As an early proponent of the use of patent pools to expand access to medical technologies, our initial reaction to the GSK announcement is that GSK is responding to several new developments.
One is the creation of the U.S. FDA priority review voucher (PRV). This legislation creates a large incentive to register new chemical entities for the treatment of the “most neglected” diseases — what the WHO calls “Type III diseases” are those that almost exclusively concern poor people living in developing countries. While the program is new and there are no PRV’s traded yet, some estimate a PRV may be worth more than $ 300 million.
Second, UNITAID is creating a patent pool for medicines. While the initial scope of the UNITAID patent pool is for second generation AIDS drugs, there is considerable interest in expanding it to other diseases and conditions.
Third, the new WHO Global Strategy And Plan Of Action On Public Health, Innovation And Intellectual Property (Wha 61.21) calls for the creation of new patent pools for both upstream and downstream uses.
GSK is, on the one hand, seeking to benefit from the new interest in Type III disease research, in order to benefit from the PRV, and on the other hand, seeking to manage the conversation about patent pools. The UNITAID patent pool is not yet set up, but so far it is designed as something new — a patent pool controlled by people who pay for drugs and other technologies, rather than by people who sell them. The UNITAID Patent Pool has the potential to solve both upstream and downstream problems in access to medicines, with an important focus on improving generic competition in the developing world.
Three companies, Gilead, J&J and Merck have agreed to negotiate with UNITAID. GSK has taken a low profile on the UNITAID proposal. The fact that GSK is explicitly excluding HIV/AIDS in their announcement and are limiting their proposal to an upstream R&D proposal is being read by some public health experts as an attempt to undermine the model presented in the UNITAID patent pool.
Gilead and J&J have also expressed a willingness to support something even more interesting, which is to create a prize fund from Global Fund, PEPFAR or UNITAID budgets to reward entities that license patents to the patent pool. If the patent pool and the prize fund mechanisms are linked, it is the beginning of a new business model for drug development, one that breaks the link between drug prices and R&D incentives, and one that gets rid of monopolies for products. So far, GSK has aggressively opposed this.
The governments of Barbados and Bolivia have asked the WHO Expert Group on R&D Financing to consider the prize fund/patent pool model. A meeting where this will be discussed will probably happen in June or July of this year. A growing number of NGOs and experts support the prize fund/patent pool model.
There are several pharma friendly alternatives being explored now, to blunt the more fundamental and transformative reforms. These include the Gates backed Advanced Marketing Commitment R&D subsidies, which work with monopolies, the Pogge/Hollis effort to co-op the prize fund/patent pool model by creating a prize fund that works with monopolies, and the Barton/Pfizer proposal to regulate drug prices in middle income countries. Now we also have the GSK announcement about an upstream patent pool, seeking again to change the conversation.
In our opinion, none of the co-opting efforts will succeed. While they offer some benefits, they are quite incomplete, particularly in the important area of designing R&D incentives that work when the products people use are free of intellectual property claims, and they fail to provide a sustainable model for innovation and access for all.