Medicines and Medical Devices Bill

Baroness Masham of Ilton Excerpts

Committee stage & Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords
Monday 19th October 2020 Grand Committee

[Baroness Walmsley (LD) [V]]

My Lords, Amendment 3 makes clear the desirability of alignment with the EMA and the EU clinical trials regulations. It sets out early in the Bill the store for those of us who feel that the advantages we have gained from such alignment must not be sacrificed on the altar of some mistaken ideology of this failed Government. I point out to the noble Lord, Lord O’Shaughnessy, that we managed to introduce the HPV vaccine before we left the European Union.

Amendment 22 attempts to define the rather vague expression “attractiveness”. We have other definitions in later clauses; we certainly need to choose one of them but I will leave my preference for a later debate.

I support Amendments 34 to 39 to Clause 4 on clinical trials. As my noble friend Lord Sharkey pointed out, they tighten up the wording in the Bill to emphasise the benefits and avoid the damage of diversion from EU clinical trials regulations. British patients benefit from alignment, British bioscience research and development benefits, and the whole system is worth millions of pounds to the Exchequer. I and other noble Lords have received briefings from a number of organisations working on behalf of patients, such as the British Heart Foundation, emphasising that any diversion from these regulations will affect the rapid availability of new medicines and treatments to British patients. They are also concerned to protect the large amount of EU research funding that they currently receive. Diversion could also affect, to use the Government’s favourite word, the attractiveness of the UK as a place to conduct clinical trials. The problem is that the Government have not told us what they might want to change unilaterally in future, as a number of noble Lords have pointed out. I invite the Minister to tell us now.

Amendment 39 asks the Government to establish a clinical trials portal that aligns us with the EMA regulations for medicines for rare diseases. This is particularly important if we are independent from the EU as our population of 68 million is so much smaller than the EU population of more than 400 million, which would make it harder to find a big enough cohort of people with rare diseases for a clinical trial. The noble Lord, Lord Patel, pointed that out.

The EU clinical trials portal, which will come into play with the new and improved EU clinical trials regulations in 2022, was to a great extent designed by British participants. This shows how important it is considered to be by British scientists because it makes applications for clinical trials so much easier and less time-consuming. In its previous inquiry, the Science and Technology Committee heard from a number of witnesses about the issues with the current system, which wastes a lot of their time. So, like the noble Lord, Lord Lansley, I feel sad to know that we will be out of the system by the time the improvements are put in place.

Our current alignment also encourages British scientists to go abroad to broaden their expertise and EU scientists to come here and become part of our very successful research teams. I know the Government are in favour of that because I heard Amanda Solloway, the Science Minister in BEIS, say so last week to your Lordships’ Science and Technology Select Committee. I hope, therefore, the Minister will be minded to accept the amendment.

[Baroness Masham of Ilton (CB) [V]]

My Lords, I support this group of amendments, especially Amendment 22, but I first congratulate the Minister on his stamina and enthusiasm at this incredibly difficult time. I hope he will be able to answer some of our questions.

I spoke at Second Reading of the need to provide an attractive life science environment for researchers coming from abroad. If we are to recruit the brightest and the best to work in research and clinical trials with the highest standards, we must improve. How will this be achieved? Should they not feel welcome and needed?

Can the Minister assure your Lordships that there will be no barriers to access to medicines for UK citizens?

How can we still have a regulatory leadership role following the UK’s exit from the European Union and the European Medicines Agency? We must not become isolated. I hope we will still collaborate with the EMA and other international regulators. We desperately need new medicines for the very rare diseases. There is nothing more frustrating than other countries having medicines which are denied to people living in England.

I hope the Government will accept the need to incorporate these points, which have been expressed today, to make the Bill clearer and more positive and will put their own amendments down on Report to further improve it.

[Baroness Sheehan (LD) [V]]

My Lords, I will speak to Amendment 125 in the name of my noble friend Lady Jolly. Like other amendments, it aims to probe the Government on their plans for future regulatory alignment with the European Union following Brexit. It also seeks to ensure that we seek full membership of any bodies or agencies that help safeguard regulatory alignment and standards in medicines and medical devices.

The EU and UK markets for medicines and medical devices are closely linked. According to the Association of the British Pharmaceutical Industry, at least 45 million packs of medicines are exported monthly from the UK to the EU, and 37 million packs come the other way. The UK also relies heavily on the EU for its supply of medical devices, with more than half of its 5 billion imported medical technology originating in the EU.

The European Medicines Agency provides a centralised approval procedure for licensing to allow pharmaceutical companies to submit a single marketing authorisation which, once granted, is valid across the EU and EEA. Given its role in harmonising the regulation of clinical trials, about which we have heard much during this debate, it is clear that divergence would have a major impact on people in the UK and the EU. With respect to medicines, should the UK develop a significantly different regulatory process to the EMA for medicines regulation, the increased regulatory burden on pharmaceutical companies could lead them to prioritise the much larger EEA market over the UK’s. This could cause delays in new drugs being made available for patients in the UK and vice versa. What is the Government’s analysis of potential delays? Is it in the order of 12 to 24 months, as some have said?