Notice & Comment

Strategies for International Drug and Vaccine Regulatory Coordination and Cooperation – the Role of Aid and Public Health Personnel

In my last post, I observed that there was a dilemma posed by the current system of producing and moving medicines and vaccines from the developed, wealthy countries of North America, Europe and the Pacific Rim to low-resource countries in Asia, Africa and South America. The public health urgency of distributing medicines and vaccines often pressures funders and providers to side step national regulatory authorities because their lack of capacity may at best delay access to essential medicines and vaccines and at worst feed corruption or waste. On the other hand, the development of strong regulatory capacity in low-resource countries is one of the critical needs not only for those countries themselves but for the global supply chain of medicines and vaccines which is most vulnerable to breaches of safety and potency in underregulated or unregulated markets. One solution to this problem is for the aid and public health authorities from wealthier countries to better coordinate their roles and responsibilities with respect to public health response and regulatory capacity building.

Two examples demonstrate. In 2009, the U.S. Agency for International Development together with the U.S. Pharmacopeia, an influential private standard-setting organization, coordinated to assist Liberia in developing a national medicines registration authority because, as its regulatory infrastructure stood at the time, the U.S. could not provide antimalarial assistance consistent with drug quality assurance requirements. Together with the Liberian Ministry of Health, U.S. aid and public health personnel assisted MOH draft the Liberia Medicines and Health Products Regulatory Authority Act which became law in 2010. To be sure, adoption of implementing regulations took time, but the authority adopted clinical trial guidelines in 2014. Now, with the commencement of clinical trials for Ebola vaccine, those clinical trials are overseen by two Liberian principal investigators, regulated by Liberian clinical guidelines regulations, with a resulting win-win for both facilitating development of Ebola vaccines and for building Liberian regulatory capacity.

By contrast, the U.S. Centers for Disease Control and Prevention undertook an Adverse Event Following Immunization (AEFI) project in Laos in 2009 (in partnership with the Laos Ministry of Health, the World Health Organization and Walgreen’s pharmacy (providing doses of Novartis Fluvirin influenza vaccine)) and opted out of supervision by an institutional review board (IRB) because the program fell under a “public health evaluation program” under Lao law. IRBs, in brief, approve, monitor, and review biomedical and behavioral research involving humans to ensure compliance with the rights and welfare of human research subjects. Whatever the efficiency benefits of obtaining AEFI information in a low-resource setting following an influenza immunization campaign (to sure, the public health community is desperate for such data), an important opportunity was missed to build or support an aspect of regulatory capacity in Laos. The former episode in Liberia demonstrates the synergies that may be achieved when aid and public health personnel commit to both population health objectives and regulatory capacity building while the latter demonstrates how easy it is to miss opportunities.