Focus on: Defending Marketing Authorization of Medicines before COFEPRIS: failure to respond and arbitrary cancelations.

RIGHT TO HEALTH, A HUMAN RIGHT.

Article 4 of the Mexican Constitution considers health as a human right, so the government is obliged to guarantee it to Mexican citizens, primarily by providing access to public health services such as public hospitals; and having a health law legal framework that sets the basis to provide safe and effective health products, services, and treatments. This means the Federal Commission against Sanitary Risks (“COFEPRIS”), the Mexican health authority that authorizes and surveils medicines must be efficient in the evaluation and authorization of medicines and therapeutic alternatives to keep quality medical products in the market and protect the health of Mexicans.

THE REGULATORY REGIME.

In Mexico, to be manufactured, imported, and marketed, medicines require marketing authorization of medicines under the General Health Law (“GHL“) and the Health Supplies Regulation (“RHS“), which must be renewed every 5 years.

To renew the marketing authorization of a medicine, it is necessary to request it 150 days before its expiration date. This is intended to give COFEPRIS enough time to evaluate and analyze the request for an extension of the marketing authorization before its expiration date and do not affect the holder. However, COFEPRIS does not currently comply with these timeframe objectives even though they are expressly stated in the law.

On the other hand, there are precedents where it is established that those requests for the renewal of the marketing authorization that have been filed on time and have not been resolved are understood to be approved.

This causes uncertainty in the purchase of products in the public sector such as the Mexican Health and Wealth Fare Services (“IMSS”), Mexican Health and Wealth Fare Services of Government Employees (“ISSSTE”), and Ministry of Defense (“SEDENA”), being these only some examples due to the validity of the products and the capacity to receive them in their warehouse when COFEPRIS has not answered the extension of the marketing authorization of a medicine. This issue is not limited to causing problems in the public sector, as the problem is also transferred to the private market.

In addition, inconsistencies have been detected in the criteria that generate arbitrary refusals without being duly grounded to these extensions of the marketing authorization that lead to the cancellation of it and as a consequence affect the continuity of the supply of medicines at a national level. This is a very serious problem as it jeopardizes the supply of medicines to patients, as well as the production chain and financial planning of companies engaged in the health sector.

LEGAL TRENDS AND DEFENSES FOR DEALING WITH REGULATORY UNCERTAINTY.

Some of the successful defense strategies to these problems are:

1. Administrative appeal.
2. Administrative Litigation.
3. Amparo Proceeding.

These means of defense allow to combat arbitrary acts of authority and the lack of response of the same in which is possible to get both provisional and definitive suspensions for the benefit of our clients.

The suspension is a precautionary measure that has the effect of maintaining things in the same state in which the law foresees them until the trial is resolved. This is a great benefit because, as mentioned above, if the authority does not respond, the extension of the marketing authorization is understood to be appropriate, and the product can continue to be commercialized.

Thanks to the suspension, health companies can maintain the production chain of the medicines that submitted the extension of the marketing authorization on time but have not received an answer from COFEPRIS and therefore continue their commercialization under the protection of a judicial resolution that authorizes it.

Likewise, thanks to administrative lawsuits, COFEPRIS has been forced to issue the renewal of the marketing authorization. This results in a great benefit for society because the medicines that people consume remain in the market and the companies dedicated to the health sector are not affected in the production chain or the commercialization.

This strategy has implied significant progress in both the regulatory and judicial spheres, as once again the judiciary has been the one to remedy the deficiencies of the executive branch, i.e. the deficiencies faced by COFEPRIS as an institution.

On the other hand, strategies have been implemented to combat unfair competition in the pharmaceutical sector through investigations and consultations on marketing authorizations, import permits, imports under the agreement of January 28, 2020, interaction with irregular importers and traders, and complaints, among others. These strategies have resulted in the authority issuing health alerts regarding products that pose a risk to the population.

CHALLENGES FACING SANITARY REGULATION IN MEXICO.

In Mexico, health regulation faces great challenges, in particular, the pharmaceutical sector, both in the field of medicines and medical devices related to regulatory uncertainty and, as a consequence, corruption.

Currently, several regulatory and operational impediments negatively affect access to medical treatments to the detriment of the health of the Mexican population. One of the major regulatory impediments is the failure of the authorities to comply with the deadlines established by law to resolve user requests.

To provide regulatory certainty, and full compliance with the regulatory framework for protection against health risks, which translates into:

1. Provide clarity to the user on the authorization requirements and their definition, the internal evaluation process, and the time associated with each of the stages of the evaluation.
2. Ensure a standardized evaluation based on technical and scientific criteria and not on arbitrary and bureaucratic criteria.
3. Effective recognition of the decisions of regulatory authorities in other jurisdictions.
4. To guarantee regulatory harmonization with internationally valid standards to favor industrial development, access to new medical treatments, and competitiveness.

On the other hand, health regulation in Mexico must promote the implementation of the recommendations issued by the World Health Organization so that the procedures, services, and resolutions provided by the health authority are similar to what is done internationally.

In this regard, in 2022 the Ministry of Health announced a regulatory certainty strategy for the pharmaceutical and medical device sector so that by 2030 the challenges mentioned in this section will have been overcome and the regulatory framework for protection against health risks will be fully complied with.