Judicial Decision a First Victory for Equivalence StandardsBy Juan Luis Serrano Leets | Wed, 04/20/2022 - 11:00
Since 2012, Mexico has issued several official communications recognizing that requisites imposed by certain foreign agencies to approve pharmaceutical products and medical devices are equivalent to those established under national laws and regulations (“Equivalence Standards”).
These communications were intended to create an accelerated approval pathway in Mexico for products that have already gone through a review process by certain foreign agencies.
The communications include recognition of approvals by:
- The WHO prequalification program
- The FDA
- Health Canada
- The Australian Therapeutic Goods Administration.
- WHO/PAHO reference regulatory agencies
In parallel to a new public policy on drug purchases – whereby the Mexican government hired the United Nations Office for Project Services “UNOPS” to conduct international tenders, seeking low prices regardless of the place of origin or if a product was approved in Mexico or not – the Equivalence Standards communications sought to bring more products into the Mexican market, both for the private and public sectors.
However, use of the Equivalence Standards had not been widespread. Even though they referred to 60-day review periods, there was no automatic approval and if that period expired then applicants would have to wait; products submitted for approval under these communications would be studied on a first in-first out basis, along with all other submissions.
This situation changed – at least on paper – in November 2020, as the Ministry of Health issued a communication that included a significant reduction to regulatory timelines, establishing:
- A five working day term to issue product marketing authorizations filed under equivalency agreements.
- A four working day term to issue requirements to the applicant, in case the information was not complete.
- A tacit affirmative response, meaning that the approvals would be considered as granted if no response was received after five days or if a deficiency letter was received and replied to.
This tacit affirmative response is a legal concept applicable to several regulatory proceedings, intended to benefit companies. If the Mexican regulatory agency (COFEPRIS) does not reply to certain petitions, such as marketing authorization renewals or advertisement permits, in the allotted time frame, they are legally considered as granted. Since 2010, several renewal petitions have been secured by the industry through this legal concept in litigation proceedings against COFEPRIS.
Thus, after the November 2020 communication, several companies filed for drug and device marketing authorizations, hoping to benefit from the shortened time frames regardless of whether they intended to sell the relevant products in the public tender proceedings run by UNOPS.
Regretfully, COFEPRIS has not observed the shortened deadlines nor the tacit affirmative response; marketing authorizations have not been issued for what has now been several months and the regulator has publicly recognized that they are facing severe backlog, both on these applications and on regular ones related to generic or innovative products.
As a way to counter the inactivity of COFEPRIS, -and at the request of one of our clients in the pharmaceutical industry, our life sciences team designed a regulatory/litigation strategy and started an administrative trial, with the purpose of obtaining a Specialized Court decision ordering the issuance of the corresponding marketing authorization. If successful, this case would allow our client to ask for similar results on its remaining – and future – equivalency standard applications.
The first-stage decision was favorable to our clients. In this decision, the Specialized Court determined that:
- Our client’s drug marketing authorization was filed under an Equivalency Standard Agreement, based on a prior EU application.
- The four-day legal term for COFEPRIS to issue a deficiency letter has expired, as has the five-day term to issue the marketing authorization. The application file does not show any deficiency letter.
- Plaintiff is correct in claiming that the automatic approval applies to its MA application, since the Equivalence Agreement from Nov. 18, 2020-First Section expressly foresees that the Commission has a four working day legal term after the due date to issue any requirement in case any was issued; or after the day when the requirement received a response to solve such petition, and if this does not happen the application will be considered as authorized.
- Therefore, the challenged administrative decision, consisting of the lack of issuance of the MA, is declared null. The court is thus ordering COFEPRIS to issue the MA.
At the time of writing of this article, we are still waiting to be served with an appeal by COFEPRIS to this decision, which will be studied by a Federal Circuit Court. We are, nonetheless, confident that we will prevail on appeal and secure a confirmation of the favorable decision.
Whereas this case can set an important precedent, it will not be binding; to obtain this benefit, companies will have to go through a similar court proceeding. However, cases of this nature may help change COFEPRIS’ current position on Equivalency Standards and start issuing expedited approvals in accordance with the intent of the relevant communications.
We hope that this will be the case. Expedited approvals based on Equivalency Standards do not present any health-related risks and can help bring in new drugs and devices into the Mexican market. Their recognition can also help alleviate some of the backlog that COFERIS is facing.