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Beyond Protecting Economic Interests – SPCs as a Tool to Support Public Health Goals

DOI https://doi.org/10.21552/eplr/2018/2/4

Florian Schmidt


This article provides an overview about the rewards and incentives provided by the EU pharmaceutical legislation. It shows how over time basic incentives have been supplemented by targeted rewards and incentives meant to directly influence the pharmaceutical development pipeline, for example in the area of medicines for children and medicines to treat rare diseases. This includes supplementary protection certificates (SPCs), which are primarily an instrument of patent law as they prolong the effective IP protection period of medicinal products. In the context of the paediatric regulation an extension of the duration of the SPC is used as a reward to companies for complying with the obligation to study products they develop for their use in children. The use of an external reward system, such as SPCs, adds however an additional layer of complexity in practical and legal terms, which is analysed in more detail in this article.

The author works for the European Commission, Directorate General for Health and Food Safety. The views and opinions expressed in this article are those of the author, they do not necessarily reflect the opinion of the European Commission. For Correspondence: <mailto:Florian.SCHMIDT@ec.europa.eu>

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