One way is to work with external manufacturers and suppliers to achieve incremental efficiencies. For ISENTRESS® (raltegravir), Merck has established a low-cost supply chain with generic partners for commercialization in all Low-Income countries and all sub-Saharan Africa. This supply chain is being registered in these countries. With the implementation of this supply chain, we have been able to reduce the price of ISENTRESS to US $1.85 per day (ex-MSD price) in these countries. We are committed to reviewing this price regularly.
In June 2011, Merck granted two non-exclusive licenses to two Indian generic manufacturers, Emcure Pharmaceuticals Ltd. and Matrix Laboratories Ltd., for the manufacture and commercialization of raltegravir in 60 Low-Income and sub-Saharan African countries. We have also granted non-exclusive licenses for efavirenz to six South African generic manufacturers.
Manufacturers to whom Merck has granted a royalty-free voluntary license for efavirenz include:
Merck, in principle, supports the objectives of the Medicines Patent Pool Foundation for expanding access to HIV medicines in the developing world. Merck has demonstrated its commitment to improved access to HIV medicines through long-standing efforts over many years, including differential pricing, voluntary licensing, public-private partnerships, philanthropic programs, and continued research and development efforts in HIV.
Given the current low demand for raltegravir, its position in treatment guidelines in the developing world, the need for ongoing clinical research to better define how it is best used in the developing world, the need for medical education and adequate monitoring tools, such as routine viral load monitoring, to ensure its appropriate use, Merck does not think that the Medicines Patent Pool presents the most appropriate tool to increase access to raltegravir in the developing world at this point in time.
While we continue to monitor and assess the Medicines Patent Pool proposal, Merck's immediate focus is on implementing our access strategy for ISENTRESS in Low-Income countries and sub-Saharan Africa as part of our ongoing efforts to further enhance global access to our HIV medicines.
Merck remains willing to meet with the Medicines Patent Pool Foundation to continue to discuss developments with the patent pool.
Merck understands that access to medicines is a particularly complex issue in many developing countries and respects that international trade agreements—especially the World Trade Organization's TRIPs agreement (trade-related aspects of intellectual property rights) and subsequent Declaration on TRIPs and Public Health agreements—provide countries with the authority, in limited circumstances, to use compulsory licensing. In the case of medicines, we further respect that compulsory licenses may be issued, under limited and specified circumstances, to meet a health crisis or emergency.
However, both the letter and spirit of international trade rules suggest that such authority should be used only in the most extraordinary and limited circumstances in order to support all forms of innovation around the world. Merck will work vigorously with governments and other stakeholders in the developing world to meet the health needs of patients and increase access to its medicines.
For more information on Merck's public policy position on compulsory licensing, click here.