STORY INLINE POST
Q: What is the scope of Ortiz & Ramírez Abogados’ services in the healthcare industry?
A: Ortiz & Ramírez Abogados mainly focuses on IP law and regulations. In the pharmaceutical sector, we focus on clinical data concerning IP law and regulations, including the enforcement and creation of patents and brands. Ortiz & Ramírez Abogados has successfully operated for 21 years in this sector and this year, we want to fully penetrate the regulatory segment and to continue growing in IP protection.
Q: What opportunities will emerge for the Mexican pharmaceutical sector following USMCA’s implementation?
A: USMCA includes a clause that reinforces the period during which generic manufacturers can study the product before its patent expires. This allows the industry to study these products for longer, facilitating their entrance to the Mexican market. This clause will not affect innovative companies as the patent remains fully protected. While some might believe that studying products before the patent expires violates the rights of patent holders, import laws that will be introduced and USMCA will prevent any issues. The generics industry will only be able to import enough quantities for research, not for commercialization. The law will be introduced in November and after that, COFEPRIS and IMPI will have three to five weeks to generate the procedures that will regulate this in Mexico to prevent the violation of IP rights.
Q: How has COVID-19 affected regulatory processes and demand for regulatory services?
A: The COVID-19 outbreak forced COFEPRIS to limit the regulatory processes it handled as an early outbreak within the institution forced it to close its offices and operate remotely, receiving documents only through mail. These circumstances led COFEPRIS to focus its actions on those products that could mitigate the impact of the outbreak, such as sanitization products, while other standard processes were paused. Moreover, this adds to last year’s halt in regulatory approvals, furthering worsening timelines for the approval and renewal of permits for all non-COVID-19-related products.
During this period, counterfeiting of medical supplies such as face masks has worsened due to the increase in demand and COFEPRIS’ reduced regulatory and oversight capabilities. Also, due to the outbreak, we are seeing an increasing interest in health prevention, especially in the medical devices sector, which has ramped up its efforts to innovate and to protect its IP rights.
Q: Once a COVID-19 vaccine is developed, what can we expect in terms of its regulatory approval?
A: Efforts to develop a vaccine for COVID-19 and the will to make it available to as many people as possible are leading researchers to be very open with this information. Moreover, several international treaties are encouraging free access to information on the vaccine to make it available as soon as possible. For instance, Mexico recently reached an agreement between the University of Oxford, AstraZeneca, the government of Argentina and Mexican company Liomont that would allow Mexico to distribute the COVID-19 vaccine throughout Latin America. Mexican companies like Liomont are heavily investing in technology and innovation to remain competitive and increase access to healthcare services. This agreement was achieved in part thanks to the Carlos Slim Foundation, which facilitated the agreement between all parties.
Q: What new challenges and opportunities are being generated by the new labeling regulations concerning food and beverages?
A: Ortiz & Ramírez Abogados worked on the development of NOM-051 that regulates the new labeling guidelines for food and beverages. While some see the new guidelines as a problem, it is in fact a significant opportunity as it empowers individuals to make better decisions on what and how much they eat. It will allow companies to redirect their product lines and marketing practices to new markets and consumers. We see this regulation as an opportunity for companies to develop new communication, products and marketing strategies.
Another important area that urgently requires regulation are cannabis products as they represent an opportunity for the generation of new business lines for all companies. The creation of comprehensive and clear regulations will ensure that companies have certainty and ability to operate in this market.
Q: What can Mexico’s pharmaceutical industry expect from the government’s plan to purchase medications through the UN?
A: This is a highly contentious topic that is generating uncertainty among Mexican companies. The government wants to acquire medications from international sellers but local regulations specify that they should be acquired from local suppliers. While the sector and CANIFARMA are reviewing the legality of this move, Congress has approved it and generated legal support for this manner of acquisition.
Another problem will be distribution of medications, as existing distribution strategies were thrown into disarray when the López Obrador administration decided to sideline distributors and buy directly from manufacturers without putting the necessary measures in place. The government is trying to fix this by creating its own distribution processes but this measure was taken only after the damage was already done. These actions indicate that the government is not fully aware of the challenges and requirements that must be undertaken to safely distribute medicine.
Ortiz & Ramíirez Abogados is a legal law firm that manages trademarks, copyright, administrative law, anti-counterfeiting and regulatory affairs for the pharmaceutical, chemical, biochemical, mechanical and computer industries