Medicine Supply Regulations Change AgainBy Miriam Bello | Fri, 11/20/2020 - 09:40
President López Obrador introduced a presidential decree to grant foreign pharmaceutical companies permission to sell medicines in Mexico without COFEPRIS’s validation.
Lopez Obrador referred to COFEPRIS’s certification processes as an “obstacle” for foreign companies already holding an approval from the regulatory agency of their country of origin. Thus, a revision by COFEPRIS once a medicine comes to Mexico would no longer be necessary. The president added that this measure would prevent medicine shortages and would support medication supply from UNOPS.
In the past, the president accused Mexican pharmaceutical companies of corruption, which drove his administration to sign a medicine supply deal with UNOPS. This week, he said that COFEPRIS’ medicine approvals delayed and discouraged international companies from entering Mexico.
COFEPRIS’ role is to establish whether a pharmaceutical product is of quality, safe and effective. Before being judged by COFEPRIS, a product must have a sanitary registration from its country of origin. Agustin Azcatl, IP and Regulation Leader at Ortiz & Ramirez Abogados, shared with MBN that with fewer paperwork, the president considers that evaluation times becomes shorter, showing this administration’s ignorance of the work behind ensuring a medication’s quality, safety and efficacy.”
Once COFEPRIS introduces the new regulations proposed by the administration, it must also establish which products fall into this new scheme, which ones do not and the legal basis for their exclusion. Otherwise the regulation would be considered discriminatory, explains Azcatl. In addition, COFEPRIS must develop new guidelines for the sanitary surveillance of the products that will be approved under this new scheme. “I think the president sent a hot potato to COFEPRIS without considering all the implications of the sanitary registration process.”
What would be the implications of this move? "This Presidential Decree to expedite the entrance and approvals of pharmaceuticals from abroad and generics by disregarding rules in the domestic and international regulatory standards, clearly disrespects the spirit of the health regulation to avoid health risk and the establishment of a balanced system," says Alejandro Luna, Partner of OLIVARES. He explains that this is the government's way of fighting corruption, however, Luna asks "the Mexican Government is only established for que acquisition of medicines but not in the materials, supplies and services for building trains, refineries and contracts with PEMEX, CFE and others?"
Because human health is one of the highest values, the pharmaceutical industry is one of the most regulated industries in the world.
-Alejandro Luna, Partner of OLIVARES
Luna identifies four major issues on the subject. “First of all, there should not be a excuse to jeopardize the health of Mexicans by short cuts in the regulatory path, which may jeopardize the health of millions of Mexicans.” Secondly, he explains that this measure ignores various chapters of Government Procurement in many of the free trade agreements subscribed by Mexico with different countries, which attracted longstanding and not only opportunity business and investment in Mexico. Thirdly, “there should not be justification to conduct an undue priority treatment to foregoing companies or products in prejudice and discrimination of national and international companies incorporated in Mexico." Lastly, according to Luna, there is no reason to contempt other applicable laws such as patent linkage established now in the new Federal Law for Protection of the Industrial Property, which should be observed during the regulatory approval.
How can pharmaceutical companies in Mexico defend themselves against this decision?
According to Azcatl, the Mexican industry must be vigilant of these new guidelines issued by COFEPRIS. “Once the new guidelines are issued, we will have more information to be able to establish some legal and business strategy to face these new provisions,” says Azcatl.
The president’s announcement, however, does not mean that foreign pharmaceutical companies can obtain a sanitary registration to commercialize drugs in Mexico without following any requirement, explained Fernando Becerril, Director of Business Development of BC&B. “This policy in no way intends to alter the conditions of quality, safety and efficacy.”
Becerril said the public sector seeks to guarantee the supply of medicine and health supplies in the current circumstances. In that sense, “lightening the administrative burden on the industry, regardless of whether a product is foreign or national, is positive. It allows the medicine to easily enter the market and address society demands.”
Hugo López-Gatell, Deputy Minister of Health, clarified that this measure “will not affect treaties such as USMCA nor will it allow the entry of poor-quality products.” He also said it is “false, false, false” to say that regulatory measures have decreased or diminished.
Since 2018, Mexico is part of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) alongside other 55 countries. PIC/S recognizes the equivalence of health records between member countries. This “is favorable because it allows access to more pharmaceutical markets,” said López-Gatell. He also highlighted that the future COVID-19 vaccine will be submitted to COFEPRIS’ regulatory process because no vaccine has been approved by any agency to date.