Voluntary patent pooling: Encouraging rapid scale-up of medicines for resource-limited countries (Guest blog)
16.06.16
For the past five years, the Medicines Patent Pool (MPP) has worked with industry, governments, international organisations, communities living with HIV/AIDS, and civil society to improve the HIV response. We’ve been successful in implementing a new business model to support rapid treatment scale-up in collaboration with top HIV manufacturers—AbbVie, Bristol-Myers Squibb, Gilead Sciences, MSD (Merck & Co. in the US and Canada), Roche and ViiV Healthcare. Companies have licensed their best-in-class medicines to the patent pool. In turn, the MPP has built a network of generic manufacturing partners to produce antiretrovirals for developing countries.
It is a simple mechanism with across-the-board benefits to drive access and innovation. By signing a licence with the MPP, companies receive a fair royalty and a presence in emerging economies. Generic manufacturers compete to drive prices down. Procurement agencies, such as the Global Fund and the US President’s Emergency Plan for AIDS Relief (PEPFAR), save on generic volumes so they can provide treatment to more people. The MPP’s licences cover countries where up to 94% of adults and 99% of children live with HIV, in the developing world. The MPP-ViiV Healthcare’s agreement for the new first-line medicine dolutegravir, for example, allows generic sales in 127 countries and was recently extended to include an additional four.
To support innovation, the MPP functions somewhat like a classical patent pool to encourage the development of new fixed-dose combinations (FDCs) and special formulations for children. Along with our funder UNITAID, the Drugs for Neglected Diseases initiative (DNDi) and the Clinton Health Access Initiative, the MPP is a partner in a Paediatric HIV Treatment Initiative to develop new, desperately-needed paediatric formulations. The MPP has worked specifically with industry on intellectual property issues to ensure a patent on one or more compounds in a combination product does not block production and eventual distribution to children. Companies waive all royalties in MPP licences for paediatric products.
With the MPP’s initial successes – licences for 12 antiretrovirals and 3.5 billion low-cost treatments delivered, through our 12 generic partners – we expanded our mandate to include treatments for tuberculosis and hepatitis C. Hepatitis C affects between 130-150 million people globally. TB is the world’s leading infectious disease killer, with more than 95% of global deaths occurring in developing nations. For hepatitis C, curative solutions are available. The MPP signed its first hepatitis C licence with Bristol-Myers Squibb for daclatasvir, a novel direct-acting antiviral recently placed on the WHO’s Essential Medicines List that has proved to be effective across multiple genotypes of the hepatitis C virus. We also hope to work with other companies to license new and pipeline drugs in the future as well.
The current treatment course for TB is long and ineffective. The emergence of multidrug-resistant (MDR-) and extensively drug-resistant (XDR-) TB, coupled with a growing number of patients co-infected with TB and HIV, has made the pandemic more deadly. The MPP is working with other actors to spur development of improved, faster-acting, and affordable therapies. We signed a Memorandum of Understanding with the TB Alliance, a leading product development partnership, and have recently announced negotiations on a licence for sutezolid, a promising TB treatment.
The World Health Assembly adopted new strategies for HIV and hepatitis C in May, which included the promotion of voluntary licensing to secure long-term supply of crucial medicines. Similarly other forums, such as submissions to the United Nations Secretary-General’s High Level Panel on Access to Medicines, and last week’s United Nations Political Declaration on HIV and AIDS, supported the Medicines Patent Pool’s pro-access licences and expansion into additional disease areas.
Other actors have raised the possibility of an MPP-like approach in tackling public health crises, such as antimicrobial resistance (AMR), or have suggested patent pooling for oncology compounds. The recent AMR review chaired by Jim O’Neill acknowledges the importance of ensuring broad access to future products through licensing mechanisms. Does the MPP have a role to play in advancing these efforts? We are willing to explore this question and continue a dialogue on how our model can support access to life-savings medicines and better health outcomes in resource-limited countries.
