Commission publishes its evaluation on the legislation for medicines for rare diseases and for children

On 11 August, the European Commission published its evaluation on the legislation for medicines for rare diseases and for children.

The joint evaluation examines the strengths and weaknesses of the Regulation on medicinal products for pediatric use and the Regulation on orphan medicinal products. It follows an evidence-based analysis of the functioning of the two regulations and consultation carried out with all relevant interested parties through workshops, as well as public and targeted consultations.

Key points

  • The evaluation observed some inefficiencies and consequences of the implementation of both regulations.
  • The document notes that both regulations fostered the development and availability of medicines for rare diseases and for children; through the introduction  of incentives, obligations and rewards, private and public investment was redirected towards previously neglected areas.
  • Furthermore, the joint evaluation showed that both regulations have not managed to support development in areas where the need for medicines is greatest; medical products continue to be developed in more profitable therapeutic areas.
  • In particular, the evaluation found that:
    1. medicines for rare diseases have reached a higher number of patients across the EU;
    2. the number of clinical trials in children increased;
    3. the ‘off-label’ use of medicines for adults in children was also reduced, which were not tested or adapted for use in children;

The results of the evaluation will guide reflections on any future changes to the current legislative framework and will inform the New Pharmaceutical Strategy.


Date: 15/09/2020 | Tag: | News: 1126 of 1153
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