Technology is developing rapidly and it generally takes the legislature years to catch up. This is particularly true in the healthcare industry, where regulations are struggling to keep up with the development of health-related technology. This situation has put Mexico in a difficult position. On the one hand, health-related technology is widely available to the general population. However, Mexico also faces numerous challenges, as it cannot quickly and efficiently regulate the use of emerging technologies.
It is a basic constitutional principle that no activity or product can be restricted or limited unless a legal provision establishes such restriction or limitation. This principle has resulted in a number of legal gaps regarding products and activities of a technical nature, as Mexican law is rarely as dynamic as technology and innovation. One of the most visible technological advances has been in the software and app arena, particularly with regard to healthcare. This has led to a challenging situation for the health authorities.
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.
Numerous laws and regulations govern the import and marketing of medicines and medical devices. In addition to purely regulatory and health-related requirements, a number of provisions which govern import procedures and products in general must be observed. Most importantly, parties which intend to market a medicine or medical device in Mexico (whether imported or manufactured domestically) must obtain the corresponding marketing authorisation from the health authorities.
Traditional medicine is still a primary health resource for millions of people who do not have access to so-called 'modern medicine'. However, traditional medicine and knowledge are not covered by the general legal provisions which govern human health or specifically recognised by the Mexican health authorities. In some cases, traditional medicine has even been deemed illegal and attempts have been made to outlaw its practice and promotion.