Impact of the European Union on access to medicines in low- and middle-income countries: A scoping review

Abstract

Summary This Scoping Review synthesises evidence of the impacts of European Union (EU) law, regulation, and policy on access to medicines in in non-EU low- and middle-income countries (LMICs), and the mechanisms and nature of those impacts. We searched eight scholarly databases and grey literature published between 1995-2021 in four languages. The EU exerts global influence on pharmaceuticals in LMICs in three ways: explicit agreements between EU-LMICs (ex. accession, trade, and economic agreements); LMICs' reliance on EU internal regulation, standards, or methods (ex. market authorisation); ‘soft’ forms of EU influence (ex. research funding, capacity building). This study illustrates that EU policy makers adopt measures with the potential to influence medicines in LMICs despite limited evidence of their positive and/or negative impact(s). The EU's fragmented internal and external actions in fields related to pharmaceuticals reveal the need for principles for global equitable access to medicines to guide EU policy.

Challenges and Strategies for Improving Access to Cancer Drugs in Malaysia: Summary of Opinions Expressed at the 2nd MACR International Scientific Conference 2022

“…One possible way forward might be to increase reliance on and collaboration with stringent authorities such as the FDA and EMA, a strategy that has been adopted in several LMICs. 28 This could include aligning local regulatory processes with these agencies or establishing mechanisms for expedited approval of already approved drugs. Nevertheless, this must be done carefully and with consideration of the local context and epidemiology of the disease.…”

The AU-EU Partnership and the COVID-19 Pandemic: Moving towards health sovereignty in Africa?

“…The latter have a final say in the matter based upon the available benefit-risk assessments which consider local conditions, whilst conducting health technology assessments of their own. EMA has thus extended its global status with LMICs' efforts to obtain market authorisations for local products from a "stringent" agency (Perehudoff et al, 2021).…”

Does EU and US paediatric legislation improve the authorization availability of medicines for children in other countries?

“…Several publications suggest only limited benefit from conducted research for other countries and call for a more active position of local regulators. [34][35][36][37][38][39][40][41][42] Among the six countries selected for this study, Canada is currently in the forefront of paediatric regulatory initiatives (Table 1).…”

“…At the same time, more than 90% of the world's children reside outside of these four high‐income regions. Several publications suggest only limited benefit from conducted research for other countries and call for a more active position of local regulators 34–42 . Among the six countries selected for this study, Canada is currently in the forefront of paediatric regulatory initiatives (Table 1).…”