Currently it is widely known that the Latin American markets operate with their respective regulatory health bodies, varying from having dedicated agencies in some nations to entrusting responsibilities like drug approval and post-marketing surveillance to their health ministries in others. The Pan American Health Organization (“PAHO”) extends technical assistance and collaboration to these regulatory authorities, as well as fosters regional collaboration and synchronization efforts to promote greater cohesion in healthcare regulatory practices across the region.

Nevertheless, there has been a growing discussion recently regarding a potential shift in this model.

In April this year, regulatory authorities from Mexico (i.e., Cofepris), Colombia (i.e., Invima), and Cuba (i.e., Cecmed) endorsed the Acapulco Declaration[1], initiating discussions to establish a novel regional regulatory body responsible for overseeing medicines in Latin America and the Caribbean, named the Latin American and Caribbean Medicines Agency, or simply “AMLAC”. Additionally, several other nations including Bolivia, Dominica, Ecuador, El Salvador, Honduras, Jamaica, and the Dominican Republic have shown interest in participating in this initiative.

The Acapulco Declaration – signed on April 26^th, 2023 – acknowledges the challenges that Latin America and the Caribbean face in the areas of healthcare, production, economy, and society, particularly during emergencies like the coronavirus pandemic.

As such, the creation of AMLAC has been proposed as a mechanism to (i) contribute to regional integration through the harmonization and convergence of health regulations – including the alignment with international regulations –, promoting access to safe, effective, and high-quality medicines and medical devices, (ii) make the region more self-sufficient in health care by supporting local manufacturing and increasing flexibility toward intellectual property, especially considering the challenges faced by Latin American nations during the coronavirus pandemic, including vaccine procurement difficulties and ongoing shortages of essential medications, and (iii) support the authorization process for medicines and vaccines (especially in health emergencies), aiming to reduce the timelines for granting access to innovative medicines. 

While not currently operational, the concept of establishing a regional pharmaceutical agency for this area has been subject to deliberation and conversation in various conferences and gatherings over time. During a meeting held in Bogota, Colombia, in June this year, representatives from Brazil, Argentina, and Chile participated in discussions alongside the three regulatory bodies spearheading the initiative. At the occasion, delegates from all six countries endorsed an agreement to collectively establish a regional institution dedicated to sanitary regulation, aiming to enhance the scientific and technical competencies of regulatory agencies, while also forming task groups to pinpoint key areas for enhancing regulatory trust throughout the region.[2]

In terms of context and regional needs, the proposal to create a regional pharmaceutical organization for Latin America and the Caribbean arises from the necessity to confront numerous obstacles encountered by some of the domestic regulatory frameworks in this area, such as insufficient manpower and financial provisions, inconsistencies in regulatory capabilities, and the absence of synchronization in regulatory prerequisites and procedures. Furthermore, the region grapples with challenges related, for example, to attaining crucial medications, maintaining pharmaceutical product quality, and combatting the spread of fraudulent or substandard drugs.

In this sense, the principal aim of AMLAC would revolve around enhancing medication regulation and availability across Latin America and the Caribbean by means of cooperative efforts and reciprocal assistance among member nations, with improved pharmacovigilance and patient safety activities.

Several pivotal roles that AMLAC could undertake encompass (i) harmonization of regulations and guidelines (i.e., AMLAC would strive to synchronize regulatory prerequisites and protocols throughout the region, streamlining the trade of medications and fostering heightened cooperation among national bodies); (ii) drug evaluation and approval (i.e., AMLAC might serve as a centralized entity for assessing and authorizing drugs, streamlining the process for greater efficiency and alleviating the administrative burden on national regulators); (iii) training and capacity enhancement (i.e., AMLAC would extend training initiatives and capacity-strengthening programs, enhancing the expertise and proficiencies of regulatory staff within the region); (iv) monitoring and quality assurance (i.e., AMLAC would aid national authorities in drug monitoring and executing quality assurance frameworks, bolstering the safety and effectiveness of pharmaceutical items within the region); (v) research and development (i.e., AMLAC could catalyze collaborative research and development efforts across the region, fostering innovation and broadening accessibility to novel medications), and (vi) global collaboration (i.e., AMLAC would function as a conduit between national regulatory bodies and other regional and international organizations, stimulating cooperation and information exchange). 

At a summit of the Heads of State and Government of the Community of Latin American and Caribbean States, held in January this year, the Head of Cofepris also outlined (and reinforced) short- and long-term industry ambitions related to stimulating and enabling R&D of innovative products and providing regulatory certainty throughout the region, supporting local production and integration of local supply chains, as well as exploring public procurement mechanisms for medicines to guarantee access and sustainable financing (what would prioritize “self-sufficiency”, such as contracts with regional manufacturers).

By spearheading these roles, AMLAC seeks to engender a more cohesive and responsive regulatory environment that effectively addresses the unique challenges faced by the Latin American and Caribbean regions in the realm of medicines. By the way, the influence of regional agencies on regulatory and pharmaceutical access can be observed through instances such as the European Medicines Agency (EMA) and the African Medicines Agency (AMA) – such organizations stand as prime illustrations of entities that have wielded substantial influence in terms of regulating and facilitating access to medicines within their respective regions.

It is important to highlight that in many Latin American countries, especially Brazil, the respective regulatory bodies have been striving to improve their regulatory frameworks. Indeed, Brazil has been positioning itself in the front line when it refers to taking actions to improve the regulatory agencies procedures. To shed some light on this, we can bring as an example the Brazilian regulatory reform that took place in 2019, when Federal Law No. 13.848/2019 (the General Law on Regulatory Agencies) was published, aimed at assigning obligations and procedures to regulatory agencies, fostered social participation in the decision-making process of the agencies and required a regulatory impact assessment to enact and change rules. Plus, the Brazilian National Health Surveillance Agency (“Anvisa”) is more than ever very committed to the implementation of regulatory harmonization and convergence measures, recognized as the international technical alignment movement that takes into account the best practices of the industry and internationally legitimized principles and standards in the regulatory processes, as well as the application or adaptation of technically justified local regulatory requirements.

In this regard, emphasis shall be placed on encouraging the strategy of regulatory trust ("regulatory reliance"), commonly identified as taking benefit from equivalent assessments already carried out by trusted regulators, foreign regulatory authorities or international entities that have regulatory practices aligned with those of Anvisa (the so-called "Equivalent Foreign Regulatory Authorities", or simply "AREEs" in Portuguese). This practice has been defended by the agency as a mechanism able to provide agility to the evaluation of requests for registration and/or regularization of health products and services, especially with regard to their quality, safety and efficacy standards, as well as access in the event of a public health emergency.

It seems improbable that Brazil will actually become an active participant in AMLAC within the upcoming years. Despite this, the country is moving towards a new model to decrease its reliance on inputs. In early April, the Brazilian federal government reinstated the Executive Group for the Economic-Industrial Complex of Health (“Geceis”). The aim is to boost the productive system of goods and services related to healthcare, including medicines, vaccines, and hospital equipment[3].

“The emergence of the Latin American and Caribbean Medicines Agency (AMLAC) presents a hopeful opportunity for enhancing the regulation and availability of medicines across the region. By means of harmonized regulations, collaborative efforts, and skill development, we are of the view that AMLAC has the potential to effectively tackle the hurdles encountered by countries in Latin America and the Caribbean concerning the caliber, security, and efficacy of pharmaceutical merchandise” – said Bruna Rocha.

The establishment of AMLAC would imply a significant stride in the direction of guaranteeing that the population of the region can access medications that are not only safe and effective but also financially accessible. In relation to the pharmaceutical sector at large, it stands to gain significant advantages from the heightened harmonization and convergence. Uniform regulations spanning the region could alleviate the regulatory burden on companies, streamlining the process of product introduction to the market. Moreover, it would establish consistent prerequisites for clinical trials, labeling, packaging, and post-marketing surveillance parameters, with clearer and more transparent regulatory pathways for new therapies. This uniformity would enhance efficiency, reduce complexities, and contribute to a more cohesive regulatory landscape, benefiting the industry and the patients as a whole, “but even so there are multiple legal factors that must be taken into account by the jurisdictions involved in, in order to make it doable and enforceable, including in relation to the national sovereignty basics” – said Bruna. 

CMA info

This article describes the current thinking at Campos Mello Advogados on these topics and should not be viewed as a legal opinion. 

Campos Mello Advogados is a Brazilian law firm which has worked in cooperation with DLA Piper LLP across the globe since 2010.

References: 

[1] Organización Panamericana de la Salud. “Declaración de Acapulco: un compromiso para trabajar por la autosuficiencia sanitária”, published on April 27th, 2023. Available at <

https://www.paho.org/es/noticias/27-4-2023-declaracion-acapulco-compromiso-para-trabajar-por-autosuficiencia-sanitaria>

[2] Gobierno de México. “Comunicado de prensa 62/2023”, published on July 16th, 2023. Available at <

https://www.gob.mx/cofepris/articulos/argentina-brasil-y-chile-ingresan-al-dialogo-para-la-integracion-de-agencia-sanitaria-internacional?idiom=es>

[3] Governo Federal do Brasil. “Reconstrução do GECEIS vai colaborar para sustentabilidade do SUS a partir da produção nacional de insumos de saúde”, published on April 4th, 2023. Available at <

https://www.gov.br/conitec/pt-br/assuntos/noticias/2023/abril/reconstrucao-do-geceis-vai-colaborar-para-sustentabilidade-do-sus-a-partir-da-producao-nacional-de-insumos-de-saude>