LONDON, UK: Millions of people are priced out of access to life-saving medicines. Use of legal tools to reduce prices has been under-reported and misunderstood to be rare, but new research published in the British Medical Journal Global Health reveals wide use by both high and low-income countries. This has important policy implications at a time when rising medicines prices are a growing global policy concern.
The legal tools, contained in the World Trade Organization Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement and known as ‘TRIPS flexibilities’, have been used hundreds of times to help governments combat health challenges ranging from pandemics like HIV and Covid-19, to rare diseases, to cancers and other non-communicable diseases. One of the key findings revealed in the research is how often wealthy countries employ TRIPS Flexibilities. The research was based on data from the TRIPS Flexibilities Database maintained by Medicines Law & Policy.
“Over the last 25 years, the balance of which countries have made use of TRIPS Flexibilities has shifted: high-income countries appear to be simultaneously making use of these tools whilst actively trying to restrict the ability of low-income countries to do the same,” said Dr Montgomery Dunn, the study’s lead author. Titled “TRIPS flexibilities help change policy and practice to increase access to medicines: Evidence from 2001-2024” the research found that over half of the compulsory licences issued in the last decade have been by high-income country governments, in many cases responding to the urgent need for vaccines and treatments for Covid-19. With a compulsory licence, the government can authorise the production of a patented medicine without the patent holder’s consent, thereby opening the market to generic producers.
“This underlines what a critical policy tool this flexibility is to treat pressing health challenges, everywhere in the world,” said Dunn.
“Public push towards the use of these tools can itself be the stimulus for price reductions,” said co-author Ellen ‘t Hoen, Director of Medicines Law & Policy. Nearly half of the compulsory licences that were not executed were due to an offer from the company to increase access, including via a voluntary license, price reduction or donation, enabling access even with the mere threat of a compulsory licence. But countries seeking to use such measures face political pressure, and may need to overcome additional obstacles such as restrictions on use of data needed to register lower-cost generic medicines.
“Use of TRIPS Flexibilities is effective, and when needed, countries must be free to use them to the full,” said ‘t Hoen. “To face current and future health challenges, governments around the world must not only enable the use of TRIPS Flexibilities but also support mechanisms for intellectual property, technology and know-how sharing, such as the Medicines Patent Pool.”
Monty Dunn MB BChir BA (Cantab), is a medical doctor, health activist and independent researcher. Over the last 5 years, he has worked on a range of projects related to access to medicines for Medicines Law & Policy, the Pharmaceutical Accountability Foundation and Universities Allied for Essential Medicines. His research interests include intellectual property law, public funding of R&D and corporate accountability.
His work at Medicines Law & Policy centres around the TRIPS Flexibilities Database.