Mexico Announces a Policy to Expedite Approval of Marketing Authorizations for Medicines from Abroad

November 4, 2020

On October 29, 2020, the Mexican President announced a Decree ordering the Ministry of Health and COFEPRIS to take the necessary measures to expedite the granting of marketing authorization of health supplies from abroad, based on the so-called Equivalence Decrees.

As previously reported, within the policy that the government has put in place for access to medicines, the following is highlighted:

• Equivalence Decrees, simplify the terms and requirements for the processing of a marketing authorization of health supplies of foreign origin. (Newsletter No. 5, March 2020)
• Agreement with the United Nations Office for Project Services (UNOPS) in order to carry out bidding procedures for the acquisition of health supplies; (Newsletter No. 119, August 2020)
• Amendment to the Public Sector Procurement, Leasing and Services Law, providing the Mexican Government with faculties to acquire medicines and other health supplies through international organizations. (Newsletter No. 119, August 2020).

In addition to the above, there is the recently announced Decree, whereby the Mexican President orders to the health authorities, as follows:

• Approve marketing authorizations in a shorter term than those established in the Equivalence Decrees; and
• Analyze the relevance of reducing the documents required in said Decrees, as long as they continue to guarantee that the supplies comply with the safety, quality and efficiency requirements.

It is considered that there is no certainty in the mechanisms that health authorities should implement to ensure that the supplies that are acquired from abroad comply with regulatory standards, patent rights and protection of clinical data, which has led to criticism of the Decree, specifically that Mexico grants facilities to companies and products that have not demonstrated, prior to the bidding procedures, that the appropriate regulatory framework has been complied with.

The publication of this Decree in the Federal Official Gazette is pending. OLIVARES will continue to analyze the possible actions to be taken by the companies and individuals that are eventually affected by this Decree once it enters into force or when applied in prejudice of certain civil rights, as some violations to the Constitution, international treaties and other laws are foreseen.