Mexico Health Review spoke with Alejandro Luna, Partner, and LifeSciences Co-Chair at Olivares on the local and international regulatory environment of the health industry.
Q: What is the most common profile of the companies you work with?
A: A significant percentage of our clients in the firm’s life science group are in the pharmaceutical industry. Our portfolio in this field specializes in the most common needs of the industry, such as patents, trademarks and copyright cases, but we also offer protection for clinical data. Our extensive expertise in life sciences allows us to work with companies not only in the pharmaceutical industry but also in the medical devices, cosmetics, food and beverages and agrochemical industries.
Q: How would you describe the existing regulatory environment for innovative products like biomedicines?
A: Our legal and regulatory system created the opportunity to have the products and services we find today in the industry but there is also a growing need to refresh these rules. The regulatory system must take into account different types of innovations and the protection of
intellectual property. Also, it must adapt to the digital era to help make the new technologies, biological innovations and the patient-centric approach more effective.
Q: What impact will CPTPP have on IP in relation to pharmaceutical products?
A: It has been 24 years since the current IP law was introduced. In general terms, the legal environment is positive for the pharmaceutical industry because there are minimum international standards to protect IP in Mexico but the country needs to improve the level of protection and
legal certainty. At the national level, it would be good to include in the CPTPP the possibility for Mexico to improve its standards, legislation and IP practices. At the regional level, the durability of IP protection in North America must be aligned. Finally, at the international level, it is necessary to synchronize the most recent IP protection protocols.
Q: What are the main challenges faced by pharmaceutical and medical devices companies when they want to introduce a product in Mexico?
A: In Mexico, there is still a certain amount of uncertainty about the timing and the outcome of some proceedings and pharmaceutical and medical devices companies tend to invest large amounts of money and time on consolidation. The government needs to provide more certainty about
the timing and merits of the cases to be decided by administrative and judicial entities to encourage companies wishing to do business in Mexico.
Q: What are the main lessons related to patents that Olivares has learned in its almost 50 years of history?
A: Technological development advances faster than legislation, a gap that inhibits the full growth of the country’s pharma industry. There is a need to understand the pharmaceutical sector as an industry of compliance. Keeping this in mind helps to understand how the patents in the healthcare sector are compatible with legislation, processes of change and the needs of the industry
Q: How is the local and international regulatory environment affecting international companies’ perception of the Mexican market?
A: The uncertainty caused by the renegotiation of NAFTA removed life sciences from the agenda and at the same time key negotiations like the protection of clinical data and IP. International companies are also kept in abeyance because our main support mechanisms are being renegotiated and current protection protocols are not updated enough to meet market needs.
Q: What are the main areas of opportunity that Olivares sees in the industry in 2018?
A: We see the possibility to protect the industry through mechanisms like CPTPP and a renegotiated NAFTA. Also, we see the opportunity to elevate the system of regulation in Mexico. If Mexico discovers how to benefit from these international agreements, a boom in the pharmaceutical industry will become a reality
Olivares is an IP law firm that works with some of the world’s biggest brands. It specializes in areas such as patents, trademarks, copyrights, regulatory, administrative and constitutional law. It has nearly 50 years of experience
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Industry Analyst and Journalist at Mexico Business Publishing