Publication of the French decree regarding the experimentation of the “direct access” to pharmaceutical products with anticipated reimbursement: a half-hearted step forward in terms of market access for pharmaceutical innovations

In a world where innovation is at the heart of our daily lives, the speed of access to market for innovations is a major challenge for companies. A new step has been taken with the publication of the decree regarding the experimentation of the “direct access” to pharmaceutical products with anticipated reimbursement.

This is a significant step, especially for products with a CAV IV (“Clinical Added Value”) or better rating. However, one point deserves our attention: the administration's silence will now be considered a refusal, and companies will have to explicitly request the reasons for this refusal.

As for the clawbacks, the scale still needs to be determined by an official order.

Unfortunately, the early access program has shown its limitations for pharmaceutical products with an CAV V rating, and even more recently in the field of oncology.

It is clear that this new system does not address all the gaps. It is currently a half-hearted step forward, and its implementation by the administration will reveal whether or not there are points of improvement for a faster access to market for innovations in France.

A convergence with the German system still seems to be a long way off. The financial framework for clawbacks confirms this, as does the implementation of regulated pricing when certain indications are included in reimbursement.

We eagerly await seeing how this new regulation will be implemented and what impact it will have on access to therapeutic innovations.