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Improving access to medicines for early medical abortion: learning from experiences of medicines licensing and service delivery
  1. Sam Rowlands1,
  2. Mira Harrison-Woolrych2
  1. 1 Department of Medical Science & Public Health, Bournemouth University, Poole, UK
  2. 2 Department of Women’s and Children’s Health, University of Otago, Dunedin, New Zealand
  1. Correspondence to Professor Sam Rowlands, Department of Medical Science & Public Health, Bournemouth University, Poole, BH12 5BB, UK; srowlands{at}

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Governments worldwide have an obligation to ensure that reproductive health information, supplies and services are available, accessible, acceptable and of good quality.1 The WHO advises that everyone has the right to access safe and effective abortion care.2 However, in 2023, there remain many factors working against people’s access to such care.3 4 This Editorial discusses two key areas which continue to restrict women’s rights to obtain safe and effective medical abortion.

Medicines licensing

Misoprostol was initially licensed in the 1980s solely for the treatment of peptic ulceration and its use in reproductive health since then has been widely off-label. It has become the prostaglandin of choice for early medical abortion (EMA) (abortion at less than 10 weeks’ gestation) even though the product licence still does not include this indication.5

In contrast, mifepristone’s sole indication is for termination of pregnancy. Since mifepristone was registered in France in 1988, it has become clear that adding mifepristone to misoprostol significantly improves efficacy.2 Used alone, misoprostol will abort about 80% of early pregnancies, although this may take some time and may involve multiple doses.6 A combined mifepristone/misoprostol regimen results in complete abortion in 95–98% of cases.6 Despite this evidence, and the fact that mifepristone is on the WHO Essential Medicines List,2 around half (98/193) of countries have not licensed it for EMA, including Brazil, Egypt, Indonesia, Pakistan and the Philippines.5 Therefore, nearly 200 million women of childbearing age in these five countries cannot access mifepristone through health services. Regulators who hesitate or decline marketing authorisation of mifepristone are not making their decisions based on scientific evidence.

The safety of mifepristone is now well established after more than three decades of use, approval in 94 countries and more than 100 studies demonstrating its safety.7–10 In the USA, among …

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  • Contributors SR wrote the first draft and MH-W edited and revised it. SR and MH-W contributed equally to writing subsequent drafts and both approved the final draft. SR is the manuscript guarantor.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; internally peer reviewed.