Introduction
In the labyrinthine web of Mexican public administration, there are entities whose work, though technical and seemingly distant from the common citizen, profoundly impacts quality of life and economic development in the country. One such entity is undoubtedly the Federal Commission for Protection against Health Risks (COFEPRIS). This organization, responsible for the safety and efficacy of a myriad of products and services—ranging from foods and cosmetics to pesticides and, crucially, healthcare inputs—faces pressing challenges that demand a structural overhaul.
COFEPRIS Under Scrutiny
It’s no news that COFEPRIS has been under the microscope in recent years. Delays in medication and medical device approvals, lack of transparency in certain processes, and a perception of inefficiency have raised concerns within the industry and medical community. However, the debate should not solely focus on pinpointing areas for improvement but propose concrete and bold solutions that enable this vital institution to fulfill its mandate effectively.
The Case for Regulatory Strategy Separation
An idea gaining traction among specialists warrants priority attention: separating the regulation strategies for healthcare inputs from the other sectors currently overseen by COFEPRIS. This proposal, far from being a simplistic measure, is grounded in the inherently distinct and critical nature of medications, vaccines, medical devices, and other essential elements for public health.
Regulation’s Critical Role
As Svarch et al. (2024) argue in their recent article, regulatory healthcare serves as a fundamental safeguard for public health, ensuring that these inputs reach the population with required quality, efficacy, safety, and accessibility.
Distinct Regulatory Needs
The magnitude of this need becomes clear when recognizing that regulating a dietary supplement or cosmetic product, however significant, operates under a different logic than a life-saving medication or medical device for critically ill patients. Response times, the depth of scientific evaluation, specialized knowledge requirements, and social sensitivity surrounding healthcare access demand a dedicated regulatory approach.
Current Challenges
COFEPRIS currently grapples with harmonizing supervision of vastly disparate sectors. While this aims for administrative efficiency, it can create bottlenecks and dilute specialized attention required in the healthcare inputs domain. Human resources, technical proficiency, and operational processes needed to assess a new pacemaker’s safety and efficacy differ significantly from those required for analyzing personal hygiene product composition or pesticide toxicity.
Regulatory Delays and Inconsistency
The challenge of evaluating new registrations cannot be postponed any longer, given what each administration faces: inherited backlogs. These products are vital for expanding medication access, a crucial factor in our country. Moreover, Mexico’s medication approval times are excessively long when compared to other nations, negatively impacting the availability of innovative treatments for Mexican patients.
Variability in Regulatory Outcomes
COFEPRIS’s regulatory outcomes show variability, with inconsistent evaluation criteria even within International Council for Harmonisation (ICH) projects. While steps have been taken to rectify this, such as creating a committee for good regulatory practices, continuous action, greater transparency, and most importantly, consistent evaluation requirements in pharmaceutical regulation are needed.
Strategic Separation: Benefits and Considerations
This proposal does not imply dismantling COFEPRIS entirely. The commission could maintain its valuable regulatory work in other sectors, strengthening its capabilities and tailoring processes to each sector’s particularities. It would be more of a strategic division allowing for greater specialization and, ultimately, enhanced public health protection.
Potential Costs vs. Benefits
Some might argue that creating this separation in operational approaches would generate additional costs and administrative redundancies. However, it’s crucial to weigh these potential drawbacks against the tangible benefits of a more agile and efficient regulation of healthcare inputs. Delays in medication approvals not only directly harm population health but also negatively impact the innovation and competitiveness of the national pharmaceutical sector, as previously discussed on the need for a healthcare inputs policy and its resulting direct investment.
Strengthening COFEPRIS
To ensure COFEPRIS functions optimally, it’s crucial to bolster its autonomy and ensure it has a budget commensurate with its responsibilities. The institution should not be overburdened by its functions, nor should its operational capacity be weakened by insufficient resources—especially financial ones.
Resource Management and Delegation
COFEPRIS generates more revenue through payment fees and/or processing charges than it receives from the Federal Economic Contribution (PEF), with a significant delay in resource availability. Therefore, it’s essential that the commission have access to and control over these generated resources for fulfilling obligations acquired after payment of such charges. This dual-source financing should be a priority in reforms to enable COFEPRIS better structuring and acquiring necessary technological and human resources.
Key Improvement Areas
In this context, process improvement, governance, and transparency become fundamental pillars. It’s imperative to develop a risk-based evaluation model that is efficient, consistent, and transparent; optimize processes; simplify evaluation rules; and standardize COFEPRIS’s evaluation model.
Digital Transformation
Digitizing processes and adopting Information and Communication Technologies (ICTs) are indispensable tools for modernizing the institution and making it more agile. Furthermore, strengthening governance through a mixed advisory council involving all relevant health ecosystem actors is crucial.
Conclusion
Regulatory healthcare is a fundamental safeguard for public health. Therefore, strengthening COFEPRIS and its focus on ensuring safe and effective medication access is essential for the population’s well-being.
*The author has 25 years of experience in the Mexican and Latin American health sector and is a founding partner of a consultancy focused on public policy analysis in health, digital health, and sustainability.
