We're seeing an interesting and positive development on the regulatory front today, as GlaxoSmithKline submits a regulatory file to European Medicines Agency (EMEA) under Article 58 for the combination vaccine candidate Globorix (diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and meningitis serogroups A and C). EMEA's Article 58 provides for the agency to offer a scientific opinion on the the efficacy, quality and safety of medicinal products intended for use exclusively outside the European Union - in this case, in Africa and Asia.
In a press release issued today, Jean Stephenne, President of GlaxoSmithKline Biologicals, says:
Using the innovative Article 58 mechanism will expedite the availability of Globorix to those in greatest need while ensuring it meets the world's most stringent standards for safety and efficacy. This vaccine candidate could be available as early as 2008 and has the potential to break the cycle of meningitis epidemics in Africa. It will provide babies with protection against 7 diseases in a combination vaccine and, administered in the classical Expanded Programme on Immunisation, it will help to simplify logistics and costs.
Good as it is to see the technical resources of EMEA being made available to focus on evaluating products for the developing world, Article 58 addresses only one of a panoply of regulatory and post-regulatory obstacles to greater access to drugs, diagnostics and vaccines. The list includes, among other issues, bottlenecks in the international processes for pre-qualification of products and establishing recommendations for use; and confusing and slow in-country procedures for licensure and registration.
One cheer for Article 58 today. Three cheers when the new vaccine, which looks like it might contribute significantly to reduce the impact of epidemic meningitis, actually makes it into the EPI programs in countries that need it.
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