We’ve come a long way, baby. In 2001, 42 pharmaceutical companies shocked the global health community when they took Nelson Mandela and the South African government to court to protest the importation of cheap, generic drugs for AIDS patients. To the global health community — who argued that saving lives was more important than profits — the move seemed questionable at best. Why would corporations take Nelson Mandela to task for trying to provide critical treatment to a disintegrating society?
The answer, of course, is that pharmaceutical companies felt that the law violated patent agreements and unfairly targeted large drug manufacturers. Patents protect developers — allowing them to invest risky capital in research and development (R&D), with the anticipation of profits without competition until the patent expires. And economists and pharmaceutical industry experts agree that intellectual property (IP) stimulates innovation. Pharmaceutical companies asked the global health community: what would happen if there was no blockbuster drug from which to create a generic?
Yet, neglected diseases are labeled as such because they are just that – neglected. Neither patent protection, nor anything else, has proved to be a silver bullet to encourage new R&D. This is beginning to change.
Fast forward eight years and we have the creation of patent pools, providing wider access to IP in the hopes of spurring the type of innovation needed for neglected diseases. In February 2009, GlaxoSmithKline (GSK) announced the formation of one such pool as part of their larger commitment to global health. They donated the proprietary research for 16 neglected diseases to this pool and were quickly joined by Alnylam Pharmaceuticals, a Boston-based biotechnology company. And other organizations are pursuing similar ideas. The World Health Organization recently called for the creation of patent pools, and UNITAID, a purchaser of AIDS treatments, has expressed interest in creating a pool focused on AIDS therapeutics.
In addition to large patent pools, some biotechnology companies have achieved one-off success in negotiating IP agreements with partners. This has proved critical to the effectiveness of partnerships when creating new interventions for neglected diseases. BVGH released a report in August 2009, Global Health Innovators: A Collection of Case Studies, that looked at six partnerships in global health R&D. In each of the case studies presented, IP agreements were reached without major conflict. For instance, in a partnership between Genzyme Corporation (Genzyme), Medicines for Malaria Venture (MMV), and the Broad Institute of MIT and Harvard aimed at malaria drug discovery, Genzyme committed from the beginning to contribute any IP related to malaria to the public good. This promise facilitated the collaboration and leading candidates are expected to enter phase 1 clinical trials in 2011.
While the debate over IP continues, it is important to recognize that access to medicines is not possible when there is no medicine to deliver. Of the 19 diseases examined in the 2009 edition of BVGH’s Global Health Primer, nine lacked a drug, vaccine, or diagnostic. Patent pools and creative interpretations of IP rights are an important incentive to companies that work in global health, but IP is one part of the larger picture that includes incentives like Advanced Market Commitments and Priority Review Vouchers. Ultimately, we must continue to unearth new ways to engage companies in global health R&D and save lives in the developing world.
Both Global Health Innovators: A Collection of Case Studies and the 2009 Global Health Primer are available for download on the BVGH Web site. Please contact info@bvgh.org to request a hard copy of the documents.