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