Debates on PrEP provision

Debates about the roll-out of PrEP would need to tackle some serious ethical questions about who gets access to the drugs, researchers from the CDC and the University of Oxford said in The Lancet in July 2007.¹

PrEP raises important ethical questions:

• What are the obligations of governments and industry to provide such prophylaxis?
• How should resources be distributed between research, treatment, counselling, testing, primary prevention, PrEP and PEP?
• Who should have priority for prophylaxis?

The authors acknowledge that HIV-related stigma poses particular challenges, since this can affect decision making. For example, one argument against provision of PrEP for groups such as sex workers, drug users and men who have sex with men “is based on the idea that providing prophylaxis expresses approval for high-risk behaviours”, analogous to arguments used against needle exchanges or condom provision to teenagers.

Thus far, several studies of potential interventions to reduce HIV transmission have not led to an increase in unsafe sexual behaviours, although that issue needs to be evaluated in the studies of PrEP, the authors advocate.

But they go further in rejecting this argument. “First, public-health policy should aim for prevention of ill-health rather than judgments of individual’s morality. Second, we do not believe that provision of prophylaxis condones risky behaviour; but rather, it acknowledges the reality of the epidemic.”

“Another issue is the perception that people choosing risky behaviours should be at lower priority for prevention than those whose risk is not affected by their behaviour”, say the authors, citing as an example those infected via vertical transmission.

But, the authors ask, “even if personal responsibility for infection was considered in setting public-health priorities, how does one ascribe the degree of responsibility?”

They point to two examples: ill-health in a smoker who was brought up in an environment in which smoking was encouraged; and the social and economic pressures on female sex workers in resource-poor countries.

“Generally, no method of ascribing personal responsibility for disease is reliable or valid. We therefore believe that neither judgments about morality, nor responsibility for risky behaviours should play a part in decision making about [PrEP]. Instead, public-health decisions should be based on relevant factors such as cost-effectiveness and clinical need.”

With efficacy studies of PrEP underway, one concern is that such programmes, if found effective, may be too expensive for the areas that have the greatest need, and many prevention programmes, of which PrEP would be part, are already underfunded.

“Nevertheless, the severity of the HIV epidemic and the potential benefits of pre-exposure prophylaxis should lead us to begin planning for implementation as soon as possible,” the authors urge:

• Which settings would be appropriate?
• What level of efficacy would warrant widespread use?
• Which populations would benefit most?

The authors propose that “in regions with HIV epidemics in specific groups, targeting of such groups (e.g., sex workers, partners of people known to have HIV, and those attending sexual-health clinics) is probably the best strategy.

However, in areas with generalised epidemics, as is seen in some African countries, potential populations could include most sexually active adults.

Defining the procedures for access and dispensing remains a challenge. PrEP should never be sold over the counter: the potential for misuse (for treatment as well as prevention) and resultant widespread HIV resistance is just too great.

PEP has shown us that some people seeking it have come across discriminatory attitudes from healthcare staff. Would the stigmatisation of marginalised, high-risk communities lead to PrEP being denied to the very people who need it most? These power inequalities and a comprehensive training programme for probable providers would have to be addressed in advance of any move to make PrEP widely available, regardless of other considerations.