Brasília, Outubro 2006Jorge A Beloqui Community involvement in HIV Vaccine activities in Brazil J. Beloqui GIV, ABIA, RNP+ IME-USP (Maths Institute, University of São Paulo)

Brasília, Outubro 2006Jorge A Beloqui Background (I) Fifteen years ago In August 1991 a GPA/WHO mission visited Brazil and talked with some AIDS/NGOs about trials for preventive vaccines in Brazil, during the First National PWHIV/AIDS meeting in Rio de JAneiro.

Brasília, Outubro 2006Jorge A Beloqui Background (II) since October 1991 the Brazilian AIDS/NGOs began to follow up the national and global HIV vaccine strategies. From the first moment they were perceived as important public health issues in AIDS, and many NGOs were interested.

Brasília, Outubro 2006Jorge A Beloqui Background (III) In December 1991, 22 representatives of AIDS/NGOs met with the GPA/WHO mission and with the National Coordinator This meeting was useful to get information ftom GPA, which led us to oppose the M. Of Health declarations about providing “guinea pigs” for trials sponsored from abroad (December 1991)

Brasília, Outubro 2006Jorge A Beloqui Background (IV) We thought that we were able to supervise the vaccine trials sponsored from abroad in order that they were conducted in an ethical way and with future access Thus the lemma was “ scientific and ethical excellency", to overcome suspicions. This approach led AIDS/NGOs to a familiarity with ethics and access issues.

Brasília, Outubro 2006Jorge A Beloqui Vaccine activities in Brazil A National Committee on HIV vaccines was created in At the request of the National AIDS Program, a 5 AIDS/NGO representations was created at the National HIV Vaccine Committee, elected every 2 years at the National AIDS/NGO Meeting. This was the first elected national representation of Brazilian AIDS/NGOs (1992)

Brasília, Outubro 2006Jorge A Beloqui Activities (II) 5 national meetings were organised (1994, 1996, 1998, 2003, 2005) together with the National Meeting of People Affected by HIV/AIDS, or with the National AIDS/NGOs Meetings, thus integrating vaccine activities within general AIDS/NGO activities 15 issues of a Bulletin were published, CD Rom Due to a solicitation by NIH, currently two CABs (Rio de Janeiro 1999 and São Paulo 2001) are formed, based on AIDS/NGOs

Brasília, Outubro 2006Jorge A Beloqui Other activities First Latinamerican Meeting on HIV Vaccines for the community (São Paulo, October 2001) (3 and a half days, 90 participants from Brazil and 10 from other Latinamerican countries and Europe (MH, IAVI, Unaids)

Brasília, Outubro 2006Jorge A Beloqui Regional AIDS/NGO meetings on HIV Vaccines Southern region in Brazil (May 2002) meeting on HIV Vaccines I ENVAH (Recife, 2004). A Declaration on HIV Vaccines was issued (MH, IAVI) II ENVAH (Natal 2005, MH, IAVI) São Paulo Meeting (2004, MH, IAVI)

Brasília, Outubro 2006Jorge A Beloqui Inclusion in the Minimum AIDS Program of the State of São Paulo AIDS/NGOs Forum of an item regarding Vaccines research and technology transfer

Brasília, Outubro 2006Jorge A Beloqui Other Initiatives (by NGOs) Creation of the HIV Vaccine Unit at the National AIDS Program Push for the behavioural research on HIV vaccines

Brasília, Outubro 2006Jorge A Beloqui Important Features Most Vaccine Committee representatives have been PWHIV/AIDS since the beginning

Brasília, Outubro 2006Jorge A Beloqui Access to Arvs in Trials For reasons of ethical excellence and conceiving prevention and care as a continuum we have always supported access to ARVs for people who get infected in vaccine trials, in the international meetings

Brasília, Outubro 2006Jorge A Beloqui Access and Ethics Estimates of the need of HIV vaccines in Brazil: Between 9 and 124 million doses (Hecht and Suraratdecha) Global HIV Prevention Working Group

Brasília, Outubro 2006Jorge A Beloqui Res. 196/96 Based upon Helsinki Declaration, Cioms guidelines, etc. III.3 Research involving human subjects, regardless of the field of knowledge, must comply with the following requirements:... n) to guarantee the individuals and communities where the research was undertaken a return on the benefits obtained in the research

Brasília, Outubro 2006Jorge A Beloqui Access to the product in places where trials have been conducted Declaration of Helsinki 2000 –Paragraph 19: “Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research.” What are the criteria for determining likelihood? What degree of likelihood is necessary?

Brasília, Outubro 2006Jorge A Beloqui CIOMS 2002 Guideline 10 Before undertaking research in a population or community with limited resources, the sponsor and the researcher must make every effort to ensure that: –the research is responsive to the health needs and the priorities of the population or community in which it is to be carried out; and –any intervention or product developed, or knowledge generated, will be made reasonably available for the benefit of that population or community.

Brasília, Outubro 2006Jorge A Beloqui US NBAC Recommendation 4.2 Research proposals submitted to ethics review committees should include an explanation of how new interventions that are proven effective from the research will become available to some or all of the host country population beyond the research participants themselves….

Brasília, Outubro 2006Jorge A Beloqui NBAC (continued) In cases in which investigators do not believe that successful interventions will become available to the host country population, they should explain to the relevant ethics review committee(s) why the research is nonetheless responsive to the health needs of the country and presents a reasonable risk/benefit ratio.

Brasília, Outubro 2006Jorge A Beloqui UNAIDS Guidelines (2) Any HIV preventive vaccine demonstrated to be safe and effective, as well as any knowledge and benefits resulting from HIV vaccine research, should be made available as soon as possible to all participants in the trials in which it was tested, as well as to other populations at high risk of HIV infection. Plans should be developed at the initial stages of HIV vaccine development to ensure such availability

Brasília, Outubro 2006Jorge A Beloqui Negotiating access No industrial sponsor, or agency will (be able to or should ) bear the entire burden of providing vaccines What is the place of sponsor, sponsoring countries, researchers and governments of the host country in these negotiations? probably governments should negotiate before end of trials When ? What kind of negotiation: access at tiered price, technology transfer?

Brasília, Outubro 2006Jorge A Beloqui ARVs for PWHIV/AIDS: learning from bad experiences 10 years after the Vancouver Conference, optimistic calculations evaluate that at most 20 % of people who need ARVs have access to them What are we doing now to antecipate access to a vaccine in a MUCH better way than access to ARVs? When should we do something?

Brasília, Outubro 2006Jorge A Beloqui Another example Phase III trials of HPV vaccines were conducted in Brazil FDA licensed the first one in June 2006; ANVISA in August Current price: 360 US dollars Declarations in August 2006: “We are talking with more than one ph. Lab (GlaxoSmithKline has a vaccine candidate in clinical trials). Yesterday, I held a meeting with them. But for the time being there is no possibility", said Jarbas Barbosa, Secretary for Health Surveillance in the M. of Health. “We are going to evaluate the cost effectivity and then suggest a price."

Brasília, Outubro 2006Jorge A Beloqui Two examples of negotiation for access to HIV Vaccines Thailand and AIDSVAX (before or during Phase III trials) India and IAVI (before initiation of Phase I trials)

Brasília, Outubro 2006Jorge A Beloqui Urgency If there is an urgent need for an HIV vaccine ( new HIV infections a day), it is because there is a need of urgent access to it

Brasília, Outubro 2006Jorge A Beloqui Worst choice Do nothing (talk, discuss, negotiate) about access NOW

Brasília, Outubro 2006Jorge A Beloqui The challenges of ethics and access persist 15 years after Because of the pressures to reduce ethical standards in trials in developing countries. Because of the worse conditions for local production of drugs and vaccines due to the agreements such as TRIPS and pressures especially from the US for bilateral and regional agreements (FTAA, FTCA) including restrictions against development of local production through Industrial Property restrictions

Brasília, Outubro 2006Jorge A Beloqui Thank you!