In line with the meeting of the United Nations High Level Panel on Access to Medicines, GlaxoSmithKline (GSK) CEO Sir Andrew Witty has set out a series of steps designed to increase access of GSK medicines to developing countries through a graduated approach to filing and enforcing patents so that intellectual property (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 to licenses 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 World Health Organization’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 says it will be the first company to take this step. Since it was established in 2010, the MPP has been successful in accelerating access to HIV, tuberculosis, and hepatitis C medicines in Low Income and Middle Income Countries through voluntary licensing arrangements. It 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. Expanding this approach to oncology would enable generic versions of GSK's 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. Being more transparent about which patents are held in which countries will make it clearer for generic companies looking to commercialize 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-drug manufacturers to share more details about their patents.

“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,” said Witty in a company statement. “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.

Source: GlaxoSmithKline