Challenges on the Road to Universal Access

At a satellite session on Sunday, a striking statistic was reported by the humanitarian organization Medecins Sans Frontieres: in one of its ARV treatment programs, 60 percent of project costs are going toward the treatment of 10 percent of patients. Why? After several years on standard ARV treatment regminens, many patients will inevitably develop resistance to the drugs and require newer ones. But newer second-line regimens are up to ten times more expensive than first-line regimens, in large part because generic forms of the former are not available from suppliers in India and elsewhere. The need for affordable and widely available second-line regimens has been echoed by countless speakers in Toronto, including Bill Clinton, Bill Gates, and most recently in an informative speech by Dr. Julio Montaner during yesterday's plenary session.

Even the $130 annual per-patient cost of first-line regimens is now in jeopardy. The WHO has issued revised guidelines (.pdf) for first-line regimens -- for example, they should contain tenofovir rather than stavudine to minimize long-term side-effects to patients. These new guidelines mean that current resources for treatment programs are likely to reach fewer people than before. Looking ahead, as patients develop toxicity or resistance, programs such as the Global Fund and PEPFAR will have to devote even more resources to keep millions of people on treatment.

What are the solutions being proposed in Toronto? Generic manufacturers are reluctant to cheaply produce some of the second-line drugs because, almost by definition, the demand for these medications is relatively small right now. The scale of production could be increased -- and prices therefore decreased -- if there were good demand forecasts of how many patients will use these drugs in the future. This will be difficult until there is agreement among clinicians on when to switch patients to second-line drugs and what second-line drugs to use, although organizations such as the Clinton Foundation are currently working with manufacturers to organize the market and facilitate low-cost production.

Another part of the solution would require developing countries to take advantage of flexibilities within the TRIPS agreement, such as the denial of patents or issuance of compulsory licenses. In some cases, patents and related intellectual property laws can be a real barrier to access, and civil society groups are working to address this aspect of the problem (for background, a good session on trade policy was held yesterday, and another is scheduled for this afternoon).

The treatment of 3 million by 2005 was the goal during AIDS 2004 in Bangkok, and universal access by 2010 is the goal during AIDS 2006. Important progress was made toward the 3-by-5 goal, but achieving universal access will be extremely difficult if the prices of first-line and second-line medicines do not decline substantially.