Geneva, Switzerland, January 2019
The World Health Organization (WHO) is governed by an Executive Board, whose meetings allow members to set the agenda for the upcoming World Health Assembly and the resolutions to be considered. This year under our Official Relations with the WHO, USP joins the 144th Session of WHO’s Executive Board Meeting to lend our voice highlighting medicines quality across global health agendas. Read USP’s Statements on WHO’s Roadmap on Access to Medicines and Vaccines, and on Antimicrobial Resistance action below:
USP Statement on WHO’s Roadmap on Access to Medicines and Vaccines
Thank you for providing us with an opportunity to share comments. The US Pharmacopeia (USP), is a 200 year-old nonprofit, public health organization committed to ensuring medical products quality globally. USP sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements.
The WHO Access to Medicines and Vaccines Roadmap 2019-2023 highlights the global rise of substandard and falsified (SF) medical products. Approximately 1 in 10 medicines in LMICs do not work as intended. These products endanger health, promote antimicrobial resistance, undermine confidence in health systems and waste resources, with disproportionate impact on low and middle income countries.
We commend the WHO for highlighting the problem and proposing activities designed to reduce the burden of SF medicines while enabling greater access to quality-assured products. In particular, three strategies impact the quality of medical products, after regulatory approval:
- Strengthen regulatory systems towards WHO listed authority status, especially in countries manufacturing products for L-MICs or for local production;
- Maintain and expand the scope of the Pre-Qualification (PQ) Service to other products and quality assurance efforts.
- Improve the prevention, detection, and response to substandard and falsified health products.
The Roadmap could make more explicit how these access strategies support vertical disease programs and other priorities. Collaboration between WHO disease programs, and the Essential Medicines Program, for example, would help all stakeholders better link access-related goals under the Roadmap to existing priorities and resources.
Technical partners already support countries and systems to adopt and implement international standards, tools, and practices to safeguard medical product quality. Including how WHO would collaborate with these partners will be critical to prioritization and planning.
USP looks forward to collaborating further with WHO to achieve these goals.
USP Statement on WHO’s Director General Report on Antimicrobial Resistance
USP appreciates the opportunity to comment on the Director General's report on Antimicrobial Resistance and notes the significant progress underway. We highlight that medicines quality should be an integral part of AMR stewardship and National Action Plans (NAPs).
Poor-quality medicines contribute to treatment failure and directly drive pathogen resistance to life-saving treatments such as antibiotics and antimalarials. When patients receive sub-therapeutic doses from medicines it has the same effect as not taking the medicine as prescribed. Treatment adherence as a strategy of AMR stewardship will be undermined in settings with substandard medicines.
Published and ongoing laboratory research suggests that degraded and substandard medicines for tuberculosis and malaria fuel drug resistance and spread and could render current treatments ineffective.
Poor-quality antimicrobial medicines are found throughout the world, disproportionately in LMICs with under-resourced regulatory systems. On average, 12.4% of antibiotics and 19.1% of antimalarials are substandard or falsified in low resource settings. Co-endemics of infectious diseases and substandard medicines threaten health security globally.
Unlike other factors driving AMR, there are known solutions to assuring medicines quality.
- We commend WHO for increasing antimicrobial drug quality surveillance under the Global Surveillance and Monitoring System.
- Coordination between WHO’s AMR and Essential Medicines programs would facilitate information-sharing about the “drug-bug” connection, where substandard medicines’ presence may inform patterns of drug resistance.
- The WHO “Prevent, Detect, Respond” framework for substandard and falsified (SF) medicines offer national regulatory authorities guidance in practically integrating medicine quality into National Action Plans, building regulatory capacity to deter SF presence in the market, while generating evidence through surveillance and research on this global problem.
We commit to collaborating with WHO and Member States to ensure antimicrobial drug quality.
USP Statement on Member State mechanism on substandard and falsified medical products
USP appreciates the opportunity to comment on the Director General’s report on the Member State mechanism on substandard and falsified medical products.
Everyone deserves access to medicines they can trust as a right, not a privilege. Yet increasingly, we see substandard and falsified medicines harming patients and threatening the public health.
We commend the WHO and Member States for the 2017 release of two landmark reports: one on the prevalence of substandard and falsified medicines and one on their socioeconomic and public health impact. These have generated greater awareness of the scope and scale of the problem, and the threat undermining progress across many areas of global health. We congratulate the Director General for his leadership on this issue; we are inspired by the heads of State from the African member states who have elevated this issue to the highest levels.
As a committed partner to the Member State mechanism, USP serves as a technical resource to the Working Group of Activity C, improving Member States’ understanding of detection technologies. Through the Promoting the Quality of Medicines program supported by USAID, USP shares field reports with the Global Surveillance and Monitoring System and supports regulatory agencies to strengthen quality assurance systems.
We believe that it is time for the Member State Mechanism to widen the tent. As a partner of the Medicines We Can Trust campaign, a global movement to raise awareness of the importance of medicines quality and the impact poor-quality medicines have on people’s lives, we welcome the opportunity to collaborate in Activities D, E and F. With the active engagement of scientists, practitioners, patients and consumers, supporting the work of regulators and public health advocates, we can stem the tide of SF medicines.