Christian López-Silva
Partner and Head of Healthcare and Lifesciences
Baker & McKenzie
/
View from the Top

Gaps in Regulation, Digital Health, Cannabis

Tue, 05/18/2021 - 18:52

Q: How were gaps between international and local health laws evidenced during the COVID-19 crisis?

A: Until recently, international treaties did not address matters of health because the area was considered to pertain to national sovereignty. This changed after NAFTA and the new treaties, such as CPPP and USMCA, which have included health issues, mainly through regulatory chapters. Therefore, local law is losing ground to international law regarding health matters.

COVID-19 highlighted that although regional manufacturing chains in the US and Mexico have been linked since 1994 through NAFTA , health law is not harmonized. There are no regional mechanisms to align decisions. The US identified certain industries as essential while Mexico identified others as such, which resulted in companies with presence in both countries operating in one and not the other, breaking the supply chain.

 

Q: What regulatory priorities should authorities have in mind regarding digital health and where should these regulations focus?

A: Telemedicine is one of the greatest areas of innovation within digital health and there is much to be done to regulate it. The legal framework is not ready to manage telemedicine because the framework being used now was created to regulate the remote service of pharmacies, which only includes rules concerning offices with provisions to provide consultations through mobile devices.

Another area are mobile applications, particularly medical apps. In the US, FDA regulations are different for each type of application, with wellness apps at one end and health solutions for diagnosis and treatment at the other. In Mexico, regulations are not clear. We have definitions of medical devices that could cover mobile applications but a problem then arises: the app is software and the question of whether software can be classified as a medical device remains unanswered.

Moreover, the previous administrations did not create regulations that provided medical apps with a health registration, so there is poor control over apps that could be considered medical devices and no accountability to ensure that users are not at risk. This administration seems to want to start regulating them and there is a draft for a Mexican Official Standard (NOM) that provides a definition of Software as Medical Device, which could provide more clarity.

Q: How are current regulations supporting or hindering the implementation of electronic clinical records?

A: Physicians have an obligation to generate and maintain a clinical record. The data in the clinical record is personal and concerns healthcare, which makes it sensitive. As such, it follows stricter confidentiality regulations. The electronic clinical record has a specific standard focused on interoperability to allow different platforms to be homologated and to make the file portable. However, because the data is sensitive, there are many protections that the platform has to implement to establish its electronic medical record. The locks have complicated interoperability. There are already multiple clinical records in place and many physicians are already using them even though the platforms are not necessarily compatible with one another. So, the conclusion is that regulation is not keeping up with the current problems.

Q: What do the recently proposed regulations tell the industry in terms of expanding a medical cannabis market?

A: The subject of cannabis is very broad. It has three general uses: recreational, therapeutic and industrial. It can also be divided according to its derivatives: THC, which provides the psychoactive effect, and CBD, which does not have this effect. Therapeutic and recreational use focuses on THC and industrial use on CBD. The latter has a more interesting market in terms of consumer products and is the least regulated.

There are already regulatory provisions for recreational and therapeutic uses but there are no clear regulations regarding industrial use. This is where there is a great commercial opportunity.