ANNUAL ACTIVITIES REPORT - Interfarma...PRESENTATION Upon celebrating its 20 years in 2010,...
Transcript of 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
2
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
Relatório Anual de Atividades - 2010 3
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
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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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INFORME PUBLICITÁRIO
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
INFORME PUBLICITÁRIO
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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Relatório Anual de Atividades - 2010 5
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.
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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
Relatório Anual de Atividades - 2010 7
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)
Relatório Anual de Atividades - 2010 9
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.
Relatório Anual de Atividades - 2010 11
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
Relatório Anual de Atividades - 2010 13
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
Relatório Anual de Atividades - 2010 15
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
Relatório Anual de Atividades - 2010 17
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)
Relatório Anual de Atividades - 2010 19
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