HIV This Week

The UNITAID Patent Pool Initiative: Bringing Patents Together for the Common Good.

Bermudez J, 't Hoen E. Open AIDS J. 2010;4:37-40.

Developing and delivering appropriate, affordable, well-adapted medicines for HIV remains an urgent challenge: as first-line therapies fail, increasing numbers of people require costly second-line therapy; one-third of antiretrovirals are not available in paediatric formulations; and certain key first- and second-line triple fixed-dose combinations do not exist or sufficient suppliers are lacking.  UNITAID aims to help solve these problems through an innovative initiative for the collective management of intellectual property rights - a patent pool for HIV medicines. The idea behind a patent pool is that patent holders - companies, governments, researchers or universities - voluntarily offer, under certain conditions, the intellectual property related to their inventions to the patent pool. Any company that wants to use the intellectual property to produce or develop medicines can seek a license from the pool against the payment of royalties, and may then produce the medicines for use in developing countries (conditional upon meeting agreed quality standards). The patent pool will be a voluntary mechanism, meaning its success will largely depend on the willingness of pharmaceutical companies to participate and commit their intellectual property to the pool. Generic producers must also be willing to cooperate. The pool has the potential to provide benefits to all.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2842943/

Editors’ note: UNITAID, launched at the UN General Assembly in September 2006 by Brazil, Chile, France, Norway, and the United Kingdom, is an innovative financing mechanism that has expanded to include more than 29 countries and the Bill and Melinda Gates Foundation. Some are providing multi-year budgetary contributions while others have placed a solidarity tax on airline tickets. A full plane from Paris to New York raises enough money to cover a year of antiretroviral treatment for 60 HIV-positive children. In addition to dedicating at least 85% of its spending on products for low-income countries, UNITAID is committed to a pro-health approach to intellectual property. The concept of patent pools is very timely now. Fixed dose combinations of the new WHO recommended first line of tenofovir, lamivudine, and nevirapine or efavirenz, do not exist or are limited in supply. Affordable second line drugs are urgently needed for patients failing first line therapy and a third of antiretroviral drugs are not available in paediatric formulation. Patent terms are normally 20 years. Patent pools have worked, for example, in agriculture, aeronautics, and information technology when relevant patents for a process are owned by many different entities. They reward pharmaceutical companies for their investment in research and development, give them a reputational boost, reduce transaction costs associated with negotiating individual license and price reductions, and avert the risk of compulsory licensing of their products. Patent pools provide generic companies access to intellectual property more easily and quickly and they ensure faster access to better, more affordable antiretroviral treatment for patients in low-income countries. Under the World Trade Organisation (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), governments can and do override patents to meet public health needs. However, a less complex and more timely process would be a voluntary patent pool. It is time to step up to the plate!

Amon JJ, Kasambala T. Structural barriers and human rights related to HIV prevention and treatment in Zimbabwe. Glob Public Health. 2009 Mar 26:1-17. [Epub ahead of print]

There has long been recognition that individual risk factors can only partially explain vulnerability to HIV infection, and that a broader range of socioeconomic, cultural and political factors must be taken into account. More recently this understanding has been applied to addressing obstacles to accessing HIV treatment. Yet, while structural interventions aimed at contextual factors related to HIV prevention and treatment have been shown to be effective, they have not been widely implemented. Using the situation of Zimbabwe as an example, Amon and Kasambala present an illustration of how contextual barriers can be understood in human rights terms, and how using a human rights analysis can specifically help define ‘structural-rights’ interventions and compel their implementation.

Editors’ note: This article, a must-read for all those interested in effective combination prevention, demonstrates how explicitly recognising human rights provides a mechanism to address structural level barriers to HIV prevention and care, reinforcing government and donor agency accountability to redress societal power differentials. In other words, situating concerns about the socioeconomic, cultural, and political barriers to HIV prevention within a context of human rights provides a framework for action founded on the obligations and responsibilities of states. Drawing on the current HIV and human rights crisis in Zimbabwe, specific examples are provided of concrete structural-rights interventions to address the right to earn a livelihood and own property; the right to freedom of expression, assembly, and information; the right to freedom from gender-based and sexual violence; and the right to the progressive realisation of health.

Amon JJ, Todrys KW. Fear of Foreigners: HIV-related restrictions on entry, stay, and residence. J Int AIDS Soc. 2008;11(1):8.

Among the earliest and the most enduring responses to the HIV epidemic has been the imposition by governments of entry, stay, and residence restrictions for non-nationals living with HIV. Sixty-six of the 186 countries in the world for which data are available currently have some form of restriction in place. Although international human rights law allows for discrimination in the face of public health considerations, such discrimination must be the least intrusive measure required to effectively address the public health concern. HIV-related travel restrictions, by contrast, not only do not protect public health, but result in deleterious effects both at the societal level - negatively impacting HIV prevention and treatment efforts - and at the individual level, affecting, in particular, labour migrants, refugee candidates, students, and short-term travellers. Governments should repeal these laws and policies, and instead devote legislative attention and national resources to comprehensive HIV prevention, care, and treatment programmes serving citizens and non-citizens alike.

Editors’ note: In the 2001 Declaration of Commitment on HIV/AIDS and in subsequent declarations, governments have committed to enact appropriate legislation to eliminate all forms of discrimination against persons living with HIV. HIV-related travel restrictions should be repealed immediately and entirely – they have no public health justification and are a human rights violation.

In developing countries, culture favours males for economic ventures more than females. There is evidence that allowing HIV-positive women inheritance rights will mitigate negative economic consequences of HIV and other related risks. This study aimed to examine the extent to which HIV-positive women have access to family resources in Abia State, Nigeria. Data collection instruments were questionnaires, focus group discussions, and interview guides using 98 HIV positive women in networks of people living with HIV. Five key informants were also interviewed to authenticate women’s responses. Eighty-five (86.7%) of the women were denied rights to family resources. Thirty-eight (64.4%) of them had negative relationship with their family members for demanding their husbands’ property. Because of limited financial assistance, the women took two types of risks in order to survive in the communities. Twenty-five women (25.5%) earned their livelihood by acting as hired labourers to others in the farm. More that half (55.1%) of the HIV-positive women were practicing unprotected sex. Although as many as 79.6% of the women were aware of risks of unprotected sex, 54 (55%) of them practised it. The commonest reason for taking the risk was sex partners’ dislike for condom use. The high proportion of HIV-positive women who were denied access to family resources could suggest lack of care and support. If this denial continues, the government’s efforts to reduce HIV prevalence would yield no significant result. There is therefore a need for an organized community education programme that emphasizes the benefits of empowering women living positively with HIV economically.

Editors’ note: Denying women living with HIV access to family resources thwarts their economic empowerment and increases sexual risk. Enactment and effective implementation of inheritance laws are needed to ensure that women can own and/or control resources such as land, housing, and livestock after the death of their husbands. Their well-being and that of their children depend on it.

WHO/UNAIDS/AAVP International Expert Group, Osmanov S. Executive summary and recommendations from WHO/UNAIDS and AAVP consultation on: ‘The inclusion of adolescents in HIV vaccine trials’, 16-18 March 2006 in Gaborone, Botswana. AIDS 2007;21:W1-10.

This report summarizes the discussions and recommendations from a consultation held in Gaborone, Botswana (16-19 March 2006), organized by the joint World Health Organization (WHO)/United Nations Programme on HIV/AIDS (UNAIDS) HIV Vaccine Initiative (HVI) and the African AIDS Vaccine Programme (AAVP). The consultation considered key challenges and strategies in enrolling adolescents into HIV vaccine clinical trials, relevant to developing countries, in particular in eastern and southern Africa. Approaches were identified that might address and resolve country-specific challenges related to scientific, legal, ethical, regulatory and community aspects of the involvement of adolescents in HIV vaccine trials. This executive summary is formulated for a broader dissemination of the outcomes of the meeting to the general clinical, scientific and regulatory community involved in the review, approval and monitoring of clinical trials and potential licensing of HIV vaccine candidates. Four major topics were discussed and recommendations developed with regard to: (i) criteria for products selection and clinical trial design; (ii) ethical and legal issues; (iii) community acceptance and participation; and (iv) regulatory considerations. The recommendations of this meeting were further discussed and endorsed by the WHO/UNAIDS HIV Vaccine Advisory Committee.

Editors’ note: UNAIDS is co-hosting with the Global Coalition on Women and AIDS, the International Centre for Research on Women and Tibotec, Inc. a consultation in December 2007 entitled ‘Making HIV trials work for women and adolescent girls’ at which the rationale, challenges and strategies for enrolling adolescent girls in HIV trials will be discussed. This article on the HIV vaccine trial context provides good background on the topic.