Relatório Anual de Atividades - Inglês by Paola Andrade

Relatﾃｳrio Anual de Atividades - 2010

ANNUAL ACTIVITIES REPORT S ﾃグ

PAU LO, D E C E M B E R 2010

MANAGEMENT COMMITTEEâ&#x20AC;&#x2122;S MESSAGE Dear associate member, Itâ&#x20AC;&#x2122;s a great satisfaction to disclose our first Annual Activities Report (AAR) with a summary of the actions and projects developed in 2010. The firm support from Management Board members has been fundamental so we close the year with highly positive results. In the next pages, we provide you with a brief report on every activity developed throughout the current year. Good reading! Eloi Bosio

Antonio Alas

Rubens Pedrosa

President

Vice-President

Secretary

Relatório Anual de Atividades - 2010

PRESENTATION Upon celebrating its 20 years in 2010, Interfarma developed a series of projects and institutional actions to kick-start a continuous and increasingly strong process of change of its profile and posture. The revision of its Articles of Association, which allows for the participation of companies and national researchers, is a proof of change. The revision extends and strengthens the entity’s representativeness and opens Interfarma to other segments dedicated to research in human health, especially in the biotechnology area. And that is followed by other important actions. In 2010, we promoted Interfarma’s brand name before society by proposing a wide debate on public health through actions and events that had a wide and positive repercussion in the media. Our relationship with the press is one of the highlights of the current report. The event held in partnership with newspaper Valor Econômico was an initiative that we’ve also highlighted. The seminar discussed health access and funding, gathering important names from the sector in Brazil and preceded the launch of the special inlets. Around 350 people took part in the event and thousands of other people were reached with the publication of the inlets inserted in the pages of Valor Econômico. The current Annual Activities Report (AAR) is born with the purpose of, to put it briefly, provide knowledge to our associate members on the many different activities developed this year and to show the efforts undertaken to consolidate our relationship with government and remaining stakeholders. We’d like to thank the Management Board and Interfarma’s Permanent Commissions for their support and trust. Antônio Britto Executive President

INSTITUTIONAL PROJECTS AND ACTIONS

During that meeting, the following issues were discussed: The importance of clinical research in Brazil Innovation, a differential factor for development How to build drug access programs Public budget and health funding

Similarly, Interfarma published three ads in that same newspaper focusing the elections and showing its new positioning.

INFORME PUBLICITÁRIO

O partido da saúde precisa vencer em 2010 A Acima dos candidatos, dos partidos, dos governos, das divergências ou dos interesses, um sistema eﬁciente e humano de saúde pública é o um compromisso u doPUBLICITÁRIO Brasil com os brasileiros e com o futuro. INFORME

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Tudo que avançamos como Nação, especialmente nos últimos 25 T aanos, exige que busquemos juntos soluções para o problema que as pesquisas apontam como o mais preocupante para os brasileiros: a p ssaúde pública. Ao comemorar 20 anos, a Interfarma, Associação que congrega os laboratórios farmacêuticos dedicados à pesquisa, quer dar sua As eleições de 2010 e a posse de novos governantes em 2011 A contribuição para o debate emdebate torno racional, da saúdesem pública no Brasil, o oferecem uma grande oportunidade para um INFORME PUBLICITÁRIO problema que as pesquisas apontam como o mais preocupante cculpados nem preconceitos. para os brasileiros e que, na visão da entidade, terá considerável peso nas discussões em torno das propostas dos candidatos à Um debate que permita idéias e avanços no que segue nos U Presidência da República. p preocupando: a insuficiência no atendimento, a falta de acesso a tr tratamentos e medicamentos para milhões de brasileiros. Um debate Em parceria com o jornal Valor Econômico, a Interfarma promove q que ofereça propostas pensando emjunho, ajudarem o futuro em vez no próximo dia 7 de São Paulo, umdeseminário com as d discutir o passado. presenças de especialistas, políticos, representantes de todos os Pesquisas apontam que a saúde é o problema que mais preocupa segmentos e de todas as posições para pensar o futuro da saúde o brasileiro. É o tema que sempre preocupou a Interfarma, a A Associação que congrega Ao comemorar pública 20 anos,noa Interfarma, Brasil. associação que congrega os laboratórios farmacêuticos dedicados à os o laboratórios farmacêuticos dedicados à pesquisa, quer dar sua pesquisa científica. E é o tema que mais deveria preocupar os futuros Nosso éocorra que o debate em torno de questões como acesso contribuição para que odesejo debate de c dirigentes domaneira País. produtiva e racional. à saúde, inovação tecnológica, oportunidades de investimentos, conhecimento científico financiamento do sistema de Por com oAo jornal ValoreEconômico, no próximo diaocorra P isto, em parceria quer dar, neste momento comemorar 20 anos, a Interfarma maneira racional e produtiva. Um debate que políticos, permita idéias 7 de junho, a Interfarma reúne, em SãodaPaulo, especialistas, importante vida democrática brasileira, sua contribuição para o ede avanços nosegmentos que segue enos a insuficiência no re representantes todos os de preocupando: todas as posições para debate em torno da saúde pública no País. Por isto, a entidade, em atendimento, a falta de acesso a tratamentos e medicamentos para parceria o jornal Valor Econômico, promove no próximo dia 7 de p pensar o futuro da saúde pública nocom Brasil. milhões de brasileiros. junho, em São Paulo, seminário com as presenças de especialistas, políticos, representantes de todos os segmentos e de todas as As eleições de 2010 e a posse de novos governantes em 2011 posições para pensar o futuro da saúde pública no Brasil. oferecem uma grande oportunidade para um diálogo racional, sem preconceitos. Tudo que avançamos como Nação, especialmente Nosso desejo é que o debate em torno de questões sensíveis no nos últimos 25 anos, exige que busquemos juntos soluções para o âmbito da saúde ocorra de maneira racional e produtiva. Um debate problema saúde pública no País. que permita idéias e avanços no que segue nos preocupando: a insuficiência no atendimento, a falta de acesso a tratamentos e Acima dos candidatos, dos partidos, dos governos, das divergências medicamentos para milhões de brasileiros. Um debate que ofereça ou dos interesses, um sistema eficiente e humano de saúde pública é propostas para o futuro em vez de discutir o passado. um compromisso do Brasil com os brasileiros e com o futuro.

2010, a eleição da saúde

Pesquisas apontam: Saúde em primeiro lugar

Around 350 people attended the debate, a public divided into:

Gerentes, Coordenadores

Presidentes, CEOs e Diretores

As eleições de 2010 e a posse de novos governantes em 2011 oferecem uma grande oportunidade para um diálogo racional, sem preconceitos. Tudo que avançamos como Nação, especialmente nos últimos 25 anos, exige que busquemos juntos soluções para o problema saúde pública no País.

Evento: “Caminhos para o ﬁnanciamento e acesso a saúde” Local: Hotel Caesar Park – Faria Lima Rua Olimpíadas, nº 205 – Vila Olímpia Inscrições:

Especialistas e Consultores

Acima dos candidatos, dos partidos, dos governos, das divergências ou dos interesses, um sistema eﬁciente e humano de saúde pública é um compromisso do Brasil com os brasileiros e com o futuro.

Evento: “Caminhos para o ﬁnanciamento e acesso a saúde” Local: Hotel Caesar Park – Faria Lima | Endereço: Rua Olimpíadas, nº 205 – Vila Olímpia Inscrições: seminariovalor@greenleaves.com.br | Vagas limitadas

Outros Governo Palestrante

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In June, Interfarma, in partnership with newspaper Valor Econômico, held the seminar “Paths to Providing Health Funding and Access” with the purpose of gathering government authorities, experts, politicians and businessmen to debate the main issues related to public health and propose solutions. The debate included names such as Reinaldo Guimarães, Secretary of Science, Technology and Strategic Inputs of the Health Ministry; Jorge Kalil, Director of the Immunology Laboratory of the Instituto do Coração/Heart Institute; Jorge Ávila, President of INPI; Gonzalo Vecina Neto, Corporate Superintendent at the Syrian-Lebanese Hospital in Sao Paulo; Dirceu Barbano, Director of Anvisa; and Adib Jatene, a former Health minister, and Emeritus Professor at FMUSP – Medicine College of the University of São Paulo - and General Director of the Heart Hospital in Sao Paulo.

Soon after the event, newspaper Valor published a supplement on health problems in Brazil, based on the issues related to the seminar. All 65 thousand subscribers of that newspaper received the special inlet and were provided with details on the debate proposed by Interfarma.

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Seminar “Paths to Providing Health Access and Funding”

Relatório Anual de Atividades - 2010

Special Health Editions Soon after the event was held, in August, there was the launch of the first volume of Interfarma’s Special Health inlets titled “Health Access and Funding in Brazil”. The other publication, “Innovation and Clinical Research in Brazil”, was published in October. Both inlets were inserted between the pages of newspaper Valor Econômico, which has 65 thousand subscribers all over Brazil. Following that, around 3 thousand copies were distributed among those registered for the seminar and opinion makers: journalists, Government representatives, ministries, health state secretariats, universities, researchers, sector leaders and public health experts.

Pharmaceutical Industry’s profile survey In 2010, the Interfarma’s Economic Department undertook another survey with associate companies in order to define the sector’s economic profile. The results as presented in the “Profile of the Research Pharmaceutical Sector in Brazil - Base Year 2009” point to a growth of investments in research and development, in wage levels and in the level of professional educational background, and in employment levels. Below, you’ll find some highlights: The 26 Interfarma’s associate companies that answered the Survey obtained, in 2009, revenues of R$ 18,5 billion, to represent 55.1% of the Brazilian pharmaceutical market. The R&D investments, in 2009, grew by 16.29% if compared to 2008 reaching a total of around R$ 252 million. Likewise, there was an increase in employment levels, which grew by almost 10%. There was also an increase in the level of professional educational background and an evolution of average wages among collaborators. Another equally important data is that today the research pharmaceutical industry employs 23.470 people in Brazil. The file with the complete Executive Summary is available for download at Interfarma’s website (www.interfarma.org.br).

Book on Innovation With the purpose of debating with authorities and society the question of Innovation in Brazil, Interfarma is organizing a book on that issue. In order to put the project into practice, it contracted consultancy company Prospectiva Consultoria to select researchers and professors from important Brazilian universities to write the book. Among the debated issues, are “Brazilian Scientific Potential”, “Innovation as a corporate strategy”, “Innovation in Brazil: comparisons and success stories” and “Evaluation of innovators’ daily lives in Brazil”. The material is in the finalization stage and its launch has been forecast to March 2011.

Conduct Code Revision This year, Interfarma also started to review its Conduct Code. The work to review the Code, whose purpose is to keep the material up to date, based on ethical principles and according to the applicable laws, started in August. The new edition will be published in the first half of 2011.

CHANGE OF THE ARTICLES OF ASSOCIATION In September, Interfarma’s Management Board approved the revision of its Articles of Association with the purpose of extending the entity’s representativeness and opening Interfarma to other segments dedicated to human health research, especially in the biotechnology area. Now, national and international companies and researchers, institutions, foundations, universities, institutes, start up companies without products, sales or earnings and even same natural people can be a part of Interfarma. By changing its articles of association, Interfarma can shelter other institutions that might contribute to the research and innovation efforts in human health.

PARTNERSHIPS Interaction between researchers and industry

Even before the effective alteration of its Articles of Association, Interfarma was dedicated to promoting exchange between researchers and associate companies. That is why during the current year it signed partnership agreements with three important institutions in the research area: foundations Biominas and Bio-Rio, institutions dedicated to creating biotechnology companies, and with the Innovation, Entrepreneurship and Technology Center (Cietec), a business incubator located in the campus of the University of São Paulo - USP. With Biominas, the association put into in practice during the year, the Human Health Biotechnological Innovation Program in Brazil, and held four editions of the Café Biotec Farma roundtables, with the exact purpose of enhancing the relationship between the industry and researchers.

Rational use of drugs In 2010, Interfarma signed a partnership contract with the Regional Pharmacy Council of São Paulo (CRF/ SP) to produce and distribute educational DVDs on the dispensation and rational use of drugs at health establishments, such as pharmacies and drugstores. The first

Relatório Anual de Atividades - 2010

volume of the 11-DVD series was launched in September, during the XVI Sao Paulo Congress of Pharmacists, the Second Brazilian Pharmacy Congress and the VIII International Seminar for Pharmacists, which are simultaneously held during the Exporfar 2010 – an event that attracts around 6 thousand people, and among them, 3.5 thousand pharmacists. The project will proceed until 2011 and will deliver every month a DVD at the homes of 40 thousand pharmacists associated to CRF/SP. The event counted on the participation of Eloi Bosio and Antônio Britto, on behalf of Interfarma, Dirceu Raposo, president of Anvisa and of representatives of the Pan-American Health Organization (PAHO).

Approximation with medical societies During the year, Interfarma kept an open dialogue with the Federal Medicine Council (CFM). At meetings with CFM’S Board, Interfarma proposed to identify the common activities that the industry and physicians may develop in favor of patients and public health in Brazil, in an ethical and transparent manner. A joint work group comprising CFM and Interfarma was created to proceed with the discussions on sponsorships to medical congresses. The debates will proceed in 2011 with the purpose of finding a solution that preserves and strengthens ethical values in the relationship between physicians and the industry. Following those same ethical principles, Interfarma has also furthered its relationship with the Brazilian Medical Association (AMB). Together, they’ve promoted meetings with the purpose of identifying joint work opportunities to favor health in Brazil. The defense of ethical values, of better health access conditions, technology incorporation and the development of social responsibility projects are some examples of issues that may be jointly developed in the next year.

Union in favor of clinical research In March, physicians, scientists, representatives from hospitals, research institutes and universities, led by Interfarma, mobilized in a movement to favor better con-

ditions for clinical research in Brazil. The group was received for a meeting, for the first time, by the Health Minister, Mr. José Gomes Temporão. During that meeting, the group offered support to the minister so that he starts a discussion on changes to allow Brazil to take advantage of the extraordinary potential it has to host clinical studies. In that occasion, visitors also asked the minister to open an objective discussion on what needs and must be changed. The meeting counted on the participation of Drs. Jorge Kalil, USP/Oswaldo Cruz; Luiz Fernando Reis, Syrian-Lebanese Hospital in Sao Paulo; Luiz Vicente Rizzo, USP; Edson Moreira, Fiocruz; Antonio Roberto Chacra, Unifesp; José Eduardo Krieger, InCor; Paulo Hoff, Director of Icesp at the Clinical Hospital of Sao Paulo and Augusto Paranhos, Albert Einstein Hospital. The participation of leaderships from outside the association was another initiative within the policy of strengthening the links and partnerships with all those involved with public health issues.

Dialogue with CONEP To proceed with the efforts to improve clinical research in Brazil, in September, a delegation of representatives of Interfarma’s Clinical Research Commission went to Brasília for a day of debates with the collegiate of the National Research Ethics Commission (CONEP). The meeting was held based on a suggestion made by Interfarma and which, represented by its Board president, Mr. Eloi Bosio, and by its executive president, Mr. Antônio Britto, gathered with some CONEP members. In that occasion, Interfarma manifested its wish to discuss the processes, terms and requirements for the authorization of clinical studies in Brazil. On the other side, CONEP informed that the industry has been making recurrent errors that hinder a greater agility in the decision-making process. After the meeting, Interfarma’s Regulatory Entities Management and Clinical Research Commission started to discuss the ways to reduce companies’ errors as regards the procedures to submit clinical research protocols. The suggestions of solutions to such obstacles in the analyses of research protocols by CONEP were turned into opinions that may be adopted by companies to facilitate the processes within the CEP/CONEP system.

COMMUNICATION In 2010, Interfarma promoted many different relationship-building meetings with journalists and considerably increased its participation in articles published in the main newspapers and radio stations in the Country. The evaluation of our relationship with the press has been positive. Between February and November 2010, Interfarma achieved a record number of quotes in the press. There were 522 interviews and articles published on important issues debated and defended by the association. Such an expressive number during that period was due to the fact that the positions and statements we’ve disclosed are being replicated also via Radioweb and Radio 2, two news agencies that produce content for distribution to all radio stations both in Sao Paulo and all over the Brazilian hinterland regions.

Resultados comparativo 2008 / 2009 / 2010 (fev-nov)

Even considering only the quotes in newspapers with which Interfarma has historically kept a relationship, the figures are still highly expressive. 108 articles were published. But even more important than their quantity, was the quality of conveyed messages: Interfarma took advantage of the opportunities, either spontaneous or generated by the public relations agency, to position itself on all matters of interest, and in a positive manner. The chart below shows a comparison between the result of the relationship efforts with the press between 2008 and 2010 - considering interviews, relationship-building meetings, published articles and news. The highlight goes to the 26 relationship-building meetings with journalists that generated twice as many articles in the main communication media in the Country. In November, the “Innovation and Clinical Research in Brazil” inlet was given highlight with a full-page exclusive note in magazine Exame, section “Grandes Números/ Great Figures”.

Relatório Anual de Atividades - 2010

Interview and editorial text in newspaper Folha In 2010, after a visit by Antônio Britto and Octávio Nunes to the newspaper Folha de Sao Paulo’s CEO, Mr. Otávio Frias, that newspaper granted an important editorial space for an interview with Mr. Britto, in the Q&A format, on clinical research and innovation. The interview, published in that newspaper’s Sciences inlet, made an important alert on the opportunities Brazil has been loosing in the clinical research area. On the following day to the its publication, the newspaper wrote an editorial in which it called the Government’s attention to that problem and stressed the need that the stakeholders involved with the issue find a solution to allow Brazil to attract new research investments in the pharmaceutical area.

Newsletter in English This year one of the first actions held by Interfarma’s Communication Management was the launch of “Interfarma’s 2-Minute Bulletin” in English. That newsletter, with a monthly periodicity, includes a summary of Interfarma’s activities and was created so that the associate companies may keep their headquarters informed on pharmaceutical market developments in Brazil. In addition, extra editions contemplate matters of interest such as the results of the 2010 elections or the decisions taken by the local regulatory entities.

New website In April, Interfarma launched its new website. The website started to count on an updated design with areas providing information on the entity, information on the health sector and market; articles and news and a pressroom which journalists can access after being registered. The “Issues under Debate” section, dedicated to the great national issues, has been given an internal division titled “Health & Elections”, where visitors were able to check how the main candidates were dealing with the public health during issue the campaign. After its renovation, the number of accesses grew and has been week after week keeping a constant growth.

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Interfarma’s Guide

Institutional booklet

In that same month, the association started to distribute the 2010 Interfarma’s Guide. That is a publication for journalists interested in public health and who follow the pharmaceutical industry, and also for associate members.

With the purpose of attracting new members, Interfarma has elaborated an institutional folder that shows what the entity is, its structure, what its defends, its commitments, Conduct Code, the changes in its Articles of Association, and why and how companies and stakeholders might become Interfarma associate members. That material, which also has an English version, will be used during presentations and relationship-building meetings.

The Guide contains essential information on Interfarma, its associate companies, the Brazilian and global markets; remaining entities that represent the pharmaceutical segment, public authorities and entities responsible for health management, as well as basic statistical data on the sector. In November, the Guide’s 2011 version started to be prepared.

Internal Communication In October, the Commissions Management System (SGC) started operating, a restricted access area in Interfarma’s website whose purpose is to decrease the communication via email and to stimulate the access through other tools. Similarly, the communication department has been organizing, since the year’s start, the association’s Databank, which includes statistical information, studies, presentations and other materials that may be useful to the entity’s staff and to its associate members.

Relatório Anual de Atividades - 2010

Workshop for journalists In November, Interfarma promoted, in partnership with the Medicine College of USP, the “Health in Brazil” workshop for journalists. The idea was to discuss issues related to the current health scenario in the Country with press professionals specialized in that segment. The event counted on the participation of representatives from the following media companies: magazine Época, newspaper Jornal de Brasília, newspaper Jornal do Commercio (PE), magazine Viva Saúde, Minha Vida Web Portal, magazine Guia da Farmácia, newspaper Correio do Estado (MS), magazine Ciência Hoje (RJ) and newspaper Estado de Minas. The workshop debated Innovation & Clinical Research, Cancer and Ageing. The lectures were given by Dr. Jorge Kalil, titular professor of clinical immunology and allergy at the Medicine College of USP and director of the immunology lab at the Instituto do Coração/Heart Institute (InCor); Prof. Dr. Paulo Hoff, Strategies Director at the Oncology Center of the Syrian-Lebanese Hospital, and Prof. Dr. Wilson Jacob Filho, Geriatric Services Director at USP’S Clinical Hospital.

Professor Jorge Kalil, from USP, talking to journalists

NEW ASSOCIATE MEMBERS Interfarma started 2010 with 31 associate members in its charts and ends the year with 39. There were 8 new associate members between January and December after a continuous effort to attract companies and strengthen the entity. The change in its Articles of Association, will allow for the arrival of more national and foreign companies, institutions, universities and independent researchers. This year, Biominas, an institution dedicated to fostering biotechnology companies, became an Interfarma member through a cooperation agreement, as well as Bio-Rio and the Innovation, Entrepreneurship and Technology Center (Cietec). Biominas was the first business incubator to become an Interfarma associate member.

INTERNAL ACTIONS Board Election An election was held in March for the 2010-2012 biennium. Eloi Domingues Bosio, general manager of Daiichi Sankyo was elected as the new Board president, having as vice-president, Antônio Alas, general manager of Eli Lilly and as secretary Rubens Pedrosa, general manager of AstraZeneca. That election marked the change in the Board’s structure, which henceforth has 16 titular members.

Members of Administration Council Eloi Domingos Bosio

Gaetano Crupi

Presidente, Daiichi Sankyo

Abbott

Antônio Alas

Heraldo Marchezini

Vice-Presidente, Eli Lilly

Sanofi-Aventis

Rubens Pedrosa

José Roberto Ferraz

Secretário, AstraZeneca

Janssen

Adriano Treve

Luiz Eduardo Violland

Roche

Nycomed

Alexandre Triebnigg

Martin Nelzow

Novartis

Boehringer

Cesar Rengifo

Tadeu Alves

GlaxoSmithKline

MSD

Devaney Baccarin

Rainer Krause

Astellas

Bayer HealthCare

Eliana Tameirão

Victor Mezei

Genzyme

Pfizer

Fiscal Council’s Composition Eder Mattioli

Anderson Garbin

Eli Lilly

Novartis

Juarez Oliveira

Ivan de Barros

Nycomed

Sanofi-Aventis

Waldir Storino

Juarez Pereira

Abbott

Janssen

Advisory Council Jorge Raimundo Filho

Board approves new structure for the Commissions In its meeting held in April, Interfarma’s Management Board approved the new structure for our Association’s work commissions. That updating was promoted with the purpose of extending associate members’ participation and adapting the list of commissions to the entity’s priorities. The associate companies appointed 230 representatives for the commissions, an evident proof of the interest of all members to actively take part in Interfarma.

Management Board approves the 2011 budget The budget for the year 2011 was approved by the Management Board at the meeting held on December 02, based on the matters discussed during the Strategic Seminar held in October.

Management Board validates, at the seminar, its operational strategy for 2011 At the start of November Interfarma organized the Strategic Seminar to evaluate scenarios, validate strategies and discuss priorities for 2011. The seminar was open with the presentation of the internal survey results, as answered by 30 general managers, which confirmed our associate members’ alignment with the strategic guidelines adopted since last year. Through a plenary session, conducted by the Management Board’s president, Mr. Eloi Bosio, and the group works, Interfarma’s associate members and managerial body were able to discuss in depth the perspectives and challenges for the year 2011.

Associate members mobilized on behalf of Haiti Soon after the earthquake in Haiti, Interfarma received a request to donate drugs to the victims of that tragedy. The request was made by the Presidency of the Republic,

Relatório Anual de Atividades - 2010

through the Economic Development Minister Miguel Jorge. A considerable part of our associate members contributed with drugs through their headquarters or regional management boards in the Caribbean, in order to show their solidarity, which was promptly recognized by the Brazilian Government. The entity received an official acknowledgement by the Brazilian Army at a ceremony held in Rio de Janeiro.

Visits by worldwide CEO’s of associate companies Throughout 2010, Interfarma’s executive president, Mr. Antônio Britto, and Interfarma’s Advisory Board president, Mr. Jorge Raimundo, undertook a wide program of visits to Interfarma’s associate members and welcomed associated members’ global officers. For foreign visitors, there were many opportunities to show to them the Brazilian economic growth, the country’s economic and political stability, and the possibilities of investing in assets and research in the Country.

INSTITUTIONAL ACTIONS Meeting with Rousseff and Serra During the election campaign for the Presidency of the Republic, the executive president Antonio Britto, attended a meeting in Brasília with the candidate Dilma Rousseff, at which he had the opportunity to show the candidate the scenario of the Brazilian pharmaceutical industry, the points Interfarma considers essential on the market and in the relationship with the Government, and the main concepts advocated by our entity. Soon after the elections, Britto attended another meeting with the president-elect at and other industry leaders, academics, and scientists. On the occasion, Ms. Rousseff

expressed her views on healthcare in Brazil and pointed out that she would like to conduct a real revolution in the sector. Also during the campaign, the then PSDB candidate, José Serra, was also received at Interfarma by members of the Board. He could hear a brief account of the problems facing the industry, especially in the relationship with the government.

Traceability The traceability of drugs, as a way to fight forgery and informality, is one of Interfarma’s main initiatives. And the system that should be adopted in order to ensure traceability has been the object of intense discussions between the pharmaceutical sector and government. The industry considers that 2 D is the best system for the adoption of traceability processes, which has been proven in many different pilot tests and got Anvisa’s approval. Months later, that Agency deliberately decided to adopt a seal that shall be made by the Brazilian Mint, without considering the technical analyses, the talks with the industry and, mainly, the most adequate drug traceability solution. In December, to fulfill a decision taken by its General Assembly, Interfarma started a lawsuit through a precautionary measure questioning Anvisa’s decision of implementing the seal on drug packages. The lawsuit’s terms technically point to the huge losses that measure will generate to consumers, to the industry and to public health, as well as mentioning the errors made by the Agency upon conducting the process. By Interfarma’s suggestion, the lawsuit started by the entity counted on the support of the remaining associations in the segment, which acted as co-authors. Interfarma also reciprocally acted as co-author in the lawsuits started by other associations.

Biologics, an achievement After several years of effort, we have important news. On December 17, 2010, the Official Gazette published the new regulation on biologics in Brazil. The regulation was absolutely in line with the negotiation, led by Solan-

ge Nappo, from the Regulatory Board. In the last weeks of the year, the intense efforts of other sectors to change the wording proposed by Interfarma, pave the way for more flexible records, or even to postpone the decision for 2011 failed. The resolution was maintained and published. Below are the key points of DRC 55/2010, which regulates biological products in Brazil.

1. Two classes remain for registration of biological products (not new) Development by Comparability and Individual Development 2. Clinical studies should be conducted with the new biological product or biological product submitted for registration. This item prevents registration requests with data from other products. 3. Extrapolation of data on safety and efficiency for other therapeutic indications of biological products registered in the development by comparability class shall be established through specific guides. 4. Extrapolation of data on safety and efficiency shall not possible for therapeutic indications of biological products registered in the individual development class. 5. Regardless of the development class used, when filing the registration request of a new biological product or biological product, the company shall provide a report on the immunogenicity report. 6. Regardless of the development class used, when filing the registration request of a new biological product or biological product, the applicant company shall submit a pharmacovigilance plan and a risk minimization plan in accordance with the current legislation on healthcare. 7. The biological product to be used as a comparator in the comparability exercise shall be the product registered at Anvisa, the record of

which has been grounded by a full dossier. § 1 in case of demonstrated commercial unavailability of the comparator biological product on the domestic and international market, the choice of drug to be used in the comparability exercise shall be previously discussed and asserted by Anvisa; § 2 in the situation described in the preceding paragraph, possible comparators shall be new biological products registered by another regulatory authority adopting technical-scientific criteria similar to those of Anvisa, and when there is likelihood of full, unrestricted access to the registration information by Anvisa; 8. Upon registration of a new biological product or biological product, information shall be posted on the website of Anvisa with the technical basis for product approval. Sole paragraph: when it comes to biological products, information on the development class used (individual or comparability) shall be included. 9. Anvisa shall perform, ex officio or at the request of the company, technical panels, with the authorization of the Board, in order to dispel doubts arising from the review of registration requests of new biological products or biological products, under the specific procedure disclosed on the website of Anvisa.

the National Congress, at the Economic Development Ministry, Ministry of Foreign Relations and at the World Trade Organization (WTO), in Geneva. Likewise, Interfarma has mobilized other entities such as Amcham, ABPI and Motion Pictures to think about joint actions and activities. In June, Brazil and the United States reached an agreement that averted the possibility of adopting measures against intellectual property in that country. The Brazilian Foreign Trade Chamber (CAMEX) communicated the approval of a “framework agreement” between both countries defining a set of “parameters for a progressive process aiming at significantly reducing the negative effects of North American subsidies programs.” The framework agreement forecasts reciprocal commitments throughout the next years, which, once fulfilled, will avert the possibility of imposing retaliations against North American interests due to the conflict.

Free samples The period also was marked by Interfarma’s articulation and negotiation in favor of its associate members so they may adapt to the requirements of articles 6th and 7th of the RDC nº 60, of November 27, 2009 on free samples. The association held a meeting with Anvisa’s publicity manager, where the professional technicians involved with free samples were able to present their arguments on the time to adapt free sample packages to the new regulations. Based on that meeting, Interfarma elaborated a document forwarded to the Agency with such arguments, including a mention that the use of packages as previously done does not represent any health risk. In June, Anvisa published in the Union’s Official Gazette the RDC 23/10 that prorogated until November 30, 2010 the term to adapt packages.

Cross Retaliation In the first half of 2010, Interfarma undertook an intense work of political articulation to avoid a cross retaliation against intellectual property rights implemented by the United States, which in August 2009 adopted subsidies to their agricultural producers. Favoring a broader dialogue, the association took the issue to be debated at

New schedule to deliver directions Based on the negotiations, Anvisa republished RDC 47/09, which establishes rules for the elaboration, harmonization, updating, publication and availability of drug directions to patients and health professionals.

Relatório Anual de Atividades - 2010

According to the new rule, new schedule and new criteria (list 1 and list 2) were established for directions’ delivery. Anvisa had established that all companies should deliver their drug directions until March 2010. In the new criteria two delivery groups were created: the first one to July 2010 and the second one to January 2011. The republication of the RDC 47/09 has the purpose of improving the text in order to facilitate the comprehension of the new rules, correct orthographic and grammar errors and redefine the adaptation terms.

Anvisa’s S.O. eliminated the possibility that, in certain cases, products might be released by GGPAF through a consultation to GGMED. Anvisa’s president, Mr. Dirceu Raposo, understood the problem and promised to provide a solution. At the same time, Interfarma prepared a suggestion to alter the Service Order sent to Anvisa in order to assist the load clearance process and to release the retained drugs that might have generated losses to Interfarma’s associate companies.

Reinaldo Guimarães at Interfarma Electronic Registration In 2010, Interfarma continued with its work related to electronic drug registration started in 2008. In September, Anvisa presented the new Electronic Drug Registration System and five associate companies – chosen by Anvisa due to the positive experiences brought from foreign countries by such companies - started to take part in a pilot project for the electronic submitting of new drugs. Interfarma evaluated the new system as being positive, since it aims at enhancing the Agency’s actions and, consequently, those of the productive sector. The new system’s implementation should save registration time, since the information may be shared, for analysis, by many technicians at the same time. Another point deemed to be important is that the safety of documents will also enhanced. In 2011, after the tests, the participating companies will present to Interfarma’s remaining associate members how the electronic registration process might function.

Service Order alteration for the load release at ports and airports Interfarma, through its Regulatory Matters manager, Solange Nappo, promoted a great mobilization and was able to sensitive Anvisa as regards the gravity of biological products retention at Brazilian ports and airports due to the joint Service Order signed by GGPAF and GGMED in order to standardize the release criteria for those drugs. The greater problem involved the drugs that should be kept at a temperature between 2ºC and 8ºC.

Interfarma, with the purposes of extending the dialogue with Brazilian public health authorities, welcomed this year at the association’s headquarters the secretary of Science, Technology and Strategic Inputs of the Health Ministry, Mr. Reinaldo Guimarães, who was accompanied Cláudio Maierovitch, Program Director at he Secretariat of Science, Technology and Strategic Inputs. During the Access Commission meeting its members were able to debate with Government representatives on issues such as agility and transparency in the drugs incorporation processes.

Association’s Position as regards Tax Adjustment Throughout 2010, Interfarma discussed, together with other industry segments, the new Aggregate Value Margins (AVMs), for Tax Adjustment before the Treasury Secretary of the State of Sao Paulo, Mr. Mauro Ricardo. Interfarma claimed that the survey on actual prices and discounts should be attributed to the Treasury Secretariat, as the initial basis for the negotiation of a formula that corresponds to the market reality. The survey pointed to a relatively small difference between the prices for reference drugs and the current AVM. That is why the entity did not accept any proposal that might apply an average among the prices found in many different drug segments. At the same time, our Association asked the Secretariat to look for a solution to similar and generic drugs, which in the survey show a great difference between the current AVM and actual discounts.

Mr. Britto discusses the sector’s situation with governor Alckmin Interfarma’s executive president, Mr. Antônio Britto, met Sao Paulo’s elect governor, Mr. Geraldo Alckmin. Mr. Britto exposed to Mr. Alckmin the sector’s situation, the opportunities for new investments in the Brazilian pharmaceutical industry, and defended a prorogation of the term for the application of new tax adjustment criteria and rates. Interfarma claimed the prorogation is fundamental so the new government team may find, by dialoguing with the industry, a solution to that matter.

MA) with that entity’s executive president, Mr. Eduardo Pisani and its entire Board. At those meetings, Interfarma made a presentation on the Brazilian market, its institutional situation and future perspectives. And it watched presentations on the structure and priorities of local associations. There was also, at all meetings, a period dedicated to debating Brazilian issues. At the end of every stage, concrete ways to extend the dialogue between Interfarma and local associations were established as well as the alignment of actions around common interests.

USA – Annual meetings

INTERNATIONAL OPERATIONS Throughout the year 2010, Interfarma intensified its international operations. The ties with entities from other countries have become narrower and there has been a greater dialogue. Due to the actions developed in the last few months, Interfarma started to be recognized as an influential entity among the remaining associations in the United States and Europe.

Europe Last May, Interfarma’s executive president, Mr. Antônio Britto, and its Legal manager, Mr. Ronaldo Pires, attended a series of meetings in Europe. The trip included meetings in Paris, with the French Association of Pharmaceutical Companies (LEEM). In Brussels, with the task force that deals only with Brazil for the European Federation of Pharmaceutical Industries Associations (EFPIA). And, also, meetings with the EFPIA Commission that deals with international matters and with representatives from the European Community’s team that deal with Brazil. The trip was concluded in Geneva with a four-hour meeting at the International Federation of Pharmaceutical Manufacturers Associations (IFP-

In November, Mr. Antônio Britto and Mr. Ronaldo Pires took part in the annual meeting of Pharmaceutical Research and Manufacturers of America (PhRMA), dedicated to Latin American markets, and in the 25th General Assembly of the International Federation of Pharmaceutical Manufacturers and Associations (FIIM/ IFPMA). Those meetings reinforced the agendas defended by the sector in other countries, which are quite similar to the agenda supported by Interfarma dealing with issues such as biological products, access to drugs, intellectual property and institutional relations, besides being excellent opportunities to exchange experiences between the main sector associations’ leaders. Being a forum for a great involvement by the main global health area stakeholders, IFPMA’S General Assembly was also marked by the election of the Federation’s new President, Mr. David Brennan (AstraZeneca’s CEO), who took office replacing Mr. Haruo Naito (EISAI). During all trips, Mr. Antônio Britto has opened his agenda for meetings with Brazilian journalists working as correspondents in the United States and Europe. Many of those meetings generated articles published in news media such as newspapers O State de Sao Paulo, Folha de Sao Paulo, Valor Econômico and O Globo.

Health Ministry’s Business Mission in Washington In September, Interfarma, represented by its Advisory Board’s president, Mr. Jorge Raimundo, went on an Health Ministry official mission to Washington. Mr. Jorge

Relatório Anual de Atividades - 2010

Raimundo took part in meetings in the North American capital with health sector companies’ businessmen from the United States, responsible for entities such as FDA and USPTO, and representatives from the American government and Congress. Extremely important issues for the pharmaceutical industry and the health sector were discussed: Intellectual Property - at a meeting, CNI presented the Intellectual Property Program for Innovation in the Industry, MSD Brazil’s corporate matters director, Mr. João Sanches, presented a work on intellectual property defense developed by Interfarma and by Amcham, while Mr. Jorge Raimundo explained the bills under evaluation at the Brazilian Congress. FDA – Anvisa Dialogue - both agencies signed a collaboration and information exchange agreement. Its purpose is to promote an exchange on new products, adverse reactions, and to discuss drug plant inspections. The work of both entities continues to be independent, and the decisions and registrations shall remain under each entity’s responsibility, in their respective countries. Health Industrial Complex - minister José Gomes Temporão presented the proposal for the Brazilian “super” pharmaceutical industry. He showed the funding programs held by BNDES and announced some partnerships with private companies.

SOCIAL RESPONSIBILITY In 2010, Interfarma also dedicated efforts to a very important segment: the third sector. The association created a work group on social responsibility and contracted a company specialized in the production and management of third-sector editorial projects, in order to obtain information from associate companies on the issue and elaborate Interfarma’s First Annual Report on Social Responsibility. That company’s functions also include

identifying common actions and indicating a social responsibility institutional project contemplating the interests of all associate members and which shall guide how members operate under Interfarma’s umbrella. The collection of information through a questionnaire elaborated by that specialized company ended in May. After that stage, a workshop was held in October where the proposed actions were taken into consideration. Similarly, the company elaborated an analytical report that led to the abovementioned annual report. The evaluation obtained some interesting data. The 29 associate companies that answered the questionnaire made Private Social Investments (PSI) in 2009 of almost R$ 35 million, distributed among 175 projects - without including donations. The average investment per company amounted to R$ 1.197 million. So the experts hired by Interfarma have concluded that there still is a lot of room in the social responsibility field to be explored. According to the survey, only 11 companies declared to have used tax breaks in 2009. They could have used around R$ 45 million, but have been using only 13% of the existing potential to direct due taxes to projects approved according to the Rouanet Law, the ICMS Tax Law, Fumcad, the Sports Law, and related laws.

SUPPORT TO PROJECTS AND EVENTS Escola Legal/Nice School Project In 2010, Interfarma continued to support the Escola Legal/Nice School Project (PEL), an initiative to fight piracy. Created in 2007 by Amcham in order to alert young people attending basic teaching public and private schools, as regards the problem of piracy in Brazil

and in the world, the PEL should reach, until this year’s end, educators in six Brazilian cities: Campinas, Curitiba, Goiânia, Recife, Sao Paulo and Blumenau. The idea is that these education professionals become multipliers of the concepts defended by the project. The Escola Legal/ Nice School Project designers believe education is the best way to achieve citizenship.

HTA International Event Held in the month of October in Buenos Aires, Argentina, the First HTAi Latin American Regional Meeting counted on the participation of lecturers from the public sector and health technology evaluation agencies from the Americas and Europe. The event’s focus was the increase in ATS all over the world and the formation and extension of collaborative networks. There is an increasing activity in South America, with the formation of many different operational networks in the segment (for ex.: Mercosur and Andina with a strong activity in Colombia). Anvisa is increasingly taking part in the process, including by providing financial support to many of those actions. Recently, Anvisa collaborated with OPAS to standardize the ATS processes in Latin America, and there has also been an intense interaction among Brazilian agents in that area in many different countries. The next HTAi Latin American Regional Meeting will antecede the HTAi International Meeting to be held in June 2011 in Rio de Janeiro.

Events The year was also marked by many different events, seminars and debates of interest to the sector, and Interfarma took part, supported and sponsored some of them, such as: XXX International Intellectual Property Congress, held by ABPI (Brazilian Intellectual Property Association) Seminar on Piracy Fight in the Health Sector, held by ABIMED (Brazilian Association of Importers of Medical and Hospital Equipments, Products and Supplies) “Medicamento Verdadeiro/True Medication” Campaign, AFEP (Permanent Pharmaceutical Care for Students) Wikimeeting on clinical research 2010 3rd Triple Frontier Seminar, FNCP (National Forum against Piracy and Informality) 7th Latin American Congress on Clinical Research – SBMF (Brazilian Pharmaceutical Medicine Society) 8th Forum on Ethics in Clinical Research, SBMF (Brazilian Pharmaceutical Medicine Society)

Relat贸rio Anual de Atividades - 2010

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