The Ministry of Health recently announced that the Federal Commission for the Protection against Sanitary Risk guidelines regarding industrial products with a tetrahydrocannabinol content of less than 1% have been suspended. In addition, all permits granted under the suspended guidelines will be reviewed and new draft regulations will be prepared in coordination with the Ministry of the Interior.
The Office of the United States Trade Representative recently issued its Special 301 Report. Section I.A.1 of the report, which concerns pharmaceutical and medical device innovation and market access, calls on Mexico to address pharmaceutical and medical device IP-related challenges, lists the steps that it should take in order to open its markets to IP-intensive pharmaceutical products and medical devices and encourages it to recognise the value of innovation in these fields.
Although it is common for the parties involved in mergers, acquisitions, asset sales, spin-offs or similar activities in the pharmaceutical, medical device and other health-related industries to treat marketing authorisations as assets which are subject to the general negotiation process, this approach is controversial. If incorrect, an allocation of a monetary value to or a transfer of a marketing authorisation could be considered an invalid act between the relevant individuals or legal entities.
Mexico is the second largest market for the pharmaceutical and medical device industries in Latin America. Thus, as mergers and acquisitions, asset sales, spin-offs and similar activities in the pharmaceutical, medical device and other health-related industries are often global or at least multinational, they often affect companies that operate in Mexico. Although there have been many unfortunate situations where such activities have been delayed or cancelled, this can be avoided.
The Federal Commission for the Protection against Sanitary Risk recently published new guidelines for the authorisation of ad applications regarding prescription and over-the-counter drugs, herbal remedies and homeopathic medicines. As the guidelines include several provisions that appear to be against the General Health Law and the Health Law Regulations on Advertisements, they may give rise to a number of interesting scenarios.
A number of changes to the cannabis legal landscape have taken place in Mexico over the past few weeks. For example, the Federal Commission for the Protection against Sanitary Risk recently published on its website guidelines on the sanitary control of cannabis and cannabis derivatives. Further, the Supreme Court issued its fifth decision granting constitutional protection against the adult use prohibition and Congress was presented with a bill to implement the General Law for Cannabis Control.