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European Commission opens a public consultation on improving the European system of orphan medicine designation
  1. Richard Price
  1. Correspondence to Richard Price, Department of Policy and Advocacy, European Association of Hospital Pharmacy, 3 Rue Abbe Cuypers, Brussels 1040, Belgium; richard.price{at}

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15 years after the passing of landmark European Commission (EU) regulation to encourage orphan medicine development, the EU is now running a public consultation to take views on revised guidance on how the regulation should operate in practice. Amongst the matters being consulted upon is whether a candidate for orphan drug designation should be required to demonstrate ‘significant benefit’ over not only existing authorised products, but also those prepared in hospital pharmacies. The consultation also seeks views on if, and how, orphan drug designation benefits could be better applied to benefit the development of treatments for low to zero prevalence infectious diseases in Europe that nonetheless pose the potential risk of becoming a serious threat to public health (eg, Ebola).

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  • Competing interests None declared.

  • Provenance and peer review Commissioned; internally peer reviewed.