Cookies on this website

We use cookies to ensure that we give you the best experience on our website. If you click 'Accept all cookies' we'll assume that you are happy to receive all cookies and you won't see this message again. If you click 'Reject all non-essential cookies' only necessary cookies providing core functionality such as security, network management, and accessibility will be enabled. Click 'Find out more' for information on how to change your cookie settings.

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

Similar stories

Bacterial infections linked to one in eight global deaths, according to GRAM study

Data showing 7.7 million deaths from 33 bacterial infections can guide measures to strengthen health systems, particularly in low-income settings

Enhanced vaccination against Japanese encephalitis virus could reduce encephalitis prevalence by one third in SE Asia

Encephalitis is a worldwide public health issue, with a substantially high burden among children in Southeast Asia. A large study of the causes of childhood encephalitis in SE Asia suggests that enhanced and effective vaccination against the Japanese encephalitis virus alone could reduce encephalitis prevalence by one third.

Laos’ first Pint of Science: warty newts, COVID, AI for Instagram, and more!

Organised by a grass-root community of thousands of scientists across the world, Pint of Science 2022 allows researchers in 25 countries and over 800 cities to share their latest findings with lay folk in interesting, informal settings. Lao PDR joined the global Pint of Science family on Monday 9 May, when the first-ever Pint of Science Laos kicked off!

Largest-ever IPD meta-analysis of malaria patients to inform haemoglobin changes

A new malaria study using a very large analysis of pooled individual patient data (IPD) from more than 70,000 patients of all ages, has been published in BMC Medicine by the WorldWide Antimalarial Resistance Network Falciparum Haematology Study Group

Lack of evidence is key barrier to using portable devices to detect poor quality medicines

A series of papers which reviewed portable devices to detect poor quality medicines has concluded major gaps in scientific evidence remain a key barrier for regulators to implement surveillance systems using such devices.

New study alerts to the risk of poor quality medicines used to prevent and treat cardiovascular disease

There are important but neglected issues with substandard and falsified medicines and medical products used to prevent and treat cardiovascular diseases. From limited available data, MORU and IDDO scientists found about one fifth of medicines reported as sampled in the literature were substandard or falsified. This systematic review suggests that more and better quality data and data sharing are needed to better understand the global burden of this problem and inform interventions.