Report launched on supplementary protection certificates, incentives and rewards

Innovative companies and inventors of pharmaceuticals are necessarily concerned with the protection of their intellectual property. A new molecule will usually gain patent protection, but this is limited to 20 years’ protection, and does not take into account the time between patent and actually entering the market. Supplementary protection certificates (SPCs), incentives and rewards were developed for use in Europe to allow pharmaceutical companies to get more advantage for their work, which has, in turn, been shown to stimulate innovation. The existing incentives and rewards are:

  • The SPC, granting five additional years of protection
  • Data protection, preventing re-use of clinical trials data for eight years
  • Market protection, preventing copies of the product entering the market for ten years
  • Market exclusivity, preventing similar products entering the market for ten years (applicable to drugs for orphan diseases)
  • Paediatric investigations, extending the SPC for paediatric products

The report produced by Copenhagen Economics analyses the effects of the incentives and rewards to determine outcomes such as the effective protection period. The report shows that between 1996 and 2016, the effective protection period has decreased from 15 to 13 years, probably due to increased regulatory burdens at EU and national levels. Alternatively, this statistic could be caused by companies taking on riskier research and development.

EUCOPE (the European Confederation of Pharmaceutical Entrepreneurs) also point out that the report discusses:

  • “The higher positive relationship between the effective protection period and the level of pharmaceutical research and development. This implies that “a reduction of the effective protection period will negatively effect the investments in research and development in the EU [but also] outside the EU”
  • The fact that accessibility is a matter of price and that innovator medicines’ prices drop by 40% on average from 6 quarters before to 5 quarters following generic entry
  • Unintended consequences with secondary patents, market exclusivity for orphans – which is said to allow companies a strong bargaining position in price negotiations – and paediatric investigation plans.”

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Published 8. June 2018 in News, News EU