Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 — House of Lords, 2019-09-30
Topic: Health
James Bethell (Conservative, Centre-right): My Lords, I thank noble Lords for a stimulating debate in the exciting area of medical SIs. I also thank noble Lords for the warm welcome they have given me. It is a thrill to be here The noble Baroness, Lady Thornton, put it very well: this SI is technical but vital. It is vital for those who depend on these medicines and devices for their health and well-being. It is also important for the businesses in Britain that the noble Lord, Lord Rennard, referred to, which have exciting, innovative and important inventions that they are trying to sell on a world stage. Getting this right is a big priority for the Government When I look through the SI and the detailed changes it includes, I must admit I have a slightly different sensation. As a neophyte, what I find remarkable is how small and detailed the changes are, and how much hard work must have gone in to getting this right—or more or less right—in the first place. I commend the House for the contribution it made to the scrutiny of these important SIs when they came before us earlier this year and also the officials who have turned an incredibly difficult challenge of Brexit into something that is clearly workable and has passed the scrutiny of a large number of organisations Safety and security are massive priorities for the Government; I very much want to convey that to the House. The Government are fully committed to a system of medicines and medical device regulation that intelligently balances patient access to new, innovative, world-leading products on the one hand with an assurance of acceptable safety. The MHRA will have in place a suite of licensing routes for medicines and vigilant systems for medicines and devices. We are committed to offering a competitive regulatory environment to ensure that the UK has access to medicines and devices meeting high standards of safety and efficacy. This SI makes technical amendments to achieve these aims, which are important and necessary I will take a moment to answer a couple of the questions that came up. The noble Baroness, Lady Thornton, asked about resources and regulations taking effect. I reassure her that, as I stated, this SI makes minor changes to the SI made earlier this year. The Government are confident that the hard work put in by the MHRA has made it ready for this challenge. It has an impressive roster of staff in place to step up to the work The noble Baroness also asked about EU legislation currently in force and what will happen when we leave the EU. The noble Lord, Lord Rennard, asked similar questions. I reassure noble Lords that all relevant EU law will be retained EU law for the purposes of the European Union (Withdrawal) Act 2018. Much of it has already been transposed, including the human medicines regulations and the medical devices regulations Questions were raised about the important NAO report, which the Government take very seriously. I reassure the House that the Government are taking every possible step to ensure the uninterrupted supply of medicines in the event of a no-deal Brexit so that patients continue to receive the medicines they need. We are working closely with suppliers to put in place stockpiles, reroute supply chains and ensure medical freight companies are ready for any changes to customs procedures Our guidance to suppliers is that there should be at least six weeks’ stock of prescription-only medicines, pharmacy medicines and medical devices. However, stockpiling is only one part of our approach, as some medicines have short shelf-lives or are tailored to individual patients. An example of the kind of measure we are putting in place is that we have supported suppliers to test and secure new routes. We are working closely with the Department for Transport on precuring our own dedicated health channels for critical products needed within a 24 to 48-hour timeframe The noble Lord, Lord Rennard, asked particularly about duplication. The UK has put in place an innovative licensing route to ensure that companies, particularly innovative companies, have a route to market that is efficient, cost-effective, speedy, effective and trusted. This allows them to produce their products on to the UK market at the same time as the EU. They will simply have to provide the MHRA with the same information as they do to the EU. The architecture for this was designed specifically to avoid duplication The MHRA intends to provide free scientific advice for UK-based small and medium-sized enterprises and to introduce a new targeted assessment, as well as an accelerated assessment route to enable licensing more quickly than the EU. It is very much part of the principle of the Government’s approach to Brexit that we want to have a competitive regulatory environment, particularly in life sciences, that gives companies the chance to compete effectively on the world stage My noble friend Lord Lansley reminds us that huge changes in this exciting industry have nothing to do with Brexit at all. In fact, Brexit is not the only challenge. There are massive regulatory innovations across the industry. He makes a strong argument to delay the implementation by the EU of new medical device regulations. I reassure my noble friend that I will certainly pass this up the line and ensure that the MHRA is made aware of his concerns This SI is detailed and was put before the House promptly before the summer. I believe that we all agree that it is important in its intent. For that reason, I beg to move.