Advancing patients’ access to medicines in the pharmaceutical legislation

In the context of the ongoing discussions on regulatory data protection periods in the revision of EU pharmaceutical legislation, the European Patients' Forum (EPF) is concerned that proposals to extend the current regulatory data protection period (RDP) and to introduce disproportionate RDP incentives risk further reducing patients’ access to medicines.

We are concerned about the emergence of a narrative that extending RDP periods would somehow benefit patients. This is not the position of EPF or our members.

The current system is failing millions of people who lack access to new medicines. Unacceptable inequalities in access remain within and between EU countries. By increasing RDP periods, the legislators would commit to an increase in spending on medicines, but without mechanisms to improve and expand patients’ access to clinical trials, approved medicines, and needs-driven innovation.

The review of the pharmaceutical legislation is a once-in-a-generation opportunity to get it right for patients and put them at the heart of the EU’s regulatory system for medicines. We will continue to engage with decision-makers to find balanced policy solutions that truly improve patients’ access to the medicines they need across the EU.  

Read the full statement here


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