EU regulation of the life sciences

25 January 2016

The Science and Technology Committee is today launching an inquiry into the impact of EU regulation and policy on the UK life sciences. The inquiry will look at how EU legislation and regulation can best facilitate, and avoid impeding, collaboration and innovation in the life sciences with particular reference to the UK life sciences sector.

Quote from the Chair

Nicola Blackwood MP, Chair of the Science & Technology Committee said:

"The UK has a thriving and world-leading life sciences sector that delivers huge economic benefits.  Given the global market place in which our life science industries compete, regulations made at the European Union level can exert considerable influence. Safeguards are essential, but we need to ensure that EU regulations help rather than hinder research and innovation in the life sciences. Focus on these issues will undoubtedly sharpen as we approach the referendum on UK membership of the European Union."


The UK life sciences industry has been one of the most successful globally. Spanning medical devices, medical diagnostics and pharmaceuticals, through to synthetic and industrial biotechnology industry, the life science sector is high-tech, research-intensive, innovative and highly diverse. Data from the Bioscience and Health Technology Database shows that, in 2014, the UK life science sector consisted of almost 5,000 companies employing 183,000 people and generating over £56 billion of turnover from sales into the UK and overseas. In December 2011, the Prime Minister launched the 'Strategy for UK life sciences’ and this was subsequently incorporated in the Government’s Industrial Strategy in 2012. The Strategy stresses that the UK is "Europe's leading destination for inward investment in the sector".

EU legislation and regulation holds the potential to facilitate collaboration and innovation across the 28 member states through harmonising the procedures under which research, and the commercialisation of that research, is conducted. It is not currently clear, however, if such benefits are being fully realised or whether other factors, such as overly prohibitive regulations or the inconsistent application of those regulations across the EU, are limiting UK innovation in the life science sector. As the Government seeks to "renegotiate the United Kingdom’s relationship with the European Union and pursue reform of the European Union for the benefit of all member states", as well as reduce the "burden of excessive EU regulation" the Science and Technology Committee wishes to examine more closely the impact of EU regulation and policy on the UK life sciences sector.

The Committee welcomes submissions by 4 March 2016 on the following issues:

  • What are the key EU regulations and frameworks that govern/influence the conduct of research and innovation in the UK life sciences?
  • In what ways do these EU regulations affect the UK life sciences? What are their benefits and the drawbacks?
  • How transparent, consultative and evidence-based are EU policy-making processes?
  • To what extent is the UK able to shape regulatory processes at the EU level that affect the life sciences?
  • Is the UK able to depart from the application, standards or timing of such EU regulation?

Submitting written evidence

Submit written evidence via our inquiry page.

The personal information you supply will be processed in accordance with the provisions of the Data Protection Act 1998 for the purposes of attributing the evidence you submit and contacting you as necessary in connection with its processing. The Clerk of the House of Commons is the data controller for the purposes of the Act. We may also ask you to comment on the process of submitting evidence via the web portal so that we can look to make improvements. If you have any queries or concerns about the collection and use of this information or do not wish your details to be used for the purpose of collecting feedback, please advise the Committee at [email protected] providing your full name, address, and if relevant your organisation.

Further information

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