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