Introduction
Cofepris, the Federal Commission for Protection against Health Risks in Mexico, plays a vital role in safeguarding public health. Its responsibilities span across an extensive range of products and services, including medications, medical devices, foods, chemicals, and even the quality of water in beaches. However, this broad mandate presents significant challenges for the agency.
Budgetary Constraints
A persistent and pressing challenge for Cofepris is its budget. With an allocation of approximately 700 million pesos, the agency is severely underfunded relative to its responsibilities. Although Secretary David Kershenobich recently indicated that budget constraints had been resolved, no concrete measures have been announced. The financial limitation restricts Cofepris’s ability to hire adequate staff, invest in technology, and fulfill its mandate. A potential solution would allow the agency to utilize the resources it collects, amounting to around 2,000 million pesos annually. This would grant Cofepris greater operational autonomy and flexibility, enabling it to function with fewer restrictions.
Extensive Mandate and Resource Limitations
Cofepris’s mandate is extraordinarily broad, encompassing industries that represent over 13% of Mexico’s GDP. This includes not only medications, medical devices, and foods—typical regulatory sectors like the FDA in the U.S.—but also hazardous chemicals, pesticides, fisheries, and beach water quality. While integral public health oversight, this extensive scope forces Cofepris to perform miracles with limited financial and human resources. Some suggest that Cofepris should concentrate solely on health inputs and foods to optimize its effectiveness.
Positive Developments
There are encouraging signs. For the first time, Cofepris’s head, Dr. Armida Zúñiga, is an expert in the field rather than a political stepping stone as in previous administrations. This shift reflects a commitment to professionalizing the agency. Moreover, an historic agreement for regulatory simplification with the Agency for Public Innovation is underway, aiming to modernize processes and reduce administrative burdens. These measures signal a willingness to enhance efficiency.
Recent Advances and Ongoing Challenges
During the recent AMIIF Innovation Week, Commissioner for Health Authorization Rafael Hernández presented an optimistic overview of regulatory progress. He highlighted strategies to address backlogs, outcomes from working groups, and a commitment to innovation for the sector’s and patients’ benefit. Some sectors are already noticing improvements, such as more efficient response times in certain processes, suggesting that these efforts are bearing fruit.
However, the journey is incomplete, particularly in digitizing processes for managing permits. The Digipris platform initiated during the previous administration left many loose ends. There is an expectation for comprehensive digital transformation, crucial for streamlining operations, reducing paperwork, and increasing transparency—a vital step in preventing irregularities, especially corruption, which continues to haunt the organization.
Corruption and Regulatory Integrity
A recent case involved a pharmaceutical company that was asked for a 5% commission to obtain authorization, with indications that the proposal originated from high-level sources. Such incidents erode trust in Cofepris and impair its regulatory capacity. It is imperative that the commissioner reinforces oversight, implements stricter internal controls, and promotes accountability to combat these practices.
The Challenge of Clinical Trials
In the realm of clinical trials to test new therapies, there is much optimism about promising signs and progress, but cases still reveal the extent of advancements needed. A pharmaceutical company shared a case where a clinical trial protocol was simultaneously submitted to the European Medicines Agency (EMA) and Cofepris. The EMA had indicated a response within five weeks and precisely responded in that timeframe, with the full approval taking three months. In contrast, Cofepris has yet to respond after a year and a half. These delays, though perhaps isolated, continue to frustrate the industry and delay patients’ access to innovative treatments, affecting Mexico’s competitiveness in the health sector.
AMIIF and Healing Wounds
Larry Rubin’s sudden departure as AMIIF’s CEO exposed an uncomfortable truth: his dual roles—leader of the innovative pharmaceutical industry and president of the American Society with a Republican background—were unsustainable. His exit also highlighted disagreements and divisions within AMIIF. Now, Karla Báez assumes the role of acting director, and Julio Ordaz becomes president. He will need to seek some time from AstraZeneca, the British pharmaceutical company he leads, to address matters in his AMIIF role, where the focus is on mending wounds and consolidating unity while a new CEO is chosen—a process AMIIF will undoubtedly handle with great care. Finding a profile that combines technical expertise, strategic vision, and the ability to navigate the complexities of such a diverse, intricate, and competitive sector is no easy task. While U.S. companies will remain key due to their economic weight, European, Asian, and Mexican companies’ growing influence demands equal representation. AMIIF, at 75 years old, has been known for its solidity and experience in achieving results for its represented parties. Now, it must carefully navigate communication with the government, collaborate in regulatory modernization, and promote Mexico as an attractive destination for clinical research.
German Company Launches Innovative Exopulse Molly
The German company Ottobock will launch today from Mexico and for Latin America its Exopulse Molly, an innovative development that uses neurostimulation to assist individuals with disabilities in movement. Designed in 23 ideal sizes for children, adolescents, and adults with conditions such as muscle weakness, spasms, and painful symptoms associated with cerebral palsy (CP), multiple sclerosis (MS), stroke (CVA), or fibromyalgia, Ottobock has been dedicated for 106 years to developing and manufacturing orthotics, prosthetics, and technologies that improve mobility for people with disabilities, as well as high-quality rehabilitation solutions for a wide range of clinical scenarios.
