Articles Tagged as 'Human rights, ethics, law and intellectual property'

January
19
2010

Human rights

Structural barriers and human rights related to HIV prevention and treatment in Zimbabwe.

Amon JJ, Kasambala T. Glob Public Health. 2009;4:528-45.

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 et al 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.

Abstract: 1

Editor’s note: In linking human rights obligations and structural-rights interventions, this paper considers four categories of global human rights concerns: 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. Using the situation of Zimbabwe as an illustration, the paper presents a list of structural-rights interventions linked to goals addressing each of these human rights concerns. This analytic framework explicitly links interventions to redress societal inequities, reduce vulnerability to HIV, and expand access to treatment with state obligations under national and international law. It reinforces the role of governments to address structural barriers and human rights abuses as part of their broader mission of public health.  
June
16
2009

Human Rights

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.
March
3
2009

Policy and law

Cameron E, Burris S, Clayton M. HIV is a virus, not a crime: ten reasons against criminal statutes and criminal prosecutions. J Int AIDS Soc. 2008;11(1):7. [Epub ahead of print]

The widespread phenomenon of enacting HIV-specific laws to criminally punish transmission of, exposure to, or non-disclosure of HIV, is counter-active to good public health conceptions and repugnant to elementary human rights principles. The authors provide ten reasons why criminal laws and criminal prosecutions are bad strategy in the epidemic.

Editors’ note: HIV is a virus not a crime and criminalisation of HIV is hostile to both HIV prevention and treatment. Knowing one’s HIV status and setting out deliberately to infect another person and achieving this aim demonstrates criminal intent warranting prosecution. However, there is no public health justification for invoking criminal law sanctions against those who unknowingly and unintentionally transmit HIV or expose others to it. Such criminalisation discourages HIV testing and counselling, the pathway to treatment access and HIV status-specific prevention; reinforces stigma, enhances fear, and isolates people living with HIV; and undercuts efforts to address the epidemic.

Human rights

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.

Enwereji EE. Sexual behaviour and inheritance rights among HIV-positive women in Abia State, Nigeria. Tanzan J Health Res. 2008;10(2):73-8.

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.

January
17
2008

Ethics

Smith CB, Battin MP, Francis LP, Jacobson JA. Should rapid tests for HIV infection now be mandatory during pregnancy? Global differences in scarcity and a dilemma of technological advance. Developing World Bioeth 2007;7:86-103.

Since testing for HIV infection became possible in 1985, testing of pregnant women has been conducted primarily on a voluntary, ‘opt-in’ basis. Faden, Geller and Powers, Bayer, Wilfert, and McKenna, among others, have suggested that with the development of more reliable testing and more effective therapy to reduce maternal-foetal transmission, testing should become either routine with ‘opt-out’ provisions or mandatory. Smith and colleagues ask, in the light of the new rapid tests for HIV, such as OraQuick, and the development of antiretroviral treatment that can reduce maternal-foetal transmission rates to <2%, whether that time is now. Illustrating their argument with cases from the United States (US), Kenya, Peru, and an undocumented Mexican worker in the US, the authors show that when testing is accompanied by assured multi-drug therapy for the mother, the argument for opt-out or mandatory testing for HIV in pregnancy is strong, but that it is problematic where testing is accompanied by adverse events such as spousal abuse or by inadequate intrapartum or follow-up treatment. The difference is not a ‘double standard’, but reflects the presence of conflicts between the health interests of the mother and the foetus – conflicts that would be abrogated by the assurance of adequate, continuing multi-drug therapy. In light of these conflicts, where they still occur, careful processes of informed consent are appropriate, rather than opt-out or mandatory testing.

Editors’ note: The continued debate over mandatory, opt-out, provider-offered, and opt-in testing is non-productive. Technologies advances should never override respect for the principle of informed consent for medical procedures. Mandatory HIV testing is not an effective public health measure and has never been recommended by WHO/UNAIDS. Nevertheless, provision of antiretroviral treatment for women who need it, whether pregnant or not, is in the interests of both the woman and her children and should be a high priority.
November
17
2007

Research

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.
October
14
2007

Ethics in research

Slack C, Strode A, Fleischer T, Gray G, Ranchod C. Enrolling adolescents in HIV vaccine trials: Reflections on legal complexities from South Africa. BMC Med Ethics 2007;8:5.

Photo credit: UNAIDS/G.PirozziSouth Africa is likely to be the first country in the world to host an adolescent HIV vaccine trial. Adolescents may be enrolled in late 2007. In the development and review of adolescent HIV vaccine trial protocols there are many complexities to consider, and much work to be done if these important trials are to become a reality. This article sets out essential requirements for the lawful conduct of adolescent research in South Africa including compliance with consent requirements, child protection laws, and processes for the ethical and regulatory approval of research.  This article outlines likely complexities for researchers and research ethics committees, including determining that trial interventions meet current risk standards for child research. Explicit recommendations are made for role-players in other jurisdictions who may also be planning such trials. This article concludes with concrete steps for implementing these important trials in South Africa and other jurisdictions, including planning for consent processes; delineating privacy rights; compiling information necessary for ethics committees to assess risks to child participants; training trial site staff to recognize when disclosures trigger a mandatory reporting response; networking among relevant ethics committees; and lobbying the National Regulatory Authority for guidance.

Editors’ note: The reflections in this article have relevance beyond HIV vaccine trials to any trials involving adolescents. They have an evolving capacity to understand and consent to experimental products and interventions. In the case of HIV, enrolling adolescents in trials of novel biomedical HIV prevention products is particularly important in high incidence settings where adolescents are at very high risk of HIV exposure. They would be the primary beneficiaries for any public health programme involving a successful biomedical prevention product.

Macrae DJ. The Council for International Organizations and Medical Sciences (CIOMS) Guidelines on Ethics of Clinical Trials. Proc Am Thorac Soc 2007;4:176-9.

Numerous bodies from many countries, including governments, government regulatory departments, research organizations, medical professional bodies, and health care providers, have issued guidance or legislation on the ethical conduct of clinical trials. It is possible to trace the development of current guidelines back to the post-World War II Nuremburg war crimes trials, more specifically the « Doctors’ Trial. » From that trial emerged the Nuremburg Code, which set out basic principles to be observed when conducting research involving human subjects and which subsequently formed the basis for comprehensive international guidelines on medical research, such as the Declaration of Helsinki. Most recently, the Council for International Organizations and Medical Sciences (CIOMS) produced detailed guidelines (originally published in 1993 and updated in 2002) on the implementation of the principles outlined in the Declaration of Helsinki. The CIOMS guidelines set in an appropriate context the challenges of present-day clinical research, by addressing complex issues including HIV research, availability of study treatments after a study ends, women as research subjects, safeguarding confidentiality, compensation for adverse events, as well guidelines on consent.

Editors’ note: UNAIDS and WHO have just completed updating of the popular 2000 UNAIDS guidance document Ethical considerations in HIV preventive vaccine research with the assistance of an expert panel composed of members from Australia, Brazil, Great Britain, India, Israel, Nigeria, South Africa, Switzerland, Thailand and the USA. Entitled Ethical considerations in biomedical HIV prevention trials: UNAIDS/WHO guidance document, it is consistent with CIOMS and other international research ethics guidelines. Containing 19 guidance points, it will be translated initially into French, Portuguese, Spanish and Russian.
September
25
2007

Research ethics

Macqueen KM, Namey E, Chilongozi DA, Mtweve SP, Mlingo M, Morar N, Reid C, Ristow A, Sahay S, Hptn T, Team SO. Community perspectives on care options for HIV prevention trial participants. AIDS Care 2007;19:554-60.

There is on-going global debate and policy-setting concerning researchers’ obligations to meet the health needs of people participating in HIV prevention trials in resource-poor settings. The perspectives of local community stakeholders on this issue are poorly understood as most of what is presented on behalf of communities where research takes place is anecdotal commentary. Using qualitative methods (130 in-depth interviews and 20 focus groups) MacQueen and colleagues assessed perceived fairness of different strategies to meet the health needs of women who become HIV-infected during a hypothetical vaginal microbicide trial. Respondents included HIV prevention research participants, community stakeholders and health-care service providers in ten sites in seven countries (South Africa, Malawi, Tanzania, Zimbabwe, Zambia, India, US). Many respondents perceived referrals to be a potentially fair way to address care and treatment needs but concerns were also voiced about the adequacy of local health-care options and the ability of trial participants to access options. Most respondents viewed the provision of antiretroviral treatment by researchers to HIV-infected trial participants as unfair if treatment was not sustained beyond the end of the trial. The results underscore the importance of effectively linking trial participants to sustainable, community-based treatment and care.

Editors’ note: This formative research with women in ten communities in Africa, India and the USA informed policy, not only at Family Health International, but among other research and community partners around the world. More information on the issues of standard of prevention and access to care is available from UNAIDS through two publications: Ethical considerations for biomedical HIV prevention trials and Good Participatory Practices in biomedical HIV prevention trials.

Tarantola D, Macklin R, Reed ZH, Kieny MP, Osmanov S, Stobie M, Hankins C. Ethical considerations related to the provision of care and treatment in vaccine trials. Vaccine 2007 Jun 21;25(26):4863-74.

Ethical principles of beneficence and justice combined with international human rights norms and standards create certain obligations on researchers, sponsors and public health authorities. These include treatment provision for participants enrolled in clinical trials of vaccines, drugs and other new preventive and curative technologies and methods. However, these obligations are poorly defined in practical terms, inconsistently understood or inadequately applied. Vaccine clinical trial designs normally define standards of prevention applicable to the population where the trial is to take place. The present document addresses specifically the setting of standards applicable to care and treatment in vaccine trials. The lack of clear guidance on how to achieve the optimal synergy between the development of new health technologies, on the one hand, and the promotion and protection of ethical and human rights principles, on the other, is a barrier to the progress of health research and therefore to the advancement of public health. The World Health Organization and UNAIDS have engaged in a series of consultations in Africa, the Americas, Asia and Europe to reflect on how this aim could best be achieved. This document highlights the outcome of these consultations. It proposes a structured approach to consensual decision making in the context of the clinical trial of vaccines against such public health challenges as HIV and newly emerging or threatening epidemics. A structured approach involving investigators and sponsors in a consultative process with trial communities and other stakeholders in research will ensure that the needs and legitimate expectations of trial participants are appropriately met, obligations towards them are delivered and, as a result, ethical research is facilitated in the interest of public health.

Editors’ note: Who will provide and who will pay for the treatment and care of people who become infected during a biomedical HIV prevention trial has been hotly debated now for ten years. UNAIDS in collaboration with WHO has revised Ethical considerations for biomedical HIV prevention trials and in collaboration with the AIDS Vaccine Advocacy Coalition, and a Working Group with diverse membership, has created Good Participatory Practices in biomedical HIV prevention trials. Both of these documents make it clear that providing access to antiretroviral treatment for those who seroconvert in an HIV prevention trial is the accepted standard.
February
27
2007

Universal access

Boisseau C, Degui H, Bruneton C, Rey JL. [Poor access to antiretroviral treatment in French-speaking Africa: situation in 2004]. Med Trop (Mars) 2006;66:589-92.

Boisseau and colleagues carried out a survey by questionnaire and interview with persons in charge of purchasing in central structures and AIDS control programs in 18 French-speaking African countries between June and October 2004. Survey data showed that a total of 3300 patients received antiretroviral treatment during the study period. This corresponds to a treatment rate of 0.1 to 9.6% of the number of patients requiring antiretroviral treatment. All countries reported interruptions of the antiretroviral supply for a variety of reasons. The main causes were budgetary issues and procedural complexity involving financial aid. The prices charged to the patients varied greatly in function of national policies. Cost price also varied in function of the negotiating leverage of the purchasing central. The authors conclude that in order to improve general access to antiretroviral treatment and to reduce the number of supply shortages more training will be required in management and distribution of medicines. They conclude that it would also be useful to improve communications between the persons in charge of national purchasing structures.

Editors’ note: Patient access and adherence to treatment are known preoccupations of treatment programmes but antiretroviral drug shortages and financing problems are management concerns at the level of central procurement that have to be urgently addressed for effective supply chain management.

Deng R, Li J, Sringernyuang L, Zhang K. Drug abuse, HIV/AIDS and stigmatisation in a Dai community in Yunnan, China. Soc Sci Med 2007 Jan 23; [Epub ahead of print]

The latest data indicate that between 540,000 and 760,000 people are infected with HIV in China. Although minority nationalities represent 8.1% of China’s total population, they account for more than 30% of the reported HIV cases. Deng and colleagues examined stigma and discrimination against drug abusers and people living with HIV in a Dai minority nationality community in Yunnan, China. The authors used qualitative research methods, which included participatory observations, in-depth interviews, focus-group discussions, transect walking and community mapping. A combination of different sampling strategies was used to maximise diversity of the initially selected sample. The data revealed deeply entrenched stigma and overt discrimination against drug abusers and people living with HIV that manifested in familial, work, civil and institutional contexts. The stigma reflected pre-existing cultural, religious sanctions against “deviant behaviours”. Intervention programmes that were insensitive to the local culture and religion may have also contributed in part to the stigmatisation of drug abusers and people living with HIV. The major impact of stigma was that it created a vicious cycle of social isolation, marginalisation and thus addiction relapse. This in turn reinforced the stigmatisation and discrimination against drug abusers and thus hindered efforts towards prevention and control of HIV.

Editors’ note: Stigma and discrimination drive the epidemic underground, undermining HIV prevention and delaying treatment provision to those most in need. Sustained efforts to overcome them are essential to progress towards universal access.

Evidence- informed decision making

Tantivess S, Walt G. Using cost-effectiveness analyses to inform policy: the case of antiretroviral therapy in Thailand. Cost Eff Resour Alloc 2006;4(1):21. http://www.resource-allocation.com/content/4/1/21

Much emphasis is put on providing evidence to assist policymakers in priority setting and investment decisions. Assessing the cost-effectiveness of interventions is one technique used by policymakers in their decisions about the allocation of scarce resources. However, even where such evidence is available, other considerations may also be taken into account, and even over-ride technical evidence. ART is the most effective intervention to reduce HIV-related morbidity and prolong mortality. However, treatment provision in the developing world has been hindered by the high costs of services and drugs, casting doubts on its cost-effectiveness. Tantivess and Walt look at Thailand’s publicly-funded antiretroviral initiative which was first introduced in 1992, and explore the extent to which cost-effectiveness evidence influenced policy. The authors review the development of the national ART programme in Thailand between 1992 and 2004. They examine the roles of cost-effectiveness information in treatment policy decisions. Qualitative approaches including document analysis and interview of key informants were employed. Two significant policy shifts have been observed in government-organised ART provision. In 1996, service-based therapy for a few was replaced by a research network to support clinical assessments of antiretroviral medication in public hospitals. This decision was taken after a domestic study illustrated the unaffordable fiscal burden and inefficient use of resources in provision of ART. The numbers of treatment recipients was maintained at 2000 per year throughout the 1990s. It was not until 2001 that a new government pledged to extend the numbers receiving the service, as part of its commitment to universal coverage. Several elements played a role in this decision: new groups of dominant actors, drug price reductions, a pro-active civil society movement, lessons from experience on treatment benefits, and global treatment advocacy. Unlike previous policy discourse, human rights, ethics and equity notions were explicitly raised to support therapy extension. In summary, in the early decision, moving from a relatively limited ART service to a research network was clearly influenced by cost-effectiveness data. But in the 2001 decision to include ART in the universal coverage package, cost-effectiveness arguments were over-ruled by other considerations. The authors conclude that Thai ART policy was shaped by many factors, and was not a simple rational process which relied on evidence.

 Editors’ note: This article clearly illustrates why UNAIDS’ preferred terminology is ‘evidence-informed’ decision making rather than ‘evidence-based’ decision making. Further, the decision this week by the Thai government to approve a generic version of Abbott Laboratories’ protease inhibitor Kaletra (lopinavir/ritonavir), a second line drug, demonstrates that when equity of access for people who fail first line regimens has been prioritised by a government, cost and other considerations can drive decisions about intellectual property.

1 Comment

  • ART policy, especially involving the use of generic medicines is certainly shaped by factors which are beyond the scope of this study. It might be cost effective to allocate resources for the production of medicines but policy makers are not sometimes free to do so because the aid/grant received by the country is subject to many conditionalities. Countries benefiting from PEPFAR are not allowed to buy generic drugs no matter how cost effective it is. This makes lobby/campaign an essential aspect of an effective ART programme.
    KB

September
22
2006

Universal Access

Steinbrook R. Message from Toronto–deliver AIDS treatment and prevention. N Engl J Med 2006;355:1081-4. http://content.nejm.org/cgi/content/full/355/11/1081

In this perspective article, Robert Steinbrook looked back on the Toronto AIDS conference arguing that the growth of the pandemic continues to outpace the broad and expanding efforts to control it. Since HAART became available a decade ago, the treatment of HIV infection has been streamlined — for example, from 10 pills daily taken in three doses with food restrictions to as little as 1 pill once a day. Many presentations at the conference showed that treating HIV is feasible in all countries. The best price for a first-line regimen of generic antiretroviral drugs in low-income countries is now about US$130 a year for adults (down from US$285 in April 2004) and less than US$200 a year for children. In 2005, there were an estimated 4.1 million people newly infected with HIV and 2.8 million AIDS-related deaths. The author reviews resource needs and estimates of actual funding, coverage of specific prevention programmes, and includes a chart which compares coverage of antiretroviral treatment by country. Countries with less than 35% of those in need on treatment include Trinidad and Tobago, Burkina Faso, Zambia, Chad, Benin, Cameroon, South Africa, Kenya, Burundi, China, Malawi, and Ethiopia. He then summarises biomedical approaches to prevention currently being evaluated, often in large controlled trials. These include cervical barriers, such as the diaphragm; therapy to suppress herpes simplex virus type 2, the primary cause of genital herpes (a risk factor for acquiring and transmitting HIV); microbicides that could be applied to the vagina or rectum; male circumcision; pre-exposure prophylaxis with antiretroviral drugs; and expanded treatment of infected persons not only for their own health but also to prevent HIV transmission. He then highlights the consensus view that providing antiretroviral therapy to subjects who acquire HIV infection during the course of a study is an indispensable part of the agreement between trial sponsors and trial participants. He suggests that there is disagreement, however, about the obligation to people whose infection is detected when they are screened for trial eligibility, as well as about who should assume the long-term financial costs and manage the complexity of treatment – trial sponsors, the country where the trial is conducted, an international fund, or someone else. Although trial participants are unlikely to need treatment until years after they become infected, they will eventually need it for life.

Editors’ note: UNAIDS is following up on the recommendations of an international consultation on creating effective partnerships for HIV prevention trials in 2005. The whole process, which included three regional consultations, was initiated as a result of the suspension of the tenofovir trials in Cambodia and Cameroon. We are planning three meetings over the coming months to address three specific recommendations: to develop Good Community Practice Guidelines which outline processes, procedures, and minimum requirements for community engagement in HIV prevention research; to identify programmatic and financing approaches for providing care and treatment to people who develop intercurrent infections (or who are screened out at recruitment for HIV prevention trials because they are found to be HIV-positive); and to revise and update the 2000 UNAIDS guidance document on ethical considerations in HIV preventive vaccine research (to be expanded to apply to all HIV prevention trials).
August
25
2006

Legal Structural Determinants

Burris S, Blankenship KM, et al. Addressing the “risk environment” for injection drug users: the mysterious case of the missing Cop. The Milbank Quarterly 2006; 82, 125–56

Ecological models of the determinants of health and the consequent importance of structural interventions have been widely accepted, but using these models in research and practice has been challenging. Examining the role of criminal law enforcement in the “risk environment” of injection drug users (IDUs) provides an opportunity to apply structural thinking to the health problems associated with drug use. Burris and colleagues reviewed international evidence that laws and law enforcement practices influence IDU risk, and conclude that more research is needed at four levels – laws; management of law enforcement agencies; knowledge, attitudes, beliefs, and practices of frontline officers; and attitudes and experiences of IDUs – and that such research can be the basis of interventions within law enforcement to enhance IDU health.

Editors’ note: Research is needed but, pending results, there are already examples from several countries to draw on of local responses meeting an urgent and visible crisis of HIV and IDU, which are advocated and championed by informed, skilled, respected, committed and concerned public health officials, community groups, and pragmatic local law enforcement officials.
July
28
2006

Human Rights and Law

Hogerzeil HV, Samson M, et al. Is access to essential medicines as part of the fulfilment of the right to health enforceable through the courts? Lancet 2006; 368:305-311.http://download.thelancet.com/pdfs/journals/0140-6736/PIIS0140673606690764.pdf

Most countries in the world have become States parties to one or more international human rights treaties, thus creating an obligation by the State to its people towards the realisation of the right to health, which includes access to essential medicines. But whether such access is enforceable in practice is unknown. Hogerzeil and colleagues did a systematic search to identify completed court cases in low-income and middle-income countries in which individuals or groups had claimed access to essential medicines with reference to the right to health in general, or to specific human rights treaties ratified by the government. They identified and analysed 71 court cases from 12 countries in which access to essential medicines was claimed with reference to the right to health. The authors found that in 59 cases, access to essential medicines as part of the fulfilment of the right to health could indeed be enforced through the courts, particularly in Central and Latin America. Success was mainly linked to constitutional provisions on the right to health, supported by the human rights treaties. Other success factors were a link between the right to health and the right to life, and support by public-interest non-government organisations. Individual cases have generated entitlements across a population group, the right to health was not restricted by limitations in social security coverage, and government policies have successfully been challenged in court. Hogerzeil and colleagues conclude that skilful litigation can help to ensure that governments fulfil their constitutional and international treaty obligations. Such assurances are especially valuable in countries in which social security systems are still being developed. However, redress mechanisms through the courts should be used as a last resort. Rather, policymakers should ensure that human rights standards guide their health policies and programmes from the outset.

Editors’ note: If you are interested in reading more about similar advances achieved in the HIV field, take a look at the excellent publication in the UNAIDS Best Practice Collection entitled “Courting Rights: Case studies in litigating the human rights of people living with HIV”.
June
1
2006

Universal Access

Schneider H, Blaauw D, et al. Health Systems and Access to Antiretroviral Drugs for HIV in Southern Africa: Service Delivery and Human Resources Challenges. Reprod Health Matters 2006;14:12-23. http://www.sciencedirect.com/science/journal/09688080

Without strengthened health systems, significant access to antiretroviral therapy in many developing countries is unlikely to be achieved. This paper reflects on systemic challenges to scaling up antiretroviral access in countries with both massive epidemics and weak health systems. The authors draw on their experience in southern Africa and on the WHO framework on health system performance. Whilst acknowledging the still significant gap in financing, the paper focuses on the challenges of reorienting service delivery towards chronic disease care and the human resource crisis in health systems. Inadequate supply, poor distribution, low remuneration and accelerated migration of skilled health workers are increasingly regarded as key systems constraints to scaling up HIV treatment. Problems, however, go beyond the issue of numbers to include productivity and cultures of service delivery. As more countries receive funds for antiretroviral access programmes, strong national stewardship of these programmes becomes increasingly necessary. The authors propose a set of short- and long-term stewardship tasks, which include resisting the verticalisation of HIV treatment, evaluating community health workers and their potential role in HIV treatment access, undertaking international action on the brain drain, and making greater investments in the national human resource functions of planning, production, remuneration and management.