COMMITTEE
LIFE SCIENCES
UK SPC law in 2021 CIPA’s Life Sciences Committee provides a summary of proposed changes to UK SPC law with effect from 1 January 2021. Input from the CIPA Life Sciences SPC sub-committee has been taken into account in the drafting of the latest draft statutory instrument (SI) and changes have been made based on the sub-committee’s input. The committee has appreciated the opportunity to provide input and think that it has been beneficial.
A
draft statutory instrument (SI), ‘The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020’1 has been laid before the UK Parliament that, if approved, will come into effect on 1 January 2021. As explained in its accompanying explanatory memorandum,2 the SI amends UK legislation relating to SPCs and is warranted by changes
to the regulation of medicines and agrochemicals once the Northern Ireland Protocol (NIP)3 comes into effect on 1 January 2021. Essentially, the instrument adjusts the current SPC regime to accommodate for future marketing authorisations that will cover only part of the UK (Great Britain or Northern Ireland). The draft SI supplements other changes made to UK SPC law in the form of SI
2019/8014 and SI 2020/1050,5 both of which resolve inoperabilities arising from the retention of EU law. SI 2019/801 made various changes to ensure that the retained EU law6 on SPCs operated effectively following exit day, and SI 2020/1050 made further amendments to reflect that we are now in a transition period and to fix inoperabilities in the ‘manufacturing waiver’ legislation that was introduced by Regulation (EU) 2019/933. We will comment further on SI 2019/801 and SI 2020/1050 in a follow-up article in next month’s issue.
Background
SPCs take effect when a patent expires and can provide up to 5½ years extension7 for medicines and agrochemicals that have endured regulatory delays in getting to market. Under current EU law, an SPC can be granted in the UK for a product that is protected by a basic patent and which has a valid marketing authorisation (MA) to place the product on the market in the UK. Until the end of the transitional period, the only MA valid in the UK is one which applies across the whole of the UK, approved by either the Medicines and Healthcare products Regulatory Agency (MHRA) or European Medicines Agency (EMA). Following the transition period, under the NIP, Northern Ireland (NI) will still be bound by EU law for the authorisation of medicines and plant protection products, while Great Britain (GB; England, Wales and Scotland) will not. This means there will be separate MAs for NI and GB alongside UK MAs, which the SPC law will need to reflect. Volume 49, number 11
NOVEMBER 2020
CIPA JOURNAL
11
