A report issued at the start of 2022 by the chief audit office of the federal government indicated that proceedings before the Federal Commission for Protection against Sanitary Risks (COFEPRIS) are experiencing significant delays. These delays are impacting various industrial sectors, affecting both patients and consumers, as COFEPRIS is in charge of approving health supplies – including drugs and medical devices – and other products such as pesticides and plant nutrients.
Delays in administrative proceedings go against the provisions of the Mexican Constitution, the General Health Law, its regulations and the Federal Administrative Proceedings Law, all of which mandate the authorities to provide responses, deficiency letters and approvals within defined timeframes.
COFEPRIS has made some efforts to reduce the bottleneck, including through digitalisation and requesting the resubmission of term extension petitions for drug products. However, delays remain frequent, complicating the operations of regulated industries.
To address this situation, parties should consider the possibility of initiating litigation proceedings in order to secure responses. These options include:
- filing for a review before the commissioner at COFEPRIS – which has proven useful in some cases linked to ad authorisations and the modification of product registration conditions;
- initiating administrative trials before the Specialised Court for Environmental and Regulatory Matters at the Federal Court for Administrative Affairs – this measure has seen some success in cases linked to tacit affirmative responses and the authorisation of term extensions; and
- Initiating constitutional "amparo" trials, where a violation of the right of petition established in article 8 of the Constitution is claimed – this can be useful even in cases of new product approvals and some modifications of approval conditions.
In such cases, parties should analyse the pending proceeding or proceedings in order to determine the response – or requirement – timeframes that COFEPRIS should observe, and determine a corresponding strategy, seeking the action that will grant the highest chance of success in the shortest period.
For further information on this topic please contact Juan Luis Serrano or Mariajosé Ayala at Sanchez-DeVanny Eseverri SC by telephone (+52 55 5029 8500) or email ([email protected] or [email protected]). The Sanchez-DeVanny Eseverri SC website can be accessed at www.sanchezdevanny.com.