The path toward universal access to quality-assured medical products requires a multidisciplinary approach whereby pharmaceutical regulation is not seen (anymore) as a technical issue that is dealt with by technical experts in isolation, but rather as an important component of pharmaceutical systems, that is strictly interconnected to the other systems’ components; and that should benefit from collaboration with policy makers, health economists, social scientists, researchers etc.. In this regard, the recent publication, in the Lancet Global Health, of the Oxford Statement and call to action for global access to quality-assured medical products, is a welcome development
By Raffaella Ravinetto
Institute of Tropical Medicine
The Oxford Statement and The MedsWeCanTrust Campaign
A Call for Equity in Global Health
Access to quality-assured medical products for all, is a fundamental prerequisite to achieve universal health coverage (UHC), but it is hampered by a variety of political, structural and financial problems. Among them, the high prevalence of substandard and falsified medical products, particularly in low- and middle-income countries (LMICs), represents a significant threat to individual and public health . Health systems worldwide need to design and implement policies that ensure availability and affordability of quality-assured products.
Strengthening the capacity of National Medicines Regulatory Authorities (NMRAs) in LMICs is surely a key priority, given that to date less than 30% of the World Health Organization (WHO) Member States have a stringent NMRA, meaning a NMRA with the capacity to fully perform the functions required to ensure that medicines, vaccines and other health products, work and do not harm . But problems faced by most LMICs are more complex and multifaced. In 2017, for instance, the Lancet Commission identified five areas that are crucial to essential medicines policies: assuring the quality and safety of medicines, but also paying for a basket of essential medicines; making essential medicines affordable; promoting quality use of medicines; and developing missing essential medicines .
This list of “priority policies” clearly shows that the path toward universal access to quality-assured medical products requires a multidisciplinary approach, including expertise in health systems, pharmaceutical regulation, quality assurance, intellectual property rights, health financing, social sciences etc. In this multidisciplinary approach, pharmaceutical regulation is not seen (anymore) as a technical issue that is dealt with by technical experts in isolation, but rather as an important component of pharmaceutical systems, that is strictly interconnected to the other systems’ components; and that should benefit from collaboration with policy makers, health economists, social scientists, researchers etc.
The recent publication, in the Lancet Global Health, of the Oxford Statement and call to action for global access to quality-assured medical products, is therefore a welcome development . It comes as a follow up to the first-ever international Conference on Medicine Quality and Public Health (Oxford, United Kingdom, 2018). At that time, delegates had issued the short Oxford Statement, calling for investment, policy changes, and action to eliminate substandard and falsified medical products . The newly-published Statement is significantly expanded with a Call to Action, in order to support some key-strategies of the WHO (i.e., the “Prevent, Detect and Respond” strategy; the Global Benchmarking Tool for NMRAs; and the WHO Prequalification team); to advocate for increased investments to build the capacity in regulation, manufacturing, supply chains and post-marketing surveillance; and to advocate for research on the impact of poor-quality medical products, and on the cost-effectiveness of interventions to eliminate them. The Call is accompanied by a detailed Research Agenda.
One decade ago -and perhaps, even more recently- the subject of poor-quality medicines was discussed by technical experts, and it was relatively neglected by other stakeholders in health systems and global health. Today, the Oxford Statement is supported by more than 150 signatories, issued from a variety of different professional backgrounds, skills and expertise, showing a growing awareness of the importance of these “technical” aspects, for the performance of health systems and for the achievement of UHC.
As recognized by the signatories of the Statement, the Call to Action will be translated into concrete actions only if supported by multi-sector political commitment, and if accompanied by solid partnerships across key-stakeholders such as regulators; Ministries of Health, Finance, Trade, Research; manufacturers, distributors and purchasers of medicines; funding and implementation agencies; researchers; law enforcement agencies; and the civil society, including patients’ and grassroots organizations. But it is already an excellent news that the initial call does not come from a group of “technicians”, but from a multidisciplinary group of committed individuals and organizations.
Those who wish to support this call, can join the #MedsWeCanTrust Campaign (https://medswecantrust.org/get-involved), a platform that raises awareness of the impact of poor-quality medicines, noting that this problem “cannot be confined to technical, isolated conversations”, since “they are a fundamental breach of patient trust with life-or-death consequences”. The Campaign strives to inspire collective action and unify a diverse and broad coalition of partners, for achieving the policy changes necessary to ensure that the medical products that reach people work. We hope that also PEAH’s readers will be inspired, and will contribute to spread the call.
 World Health Organization. WHO Global Surveillance and Monitoring System for substandard and falsified medical products. Geneva: World Health Organization, 2017. http://apps.who.int/medicinedocs/en/m/abstract/Js23373en/
 Newton PN, Bond KC, on behalf of the Oxford Statement signatories. Global access to quality-assured medical products: the Oxford Statement and call to action. Lancet GH 2019; 7: e1609-11