Access to medicines is a complicated topic. It’s shaped by scientific factors, manufacturing processes, regulatory requirements (including expectations for quality), purchasing practices, health insurance coverage and benefits, healthcare practitioners and numerous other complex realities. What we have learned is that real progress happens when stakeholders work together to develop solutions.
USP is using its capabilities to facilitate access to quality medicines through standards, education, regulatory system strengthening, and advocacy. We recognize that our work is just one piece of the overall access puzzle, but quality standards help ensure patients can trust the quality of their medicine. This is significant since access without quality can mean harm to patients. Aside from being dangerous, poor-quality medicines waste scarce public health resources and undermine trust in healthcare. Therefore, quality has to be a foundational element in the access to medicines imperative.
This week, I traveled with USP Board of Trustees Chair Susan Winckler to New Orleans for the Annual Meeting of the Association of Accessible Medicines (AAM) to accept the AAM Champion of Access award on behalf of USP. It means a lot to receive an award acknowledging our commitment to greater access to medicines from an organization for which the issue is so central that “access” is part of its name.
We are proud of the link between USP standards and facilitating access to medicines. In addition to their role in quality-assurance, USP standards can help facilitate generic product development because they provide manufacturers and regulators with testing methods and other requirements, as well as guidance on expectations for quality. To further our efforts, we announced the Generics Access Plan which details how we are working closely with FDA, AAM and other stakeholders to develop new and revised standards to support generics product development.
Quality standards are important, but to optimize their impact they must be applied appropriately. USP Education has trained thousands in how to utilize standards in manufacturing and regulatory settings. We have helped over 50 countries build key quality-assurance capabilities among their regulators. And we advocate for quality to help ensure that governments prioritize investment in it.
To help health policymakers and other global health leaders make strategic decisions about these investments they need more data. USP’s Quality Institute is partnering with academic centers to conduct research about the importance of quality medicines. Current research is generating evidence about the connection between poor-quality medicines and AMR. Two new research themes will launch soon, one on the quality of excipients and the other on how procurement practices impact pricing in ways that could inadvertently disincentivize assurance of quality.
We can’t and shouldn’t do this alone. Change happens when communities unite around a common goal, presenting evidence and advocating for action with a sense of urgency. To help facilitate this, USP founded the global Medicines We Can Trust campaign, a platform for individuals and organizations committed to medicine quality. The campaign helps regulatory agencies, global health and patient organizations, academia and others advocate together and amplify our voices. Since it began last year, over 250 organizations have signed up.
As we remain focused on this work over the next year, USP will also begin to celebrate our 200th anniversary. That’s right, USP will be 200 years old in 2020! We will use this milestone to showcase a 200-year legacy of building trust in medicines with regulators, academia, practitioners, patients, the pharmaceutical industry and so many others.
We especially appreciate the many socially-responsible pharmaceutical companies who donate scientific methods, monographs, and materials that help fuel an efficient USP standard-setting process. By making these donations, industry is sharing their science with our expert committees who use donations of monographs and methods as the foundation for our standards. It’s important to note that both innovator and generics manufacturers contribute to the process.
USP’s standards-setting process remains volunteer-based, as it was when USP was founded in 1820, though now there are nearly 1000 experts from academia, government and industry and 1200 staff working in eight locations around the world. Still more people contribute to the development of standards by offering comments on proposed standards that are then considered by expert committees. Once standards are finalized, they are published in the USP-NF compendium so that regulators approving medicines and monitoring their quality, companies manufacturing medicines, and practitioners prescribing them can help ensure that patients around the world have access to medicines they can trust.
USP is proud to be recognized as a Champion of Access by AAM. Our access efforts are built on collaboration and are a story of shared success. Working together with industry and other stakeholders, I am confident that we can do even more to advance access to quality medicines in the coming years.