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GSK expands graduated approach to patents & IP to widen access to medicines in least developed countries
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London
Saturday, April 02, 2016, 10:00 Hrs  [IST]

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

GSK has a deep commitment to improving healthcare by developing innovative new medicines and widening access to them around the world. Over the past eight years, the company has taken steps in a number of areas including tiered pricing, healthcare infrastructure building, data-sharing and innovative partnerships.

GSK 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.

Additionally, GSK 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 GSK’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, 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. We continuously look at ways that GSK can further contribute to increasing access to medicines.

“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.

“The changes we are setting out aim to make it as clear and simple as possible for generic manufacturers to make and supply versions of GSK medicines in LDCs, LICs and most LMICs.

“Changes to patents and IP systems will not solve the multi-faceted challenges of improving healthcare in developing countries. In cancer for example, improving outcomes in developing countries requires better funding, improved screening and diagnosis, more cancer doctors and better hospital services as well as access to treatments. However, we believe the measures outlined today add to the wider contribution GSK makes to improve access to effective healthcare around the world.”

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

The UN High Level Panel on Access to Medicines, convened by UN Secretary-General Ban Ki-moon, brings together experts from the across the healthcare industry, public health, human rights and legal sectors to consider a broad range of approaches to promote innovation and access to healthcare around the world.

The Medicines Patent Pool (MPP) is a UN-backed initiative designed to facilitate voluntary licensing of innovative HIV, Hepatitis C and tuberculosis treatments in Low Income and Middle Income Countries. It has a number of agreements with ViiV Healthcare, a specialist HIV company majority owned by GSK, with Pfizer and Shionogi. This includes an agreement made in 2014 to facilitate the manufacture and sale of versions of the company’s medicines generic versions of ViiV’s innovative treatment, Tivicay (dolutegravir), in least-developed, low income, sub-Saharan African and specific middle-income countries, where the need is most pressing.

Courtesy – Pharmabiz



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