My Lords, I thank the noble Baroness, Lady Wheeler, and the noble Lord, Lord Warner, for their valuable contributions to this debate. I take the opportunity once again to reassure the House that, as a Government, we are fully committed to a system of medicines and medical device regulation which intelligently balances patients’ access to new, innovative and world-leading products. I reassure the noble Baroness that we will continue to work in close partnership with the EU. I stress again that the fundamentals of how medicines and medical devices are regulated and how clinical trials operate will remain the same; I say this very clearly to the noble Lord. We have sought to maintain existing arrangements for the UK’s regulatory system wherever possible rather than create new ones.
I want to answer a number of the questions put to me. At the heart of the questions raised by both the noble Baroness and the noble Lord was the issue of the regulator. I stress that the MHRA brings real expertise to many areas, including the licensing of medicines, pharmacovigilance and clinical trials regulations. This expertise already provides benefits to patients across the UK and the EU. As I said in my opening comments, the MHRA has over 30 years of knowledge as lead regulator on over 3,500 medicines on the EU market. The expertise of its licensing, devices, inspections, batch release and pharmacovigilance regime is globally recognised and respected. We want to ensure that this expertise and our shared experience continues to be of benefit to UK and to EU patients.
On medicines, the MHRA is globally recognised, as I said, for its experience and typically undertakes a significant proportion of EMA pharmacovigilance work and safety referrals. This is already a national route for the licensing of medicines in the UK and, where we collaborate with the EU over licensing, most products ultimately receive a UK rather than EU-level licence.
Clinical trials are managed nationally in the UK by the Medicines and Healthcare products Regulatory Agency. This will remain the case in the event of no deal. The UK will continue to recognise existing approvals for both regulatory and ethics approval—the noble Baroness asked about that—and there will be no need to reapply. She also asked how we will ensure that false medicines do not enter the UK market. I reassure her that the UK’s strict regulatory controls govern the sale, supply, manufacture, distribution and advertising of medicinal products. The potential harm of falsified medicines to patient health is taken seriously across the Government. Combating the real and present threat posed by falsified medicine products will continue to be a priority for the MHRA. The majority of the falsified medicines directive was implemented in 2013 and would remain in UK law even after a no-deal exit. The Government want to retain a close working relationship with the EU, as I have said, to ensure public health across the EU and UK.
The noble Baroness asked about MHRA skills and expertise in relation to any gaps. I have already indicated the MHRA’s immense expertise, and this will not cease. We will continue to ensure that, if there are any gaps, they will be looked at carefully. She asked how the Government would use serious shortage powers in regulations to ensure medicines supply. She will be aware that the Human Medicines Regulations are made under the European Communities Act 1972. If we leave the UK without a deal, we can no longer make regulations under that Act. The amendments made by this SI are necessary so that, if we are faced with a serious shortage of medicines and the need arises to temporarily modify the Human Medicines Regulations to ensure that patients get their medicines, we can do so.
The department has well-established processes for managing and mitigating shortages in collaboration with manufacturers, suppliers, clinicians, the NHS and the Medicines and Healthcare products Regulatory Agency. Temporary modifications to the regulations would be considered only where other options have been exhausted.
On the question of how we can ensure safe, effective medicines in the transition period, I say to the noble Baroness that provisions, including the transition provisions, have at their heart a recognition of the need for safe, effective medicines. The transitional provisions have been carefully developed with this in mind. While, wherever possible, they allow businesses time to adapt, this is not at the expense of safety, quality or efficacy. For example, wholesale dealers who import from the EEA will have two years to put in place responsible persons for import, but checks that qualified person certification has taken place will continue in the meantime.
The noble Baroness also asked about EU funding of clinical trials and participation. The UK will still be able to take part in multinational trials, as I said in my opening comments. The Government have previously confirmed that UK law will remain aligned as far as possible with the new EU clinical trials legislation, which is expected to apply from 2020. Of course, this will be subject to the usual parliamentary approvals.
Both the noble Baroness, Lady Wheeler, and the noble Lord, Lord Warner, asked about the supply of IMPs after exit. IMPs will continue to be supplied direct from the EU to UK sites as they are today and, as I have said, the UK will be able to participate in all multinational trials. The Government are actively working with organisations that run clinical trials to ensure continuity of supply of IMPs. We are also putting in place contingency plans including for access to the same prioritised shipping routes as are available for licensed medicines.
The noble Baroness asked about the review by my noble friend Lady Cumberlege and how these SIs will take account of the new arrangements. The MHRA has provided, and will continue to provide, all relevant information to the review. It has already made written and oral contributions. In the event of a no-deal exit, we will ensure that these regulations and their practical effect continue to form part of that process.
The noble Baroness also asked what plans and resources are in place for dealing with expanded roles for devices. I reassure her that there will not be any radical change in the MHRA’s role in relation to devices. This will be an expansion of what the MHRA already does and, as I said in an earlier response, it has plans to build up its skilled resources.
The noble Lord asked about the industry’s view on the market. There is currently a single EU-wide start date for data exclusivity, due to the reciprocal arrangements and other arrangements of centralised and decentralised procedures, which apply across the EU. Once the UK is no longer part of those arrangements, this single state would no longer apply automatically, and this has the potential to result in delays in new medicines being brought to the UK market.