Medicines and Medical Devices Bill

Munira Wilson Excerpts

2nd reading & 2nd reading: House of Commons & Money resolution & Money resolution: House of Commons & Programme motion & Programme motion: House of Commons & Ways and Means resolution & Ways and Means resolution: House of Commons
Monday 2nd March 2020 Commons Chamber

[Chris Green]

That is a significant concern. The Government have reduced the starting point in the immigration Bill from £30,000 to about £25,000 and I believe the points-based system will have the flexibility we require, but those areas should be judged and reviewed as time goes on. Certainly in these sectors we want highly qualified, highly skilled and highly experienced people to come to the UK.

One big concern in medicine is data. A lot of what we do in medicine falls into the category of big data: the acquisition, transmission, storage and application of that data. This is a really interesting time for technology. The devices themselves are able to generate good quality data. As has been highlighted, it is now so much easier for personal devices to be worn not just for a few hours or a couple of days, but for a long period of time. People are now able to go about their daily lives in a normal way, whether they are exercising or doing something as basic as having a shower. Some devices could not previously cope with people taking exercise or having a shower, but increasingly, devices are able to cope. They can amass a vast amount of data. It is pretty much impossible for a clinician or a GP to judge such a huge wealth of data, so we are increasingly looking at how GPs and hospital consultants can use artificial intelligence and other methods to give them a helping hand in carrying out the assessments. They might end up with tens of thousands of pages of data and a consultant just will not have time to consider it all. Using artificial intelligence could help them to do the assessments and come to conclusions.

[Munira Wilson (Twickenham) (LD)]

Does the hon. Gentleman agree that all Members, on both sides of the House, still have a big job of work to do with the public to inspire confidence in how their data is used in an appropriate and anonymised way? What he is saying is really important. Data saves lives and can improve outcomes, but there is, understandably given previous experiences, a great deal of suspicion among the public about how their medical data might be used.

[Chris Green]

That is an incredibly important point. We need confidence that when data is taken, it is secure, protected and anonymised in the appropriate way, and that only the right organisations have access to it. I believe that data is a key area for the NHS and what it ought to be able to deliver. The NHS should be a huge repository of data, and universities, charities and businesses, with the appropriate controls, ought to be able to use it. As we move on—perhaps a particular aspect relates to rare conditions—the size of population needed in order to gather and analyse that data will increase. I hope my hon. Friend Minister will take note of this point and perhaps elaborate on it at the end of the debate. We need to ensure that our relationship with the EU will enable us to continue to collaborate on clinical trials and that data transmission across the European Union, and across Europe more widely, is efficient and effective.

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[Munira Wilson (Twickenham) (LD)]

I must start by declaring an interest: before arriving in this place, I spent some nine years working in the pharmaceutical industry for two European companies, and I continue to hold a small number of shares granted to me by Novartis Pharmaceuticals Ltd.

Although I and my party support this legislation, clearly it is important that the UK should have the ability to regulate human medicines, veterinary medicines and medical devices following the end of the transition period. It will not surprise Members to hear me say that we believe it is extremely regrettable that we are even in this position in the first place. Clearly, in terms of ensuring that British patients have safe and swift access to medicines and medical devices, and ensuring our life sciences industry continues to remain competitive, our interests would have been best served by staying in the EU. That is why we will continue to fight tooth and nail against a hard Tory Brexit, despite the reckless and threatening approach to negotiations being taken by this Government. A hard, no-deal Brexit at the end of this year could spell catastrophe for British patients and the life sciences industry.

My main concern is that the provisions of this Bill could allow for significant regulatory divergence for medicines and medical devices from the rest of the EU. The medical research community and manufacturers are united in their call for the UK to remain as close as possible to the EU, preferably through negotiating associate membership of the European Medicines Agency. Any divergence from European regulation should take account of three principles: patient safety; early access for British patients to the latest innovations; and the competitiveness of the UK life sciences sector. In using the powers of this Bill to seek any divergence from the European regulatory framework, the No. 1 consideration should always be protecting patient safety. Any bid to make a UK stand-alone regulatory system more competitive than Europe must not seek to undercut the EU in safety standards, be that in terms of clinical trial regulation or the hurdles a new medicine, vaccine or device must clear to secure marketing authorisation or accreditation in the UK.

I would also take this opportunity to urge Ministers to consider, as they enter into negotiations with the EU, the critical and indeed life-saving importance of remaining part of the EMA’s pharmacovigilance network. By collecting and sharing real-time data on approved medicines, the EMA is able to identify trends and quickly take actions to inform patients and health professionals about safety concerns. By remaining part of a network across 28 countries rather than just the UK on its own, our network would have far wider coverage, with a far greater number of patients using a drug, thus increasing the likelihood of the data collected being more accurate, and concerns being picked up at an earlier stage. Related to that point, I wish to highlight the shocking and wanton disregard for public health and safety that we have heard from the Government about wanting to withdraw from the EU’s early warning system on pandemics, given the serious global challenge we face on coronavirus. Even the Government’s former Minister Baroness Blackwood has been saying in the media today that that is not the way forward to ensure that we protect patient safety. We all know that disease knows no borders, so it is ridiculous and isolationist, as the hon. Member for Central Ayrshire (Dr Whitford) has said, to withdraw from that system.

The second principle to consider when using the powers within this Bill to diverge from European regulation is ensuring that British patients continue to have swift and early access to the latest innovations. I welcome the Government’s intention to use these provisions to ensure that NHS hospitals are able to manufacture and trial the most innovative new personalised and short-life medicines. The UK should be at the cutting edge of supporting those pioneering new treatments to be made available to British patients. However, we must not forget that the vast majority of medicines, and indeed devices, coming through the pipeline are not in that category. Any significant divergence from the EU regulatory framework will inevitably lead to delays in new technologies being made available to British patients.

As has been mentioned, the maths is obvious: the EMA covers 25% of global medicines sales, whereas the UK on its own makes up only 3%. Companies are likely to submit applications for new drugs to the EMA before the MHRA, meaning that UK patients risk having slower access to the latest medicines—we see this with Switzerland, Canada and Australia already. How will the Government ensure that the MHRA’s processes remain among the fastest in the world, while maintaining patient safety? The hon. Member for Newton Abbot (Anne Marie Morris) implores us to be a leader in that regard, not a follower, but it makes no commercial sense for us to be outside the European regulatory framework. I know that from my personal experience of working on the dreaded Brexit taskforce when I was in industry. My European regulatory colleagues were not in the slightest bit interested in helping me and British colleagues define, and then represent to Government, what a competitive new divergent system might look like. Understandably, commercially their priority was and remains the 445 million inhabitants of the other EU27, as opposed to the 66 million or so in the lone ranger that is the UK. That point is not lost on Cancer Research UK, which has specifically called for clause 2(1) in part 1 of the Bill to be used to facilitate UK recognition of and participation in the EMA’s medicines licensing processes.

One of the earliest ways that patients gain access to the latest innovations is through clinical trials. The Bill could be used to amend the regulations that govern clinical trials in the UK. It is worth noting that the number of trials conducted in the UK has fallen since 2016, with the UK falling behind the USA, Germany, Canada and Spain for phase 3 commercial clinical trials. Although there is an opportunity to make the UK more attractive for clinical trials, any such opportunity must not come at the cost of patient safety, and high standards should be maintained. Any stimulation of the clinical trial environment must include continued UK-EU collaboration on trials, which is critical for trials involving medicines for rare diseases or children, in respect of which the population in any one country is not sufficiently large for a trial. Furthermore, the EU’s clinical trials regulation, which is due to be implemented in 2022, should accelerate trial setup times, improve safety reporting and facilitate collaborative research, because of the digital infrastructure that underpins it. The UK played a pivotal role in developing the CTR and our patients would benefit greatly from it being implemented here.

My third point is closely connected to my previous point: any divergence from European regulation should take account of the competitiveness of the life sciences sector, which successive Governments have often described as a “jewel in the crown” of UK plc. Our remaining an early launch market by keeping in step with EMA is key to our continuing to attract high levels of foreign direct investment into the UK from pharmaceutical companies. Any additional burden on applying for marketing authorisation for medicines, or a separate system for the accreditation of medical devices in the UK, away from the CE marking scheme, will make the industries less competitive. Also key to competitiveness is the securing of frictionless and tariff-free trade as part of the negotiations with the EU. That is critical given the integrated and complex cross-border supply chains in the manufacture of medicines and medical devices.

To summarise, the Bill is necessary in view of the UK’s unfortunate decision to leave the EU. However, I urge caution on Ministers in respect of how the powers in the Bill are used. British patients must be kept safe, they must be able to access the latest medicines and technologies at the earliest opportunity, and we must not undermine the thriving life sciences industry in the UK. The Government’s quest to make the UK a Singapore-style regulation-light country must not see us undercutting safety standards in a bid to improve our competitiveness. As the Government seek to negotiate a trade deal with the EU, the way to safely ensure that British patients can access the medicines and technologies that they need, and the way to keep attracting industry investment into the UK, is by remaining as close as possible to the European regulatory regime.