8 September 2017
Last week saw the release of the Life Sciences Industrial Strategy report. The report provides a clear – and we think accurate – vision of what policy and infrastructural changes are necessary to make post-Brexit UK a global hub for clinical and medical innovation. However, the strategy contains one glaring lacuna: a plan for regulation.
The report, while giving regulation its own section, has little to say on the topic and certainly offers no cohesive strategy in regard to law. This is particularly troublesome because the Life Sciences sector is one that relies heavily on export to the EU. Indeed, 56% of the UK pharmaceutical and chemical industries’ total exports are to EU countries. Specifically, there are three significant shortcomings in the strategy’s consideration of regulatory issues.
Firstly, the report makes no mention of some key pieces of forthcoming EU legislation, namely: the In Vitro Diagnostic Medical Devices Regulation (IVDR), the Medical Devices Regulation, and the Clinical Trials Regulation (CTR). These pieces of legislation are likely to determine the UK’s fate when it comes to selling medical devices to and conducting clinical research with the EU. The report does stress that the industry is now ‘planning its future outside the EU’. Despite this, a successful future must surely include trade with EU Member States, in which case it is essential that governing EU legislation be included in the strategy. Hence, it is disappointing that an industrial strategy meant to define industry vision lacks any mention of these important pieces of legislation.
Secondly, whilst it does mention the General Data Protection Regulation (GDPR), the report offers little in the way of constructive strategy, or even comment. Contrasting with the bold vision of other sections, the report here only offers the suggestion that the UK should ‘attempt to maintain the current balanced approach to data sharing regulations’. Whilst this is correct, the relative silence on regulatory matters sits oddly with the emphasis on data policy and infrastructure found in the NHS collaboration section. It begs the question: why does regulation – a keystone part of any industrial strategy – contain so little detail?
Thirdly, to its credit, the strategy does outline what future relationship the UK Medicines and Healthcare Regulatory Agency (MHRA) should have with the European Medicines Agency (EMA). It is certainly prudent to consider what relationship the UK would like to have with the EMA. Nevertheless, this relationship will be negotiated for and partially determined within the framework of EU law that the UK either complies or does not comply with. On this basis, compliance with the GDPR and other key pieces of legislation already outlined will be crucial to the shape of the future relationship between the UK and the EMA.
Given the undoubted strength of much of the Life Sciences Industrial Strategy, the dearth of regulatory detail may reflect the current degree of uncertainty with respect to wider Brexit negotiations. However, moving forward, the life sciences industry ignores this legal context to its peril. To quote respected legal commentator, Erik Vollebregt:
‘If your management does not understand this, tell them in these words: the company will not be able to sell products in the EU anymore if you do not get this right in time. Cash flow will collapse, the business will tank, competitors will take your market share, your company may go bankrupt or be acquired by another as the sitting duck that it has become.’
Regulation, as with infrastructure and policy, ought to be an urgent priority if it is to form part of a cohesive industrial strategy. It is to be hoped that a more detailed vision will follow shortly.
PHG Foundation's legal and regulatory specialists are focused on the implications of the GDPR and IVDR for bioscience companies and can offer advice and consultancy to help you ensure that your organisation is equipped to comply.
If you would like to discuss your requirements in confidence, please contact Dr John Chevers