensure a naturally clear delimitation of health services that is equal in all contexts, and which thus naturally includes aesthetic plastic surgery also Høringsutkastet gir inntrykk av at man vil vise en form for handlekraft for å dempe kroppspress. Det har skjedd en vulgarisering av estetisk medisin. Myndighetene har nylig reagert mot

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udokumenterbare kampanjer om kollagen- og proteinpulver. Det er bra. Vi har lenge påpekt in VAT context. The specialty of plastic surgery includes both and cosmetic behovet for regulering av den estetiske delen av bransjen, som må reconstructive skilles fra kosmetisk behandling so refthat punkt 2. Det skjer synlige overtramp i stort omfang myndighetenes manglende principles, approved practitioners can master this in all og meetings with their patients. handlekraft må ta sin del av skylden for utviklingen vi har sett. Utviklingen er uheldig, men kroppspresset unge står overfor har åpenbart mer sammensatte årsaker med rot i en The Norwegianmed Society Aesthetic Plastic Surgery the harmonization of health forbrukskultur sterkefor markedsaktører. Forslaget somwelcomes nå foreligger tar opp estetisk kirurgi, kosmetisk behandling under ett, surgery, og uten åprovided nevne noebyom den unntatte services in behandling section 3-2og(2)alternativ to; ”Health care, including professional «kroppsmoten» tatovering, eller «kroppsmoten» kroppsbygging i avgiftsunntatte helsestudio. Det groups authorization stiller viwith oss undrende til. or license the Health Personnel Act,” and “is covered by the Alle klinikker i Norge har 18 estetisk Health kirurgi, Services noen har Act.” 20, enNorwegian grense som Patient ikke Health and Care Services Actårsgrense and thefor Specialist nødvendigvis praktiseres av klinikker i utlandet. Fordi vi ikke er å betrakte som hovedkilden til Injury Compensation is a public compensation that includes injuryavormoms treatment kroppspress, vil en reduksjon i vår virksomhet ikkescheme dempe dette. En innføring vil også gjøre det mer kostbart å være pasient medthe skamfølelse eget utseende, flere failure in mer the utrygt healthog service. Their practice supports aesthetic for of plastic surgeryda place av disse vil måtte operere seg i utlandet. Vår forening har i fellesskap med Norsk in health care. Plastic surgery performed under public or private auspices falls under Plastikkirurgisk Forening v/leder Kjersti Ausen lenge påpekt behovet for regulering av den Norwegian patient injury som compensation. estetiske delen av bransjen ved fillere. Plastic surgery performed by authorized

healthcare professionals is therefore defined as health care regardless of whether this health Våre regler for kosmetisk kirurgi er basert på at den behandlende lege viser spesiell varsomhet care is considered necessaryfor health carePasientens or not. There “health services” in the ved vurdering av indikasjon inngrep. besteare måseveral alltid være det overordnede hensynet for virksomheten. Den behandlende lege må aldri utføre tjenestene ut fra pasientens public sector where the health benefits are weak or non-scientific documentation. An ønske om en spesiell behandling uten at legen ut fra en helhetsvurdering mener at dette vil være example is cutting tongue ligaments in babies who are not breastfeeding well. Another til pasientens beste. Brudd på disse reglene kan/vil medføre eksklusjon og ytterligere sanksjoner. 1: Etiske regleroffor plastikkirurger i Norge isVedlegg operative treatment ingress. In addition, you have all the treatments that are done by physiotherapists and chiropractors. It is not possible to document health benefits in each visit to GP When one now tries with unclear criteria to weed out a field 5. Utfordringer vedeither. praktisering av forslaget from the concept of health in order to tax it for VAT, all established health services will 5.1 Utfordringer – skillet medisinske og kosmetiske indikasjoner have to undergo the same assessment. You will then also face the same challenges when it De fleste har både medisinske og kosmetiske indikasjoner. I en operasjon er det derfor comes to inngrep delimitation” medical / non-medical.” There are also public health services that umulig, eller svært krevende, å skille mellom medisinsk og kosmetisk kirurgi. Vi utøver ikke mainly work through its aesthetic function such as protruding ears inåchildren, breast sjelden kirurgi der indikasjonen er medisinsk, men hvor pasienten ønsker betale selv på grunn av ventetid, ellerscar av andre årsaker. I hvor grad et inngrep er kosmetisk i forhold reconstruction, improvements, hairstor transplants after injuries, restriction of til length medisinsk, er knapt mulig å fastslå uten inngående kjennskap til hver enkelt pasients situasjon growth in girls who is likely to be over 190, as well as hormone therapy to increase height kombinert med svært erfaringsbasert kunnskap om det enkelte inngrep. Når man som lege growth short adults. combating pressure is used pretextoperasjon. to narrowDet down opererer,inutbedrer man enIfmedisinsk ogbody kosmetisk tilstand i énas ogasamme eksisterer dermed ikke én avgrenset del av inngrepet, som kan legges til grunn ved beregning the concept of health, will one had to “turn every stone” to infinity. In addition, one willav mva. for den kun kosmetiske gevinsten ved et inngrep. certainly in the future get even more scientific evidence on the impact of the aesthetic Før Finansdepartementet lanserte merverdiavgiftsreformen i Ot. prop. nr. 2 (2000-2001) hadde function on health. When you then will have to compare with all other health services in Departementet nedlagt flere års arbeid med å finne frem til den rette avgrensningen av terms of effect, there will be one absurd exercise and waste of resources. We must keep merverdiavgift. Det er prinsipielt viktig at flest mulig tjenesteområder inngår i merverdiavgiftssystemet, er enkelte områder, som helsetjenesteområdet, som konsistent the health perspective formen ourdet patients. They are a vulnerable group in need high quality og konsekvent bør holdes helt utenfor med enklest mulig avgrensning. surgical treatment. Aesthetic surgery is surgery that is in any case a health service.

Finansdepartementet utformet den gjeldende lovtekst i merverdiavgiftslovgivningen upåvirket av næringsinteresser, eller særskilte ønsker om å legge merverdiavgift på tjenester enkeltvis. I tiden mellom lovvedtaket og ikrafttredelsen av merverdiavgiftsreformen, ble enkeltstående tjenester

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som tatovering og helsestudioer foreslått unntatt, mens estetisk plastikkirurgi ble foreslått Aesthetic surgery is health care according to the Health Personnellagmannsretts Act § 3 thirddom paragraph. avgiftsbelagt. Forslaget ble nedstemt. Høringen er omtalt i Borgarting av 8. juli 2009 (LB-2008-187928): Health care is defined here as «any action which has preventive, diagnostic, therapeutic, «Det vises for så vidt til uttalelsen fra Den norske Lægeforening 23. april 2001, der det blant health-preserving, rehabilitative or nursing and care purposes and which are performed by annet heter at "sondringen mellom kosmetiske og medisinsk indiserte inngrep vil bli svært health personnel ». iItpraksis. is important to emphasize that aesthetic surgery is healthcare in any vanskelig å håndtere Regelmessig vil slike inngrep ha både medisinske og kosmetiske indikasjoner." Tilsvarende innvendinger brevof16. mai 2001 service fra Norsk relevant context and therefore cannotframkom be takeni out the health concept in the VAT Plastikkirurgisk Forening og Norsk Forening for Estetisk Plastikkirurgi der det blant annet Act without it getting unfortunateerconsequences. Thekosmetiske VAT exemption must be heter: "Ved tilnærmet alleconfusing plastiske operasjoner det estetiske eller aspekt av betydning.", practicable.og lenger ut i samme brev: "Da samme type inngrep kan ha både vesentlig medisinsk, vesentlig kosmetisk eller 50-50-kosmetisk/medisinsk fordeling, vil det være umulig å sette opp en liste over hvilke inngrep som skal klassifiseres på den ene eller andre måten.". Uttalelsens konklusjon ”Konklusjon: 4. Our society worksvar: against body pressure Forskriftsutkastet er uklart og vil på enkelte av de ovenfor beskrevne punkter bli tilnærmet The consultation draft gives the impression that one wants to show a form of action to umulig å praktisere. Forskriften vil representere en betydelig fare for forskjellsbehandling. reduce body pressure. There has been a vulgarization of aesthetic medicine. DNLF The authorities Forslaget skaper ikke tillitt til regjeringens planer om forenkling i forvaltningen. vil på denne bakgrunn kreve at helsetjenester i sin helhet må unntas fra merverdiavgiften utenpowder. de have recently reacted against undocumented campaigns on collagen and protein foreslåtte kompliserte avgrensningsforsøk. Legeforeningen ber Akademikerne om å følge de It is good. We have long pointed need for regulation of the aesthetic parthilsen. of the ovenstående synspunkter videre opp out i sinthe høringsavtale til departementet. Med vennlig Den norske lægeforening, Generalsekretær H.M Svabø Forhandlingssjef Øyvind Sæbø”. industry, which must be distinguished from cosmetic treatment ref point 2. There is

visible abuse largepånumbers and the authorities’ lack ofsom it action must take its share Forslaget som erinsendt høring vil i likhet med det forslaget ble tilbakevist i 2001, væreof basert på at det naturlig integrert helsetjeneste, ekskluderende unntaksbestemmelse. the blame forfor theendevelopment we have seen. Thegis development is unfortunate, however Det foreslås at «som helsetjeneste etter første ledd anses ikke kosmetisk kirurgi eller kosmetisk the body pressure young people face obviously has more complex causes rooted in one behandling som ikke er medisinsk begrunnet og ikke finansieres helt eller delvis av det consumerjf.culture strong market players. current proposal aesthetic offentlige», mval §with 3-2(3). Bakgrunnen for at en The helsetjeneste utføres ogaddresses hvem som betaler, bør ikke bestemme Dette vil være treatment uoverprøvbare surgery, cosmeticavgiftsplikten. treatment, and alternative as a helseforvaltningsskjønn. whole, and without mentioning anything about the exempt “Body fashion” tattoo, or fashion” body buildingskal in taxVerken det svenske Skatteverket eller EU-kommisjonen har“body gått inn for at merverdiavgift gripe inn igyms. deres lovgivningers unntak for merverdiavgift på helsetjenester. Et svensk selskap exempt The we wonder. PFC Clinic AB, anla imidlertid sak mot det svenske Skatteverket for å oppnå fradragsrett for inngående avgift. PFC Clinic AB vant saken mot det svenske Skatteverket i den europeiske domstolen 23. mars (C-91/12). Følgen at man blesurgery, tvungetsome til å innføre All clinicsved in dom Norway have2013 an 18-year age limit foreraesthetic have a 20-year merverdiavgift innenfor plastikkirurgi i EU, med de avgrensnings- og fordelingsproblemer det age limit necessarily practiced by clinics abroad. Because we are not to be considered medfører, men i EU er denne, fra merverdiavgiftsmyndighetenes side, uønskede momsplikten as the main source of body pressure, a reduction in our business will not curb this. An avhjulpet av lave merverdiavgiftssatser. introduction of VAT will also make it more unsafe and more expensive to be a patient with shame for one’s own appearance, then more of these will have to operate abroad. ”Skatteverket harini common ett ställningstagande för verkets uppfattning om Kjersti när estetiska Our society has with Norskredogjort Plastic Surgery Society v / leader Ausen operationer och behandlingar är skattepliktiga till mervärdesskatt. Ställningstagandet innebär long pointed out the need for regulation of its aesthetic part of the industry as by fillers. en ändring i sak av verkets tidigare syn på estetiska operationer och behandlingar på så sätt att vissa Our rulesblir forskattepliktiga. cosmetic surgery are based on the treating physician showing special care Estetiska operationer och behandlingar som görs i rent kosmetiskt syfte utan att vara when assessing the indication for intervention. The patient’s best interests must always medicinskt motiverade är skattepliktiga tjänster. Utmärkande för sådana ingrepp är att de be paramount consideration for the och/eller business.förbättra The treating physician must never perform utförs uteslutande i syfte att förändra utseendet och bara utförs som en följd av patientens egetthe önskemål. operationer eller behandlingar till någon del the services based on patient’sEstetiska desire for a special treatment without som the doctor, based

Fra Skatteverkets endrings-uttalelse (dnr: 131 532863-14/111) hitsettes innledningen:

är medicinskt motiverade är från skatteplikt undantagen sjukvård. Bedömningen av om

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ingreppet är medicinskt motiverat ska göras av legitimerad personal inom hälso- och onsjukvården an overall inom assessment, believing that this will be the case for the benefit of the patient. ramen för deras legitimation.”

Violation of these rules may / will result in exclusion and further sanctions.

De fleste inngrep har både medisinske og kosmetiske indikasjoner. I en enkelt operasjon er det derfor ofte umulig, eller svært krevende å skille mellom henholdsvis medisinsk og estetisk Appendix 1: Ethical rules for plastic surgeonsSkatteverkets in Norway uttalelse (dnr: 131 532863-14/111). plastikkirurgi. Dette illustreres i det svenske Vi hitsetter fra vurderingen: ”Estetiska operationer och behandlingar som är medicinskt motiverade är från skatteplikt undantagen sjukvård. Det är legitimerad personal inom hälso- och sjukvården som ska göra 5. bedömningen Challenges in proposal attpracticing åtgärden ärthe medicinskt motiverad. Den legitimerade personalen ska göra bedömningen inom ramen för sin legitimation. Så länge åtgärden är medicinskt motiverad är det från skatteplikt undantagen sjukvård.

5.1 Challenges - the distinction between medical and cosmetic indications Estetiska operationer eller behandlingar kan utföras mot bakgrund av operation att de bådeitäris Most procedures have both medical and cosmetic indications. In an medicinskt motiverade och har ett kosmetiskt syfte. Skatteverket gör bedömningen att om therefore impossible, demanding, to distinguish between medical and cosmetic ingreppet till någon or delvery är medicinskt motiverat är det från skatteplikt undantagen sjukvård. surgery. We often perform surgery where the indication is medical, but where the Rekonstruktion av kroppsdelar efter olycka eller sjukdom och åtgärdande av medfödda patient wants to pay even due for waiting or formotiverade. other reasons. To what extent a missbildningar är sådana åtgärder som ärtime, medicinskt Sådana åtgärder handlar om att förbättra funktionen och att patienten utifrån en antagen normalitet bedöms vara procedure is cosmetic in relation to medically, is hardly possible to determine withouti medicinskt behov av behandlingen. Rekonstruktiva ingrepp är således från skatteplikt in-depth knowledge of En eachomständighet individual patient’s combined with veryundantagen experiential undantagen sjukvård. som talarsituation för att det är från skatteplikt sjukvård är att åtgärden finansieras av någon av de offentliga sjukvårdshuvudmännen. knowledge of the individual procedure. When you as a doctor operates, a medical and cosmetic condition in one and the same operation. there is Det er verdt å merke is segcorrected at i Sverige er det avgiftsunntak for inngrepThe somthus, «til någon delnoärsingle medisinskt motiverat», samt at offentlig finansiering kun er en «omständighet som talar för»the og limited part of the intervention, which can be used as a basis for calculating VAT. for absolutt ikke et særskilt vilkår for unntak, slik forslaget på høring uheldigvis er formulert. only cosmetic benefit of a procedure. Forslaget som er på høring vil nødvendigvis medføre merverdiavgift utover det som tilsiktes. Verken the det Ministry helsefaglige eller svenske statinhar noen No. måte2ønsket, eller Before of miljøet Financei Sverige launched theden VAT reform Ot.påprop. (2000-2001) har hatt noe å vinne på, at en vanskelig avgrensning innen kirurgi, er blitt innført i svensk had The Ministry put in several years of to find the right delimitation of VAT. It is merverdiavgiftslovgivning. Det skjedde motwork Skatteverkets vilje, som følge av ECJ-dommen 23. mars 2013 (C-91/12), som varasinitiert en enkelt ønske om forVAT system, in principle important that manyav service areasaktørs as possible are fradragsrett included the merverdiavgift på kostbart medisinsk teknisk utstyr for kosmetisk laserbehandling. but there are some areas, such as the health service area, that are consistent and consistently Det er derfor et paradoks at det til Regjeringens forenklingstiltak og i strid med should be kept completely outi sterk with kontrast the simplest possible delimitation. The Ministry merverdiavgiftssystemets tjenesteartsbestemte avgrensning likevel foreslås innført of Finance formulated the current legal text in VAT legislation unaffected by business merverdiavgift på helsetjenesten estetisk plastikkirurgi. Det virker som om forslaget er tuftet på interests, or special imposehvor VAT on services individually. the time between the at «kroppspress» skalwishes lede tiltokirurgi, ideen om merverdiavgift somInvirkemiddel mot kroppspress har gitt en foranledning til også å foreslå merverdiavgift på tjenester hvor man i legislative decision and the entry into force of the VAT reform, became individual services merverdiavgiftsreformen tilsiktet merverdiavgift. De avgrensnings- og fordelingsproblemer som as and suggestedinnenfor except, plastikkirurgi while aesthetic surgery was suggested taxed. en tattoos innføring avgyms merverdiavgift vilplastic medføre, bør gjennomgås nærmere. Etter det vi kan se vil forslaget få utilsiktede konsekvenser også for blant annet The proposal was voted down. tannlegebehandling, hvor deler av behandlingen er kosmetisk behandling «som ikke er medisinsk begrunnet og ikke finansieres helt eller delvis av det offentlige». Er det tilfelle for estetisk kirurgi er dethearing også tilfelle for tannlegebehandling: «At denne tjenesterjudgment er unntatt of fra8loven The is mentioned in the Borgarting Courttype of Appeal’s July 2009 innebærer en skattefavorisering og fører til kunstig lave priser i forhold til prisene på

(LB-2008-187928):

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avgiftspliktige varer og tjenester». Norsk Forening for estetisk plastikk-kirurgi er uenig i at den Referencegjelder is made from the Norwegian Medical Society on 23 April 2001, påstanden for to noethe av statement det tannlegen eller plastikkirurgen gjør.

where it is included other states that “the distinction between cosmetic and medically indicated procedures will be severe difficult to deal with in practice. On a regular basis, Forslaget som er sendt høring vilmedical ta inn enand ny lovbestemmelse § 3-2 tredje objections ledd. Det such procedures willpåhave both cosmetic effectsi mval Corresponding foreslås i lovtillegget at «som helsetjeneste etter første ledd anses ikke kosmetisk kirurgi eller emerged in a letter dated 16 May 2001 from Norsk Plastic Surgery Society and the kosmetisk behandling som ikke er medisinsk begrunnet og ikke finansieres helt eller delvis av det offentlige». Norwegian Society for Aesthetic Plastic Surgery where, among other things is called: “In almost all plastic surgeries, the aesthetic or cosmetic aspect of meaning. “, and further out Avgrensningsproblemene som følger av det nye tillegget til gjeldende avgrensning av in the same letter:” Since same type of intervention can have significant medical, helsetjenester, er ikke kun at the det skurrer når estetisk plastikkkirurgi somboth reelt sett er helsetjenester, og klart helsetjenester etterdistribution, merverdiavgiftsloven 3-2 andre ledd, essential cosmetic orinngår 50-50som cosmetic / medical it will be§impossible to set likevel ikke skal anses som helsetjenester etter merverdiavgiftsloven § 3-2 tredje ledd. up a list of interventions to be classified in one way or another.” The conclusion of the Vistatement stiller osswas: spørsmålet med hvorvidt vilkårene hhv. vilkår 1: «ikke medisinsk begrunnet», on “Conclusion: The draft regulations are nr. unclear anderwill be approximated og vilkår nr. 2: «ikke finansieres helt eller delvis av det offentlige», er ment å være to kumulative some eller of the abovesom impossible to practice. The regulations will represent vilkår, ompoints kirurgidescribed ikke skal anses en helsetjeneste i merverdiavgiftslovens forstand, dersom denne helsetjenesten ikke oppfyllerThe ett avproposal to vilkår.does not create confidence in the a significant danger of discrimination. for simplification of administration. DNLF will on begrunnet. this background I government’s Sverige gjelderplans unntaket estetiske operasjoner som for noen del er medisinsk Det svenske til in grunn eksempelvis en VAT pasient gjennomgår requireSkatteverket that health legger services theirat entirety mustbukplastikk be exemptsom from without thempå eget initiativ og bekoster med egne midler, er avgiftsuntatt i de tilfeller hvor den utførende leges proposed complicated delimitation attempts. The Norwegian Medical Society asks the vurdering er at inngrepet i noen grad er medisinsk begrunnet. Dessuten er offentlig finansiering i Academics follow som themtaler thefor above views up in itsom consultation agreement with Sverige kun ettomoment unntak, nårfurther legen vurderer det foreligger merverdiavgiftsplikt. Merverdiavgiftvurderinger er ikke noe for leger. the Ministry. With best regards. 5.2 Avgrensning av merverdiavgift på kirurgi

Det forslaget som nå er fremlagt er ment å avgrense mellom medisinsk og estetisk indiserte inngrep, men dersom offentlig finansiering blir et vilkår, vil dermed medisinsk indiserte The Norwegian Medical Society, Secretary General H.M Svabøogså Chief Negotiator Øyvind inngrep bli merverdiavgiftspliktige. Som eksempel kan nevnes at bukplastikk med operasjon av Sæbø ”. The proposal that has been sent for consultation will be similar to the proposal en 4,5 cm omslagsfold er medisinsk indisert, men av hensyn til prioriteringer og ventelister er retningslinjene for atinbukplastikken finansieres detfor offentlige blitt fastsatt til 5 health cm that was rejected 2001 based on the factav that a naturally integrated service, omslagsfold. Tilsvarende finansieres arrkorreksjon i ansikt og på underarm etter retningslinjene an exclusive exemption provision is given. It is proposed that «as a health service under dersom det er et «klart forbedringspotensial ved kirurgi». En svært dyktig plastikkirurg kan utføre en klar forbedring av arr for en pasient som har mottatt beskjed om treatment at kirurgi ikke the first paragraph, cosmetic surgery or cosmetic is not considered that is not finansieres av det offentlige. For operasjon av øyelokk er synsinnskrenkning blitt vilkår for medically justified and is not financed in whole or in part by it public », cf. section 3-2 finansiering av det offentlige. Ettersom det nesten ikke er mulig å skille ut estetisk fra medisinsk (3) of ithe Act. The why health service is performed who en pays, should not gevinst inngrepet for reason eksempel fora øyelokk, vil avgrensningen herand etablere styringsfunksjon for hva som enten er medisinsk etter kosmetisk indisert utfra den vurdering som den utøvende determine the tax liability. This will be unprovable health management discretion. Neither legen vil forsøke å anta at blir lagt til grunn på et gjennomsnitts sykehus.

the Swedish Tax Agency nor the EU Commission has advocated that VAT should intervene

Viinvet allelegislation’s at dette er helt subjektivtfrom knyttet til vurderingen av legenAsom pasienten møter. PFC Man their exemption VAT on health services. Swedish company tar ikke her en dybdevurdering for hvilken helsegevinst inngrepet vil gi for den enkelte, men Clinicmålbånd AB, however, a lawsuit against Swedish Tax Agency to obtain right to bruker for å se filed om man faller inn underthe såkalt medisinsk indikasjon. Denne apraksisen erdeduct ikke styrt av graden av medisinsk da det finnesthe dokumentasjon om f. eks input fee. PFC Clinic ABeffekt, won the caseikke against Swedish Taxpå Agency in the forskjellen mellom 4 cm og 6 cm fold på buken utgjør noen forskjell i helsegevinst. Det er av European the Court judgment March (C-91/12). hensyn til ventelister ogby ressurser man of har23 laget disse2013 prioriteringene.

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Vi har henvist alvorlige lipødem- pasienter som knapt kan gå til det offentlige, der de har fått The consequence is thatdefineres one wassom forced to introduce in plastic surgery the EU, for beskjed om at tilstanden kosmetisk. En slikVAT standard kan ikke værein grunnlaget helsetilbudet til norske pasienter. Ofte harproblems disse inngrepene som brystløft, armplastikk, with the delimitation and distribution there entails, but in the EU this is, from bukplastikk etc. lang ventetid. Da opererer mange seg i det private og bekoster både inngrepet the point of view of the VAT authorities, unwanted VAT liability remedied by low VAT og sykemeldingsperioden selv.

rates.

Vi opererer også pasienter som er betraktet som "ferdigbehandlet" i det offentlige

From the Swedish Tax Agency’s amendment (dnr: 111)enthe helsevesenet. Pasientene kan typisk komme og statement fortelle at de har 131 dårlig532863-14 livskvalitet/etter sykdom eller skade somAgency rekonstruktiv kirurgi. on Etter introduction is hit:som “In opprinnelig a position, ble thebehandlet Swedish Tax has reported theflere agency’s revisjoner der kun den estetiske funksjonen sto i fokus, har de gitt opp. Pasienten søker da hjelp perception of when aesthetic andmer treatments are taxable at VAT. The stance hos spesialister i estetisk kirurgioperations for å oppfylle av den integrerte estetiske funksjonen i det rekonstruktive inngrepet. Et eksempel kan være rekonstruksjon av bryst operations med eget vev. means a substantive change in the work’s previous view of aesthetic and treatments in this way that some become taxable. Aesthetic surgeries and treatments Så hvem skal definere i hvilken grad den estetiske funksjonen betyr noe for pasientens performed forvanskelig, purely cosmetic being medically motivated arepå taxable helse? Det er og det erpurposes ikke slik without at den avgjørelsen gjøres best av en lege sykehus. Den estetiske funksjonen er tett knyttet opp mot eget kroppsbilde og selvbilde hos noen. Dersom services. Characteristic of such interventions is that they performed exclusively for the det blir slik at man ikke liker hvordan man ser ut, vil det for noen bli slik at man ikke liker seg purpose or improving the fast appearance performed only as one as at selv. Og of dachanging følger det and med/uhelse. Det er slått gjennomand forskning av kosmetisk kirurgi det tilfører helsegevinst i et psykososialt perspektiv. a result of the patient’s own wishes. Aesthetic surgeries or treatments to some extent are medically motivated are tax-exempt healthcare. The assessment of if the procedure Vår søsterorganisasjon, Svensk for estetisk plastikkirurgi, ned et personnel omfattende is medically justified and mustforening be performed by licensed healthhar andlagt medical arbeid med å avklare en tilsvarende avgrensning, som vi i Norsk forening for estetisk healthcare within the framework of their identification. “ Most procedures have both plastikkirurgi gjerne videreformidler i denne sammenheng: medical and cosmetic indications. In a single operation it is therefore often impossible, or “Den estetiska plastikkirurgen ser tillstånd hos sina patienter som läkare inom andra very demanding toser distinguish between medical and aesthetic, plastic specialiteter inte trots att de är vanligt förekommande. Detrespectively är vår uppgift att surgery. definiera genesen av dessa. En god hälsa innebär att man är fysiskt och psykiskt frisk This is illustrated in the Swedish Tax Agency’s statement (dnr: 131 532863-14 / 111). med normal rörelseförmåga och ett utseende som inte avviker alltför mycket från det som betraktas som normalt. En avvikelse från den allmänt accepterade manliga eller kvinnliga utgör ofta ett utseendehandikapp och innebär betydande We hit fromkroppsbilden the assessment: Aesthetic surgeries and treatments that areen medically justified psykisk påfrestning. I sådana fall innebär en operation i syfte att minska psykiskt lidande are taxable except healthcare. It is licensed personnel in the health care system who ett skyddande av individen och är därmed sjukvård, på samma sätt som ett stödjande must do the assessment that the measure is medically på justified. Theutseendemässig licensed staff must psykologsamtal eller medicinering vid nedstämdhet grund av avvikelse. do the assessment within the framework of their identification. As long as the action en graviditet kan uppstå skador på bäckenbotten, underlivet och bukväggen. isVid medically justified thedet tax-exempt healthcare. Aesthetic surgeries or treatments can Kvinnokroppen utsätts för stort slitage genom den kraftiga övervikten. En viktuppgång bepåperformed on the basis that they are both medically motivated and has a cosmetic 20 kg hos en kvinna som väger 50 kg innebär en 40-procentigt ökad risk för belastningsskador påTax ryggen. Livmoderns med purpose. The Swedish Agency makes theanteversion assessmentkan thatgeif en thetöjningsskada procedure is to some isärglidning av de raka bukmusklerna samt hudbristningar. Dessa resttillstånd efter extent medically justified, it is medical care that is exempt from tax. Reconstruction of fysiologiska skeenden uppmärksammas inte tillräckligt. body parts after accident or illness and remediation of congenital Malformations are those Graviditeten och amningen utsätter brösten för stora förändringar, exempelvis that are medically Such measures act about improving the function and that the körteltillväxt och justified. atrofi efter avslutad amning. En del blir bestående, som tomma, platta eller uttöjda bröst. Att lägga in ett bröstimplantat vid kraftig bröstatrofi är ett patient, based on an assumed normality, is judged to be in medical need for treatment. rekonstruktivt ingrepp som ska betraktas som sjukvård. Cirka två tredjedelar av de Reconstructive interventions are thus from tax liability except healthcare. A circumstance

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that suggests that it is exempt from tax healthcare is that the measure is financed by

kvinnor som söker för vad som, lite slarvigt, kallas bröstförstoring tillhör denna one of the public healthcare authorities. It is worth noting that in Sweden there are tax kategori.

exemptions for interventions that to some extents are medically motivated, and that

Noen vanlige utfordringer som gjør det umulig å behandle pasientene etter objektive public funding is only a circumstance that speaks for certainly not a special condition for etterprøvbare kriterier, er følgende:

exemption, as the proposal for consultation is unfortunately formulated.

Eksempel 1-En pasient som plages av underutviklede bryster ønsker brystforstørrelse som gir et naturlig proporsjonalt uttrykk etter operasjonen. Er dette en operasjon som objektivt er uten psykososiale positive gevinster for pasienten? The proposal that is being consulted will necessarily entail VAT in addition to what is

intended. Neither the health professional environment in Sweden nor the Swedish state has in any way has had something gain from the fact thatvar a difficult delimitation Eksempel 2-Enwanted voksenor pasient forteller at han to i barneog ungdomsårene plaget med mobbing pga. utstående ører. Han er blitt avvist av en lege ved ØNH avdelingen med in surgery has been introduced in Swedish VAT legislation. This happened against the will begrunnelsen at problemstillingen hovedsakelig er estetisk. Bør dette avgjøre om pasienten, i of thetilSwedish Tax Agency,selv, as a skal result of the ECJtiljudgment 23.erMarch 2013 (C-91/12), tillegg å betale operasjonen betale moms staten? Det vitenskapelig dokumentert at operasjon av voksne pasienter, i tillegg til økt psykososial helsegevinst, også gir which was initiated by a single actor’s desire for a right to deduct for VAT on expensive til positive sosioøkonomiske gevinster. medical technical equipment for cosmetic laser treatment. It is therefore a paradox that in Eksempel 3-En pasient for brystreduksjon og brystløft, er blitt avvisttopåhowever, sykehusetit is stark contrast to thekommer Government’s simplification measuresogand contrary fordi hun ikke ønsker å fjerne så mye som 250 gram per bryst, som er den grensen som proposed that the VAT system’s service type-specific delimitation be introduced VAT on kvalifiserer for offentlig operasjon. Pasienten er 160 cm høy, og er smal over brystkassen. En the health serviceavaesthetic surgery. It seems that thebryster proposal based on offentlig reduksjon 250 gramplastic per bryst ville føre til unormale rentisestetisk. Børthat “body pasienten håndteres som bør betale moms på brystreduksjonen sin? pressure” should som lead en to kunde surgery, where the idea of ​​VAT as a tool against body pressure has given rise to propose value addedkirurgi tax oner services where one inogVAT reform intended Avgrensning avalso merverdiavgift innenfor både svært vanskelig svært betenkelig. for VAT. The delimitation and distribution problems that an introduction of VAT in plastic 5.3 Etiske utfordringer surgery will entail,advokat, should be inforplikter more detail. Asåfar as we can see,og thekosmetisk proposal will Legen er pasientenes og reviewed legeetikken oss til gi rett medisinsk behandling. vil undergrave den nødvendige tilliten mellom legedental og pasient dersomwhere legen parts also have Det unintended consequences for, among other things treatment, først anbefaler et inngrep som har både medisinske og kosmetiske gevinster, og deretter må of the treatment are cosmetic treatment «which is not medical justified and not financed in opplyse pasienten om at det må legges mva. på den kosmetiske delen av inngrepet. whole or in part by the public sector ». Is that the case for aesthetic surgery this is also the Vicase somfor er aktører helseperspektiv, en forsikring at pasientene et helsedental med treatment: “That thisertype of serviceom is exempt fromvurderes the law utfra involves a tax og omsorgsperspektiv. Vi har selv etablert etiske retningslinjer, og vi driver forskning på disse preference and leads to artificially low prices in relation to the prices of taxable goods pasientene i et helseperspektiv. Vi vet også hva uhelse er. Dersom moms innføres vil tjenestenand etableres en konsument-tjeneste. dagAesthetic har vi visse reguleringer markedsføringsloven. servicessom ». The Norwegian SocietyI for Plastic Surgerysom disagrees that it the claim Det er kun spesialisert helsepersonell som kan utføre tjenesten. Dersom disse kirurgiske applies to any of the things the dentist or plastic surgeon does. inngrepene som altså er integrerte og tett sammenvevd med rekonstruktive inngrep blir rent kommersialiserte, er det bekymringsfullt med tanke på fremtiden. Vi kan se for oss at aktørene da om 20 år har en helt annen bakgrunn f.eks. utdannet i utlandet i minimal invasive cosmetic 5.2 Delimitation of VAT on surgery surgery, og at pasientene våre er blitt degradert til kunder uten det omsorgsaspektet de trenger.

The proposal that has been sent for consultation will include a new legal provision in section 3-2, third paragraph of the Mval. The it is proposed in the supplement to the law Moms men på utgiftssiden det ikke bare kommesurgery utgifteror tilcosmetic that vil «as medføre a healthinntekter, service according to the firstvilparagraph, cosmetic administrasjon, men også behov for kontroll. Hva er et brystløft? Det er jo også en treatment thatAlle is not andogiskontrollfunksjonen not fully or partially funded by it public”. brystreduksjon? vil medically tolke dettejustified forskjellig, må være altoppslukende 5.4 Administrative utfordringer

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Theå bli delimitation problems thatUtgifter follow for from the new addition to the currentvildelimitation for rettferdig for pasientene. behandlinger av utenlandsopererte øke og disse of operasjonene vil heller staten skatteinntekter. health services, is notikke onlygithat it grinds when aesthetic plastic surgery as it really is health services and is clearly included as health services pursuant to the Value Added Tax Act §

Utfordringene omtalt 5.1 og 5.2 viser at objektive, etterprøvbare kriterier er avgjørende dersom 3-2leger second nevertheless shall not regarded as health to av the alle skalparagraph, kunne praktisere mva.-reglene likt.beUten slik regler, ingenservices identiskpursuant etterlevelse reglene. Objektive er enWe forutsetning for forutberegnelighet for Value Added Tax og Actetterprøvbare § 3-2 third kriterier paragraph. ask ourselves the question of whether the pasientene som skatteytere og legene som tjenesteytere.

terms resp. condition no. 1: «is not medically justified», and condition no. 2: “not financed

Følgende in wholeadministrative or in part by utfordring the publicfremgår sector”,avis høringsnotatet: intended to be two cumulative conditions, or

whether surgery is not be regarded as a health within the uten meaning «All kosmetisk kirurgi og to kosmetisk behandling utførtservice i private klinikker at detoferthe tattVAT stilling retthealth til behandling etternot pasientbrukerrettighetsloven Act, if til this service does meetog one of two conditions. vil dermed være avgiftspliktig. Det må altså foreligge en beslutning fra helsetjenesten/helsemyndighetene på at det konkrete kosmetisk kirurgiske inngrepet eller den kosmetiske behandlingen er medisinsk In Sweden, the exception applieshelt to aesthetic operations which to some extents are indisert og dekkes av det offentlige eller delvis». medically justified. The Swedish Tax Agency assumes that, for example, tummy tuck that a

Pasienter henvises i dag normalt uten at det foreligger «en beslutning fra helsetjenesten/ patient undergoes own and pays own funds, is pålegget tax-exempt in cases helsemyndighetene» om atinitiative det foreligger rett tilwith behandling. Dette fremstår somwhere the byråkratisk tungvint og svært kostbart for alle involverte. Hvor er Regjeringens forenkling? performer is cured assessment is that the procedure is to some extent medically justified.

In addition, public funding Swedenforonly a factor that speaksharforfølgende exceptions, when Vår søsterorganisasjon, Svenskinforening estetisk plastikkirurgi, forslag til hvordan vi som legerwhether muligensitkan klare å takle de økonomisk administrative utfordringene the doctor assesses exists VAT liability. VAT assessments are not for doctors.med å fordele inngående avgift som forslaget skaper:

The proposal that has now been presented is intended to delimit between medically ”Skatteverkets (det villbut säga att domen medför att »rättsläget har so and aestheticallyställningstagande indicated interventions, if public funding becomes a condition, ändrats för bedömningen av vilka sjukvårdstjänster som är undantagna från will medicallyhar indicated become subject As an att example, skatteplikt«) lett till interventions en komplex situation. Ett sätt to förVAT. utföraren hanteracan denbeär att »dela upp« verksamheten; det vill säga redovisa moms för en procentuell del av mentioned that tummy tuck with surgery of a 4.5 cm cover fold is medically indicated, verksamheten baserad på en årlig revision. Andelen sjukvård/icke sjukvård kan då but for the sake ofpå priorities and waiting lists arevariation, the guidelines for the tummy tuckoch being variera beroende patientklientel, geografisk specialistens inriktning läkarens by bedömning ingreppen.” financed the publicavsector have been set at 5 cm cover fold. Similarly, scar correction on the face and forearm is financed according to the guidelines if there is a «clear potential for En tilsvarende oppdeling ble akseptert av Høyesterett i Rt 2002.1469, "Eksakt regnskap". improvement in surgery». A very skilled plastic surgeon can perform a clear improvement Norsk forening for estetisk plastikkirurgi vil helst unngå de vanskelige fordelingsproblemene, og of scars for a patient whosom hasforslaget been notified that surgerypå does not financed by the public den administrative byrden om merverdiavgift enkelte inngrep medfører. sector. For eyelid surgery, visual impairment has become a condition for public funding. 6. Konsekvenser ved forslaget

As it is almost impossible to distinguish aesthetically from medical gain in the procedure,

6.1 Medisinturisme, reoperasjoner og infeksjoner for example for eyelids, the delimitation here will establish a control function for whatever Innføring av mva kan øke omfanget av medisinsk turisme, som i betydelig grad øker faren både is medically after cosmetically indicated based the assessment of the executive the doctor for MRSA-infeksjoner og for komplikasjoner, somon i neste omgang nødvendiggjør medisinsk indiserte reoperasjoner, kan en helsemessig trygghet i Norge, grundig har will try to assume thatogis som based onsvekke an average hospital. We all know thatvithis is completely erfart nødvendigheten av. Pasientsikkerheten er dårligere i utlandet. Mens private klinikker i subjectively related to the assessment theatdoctor that thei Norge patientmå encounters. does Norge tar ansvar ved komplikasjoner, serofman det offentlige tre inn når Man det oppstår komplikasjoner ved behandling i utlandet. 2: VG benefits Jakten påthe perfeksjon endte not take an in-depth assessment here forVedlegg what health procedure willgalt provide

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for the individual, however, uses measuring tape to see if one falls under the so-called medical indication. This practice is not governed by the degree of medical effect, as there is no documentation on whether eg the difference between 4 cm and 6 cm fold on the Ved Ahus har man ikke registrert noen tilfeller av komplikasjoner fra private klinikker siden abdomen makes someI difference in13 health gain. It’s off with regard to waiting lists and korona krisens utbrudd. 2019 var det innlagte pasienter med alvorlige /sykehusinnleggelses/krevende etter inngrep ved private klinikker, hvorav 80% resources one has made thesekomplikasjoner priorities. av disse var operert i utlandet. Eksempler på komplikasjoner er postoperative infeksjoner og sårrupturer, f.eks. ved brystimplantater eller bukplastikker. Faren for økning i MRSAinfeksjoner, som kanserious ha dødelige utfallpatients er høystwho reell.can barely go to the public where they We have referred lipedema

have been given notice that the condition is defined as cosmetic. Such a standard cannot

Pasienter med svakest økonomi vil erfaringsmessig i størst grad velge billigere behandling i be the basis forkomplikasjoner the health services for Norwegiankan patients. Often, procedures utlandet. Gitt at ved feilbehandlinger medføre plagerthese og økte kostnaderinclude for den enkelte forsterker forslaget sosiale helse.time. Innføring moms vil in breast lift, pasient, arm plastic surgery, tummy tuck ulikheter etc. longi wait Thenav many operate favorisere aktører i utlandet. Vi vil se økt spredning av urealistiske før/etter bilder på nett og the private sector and pay for both the procedure and the sick leave period itself. We also flere utenlandske konsultasjoner utført i Norge, uten at disse gjennomføres etter etiske operate on patients who are considered in the public sectori Oslo health care. Patients retningslinjer gjeldende i Norge. Vedlegg 3:“finished” VG Utenlands konsultasjoner

can typically come and tell that they have poor quality of life after one disease or injury that was originally treated as reconstructive surgery. 6.2 Bidrag til økte sosiale forskjeller Grunnet ressurssituasjonen i det offentlige helsevesenet, og lange ventelister, blir kosmetiske inngrep ofte behandlet ved private klinikker der pasientene selv må betale for behandlingen. After several audits where the aesthetic function infører focus, given up. Mange pasienter har ikke rådonly til å dekke slik kostnader, noewas som til they sosialhave ulikhet i helse. Kostnadene øke seeks som følge moms og det vil øke densurgery sosialeto ulikheten i innen The patientvilthen help av with specialists in det aesthetic fulfill more of helse. the Ressurssterke pasienter vil fortsatt ha råd til å sikre seg rett behandling.

integrated aesthetic function in its reconstructive intervention. An example could be breast

reconstruction with its hovedregel own tissue.unntatt So, who define to what extentpsykolog the aesthetic Psykologtjenester er som fra should mva. Pasienter som oppsøker grunnet kosmetiske komplekser og lav selvtillit, betaler derfor ikke mva. At kosmetisk kirurgi har function means something to the patient health? It is difficult, and it is not the case that dokumentert effekt som måte å fjerne årsaken til en psykologisk plage, viser blant annet en solid the studie. decision is best made a doctorinngrep in a hospital. The aesthetic function is closely tysk Alternativet til etby kosmetisk kan være svært langvarig behandling hos linked psykolog uten dokumentert effekt. (1 En studie av 550 pasienter foretatt ved Ruhr-Universitaetto one’s own body image and self-image. If it becomes so that you do not like how you Bochum - viser økt livskvalitet og selvtillit etter kosmetiske inngrep. look, it will be for some that you do not like yourself self. And then it comes with ill (https://www.sciencedaily.com/releases/2013/03/130311091121.htm) Nettside : www.nfep.no health. It has been established through research of cosmetic surgery that it adds health

6.3 Potensielt tap av viktig kompetanse benefits in a psychosocial perspective. Kvaliteten innen estetisk kirurgi kan bli svekket. Det må den ikke. Den «gode» hensikt å redusere visse operasjoner forsvarer ikke at standarden svekkes av at det blir færre operasjoner, og vedsister at kirurgi forsøkes utført «billigere». Vårefor relativt få plastikkirurgi-spesialister er down Our organization, the Swedish Society Aesthetic Plastic Surgery, has closed avhengig av «mengdetrening» for å utføre medisinsk indiserte inngrep på høyest mulig nivå. Det work dagens to clarify a similar we in the Norwegian Society for erextensively kostbart å holde standard. Detdelimitation, er velkjent at as merverdiavgift vrir forbruksmønsteret.

Aesthetic plastic surgery is happy to convey in this context: The aesthetic plastic surgeon

Forslaget vil bidra til å svekke private klinikker som gjennomfører medisinsk og kosmetisk sees conditions his patients as doctors within other specialties do og notventelistene look even though behandling der detinoffentlige helsevesenet ikke har tilstrekkelig kapasitet er lange. Mange private It klinikker harto avtaler ogGood gjennomfører operasjoner they are common. is our job definemed thehelseforetakene, genesis of these. health means that you betalt av det offentlige.

are physically and mentally healthy with normal mobility and an appearance that does not

too much from what considered normal. 7.deviate Konklusjon

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På denne bakgrunn mener vi helsetjenester i sin helhet fortsatt må unntas fra merverdiavgiften uten det foreslåtte kompliserte avgrensningsforsøk.

A departure from the generally accepted male or female body image often constitutes a visual impairment and involves a significant mental strain. In such cases, an operation aimedi at reducing mental suffering a protection of the individual and is thus healthcare, Styret Norsk forening for estetisk plastikkirurgi in the same way as a supportive psychologist call or medication in case of depression due Amin Kalaaji, overlege dr.med. leder. Email: ami.kal@online.no to appearance deviation. pregnancy, damage to the pelvic floor, abdomen and Bjørn Jarle Tvedt, overlege,During styremedlem Christian Busch, dr.med. styremedlem abdominal wall overlege can occur. The female body is exposed to great wear due to the heavy overweight. A weight gain of 20 kg in a woman who weighs 50 kg means a 40% increased risk of strain injuries to the back. The anteversion of the uterus can cause a strain injury dislocation of the straight abdominal muscles and stretch marks. These residual conditions after physiological events are not given enough attention. Med vennlig hilsen

Vedlegg 1: Pregnancy Etiske reglerand for breastfeeding plastikkirurgerexpose i Norgethe breasts to major changes, for example glandular

growth and atrophy after breastfeeding. Some become permanent, as empty, flat or

Vedlegg 2: stretched Inserting breast implant in case of severe breast atrophy is one VG Jakten breasts. på perfeksjon endtea galt Om medisinturisme. Belyser problematikken knyttet care. til manglende oppfølgning behandling reconstructive surgery to be considered medical About two-thirds of ved them women i utlandet og belastningen for det offentlige helsevesen i Norge ved komplikasjoner. Klinikker i who are for what, a little carelessly, is called breast augmentation belong to this Norge tarlooking selv ansvar ved eventuelle komplikasjoner.

category. Some common challenges that make it impossible to treat patients objectively

Vedlegg 3: verifiable criteria are the following: Example 1-A patient who suffers from underdeveloped VG Utenlands konsultasjoner i Oslo breasts wants breast augmentation that av gives a natural proportional after surgery. Om utenlandske klinikkers gjennomføring konsultasjoner i Norge utenexpression godkjenning, samt ulovlig i Norge. Is this markedsføringsvirksomhet an operation that is objectively without psychosocial positive gains for the patient?

Example 2-An adult patient says that he was bothered with in childhood and adolescence bullying due to protruding ears. He has been rejected by a doctor at the ENT department the reason that the problem is mainly aesthetic. Should this determine whether the patient, I in addition to paying for the operation yourself, should pay VAT to the state? It’s scientific documented that surgery of adult patients, in addition to increased psychosocial health benefits, also provides to positive socio-economic gains. Example 3-A patient comes for breast reduction and breast lift and has been rejected at the hospital because she does not want to remove as much as 250 grams per breast, which is the limit qualifies for public operation. The patient is 160 cm tall and is narrow above the chest. One public reduction of 250 grams per breast would lead to abnormal breasts aesthetically. Should the patient be treated as a customer who should pay VAT on his breast

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På denne bakgrunn mener vi helsetjenester i sin helhet fortsatt må unntas fra merverdiavgiften reduction? Defining VAT inavgrensningsforsøk. surgery is both very difficult and very worrying. uten det foreslåtte kompliserte Med vennlig hilsen

5.3 Ethical challenges The idoctor is the patients’ lawyer, and medical ethics obliges us to give the right medical Styret Norsk forening for estetisk plastikkirurgi and cosmetic treatment. It will undermine the necessary trust between doctor and patient Amin Kalaaji, overlege dr.med. leder. Email: ami.kal@online.no if the doctor first recommends a procedure that has both medical and cosmetic benefits, Bjørn Jarle Tvedt, overlege, styremedlem Christian Busch, styremedlem and then mustoverlege inform dr.med. the patient that VAT must be added. on the cosmetic part of the procedure. We who are actors with a health perspective are an assurance that patients are assessed on the basis of a health and care perspective. We have established ethical guidelines ourselves, and we conduct research on these patients in a health perspective. We also know what ill health is. If VAT is introduced, the Vedlegg 1: service willfor beplastikkirurger established as iaNorge consumer service. Today we have certain regulations such Etiske regler as the Marketing Act. Only specialized healthcare professionals can perform the service. Vedlegg 2: these surgical the interventions VGIfJakten på perfeksjon endte galt that are thus integrated and closely intertwined with Om medisinturisme. Belyser problematikken knyttet til manglende itoppfølgning reconstructive interventions become clean commercialized, is worryingved forbehandling the future.i utlandet og belastningen for det offentlige helsevesen i Norge ved komplikasjoner. Klinikker i We can imagine that actors then in 20 years has a completely different background eg Norge tar selv ansvar vedthe eventuelle komplikasjoner. educated abroad in minimally invasive cosmetic surgery, and that our patients have been Vedlegg 3: degraded to clients without the care aspect they need. VG Utenlands konsultasjoner i Oslo Om utenlandske klinikkers gjennomføring av konsultasjoner i Norge uten godkjenning, samt ulovlig markedsføringsvirksomhet 5.4 Administrative challengesi Norge.

VAT will bring income, but on the expenditure side, there will not only be expenses administration, but also the need for control. What is a breast lift? There is also one breast reduction? Everyone will interpret this differently, and the control function must be allconsuming to be fair to patients. Expenses for treatments of foreign surgeons will increase and these the operations will also not provide the state with tax revenue. The challenges discussed 5.1 and 5.2 show that objective, verifiable criteria are decisive if all doctors must be able to practice the VAT rules equally. Without such rules, no identical compliance the rules. Objective and verifiable criteria are a prerequisite for predictability patients as taxpayers and doctors as service providers. The following administrative challenge appears from the consultation memorandum: «All cosmetic surgery and cosmetic treatment performed in private clinics without it being taken position on the right to treatment according to the Patient and User Rights Act will thus be taxable. There must therefore

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På bakgrunn vi helsetjenester i sin helhet fortsattthat må the unntas fra merverdiavgiften be denne a decision frommener the health service / health authorities specific cosmetic surgery uten det foreslåtte kompliserte avgrensningsforsøk.

or cosmetic treatment is medical indicated and covered by the public sector in whole

Med or invennlig part ». hilsen Patients today are normally referred without a «decision from the health

servicei Norsk / the health authorities »that there is a right to treatment. This order appears as Styret forening for estetisk plastikkirurgi

bureaucratic cumbersome and very costly for everyone involved. Where is the Government’s

Amin Kalaaji, overlege dr.med. leder. Email: ami.kal@online.no simplification? Our sister organization, the Swedish Society for Aesthetic Plastic Surgery, Bjørn Jarle Tvedt, overlege, styremedlem has the following proposals howstyremedlem we as doctors can possibly cope with the financial Christian Busch, overlege dr.med.

administrative challenges to distribute the input tax that the proposal creates: “The Swedish Tax Agency’s position (that is to say that the judgment means that» the legal situation has amended for the assessment of which healthcare services are excluded from tax liability «) has led to a complex situation. One way for the performer to handle it is to “Divide” the business; that is, report VAT for a percentage of operations based on an annual audit. The Vedlegg 1: proportion of healthcare / non-healthcare can then vary depending on the patient clientele, Etiske regler for plastikkirurger i Norge geographical variation, the specialist’s focus and the doctor’s assessment of the procedure. “ Vedlegg A similar2:division was accepted by the Supreme Court in Rt 2002.1469, “Exact accounts”. VG Jakten på perfeksjon endte galt Themedisinturisme. Norwegian Society forproblematikken Aesthetic Plastic Surgery would prefer to avoidved thebehandling difficult i Om Belyser knyttet til manglende oppfølgning utlandet og belastningen for det offentlige helsevesen i Norge ved komplikasjoner. Klinikker i distribution problems, and the administrative burden that the proposal for VAT on certain Norge tar selv ansvar ved eventuelle komplikasjoner. interventions entails. Vedlegg 3: VG Utenlands konsultasjoner i Oslo 6. Consequences of the proposal Om utenlandske klinikkers gjennomføring av konsultasjoner i Norge uten godkjenning, samt ulovlig markedsføringsvirksomhet i Norge.

6.1 Medical tourism, reoperations and infections The introduction of VAT can increase the scope of medical tourism, which significantly increases the risk of both for MRSA infections and for complications, which in turn necessitate medical treatment indicated reoperations, and which can weaken a health security in Norway, we thoroughly have experienced the necessity of. Patient safety is poorer abroad. While private clinics in Norway takes responsibility for complications, it is seen that the public sector in Norway must step in when it occurs complications of treatment abroad. Appendix 2: VG The pursuit of perfection ended wrong. At Ahus, no cases of complications from private clinics have been registered since corona crisis outbreak. In 2019, there were 13 hospitalized patients with severe / hospitalization / demanding complications after surgery at private clinics, of which 80% of these were operated abroad. Examples of complications are postoperative infections and wound ruptures, for example, for breast implants or tummy

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På denne bakgrunn mener vi helsetjenester i sin helhet fortsatt må unntas fra merverdiavgiften tuck. risk ofkompliserte increase in avgrensningsforsøk. MRSA infections, which can have fatal outcomes is highly real. uten detThe foreslåtte Med vennlig hilsen

Experience has shown that patients with the weakest finances will to a greater extent choose cheaper treatment abroad. Given that complications of incorrect treatment can lead Styret i Norsk forening for estetisk plastikkirurgi to ailments and increased costs for the individual patient, the proposal reinforces social Amin Kalaaji, overlege dr.med. leder. Email: ami.kal@online.no inequalities in health. Introduction of VAT will favor actors abroad. We will see increased Bjørn Jarle Tvedt, overlege, styremedlem Christian Busch, dr.med. styremedlem proliferation ofoverlege unrealistic before / after photos online and several foreign consultations conducted in Norway, without these being conducted in accordance with ethics guidelines applicable in Norway. Appendix 3: VG Utenlands consultations in Oslo 6.2 Contribution to increased social differences Due to the resource situation in the public health service, and long waiting lists, are Vedlegg 1: becoming interventions are often treated at private clinics where patients have to Etiske reglercosmetic for plastikkirurger i Norge pay for the treatment themselves. Many patients cannot afford to cover such costs, which Vedlegg 2: leads to social inequality in health. VG Jakten på perfeksjon endte galt The costs will increase as a result of VAT and this will Om medisinturisme. problematikken knyttet til manglende oppfølgning ved to behandling increase the social Belyser inequality in health. Resourceful patients will still be able afford thei utlandet og belastningen for det offentlige helsevesen i Norge ved komplikasjoner. Klinikker i right treatment. Psychologist services are, as a general rule, exempt from VAT. Patients Norge tar selv ansvar ved eventuelle komplikasjoner. who consult a psychologist due cosmetic complexes and low self-esteem, therefore, do not Vedlegg 3: That cosmetic surgery has documented effect as a way to remove the cause of a pay VAT. VG Utenlands konsultasjoner i Oslo psychological shows, among other things, a solid German The alternative to Om utenlandskedistress, klinikkers gjennomføring av konsultasjoner i Norge utenstudy. godkjenning, samt ulovlig markedsføringsvirksomhet i Norge. a cosmetic procedure can be very long-term treatment psychologist without documented effect. (1 A study of 550 patients - conducted at the Ruhr-Universitaet- Bochum - shows increased quality of life and self-confidence after cosmetic procedures. (https://www. sciencedaily.com/releases/2013/03/130311091121.htm) Website: www.nfep.no 6.3 Potential loss of important competence The quality of aesthetic surgery can be impaired. It must not. The “good” intention to reducing certain operations does not justify weakening the standard by having fewer operations, and by attempting to perform surgery «cheaper». Our relatively few plastic surgery specialists are depending on “mass training” to perform medically indicated procedures at the highest possible level. The is expensive to maintain today’s standard. It is well known that VAT distorts consumption patterns. The proposal will help weaken

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På denne bakgrunn mener vi helsetjenester i sin helhet fortsatt må unntas fra merverdiavgiften private clinics that carry outavgrensningsforsøk. medical and cosmetic procedures treatment where the public uten det foreslåtte kompliserte

health service does not have sufficient capacity and the waiting lists are long. Many private clinics have agreements with the health trusts and carry out operations paid for by the government. Styret i Norsk forening for estetisk plastikkirurgi Med vennlig hilsen

Amin Kalaaji, overlege dr.med. leder. Email: ami.kal@online.no 7. Conclusion Bjørn Jarle Tvedt, overlege, styremedlem Christian overlege dr.med. styremedlem AgainstBusch, this background, we believe that health services in their entirety must still be

exempt from VAT without the proposed complicated delimitation attempt. With best regards The board of the Norwegian Society for Aesthetic Plastic Surgery Amin Kalaaji, chief physician dr.med. manager. Email: ami.kal@online.no Vedlegg 1: Bjørn Jarlefor Tvedt, chief physician, Etiske regler plastikkirurger i Norgeboard member Christian Busch, chief physician dr.med. board member

Vedlegg 2: VG Jakten på perfeksjon endte galt Om medisinturisme. Attachment 1: Belyser problematikken knyttet til manglende oppfølgning ved behandling i utlandet og belastningen for det offentlige helsevesen i Norge ved komplikasjoner. Klinikker i Ethical rules for plastic surgeons in Norway Norge tar selv ansvar ved eventuelle komplikasjoner. Vedlegg 3: 2: Appendix VG Utenlands konsultasjoner i Oslo VG The pursuit of perfection ended badly Om utenlandske klinikkers gjennomføring av konsultasjoner i Norge uten godkjenning, samt ulovlig i Norge. Aboutmarkedsføringsvirksomhet medical tourism. Illuminates the problem associated with lack of follow-up during

treatment in abroad and the burden on the public health service in Norway in the event of complications. Clinics in Norway takes responsibility for any complications. Appendix 3: VG Utenlands consultations in Oslo About foreign clinics conducting consultations in Norway without approval, as well illegal marketing activities in Norway.

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Norsk Plastikkirurgisk Forening v/leder Kjersti Ausen og Norsk Forening for Estetisk Plastikkirurgi v/leder Amin Kalaaji Trondheim, 3. august 2019

Norsk Plastikkirurgisk Forening v/leder Kjersti Ausen og

Norsk Forening for Estetisk Plastikkirurgi v/leder Amin Kalaaji Helsedirektoratet Juridisk avdeling Trondheim, 26. september 2019 Helsedirektoratet Forskrifter som omhandler kosmetiske inngrep hjemlet i Lov om Juridisk avdeling helsepersonell: Behov for endrede definisjoner. Tilleggsinformasjon til henvendelse av 13. september 2019:

Norsk Plastikkirurgisk Forening og Norsk Forening for Estetisk Plastikkirurgi mener uklarheter Forskrifter som omhandler kosmetiske inngrep hjemlet i Lov om helsepersonell: Behov for endredeforskrifter definisjoner. i følgende kan være til hinder for medisinsk og etisk forsvarlig utøvelse av kosmetisk kirurgi og kosmetiske behandlinger: Vi viser til henvendelsen nevnt over og vedlegger her et illustrativt eksempel som demonstrerer konsekvensene av manglende regulering av injeksjonsmarkedet i Norge:

1. Forskrift om tillatelse til å utføre kosmetiske kirurgiske inngrep 2. Forskrift om markedsføring av26. kosmetiske Se vedlegg som er kopi av nettsider den september inngrep 2019. Cliniika Akademi, som angivelig

er lokalisert i Drammen, annonserer her kurs i bruk av såkalte fillers, og spesifiserer på side 2 i vedlegget at «I henhold til det norske regelverket, trenger du ikke være autorisert helsepersonell fortillatelse å utføre fillerbehandling» (Uthevingen i dokumentet er gjortBehov av oss).for å endre Ad 1: Forskrift om til å utføre kosmetiske kirurgiske inngrep. Samtidig beskriver de at kurset skal ta for inngrep» seg fillerbehandling på kinnben, hvor injeksjoner definisjonen av «kosmetiske kirurgiske må gjøres ned mot benhinne med assosiert risiko for blodpropp i viktige ansiktsarterier og skade av nerver som går gjennom kinnbenet.

I forskrift om tillatelse til å utføre kosmetiske kirurgiske inngrep § 2 defineres «kosmetiske Dette er eninngrep» sak som visom: intuitivt ønsker å melde til Fylkeslegen/Helsetilsynet. Imidlertid tilsier

vår erfaring med tidligere saker at Helsetilsynet ikke har hjemmel i dagens lovverk til reagere selv i en sak som denne, og at aktøren derfor har sørgelig rett i forhold til sin uttalelse om at inngrep i henhold for til denne er inngrep hvor man«Kosmetisk «ikke trengerkirurgiske være autorisert helsepersonell å utføreforskriften, fillerbehandling».

kosmetiske hensyn er avgjørende indikasjon for inngrepet, dvs. inngrep som utføres i

Vi anbefaler følgende innskjerping av regelverket, jfr forrige henvendelse: den hensikt å forandre utseendet.»

- Fillers, høyenergilasere og alt annet utstyr for kosmetiske behandlinger som gir reell effekt- og dermed samtidig reell fare for bivirkning- må reguleres som medisinsk I merknad forskriftens 2 står følgende: side, og vi håper dette vil vedtas. utstyr. Dette er til allerede foreslått§fra myndighetenes 10. Regulations concerning cosmetic procedures «Forskriften er begrenset å omfatte inngrep med bruk av kirurgisk kniv. Ved bruk av// 103 -Anvendelse av alt utstyrtilsom er regulert som medisinsk utstyr må være reservert andremed metoder som benyttes innenfor feltet,Kosmetiske legges helsepersonelloven 4 om personer tilstrekkelig medisinsk kompetanse. behandlinger som§tar i bruk forsvarlighet Denneavbestemmelsen innebærer blant annet at helsepersonell ikke denne type utstyr til mågrunn. være initiert lege. Dersom ansvar for anvendelse delegeres til annet

«kosmetiske inngrep» som: «Kosmetisk kirurgiske inngrep i henhold til denne forskriften, er inngrep hvor kosmetiske hensyn er avgjørende indikasjon for inngrepet, dvs. inngrep som utføres i den hensikt å forandre utseendet.» I merknad til forskriftens § 2 står følgende: «Forskriften er begrenset til å omfatte inngrep med bruk av kirurgisk kniv. Ved bruk av andre metoder som benyttes innenfor feltet, legges helsepersonelloven § 4 om forsvarlighet til grunn. Denne bestemmelsen innebærer blant annet at helsepersonell ikke skal gå ut over sine kvalifikasjoner i forbindelse undersøkelse, behandling og annen helsehjelp til pasienter.»

Den gjeldende definisjon av kosmetisk kirurgiske inngrep i forskriften er begrenset til «bruk 1 av 12 av kirurgisk kniv». Dette er etter vår mening uheldig og til fare for pasientsikkerhet. DeSide siste årene har minimalt invasive metoder i økende grad blitt tatt i bruk innen de kirurgiske spesialiteter, også innen plastikkirurgi. Disse teknikkene ar det til felles at det tilstrebes minst mulig ytre tilgang gjennom hud. Selve operasjonen gjennomføres ikke med kniv, men med lange, tynne instrumenter. Som eksempler fra andre kirurgiske spesialiteter kan nevnes kikkhulloperasjoner med tilgang til bukhuen (laparoskopi), til brysthulen (thorakoskopi) eller blokking av blodkar med stenter eller katetre (endovaskulær behandling). Selv om snittet i huden ved disse behandlingene kan være minimalt og til dels kan lages uten kniv er det risiko for komplikasjoner og vesentlig skade. Minimalt invasive teknikker som er benyttet innen kosmetiske inngrep omfatter særlig forenklet fettsuging samt ansiktsløfting ved bruk av fremmedmaterialer i underhud (se vedlegg 1). Norsk Forening for Estetisk Plastikkirurgi sendte primo 2019 bekymringsmeldinger til Helsetilsynet både angående fettsuging i form av «laserlipolyse» (3.februar 2019) samt arrangement av «trådløftkurs» kun for sykepleiere (28. mars 2019). I begge saker har Helsetilsynet åpenbart vært i tvil med hensyn til hvordan man skal forholde seg til forskriftens angitte «bruk av kirurgisk kniv», og de har sendt saken videre til Helsedirektoratet for ytterligere klargjøring (Se vedlegg 2 og 3 for fulltekstdokumenter). Angående laserlipolyse: Helsetilsynet har sendt følgende vurdering videre til Helsedepartementet (Ref 2019/1019 3 SUL av 8. mai 2019): «Det fremgår av merknaden til forskrift om tillatelse til å utføre kosmetisk kirurgiske inngrep § 2 at forskriften er begrenset til å omfatte inngrep med bruk av «kirurgisk kniv». Spørsmålet blir dermed om inngrepet figurforming/fettsuging med laserlipolyse kan anses å gjøre bruk av kirurgisk kniv. I sin henvendelse hit viser Fylkesmannen til Statens helsetilsyns avgjørelse av 1. november 2013 i vår sak 2013/922. (...) I avgjørelsen kom Statens helsetilsyn til at laserlipolyse ikke kunne sies å innebære bruk av kirurgisk kniv. I vurderingen har vi lagt vekt på at perforasjonsområdet er knappenålsstort og at det heller ikke er behov for suturering. Det fremgår av bekymringsmeldingen av 3. februar 2019 at NFEP er uenig i at behandlingen med laserlipolyse ikke utføres med kirurgisk kniv. Vi viser til henvendelsen i sin helhet når det gjelder begrunnelsen for dette. Statens helsetilsyn ber om Helsedirektoratets uttalelse til om laserlipolyse er en behandlingsform som omfattes av forskrift om tillatelse til å utføre kosmetiske kirurgiske inngrep» 10. Regulations concerning cosmetic procedures 104 //

I avgjørelsen kom Statens helsetilsyn til at laserlipolyse ikke kunne sies å innebære bruk av kirurgisk kniv. I vurderingen har vi lagt vekt på at perforasjonsområdet er knappenålsstort og at det heller ikke er behov for suturering. Det fremgår av bekymringsmeldingen av 3. februar 2019 at NFEP er uenig i at behandlingen med laserlipolyse ikke utføres med kirurgisk kniv. Vi viser til henvendelsen i sin helhet når det gjelder begrunnelsen for dette. Statens helsetilsyn ber om Helsedirektoratets uttalelse til om laserlipolyse er en behandlingsform som omfattes av forskrift om tillatelse til å utføre kosmetiske kirurgiske inngrep» Beskrivelsen av «knappenålsstore innstikksteder» uten behov for suturering er direkte villedende. Mange plastikkirurgiske klinikker har blitt oppsøkt av pasienter som etter laserlipolyse hos landets største aktør har multiple innstikksteder med sutur som skal fjernes etter 14 dager, og også med underhudsblødninger/hevelser som reflekterer en vesentlig kirurgisk påvirkning av bløtvev. Innstikkstedet reflekterer på ingen måte den underliggende Side 9 av 12 vevsskaden. Angående trådløft: Helsedirektoratet har sendt følgende svar på Helsetilsynets/Fylkesmannens anmodning om hjelp til lovtolking; «For å omfattes av forskriften, må den aktuelle behandlingen med trådløft omfattes av definisjonen på kosmetisk kirurgiske inngrep i § 2. Kosmetisk kirurgiske inngrep er etter § 2 inngrep hvor kosmetiske hensyn er avgjørende indikasjon for inngrepet. Trådløftet omfattes derfor i utgangspunktet av denne definisjonen. Det fremgår videre av Helse- og omsorgsdepartementets merknader til § 2 at forskriften er begrenset til å omfatte inngrep med bruk av "kirurgisk kniv". Det presiseres ikke nærmere i merknadene hva som omfattes av uttrykket, for eksempel om uttrykket kniv kan omfatte mer enn en skalpell. Den nærmere vurderingen av hva som anses som "kosmetisk kirurgiske inngrep" i forskriften § 2 og hvilke metoder som anses som bruk av "kirurgisk kniv" må skje gjennom praksis. Relevante momenter kan være hvilket redskap som brukes, størrelsen på innstikksåpningen og om man må sy eller ikke etter inngrepet. Dersom metoden innbefatter bruk av kniv/skalpell, omfattes den av forskriften, og metoden kan da bare utføres av lege som enten har en generell tillatelse, jf. § 3, eller som har særlig tillatelse etter § 4.» I begge disse tilfellene blir håndheving av Forskrift om tillatelse til å utføre kosmetiske kirurgiske inngrep knyttet opp til utseende på innstikksåpning og hva som kan kalles kirurgisk kniv. Vi mener dette er et lite relevant og potensielt villedende medisinsk mål på inngrepets størrelse og assosiert pasientrisiko, særlig i dagens behandlingsbilde med stadig økende bruk av minimalt invasiv kirurgi. Vi mener også at § 4 som viser til forsvarlighet, ikke i tilstrekkelig grad sikrer pasientene mot vesentlig kosmetiske kirurgiske inngrep kamuflert som minimale inngrep. Vi ber om at merknad til forskrift endres for bedre å reflektere inngrepenes risikoprofil. Vi foreslår at formuleringen «Forskriften er begrenset til å omfatte inngrep med bruk av kirurgisk kniv.» i merknad til forskriften utgår og erstattes med «Forskriften omfatter inngrep som involverer bruk av instrumenter i vev dypere enn dermis (lærhuden). Dette omfatter kniv eller andre instrumenter som er egnet til å forårsake vevsskade»

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Ad 2: «Forskrift om markedsføring av kosmetiske inngrep»: Behov for endret definisjon av «kosmetiske inngrep». Et økende antall klinikker har de siste år tilbudt såkalte kosmetiske behandlinger uten lege tilstede. Klinikkene har tilbudt injeksjonsbehandlinger i hud og underhud av både nervetoksiner (botox), skleroserende medikamenter, volumekspanderende preparater (fillers), samt mekanisk/kjemisk manipulering av hud med laser/syre. De skisserte behandlinger medfører risiko for bivirkninger og varig vevsendring. Ny lov og forskrift om medisinsk utstyr er nylig sendt ut på høring. Denne angir at produkter med primært kosmetisk effekt skal være underlagt samme regelverk som medisinsk utstyr, da de har sammenlignbart skadepotensiale. Tilbydere må kun utføre slike behandlinger på riktig indikasjon, og da kreves tilstrekkelig medisinsk kompetanse i henhold til forsvarlighet jfr helsepersonelloven. Forskrift om markedsføring av kosmetiske inngrep burde omfatte alle kosmetiske behandlinger som nevnt over, da slike behandlingsformer i henhold til merknad til forskrift kan omfattes av forskriften. Myndighetene har imidlertid til nå ikke håndhevet forskriften ovenfor denne type kosmetiske behandlinger, men begrenset restriksjonen til estetisk kirurgi. Innen annen estetisk behandling foregår utstrakt bruk av både før/etter-bilder samt tilbud om gratiskonsultasjoner og rabatter. Behandlinger som kan påføre vev varig endring og potensielle alvorlige bivirkninger må være underlagt samme markedsføringsrestriksjoner som kosmetisk kirurgiske inngrep. Denne type behandlinger må i tillegg kun tilbys under medisinsk forsvarlige forhold. Forskriften definerer «kosmetiske inngrep» i § 3: «Med kosmetiske inngrep menes plastikkirurgiske inngrep og inngrep i hud og underhud hvor kosmetiske hensyn er en avgjørende indikasjon for inngrepet.» I merknad til § 3 står følgende: «Et kirurgisk inngrep er å anse som et kosmetisk inngrep når det avgjørende hensynet for å utføre inngrepet er av kosmetisk karakter og ikke av medisinsk karakter. Forskriften omfatter «kirurgiske inngrep». Med dette menes først og fremst inngrep med bruk av kirurgisk kniv, men også markedsføring av andre behandlingsformer (som bruk av laser, kanyler for utsuging eller deponering/implantasjon av kunstige materialer under huden og sprøyter), vil kunne omfattes. Det er imidlertid en forutsetning at inngrepet anses for å være helsehjelp og at det utføres av helsepersonell eller på delegasjon av helsepersonell. Dette innebærer at for eksempel hudpleie eller kosmetisk pleie som naturlig utføres av hudpleiere/kosmetologer faller utenfor forskriftens virkeområde»

Vi foreslår at andre avsnitt i merknad til forskrift endres til følgende:

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10. Regulations concerning cosmetic procedures Side 9 av 12

«Med kosmetiske inngrep menes inngrep som kan påføre vev en varig endring, enten dette er i form av kirurgi, injeksjon av kunstige substanser eller legemidler, eller mekanisk/kjemisk manipulering av hud og underhud, og hvor kosmetiske hensyn er en avgjørende indikasjon for inngrepet»

Behov for ytterligere regulering av kosmetiske behandlinger: Kosmetiske behandlinger som skissert innebærer risiko for varig skade, og må være underlagt medisinsk tilstrekkelig regulering. Botox og skleroserende substanser er legemidler og derfor allerede underlagt regulering. En nylig advarsel fra Helsetilsynet til både lege og sykepleier etter ikke-supervisert utskriving av disse substansene har stor prinsipiell betydning, og en presisering av legeansvaret ved bruk av Botox har i ettertid blitt sendt ut av Helsedirektoratet (vedlegg 4). Begge disse hendelsene er viktige og riktige steg i reguleringen av det estetiske markedet. Ut fra forslag til ny lov for medisinsk utstyr, skal produkter til estetiske behandlinger nå likestilles med medisinsk utstyr ut fra skadepotensiale. Forsvarlighetskravet i Helsepersonelloven må da også gjelde produktene som listes i vedlegg XVI til forordningen om medisinsk utstyr. Dette innbefatter Injeksjonspreparater med volumekspanderende effekt, impanterbart materiale som tråder brukt til «trådløft», samt mekaniske og kjemiske metoder for å påføre begrenset vevsskade for oppstrammende effekt. Helsedirektoratet bør formulere en tydeliggjøring rundt rekvirering og bruk av denne type utstyr som for botox (vedlegg 4). Endringen i lov og forskrift om medisinsk utstyr er ut fra en intensjon om øket pasientsikkerhet. Siden lov om medisinsk utstyr så tydelig omfatter produkter brukt i kosmetiske behandlinger, styrkes behovet for endrede definisjoner som nevnt i denne henvendelsen. Da vil man kunne håndheve forskriftene i henhold til intensjonen. Med vennlig hilsen Kjersti Ausen, Leder Norsk Plastikkirurgisk Forening Amin Kalaaji, Leder Norsk Forening for Estetisk Plastikkirurgi 4 vedlegg: 1. Illustrasjon av reklame på nett om laser-lipolyse og trådløft 2. Forespørsel fra Helsetilsynet til Helsedirektoratet om definisjon av «kirurgi» i forbindelse med klagesak rundt laser-lipolyse. 3. Svar angående sak i vedlegg 2 med illustrasjon av fokus på «kniv» ved kirurgi. 4. Helsedirektoratets presisering av regler rundt botoxinjeksjon

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Appendix 1

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Vedlegg 22 Appendix

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Vedlegg 3 3 Appendix Emne: Klage på trådløftkurs sendt til Statens helsetilsyn

Til Amin Kalaaji Jeg viser til din henvendelse til Statens helsetilsyn datert 28.03.19 om "Klage på trådløftkurs". Henvendelsen ble videresendt til Fylkesmannen, som 15.05.19 sendte din henvendelse videre til Helsedirektoratet med spørsmål om lovtolking. Du viser til at det inviteres til trådløftkurs for sykepleiere, og at dette er et inngrep som innebærer penetrering av hud og som kan føre til skader når det ikke gjøres av kirurger/plastikkirurger. Du ber om at denne virksomheten følges opp. Du viser også til at det reklameres med bilder som er villedende. Helsedirektoratet kan uttale seg generelt om hvordan regelverket skal forstås, men den nærmere anvendelsen av regelverket i praksis må foretas av Fylkesmannen og Statens helsetilsyn. Generelt har helselovgivningen få regler med hensyn til hvem som kan utføre forskjellige former for inngrep. Forskrift om tillatelse til å utføre kosmetisk kirurgiske inngrep er et unntak. Det fremgår av forskriften § 1 at kosmetisk kirurgiske inngrep kun kan utføres av leger som har generell tillatelse, jf. § 3, eller leger som har fått spesiell tillatelse fra Fylkesmannen etter § 4. Det er bare inngrep som anses som kosmetisk kirurgiske inngrep som omfattes, jf. § 2. For å omfattes av forskriften, må den aktuelle behandlingen med trådløft omfattes av definisjonen på kosmetisk kirurgiske inngrep i § 2. Kosmetisk kirurgiske inngrep er etter § 2 inngrep hvor kosmetiske hensyn er avgjørende indikasjon for inngrepet. Trådløftet omfattes derfor i utgangspunktet av denne definisjonen. Det fremgår videre av Helse- og omsorgsdepartementets merknader til § 2 at forskriften er begrenset til å omfatte inngrep med bruk av "kirurgisk kniv". Det presiseres ikke nærmere i merknadene hva som omfattes av uttrykket, for eksempel om uttrykket kniv kan omfatte mer enn en skalpell. Den nærmere vurderingen av hva som anses som "kosmetisk kirurgiske inngrep" i forskriften § 2 og hvilke metoder som anses som bruk av "kirurgisk kniv" må skje gjennom praksis. Relevante momenter kan være hvilket redskap som brukes, størrelsen på innstikksåpningen og om man må sy eller ikke etter inngrepet. Dersom metoden innbefatter bruk av kniv/skalpell, omfattes den av forskriften, og metoden kan da bare utføres av lege som enten har en generell tillatelse, jf. § 3, eller som har særlig tillatelse etter § 4. Du viser i din henvendelse til at det både er reell fare for blødninger og for nerveskader når inngrepet ikke utføres av autoriserte kirurger/plastikkirurger. Kravet til forsvarlig virksomhet etter helsepersonelloven § 4 gjelder, også når et inngrep ikke omfattes av forskrift om tillatelse til å utføre kosmetisk kirurgiske inngrep. Se til orientering også anledningen til å

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benytte medhjelper etter helsepersonelloven § 5 og Helsedirektoratets Rundskriv til helsepersonelloven. Helsepersonell skal ikke gå ut over sine kvalifikasjoner ved ytelse av helsehjelp, og slik jeg forstår din henvendelse mener du at en sykepleier som utfører et slikt inngrep gjør det, uavhengig av om det kreves særlig tillatelse etter forskriften eller ikke. Eventuell videre oppfølging av virksomheter som har tilbud om trådløft er en oppgave for Fylkesmannen og Statens helsetilsyn. Ta gjerne kontakt dersom du har flere spørsmål. Vennlig hilsen Eva Elander Solli seniorrådgiver/ jurist Avdeling helserett og bioteknologi tlf. 810 20 050, mobil 948 00 986

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Appendix Vedlegg 44 https://www.helsedirektoratet.no/tema/helsepersonelloven/rekvirering-og-bruk-avbotulinumtoksin-botox#!

Rekvirering og bruk av botulinumtoksin Bare leger kan forskrive og rekvirere botulinumtoksin fra apotek Botulinumtoksin, som Botox, kan kun rekvireres av lege til humanmedisinsk bruk. Annet helsepersonell, som for eksempel sykepleiere, kan ikke beslutte at en person skal behandles med botulinumtoksin.

Hvem kan behandle med botulinumtoksin? Botulinumtoksin er et reseptpliktig legemiddel og behandling med botulinumtoksin kan derfor kun foretas av helsepersonell med nødvendig kompetanse. Dette følger av forsvarlighetskravet i helsepersonelloven. Forsvarlighetskravet innebærer at helsepersonell ikke kan gå ut over sine kvalifikasjoner i forbindelse med undersøkelse, behandling og annen helsehjelp. Botulinumtoksin er et registrert reseptbelagt legemiddel som har skadepotensiale ved feil bruk, se preparatomtalen for Botox. Helsepersonell som behandler med botulinumtoksin, skal før behandling gis, ha fått opplæring i hvordan man bruker legemidlet. Opplæringen skal blant annet omfatte kunnskap om hvordan legemidlet gis, men også kunnskap om oppfølging og observasjon etter at legemidlet er administrert. Dette betyr at helsepersonellet må kunne håndtere en 112 //

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Side 9 av 12

uventet utvikling etter at botulinumtoksin er satt, for eksempel allergiske reaksjoner, anafylaktisk sjokk eller skade på vev.

Bruk av medhjelper Når annet helsepersonell enn lege injiserer botulinumtoksin, vil helsepersonellet som injiserer opptre som rekvirerende leges medhjelper etter helsepersonelloven § 5. Det er rekvirerende leges ansvar at medhjelperen har tilstrekkelig kompetanse. Legen skal gi nødvendige instruksjoner og føre tilsyn med medhjelperen. Dette innebærer at ansvarlig lege må være tilgjengelig for å gi råd, veiledning og instruksjon.

Oppsummering En sykepleier kan ikke ta beslutningen om å tilby behandling med botulinumtoksin. Sykepleieren kan imidlertid injisere legemidlet dersom en lege har besluttet behandling med botulinumtoksin for en konkret person. Det er et krav at sykepleieren har fått tilstrekkelig opplæring. Sykepleiere kan kun injisere botulinumtoksin som legens medhjelper. Ansvarlig lege skal på forhånd ha vurdert at sykepleieren har den nødvendige kompetansen og tilgjengelige midler for å håndtere uventede hendelser, som for eksempel allergiske reaksjoner.

Referanser Helsepersonelloven §§ 4, 5 og 11

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Sykepleiere kan kun injisere botulinumtoksin som legens medhjelper. Ansvarlig lege skal på forhånd ha vurdert at sykepleieren har den nødvendige kompetansen og tilgjengelige midler for å håndtere uventede hendelser, som for eksempel allergiske reaksjoner.

Referanser Helsepersonelloven §§ 4, 5 og 11 Rundskriv - Helsepersonelloven med kommentarer - krav til bruk av medhjelpere Forskrift om rekvirering og utlevering av legemidler fra apotek §§ 2-1 og 2-2

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Forskrift om legemiddelhåndtering § 4 tredje ledd Rundskriv - Legemiddelhåndteringsforskriften med kommentarer Preparatomtale for Botox

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Norsk Plastikkirurgisk Forening v/leder Kjersti Ausen og Norsk Forening for Estetisk Plastikkirurgi v/leder Amin Kalaaji Norsk Plastikkirurgisk Forening v/leder Kjersti Ausen og Norsk Forening for Estetisk Plastikkirurgi v/leder Amin Kalaaji

Trondheim, 26. september 2019 Trondheim, 26. september 2019

Helsedirektoratet Helsedirektoratet Juridisk avdeling Juridisk avdeling

Tilleggsinformasjon til henvendelse av 13. september 2019: Tilleggsinformasjon til henvendelse av 13. september 2019: Forskrifter som omhandler inngrep hjemlet i Lov om helsepersonell: Behov for Forskrifter som omhandlerkosmetiske kosmetiske inngrep hjemlet i Lov om helsepersonell: Behov for endrede definisjoner. endrede definisjoner. Vi viser til henvendelsennevnt nevnt over over og herher et illustrativt eksempel som som Vi viser til henvendelsen ogvedlegger vedlegger et illustrativt eksempel demonstrerer konsekvensene av av manglende manglende regulering av injeksjonsmarkedet i Norge: demonstrerer konsekvensene regulering av injeksjonsmarkedet i Norge: Se vedlegg som er kopi av nettsider den 26. september 2019. Cliniika Akademi, som angivelig Se vedlegg som er kopi av nettsider den 26. september 2019. Cliniika Akademi, som angivelig er lokalisert i Drammen, annonserer her kurs i bruk av såkalte fillers, og spesifiserer på side 2 er lokalisert i Drammen, annonserer her kurs i bruk av såkalte og spesifiserer på side 2 i vedlegget at «I henhold til det norske regelverket, trenger du ikkefillers, være autorisert i vedlegget at «I henhold til det norske regelverket, trenger du ikkeer være helsepersonell for å utføre fillerbehandling» (Uthevingen i dokumentet gjortautorisert av oss). helsepersonell for å utføre fillerbehandling» (Uthevingen i på dokumentet er injeksjoner gjort av oss). Samtidig beskriver de at kurset skal ta for seg fillerbehandling kinnben, hvor må gjøres ned mot risiko for blodpropp i viktige ansiktsarterier og Samtidig beskriver debenhinne at kursetmed skalassosiert ta for seg fillerbehandling på kinnben, hvor injeksjoner skade av nerver går gjennom må gjøres ned motsom benhinne med kinnbenet. assosiert risiko for blodpropp i viktige ansiktsarterier og skade av nerver som går gjennom kinnbenet. Dette er en sak som vi intuitivt ønsker å melde til Fylkeslegen/Helsetilsynet. Imidlertid tilsier vår erfaring med tidligere saker at Helsetilsynet ikke har hjemmel i dagens lovverk til reagere Dette eri en saksom somdenne, vi intuitivt ønsker derfor å melde Fylkeslegen/Helsetilsynet. Imidlertid selv en sak og at aktøren har til sørgelig rett i forhold til sin uttalelse om at tilsier vår erfaring med tidligere saker at Helsetilsynet ikke har hjemmel i dagens lovverk til reagere man «ikke trenger være autorisert helsepersonell for å utføre fillerbehandling».

selv i en sak som denne, og at aktøren derfor har sørgelig rett i forhold til sin uttalelse om at anbefaler følgende regelverket, jfrfor forrige henvendelse: manVi«ikke trenger væreinnskjerping autorisert av helsepersonell å utføre fillerbehandling». - Fillers, høyenergilasere ogav altregelverket, annet utstyr for behandlinger som gir Vi anbefaler følgende innskjerping jfr kosmetiske forrige henvendelse: reell effekt- og dermed samtidig reell fare for bivirkning- må reguleres som medisinsk utstyr. Dette er allerede foreslått fra myndighetenes side, og vi håper dette vil vedtas.

- Fillers, høyenergilasere og alt annet utstyr for kosmetiske behandlinger som gir reell effektog dermed reellerfare for bivirkningmåutstyr reguleres somreservert medisinsk -Anvendelse avsamtidig alt utstyr som regulert som medisinsk må være utstyr. Dettemed er allerede foreslått fra myndighetenes side, ogbehandlinger vi håper dette personer tilstrekkelig medisinsk kompetanse. Kosmetiske somvil tarvedtas. i bruk denne type utstyr må være initiert av lege. Dersom ansvar for anvendelse delegeres til annet

-Anvendelse av alt utstyr som er regulert som medisinsk utstyr må være reservert personer med tilstrekkelig medisinsk kompetanse. Kosmetiske behandlinger som tar i bruk denne type utstyr må være initiert av lege. Dersom ansvar for anvendelse delegeres til annet Side 1 av 4

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helsepersonell, må delegerende lege være tilgjengelig i lokalene. Dette er utstyr med reell fare for skadelig bivirkning og må ansees som medisinsk behandling jfr Helsepersonelloven. -Anvendelse av alt utstyr som er regulert som medisinsk utstyr må defineres som kosmetiske inngrep og må derfor underlegges Forskrift om markedsføring av kosmetiske inngrep. Se vårt forslag i forrige brev til endring av definisjonen av «kosmetiske inngrep» i merknad til forskriftens § 3. Dersom Helsedirektoratet mener det er på sin plass å melde denne saken til Helsetilsynet, så gjør vi gjerne dette. Vi frykter imidlertid at dette er en sak tilsvarende de eksempler vi har nevnt i forrige henvendelse, hvor Helsetilsynet kan ønske å få veiledning fra Helsedirektoratet mht tolkning av lovtekst, som pr dags dato er utilstrekkelig for å kunne få stoppet slik åpenbar pasientskadelig praksis. MVH Kjersti Ausen Leder Norsk Plastikkirurgisk Forening Amin Kalaaji Leder Norsk Forening for Estetisk Plastikkirurgi Vedlegg ang Cliniica Akademi:

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Norsk Plastikkirurgisk Forening v/leder Kjersti Ausen og Norsk Forening for Estetisk Plastikkirurgi v/leder Amin Kalaaji Norsk Plastikkirurgisk Forening v/leder Kjersti Ausen og Norsk Forening for Estetisk Plastikkirurgi v/leder Amin Kalaaji

Trondheim, 26, november 2019 Trondheim, 26. september 2019 Helsedirektoratet Juridisk avdeling Helsedirektoratet Juridisk avdeling

Tilleggsinformasjon henvendelse av 13. september 2019: Nytt innspill til saktil19/34886 Forskrifter som omhandler kosmetiske inngrep hjemlet i Lovhjemlet om helsepersonell: Forskrifter som omhandler kosmetiske inngrep i Lov omBehov for endrede definisjoner. helsepersonell: Behov for endrede definisjoner. Vi viser til henvendelsen nevnt over og vedlegger her et illustrativt eksempel som demonstrerer konsekvensene av manglende regulering av injeksjonsmarkedet i Norge: Kjære Helsedirektoratet. Se vedlegg som er kopi av nettsider den 26. september 2019. Cliniika Akademi, som angivelig

Vi etterlyser svar på tidligere to innspill av juni 2019 og september 2019 i sak 19/34886 er lokalisert i Drammen, annonserer her kurs i bruk av såkalte fillers, og spesifiserer på side 2 vedrørende inngrep behov for endret ordlyd relevante forskrifter, og vi i i vedleggetestetiske at «I henhold til detog norske regelverket, trenger duiikke være autorisert helsepersonell foret å utføre fillerbehandling» (Uthevingen i dokumentet er gjort av oss). vedlegger her nok eksempel på bruk av før/etter-bilder ved markedsføring av estetiske Samtidig beskriver de at kurset skal ta for seg fillerbehandling på kinnben, hvor injeksjoner inngrep i form av injeksjoner og deponering av fremmedmateriale (Vedlegg 1). Bildene må gjøres ned mot benhinne med assosiert risiko for blodpropp i viktige ansiktsarterier og inkluderer som kinnbenet. representerer dyp injeksjon av fremmedmateriale ned mot skade avhakeforstørrelse, nerver som går gjennom ben og på ingen måte kan ansees å være en overflatisk kosmetisk hudbehandling. I Dette er en sak som vi intuitivt ønsker å melde til Fylkeslegen/Helsetilsynet. Imidlertid tilsier annonseringen presiseres også at injeksjonene utføres av helsepersonell. Den aktuelle vår erfaring med tidligere saker at Helsetilsynet ikke har hjemmel i dagens lovverk til reagere klinikken skriver i sin markedsføring de i henhold tilrett norsk lov ikke kan vise før/etter-bilder selv i en sak som denne, og at aktørenat derfor har sørgelig i forhold til sin uttalelse om at man «ikke trenger være autorisert helsepersonell å utføre fillerbehandling». etter kirurgi, men mener altså at dette er tillattfor etter injeksjonsbehandlinger. Vi anbefaler følgende innskjerping av regelverket, jfr forrige henvendelse:

Vi antar denne uttalelsen er basert på at det i Norge praktiseres et frislipp av reklame for Fillers, høyenergilasereside. og altDa annet utstyrom for markedsføring kosmetiske behandlinger som girinngrep fillere fra -helsemyndighetenes forskrift av kosmetiske reell effektog dermed samtidig reell fare for bivirkningmå reguleres som medisinsk allerede angir at «deponering/implantasjon av kunstige materialer under huden og sprøyter, utstyr. Dette er allerede foreslått fra myndighetenes side, og vi håper dette vil vedtas. vil kunne omfattes av forskriften», synes vi det er underlig at HDir og Helsetilsynet har valgt å trekke grensen ved av hvorvidt det er er brukt kirurgisk kniv, jfr praksis etter prøvd sak -Anvendelse alt utstyr som regulert som medisinsk utstyr må være reservert personer (Vedlegg med tilstrekkelig medisinsk kompetanse. behandlinger Forening som tar i bruk 2019/1019 2). Denne praksis fører til at Kosmetiske Norsk Plastikkirurgisk sine interne denne type utstyr må være initiert av lege. Dersom ansvar for anvendelse delegeres til annet etiske regler som forbyr bildebruk i markedsføring oppfattes som urimelig av enkelte av våre medlemmer. Vi opprettholder at all bruk av metoder som har medisinsk virkning men også Side 1 av 4

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potensiell bivirkning må ansees som helsehjelp og en medisinsk mulighet, men ikke som et kommersielt produkt der målet blir å selge mest mulig. Forskrift om markedsføring av kosmetiske inngrep i medhold av helsepersonelloven § 13 gjelder markedsføring av enhver art og i ethvert medium, jf. § 2. «Med kosmetiske inngrep menes «plastikkirurgiske inngrep og inngrep i hud og underhud hvor kosmetiske hensyn er en avgjørende indikasjon for inngrepet», jf. § 3. Forskriften avgrenser mot inngrep der det avgjørende hensynet er av medisinsk karakter. Den gjelder først og fremst inngrep ved bruk av kirurgisk kniv, men bruk av laser, kanyler for utsuging, deponering/implantasjon av kunstige materialer under huden og sprøyter, vil kunne omfattes av forskriften. Som for helsepersonelloven kreves det imidlertid at inngrepet anses for å være helsehjelp, og at det utføres av helsepersonell eller på delegasjon av helsepersonell. Dette innebærer at for eksempel hudpleie og kosmetisk pleie som naturlig utføres hos hudpleiere/kosmetologer faller utenfor forskriftenes virkeområde.» Fillere, som f eks Restylane og Juvaderm, er definert som medisinsk utstyr, jfr Lov om medisinsk utstyr § 3 (1) c). Disse kan på ingen måte ansees å være hudpleie/kosmetisk pleie. Dermed må administrasjon av dette utføres av helsepersonell eller på delegasjon av helsepersonell. Fillere er deponering/implantasjon av kunstige materialer under huden ved hjelp av sprøyter, jfr definisjonen tilknyttet Forskrift om markedsføring av kosmetiske inngrep. Vi ber om at også dette innspillet linkes til sak 19/34886, og vi etterlyser tilbakemelding i saken. Norsk plastikkirurgisk forening har ikke meldt noen saker angående markedsføring av denne type kosmetiske inngrep videre til Helsetilsynet siden sak 2019/1019, da tolkningen signalisert fra HDir dengang tilsier at å prøve ytterligere saker vil være fånyttes. Dersom HDir mener det er på tide å få en ny sak meldt inn til Helsetilsynet, for å eventuelt kunne tolke lovteksten slik den står med fokus på hva som potensielt kan gi helsemessige bivirkninger og ikke bruk av spesifikt kirurgisk kniv, så vil vi gjerne ha beskjed om dette. For Norsk Plastikkirurgisk Forening og Norsk Forening for Estetisk Plastikkirurgi, Kjersti Ausen Amin Kalaaji

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Appendix Vedlegg 1 1

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11. PROPOSED NORWEGIAN STANDARD FOR EXTENDED INFECTION CONTROL BY: AMINCOVID-19 KALAAJI, MD, PHD CONTROL

PRESIDENT OF THE NORWEGIAN SOCIETY OF AESTHETIC PALSTIC SURGERY AMI.KAL@ONLINE.NO April 22, 2020 BRANCH STANDARD PROPOSAL FOR THE REOPENING OF AESTHETIC PLASTIC SURGERY WHILE CONTAINING THE SPREAD OF COVID-19 DURING THE PERIOD FROM APRIL 20th 2020 UNTIL NORMALIZATION KINDLY NOTICE THAT THESE ARE GUIDELINES TO OPERATE ON COVID-19 NEGATIVE INDIVIDUALS ONLY, NOT INFECTED PATIENTS OR SUSPECTED CASES. THERE WILL ALWAYS BE A SMALL PORTION OF ASYMPTOMATIC PATIENTS. WE CAN NEVER ELEMINATE THE RISK, BUT WE CAN REDUCE IT TO A MINUMUM. THESE GIUDLINES ARE MORE SPECIFIC TO AESTHETIC SURGERY PROCEDURES. YOU OUGHT TO ADD THEM TO YOUR HEALTH AUTORITIES GENERAL GUIDELINES. WITHOUT THE EFFECTIVE CONTROL OF THE COVID-19 PANDEMIC IN THE COUNTRY ITSELF AND AMONG THE POPULATION, THESE GUIDELINES WOULD NOT SERVE THE PURPOSE THEY WERE WRITTEN FOR. MANAGEMENT OF COVID-19 IS ESSENTIAL BEFORE YOU AIM FOR A REALISTIC AND SAFE APPLICATION OF THESE GUIDELINES (I.E. RATIO OF VIRAL TRANSMITION TO HEALTHY INDIVIDUALS SHOULD BE LOWER THAN 1). INTERGRATE/MODIFY WHAT YOU THINK IS MORE PRACATICAL AND/OR AVAILABL IN YOUR OWN COUNTRY/COMMUNITY. DO NOT WAIT FOR HEALTH AUTHORITIES TO DECIDE FOR YOU BUT PROVIDE THEM THE POSSIBILTY TO RATHER COMMENT AND ENDORSE WHAT YOU THINK IS BEST FOR YOUR SPEICALITY. BE PROACTIVE AND START PLANING FROM NOW. I WISH YOU GOOD LUCK. AMIN KALAAJI, MD, PHD PRESIDENT OF THE NORWEGIAN SOCIETY OF AESTHETIC PALSTIC SURGERY AMI.KAL@ONLINE.NO

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BRANCH STANDARD PROPOSAL FOR THE REOPENING OF AESTHETIC PLASTIC SURGERY WHILE CONTAINING THE SPREAD OF COVID-19 DURING THE PERIOD FROM APRIL 20th 2020 UNTIL NORMALIZATION TELEPHONE-BASED SCREENING OF ALL PATIENTS ONE DAY BEFORE ADMISSION AND REPEATED UPON ADMISSION 1 Do you feel sick? YES NO 2 Are you currently experiencing fever? YES NO 3 Are you currently experiencing cough? YES NO 4 Were you tested for coronavirus? YES NO 5 If yes: was the test positive? YES NO 6 Are you in quarantine? YES NO 7 Are any of the people you live with in isolation or quarantine? YES NO 8 Have you been traveling outside Norway (your country) within the last 14 days? YES NO 9 Have you had cold / flu symptoms during the last 14 days? YES NO If the answer to one or more questions is YES, the patient should be rejected. Forms should be scanned and added to the patients record and inserted as a note into the journal. EXTENDED PROCEDURES AT THE CLINIC 1 Door sign with a screening questionnaire and other precautionary measures such as maintaining a two-meter distance etc. In case of a positive screening result, the patient should not be allowed to enter the clinic. 2 All patients need to be screened for elevated temperature. 3 On arrival, all patients need to wash their hands with soap and water. 4 All activities are adjusted to avoid queuing, and placed so that a 2-meter distance can be maintained.

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5 Ensure a 2-meter gap between patients sitting in the waiting room. Take sufficient time for consultations - 30 minutes for controls and 60 minutes for new consultations. Extend opening hours if needed. 6 Restrict/eliminate the use of cash. 7 NO handshakes. Adhere to a rigorous cough and hand hygiene. 8 Establish distance between patients on the post-operative care unit. 9 Have only one patient on surveillance at a time, when keeping a 2-meter distance cannot be realized. Relatives are only allowed to pick up patients at the hospital entry. 10 Make 2-meter markings at the entrance, in the waiting room and the post-operative care unit.

SUGGESTED EXTENSION OF CLINICAL PROTECTION MEASURES – EMPLOYEES 1 Do not handshake, comply with cough and hand hygiene, and follow local work clothing guidelines. 2 To minimize the spread of infections through objects, remove all non-essential furniture and equipment such as magazines, coffee machines, etc. 3 Regular liquor washing of door handles, card terminals, surfaces etc. 4 Ensure patient compliance with distance and infection control rules. 5 Use disposable gloves with every patient contact. 6 Personnel with respiratory symptoms, cough or fever should not be at work. A 7-day asymptomatic interval is required before work is resumed. 7 Responsible physicians and general managers of companies have joint responsibility for the implementation of extended infection control measures. 8 The entire staff must be taught extended infection prevention measures.

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9 In waiting rooms, a minimum of a 2-meter safety distance must be respected. 10 Patients are encouraged to NOT socialize with people outside their household for at least one week after surgery. 11 All surfaces in the operating room need to be washed between two consecutive procedures. 12 Operations need to be structured so that distance between employees can be facilitated.

MEDICAL ASSESSMENTS TO BE MADE DURING THIS PERIOD. 1 Avoid major combination procedures with increased risk of complications such as circumferential abdominal plastic, abdominal surgery combined with breast reduction or breast lift, thigh plastic and the like. 2 Avoid prolonged interventions exceeding 3 hours. 3 Avoid high-risk patients such as patients with high BMI and smokers. Select ASA 1 and 2 (see appendix). 4 Be extra careful in the preoperative assessment and avoid risk groups. 5 The clinic must have established readiness to address postoperative complications. 6 The entire team should use facial masks in the operating room. 7 Treatment: wear gloves during all patient contact. 8 During intubation: anaesthesia personnel should use headgear with neck and visor and mouth bandage for intubation. 9 In the case of Rhinoplasty, all staff members should use at least an all-face head mask extended to the neck. However, this procedure is considered to be among Aerosol Generating Procedures (AGP) by health authority and therefore, certain precautions should be applied to the infected patient or patient suspected to be Covid-19 positive. This means that there is an increased risk for infections so that glasses as well as FFP 3 masks should be used by the whole team working in the operating room. It is up to you as surgeon to decide whether to use such equipment or not if you consider your healthy patient to be an asymptomatic carrier.

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10 Consider starting with consultations and checking the first days of April 20 to give the staff a 10 Consider good insight starting into the with new consultations procedures. and checking the first days of April 20 to give the staff a good insight into the new procedures. 11 Use of total face masks on the dermal and ablative laser as well as procedures that could cause 11 Use of total face masks on the dermal and ablative laser as well as procedures that could cause splashing. splashing. With best regards, With best regards, Amin Kalaaji, MD, PhD Amin Kalaaji, PhD Association for Aesthetic Plastic Surgery President of theMD, Norwegian President of the Norwegian Association for Aesthetic Plastic Surgery ami.kal@online.no ami.kal@online.no

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G. PICTURES

From NAAM October 3, 2019

1. PRESIDENTS NFEP THROUGH 37 YEARS

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1983-1986 Chairman: Gorm Bretteville

1986-1988 Chairman: Morten Kveim

1990-2000 Chairman: Kjell Aass

2000-2004 Chairman: Frode Samdal

2004-2008 Chairman: Frode Amland

2010-2012 Chairman: Helge Einar Roald

2012-2014 Chairman: Ayman Zakaria

2014-2016 Chairman: Bjørn Rosenberg

2018-2020 Chairman: Amin Kalaaji

1. Presidents NFEP through 37 years

2. MISCELLANEOUS HISTORICAL PICTURES Various photos: The photos below show some key people in Norwegian Society for Aesthetic Plastic Surgery. by Kjell Aas

Johs. Smehaug, Fredrikstad - First spring meeting in Stavanger for NPF - spring 1990

Målfrid and Roar Rindal, Oslo - spring meeting 1990 2. Miscellaneous historical pictures

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Berit Aass, Kjell Aass, Målfrid Rindal - spring meeting 1990

Kjell Aass and Gorm Bretteville, Nordic meeting Iceland 1991

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Kjell and Mossik Andenæs, European Congress Berlin 1993

Morten Kveim, European Congress, Berlin 1993

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The Norwegian Society for Aesthetic Plastic Surgery (NFEP) is a society for specialists in plastic surgery who work with aesthetic surgery in Norway. The society is only open to experienced specialists who are in active practice of cosmetic surgery. The society works to promote a high professional standard, medical as well as ethical, in cosmetic surgery. NFEP seeks to safeguard the interests of the subject area and contribute to factual information on the subject.