Opportunities Abound in Mexico’s Life Sciences SectorThu, 01/21/2021 - 13:58
Q: What is the scope of Sánchez Devanny’s work in the healthcare sector?
A: We work with all industries regulated by COFEPRIS so our clients include pharmaceutical companies (both innovators and generics), medical device manufacturers, technology companies venturing into the healthcare sector, for example through telemedicine, CROs, hospitals and companies that provide laboratory analyses. We also offer consulting regarding government procurement processes, as the main provider of health services in Mexico is the government (both federal and state level). Many legal issues often arise when selling medications or medical devices to the government and we advise manufacturers when purchasing problems arise. While we do not do regulatory submissions, we advise on the process.
We also deal with import issues and with crossover IP and regulatory matters, such as approval of brands for life sciences companies. We work with the tobacco and vaping industries, advising them on local regulatory issues, for example in challenging COFEPRIS’ recent position against vaping devices. We also have important clients in the cosmetics sector, which we support on labeling and consumer protection issues.
Q: How is Sánchez Devanny contributing to the development of local regulations concerning the life sciences sector?
A: In addition to addressing the specific needs of our clients, we participate in several industry chambers and committees where we help shape policy decisions in Mexico. We work both on what is best for the industry and on the specific case in front of us. We have been fortunate enough to participate in many cases that have changed the legal landscape in Mexico. For example, we participated in the initial lawsuit that led to the recognition of clinical data exclusivity based on NAFTA and later on USMCA. These types of cases have greatly supported innovative companies in securing protection for their products.
Q: What opportunities do you see in the recent regulations regarding cannabis products?
A: Cannabis finally moving forward in Mexico, in great part thanks to the litigation process, but a significant threshold was reached this month with the issuance of the Regulations associated to health products containing cannabis derivatives. We are also waiting to see the final version of the law, which will regulate adult use. The Senate already passed it but we are still waiting for Congress to approve it. Once cannabis is legalized, there will be significant opportunities for local and international companies in this market.
There are many different potential players in the cannabis market, from large multinational companies small stores and farmers. The main challenge for local companies is to fully understand the law, its implications and the possibilities it brings. As long as the rules are clear, there is an opportunity for everyone to participate.
Q: How are the recent changes in government procurement processes affecting the Mexican healthcare sector?
A: Recently, there have been significant changes in the government’s procurement processes as local authorities are now working directly with UNOPS. It is still to be determined how this situation will evolve but it is creating a great deal of noise in the pharmaceutical industry.
The government is negotiating contracts with companies that have no regulatory approvals in Mexico. I do not believe this is the best policy, to be honest, as the government must ensure that all companies participating in the Mexican market adhere to the same regulatory standards and policies. These regulatory changes are forcing Mexican companies to work extra hard to compete.
Q: What measures should be taken to strengthen the role of local regulators?
A: It is necessary to pay greater attention to COFEPRIS, which has been underfunded for the past year, and to clarify and strengthen its role as an independent regulator. COFEPRIS should be at the same level as the regulatory agencies of major powers in the world such as Europe, the US, Australia and Canada. A strong regulatory framework and regulator can ensure the industry has a good combination of multinationals and strong national companies.
Q: What sets Sánchez Devanny apart from other legal firms working in the life sciences industry?
A: We offer our clients a very unique combination of attorneys with experience working at large multinational companies and those developed in our law firm. We can also offer advice that goes beyond a singular contract or patent application. We consider how the government and the industry are seeing these types of contracts. This combination puts us in a unique position to support life sciences companies.
Q: How can local regulations concerning IP in the life sciences sector improve to strengthen the industry?
A: Mexico has a very strong internal IP framework developed in part after dealing with the US so much. The legal framework is there but enforcement could be better. Not just in pursuing counterfeiters but in ensuring that when compensation is awarded, it can be collected quickly. There was a change in the law last year but the framework is not yet where it needs to be and it is still necessary to continue working in this area.
Q: What other opportunities do you see in the Mexican market?
A: There are significant opportunities regarding COVID-19, clinical trials for vaccines and other areas in the respiratory sector. COVID-19 insurance is also gaining strength in Mexico and abroad. Our priorities for 2021 concern the procurement process with UNOPS, distribution of medical devices, cannabis regulations and the evolution of vaping and tobacco regulations.
Sánchez Devanny is a Mexican law firm that works with Mexican and international companies in the life sciences, energy, automotive, retail, real estate and manufacturing industries.