The Latin American and Caribbean Medicines Agency (AMLAC) may provide improved consistency in regulation, but what does that mean for access?

In April 2023, medical regulatory authorities of Colombia (INVIMA), Cuba (CECMED), and Mexico (COFEPRIS) signed the “Declaration of Acapulco” for the creation of the Latin American and Caribbean Medicines and Medical Devices Regulatory Agency (AMLAC) [1]. The declaration was confirmed in Bogota, Colombia in June 2023, along with the heads of medicine regulatory agencies from Argentina, Brazil, and Chile to further bolster support for the proposed agency [2]. While not yet operational, the objective of AMLAC is to harmonize health regulation to promote access to safe, effective, and quality medicines and medical devices across the region [3].

Background

Latin America and the Caribbean (LAC) countries currently operate with their independent respective regulatory health bodies, which has resulted in a variation of product information, drug approval processes, and post-market surveillance practices across nations [4]. This lack of regional standardization has also led to inconsistencies in regulatory requirements and processes which is further challenged by a lack of human and financial resources and the variability in regulatory capacities [5]. These challenges became increasingly apparent during the COVID-19 pandemic, as the existing health inequalities and shortcomings of healthcare systems ultimately led to health supply shortages across the region [6]. Some of the low-income countries in the region (e.g., Colombia, Nicaragua, Guatemala, Bolivia, etc.) had 2- to 8-times higher excess mortality than wealthier countries, (i.e., Costa Rica, Uruguay, Cuba, etc.) driven by a lack of healthcare resources [7]. This global health emergency pushed regional health agency policy leaders to question the diverse regulatory landscape in LAC and has since led to the proposed establishment of AMLAC.

Insights

While it is uncertain when AMLAC will be fully operational, the proposed policy aims to ensure wide-spread adoption and shared benefit. One of the primary objectives will be to align regional with international regulations to create more uniform policies that can further progress self-sufficiency [8]. AMLAC also proposes the removal of trade barriers for the raw materials used in medicines and vaccines in hopes to expedite authorization of new products during times of health emergencies [3]. Beyond policy, AMLAC will offer training and capacity-building programs to improve the skills and knowledge of regulatory personnel [9]. In addition, AMLAC aims to develop a regional register of medicines more in line with WHO recommendations on drug selection and to promote the use of generic medicines. Overall, AMLAC promises a “patient-centric” approach, protecting and restoring the health of citizens in the region, with a heightened focus on addressing the inequalities in low-income nations [3].

Windrose’s Take

How will this innovate and improve access in the region?

As a uniform regulatory body in the region, AMLAC will move towards guaranteeing that all medications are safe and effective, with a focus of eliminating low-quality generics from markets. This should give LAC nations “regulatory reliance” when making treatment and coverage determinations, particularly improving patient safety outcomes [9]. As seen with the establishment of the European Medicines Agency in 1995, harmonization brings countries together and can be highly effective in reducing drug approval delays because of the standardized guidelines and target approval timelines [10]. However, to be successful relies on participation of member states, and the African Medicines Agency proposed in 2019, is still awaiting a minimum of 15 member states to be aligned and to come into force [11].

How would this impact manufacturers?

The uniform AMLAC policy may alleviate some of the regulatory hurdles for manufacturers, as the product approval process would be streamlined to allow for a more efficient introduction to the markets. It would establish a transparent, consistent process for clinical trials, product labeling, packaging, and post-market surveillance criteria. Generic manufacturers are likely to benefit the most from the more predictable regulatory pathway, but all manufacturers may see improved time-to-access for products available on the private / out-of-pocket market. Nonetheless, despite an improved regulatory pathway, the path to public reimbursement will still require individual member state HTA and pricing negotiations.