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GSK introduces new measures to widen medicines access in poorest countries

pharmafile | March 31, 2016 | News story | |   

GSK has set out a series of measures it is introducing to help improve access to the company’s innovative medicines in the world’s poorest countries.

Chief executive Sir Andrew Witty, who last week revealed he will leave the company next year, introduced the measures ahead of today’s meeting of the UN High Level Panel on Access to Medicines.

Allowing generics

The UK-based pharma major says it will evolve a “graduated” approach to intellectual property (IP) protection, and will file and enforce patents in a way that reflects the economic status of the country in question.

Specifically, in the least developed countries (LDCs) and low income countries (LICs), GSK will not file patents for its medicines, which will allow generic companies to manufacture and supply cheaper unbranded versions of GSK medicines in those countries.

For Lower Middle Income Countries (LMICs), GSK says it will generally file for patents, but will seek to offer and agree licences to allow supplies of generic versions of its medicines for 10 years, while seeking a small sales royalty. 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, and any GSK medicines on the World Health Organisation’s list of essential medicines will be included in these changes.

Cancer drugs

Additionally, GSK said it plans 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 noted that it is the first company to take this step, as the Medicines Patent Pool (MPP) currently deals with accelerating access to HIV, TB and hepatitis C drugs.

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.

Sir Andrew Witty, chief executive of GSK says: “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.”

Joel Levy

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