The European Medicines Agency facilitates access to medicines in low- and middle-income countries

Introduction: As part of its contribution to promoting global health, the European Medicines Agency can assess medicines for use outside the European Union (EU) and issue scientific opinions in collaboration with the World Health Organization and non-EU national regulatory authorities. Ten positive scientific opinions have been adopted by the Committee for Medicinal Products for Human Use of the European Medicines Agency medicines (EU-M4all, or article 58). We have investigated for the first time their impact. Method: We included all positive scientific opinions (n = 10), contacted the sponsors (n = 8) and obtained and analyzed the lists of approval granted based on these opinions. Findings: 138 regulatory approvals have been granted in 90 countries, with 75 approvals in Africa, and the remainder in Latin and South America, Middle East and South-East Asia, and non-EU Europe and Central Asia. Discussion: These scientific opinions reflect the conditions of use and rely on high standards, but the final approval decision remains with these countries. Despite the small number of EU-M4all opinions, the many approvals have had an impact and contribute to access to innovation for patients with unmet needs in target countries.