Statement by ReAct – in response to the EC’s proposal for revising EU pharmaceutical legislation

2023-04-26

The European Commission finally presented their proposal for revising all EU pharmaceuticals legislation after months of delay. The proposal seeks to improve access to medicines in a number of ways including by introducing a new incentive to support the development of new antibiotics. However, the ‘transferable exclusivity voucher’(TEV) builds on a deep-rooted misconception that big pharmaceutical companies are indispensable for the development of new antibiotics.

It is quite remarkable that the European Commission has insisted on including the ‘Transferable Exclusivity Voucher’ in the revised pharma legislation proposal despite the widespread lack of support among Member States in the Council, experts in the antibiotics innovation field and in civil society.

It is a testament to how entrenched some parts of the European Commission is in the outdated narrative that only multinational pharmaceutical companies can do innovation and bring medicines to market.

Helle Aagaard, Deputy Director ReAct Europe, comments:

“The TEV is really an incentive targeting the multinational pharmaceutical companies. As such it ignores the hard work done by academic researchers, small-and-medium enterprises and non-profits that essentially has kept the field alive, when one after one the multinationals has abandoned it. The expertise and the motor of innovation in antibiotics R&D does not sit with the big multinationals– and hasn’t done so for a very long time“.

A few weeks back the new directorate general for the Health Emergency Preparedness and Response Authority – DG HERA – came out with a report that outlined a number of far more appropriate pull incentives that could be implemented without requiring any legal changes.

Considering the dire state of the pipeline for new antibiotics, and the unprecedented speed with which resistance is developing to existing antibiotics, it is indeed good news that DG HERA not only has the foresight to present better models for pull incentives, like milestone prizes, but also can implement them swiftly.

Helle Aagaard says:

“With the HERA proposals already on the table and being discussed in the Council, the TEV proposal in my mind becomes irrelevant. Why would anyone put any effort into creating an overly expensive and inefficient model, that takes years to establish, when you can act now and get far bigger impact by implementing some of the HERA proposals?”