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

ABSTRACT

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.

KEYWORDS:

• Global health
• drug
• marketing authorization
• Europe
• WHO
• sustainable Development Goals
• patient access

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Contributors

MHA conceived the idea, MCB and CL obtained and analyzed the data. MCB, MHA, and ASR wrote the manuscript.

Reviewer disclosures

A reviewer on this manuscript has disclosed that they work as scientific officer at the European Medicines Agency (EMA) and may know some authors of the article. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Disclaimer

The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the EMA or one of its committees or working parties.

Additional information

Funding

This paper was not funded.