World AIDS Day: Foundation and CHAI publish paper on licensing ARVs to improve access
Approximately 20.9 million people living with HIV/AIDS now have access to treatment – out of an estimated 36.7 million people worldwide living with the disease. Licensing is a critical tool in the global push to reach the remaining 15.8 million people. For World AIDS day this year, the Access to Medicine Foundation and Clinton Health Access Initiative (CHAI) have published a paper outlining what best practice in ARV licensing looks like when it comes to improving availability.
But a licence is not enough on its own to ensure access; the paper also identifies supporting actions that patent-holding pharmaceutical companies can take to maximise the impact of their licensing agreements on availability. The paper also provides specific examples of where pharmaceutical companies are already putting these ideas into practice.
Defining best practice
Licensing gives companies the right to manufacture generic versions of on-patent products and sell them for a cheaper price in specific territories. The last ten years have proven that licensing can boost competition and improve the supply and affordability of high-quality treatment. In fact, generic ARVs have become the mainstay of HIV treatment in low- and middle-income countries – almost all on-patent ARVs on the market today have now been voluntarily licensed by pharmaceutical companies.
The best quality licences, as far as ensuring access to ARVs is concerned, aim to impose as few restrictions as possible on generic medicine manufacturers and are agreed on a non-exclusive basis (i.e., they do not restrict the number of companies that a patent can be licensed to). The paper dives into four best practices in licensing:
- Agree licences as early in the development process as possible with generic manufacturers;
- Broaden the geographic scope of licences so that generic versions can be sold in more countries;
- Allow the licensed ARV to be included in new drug combinations; and
- Actively seek to limit other terms that can place restrictions on generic licensees, for example, when it comes to sourcing ingredients.
Maximise the impact
Once a licence has been agreed, patent-holding companies can take other actions to support the impact of their licences on access. For example, companies can ensure the rapid registration of the patented product in all countries included in the licence, and carry out further clinical tests among specific populations to inform WHO treatment guidelines. Pharmaceutical companies can put strong governance structures in place to oversee their access to medicine activities.
Great strides are being made toward global targets for combating the AIDS epidemic. Between 2010 and 2015, the number of people worldwide living with HIV and on antiretroviral therapy more than doubled (from 7.5 million to 17 million). Companies that hold patents on key ARVs – or have promising candidates coming through the pipeline –have a key enabling role to play in reaching the remaining people without access to ARVs. They are encouraged to systematically apply this model in their ARV licensing strategies.
The paper was co-authored by the Access to Medicine Foundation and Clinton Health Access Initiative (CHAI). The authors are:
Clarke B. Cole, Researcher at the Access to Medicine Foundation
Danny J. Edwards, Research Programme Manager for the Access to Medicine Index
Neel Lakhani, Director of Global Markets at Clinton Health Access Initiative
Vineet R. Prabhu, Senior Manager of Market Intelligence for Clinton Health Access Initiative
Alan Staple, Alan Staple, Head of Global Markets at Clinton Health Access Initiative