Many decisions concerning the reimbursement of healthcare products must be preceded by a contradictory procedure. The aim of this procedure is to enable companies against which the authorities intend to take an unfavorable decision to submit their observations before the decision is taken.
When it is provided for, the contradictory procedure does not replace the appeal procedures, but adds to them:
- before the decision is taken, the company can submit its observations in an attempt to influence the direction of the decision to be taken;
- once the decision has been taken, they can appeal against it. Appeals may be filed either directly before the administration, or directly before the courts (depending on the strategy most appropriate to the case).
The case law and decisions of recent months illustrate the importance of respecting the contradictory principle in matters of early access.
Contradictory proceedings when early access is withdrawn
As stipulated in article R. 5121-72-1 of the French Public Health Code, early access may only be withdrawn after the authorization holder has been invited to comment. The ANSM and HAS can only waive the contradictory procedure in an emergency.
In other words, a decision to suspend or withdraw early access is, except in an emergency, illegal if the pharmaceutical company has not first been invited to present its observations. The pharmaceutical company can then obtain the withdrawal of the unfavorable decision, by filing an appeal (administrative and/or contentious).
The HAS has just reminded us that administrative appeals are not (always) doomed to failure! Following an appeal filed by the AMGEN pharmaceutical company concerning the withdrawal of early access to LUMYKRAS, the HAS acknowledged that the decision was illegal, as it had not been preceded by a contradictory procedure.
It therefore withdrew its decision and invited the pharmaceutical company to file written and oral observations on the possible withdrawal of early access.
Contradictory proceedings in the event of an appeal against unwinding paybacks
The French Social Security Code stipulates that when the CEPS considers charging a pharmaceutical company with early access paybacks, it must inform the company and the latter may file written observations and, where appropriate, ask to be heard.
Arguing in particular that it had not been heard by the CEPS, MedDay challenged before the judge the amount of the paybacks charged to it for the unwinding of its derogatory access[1].
The judge ruled that the hearing was a mandatory one, since MedDay had asked to be heard. He concluded that the CEPS decision to charge the company for the unwinding paybacks was irregular and, for this reason in particular, annulled the decision.
GD Avocats advises and assists companies with their market access strategy and the associated pre-litigation and litigation procedures. Contact us by e-mail: contact@gd-associes.com
[1] In this case, the derogatory access was an ATU. The provisions relating to the contradictory procedure are essentially worded in the same way for unwinding paybacks paid under ATUs and early access authorizations.
