Date: 25 November 2020
In advance of Brexit, the EU Supplementary Protection Certificate (SPC) Regulation has been incorporated into UK statute. Therefore, many aspects of SPC protection in the UK will remain the same as before. There will be no effect on SPCs granted in the UK before the end of the transition period.
During the Brexit transition period which will end on 31 December 2020, SPCs in the UK are governed by the EU SPC Regulation (Regulation (EC) No 469/2009).
At present, an application for an SPC requires details of the first Marketing Authorisation issued within the EEA for the relevant product. An EEA Marketing Authorisation is centralised and thus covers all EU member states. The date of this Marketing Authorisation determines the term of additional protection granted by the SPC. However, from the end of the transition period, the UK statute incorporating the EU SPC Regulation requires that a UK SPC is to instead be based on a UK Marketing Authorisation and thus cannot be based on an EEA Marketing Authorisation. For SPC applications filed after the end of the transition period, it will be necessary to:
For a UK SPC application filed after the transition period, its term will begin from the date of the earliest Marketing Authorisation obtained in either the UK or EEA.
With respect to EEA Marketing Authorisations which are pending at the end of the transition period, they will require re-filing at the UK MHRA. EEA Marketing Authorisations which are granted before the end of the transition period will be converted automatically to equivalent UK Marketing Authorisations.
After the transition period, it will also be possible to apply to the UK MHRA for marketing authorisations for different UK territories, i.e. either the UK as whole, Northern Ireland only or Great Britain only. This is based on the continuing application of EU law in Northern Ireland under the Northern Ireland Protocol.
The SPC stockpiling and manufacturing waiver provides an exemption to infringement of an SPC in the final six months preceding its expiry. The waiver came into force on 1 July 2019 permits third parties in Europe to manufacture biosimilar or generic versions of products under SPC protection for either export to countries where no equivalent or parallel SPC protection exists and/or stockpiling of the product in Europe in order to allow for quick entry into the market to improve access to medicines.
The waiver was originally proposed to be incorporated into UK statute. However, the proposal has been amended subsequent to a stakeholder consultation. A more restricted proposal has been made to limit UK-based companies to manufacture biosimilars or generics for export to countries outside of the EU. This proposal has not yet been passed by parliament.
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