I had the opportunity to work at the Medicines Patent Pool last summer. From my work at the Pool, meetings and conferences I was able to attend, and conversations with various individuals, I was able to learn about some trends and challenges facing the Pool and access to medicines in general. I wanted to share a few of these.
Access to medicines in middle-income countries
When the Medicine Patent Pool’s first license with a pharmaceutical company, Gilead Sciences, was signed, it sparked a deluge of comments from NGO’s and civil society groups. The reactions generally fell into two categories. First, many expressed gratification at what the license represented and the promise of increasing access to Gilead’s products.
However a sizeable number expressed displeasure at some of the specific terms in the license. The problem for many was that the license excluded those in middle-income countries, where most of the world’s poor currently live. This is likely to represent a source of considerable tension moving into the future. While it is relatively easy for a pharmaceutical manufacturer to write off the market in Gabon or Burundi, it is far less likely that they will do so in Brazil, India, China or South Africa, which they see as huge sources of future revenues. Unfortunately, a large proportion of people in these middle-income countries still live in dire poverty, little better than those in most developing countries. The debate over access licensing in middle-income countries is unlikely to be resolved easily or soon.
Another important issue that has been present since TRIPS was passed, but has become increasingly in the spotlight in the past few years, are “TRIPS-plus” agreements, which are generally free-trade agreements. Two prominent current examples are the Anti-Counterfeiting Trade Agreement (ACTA) and the India-E.U. FTA, which have been criticized for attempting to introduce provisions imposing onerous data-exclusivity requirements, civil trademark enforcement mechanisms without a requirement of intent, cross-border seizure, and extreme punishments for IP violations.
With political consensus for stricter IP rights having largely evaporated from international organizations such as WTO and WIPO, access battles are increasingly being fought bilaterally. This imposes special challenges to those who want to insure access is being protected since even the existence of these negotiations is often kept secret.
We’ve touched on this in class, but the concept of Treatment 2.0, or Treatment-as-Prevention, is having a profound effect on the access to medicines community. This has muted an often-contentious debate between those advocating for treatment vs. prevention and has increased the demand for treatment. It means that access to ART is an increasingly important tool in the fight against HIV/AIDS.
Confronting budget constraints
With vital programs such as PEPFAR and the Global Fund facing increasingly severe budget cuts or instability—and with the probability of this trend continuing into the foreseeable future—the access to medicines community has to find creative ways to provide more treatment with fewer funds. The shift from a single focus on HIV has become (rightly, I believe) a more diffuse effort to address diseases and conditions that effect resource-limited settings (e.g. the shift in U.S. emphasis from PEPFAR to the Global Health Initiative). However, this means that achieving the level of access to ART necessary to end the pandemic will require creative strategies, more funding, and lower prices, particularly for second- and third-line ART, which will become increasingly important as people in resource-limited settings live longer.