Notice & Comment

Strategies for International Drug and Vaccine Regulatory Coordination and Cooperation

My last several posts dealt with the complicated relationship between the Ebola outbreak in Guinea, Liberia, and Sierra Leone and the International Health Regulations that were adopted in 2005 (with an effective date in 2007) in order to address exactly such a threat. The overwhelming consensus is that they failed to effectively manage the outbreak at its inception although history will likely be more generous about the IHR’s mechanisms after WHO’s Director General declared a public health emergency of international concern on August 8, 2014. My last post concluded with the initiation of clinical trials of an Ebola vaccine jointly developed by GlaxoSmithKline and the U.S. National Institutes of Health, closely coordinated with WHO and CDC, a topic I wish to use as a segue to a broader discussion of the current global framework for governing or even regulating the development, registration, and administration of vaccines largely developed in Australia, Europe, Japan, and North America for use in lower and middle income countries.

The reality is that referring to the current patchwork system moving vaccines from wealthy countries to poor ones as a framework is an overstatement. In many lower or middle income countries, a system for national registration of medicines, including vaccines, exists by statute or by regulation but the process for complying with legal requirements is opaque or entirely unmanageable. The World Health Organization offers a prequalification service for vaccines whereby it vets the dossiers submitted by manufacturers to sophisticated national regulatory authorities, but only approximately half of low- or middle-income countries have through statute or regulation established that WHO prequalification is an adequate and effective substitute for national registration including in many cases evidence supported by in-country clinical trials. Even UNICEF, the most important procurement entity for the GAVI Alliance’s financial support for vaccines, includes in its agreements obligations only to make all reasonable efforts to register vaccines in-country. There is therefore a widespread and difficult dilemma: how does the global public health community advance the interest in individual and population health benefits vaccinations bring while also supporting the development of competent regulatory authorities in low- and middle-income countries? Surely sidestepping those authorities entirely is not the right answer.

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