Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 — House of Lords, 2019-03-07
Topic: Health
Margaret Eileen Joyce Wheeler (Labour, Centre-left): My Lords, I thank the Minister for introducing these three EU exit instruments on human medicines, medicines for human use in clinical trials and medical devices, two of which are long, complex and tortuous documents full of technical guidance and information and new schedules—so much so that the relatively short and straightforward clinical trials SI comes as light relief. Thank goodness for the Explanatory Notes It is hard to see how even the most enthusiastic advocate of separating ourselves from the EU and going alone on such crucial medical treatment and patient safety issues and provisions on which we have worked for so long in partnership with the EU, to mutual benefit, can view these instruments with any enthusiasm, clarity and certainty about the efficacy and quality of what is to replace the current arrangements, particularly in the event of a no-deal Brexit The human medicines and medical devices regulations were considered in the Commons yesterday, and a range of issues and concerns were raised that will need to be addressed. There is no time today to raise all these issues, but I can assure the Minister that we will vigorously pursue these key matters at every opportunity in the future. The regulations we are discussing now are nearly or over 200 pages long, cover several EU directives and cannot possibly be read in the time left before so-called Brexit day, let alone debated and scrutinised sensibly. We therefore place on record our deepest concerns that the process for these regulations is not as accessible and transparent as it needs to be The first SI, on human medicines, makes amendments to legislation and the regulation of medicinal products for human use. It allows the UK licensing authority, acting through the MHRA, to operate the functions previously carried out by the European Medicines Association and other EU bodies and procedures and to function as a stand-alone regulator in the event of a no-deal EU exit Sadly, as a direct consequence of Brexit, the European Medicines Agency has relocated to Amsterdam. Indeed, it closed its London offices at the start of this month. However, we know that in a post-Brexit scenario, deal or no deal, there must be a strong and close relationship and alignment with the EMA to protect UK patients’ swift access to new medicines. As Cancer Research UK has pointed out, without an agreement to participate fully, licensing could be disrupted and there could be serious delays in life-saving medicines reaching UK patients Paragraph 2.5 of the Explanatory Memorandum to the statutory instrument contends that the MHRA as a stand-alone regulator will be able to, "ensure patient access to safe and effective medicines as well as monitor the ongoing safety of those medicines and where necessary to protect patients" Can the Minister explain how this is to be achieved, particularly in the transition period when the new UK processes and structures are being established, or in a no-deal scenario I understand that the MHRA will not be able to act as the lead authority on marketing authorisation applications for new drugs in the transition period. Without the ability to act as a lead assessor, there could be ramifications for patients around Europe, given the loss of MHRA capacity and expertise, which could undermine the UK’s world-leading life sciences environment With regard to supply, it is imperative that we retain the uninterrupted movement of medicines and medical supplies between the UK and EU in any eventuality. Pragmatic government and industry planning to secure the supply of medicines in the short term is vital, but any delays in cross-border supply as a result of new customs or regulatory checks would be damaging, especially for novel medicines that are not easily stockpiled Specifically on serious shortage powers—SSPs—this contingency legislation enables regulations to be made to modify the application of the 2012 regulations to deal with a serious shortage of medicinal products, which, as we know, is a matter of great public interest. That would replace the regulation-making power in the European Communities Act 1972 for certain limited purposes and ensure that the Government continue to have the power to make temporary changes to the 2012 legislation in a no-deal scenario. Is this not yet another example of Ministers being given Henry VIII powers over regulations if they think there is an urgent need because of shortages? Does the Minister anticipate a doomsday scenario in which it will be necessary to use these powers, or are the Government saying that they do not anticipate any problems but need the powers anyway? Will the Minister outline how the process will be handled if there are shortages and what scrutiny will be available for decisions made under it? Will the Minister also say how the Government intend to secure the supply of novel investigational medicinal products—IMPs—used in clinical trials? The regulations for them are also under consideration today. Many of the IMPs used in CRUK trials would prove very difficult to stockpile and would suffer from delays at borders, causing significant disruption to trials Finally on the first set of regulations, will the Minister acknowledge the serious concerns in the NHS and in the pharma and biotech industries about the MHRA’s announcement that the falsified medicines directive will not apply in the UK under a no-deal Brexit? Not only would we have no access to key EU-wide safety databases and checking systems, but the tougher rules to ensure that all medicines are safe and that trade is rigorously controlled will not apply to us. We were told last month that the Government were evaluating the options for a future framework. Will the Minister explain how interim arrangements will work to protect patients from fake medicines? Will she also respond to the warnings from the UK pharmaceutical and biotech industries about a no-deal Brexit increasing the risk of counterfeit medicines entering the UK and EU supply chains, and the UK becoming a target for counterfeiters? How are the Government going to ensure that the UK and the EU will co-operate on protecting citizens from counterfeit medicines and prevent fake or fraudulent medicines entering the legal supply chain?