Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 — House of Lords, 2020-12-02
Topic: Health
James Bethell (Conservative, Centre-right): My Lords, I am enormously grateful for the penetrating and thoughtful questions on this important set of SIs. There were far too many for me to be able to cover them in all the detail they deserve this afternoon, but I will undertake to write to noble Lords if I have failed to address any specific questions I start by sharing with the noble Lord, Lord Blunkett, the very positive vibe he gave out about the vaccine. He is entirely right that I have been at this Dispatch Box answering questions on PPE, test and trace and all manner of government challenges, but today is a great day. I do not want to bang on about it, but it is a huge relief to see the authorisation of this vaccine: it is a huge triumph for medical science and a massive breakthrough for humanity. I cannot help emoting so positively on it On the precise procedures used, I reassure the noble Lord that, in fact, the procedures used for the authorisation of this vaccine were exactly the same as those we could have used, and do use, under current EU regulations—as he probably knows. Those will change at the end of the month, but, as he probably knows, in October, we brought in specific regulations to allow us to have this opt-out procedure. I pay tribute to the EMA, which is a fantastic regulator with which we intend to work extremely closely. I pay enormous tribute to the MHRA, which has worked with phenomenal diligence, enormous scientific insight and great precision and confidence in order to get this authorisation done so promptly. Dr June Raine, who runs the MHRA, has done a fantastic job, and we should be extremely proud of the role of British regulation in this matter On a serious point, this incident demonstrates some of the benefits that will come to Britain’s life sciences industries from the transition. As noble Lords will know very well, we are not planning a massive divergence from either the EMA or the cohort of other regulators—the FDA and others—on a large number of matters. In fact, we have a huge amount of respect for our partners in other countries, especially the EMA. However, in the areas of innovative medicine, where there are new techniques and novel science, and where thoughtful, rapid processing makes a huge impact on the velocity of innovation and where expertise and scientific insight are particularly important, Britain can make a difference. This is where the MHRA will help not only British industry but all of humanity. I very much look forward to reporting back to the House on the progress that we can make in that area There have been a large number of questions from noble Lords on whether we are ready for these changes. I assure all noble Lords that we are in great shape. We are in constant liaison with industry and I have regular phone calls, meetings, webinars and bilaterals with industry to ensure that things are in good shape. When it comes to batch testing, which was raised by the noble Baroness, Lady Wheeler, the stockpiling of medicines, and the other matters raised, I can assure noble Lords that we are indeed in good shape. The noble Baroness asked specifically about our conversations with the DPRRC; I cannot give precise answers to her detailed and very reasonable questions, but I will write to her I am particularly abreast of the matter of stockpiles, having presented to the Project Defend board earlier today for three hours. I assure noble Lords that the Government are considering the resilience of the country as we approach not only the transition, but also the ongoing pandemic and the winter, simultaneously. We are in very good shape. There is a nationwide, government-wide project to ensure that we are truly resilient. In terms of health provisions, this means not only having stockpiles, but also strengthening our relationships with our suppliers, ensuring the provenance of those supplies and, where necessary—I emphasise that—building up domestic supply. Phenomenal progress has been made regarding medicines and devices, as well as PPE, which typically one associates with production in Asia. We are currently producing more than half our PPE in the UK, and it is possible that we will be producing more than that The noble Baroness, Lady Wheeler, is entirely right about the MHRA. We have a winning organisation there, but the emphasis and pressure on it going forward will be extremely important. I assure her that I have regular meetings with the MHRA through the spending review, and its financial plans have been gone through with a fine-toothed comb. Both the MHRA management and the policymakers at the department are reassured that the budgets and the human resources are in place for the MHRA to step up to that challenge These are important regulations. I am extremely grateful for the scrutiny that noble Lords have given them and, in that spirit, I commend them to the House.