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?
These are three very lengthy SIs, and I am now moving on to the second, on clinical trials. The Minister will be familiar with the views and concerns of noble Lords across the House on this crucial issue, which were forcefully expressed during debates on the EU withdrawal Bill, and their concerns that the new EU clinical trials regulations, which the UK played a leading role in developing, will not be in force on the current EU exit day. All the organisations currently involved in conducting clinical trials urgently need the certainty of the Government’s implementation of their promise to ensure speedy alignment with the CTR in the UK after the EU adopts the new regulation being enacted without delay after Brexit. The draft SI recorded this commitment and the priority the Government promised to give to it, but it is not addressed in the SI. The commitment is to be,
“delivered through a separate legislative vehicle which will be brought forward when the application date of the new Regulations is known”.
Will the Minister explain what procedures and timescales are envisaged once it is known? What advanced planning work is taking place on this vital issue?
The regulations require all interventional clinical trials to be authorised by the MHRA as the national competent authority in the UK, to have favourable ethics opinions and to be conducted in accordance with good clinical practice. The requirements for the assessment and supply of investigational medical products—IMPs—and for safety reporting are also crucial. However, agreement has still to be reached in negotiations on the UK’s participation in the single assessment process and on access to the portal and database that underpin this regulation. No access to the portal would severely reduce the ease of UK-EU trials set-up and cause severe damage to our life sciences industry.
Urgent negotiations on access to the EU’s current trials portal and database are vital to ensure that the UK remains a global leader in medical research and pioneering clinical trials and to provide the certainty that is needed for researchers and patients. We know there are concerns that, because the UK will be seen as a smaller market for new drugs, companies will be more likely to prioritise the authorisation of new drugs in the EU rather than in the UK. What assessment have the Government made of this risk?
Will the Minister tell the House what the implications of no deal would be for clinical researchers who are EU nationals? Will the UK be eligible for EU funding for clinical trials in a no-deal scenario? The MHRA will have power to publish its own guidance on clinical trials applications and on ethics committee consideration and opinion, as well as declarations of the end of clinical trials and the content of documents forming trial master files. Could the MHRA continue to work with EU states in order to keep regulation in line with the EU? Will the Minister review important details such as ethics when concerns are raised?
In his previous role, the noble Lord, Lord O’Shaughnessy, promised that, in the event of no deal, the new systems would not impose additional bureaucracy. The jury is out on whether these regulations will meet that challenge, given the scale, size and risks of what will need to be undertaken if we crash out of the EU.
Finally, the medical devices regulations bring into sharp focus many of the issues raised in last week’s excellent debate on the safety of medicines and medical devices. We have more than 200 pages of regulations, aiming to cover the key elements contained in existing EU regulations, which ensure the safety and quality of general medical devices, active implantable medical devices and in vitro diagnostic medical devices, and we have the commitment made by the noble Baroness, Lady Blackwood, in that debate, which was repeated today, that after Brexit the Government intend fully to align the UK with the new EU medical in vitro diagnostic devices regulations that will come into force after the UK leaves.
Again, it is intended that there will be an enhanced role for the MHRA, and the questions to the Government on the earlier statutory instrument on MHRA resourcing, expertise and capacity to carry out the new tasks need to be re-emphasised here. What plans are in place for increasing and recruiting MHRA staff with the specialisms and expertise that will be needed for its new roles and responsibilities, particularly under a no-deal Brexit scenario? The BMA has already warned about the skills gaps in pharmacovigilance to support discovering and verifying adverse events in the development of medical devices, such as the surgical mesh implants we heard about last week that caused terrible suffering to patients. How are these and other skills gaps that will arise from the loss of expertise as a result of the EMA’s move from the UK to be addressed?
The regulations mean that in a no-deal Brexit the UK’s current participation in the European regulatory network for medical devices will end, with the MHRA taking on those responsibilities and having a strengthened market surveillance and assurance role. All medical devices, including active implantable medical devices, IVDs and custom-made devices, will need to be registered with the MHRA prior to being placed on the market so as to ensure that the agency can become a stand- alone regulator. After a no-deal exit, does the Minister really believe that the MHRA, as currently staffed and constituted, will be able to take on its extensive new role and responsibilities?
On data exchange, no deal will mean that the UK no longer has access to key EU data systems, including the European Databank on Medical Devices, which is to be overhauled and enhanced under the new EU regulations to be bought in after the UK has left. The new enhanced Eudamed database will include key data on CE certificates, incidents, clinical investigations and market surveillance, all of which we will have no access to. Not to worry, though, because the regulations assure us—as the noble Baroness did today—that the MHRA is building is own electronic system to mirror Eudamed requirements. Has work begun on this yet, and what costs are involved in the replacement and development of this and other EU IT database systems that we will no longer be able to use?
On data collection, the Government have said that they are considering the establishment of a national medical devices register, and that has been welcomed by the Royal College of Surgeons. It would be helpful if the Minister could tell the House what progress is being made in the consideration of this. The RCS has stressed that all new surgical procedures and devices should be registered, with related data collected, before they are routinely offered to patients, and that implantable devices should also be registered and tracked to monitor efficacy and patient safety. It also supports the conducting of clinical trials for medical devices wherever possible. In many cases this would play a crucial role in improving patient care and in testing the safety and efficacy of new innovations.
Finally, in last week’s debate we heard from the noble Baroness, Lady Cumberlege, the chair of the Government’s Independent Medicines and Medical Devices Safety Review, about the review and its work so far, talking to patient groups about their concerns and experiences. The review was welcomed by noble Lords and is due to report this year. How will these new arrangements be considered by the review?