Mikel Andoni Arriola Peñalosa1, Ricardo Cavazos Cepeda1, Mario Alanis Garza2, Murray M Lumpkin3. 1. 1 Instituto Mexicano del Seguro Social (IMSS), Ciudad de México, D.F., México. 2. 2 Comisión Federal para la Protección contra Riesgos Sanitarios, Ciudad de México, D.F., México. 3. 3 The Bill and Melinda Gates Foundation, Seattle, WA, USA.
Abstract
BACKGROUND: Medicines regulators, while performing a vital public health activity, are often perceived as both negative cost centers for governments and as impediments to innovation and economic development. The Mexican government recently undertook a regulatory optimization program focused on transforming the Mexican medicines regulatory pathway into one that is efficient, value-added, aligned with international norms, resource accountable, and one that protects and promotes public health, while also facilitating economic development. METHODS: To facilitate the implementation of a new national access to medicines policy, the national government and the Mexican medicines regulatory agency instituted a multifaceted series of regulatory and legal reforms, which are described in this paper. These reforms encompassed multiple aspects of the regulatory oversight of medicines: administrative processes, clinical trials oversight, reliance on market authorization information and reports (ie, "work products") of other trusted regulators, and validation of activities by both Pan American Health Organization (PAHO) and WHO. FINDINGS: These reforms have resulted in a marked positive impact on the availability of safe, effective, quality medicines at lower costs for Mexicans, both in the private and public sectors, while simultaneously facilitating expansion of the Mexican pharmaceutical industry. INTERPRETATION: The regulatory optimization approach undertaken by Mexico could be a useful model for other countries that are trying to provide appropriate public health protection to their citizens, facilitate access to needed quality medicines, and encourage local economic development.
BACKGROUND: Medicines regulators, while performing a vital public health activity, are often perceived as both negative cost centers for governments and as impediments to innovation and economic development. The Mexican government recently undertook a regulatory optimization program focused on transforming the Mexican medicines regulatory pathway into one that is efficient, value-added, aligned with international norms, resource accountable, and one that protects and promotes public health, while also facilitating economic development. METHODS: To facilitate the implementation of a new national access to medicines policy, the national government and the Mexican medicines regulatory agency instituted a multifaceted series of regulatory and legal reforms, which are described in this paper. These reforms encompassed multiple aspects of the regulatory oversight of medicines: administrative processes, clinical trials oversight, reliance on market authorization information and reports (ie, "work products") of other trusted regulators, and validation of activities by both Pan American Health Organization (PAHO) and WHO. FINDINGS: These reforms have resulted in a marked positive impact on the availability of safe, effective, quality medicines at lower costs for Mexicans, both in the private and public sectors, while simultaneously facilitating expansion of the Mexican pharmaceutical industry. INTERPRETATION: The regulatory optimization approach undertaken by Mexico could be a useful model for other countries that are trying to provide appropriate public health protection to their citizens, facilitate access to needed quality medicines, and encourage local economic development.
Keywords:
Mexico; medicines regulation; public health and economic impact of regulatory systems; reform of medical regulatory systems; regulatory reliance