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Regulatory Convergence Could Benefit Health Services

By Miriam Bello | Thu, 09/22/2022 - 09:28

Q: What are the main areas of expertise for Health Sanitary Consulting in relation to the health industry?

A: We are a consulting firm that specializes in regulatory issues, focusing mainly on technical and business strategy evaluations for goods, services and products for the pharmaceutical, food and beverages industries. We solve the problems that arise during sanitary authorization processes in Mexico and abroad, while also managing procedures for foreign trade and distribution.

The company is composed of multidisciplinary professionals based in Mexico. Our headquarters are in Mexico City but we also have offices in Tijuana and partners in Latin and Central America, which allow us to provide services in many countries, including Costa Rica, Panama, Colombia, Chile, Brazil and Argentina.

Q: How are Mexico’s regulations regarding cannabis use advancing?

A: Health Sanitary Consulting advises companies, investors and startups that want to enter the cannabis market, not only in Mexico but also in Latin America. In Mexico, some important milestones have been achieved since the reform of the General Health Law in 2017 removed an absolute prohibition on the use of cannabis products, opening the door to the use of cannabis for medicinal, research and industrial applications.

After that, the Supreme Court of Justice of the Nation allowed the recreational use of cannabis, although only by those who acquired an individual permit from COFEPRIS. Recreational use, unlike medicinal use, is not regulated by law but it is allowed in special circumstances through jurisprudential criteria.

The regulation for the medicinal use of cannabis was issued in January 2021. It also addresses cultivation for medicinal use but does not include a planting protocol. This law allows the consumption of cannabis products with a doctor’s prescription but does not mention supplements, cosmetics, food or drinks containing cannabis. This regulation also allows the commercialization of seeds that could boost the research and production of cannabis for pharmaceutical purposes. Cannabis can be used for pharmaceutical research but the technical aspects for the analysis and evaluation of these products are lacking.

Q: Where do regulations stand regarding the industrial use of cannabis?

A: The industrial use of cannabis is a complex and confusing area. It entails its use in plastics, textiles and even cosmetics and has been regulated since 2017 through the General Health Law, which expressly says that products with cannabis can be produced for broad industrial purposes as long as the products are aligned with the health regulation and contain less than 1 percent of THC. Despite this statement, health authorities are not following this regulation and companies that want to venture into this market need permission from COFEPRIS.

Regulations have advanced since 2017 but it is still quite difficult to interpret the law. The Supreme Court made an important decision regarding recreational use but the certainty necessary for the market to grow is lacking. Mexico can become one of the largest cannabis markets in the world due to its production capacity if regulations provide certainty for those producers that are trying to leverage the biological and technical value of the plant.

Q: How should regulators respond to the fast-changing requirements of tech regulations?

A: The technological transition is one of the largest the world has experienced in recent years. Alongside the epidemiological and demographic changes, this transition has generated various health challenges. People no longer get the same diseases as they did 30 years ago. The main health concerns of today are chronic non-communicable diseases, such as cancer, hypertension and diabetes. This scenario demands more effective health solutions that require a larger budget. Fortunately, there is a great solution, which is technological development.

The challenge is that the regulatory environment is not aligned with technology development. Health regulation is always a few steps behind the technology. WHO’s Resolution 64, issued in 2014, said that health authorities can contribute to the achievement of global health goals but if regulation does not work efficiently, the authorities themselves become an obstacle. The existing regulatory system is completely misaligned with technology. The necessary technology already exists and regulations should consider their technological aspects and introduce them to the private sector and then to the public sphere. We lack adequate regulation to allow technological developments to generate health benefits.

Q: How can trust and coordination among regional regulatory units benefit innovation and safety in Latin America?

A: There is an underlying issue among Latin American governments regarding regulatory systems, which can be difficult to navigate since they are not always in agreement. Latin American countries have collaborated with the Pan American Health Organization (PAHO) to create trust between regulatory systems and authorities, leading to the generation of institutional models that promote harmonization. For example, the Pan-American Network for the Harmonization of Pharmaceutical Regulation (PARF), which has existed for 20 years, is in charge of promoting communication among regulatory authorities. This network has also driven convergence. Attempts have been made to harmonize all the technical regulations but it has not been possible to harmonize everything in a single document. Regulatory harmonization is feasible but requires a lot of time.

For five years now, regulatory authorities have started to follow the concept of reliance, which is based on their trust of the processes performed by other regulatory authorities. Reliance offers several benefits. For example, Mexico has an authorization process based on reliance to register innovative molecules, which does not require clinical studies if another highly regulated health authority has previously approved them.

El Salvador’s health law allows for faster processes for molecules with a health registry issued by reference authorities in Latin America. The world is moving toward regulatory convergence. Some international organizations are privately contemplating the convergence of regulations. This is the main objective of the Latin American Association of Professionals in Regulatory Affairs (Aló ProCiencias), which seeks to promote regulatory convergence, reliance and technical knowledge in regulatory matters. It also provides training and meets the pharmaceutical industry to discuss these matters. Aló ProCiencias is also a member of the US Pharmacopeia (USP). We are open to membership regardless of profession and our main objective is to reduce this gap in knowledge.

Q: In 2020, COFEPRIS became part of the Deputy Ministry of Prevention and Health Promotion. How has this affected its operations?

A: When health authorities have technical autonomy, they can make decisions based on science and not on politics. However, health authorities are government offices and must align with the government despite their autonomy. In healthcare, authorities play a relevant role as regulators but governments must be able to make decisions regarding health without having to negotiate with an independent organization.

The technical autonomy, processes and legal nature of COFEPRIS were not transformed or eliminated. COFEPRIS continues to be a decentralized body of the Ministry of Health with technical, operational and administrative autonomy for decision-making, in accordance with the General Health Law. What changed was that now the head of COFEPRIS reports directly to a deputy minister.

 

Health Sanitary Consulting is a strategic consulting firm that specializes in regulatory policy in Latin America and operates in 13 countries in the region.

Miriam Bello Miriam Bello Senior Journalist and Industry Analyst