Search for:

In brief

After having rejected initially any possibility in this regard, the Federal Ministry of Health (“MoH”) issued a Decree, published in the Official Gazette on 25 January 20211 establishing the conditions under which the local (State) governments and the private sector, can participate in the National Vaccination Program for COVID-19. Although it does not eliminate many uncertainties, it opens certain possibilities of action.


Key takeaways

Companies who had planned to acquire vaccines for their employees should carefully review both implicit and explicit conditions found in this Decree, which should be read together with the National Vaccination Policy2. Noteworthy, not all of the models that some stakeholders in the private sector had suggested publicly before, would now be consistent with this Decree.

In more detail

The Decree reflects a policy change regarding the initial rejection of the Federal government to allow local governments and the private sector to participate in the acquisition, import, distribution and application of COVID-19 vaccines in Mexico.

However, this instrument does not address all key aspects or eliminate all relevant uncertainties, leaving some key questions still open. For example, the Decree does not: (i) refer to those non-healthcare related companies who want to participate; or (ii) refer to important product authorizations, such as marketing authorizations or import permits.

On the other hand, the Decree does require:

  • sharing the purchase agreement with the MoH
  • sharing data on doses and applications with the MoH
  • respecting the roll-out criteria and calendar defined by the Federal MoH
  • comply with measures to be defined by the Federal MoH
  • guarantee traceability and share periodic reports with the MoH

Our Healthcare and Life Sciences Industry Group can support companies to review their plans to acquire vaccines for their employees in the light of this key normative development. We can help them devise and implement a strategy to have access to these important treatments as soon as possible, in a way that can be complaint with the current legal and regulatory framework.

#LifeSciencesBakerMcKenzie


1 Available here: http://dof.gob.mx/nota_detalle.php?codigo=5610327&fecha=25/01/2021

2 Available here: https://coronavirus.gob.mx/wp-content/uploads/2021/01/PolVx_COVID_-11Ene2021.pdf

Author

Raymundo Enriquez is currently a partner in Baker McKenzie's Antitrust Practice Group in Mexico City. Mr. Enriquez focuses his practice on foreign trade and competition law. He advises and represents clients in proceedings before the Mexican antitrust authority. He also has extensive experience assisting clients in a wide range of issues involving merger control, compliance programs, cartel investigations and antidumping proceedings involving WTO.

Author

Dr. Lopez Silva is the head of Healthcare & Life Sciences Industry Group in Mexico, as well as a member of the Steering Committee of the North American and Latin America Healthcare Group. He has more than 17 years of experience in regulation of life sciences, pharmaceutical law and biotechnology matters, having worked in the private and public sectors and at the national and international level. For several consecutive years, Dr. Lopez Silva has led the rankings for Life Sciences both nationally (Chambers Latin America) and internationally (Chambers Global).