Four Steps to Help Widen Access to Innovative Medicines

By Jon Pender, Vice President, IP, Access and Global health, GSK

Four Steps to Help Widen Access to Innovative Medicines

Getting medicines to patients living in the world’s poorest countries is no easy feat. A dearth of trained health workers, out-of-pocket payments, poorly stocked clinics and unreliable transport links can all conspire to keep medicines out of reach from those who need them.

When it comes to unlocking such a complex challenge, there’s no single fix – a multi-faceted approach is needed. One part of the solution is being flexible with intellectual property (IP) protection. There is no doubt that IP is a vital part of healthcare innovation. It provides the necessary incentives for investment in research to create new treatments which can help people around the world. But being flexible with IP can help address some of the most pressing health challenges.

That’s why GSK – the global healthcare company – has set out a series of steps to help bring our innovative medicines to more people living in the world’s poorest countries. At the heart of this approach, unveiled last week, is a philosophy of deploying IP in a graduated manner that reflects a country’s economic maturity. Here are the four steps we’re taking to help widen access to medicines:

1. For the Least Developed Countries (LDCs) and low-income countries, we will not file patents for our medicines. That’s already the case in some countries but we’re taking what was a patchwork approach and making it uniform. This will help give clarity and confidence to generic companies seeking to manufacture generic versions of GSK medicines for those countries.

2. For Lower Middle Income Countries (LMIC) generally, GSK will file for patents but will seek to offer and agree licences to allow supplies of generic versions of our medicines for a decade. This offer will apply even for those countries that move out of LMIC status due to economic growth during this period, providing reassurance and visibility that countries will not have to suddenly change systems because of a new classification of their national wealth. This is similar to the 10 year price freeze we have granted to countries graduating from support from Gavi, the vaccine alliance.

3. Non-communicable diseases like cancer are on the rise in developing countries. In response, we have outlined our intent to commit our future cancer products to patent pooling and will explore this concept with the Medicines Patent Pool – with whom we have already shared our HIV medicines. Expanding this approach to oncology would enable generic versions of GSK’s next-generation cancer medicines, currently in clinical development, to be made available in poorer and some middle-income countries once approved.

4. Finally, we will work towards making information about our current and future patent portfolio freely available. Sometimes we hear from manufacturers of generic medicines that they have struggled to figure out whether we do or don’t have a patent. By having a simple to access, one-stop point of information, people would be able to see exactly what our patents are; hopefully this should speed up development of generic medicines.

These steps all build on the changes GSK has been making over the last eight years to evolve our business model and improve access to healthcare. From tiered pricing and product development partnerships to reinvesting one-fifth of profits made in LDCs back into their health systems, we have sought to demonstrate that increasing access, incentivising innovation appropriately and achieving business success can go hand in hand.

This takes time and the steps we outlined last week will not all happen straight away – they will be subject to local laws and we’ll now consult with our licensing and co-development partners on the changes. Moreover, we’re under no illusion that they are a panacea for enabling access to medicines in the poorest countries, where poverty is a primary challenge. Instead they are part and parcel of a holistic approach. By removing any doubt about our approach to IP, we hope this can focus attention on other areas that are important to improving access to healthcare which include better funding, improved diagnosis, better equipped facilities and more frontline health workers.

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