Voluntary licences are granted by patent holders to allow a generics company to manufacture and sell their products. Some people assume that generics are always cheaper than branded products and are seen by many as a key solution to the access crisis in the developing world. Pharmaceutical companies are under increasing pressure to grant licences.
However, generics are not always cheaper and the success of a voluntary licence will depend on the right licensees being chosen. This is particularly true for the treatment of a chronic disease like HIV/AIDS, where the sustainable supply of good-quality anti-retrovirals (ARVs) is key.
We do not believe that voluntary licences are a universal solution to tackling HIV/AIDS or disease in general. In most cases local manufacture of ARVs will make little difference to their affordability and access to patients. This is a point endorsed by the WHO. This is because the real barriers to access are the lack of healthcare infrastructure and resources to pay for medicines regardless of where they come from.
However, funding from the World Bank and other international donors has meant that voluntary licences can have a role to play in efforts to tackle the HIV/AIDS epidemic in sub-Saharan Africa by helping to increase the availability of medicines and contribute to better security of supply.
A decision to grant a voluntary licence depends on a number of factors including, in the case of HIV/AIDS, the severity of the epidemic in that country, local healthcare provision and the economic and manufacturing environment.
We discuss voluntary licences with potential partners on a case-by-case basis. We need to be sure that the manufacturer can provide a long-term supply of good-quality medicines and will implement safeguards to prevent the diversion of medicines to wealthier markets.
We continue to consider the role of voluntary licensing in helping to increase access to medicines in middle-income countries without undermining our commercial business.
We granted our first voluntary licence (VL) in 2001 and have now negotiated eight licensing agreements for our ARVs in Africa. Some of our VLs cover individual countries or trade blocs while others cover all of sub-Saharan Africa. In July 2009 we extended these licences to include abacavir and also made the licences royalty free.
In August 2007 we gave consent to enable a Canadian company, Apotex, to manufacture a generic fixed-dose combination ARV, containing two molecules over which GSK had patent rights, for the treatment of HIV/AIDS in Rwanda.
This consent was granted under Canada’s Access to Medicines Regime which reflects the WTO ‘31f’ agreement. This enables governments to authorise the production of certain patented medicines for export. GSK agreed to waive royalties on the basis that Apotex’s triple combination generic ARV will be supplied on a not-for-profit basis.
Our licensees supplied 279 million tablets of their versions of Epivir and Combivir to Africa in 2008. This represents more than 50 per cent growth over 2007, and 130 per cent more than in 2006. We welcome this trend as it gives customers in sub-Saharan Africa greater choice and contributes to better security of supply.