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Study on pharmaceutical incentives published today!

Scritto da CYBERMED NEWS
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A study on the economic impact of pharmaceutical incentives and rewards in Europe, requested and funded by the European Commission, and carried out by Copenhagen Economics has been published today. This study has been conducted in response to the invitation of Member States in the Council Conclusions of June 2016 to conduct an analysis on the functioning and actual use of the various pharmaceutical incentives.

The study provides an overview of pharmaceutical incentives and economic evidence on how Supplementary Protection Certificates and regulatory data protection are used in practice and their overall effects on innovation, availability and accessibility of medicinal products.

 

More specifically, the factual and evidence-based report presented by Copenhagen Economics gives insights into the following 5 types of pharmaceutical incentives:

  1. The supplementary protection certificate (SPC) which extends the standard duration of patent protection to a medicinal product;
  2. Data protection which prevents marketing authorisation applications for generics to refer to the results of pre-clinical tests and clinical trials of authorised medicinal products;
  3. Market protection which ensures that generic copies of authorised medicinal products are not marketed;
  4. Market exclusivity for orphan medicinal products; and
  5. Rewards for paediatric medicinal products (i.e. used for treating children aged 0 to 18), which can benefit from a 6 month extension of the SPC or additional 2 years of market exclusivity in the case of orphan medicinal products.

The Commission intends to use the study as an external input in the ongoing analysis requested by Member States in the Council Conclusions of June 2016. It is therefore part of a broader reflection process on the future of pharmaceutical policy. This reflection will also be based on the findings of the previous study on the economic impact of the Paediatric Regulation and the ongoing study on the functioning of the EU regulation for medicines for rare diseases (orphans). All these elements will in the end contribute to the evaluation of the orphan and paediatric Regulations.

The Commission will continue to discuss with all interested parties during the whole process with the aim to provide results by 2019 to allow the next Commission to take informed decision about possible policy options.

Click here to read the report in full

For further information:


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