Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries

Abstract

Objective. To describe the current status of regulatory reliance in Latin America and the Caribbean (LAC) by assessing the countries’ regulatory frameworks to approve new medicines, and to ascertain, for each country, which foreign regulators are considered as trusted regulatory authorities to rely on. Methods. Websites from LAC regulators were searched to identify the official regulations to approve new drugs. Data collection was carried out in December 2019 and completed in June 2020 for the Caribbean countries. Two independent teams collected information regarding direct recognition or abbreviated processes to approve new drugs and the reference (trusted) regulators defined as such by the corresponding national legislation. Results. Regulatory documents regarding marketing authorization were found in 20 LAC regulators’ websites, covering 34 countries. Seven countries do not accept reliance on foreign regulators. Thirteen regulatory authorities (Argentina, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay, and the unique Caribbean Regulatory System for 15 Caribbean States) explicitly accept relying on marketing authorizations issued by the European Medicines Agency, United States Food and Drug Administration, and Health Canada. Ten countries rely also on marketing authorizations from Australia, Japan, and Switzerland. Argentina, Brazil, Chile, and Mexico are reference authorities for eight LAC regulators. Conclusions. Regulatory reliance has become a common practice in the LAC region. Thirteen out of 20 regulators directly recognize or abbreviate the marketing authorization process in case of earlier approval by a regulator from another jurisdiction. The regulators most relied upon are the European Medicines Agency, United States Food and Drug Administration, and Health Canada.

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“…EMA, FDA and Health Canada are trusted regulators for all LA regulators relying on third parties. Hence, once a drug gets a MA issued by one of them, it becomes the golden key to be approved in 27 (out of 34) Latin American and Caribbean countries [ 15 ]. As example, of the 45 new drugs approved by Argentina in 2016, EMA and FDA earlier approved 78% and 80% of them, respectively.…”

“…However, the governing axiom of early access to any new oncologic drug is jeopardizing the in-depth and careful evaluation of new medicines worldwide, with enormous consequences to low and middle income countries. Reliance may foster cooperation and resource optimization [ 52 , 53 ] but it may also induce loss of national control over approvals of doubtful new medicines, and promote quick approvals where the capacity to monitor or withdraw MA when new contrasting evidence emerges is almost nonexistent [ 15 ].…”

“…Second, regulatory reliance has emerged as a broad concept where a national regulator relies on regulatory decisions taken by a third trusted party [27,28,41], usually a reputed regulator located in another jurisdiction. LA [15] as well as countries in other regions [42][43][44][45] have widely adopted it. Nowadays, several LA countries directly accept or abbreviate the MA process in case of earlier authorization by a designated trusted party, e.g.…”

“…The region experienced a decade (2006)(2007)(2008)(2009)(2010)(2011)(2012)(2013)(2014)(2015) of sustained economic growth, with an increased access to new oncologic therapies. During this period, most LA countries reformed their MA rules to allow quicker access to new oncological drugs by directly recognizing the MA, or abbreviating the authorization processes, in case of earlier authorization by reputed regulators, such as EMA, FDA and few others [14,15].…”

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“…In addition to voluntary licensing, some companies, such as AstraZeneca, have declared that they will sell their vaccine at cost during the pandemic period, and Moderna pledged to not enforce its COVID-19 related patents against "those making vaccines intended to combat the pandemic." 49 Philanthropic patent pools, such as the Medicine Patent Pool (MPP), have also been effective in promoting affordable access through the facilitation of licence agreements between patent holders and generic manufacturers.…”