ANNUAL ACTIVITIES REPORT - Interfarma...PRESENTATION Upon celebrating its 20 years in 2010,...

Relatório Anual de Atividades - 2010 1

ANNUAL ACTIVITIES

REPORTS Ã O P A U L O , D E C E M B E R 2 0 1 0

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MANAGEMENT COMMITTEE’S MESSAGEDear associate member,

It’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 develo-

ped throughout the current year.

Good reading!

Eloi Bosio Antonio Alas Rubens PedrosaPresident Vice-President Secretary


PRESENTATIONUpon 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 ini-

tiative 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 in-

serted 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 Com-

missions for their support and trust.

Antônio BrittoExecutive President

44

INSTITUTIONAL PROJECTS AND ACTIONS

Seminar “Paths to Providing Health Access and Funding”

In June, Interfarma, in partnership with newspaper Va-

lor Econômico, held the seminar “Paths to Providing

Health Funding and Access” with the purpose of ga-

thering government authorities, experts, politicians and

businessmen to debate the main issues related to public

health and propose solutions. The debate included na-

mes 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.

During that meeting, the following issues were discus-

sed:

The importance of clinical research in Brazil

Innovation, a differential factor for development

How to build drug access programs

Public budget and health funding

Soon after the event, newspaper Valor published a su-

pplement on health problems in Brazil, based on the

issues related to the seminar. All 65 thousand subscri-

bers of that newspaper received the special inlet and

were provided with details on the debate proposed by

Interfarma.

Similarly, Interfarma published three ads in that same

newspaper focusing the elections and showing its new

positioning.

Around 350 people attended the debate, a public

divided into:

Presidentes, CEOs e Diretores

Gerentes, Coordenadores

Outros

Especialistas e Consultores

Palestrante

Governo

INFORME PUBLICITÁRIO

O partido da saúdeprecisa vencer em 2010

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.

Tudo que avançamos como Nação, especialmente nos últimos 25

anos, exige que busquemos juntos soluções para o problema que as

pesquisas apontam como o mais preocupante para os brasileiros: a

saúde pública.

As eleições de 2010 e a posse de novos governantes em 2011

oferecem uma grande oportunidade para um debate racional, sem

culpados nem preconceitos.

Um debate que permita idéias e avanços no que segue nos

preocupando: a insuficiência no atendimento, a falta de acesso a

tratamentos e medicamentos para milhões de brasileiros. Um debate

que ofereça propostas pensando em ajudar o futuro em vez de

discutir o passado.

Ao comemorar 20 anos, a Interfarma, Associação que congrega

os laboratórios farmacêuticos dedicados à pesquisa, quer dar sua

contribuição para que o debate ocorra de maneira produtiva e racional.

Por isto, em parceria com o jornal Valor Econômico, no próximo dia

7 de junho, a Interfarma reúne, em São Paulo, especialistas, políticos,

representantes de todos os segmentos e de todas as posições para

pensar o futuro da saúde pública no Brasil.

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

Inscrições:

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2010, a eleição da saúde

Ao comemorar 20 anos, a Interfarma, Associação que congrega os laboratórios farmacêuticos dedicados à pesquisa, quer dar sua contribuição para o debate em torno da saúde pública no Brasil, problema que as pesquisas apontam como o mais preocupante para os brasileiros e que, na visão da entidade, terá considerável peso nas discussões em torno das propostas dos candidatos à Presidência da República.

Em parceria com o jornal Valor Econômico, a Interfarma promove no próximo dia 7 de junho, em São Paulo, um seminário com as presenças de especialistas, políticos, representantes de todos os segmentos e de todas as posições para pensar o futuro da saúde pública no Brasil.

Nosso desejo é que o debate em torno de questões como acesso à saúde, inovação tecnológica, oportunidades de investimentos, conhecimento científico e financiamento do sistema ocorra de maneira racional e produtiva. Um debate que permita idéias e avanços no que segue nos preocupando: a insuficiência no atendimento, a falta de acesso a tratamentos e medicamentos para milhões de brasileiros.

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.

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: [email protected] | Vagas limitadas

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2010, a eleição da saúde


Pesquisas apontam:Saúde em primeiro lugar

Pesquisas apontam que a saúde é o problema que mais preocupa o brasileiro. É o tema que sempre preocupou a Interfarma, a associação que congrega os laboratórios farmacêuticos dedicados à pesquisa científica. E é o tema que mais deveria preocupar os futuros dirigentes do País.

Ao comemorar 20 anos, a Interfarma quer dar, neste momento importante da vida democrática brasileira, sua contribuição para o debate em torno da saúde pública no País. Por isto, a entidade, em parceria com o jornal Valor Econômico, promove no próximo dia 7 de junho, em São Paulo, seminário com as presenças de especialistas, políticos, representantes de todos os segmentos e de todas as posições para pensar o futuro da saúde pública no Brasil.

Nosso desejo é que o debate em torno de questões sensíveis no âmbito da saúde ocorra de maneira racional e produtiva. Um debate que permita idéias e avanços no que segue nos preocupando: a insuficiência no atendimento, a falta de acesso a tratamentos e medicamentos para milhões de brasileiros. Um debate que ofereça propostas para o futuro em vez de discutir o passado.

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.

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: [email protected] | Vagas limitadas

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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 Econô-

mico, which has 65 thousand subscribers all over Brazil.

Following that, around 3 thousand copies were distribu-

ted among those registered for the seminar and opinion

makers: journalists, Government representatives, minis-

tries, health state secretariats, universities, researchers,

sector leaders and public health experts.

Pharmaceutical Industry’s profi le survey

In 2010, the Interfarma’s Economic Department under-

took 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 hi-

ghlights:

The 26 Interfarma’s associate companies that answe-

red the Survey obtained, in 2009, revenues of R$ 18,5

billion, to represent 55.1% of the Brazilian pharma-

ceutical 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 rese-

arch pharmaceutical industry employs 23.470 people

in Brazil.

The file with the complete Executive Summary is avai-

lable for download at Interfarma’s website (www.inter-

farma.org.br).

Book on Innovation

With the purpose of debating with authorities and so-

ciety 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 com-

pany Prospectiva Consultoria to select researchers and

professors from important Brazilian universities to wri-

te 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.

6

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.

PARTNERSHIPS

Interaction between researchers and industry

CHANGE OF THE ARTICLES OF ASSOCIATIONIn September, Interfarma’s Management Board approved

the revision of its Articles of Association with the purpo-

se of extending the entity’s representativeness and ope-

ning Interfarma to other segments dedicated to human

health research, especially in the biotechnology area.

Now, national and international companies and resear-

chers, institutions, foundations, universities, institutes,

start up companies without products, sales or earnings

and even same natural people can be a part of Interfar-

ma. By changing its articles of association, Interfarma

can shelter other institutions that might contribute to the

research and innovation efforts in human health.

Even before the effective alteration of its Articles of As-

sociation, Interfarma was dedicated to promoting ex-

change between researchers and associate companies.

That is why during the current year it signed partnership

agreements with three important institutions in the re-

search area: foundations Biominas and Bio-Rio, institu-

tions dedicated to creating biotechnology companies,

and with the Innovation, Entrepreneurship and Tech-

nology 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 Innova-

tion 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 esta-

blishments, such as pharmacies and drugstores. The first


volume of the 11-DVD series was launched in Septem-

ber, during the XVI Sao Paulo Congress of Pharmacists,

the Second Brazilian Pharmacy Congress and the VIII

International Seminar for Pharmacists, which are simul-

taneously 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 com-

mon activities that the industry and physicians may de-

velop 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 mee-

tings with the purpose of identifying joint work oppor-

tunities to favor health in Brazil. The defense of ethical

values, of better health access conditions, technology in-

corporation 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 In-

terfarma, 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 po-

tential it has to host clinical studies. In that occasion,

visitors also asked the minister to open an objective dis-

cussion 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, Di-

rector of Icesp at the Clinical Hospital of Sao Paulo and

Augusto Paranhos, Albert Einstein Hospital.

The participation of leaderships from outside the asso-

ciation was another initiative within the policy of streng-

thening the links and partnerships with all those invol-

ved 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 Na-

tional Research Ethics Commission (CONEP). The me-

eting 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 Ma-

nagement 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 opi-

nions that may be adopted by companies to facilitate the

processes within the CEP/CONEP system.

8

COMMUNI-CATIONIn 2010, Interfarma promoted many different rela-

tionship-building meetings with journalists and consi-

derably increased its participation in articles published

in the main newspapers and radio stations in the Coun-

try. 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 Bra-

zilian hinterland regions.

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 it-

self on all matters of interest, and in a positive manner.

The chart below shows a comparison between the re-

sult 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 exclusi-

ve note in magazine Exame, section “Grandes Números/

Great Figures”.

Resultados comparativo

2008 / 2009 / 2010 (fev-nov)


w w w. inter far ma.org .brma.org .br

Interview and editorial text in newspaper Folha

In 2010, after a visit by Antônio Britto and Octávio Nu-

nes to the newspaper Folha de Sao Paulo’s CEO, Mr.

Otávio Frias, that newspaper granted an important edi-

torial space for an interview with Mr. Britto, in the Q&A

format, on clinical research and innovation. The inter-

view, 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 edi-

torial 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 news-

letter, with a monthly periodicity, includes a summary of

Interfarma’s activities and was created so that the asso-

ciate 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 we-

bsite 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 press-

room 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.

10

Interfarma’s Guide

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.

The Guide contains essential information on Interfarma,

its associate companies, the Brazilian and global ma-

rkets; remaining entities that represent the pharmaceu-

tical 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.

Institutional booklet

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.

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 de-

partment has been organizing, since the year’s start, the

association’s Databank, which includes statistical infor-

mation, studies, presentations and other materials that

may be useful to the entity’s staff and to its associate

members.


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 Com-

mercio (PE), magazine Viva Saúde, Minha Vida Web

Portal, magazine Guia da Farmácia, newspaper Correio

do Estado (MS), magazine Ciência Hoje (RJ) and news-

paper 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 aller-

gy at the Medicine College of USP and director of the

immunology lab at the Instituto do Coração/Heart Ins-

titute (InCor); Prof. Dr. Paulo Hoff, Strategies Director

at the Oncology Center of the Syrian-Lebanese Hospital,

and Prof. Dr. Wilson Jacob Filho, Geriatric Services Di-

rector at USP’S Clinical Hospital.

NEW ASSOCIATE MEMBERSInterfarma 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 af-

ter a continuous effort to attract companies and streng-

then 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 dedica-

ted 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.

Professor Jorge Kalil, from USP, talking to journalists

12

INTERNAL ACTIONS

Board Election

An election was held in March for the 2010-2012 bien-

nium. Eloi Domingues Bosio, general manager of Daii-

chi Sankyo was elected as the new Board president, ha-

ving as vice-president, Antônio Alas, general manager

of Eli Lilly and as secretary Rubens Pedrosa, general ma-

nager of AstraZeneca. That election marked the change

in the Board’s structure, which henceforth has 16 titular

members.

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’ participa-

tion and adapting the list of commissions to the entity’s

priorities. The associate companies appointed 230 re-

presentatives for the commissions, an evident proof of

the interest of all members to actively take part in In-

terfarma.

Management Board approves the 2011 budget

The budget for the year 2011 was approved by the Ma-

nagement Board at the meeting held on December 02,

based on the matters discussed during the Strategic Se-

minar held in October.

Management Board validates, at the seminar, its operational strategy for 2011

At the start of November Interfarma organized the Stra-

tegic Seminar to evaluate scenarios, validate strategies

and discuss priorities for 2011.

The seminar was open with the presentation of the inter-

nal 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 Manage-

ment 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,

Eloi Domingos BosioPresidente, Daiichi Sankyo

Antônio AlasVice-Presidente, Eli Lilly

Rubens PedrosaSecretário, AstraZeneca

Adriano TreveRoche

Alexandre TriebniggNovartis

Cesar RengifoGlaxoSmithKline

Devaney BaccarinAstellas

Eliana TameirãoGenzyme

Gaetano CrupiAbbott

Heraldo MarcheziniSanofi-Aventis

José Roberto FerrazJanssen

Luiz Eduardo ViollandNycomed

Martin NelzowBoehringer

Tadeu AlvesMSD

Rainer KrauseBayer HealthCare

Victor MezeiPfizer

Members of Administration Council

Fiscal Council’s Composition

Eder MattioliEli Lilly

Juarez OliveiraNycomed

Waldir StorinoAbbott

Anderson GarbinNovartis

Ivan de BarrosSanofi-Aventis

Juarez PereiraJanssen

Advisory Council

Jorge Raimundo Filho


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 presi-

dent, Mr. Jorge Raimundo, undertook a wide program

of visits to Interfarma’s associate members and welco-

med 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, at-

tended 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, aca-

demics, 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 pro-

blems 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 ap-

proval. 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 pre-

cautionary 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 seg-

ment, which acted as co-authors. Interfarma also reci-

procally 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-

14

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 pu-

blished. Below are the key points of DRC 55/2010, which

regulates biological products in Brazil.

the National Congress, at the Economic Development

Ministry, Ministry of Foreign Relations and at the World

Trade Organization (WTO), in Geneva. Likewise, In-

terfarma 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 agree-

ment that averted the possibility of adopting measures

against intellectual property in that country. The Brazi-

lian Foreign Trade Chamber (CAMEX) communicated

the approval of a “framework agreement” between both

countries defining a set of “parameters for a progressi-

ve process aiming at significantly reducing the negative

effects of North American subsidies programs.”

The framework agreement forecasts reciprocal commit-

ments 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 elabo-

rated 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.

New schedule to deliver directions

Based on the negotiations, Anvisa republished RDC

47/09, which establishes rules for the elaboration, har-

monization, updating, publication and availability of

drug directions to patients and health professionals.

1. Two classes remain for regis-

tration of biological products (not

new) Development by Compara-

bility and Individual Development

2. Clinical studies should be con-

ducted with the new biological

product or biological product sub-

mitted for registration.

This item prevents registration

requests with data from other pro-

ducts.

3. Extrapolation of data on safety

and efficiency for other therapeutic

indications of biological products

registered in the development by

comparability class shall be establi-

shed through specific guides.

4. Extrapolation of data on safety

and efficiency shall not possible for

therapeutic indications of biological

products registered in the individu-

al development class.

5. Regardless of the development

class used, when filing the regis-

tration 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 regis-

tration 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 he-

althcare.

7. The biological product to be used

as a comparator in the comparabi-

lity exercise shall be the product

registered at Anvisa, the record of

which has been grounded by a full

dossier.

§ 1 in case of demonstrated com-

mercial unavailability of the com-

parator biological product on

the domestic and international

market, the choice of drug to be

used in the comparability exerci-

se shall be previously discussed

and asserted by Anvisa;

§ 2 in the situation described in

the preceding paragraph, pos-

sible comparators shall be new

biological products registered

by another regulatory authority

adopting technical-scientific cri-

teria similar to those of Anvisa,

and when there is likelihood of

full, unrestricted access to the re-

gistration information by Anvisa;

8. Upon registration of a new biolo-

gical 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 (in-

dividual or comparability) shall be

included.

9. Anvisa shall perform, ex officio

or at the request of the company, te-

chnical panels, with the authoriza-

tion of the Board, in order to dispel

doubts arising from the review of

registration requests of new biologi-

cal products or biological products,

under the specific procedure disclo-

sed on the website of Anvisa.

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 dia-

logue, the association took the issue to be debated at


According to the new rule, new schedule and new crite-

ria (list 1 and list 2) were established for directions’ de-

livery. 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 comprehen-

sion of the new rules, correct orthographic and grammar

errors and redefine the adaptation terms.

Electronic Registration

In 2010, Interfarma continued with its work related to

electronic drug registration started in 2008. In Septem-

ber, Anvisa presented the new Electronic Drug Registra-

tion System and five associate companies – chosen by

Anvisa due to the positive experiences brought from fo-

reign 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 de-

emed 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 asso-

ciate 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 biologi-

cal products retention at Brazilian ports and airports due

to the joint Service Order signed by GGPAF and GG-

MED in order to standardize the release criteria for tho-

se drugs. The greater problem involved the drugs that

should be kept at a temperature between 2ºC and 8ºC.

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

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 accompa-

nied Cláudio Maierovitch, Program Director at he Se-

cretariat 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 Mar-

gins (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 Secreta-

riat, as the initial basis for the negotiation of a formula

that corresponds to the market reality. The survey poin-

ted 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 be-

tween the current AVM and actual discounts.

16

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.

INTERNATIONAL OPERATIONSThroughout the year 2010, Interfarma intensified its in-

ternational 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, atten-

ded a series of meetings in Europe. The trip included

meetings in Paris, with the French Association of Phar-

maceutical 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 Com-

mission 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-

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 fu-

ture perspectives. And it watched presentations on the

structure and priorities of local associations. There was

also, at all meetings, a period dedicated to debating Bra-

zilian issues. At the end of every stage, concrete ways to

extend the dialogue between Interfarma and local as-

sociations were established as well as the alignment of

actions around common interests.

USA – Annual meetings

In November, Mr. Antônio Britto and Mr. Ronaldo Pi-

res took part in the annual meeting of Pharmaceuti-

cal 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 defen-

ded 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 offi-

ce replacing Mr. Haruo Naito (EISAI).

During all trips, Mr. Antônio Britto has opened his agen-

da 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 He-

alth Ministry official mission to Washington. Mr. Jorge


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 go-

vernment 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 In-

dustry, MSD Brazil’s corporate matters director, Mr. João

Sanches, presented a work on intellectual property de-

fense 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 collabo-

ration 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 Tem-

porão presented the proposal for the Brazilian “super”

pharmaceutical industry. He showed the funding pro-

grams held by BNDES and announced some partner-

ships with private companies.

SOCIAL RESPONSIBILITYIn 2010, Interfarma also dedicated efforts to a very im-

portant segment: the third sector. The association crea-

ted a work group on social responsibility and contracted

a company specialized in the production and manage-

ment of third-sector editorial projects, in order to ob-

tain 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 res-

ponsibility institutional project contemplating the inte-

rests 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. Si-

milarly, 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 com-

pany 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 pri-

vate schools, as regards the problem of piracy in Brazil

18

and in the world, the PEL should reach, until this year’s

end, educators in six Brazilian cities: Campinas, Curiti-

ba, 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, Argen-

tina, the First HTAi Latin American Regional Meeting

counted on the participation of lecturers from the pu-

blic 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 in-

creasing 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 pro-

cess, 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 Bra-

zilian 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, se-

minars and debates of interest to the sector, and Interfar-

ma took part, supported and sponsored some of them,

such as:

XXX International Intellectual Property Congress,

held by ABPI (Brazilian Intellectual Property Asso-

ciation)

Seminar on Piracy Fight in the Health Sector, held

by ABIMED (Brazilian Association of Importers of

Medical and Hospital Equipments, Products and Sup-

plies)

“Medicamento Verdadeiro/True Medication” Cam-

paign, 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 (Bra-

zilian Pharmaceutical Medicine Society)

20

Rua Verbo Divino, 1.488 – 7º andar – Cj. 7A

Chácara Santo Antônio – São Paulo – SP

CEP: 04719-904

Tel.: (55 11) 5180-2380

Fax: (55 11) 5183-4247

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ANNUAL ACTIVITIES REPORT - Interfarma...PRESENTATION Upon celebrating its 20 years in 2010,...

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