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Voluntary licensing and partnerships

We want to play an active role in addressing the healthcare crisis in developing countries. We believe preferential pricing arrangements are the best way to do this because we are able to ensure delivery of a safe, quality product at an affordable price for as long as it is needed. This is where we focus our efforts. But in some situations partnerships and voluntary licences may also help to increase the supply of medicines.

Voluntary licences
Voluntary licences (VL) enable local manufacturers to produce and sell generic versions of our products. GSK has granted six VLs for our antiretrovirals (ARVs) in Africa where HIV/AIDS is having a devastating impact. This is a creative response to a unique situation.

A decision to grant a VL depends on a number of factors including the severity of the HIV/AIDS epidemic in that country, local healthcare provision and the economic and manufacturing environment. VLs are not a universal solution to HIV/AIDS but a specific response to a particular set of circumstances.

We discuss VLs with potential partners on a case-by-case basis. Selecting the most appropriate licensees is key. We need to be sure that the manufacturer will be able to provide a long-term supply of good-quality medicines and will implement safeguards to prevent the diversion of medicines to wealthier markets. (See preferential pricing).

We do not seek to prevent voluntary licence holders from combining the active ingredients they have licensed from us with other licensed active ingredients to produce Fixed Dose Combinations. They can also use the US Food and Drug Administration’s fast track approval process for ARVs to accelerate the availability of generic ARVs for PEPFAR programmes in Africa.

There has been much discussion about the use of compulsory licences, under which intellectual property rights are taken away from rights holders. Compulsory licenses are one of the flexibilities in the World Trade Organisation’s Trips agreement agreement on intellectual property, which can be used for humanitarian purposes. However, widespread use of compulsory licences will undermine the intellectual property framework and be counter-productive in the long term. R&D into new treatments, especially where commercial markets exist, such as for HIV/AIDS, depends on protection for intellectual property.

Progress in 2004

• GSK granted five VLs in 2004, four in South Africa and one in Kenya.
• We have now granted a total of five VLs to South African generics companies for the sale of some of our antiretrovirals¹ to public and private sector customers in South Africa. Three of these VLs also include rights to sell in other countries in sub-Saharan Africa.
• In 2004 we granted a similar VL to Cosmos, a Kenyan pharmaceutical company, for manufacture and sale in Kenya and other countries in East Africa.
  

Partnerships
HIV treatment is complex, often requiring patients to take a combination of different tablets at different times of the day. This increases the risk of patients missing a dose or taking their medicine at the wrong time, which can reduce the effectiveness of treatment.

In July 2004, GSK and Boehringer Ingelheim (BI) agreed to assess the development of co-packaging for Combivir and Viramune (BI’s HIV treatment sometimes used in conjunction with GSK ARVs) for use in developing countries. Given the complexities of HIV treatment, we recognise the need for multiple treatment options and support efforts to simplify treatment regimens. Aspen Pharmacare is developing the combined pack through the voluntary licences granted by both GSK and BI.

¹lamivudine, zidovudine, and the combination containing lamivudine and zidovudine.

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