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medicines matter The Irish Phar maceutical Healthcare Association

MARCH 2007

HIGH QUALITY INFORMATION WILL BENEFIT IRISH PATIENTS Value

Patients have a legitimate need for, and right to, information about diseases, therapeutic strategies and medicinal products. There is widespread agreement among EU institutions and the public that communications with patients and the public about prescription medicines should be improved with the objective of having better informed patients, so they can make sensible choices about their treatment. Patients are being provided with increasing amounts of information from different parties with various objectives and sent through multiple channels, particularly on the internet. This information is of varying quality and accuracy. Ironically the manufacturers of medicines are largely restricted from providing information to patients whilst anyone else it seems is free to do so. Would it not be better for patients to get good quality information, in a wellregulated way, from the actual source of their treatments? As noted recently by European Commission Vice President Gunter Verheugen the current restrictive position in many Member States and EU citizens’ uneven access to information, are ”unsatisfactory and (…) even unacceptable.”

Industry has a key role to play The pharmaceutical industry firmly believes that better informed patients will lead to safer and more successful health

outcomes, a more efficient use of healthcare resources and ultimately, to healthier societies. It is clear that no single source can provide all the available information but pharmaceutical companies have a wealth of knowledge and information to share about health and medicines having researched and developed their products over a long period (average 10-12 years per approved product). The pharmaceutical industry is not advocating US style Direct-to-Consumer-Advertising as an appropriate model for Europe; rather it believes that it should be enabled, along with a range of other sources, to supply non-promotional, high quality disease and health related information to EU citizens.

Taking the initiative in Ireland There are examples of excellent educational activities produced or supported by pharmaceutical companies in Ireland. The obvious example is disease awareness activities (see related article), which broadly encourage patients to seek medical help for conditions, which they thought were untreatable, are subject to stigma or taboo (such as sexually transmissible diseases) or simply too “embarrassing” (e.g. incontinence). Pharmaceutical companies also produce materials solely for distribution after their medicine has been prescribed. These help patients to use their medicines correctly in a variety of ways; for example, by

Partnership

NEW IPHA PRESIDENT Mr John McLaughlin was recently elected as President of the Irish Pharmaceutical Healthcare Association (IPHA). John has over 20 years’ experience in the European pharmaceutical industry having held positions in the UK and Sweden. John is also Managing Director of sanofiaventis in Ireland – he became MD following the merger of Sanofi-Synthelabo and Aventis Pharma in December 2004. He has been an active member of the IPHA Strategy Board since the Association’s inception in 1996. Upon taking office John said that an important goal of his Presidency will be to establish even deeper relationships with Irish healthcare partners and State Agencies.

Novo Nordisk

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Within the High Level Pharmaceutical Forum it was decided to develop information on diabetes as an example of the type of information which maybe provided to patients. In Ireland alone, it is estimated that there are 200,000 people with diabetes and a further 200,000 who have diabetes but are unaware that they have the condition. According to Diabetes Ireland “It is generally accepted that there is a distinct lack of awareness in the community about diabetes and its symptoms.” Information is the key to helping these people live longer, healthier and more productive lives.

IPHA President Mr John McLaughlin

In a recent address at the IPHA Annual Dinner he noted that as an industry we are moving from the old model of “develop and sell” to a model based on “innovation and engagement”. Increasingly pharmaceutical companies are becoming more collaborative, more transparent and more sensitive to customer needs, delivering more complete healthcare solutions. As an example, IPHA members, with the support of IDA Ireland and (continued on back page)


HIGH QUALITY INFORMATION WILL BENEFIT IRISH PATIENTS (CONTINUED) explaining simply what the condition is, what the medicine does and the importance of using it properly, by providing advice and aids on selfadministration techniques where, e.g. eye drops or inhalers, are involved, by providing memory aids for dose timing and by providing self-help advice and support. The IPHA Medicines Compendium CD provides independent, regulatory authority approved information on over 2,000 medicines currently on the market. The latest CD was provided free of charge to all GPs, Consultants, community and hospital pharmacists in the country. It allows the user to learn more about the correct use of medicines – such as what the possible side effects of any medication might be and how a particular medicine might interact with another. It is an accompaniment to the IPHA hosted website www.medicines.ie which provides up to the minute information on prescription and ‘overthe-counter’ (non prescription)

medicines. These materials support health professionals’ work and help to ensure the safe and effective use of medicines.

Informed patients are healthier patients The High Level Pharmaceutical Forum, which brings together Ministers from EU Member States, representatives of the European Parliament, patients, the pharmaceutical industry, health care professionals, and insurance funds, was established in June 2005 to examine the competitiveness of the European-based pharmaceutical industry and related public health issues. One of the issues it is examining is that of information to patients. It is charged with advising on ways to improve the quality of information on authorised medicines available to European patients. In a recent progress report, the Forum welcomed the proposal for developing guidance on the production of high quality, easily understandable and

accessible information on diseases and medicines (including prevention where appropriate) for people in Europe. It further stated that information creation and exchange based on partnerships should be defined according to different situations (e.g. differences between national health systems) – possible partners it identified included Member States, patient/consumer organisations, physicians, pharmacists, other health care professionals, industry, social insurers and the wider stakeholder community including learned societies and academia. This was echoed by Commissioner Verheugen. He stated that “a potential source of information is the industry which has the knowledge, skills and resources to provide, at least, basic information. National and European regulatory authorities already depend on the industry to provide information for leaflets, labels and national databases. There is no reason why we should not build on this.”

Responsibility

DISEASE AWARENESS CAMPAIGNS QUALITY HEALTH INFORMATION, A WIN-WIN FOR ALL In recent years, a number of pharmaceutical companies have been associated with public advertising campaigns designed to raise awareness of specific diseases and encourage sufferers or at risk people, to seek advice on treatment. These campaigns can be of great benefit to the public, informing them of facts about their condition and highlighting appropriate sources of advice. Many of the campaigns have been run under the umbrella of patient associations and have been funded wholly or in part by the industry. The campaigns are particularly useful for conditions or symptoms that might otherwise go untreated,

including asymptomatic diseases like diabetes and hypertension, and embarrassing conditions like impotence and incontinence. When it comes to serious, life-threatening and quality-of-life-threatening diseases, such as diabetes, lack of patient knowledge can lead to problems. Appropriately planned and structured disease awareness campaigns run in conjunction with credible patient associations can grow a patient population, not by drawing in people who don't need treatment, but by educating those who do, to recognise the fact.

Naturally, this can lead to increased demand on the health services but surely that's better than letting these patients wait until their condition becomes much more serious, perhaps requiring expensive hospital treatment? And that's just the economic viewpoint. What about the harm done to the quality of life of those who live in ignorance of the treatments available for their condition - or even of the condition itself? The pharmaceutical industry in this country is committed to behaving in a responsible, ethical and professional manner. All of the activities of the industry including disease

awareness campaigns are subject to stringent pharmaceutical regulations and rigorous Codes of Practice (see www.ipha.ie). Industry is committed to improving information and cooperating with all involved parties, such as doctors, regulators and pharmacists, to ensure the appropriate use of medicines. Disease awareness campaigns motivate people to seek help and advice from healthcare professionals for symptoms they have simply been tolerating, for serious conditions they didn't know they had, or for conditions they thought untreatable. For further information contact Mr Ronan Collins (ronancollins@ipha.ie).


IPHA ANNUAL MEETING Innovation

CLINICAL RESEARCH: REAL VALUE FOR IRELAND “Innovation is the central issue in economic prosperity” according to Michael Porter. His words are quite appropriate for Pharma Ireland today. At the recent IPHA Annual Meeting industry professionals heard that the pharmaceutical industry in Ireland will have to move up the value chain if Ireland is to remain a key location for the pharmaceutical industry into the future. The value chain, a systematic approach to examining the development of competitive advantage was a term created by Porter in his book, Competitive Advantage (1985) where by activities such as R&D created and build value. These theories were echoed by the Minister for Enterprise Trade and Employment Michael Martin when he said that the country needed to attract a new type of high end manufacturing concentrating on research and development, process development and drug discovery. He said that the Government was working to refine the current R&D tax credit so that it could better help to assist in making Ireland a centre renowned for its research excellence. IPHA President John McLaughlin said that over the last 20 years Ireland had become a location of choice for the international research based pharmaceutical industry. Fourteen of the top fifteen pharmaceutical companies worldwide now had manufacturing operations in Ireland and the country is the largest net exporter of pharmaceuticals in the world. He said that that there were many competing centres around the globe for pharmaceutical investment and the challenge was to move up the value chain in the years ahead. A vibrant, research-led pharmaceutical industry was needed to help create the knowledge-based economy Ireland needs to be successful in the 21st Century.

Ms Anne Nolan, IPHA Chief Executive with Minister for Enterprise, Trade and Employment, Mr Micheal Martin TD and Mr John McLaughlin, IPHA President at the opening of the IPHA Annual Meetings.

Value Professor Des Fitzgerald, Chairman of the Health Research Board, identified clinical research as ‘a real opportunity for Ireland’. He pointed out that the quality of clinical care and research, the scale of the population, the level of investment in academic research and the commitment of government to invest in the knowledge economy had all created this opportunity. To turn this opportunity into reality further investment was required to ensure more clinicians could engage in clinical research. IPHA President John McLaughlin identified three things that needed to be done if Ireland was to become a world centre for clinical research:

“We need to standardise the ethics committee approval system and enhance its predictability. We need to have full compliance with the existing legislation and we need sufficient funding to enable the employment of dedicated health researchers throughout the health services.” He said that unless the current problems were ironed out, Irish patients and researchers would continue to miss out on the benefits of early access to important new treatments. For further information contact Mr Ronan Collins (ronancollins@ipha.ie).

Innovation

“In order for Ireland to be successful going forward we must assist more companies gain a corporate R&D mandate as well as, develop Irish R&D value propositions that attract corporate R&D decision makers.” stated Dr Bishop. According to Dr Bishop these include:

The impact of nurse prescribing on the NHS in the UK was summed up in just a few words at the recent IPHA Annual Meeting. Ms Trudy Granby, Assistant Director of the NHS National Prescribing Centre said that “the extension of prescribing responsibilities to nurses was fundamental to modernising the NHS”. Ms Granby has been involved in the implementation of nurse prescribing, at both local and national level, since the early pilot sites were established in the UK in 1996. She identified research carried out by the National Prescribing Centre on the key areas where nurse prescribing has had an impact within the health services in the UK. It showed that: •

BUILDING R&D IN LIFE SCIENCES Dr Leonora Bishop, Head of Life Sciences within the Research, Skills & Manufacturing Division of IDA Ireland spoke about the IDA’s work in creating and implementing strategic initiatives that encourage multinational companies to carry-out R&D activities in Ireland. Having attracted leading pharmaceutical companies to this island Ireland is already identified as a key location for the global pharmaceutical industry.

IMPACT OF NURSE PRESCRIBING

• • • • •

Having the people with the right research expertise; Having the right science and technology platforms; Sharing a substantial proportion of the risk; Providing simple and reasonable access to intellectual property; Having the right fiscal environment to incentivise spend and subsequent exploitation.

• • • • • •

Patients’ access to medicines had increased; Patient waiting time had been reduced; Existing services had been improved; New services had been developed; Doctor time had been freed up; Nurse time had been saved; There was increased job satisfaction within the profession.

Dr Bishop explained the approach taken by IDA Ireland. She stated that “marketing and branding Ireland internationally as a knowledge, innovation and technology business location; creating a major operational focus on developing R&D capability in-company as well as developing ‘connectedness’ between Industry and Academia through collaborative R&D are all key elements of the IDA strategy to encourage multinational companies to carry-out R&D activities in Ireland.”

IPHA recently submitted comments to the Department of Health and Children on this topic welcoming proposals that widen access to modern and effective medicines in accordance with good clinical care to the benefit of patients.

For further information contact Ronan Collins (ronancollins@ipha.ie).

For further information contact Dr Rebecca Cramp (rebeccacramp@ipha.ie).


NEW IPHA PRESIDENT (continued from page 1)

Science Foundation Ireland, are developing partnerships with Irish third level institutions. These partnerships offer great hope of improved treatments not only for Irish patients but for patients around the globe and they will consolidate our image and reputation as an increasing player, of world class standard, in the area of pharmaceutical research and innovation. He will also focus on developing IPHA’s role as an important player in Irish healthcare. IPHA will remain keenly focused on developing partnerships that build healthier societies during the course of his Presidency. John will hold the position of IPHA President for a term of two years.

Minister for Health and Children Ms Mary Harney TD with IPHA President Mr John McLaughlin at the IPHA Annual Dinner 2006

Irish Pharmaceutical Healthcare Association Franklin House 140 Pembroke Road Dublin 4 Ireland T: +353 1 660 3350 F: +353 1 668 6672 E-mail: info@ipha.ie Website: www.ipha.ie Content: Anne Nolan, Brian Murphy, Ronan Collins, Rebecca Cramp Publisher: © Irish Pharmaceutical Healthcare Association Ltd Design and production: Slick Fish Design, Dublin

Innovation

SOMEONE HAS TO PAY FOR INNOVATION The cost of healthcare is rising in nearly all countries of the European Union (EU). Since there are hardly any options to increase revenue – except by raising taxes or introducing higher charges, those responsible are searching desperately for ways to save costs. Items such as medical doctors’ salaries or hospital budgets are considered taboo, and so the expenditure for medications is usually the main focus – to an extent that far exceeds this segment’s proportion of total costs. The paradox is that EU experts are fully aware of the importance of a competitive and innovative pharmaceutical industry. But, in comparison with the U.S., for instance, the pharmaceutical sector in the EU has recently lost ground. There are many reasons for this, such as less networking between academic and industrial research, the highly fragmented European market, a lack of risk capital and the unpredictable development of health policy. However, focusing on drug costs frequently fails to achieve the desired effect – especially in pricing policy. Medicines are often considered isolated from the total picture. Instead of silo budgeting, the commonly used form today, a look at the overall economic situation would be far more informative. For example, medicines can sometimes help shorten stays in hospital. But one thing should be perfectly clear to everyone: lower earnings will also reduce the financial possibilities of pharmaceutical manufacturers to develop new innovations. Above all they must have the prospect that investment in innovative products will some day pay off in the market. Without this certainty an important incentive is lacking. Some people even propagate the erroneous idea that true innovation in the healthcare sector only comes from small biotech companies and not the major pharmaceutical manufacturers. Indeed, the truth is that both depend on each other. Most

biotech companies simply do not have the capacity to turn their ideas into marketable products. Because of this mutual interdependence it damages the entire branch if one partner, i.e. the large companies, is weakened by certain regulations. And this occurs through pricing policy. Generics cause further problems. In some EU countries the amount of the reimbursement for drugs is reduced to the price level of generics after patent protection ends. And this price restriction often extends to include “similar” medications that are still under patent protection. This policy is not only an attack on the rights to intellectual property, it also frustrates the incentive to develop more innovative drugs. Many European governments act as if drug innovation is a matter of course and completely independent from their own policies. Since innovative medications are available today beyond borders, more and more people forget that innovation can only continue if somewhere someone pays for it. Governments that reduce their national drug prices lower their contribution to accrued costs and hope that others will take care of it. If everybody acted this way, the consequences would be clear. The strategy of the individual country ends up contradictory to the common goal. One is reminded of the prisoner’s dilemma in game theory. It assumes that the player who acts selfishly, but trusts in the cooperation of his partner supposedly gets the rewards. But in fact the game shows that at some point, nobody cooperates anymore and consequently, everyone loses out.

The prisoner’s dilemma demonstrates that in the long term everyone stands to gain when the players cooperate with each other.

The prisoner’s dilemma also demonstrates something else: in the long term everyone stands to gain when the players cooperate with each other.

THE ABOVE ARTICLE WAS WRITTEN BY PROF. CLAUDE LE PEN Prof. Claude Le Pen is Professor of economics at the Paris-Dauphine University, where he has specialised in healthcare economics since 1985. He is founder and Scientific Director of AREMIS Consultants. Le Pen has acted as an advisor to several commissions of the French government and also worked as an expert for the European Union in public health issues. He is President of the “Collège des Economistes de la Santé” and a member of the editorial boards of several scientific journals.


Medicines Matter 15  

Newsletter for the Irish Pharmaceutical Healthcare Association

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