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EF: What is your role as commissioner of COFEPRIS? What are COFEPRIS' current priorities concerning health standards and regulations in Mexico?
PQ: I have been the Health Promotion Commissioner for a year. My area has three main functions; we are mainly in charge of sectoral liaison since we are the first point of contact with the companies. COFEPRIS defines what type of interaction it has with the company, discusses investment projects, and future projects for plant openings and gives indications on the regulatory path to follow.
We are also responsible for training the productive sector. Because regulation is extremely complex and lively, training is always necessary, even for experts in the field, and we must have different strategies for communicating changes.
Finally, we support industrial promotion, since COFEPRIS' activities and work plans must be aimed at promoting the sectors we regulate.
Based on our responsibilities, we have different strategies to improve communication and interaction between the productive sector and COFEPRIS. Mexico has managed a dynamic and highly diversified trade compared to other Latin American countries, but the pharmaceutical industry has been negatively affected. We have lost sovereignty and productive capacity despite the pandemic teaching us the importance of health self-sufficiency.
We are addressing several issues, such as the administrative backlog, the lack of regulatory updates and the limitations in access to generic and biosimilar drugs. To address these issues, we have decided to implement an initiative called "Regulatory Certainty Strategies". This initiative is broken down into an umbrella covering the pharmaceutical sector, medical devices and biosimilars. Our regulatory strategies and philosophy are in line with WHO and NGO recommendations for better communication and interaction between the parties and aim to increase the therapeutic offer in the country and provide investment conditions for the economic development of the productive sector. This plan includes the adoption of international standards to increase confidence in the decisions of the health authorities and streamline processes in Mexico. The importance of political willingness and commitment to carry out this agenda is emphasized.
In addition, technical barriers are being eliminated, simplifying procedures for companies and establishing effective channels of communication between regulators and regulated parties to provide the necessary clarity.
EF: If a unified regulatory ecosystem is achieved in the region, what role would COFEPRIS and Mexico play?
PQ: We are not a passive agent or waiting for others to make the decisions; our approach is to promote communication and collaboration between agencies, as announced by the Federal Commissioner, Dr. Alejandro Svarch. We have a region with a great productive capacity and talent in pharmaceutical companies that stand out for their work. Yet, despite this, we do not supply or trade with each other, and our supply chains are disjointed.
Our region has a high demand for pharmaceutical supplies, but regulatory barriers prevent us from trading. For this reason, we are promoting the project to create a Latin American agency for drugs and medical devices. We are responsible for carrying out the first step of this project, which consists of the creation of the Regional School of Health Regulation (ERRS).
EF: Considering the importance of digital technology and AI worldwide, could you elaborate on the evolution of digitalization in Mexico and how it will affect COFEPRIS operations?
PQ: Considering the size of our economy and COFRPRIS's importance in the region, it is inconceivable that the health agency is still not digitalized. As a result, there is a lot of downtime in administering and mobilizing the medication dossiers and the lack of digitalization increases our mistakes. There is a firm intention to digitalize but with a regulatory optimization logic (bureaucracy cannot be digitalized). In parallel with digitalizing, we must improve the regulatory framework based on risk-based decisions. For example, the extension of medicines is a payment of rights, giving us the first major deliverable. In Singapore, a company pays and has its registration extended; in Mexico, every five years, we re-evaluate the pharmaceutical product as if it had never existed, creating permanent administrative cycles that can affect the supply because the product cannot be manufactured or imported in that period. We plan to digitalize and only evaluate the first extension. We will take care of the constant sanitary surveillance and review the correct operation of the manufacturing sites. If everything is in order, it will be extended and no longer be an administrative procedure.
We are currently in the process of digitizing and optimizing modifications to the conditions of registration, known as post-approval modifications. Inspired by the European Medicines Agency (EMA) model, we have established three categories based on the level of risk (minor, moderate and major modification). Moderate and minor modifications are handled automatically, functioning as notifications to the agency. In these cases, only the necessary technical modifications are evaluated. Although we have not yet completed the digitalization of all procedures, we estimate that, once completed, it will allow us to reduce up to 60% of the administrative burden.
EF: What would be the three key points for a roadmap to grow the industry and bring more investment to the country?
PQ: There are two pending issues that should be a priority for future administrations. First, Mexico urgently needs a national pharmaceutical policy that covers aspects such as innovation, quality assessment of pharmaceutical products and improvements in their distribution.
Secondly, it is essential to build an industrial pharmaceutical policy that oversees the supply chain. Currently, Mexico imports approximately 80% of its pharmaceutical raw materials, which makes us less competitive. For example, compared to Brazil, our medicines are more expensive due to the lack of sovereignty in this aspect. To grow the pharmaceutical sector and reach self-sufficiency we have to work beyond regulatory issues, look at fiscal stimuli, the creation of free zones and even tenders go above the criterion of sovereignty and price because it is a national security issue. We will never be as competitive as India, which is a major supplier of raw materials; however, we must consider sanitary sovereignty as a fundamental value, even if it means paying more to have control over our own raw materials.
EF: Does COFEPRIS offer incentives to promote Mexican development?
PQ: In our work related to clinical research, there are two important issues on the agenda.
First, improving clarity in requirements and procedures for clinical research evaluation. The lack of transparency in the process leads to companies submitting incorrect or insufficient documentation, resulting in poor evaluations. It is crucial to close these gaps and provide clear and accurate information to improve this aspect.
The second is to optimize authorization time since competitiveness in clinical research is linked to approval time. For example, Argentina implemented a science and technology law that streamlined product approval times, allowing approval times of only forty-five days. We aspire to achieve the same, providing regulatory certainty through faster and more efficient approval times.
EF: How does COFEPRIS collaborate to generate a positive impact and promote sustainable structures in Mexican health?
PQ: The issue concerns us, and we are constantly looking for a way to participate; “less desk and more territory,” as our president says, although it is complicated to bring health regulation to the people. In emergencies, COFEPRIS is always present, preventing health risks. After Hurricane Otis in Acapulco, we immediately detected the threat garbage posed and launched a campaign; we also warned the population about vector-borne diseases.
This administration has carried out initiatives to support small producers of food, alcohol, and different cosmetic products so that the producer understands the regulation and that their manufacturing site complies with the regulated minimum and is in conditions of economic development to sell or even export. The regulatory framework can be complicated, and we must teach efficiently.
It has been a year full of learning, marked by the promotion of a change management vision in COFEPRIS, with the objective of turning it into an investment promoter. For the future, it is essential to maintain this momentum and ensure continuity. The best strategy to achieve this continuity is to involve the productive sector in the projects.
EF: Is there a final message you would like to share?
PQ: The best way to improve COFERIS is to believe it is not a government institution but an institution for all the stakeholders of the health industry ecosystem.
