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Noting that substandard and falsified medical products (including medicines, vaccines, biologics, and diagnostics) represent a significant and growing threat to human health, The Lancet Global Health published 'The Global access to quality-assured medical products: the Oxford Statement and call to action'.

Hand-held device to check for substandard and falsified medicines

Oxford, 7 Nov 2019 – Signed by 159 attendees to the 2018 Oxford Conference on Medicine Quality and Public Health representing governments, multilateral agencies, academia and civil society, the Oxford Statement and call to action outlines four key interventions to ensure universal access to quality medical products:

  • Adoption of the WHO’s “Prevent, Detect and Respond” strategy
  • Greater collaboration and harmonization across national regulatory authorities
  • Increased investments to strengthen supply chains and regulatory systems
  • Multidisciplinary research to understand the impact and solutions to this problem

“Poor-quality medicines reverse progress against disease – from curbing antimalarial resistance to reducing the burden of malaria. But that’s just the tip of the iceberg. More resources and better data are critical to inform prevention, detection and response efforts,” said Oxford Statement author Prof Paul Newton who leads Medicine Quality at IDDO and the Mahidol Oxford Tropical Medicine Research Unit (MORU).

Substandard medical products result from errors, corruption, negligence, or poor practice in manufacturing, procurement, regulation, transportation, or storage. In contrast, falsified products result from criminal fraud. Although they have been traded for many centuries, in the last few decades the problem has grown due to the increased complexity of the global pharmaceutical economy and internet sales.

“Little research has been done to date and existing data in this area are limited with many gaps, and improvements are needed in data quality, collection and data sharing,” said Prof Newton. “The Oxford Statement underlines the urgent need for wider, multidisciplinary research to build the evidence base globally and to use these data for informing interventions and policy to ensure that we all have access to good quality medical products.”

Authors backing the initiative are from a wide range of fields and organisations, alongside IDDO, the MORU Tropical Health Network and the United States Pharmacopeia (USP), these include: Wellcome; Save the Children; Marie Stopes International; London School of Hygiene & Tropical Medicine; Ministry Of Public Health, Cameroon; Mongolian Association Of Pharmacy Professionals; National Agency for Food & Drug Administration & Control, Nigeria; National Department Of Health, Papua New Guinea; Addis Ababa University; University of Malawi; Kathmandu Medical College; and the University Of Notre Dame among many others.

In September, 2018, the first international Medicine Quality and Public Health Conference was held at Oxford University, UK, to discuss opportunities and solutions to ensure that all people have access to affordable and quality-assured medical products. Delegates developed the short Oxford Statement, calling for investment, policy change, and action to eliminate substandard and falsified medical products. The statement was born out of discussion between governments, national and international agencies, non-governmental organisations, professional associations, and academic institutions who together examined the latest evidence on the epidemiology and public health implications of substandard and falsified medical products.

Falsified and substandard medicines put millions of people at risk of further health issues and, in some cases, are fatal. The World Health Organization (WHO) estimates that 1 in 10 medical products circulating in low- and middle-income countries (LMICs) are either substandard or falsified. The Oxford Statement aims to raise awareness and encourage investment, research and action into this global issue.

The Medicine Quality team led by Professor Paul Newton is part of the Infectious Diseases Observatory (IDDO) and the Mahidol Oxford Tropical Medicine Research Unit (MORU), both of which are part of the Centre for Tropical Medicine & Global Health at the University of Oxford.

Find out more about IDDO’s work in Medicine Quality