European Union (Withdrawal) Bill — House of Lords, 2018-03-12
Topic: Health
Matthew Ridley (Conservative, Centre-right): My Lords, I have added my name to this amendment. Unlike many amendments to the Bill, this one really is intended to be helpful to the Government and the Bill. Unlike many, it has a genuine point to make and is not merely an excuse to filibuster. Unlike some speeches in support of the amendments, when I say I shall be brief I shall mean it As the noble Lord, Lord Patel, says, the Prime Minister’s speech 10 days ago removed the need for lots of amendments to the Bill. In saying that we intend to join or align with the European Medicines Agency if possible, I think she has effectively indicated that the amendment is welcome. However, it is worth pressing the point briefly to get clarity. The background, as the noble Lord, Lord Sharkey, has said, is that the EU passed a disastrous clinical trials directive in 2004, destroying much of a thriving British clinical trial industry almost overnight—a crown jewel of our world-leading biomedical sector. It was not one of Brussels’ finest hours. None the less, the UK remains the leader in Europe and one of the leaders in the world in discovering, developing and testing new treatments for diseases, thanks to our strong pharmaceutical industry and our superb academic sector The UK’s MHRA—I shall not spell it out; we know what it stands for—in particular has been instrumental in designing and delivering a robust regulatory environment across the EU, providing an attractive and harmonised framework for clinical trials. It is the senior agency relating to the EMA. This includes reviewing the shortfalls of the clinical trials directive and putting its considerable expertise towards drafting the new clinical trials regulation that is coming along to undo some of the harm done by the 2004 directive. We have already agreed to the CTR in full but, as the noble Lord, Lord Patel, says, due to a minor delay we risk not only failing to adopt its vastly improved principles in data sharing and expedience but, in the process, losing alignment with our European partners on vital shared research. The CTR will be applied in late 2019, as opposed to this year as originally planned. It will therefore not be covered by the EU withdrawal Bill as it stands. The resulting uncertainty is already having an effect. Clinical trials can run over many years and require significant planning. Uncertainty is already having consequences The Government have sent out strong signals that the UK should be a leading centre for the life sciences through the life sciences industrial strategy and associated sector deal. Aligning with the CTR and allowing collaboration to continue to underpin the UK’s thriving research sector will help the Government to achieve that ambition. I and many others are rightly concerned about new regulations that could come in during the implementation period that the UK will have no say in. The clinical trials regulation is categorically not one of those. It was devised with enormous input from British research expertise, was fully agreed to by British representatives in the EU and is regarded as a significant step forward for the governance of cross-national clinical trials. So I hope the Minister will be able to reassure us and the vital biomedical sector in this country by clarifying that we will align with the CTR, as implied by the Prime Minister 10 days ago.