Following petition by The Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA) and others within the industry, the UK Government has changed its position on when protection will begin for a number of regulatory exclusivities post-Brexit. Such changes demonstrate that the UK Government is receptive of industry views – and also the power of collective lobbying.
This change is applicable to regulatory data protection (data and market exclusivity) and orphan market exclusivity in Great Britain. Rules for Northern Ireland (NI) will differ in accordance with the requirements of the NI Protocol (where regulatory data protection and orphan exclusivity will be determined by the EU MA date in line with EU regulation). Under the Government’s previous position, protection would begin from the date of first Marketing Authorisation (MA), whether that be an EU or a UK MA. The unfortunate consequence of this stance was that if a company was granted an MA in the EU before the UK, the term of UK protection was effectively shortened, as its start date was triggered before the company had a permit to sell in the UK. This has been changed so that the term of the relevant protections in Great Britain only begins after the grant of the UK MA.
It should be noted that, despite similar lobbying efforts, the term of supplementary protection certificates (SPCs) will still be calculated by reference to the first of the UK or EU MA. The ABPI and its sister organisations intend to continue to lobby the UK Government to seek to secure a similar change in approach for SPCs.
The proposed changes have been laid before Parliament as The Human Medicines (Amendment etc) (EU Exit) Regulations 2020. This statutory instrument is estimated to become law at the end of the year and will take effect from 1 January 2021. The new position has already been incorporated into the latest guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) for reference medical products and orphan exclusivity.