Demanding Commitments from Regulatory Authorities

Q: What health opportunities could homogenization of the rules between the US, Canada and Mexico bring to Mexico?

A: Regardless of what happens with NAFTA, it is necessary to accelerate and unify the sanitary requirements between Mexico and the US. Mexico should expedite the procedures to adhere to international laws that provide access to more modern medical devices and drugs and COFEPRIS must rely on the verification and authorization capacity of other countries and recognize the lack of budget and capacity to carry out international inspections.

Q: How does the lack of up-to-date regulations affect topics such as telemedicine?

A: It creates uncertainty with regard to potential health solutions providers because having to contact the authorities to resolve questions not covered in the regulation is inefficient and is not beneficial for the industry. There are also contradictions in the law; for example, the definition of “biotechnology” in the General Health Act is different from that in the specific act, which means that the authorities have created more uncertainty. The concentrated workload, the lack of budget and the rigidity in COFEPRIS’ processes distract attention from areas of improvement.

Q: What are the most urgent changes that you would carry out in the current health regulation?

A: The first thing we must do is consider what modifications are essential to improve the access to modern drugs and medical devices instead of creating last-minute solutions or patching each problem. Second, allow health industry manufacturers to self-evaluate with the support of an authorized third party. In this way, the sanitary authority can focus on topics like illegal products or the black market, instead of dealing with bureaucratic formalities. Last but not least, simplify all COFEPRIS formats.

Q: What tools can the sector use to demand better performance from sanitary authorities?

A: The sector must begin to create a culture that restricts the discretionary power of the health authorities. This means limiting the power to assess fines and the processing times of COFEPRIS through challenging administrative decisions taken without proper legal grounds via the legal system. Today, players are afraid to move these issues to court, but this would help improve the service.

Q: How do authorized third parties contribute to the simplification and modernization of product inclusion?

A: They have had a positive impact, but the goal should be to make them less necessary through administrative simplification or to commit to increasing the number of authorized institutions permitted to compete against each other.

Q: How does Jones Day assess competitiveness in the Mexican healthcare industry? What are the main concerns of your clients?

A: The Economic Competition Commission is beginning to see obstacles in the healthcare sector. They are seeing that the excessive regulation in terms of health is an obstacle to free competition. Nevertheless, the view on competition issues remains macro and they have not yet found the right way to address the required amendments on a detailed basis.

Q: What are your foreign investment forecasts for 2018?

A: Investment will be aimed at service providers, such as hospitals, medical device manufacturers and generics laboratories. In addition, the medical tourism market is also becoming attractive. However, there are obstacles like bureaucracy. The regulation is complex, discretional and highly formal, which ends up restricting access to a better and wider range of healthcare services. Mexico needs to establish clearer regulations to increase investment. One of the most frequent requests from institutions is the establishment of clearer rules and conditions for tenders in the healthcare industry.