Smoothing the Import Process

Q: What main issues has Jones Day noted in the Mexican healthcare industry?

A: It is important to consider that modifications to sanitary registrations require the consent of the rights holder. It is common for Mexican distributors to become the owners of such registrations, which on a day-to-day basis protects them from contract infringements. This makes it difficult for international manufacturers or sellers to claim their rights in a dispute and thus the Mexican holder of the registration that breached its commercial responsibilities has a clear advantage in any possible conflict. Therefore, foreign companies must think carefully about how to structure a contract before coming to an agreement with a Mexican distributor

A matter for concern is that Mexican legislation lacks a clear mechanism for approaching the authorities about how to resolve doubts on the interpretation of regulations. If sanitary regulations established certain steps to approach the authorities in good faith in such cases, this would in all likelihood lead to an opportunity to improve the relations between authorities and manufacturers or distributors of healthcare products and to improve the authorities’ surveillance.

Q: What does COFEPRIS need to do to improve this situation?

A: In general, there are many discrepancies in the application of regulations. We also believe that better access should be provided to communicate with the decision-making authorities. Additionally, the pharmacopeia is not yet published in the Official Journal of the Federation, despite it being the official support of COFEPRIS’ actions for medicine approval procedures. We believe that there are procedures not included in the law. For example, there is no clear regulation on advertising alcoholic beverages in certain places or on advertising tobacco in duty-free shops for certain events.

Q: Despite these issues, foreign companies still want to come to Mexico. What is driving international investment?

A: The Mexican population is over 120 million and its purchasing power is growing. We are also a neighbor to the largest producer of medicines and patent-holders in the world while the medical devices manufacturing industry has grown enormously and is located close to the border. Therefore, Mexico represents a great opportunity for foreign investment. During these times of uncertainty, it helps that we are a global firm with a large presence in the US and we have broad knowledge of its commercial regulations. We can provide our clients with up-to-date information and we also accompany them through the regulatory changes and the industry’s evolution.

Q: What opportunities does homogenization between the FDA and COFEPRIS bring to the industry?

A: These homogenization opportunities became possible through an agreement signed in October 2012 that allowed faster healthcare registration of American products. COFEPRIS has replicated this procedure with Health Canada and through other agreements with South American countries, which makes the process faster for medicine and medical devices. Authorized third parties are not included in this process for medical devices. The inclusion of these institutions is positive, but there should be room for accommodating more institutions, otherwise it becomes a monopoly. They should standardize requirements and there should be more players.

Q: What is the added value Jones Day offers that similar firms in Mexico cannot?

A: We have over 2,500 lawyers in 44 locations worldwide. We have great depth in the US and our clients are some of the largest laboratories in the world. We are truly one firm worldwide, which ensures a seamless communication across jurisdictions and shared experience and knowledge with practice leaders and healthcare regulators across the world. The lawyers also receive continued education and we share knowledge and experiences among our offices. Most international firms have local offices and they are not coordinated.