United States Pharmacopoeia Convention

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144th session of the Executive Board<br>24 January - 1 February 2019
Agenda Item: 
5.7.1 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 SF medicine burden while enabling greater access to quality-assured products. Three strategies impact the quality of medical products after regulatory approval:

1. Strengthen regulatory systems towards WHO listed authority status, especially in countries manufacturing products for LMICs or for local production;
2. Maintain and expand the scope of the Pre-Qualification (PQ) Service to other products and quality assurance efforts.
3. Improve the prevention, detection, and response to SF health products.

The Roadmap could make more explicit how these strategies support vertical disease programs and other priorities. Collaboration between WHO disease programs and the Essential Medicines Program would help all stakeholders better link access-related goals 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.