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Poor-quality medical products: social and ethical issues in accessing ‘quality’ in global health
  1. Patricia Kingori1,
  2. Koen Peeters Grietens2,3,
  3. Seye Abimbola4,5,
  4. Raffaella Ravinetto2
  1. 1Ethox Centre, Wellcome Centre for Ethics and Humanities, Oxford, UK
  2. 2Public Health Department, Institute of Tropical Medicine, Antwerpen, Belgium
  3. 3School of Tropical Medicine and Global Health, Nagasaki University, Nagasaki, Japan
  4. 4School of Public Health, University of Sydney, Sydney, New South Wales, Australia
  5. 5BMJ Global Health, London, UK
  1. Correspondence to Dr Raffaella Ravinetto; rravinetto{at}itg.be

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Assuring access to medicines, vaccines and medical devices of adequate quality is a key pillar of any well-functioning health system and a prerequisite to achieving universal health coverage. However, high prevalence of substandard and falsified (SF) medical products, particularly in low-income and middle-income countries (LMICs),1 2 and widespread inadequate practices in the management,3 prescription and use4 of medical products along their life cycle, all undermine access to quality-assured medical products and the performance of health systems. In addition, what counts as ‘quality’ can be highly variable and greatly contested, with perceptions of what constitutes ‘good standards’ shaped by a range of geographical, contextual, sociopolitical and cultural factors.

In more technical domains, significant advances towards a common understanding of quality are taking place. In 2017, at the Seventieth Assembly of WHO, a key step forward was made in clarifying and gaining WHO Member States’ agreement on the use of the terms “Substandard and Falsified (SF) medical products” to describe medical products of unverified or poor quality, adding clarity to previous unspecific wording in regulation and practice.5Substandard” medical products are those authorised by national regulatory authorities, but lacking adequate quality standards, while “falsified” medical products deliberately or fraudulently misrepresent their identity, composition or source. The emphasis on clear definitions is reflective of greater concerns …

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