What it means for you?
If your company lost a MA because the renewal application was not filed on time, but the health regulator did not meet legal deadlines either, we can help you recover that MA.
In more detail
Many healthcare companies, for different reasons, failed to submit on time some applications to renew MAs, particularly during the pandemic. In those cases, eventually, COFEPRIS: (i) rejected the renewal applications and (ii) cancelled the original MAs. This had a significant commercial impact.
Noteworthy, at the same time:
- This federal administration has experienced huge regulatory delays, failing constantly to meet applicable legal deadlines.
- Around half of the time, when the specialized health regulation foresees the need to obtain an authorization*, it introduces also a positive legal rule, thanks to which, if the authority fails to take a decision within the applicable legal deadline, the application for all legal purposes "shall be considered approved". The renewal of MAs is one of those cases.
In the cases we won, the courts ordered COFEPRIS to grant the renewal, even if the MA renewal application was filed extemporaneously.
These are important precedents because they change prior understandings that were common in the industry, which considered that nothing could be done, once a cancellation had occurred in the circumstances described above.
For further information and individual assistance regarding this new opportunity, please get in touch with our experts.
* Lopez-Silva C. The afirmativa ficta as a regulatory tool in health regulation. In Health Law: An integral perspective. Tirant Lo Blanch. 2022.
