Medicines and Medical Devices Bill

Chris Green 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 (Bolton West) (Con)]

It is a pleasure to follow the hon. Member for Leicester South (Jonathan Ashworth) and to speak in this important debate. This is an immensely important subject of great national interest. In the context of leaving the European Union, the Bill will allow existing European Union regulations on medicines and medical devices to be transposed into UK law. The Bill is closely linked to the timings of the transition period as we leave the EU—and perhaps to any extension, which we hope to avoid.

I welcome the Bill’s principal thrust, which is to remove unnecessary bureaucracy for the lowest risk clinical trials, to encourage the rapid introduction of new medicines, to ensure patient safety by combating counterfeit medicines, and to extend the UK’s global lead in personalised medicines and artificial intelligence in health. Ultimately, all those concerns link up to what ought to be our principal focus in this debate: better patient outcomes and creating a healthier society.

Many people would be surprised to hear just what a contribution the life sciences sector makes to the UK economy. It encompasses pharmaceuticals, medical devices and medical technology, and it is worth over £74 billion per annum. The sector also employs close to 250,000 people in the UK. Many of those jobs are often secure, and are highly skilled and highly qualified. We will shortly introduce an immigration Bill. It is right that we focus on the skills and the contribution people can make to the UK. Bringing more people to the UK with PhDs and STEM—science, technology, engineering and maths—qualifications ought to complement and enhance the support of our life sciences sector. The more we hear about technicians, engineers and scientists who want to come to the UK, the more it will be a really positive thing not only for the sector but for immigration to the UK as a whole, and how people perceive it.

[Dr Whitford]

Does the hon. Gentleman recognise that young graduates with a degree or a PhD, technologists and researchers often do not earn more than the threshold the Government have set for a visa?

[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.

[Dr Luke Evans]

My hon. Friend talks wisely about big data. Big data can be used to empower patients as individuals. Providing them with more data to understand and interpret, if it is provided in the right way, can empower them to make better choices. After all, the biggest under-utilised resource we have in healthcare is our patients. Healthcare is very doctor-heavy and nurse-heavy. Empowering patients helps them to make better choices. For example, patients with diabetes can monitor their own blood sugar. That has revolutionised the way in which people care for themselves. I would like my hon. Friend’s thoughts on whether he thinks we should explore this area further.

[Chris Green]

That is a vital and well-made point. Data can empower the individual. They can have more detailed access to their own records and their own data. The data generated by someone wearing a device day in, day out, week in, week out can be transmitted to a consultant, who can call a patient more promptly if there is anything a little worrying. If there is a heart murmur or someone feels a bit dizzy, the person can register that concern at that moment. That is useful information for the clinician, who will be able to recognise when someone’s lifestyle has aggravated a condition. There are many ways that the data can be used. I think we are in relatively early days. I am not sure I would include Fitbits and that kind of technology—there is far more interesting and advanced technology—but it is important that people are increasingly engaged.

There is a concern about the embrace of technology, devices and data, and the streamlining of processes in hospitals. The contribution of individuals, GPs and consultants provides an opportunity to consider a more engaged approach to hospital and GP services in a way that could reduce the number of appointments that are necessary. Some hospital trusts have a chief innovation officer on their board. I think there are about 20 across the country, which is a relatively small proportion. It may be worth considering what the Minister can do to promote that. Ideally, we need the early adoption of approved medicines in the system. This is where the register ought to help. If we can have people in hospital trusts leading and championing the adoption of new technologies, providing information and insight, perhaps we can give more confidence to chairmen and boards as a whole. We could then have more trusts adopting technologies. We could therefore support the industry and patients, and get them the medical treatment they need earlier.

[Dr Whitford]

That might well be the case with gadgets, devices or new digital apps, but with new drugs, it is usually the clinicians who are desperate to get their hands on them. Most new drugs, particularly for challenging conditions such as cancer, are expensive and it will be several years before they are passed by NICE in England or the Scottish Medicine Consortium. The delay is not the clinicians not wanting access; it is the cost of introducing them.

--- Later in debate ---

[Chris Green]

I agree—the hon. Lady makes a good point. What I was saying relates more to devices than drugs. Devices and drugs each have their own challenges and we will hopefully make some progress in resolving those concerns.

One of the concerns about the current system relates to the legal framework, which has been criticised for being complex and lacking in consistency and transparency, and it is somewhat difficult for it to respond quickly to problems, especially when patient safety is at risk. The Bill provides us with the perfect opportunity to streamline our approach to giving access to new and innovative treatments to patients, particularly those with rare diseases and conditions, while ensuring that we are fully committed to a system of regulation for medicines and medical devices that can respond to changes in technology and patient safety concerns as soon as possible. This is more relevant now than ever, given the dramatic expansion of digital health and artificial intelligence, and other rapid advances.

I have some questions about the Bill. Will the Minister provide clarification about the exact role that the Medicines and Healthcare Products Regulatory Agency will play in constructing and maintaining a register of devices that have been approved for industry use? Industry has generally welcomed the idea of registries and their usage, but how will registry data be used in the future? Should the Bill not consider changing the way in which NICE prioritises data? NICE currently prioritises level one data—data gained through randomised clinical trials—ahead of real-world registry data. For medical devices, it is often impossible to conduct a blind, randomised clinical trial, so this level of data is unavailable, making it more difficult to get positive NICE guidance. Can we perhaps consider placing a higher weighting on registry data in decision-making processes and use it to inform outcome measures to assess the success of treatments? Registries could support the collection of data on longer-term outcomes—perhaps five to 10 years, for example, rather than the standard 12 months. There is a very significant concern relating to the contrast between drugs and devices. A drug will perhaps be more likely to have in-year savings or result in an in-year delivery, whereas it might take two, three, four, five or even 10 years to see the improvements, delivery or financial return from a device, or medical technology that has been purchased. It is not certain that the current financial landscape lends itself to longer-term planning.

Will the Minister clarify whether the Bill will include provisions on how countries and notified bodies might be considered competent to make an assessment on behalf of the United Kingdom? This would help to avoid duplication and having to seek approval for new devices and treatments from bodies in different countries that share very similar standards.

Much of industry has expressed the need for further clarification on how closely we will remain aligned with European Union regulations after the end of the transition period. That is particularly relevant to how we conduct clinical trials, particularly for rare diseases, where there are not a significant number of patients to test new ideas on. Maintaining easy access to patients and co-operation around data sharing has been cited as a top priority, so will the Minister clarify whether she intends for us to remain closely aligned with the EU regulations where there is a mutual interest in doing so? The transition from the clinical trials directive to the clinical trials regulation is of particular interest. It has not yet been adopted across the EU and there has been a succession of delays. I understand that it should have been adopted in 2016, but it has been delayed and delayed, and there are plans for it to be adopted later this year if conditions work in its favour.

In conclusion, I welcome the Bill and the framework that it seeks to create by ensuring that the UK remains a global player in the world of R&D. The powers in the Bill provide us with the perfect opportunity to significantly build on and improve aspects of medicine development processes in the UK—notably, by speeding up the approval process. The Bill has been generally welcomed by industry, but I would be grateful if the Minister, time permitting, took note of the questions I have asked and offered as much clarification as possible.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

The Bill is necessary because of Brexit, as the UK is losing the European Medicines Agency—one of the great advantages was working together to have a single licensing system that licensed new drugs right across Europe. As the hon. Member for Bolton West (Chris Green) described, it is about working with other countries to avoid duplication and to speed up getting new drugs from the laboratory to patients who need them.

The problem is that manufacturers will have to apply separately to the UK, which means extra processes and additional costs. It is important, therefore, that whatever system is adopted is as similar to the EU as possible and does not ask for a whole different set of work-up, investigation and paperwork, or that will put manufacturers off launching their drugs in the UK. The same issues apply to veterinary medicines, hence they are in the Bill.

The simple fact is that the EU is a market of 500 million people—a quarter of the world pharmaceutical market. The UK on its own is only 3%, which is why drugs tend to be launched in the US and Europe at the same time. In all my 33 years on the frontline, I saw an acceleration of drugs getting from the bench top to the patient, because of the EU and the European Medicines Agency. This means that there are likely to be delays for patients. Canada and Australia wait another six to 12 months before drugs are launched there, so how will the Government avoid a delay in patient access, particularly for new drugs from outside the UK and for conditions such as cancer, where patients are literally waiting for the drug?

[Chris Green]

I realise that this is a distinct area, but does the hon. Lady share my concern that sometimes the EU as a whole is quite slow at reform—for example, with the clinical trials directive and the clinical trials regulation? The CTD was first devised in 2001. We are now in 2020 and we have not yet updated it. Industry and wider sectors would like the update to happen, but it is taking a very long time.

[Dr Whitford]

I thank the hon. Gentleman for that point. When we are trying to collaborate and get a group of 28 countries—indeed, 31 countries, because the European economic area is involved—to all agree to such enormous changes, with legal ramifications for their drug and device producers, and so on, it takes time, but in the end, I think it will be worth it. Of course, I would have liked it earlier. Having been involved in breast cancer trials, I know that the clinical trials directive was clunky and bureaucratic, but it is being changed.