The European Commission is proposing a new exception from infringement of supplementary protection certificates (SPC), which protect medicines. SPCs are national IP rights provided for by EU regulations. A draft proposal for a Regulation was published on 28 May 2018. This Regulation aims to amend Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products.
The proposed waiver introduces a limited exception to the current system. It applies to SPC medicinal products manufactured in the EU. It allows their manufacture for export outside of the EU. Such activities would currently infringe an SPC. The draft Regulation also introduces measures intended to promote transparency and reduce the risk of diversion of IP-infringing products onto the EU market.
The European Commission has issued a press release outlining why there is a need for an SPC waiver.
The IPO welcomes views on the draft legislative proposal. For example, evidence on the possible impact of the legislation for the UK, views on the draft legal text and comments on the Commission’s impact assessment.
Evidence should be clear and verifiable in line with our Guide to Evidence for Policy.
It would be helpful to receive views before the end of June 2018 to help inform working group discussions on the proposal between EU member states which may take place midsummer. Initial views can be followed with more substantive detail at a later date.
Please send your views to firstname.lastname@example.org.