As the COVID pandemic started, expectations in the “access to medicines” community raised. After all, if a pandemic could not build the case for equitable access to vaccines and medicines, what would?
Yet, initial promises, such as Von der Leyen’s commitment to treat COVID vaccines as global public goods, quickly vanished during negotiations with pharma companies. Public payers ended up with a huge bill, industry obtained substantial profits with no conditions attached, proposals to waive intellectual property for the public interest got watered down during international negotiations, and part of the world got excluded from vaccines.
The world missed its opportunity to improve access to medicines during the pandemic. The revision of the EU pharmaceutical legislation, the negotiation of a Global Pandemic Accord, the new EU Global Health Strategy, and the recent launch of the multi-stakeholder platform of the WHO Oslo Medicines Initiative could now provide further opportunities to advance on this front. These opportunities should not be missed.
The do’s
“Imagine what we could achieve if we could develop a pharmaceutical system that makes safe and effective medicines swiftly available to all patients in Europe”. The proposed multi-stakeholder platform under the WHO Oslo Medicines Initiative is meant to do just this. To deliver on its promise, it needs to be kept as a platform that promotes fruitful and balanced dialogue with all sectors.
The upcoming revision of the EU pharmaceutical legislation provides an opportunity to rebalance an (un)balanced system. The revision could reset the bar for regulatory evidentiary requirements, limit fast-track authorisation procedures to specific cases, tackle the lack of transparency around pharmaceutical R&D costs and tight market incentives to obligations to ensure that medicines become available and affordable in all EU countries and that neglected areas of research are prioritized.
Additional pieces of the EU pharmaceutical strategy, including the implementation of the forthcoming HTA Regulation could further contribute to address barriers and increase the uptake of enablers of access.
As a new (and potentially binding) international instrument, the Pandemic Accord could deliver a more equitable access to medicines system. To do this, the Accord should strengthen transparency in the pharmaceutical system, support technology transfer and IP rights sharing, and guide countries in attaching strings to public funding for biomedical R&D to ensure final products are accessible to (all) those in need.
The don’ts
What the upcoming revision of the EU pharmaceutical legislation should not do is to try to solve market failures such as the dearth of new antibiotics through the creation of market incentives. Not only would this be inefficient, but it would run counter to the same spirit of the revision.
The Pandemic Accord, the EU Global Health Strategy and the Oslo Medicines Initiative should not fall short of ambition to rebalance the system and to increase transparency in the pharmaceutical sector.
The stakes are high, and the window of opportunity is closing fast.
