Medicines and Medical Devices Bill — House of Commons, 2020-03-02
Topic: Health
Jonathan Michael Graham Ashworth (Labour, Centre-left): We do not intend to divide the House on the Bill this evening. We understand the need for the Bill because its purpose is for the UK Government to take the powers they need as a result of Brexit. In that respect, we broadly support the principles of the Bill, and we offer to work constructively with the Government on strengthening and improving aspects of it. I have a couple of remarks to make that are related to this, but not to the exact contents of the Bill May I start by saying that we all know, not least because of the coronavirus outbreak, that disease knows no borders and defeating disease cannot be done in isolation? International co-operation and research and development are vital and must be accelerated, not hindered. Will the Secretary of State—or indeed the Under-Secretary of State for Health and Social Care, the hon. Member for Bury St Edmunds (Jo Churchill), in her winding-up speech—explain or comment on the press reports today suggesting that the UK is not seeking to participate in the EU pandemic preparedness measures, which may obviously help in relation to coronavirus and other future outbreaks I am of course talking about the early warning and response system. It was suggested in The Daily Telegraph today that No. 10 had overruled the Secretary of State. Since then, a former Minister, Baroness Blackwood, has told Sky News: "My advice while I was in there was that I thought it was absolutely appropriate that we should stay engaged with that system… I think this is something that the EU would want to maintain and we as Britain should seek to maintain." I agree with her. I believe it would be foolhardy to pull out of something like this at the best of times, but to do so at the time of an outbreak such as this is surely putting narrow dogma before the public health of the country. I would be grateful if the Minister responded on that Secondly, we also learned at the weekend that the UK will not participate in the unified patent court, which will make developing medicines here in the UK more expensive, not cheaper and easier, and it may make doing clinical trials here less attractive. The Government have done lots of briefing on this Bill, but over the weekend they slipped it out while briefing trade magazines that the UK will not be seeking involvement in the unitary patent system. Again, that is disappointing, and I would welcome some remarks from the Minister on that front when she sums up However, this Bill is important, and we do not want to see anything that undermines what has been built up over many years in the United Kingdom. We do have much to be proud of in the field of medical innovation. We have long history of taking a leading role in scientific advance and novel trial design. Indeed, the recent deal to give NHS patients early access to a new cholesterol treatment demonstrates that the UK is already a world-leading destination in which to develop cutting-edge treatments. We want to build on that, not undermine it Members across the House will be aware that our pharmaceutical industry is the single largest private sector investor in UK R&D and provides many jobs across the country for many of our constituents. We should be proud of that sector and of the contribution that life sciences make in providing access to the most cutting-edge treatments. We should be proud that they are vital to economic growth, enhance UK productivity and ensure prosperity for the future Yet while the opportunities before us to develop medicines and medical devices are transformative—both saving lives and radically improving the quality of life for those with the most debilitating of conditions—we also know that things can go wrong. There must never be any compromise on patient safety. Patients put their trust in practitioners, literally trusting them with their lives, and they rightly expect medicine and medical devices to be safe, yet too often in recent years the system has failed patients For many years, long before I acquired the health brief in my party, I worked closely with a constituent, Emma Friedmann, who has campaigned for justice for women whose children were impacted by sodium valproate. Members from across this House have spoken with passion and eloquence on behalf of women affected by Primodos. Equally, we have heard heartbreaking stories in this House about the surgical mesh scandal. My hon. Friend the Member for Washington and Sunderland West (Mrs Hodgson), the shadow Minister, has been one the leading campaigners on this issue, along with colleagues across the House. We eagerly anticipate the Cumberlege independent medicines and medical devices review, but there have been other scandals too—breast implants, hip replacements—that are not necessarily covered. We would welcome an update from the Minister about that review and some remarks on whether the Government expect to implement its findings My point is that a robust regulatory framework for medical devices to protect patients and users is paramount. We will be testing this Bill to ensure that it provides the safety standards that our constituents deserve, while at the same time ensuring it is forward looking enough to be the correct framework to capture the fast pace of innovation in this field, which the Secretary of State mentioned. However, I believe that the existing regulatory framework has become complex and, arguably, unwieldy. The House will be aware that much of the regulatory landscape derives from EU directives that have been implemented in domestic legislation. At the end of the transition period, these frameworks will be preserved as retained EU law, but as I understand the Bill, the Secretary of State is proposing to take delegated powers to allow these existing regulatory frameworks to be updated without the need for primary legislation. The Bill requires the Secretary of State, as he said, to have regard to the safety and availability of medicines and medical devices, as well as to the attractiveness of the relevant part of the UK with respect to the life sciences sector. We argue that that attractiveness clause could benefit from some definition, and it would allay concerns if the Government accepted an amendment in Committee to indicate that the Secretary of State, or some other appropriate authority, would always prioritise safety The overall effect of the provisions is to confer on the Secretary of State an extensive range of delegated powers to make regulations that span the manufacture of medicines, marketing and supply, falsified medicines, clinical trials, fees, information and offences, and emergencies. That extensive range of powers risks inadequate scrutiny of what will become major policy decisions, and in Committee Labour will press Ministers to support time-limiting those delegated powers.