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

Global View, Digital Resources for New Challenges

Wed, 09/06/2017 - 10:15

Q: How is Baker McKenzie helping clients overcome new challenges in the Mexican market?

Being a global law firm enables us to quickly identify major industry trends, giving us the opportunity to dedicate resources to create quite early high-value projects, such as our digital health initiative, where we integrate key areas of legal service such as health regulation, information technology and privacy law.

We have also embraced technology and have developed useful mobile apps for our clients, such as our Global Healthcare MapApp and our Global Antitrust Dawn Raid App. The MapApp is a mobile application that provides access to real-time information on the laws and regulations impacting the healthcare industry in more than 40 countries. MapApp also provides users with the contact details of Baker McKenzie’s healthcare specialists, which makes it an invaluable tool for healthcare companies that need quick access to information. Dawn Raid provides clients across 44 countries that are experiencing a raid with real-time step-by-step guidance on their rights and obligations, as well as instant access to Baker McKenzie’s antitrust lawyers. The app is a cutting-edge platform that provides practical assistance and peace of mind for individuals on the ground handling unannounced inspections. It answers a range of practical questions on a country by country basis under local law. The Antitrust Commission in Mexico has increased its activities and oversight of the healthcare markets with several ongoing investigations and the adoption of the first criminal action in the country.

Q: Many regulatory agencies speak of homogenization of Mexican law and regulations with US and EU laws. To what extent is this possible?

A: We have a lot of experience comparing different regulatory frameworks. For instance, we were commissioned to conduct a broad study comparing the health regulation for medicines in the EU and in Mexico. This was funded by the European Commission and formally delivered to COFEPRIS. However, on a regular basis we also prepare webinars comparing regulation in different jurisdictions using our experts from different regions and multijurisdictional surveys on specific topics.

The main lesson is that health regulation is not harmonized at the international level, as every country has different rules. There is not a body of international treaties on health law. That is why the negotiation of certain international trade treaties has attracted so much interest. First the Pacific Alliance (PA) and then the Trans-Pacific Partnership (TPP) pioneered an international law approach where health law was incorporated into the disciplines of international trade law. This represents a new avenue to pursue what is now being called regulatory convergence and may constitute the new way to approximate the regulatory frameworks of different jurisdictions. Of course, this normative development was impacted by certain decisions of geopolitical impact such as the withdrawal of the US from the TPP. However, the approach is likely to remain for future negotiations. It will also depend on the success of the PA in this regard.

Q: What are the main legal challenges faced by foreign companies looking to invest in health in Mexico?

A: One of the main challenges would be to navigate the rules for holding regulatory approvals. This aspect varies for different products and creates constant misunderstandings among advisers not familiarized with health regulations. This has a great impact on M&A transactions. The best practice is to include in full the regulatory component within the scope of the supported transaction, from the initial due diligence process to the planning process and its implementation.

Q: What regulatory challenges will most impact the industry in 2017/2018 and how?

A: Developments are expected in the areas of access to public formularies, prescription-review mechanisms in public institutions, transparency on interactions with healthcare professionals, digital, personalized medicine and biotech products. At the same time, we have seen increased oversight of the industry from the tax and antitrust authorities.