Our June newsletter is dedicated to the window of opportunity offered by the ongoing revision of the EU’s pharmaceutical legislation to improve access to effective and affordable medicines for everyone. Contrary to what the pharmaceutical industry claims, high prices of medicines (especially for cancer treatment) and the lack of obligations for the industry to place their products in the market are driving unequal access to medicines across the Union. As explained by the European Consumer Association (BEUC), both issues can be addressed through the revision of the EU pharmaceutical legislation.
For fair price – one that reflects the value of medicines while providing reasonable compensation for the costs of bringing new medicines into the market – to become a reality, the EU needs to take a few bold steps. To begin with, EU pharmaceutical policies need to shine light into the black box of research and development (R&D) costs, as argued by the European Cancer Leagues (ECL). The Pharmaceutical Strategy for Europe recognised the need for transparency, and the EU pharmaceutical legislation should now operationalise this.
When it comes to affordability, the EU pharmaceutical legislation can (and should) address it by ensuring that pharmaceutical incentives are proportionate and linked to actual access to products across Europe. To get there, the legislator can start by reversing the burden of proof: extended exclusivities granted to industry in areas of low commercial return, should only be possible if there is an evidence-based justification on a lack of return on investment.
The EU pharmaceutical legislation should also provide concrete solutions to the increasing problem of shortages of medicines. As argued by France Assos Santé, ‘a bold patient-centred set of rules on the prevention and management of medicine shortages’ should be included in the revised pharmaceutical legislation. This patient-centric approach requires a balanced dialogue with all parties and there is much that we can learn from the shortcomings of the Structured Dialogue on the security of medicine supply.
EPHA’s longstanding advocacy in the access to medicines area has contributed to crucial steps, such as the inclusion of access to affordable medicines in the mandate of the current Health Commissioner, as a key pillar of the pharmaceutical strategy for Europe and as an ambition of the revision of the EU pharmaceutical legislation. Along with our members and other partners, we have also produced recommendations to address shortages of medicines at EU level. It is due time to move from ambitions into concrete actions.
The impacts of the EU pharmaceutical legislation will be felt for decades. And as the ongoing COVID-19 pandemic, and emerging monkeypox outbreak have reminded us, no country is an island. The EU pharmaceutical legislation is likely to spill over into other parts of the world via free trade agreements. By placing the public interest and access to affordable medicines at the forefront, the EU will once again set up the best standards for the rest of the world.
