GSK Expands Graduated Approach to Patents and Intellectual Property to Widen Access to Medicines in the World’s Poorest Countries

March 31, 2016 /3BL Media/ - Ahead of today’s meeting of the UN High Level Panel on Access to Medicines, 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.

Notes to editors

Voluntary licensing for future oncology portfolio

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.

While progress is being made globally on infectious diseases such as HIV and malaria, global forecasts predict cancer rates in developing countries to soar over the next two decades as a result of changing lifestyles, placing an increasing burden on stretched health systems. According to WHO, 8.2 million people died from cancer in 2012, with two thirds of those deaths occurring in LMICs, more than AIDS, tuberculosis, and malaria combined.1

GSK has a pipeline of next generation immuno-oncology and epigenetic therapies in clinical development. Building on the success of the MPP in responding to the challenge of HIV, GSK is setting out proposals that would enable the generic manufacture and supply of its portfolio of future treatments to accelerate access to patients in developing countries, if and when they receive regulatory approval.

Increased transparency of patent portfolio

GSK will also work towards making available information about its current and future patent portfolio. Being more transparent about which patents are held in which countries will make it clearer for generic companies looking to commercialise products in developing countries. Following a similar move by Merck KGaA, GSK hopes this will stimulate a wider approach and provide a best practice template for other companies, academic institutions and generic manufacturers to share more details about their patents.

GSK’s approach to innovation and access

Over the past decade, GSK has made significant changes to its business model to support increased access to medicines. It has pioneered tiered pricing models, prioritised investment in R&D for diseases of the developing world and formed partnerships to help improve health for people in poorer countries. GSK has adopted a flexible approach with intellectual property, pooling its patents and know-how to encourage more research into neglected diseases and agreeing voluntary licenses to enable generic manufacturers to make HIV medicines for the countries most affected by HIV.

• GSK has a special unit dedicated to increasing access to medicines in the world’s poorest countries. It caps the price of its patented medicines in LDCs at no more than 25% of developed world prices and reinvests 20% of any profits made in LDCs back into training community health workers in those countries. Since 2009, this has contributed to the training of 40,000 health workers. The company has also adopted a tiered pricing approach for its products, where countries pay a price based on their Gross National Income (GNI) per capita.

• GSK had used a tiered pricing model for decades to improve access to its vaccines and enable low-income countries to roll out national immunisation programmes. It reserves its lowest prices for organisations such as Gavi, the Vaccine Alliance, which supports vaccination for children in the world’s poorest countries. In 2015, GSK froze prices of its vaccines for countries that graduate from Gavi support so they can continue to buy vaccines at discounted prices for a further decade.

• In 2015, GSK’s malaria candidate vaccine, the product of 30 years of research, received a positive scientific opinion from European regulators for use in the prevention of malaria in young children in sub-Saharan Africa. This is an important step towards making the vaccine available, alongside other tools, to protect children from malaria. GSK will provide the vaccine at a not-for-profit price.

• In 2009, GSK opened up access to its intellectual property for neglected tropical diseases (NTDs). Today, seven other pharmaceutical companies are doing the same through a consortium, WIPO Re:Search. GSK has also screened its entire compound library – some 2 million compounds – and made publically available the 13,500 compounds which showed signs of activity against malaria and 200 which show signs of activity against TB to encourage research in these areas.

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2015.