COFEPRIS Backlog: What Should Happen and What Can Companies Do?

The Mexican Constitution establishes in Article 8 a right to obtain responses from authorities to any petition, within a brief period of time. This right is further regulated by the Federal Administrative Proceedings Law, which establishes, among others, three relevant obligations, as follows:

• Authorities must allow petitioners to know the status of any ongoing request, at any time.

• They must inform petitioners of legal or technical requisites for proceedings.

• They must allow access to physical or digital files.

• They must respond to petitions within the time frames established by law or regulations.   

The Mexican Regulations for Health Supplies (which govern drug and device approvals) contain several relevant time frames, including:

• Approvals for a generic drug product must take place within 180 days after submission.

• New molecules must go through a prior review at the New Molecules Committee;  after a favorable review by this committee, approvals must take place within 180 days.

• Products approved abroad by recognized agencies have accelerated time frames for approval (60 or five days). 

• Sanitary licenses must be issued within 60 days.

Furthermore, there are two general rules applicable to any proceeding before COFEPRIS:

• Once a petition is filed, requirements to the petitioner can only be issued within two-thirds of the maximum response period. 

• If there is no set time frame, petitions under the Regulations for Health Supplies must be addressed within 45 days. 

Unfortunately, observance of these provisions has not been the standard in recent years at the Federal Commission for Protection against Sanitary Risks (COFEPRIS h). According to a report published by the Chief Audit Office of the federal government in Q1 of this year, there are significant delays in all sorts of regulatory proceedings. The report even includes recommendations to initiate administrative responsibility proceedings against the officers responsible for the delays. 

These delays impact different industrial sectors, affecting both patients and consumers, as COFEPRIS is in charge of approving health supplies, including drugs and medical devices, and other products like pesticides and plant nutrients.  

COFEPRIS has made an effort to reduce this bottleneck, including the digitalization and request for resubmission of term extension petitions for drug products; nonetheless, there are multiple cases of delays, complicating the operations of regulated industries.  Another area of impact has been the refusal to grant meetings to discuss legal or technical aspects of ongoing proceedings (COFEPRIS has only allowed for informational meetings regarding general rules and not specific files). 

To address this problem, there are two additional actions that can be taken by regulators, and one alternative to consider from the private sector, as follows:

1. COFEPRIS can take advantage of the tacit affirmative provisions in the relevant regulations, which state that certain petitions (such as a modification to an existing marketing authorization or an advertisement permit) will be considered as favorable to the petitioner if the authority does not decide within the allowed time frame. Several delayed proceedings could be decided in a very short time frame, allowing for technical resources at COFEPRIS to be focused on hastening new authorizations. 

2. Additionally, it would be beneficial to re-open the possibility to hold meetings with examiners or other offices at COFEPRIS – in a transparent fashion – to allow companies to explain the priorities and details of complex matters (as opposed to doing everything through written filings). According to official communications, these meetings have been limited as a way to combat corruption but mechanisms such as video recording would prevent any wrongdoing. 

3. Until the matter is addressed, companies in the private sector can either wait for decisions or analyze litigation alternatives to secure responses, including: 

4. Filing of review resources before the Commissioner at COFEPRIS.

5. Administrative trials before the Specialized Court for Environmental and Regulatory Matters at the Federal Court for Administrative Affairs, which has issued several precedents ordering COFEPRIS to observe tacit affirmative responses. 

6. Constitutional “amparo” trials, where a violation of the right of petition established in Constitutional Article 8 is claimed, and which can be useful even in cases of new product approvals and some modifications of approval conditions.

Of course, having to go through litigation is not an ideal scenario for regulatory approvals (as it increases costs and further stresses the resources of COFEPRIS, which would  have to respond to relevant claims). Actions of this nature should be considered carefully, and can be resolved quickly if the authority decides the relevant petitions in favor of the petitioner. 

Furthermore, with the proposed actions for COFEPRIS – and in any litigation proceeding – the spirit and letter of the Constitution and the law would be observed, and a serious problem would be alleviated.  In addition, by addressing this problem, COFEPRIS would prevent administrative responsibility proceedings (like those  suggested by the Chief Audit Office).