In a statement, the Association points out that the agreement signed with INSABI contains elements that, in principle, jeopardize the protection of industrial property rights for patented medicines.

Furthermore, it points to potential risks related to requirements regarding the primary labeling of medicines that, being outside Mexico's regulatory framework, would prevent companies established in the country from participating in the tender.

For the industry, this scenario contradicts what Mexican authorities have stated about applying equal opportunities to participate and their commitment to adhering to the country's laws and regulations.

In its opinion, if the tender continues as it is, it believes it could even contribute to several drug product codes becoming unlicensed.

Authorities are alerted

The risks identified by the biopharmaceutical industry regarding innovation in this regard have already been formally notified to the Institute of Health for Well-being (INSABI), as the authority responsible for procurement by the Mexican government.

Likewise, UNOPS was also informed to request immediate action to avoid a potential shortage that would affect the Mexican population.

Risks

Given this scenario, AMIIF members believe that maintaining the requirements for labeling on primary packaging would contradict the declarations regarding the application of equal opportunities to participate in the procurement process.

This, in addition to the commitment to adhere to Mexican laws and regulations, would lead to the disqualification of companies that cannot comply with this requirement due to the aforementioned complications, thus creating a potential risk that multi-key purchases would be declared void.