By Cheryl Overs, Michael Kirby Centre for Public Health and Human Rights, Monash University in Australia and the Institute of Development Studies, UK
Everyone who was at the Durban AIDS conference in 2000 remembers the moment we learnt of effective medications for HIV. Some of us were too scared to believe it. But it turned out to be true and what unfolded was relatively straightforward. Life rapidly changed for people with the virus who were able access treatment. Reasons to avoid HIV testing fell away. Ageing with HIV would emerge as a paradoxically welcome addition to the agenda. Advocacy rightly became a mantra of demand for universal access to treatment and care especially in poor countries where the epidemic was causing millions of deaths.
In a way the development of anti-retroviral (ARV) based prevention is a similar moment. We now know that when positive people take treatment it can reduce the amount of HIV in their bodies to non-transmissible levels. Pre-exposure prophylaxis (PrEP) for HIV negative people, unarguably has the potential to stop transmission on a scale that could play a significant role in ending the HIV epidemic.
But in another way it is a quite different moment. Rather than a single, self-evidently justified demand PrEP creates a complicated set of ethical, legal, policy and practical challenges. Many of these relate to gender, equity and rights. In the lead up to International Women’s Day it is worth considering how we might collectively meet these challenges and learn from them in relation to the creation of new health technologies.
For people living with HIV the preventive value of ARV medication is a side effect of lifesaving treatment whereas PrEP is taken by well people. In medical ethics it is accepted that the safety level required of medication for treatment differs from that for prevention. The issue is simple, if a drug that might cause damage in the long term saves the lives of patients it is ethical to approve it as treatment but not ethical to provide it to people who are not ill.Despite many studies that suggest that PrEP will, or will not, have harmful side effects, the fact is we don’t know what might emerge in millions of PrEP users over decades. Medical history is littered with such scenarios.This concern led the trials of PrEP to be closed in Cameroon and Cambodia, when sex workers who were the subject of study realised that if the drug damaged them in years to come they would not be eligible for any kind of support. In response to the complaint in Cambodia researchers offered compensation of $36 per participant, which sex workers unsurprisingly took as a deal breaking insult.
A further ethical complication is that since PrEP is not a contraceptive and does not protect from sexually transmitted infections there is potential for harm to come to users who replace a proven prevention technology, condoms, with PrEP. This generates obligations in respect of the messages and targeting of the medication to women. Most research is focused on men, and the most vocal demand for PrEP to be approved and subsidised comes from men. The product developed for ‘high risk’ women whose adherence to daily pills is likely to be poor is a microbicide ring which can be inserted into the vagina for a month at a time. Enthusiasm for the ring has come primarily from public health agencies rather than potential consumers who are keen to lower their HIV risk. Notably the efficacy of the vaginal ring appears to be far lower than for oral PrEP.
Useful, independent research and rich discussions about PrEP and women in various settings do not seem to be occurring. If insightful guidelines about who should, and should not, be prescribed PrEP are being developed this is not an open process. Nor are plans for the anti-discrimination measures or public health messages that will be needed if PrEP is to fulfil its potential. So far we are only seeing grand claims about ‘saving millions of lives’ of people classified as being at risk. These are based on epidemiology’s crude mega-populations – sex workers, men who have sex with men, sero-discordant couples and transwomen.
It is certainly true that many of those most in need of access to PrEP live precarious lives but that precarity is driven by discrimination, violence and laws against drugs, sex work, and homosexuality that form a powerful barrier to any form of health care or preventative measure. The tension between public health and human rights on one hand, and punitive legal environments on the other, has been well documented in relation to HIV. But in many countries law has not kept up with developments in HIV so that the work of public health authorities and services to ‘key populations’ continues to be impeded by policy that reflects irrational fear and stigma. Criminalisation of HIV, sex work, adultery, abortion and the potential for civil legal actions remain a reasonable fear that drives barrier to the regular testing that must accompany PrEP.
One of WHO’s building blocks of the health system is ‘medical products and technologies’. Yet the example of PrEP demonstrates that the existence of an efficacious medication is only the starting point for the complex array of ethical and practical decisions that need to be made to improve health outcomes. And these decisions are molded by, and imbued with, questions of power, gender, and marginality. In the case of HIV sexuality, legal status, and poverty are particularly profound intersecting issues.
All too often we are lacking vital social science research that demonstrates – not that particular medication works – but the situations under which the introduction of a new technology can bring positive benefits, the unanticipated consequences of change, the beliefs and the preferences of particular ‘beneficiaries’ of interventions, and the motivation of those who seek to intervene.
Recent discussions about universal health coverage and its relation to human rights have highlighted that health policy change is not purely a technical, quick fix, driven by costing data alone. Rather there are political questions at play which are profoundly influenced by national and international law and the power and agency of citizens to demand their entitlements.
As discussions about PrEP move forward – and significant progress is being made quite rapidly – there is an urgent need for activists, health systems researchers and public health agencies to use their skills to ensure that due consideration is given to the health and human rights of women. Unless that happens the epidemic ending potential of ARV based HIV prevention will not be realised.