How the Retained EU Law Bill could impact the UK’s life sciences sector

Last year the government identified the life sciences sector as one of five key growth sectors and committed to identifying changes to retained EU law that had the greatest potential to unlock the competitiveness of the sector. While no specific examples have yet emerged, there may well be opportunities in the near future for organisations to inject ideas and influence the government’s direction of travel.

The Bill (42 pages / 1.86MB PDF), designed to remove the special features of EU law that remain in the UK legal system, will see large parts of ‘retained EU law’ repealed automatically on 31 December 2023 – unless ministers decide to preserve or replace them beforehand. ‘Retained EU law’ – former EU law that was incorporated into the UK legal system after Brexit – currently covers significant aspects of UK law. Depending on which elements of retained EU law ministers decide to repeal – or ‘sunset’ – by the end of the year, the Bill could have a significant impact on the UK life sciences sector.

UK life sciences after Brexit

Legal and regulatory divergence from the EU has always been a universally accepted consequence of Brexit; the UK choose sovereignty over regulatory alignment. What was less clear was the degree to which UK law might deviate from the bloc. However, the UK will not want to do anything that is inconsistent with its obligations in international and trade agreements including those in the Trade and Co-operation Agreement (TCA), its trade agreement with the EU.

The government has already announced proposals to change the clinical trials regime, remaining aligned with the new EU regime where appropriate. Ministers have committed and, in some cases, consulted with industry stakeholders on proposed changes to the medical devices framework, the falsified medicines regime and exhaustion principles. The Retained EU Law Bill potentially hastens change by enabling reforms to be made by secondary legislation, though with limited parliamentary scrutiny and no requirement to consult with stakeholders.

The future of life sciences regulation

Although some legislation relevant to the life sciences industry, like the Patents Act and the Trade Marks Act, will fall outside the scope of the Bill’s sunset clause, there are a number of relevant areas that do including, the general medicines regulatory framework, rules relating to supplementary protection certificates and exhaustion of rights – among others.

A thorough and thoughtful reflection on the UK's wider regulatory and legislative policy for the sector would be welcome but relevant government departments will need time and resources to consider, with stakeholders, the implications for the sector of any proposed reforms using powers under the Bill.

Engaging with the government

The Bill, which has already been passed by MPs, is currently being considered in the House of Lords, where it faces potentially significant amendments. Despite the progress of the Bill, there are still opportunities for organisations in the life sciences sector to engage with ministers on reforms to the Bill.

Many industry insiders are keen for the government to address the potential impact of the Bill in areas of law and regulation where divergence from EU could place the UK at an advantage. Ongoing reforms to EU legislation that is relevant to the life sciences sector, including those under the Pharma Strategy for Europe, add additional potential for divergence. UK firms will want to encourage the government to take account of relevant proposed reforms at the EU level when examining its own approach to life sciences regulation.

Co-written by Belinda Lavin and Angelika Gornikowska of Pinsent Masons.