GSK adopts groundbreaking IP approach to expand access to its medicines

GSK CEO Sir Andrew Witty has set out a series of steps designed to help bring innovative GSK medicines to more people living in the world’s poorest countries.

The company has said it recognises that improving access around the world requires a flexible and multi-faceted approach to intellectual property (IP) protection. While IP stimulates and underpins continued investment in research and development, GSK believes being flexible with its IP can help address pressing health challenges in developing countries.

Building on this perspective, GSK is evolving its graduated approach to filing and enforcing patents so that IP protection reflects a country’s economic maturity. For Least Developed Countries (LDCs) and Low Income Countries (LICs), GSK will not file patents for its medicines, so as to give clarity and confidence to generic companies seeking to manufacture and supply generic versions of GSK medicines in those countries. For Lower Middle Income Countries (LMICs) generally, GSK will file for patents but will seek to offer and agree licences to allow supplies of generic versions of its medicines for 10 years. GSK intends to seek a small royalty on sales in those countries. This offer will apply even for those countries that move out of LMIC status due to increased economic growth during this period. For High Income Countries, Upper Middle Income Countries and G20 countries, GSK will continue to seek full patent protection. Any GSK medicines on the WHO’s list of essential medicines will be included in these changes.

Sir Andrew Witty, CEO of GSK said: “Intellectual property protection is a vital part of healthcare innovation, providing necessary incentives for investment in research to create new treatments which can help people around the world.

“In itself, IP is not a barrier to access to medicines. However, we recognise that the global healthcare challenge requires us to be flexible in our approach and responsive to different needs, particularly as the disease burden shifts from infectious to non-communicable diseases.”

GSK to commit its future cancer treatment portfolio to patent pooling

Additionally, the company outlined its intent to commit its future portfolio of cancer treatments to patent pooling and will explore the concept with the Medicines Patent Pool (MPP) to help address the increasing burden of cancer in developing countries. GSK would be the first company to take this step. Since it was established in 2010, the MPP has been successful in accelerating access to HIV, TB and hepatitis C medicines in Low Income and Middle Income Countries through voluntary licensing arrangements. Expanding this approach to oncology would enable generic versions of the company’s next generation immuno-oncology and epigenetic therapies, currently in clinical development, to be made available in LDCs, LICs and certain middle income countries, if and when they receive regulatory approval.

GSK will also work towards making information about its current and future patent portfolio freely available.

Sir Andrew Witty commented: “The experience GSK has with the Medicines Patent Pool for Tivicay – our newest HIV medicine and one of our most commercially successful products – gives us confidence that increasing access, incentivising innovation appropriately and achieving business success can go hand in hand.”

Implementation of these proposals will be subject to local laws. The company will now consult with its licensing and co-development partners on these changes.

Commenting on the announcement, Matthew Royle, Partner in the IP/IT group at Taylor Wessin, told European Pharmaceutical Review: “This is very positive news for access to medicines in the developing world.  Previous attempts to improve access have not had the intended impact.  For instance the Aricle 31bis of TRIPS, which introduced a route to obtain a compulsory licence to supply drugs to developing countries, has still only been used once – by Canadian company Apotex to supply a triple combination HIV therapy to Rwanda.  It will be interesting to see whether or not other drugmakers follow GSK’s lead.”