WHO’s Draft Pandemic Treaty Calls For More Regulatory Harmonization
Regulatory convergence and the sharing of dossiers, together with the timely and equitable sharing of pathogens, could help to speed up access to diagnostics, vaccines and medications in pandemic situations, according to the first draft of the World Health Organization’s proposed pandemic treaty.
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A World Health Organization negotiating body will shortly examine the “zero draft” of a proposed pandemic treaty aimed at better preparing the world for future health crises. But the international pharmaceutical industry claims the draft as currently worded could actually undermine equitable access to pandemic countermeasures.
New, more flexible regulatory approaches will be needed to deal with the integrated therapies coming through company pipelines, and the European Medicines Agency should play a “key orchestrating role” in smoothing the way, says Sabine Atzor, Roche’s head of EU regulatory policies.
If successful, a new Swedish model for reimbursing antibiotics that involves guaranteed minimum annual revenues for companies, could be tested on other kinds of products.