Medicines and Medical Devices Bill DebateFull Debate: Read Full Debate
Liz TwistMain Page: Liz Twist (Labour - Blaydon)
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I welcome this Bill. It is crucial that we have an effective regulatory system in this country, so we should enable the Government to amend existing regulations post Brexit. We could be a little more ambitious, however. Government time is precious, and I doubt we will have many occasions to discuss medicines and medical devices, which I suspect is why many of my colleagues have raised things that are not covered in the current legislation.
In a world in which medicines and medical devices are changing fast, the Government need to take greater powers to meet those changes and take advantage of them post Brexit. They need to be able not just to amend but to create regulations. My real concern is that the parameters of these new powers are drafted in such a way that they give power to the Government only to amend existing regulations—four sets of them. The Bill does not give the Government the power to do more, which is a missed opportunity.
Although I am conscious of the need to consider this at a European level, medicines and medical devices are, for most of us, a global issue. This Bill should not just be about ensuring we can cope after leaving Europe; it should be about the opportunity that can be created in the new global world we are entering.
A lot has been said, and rightly so, about the challenge of medical devices, which is a fast-growing area in which Britain is a leader, but it involves a huge variety of small and medium-sized enterprises, and innovation within devices is happening at a faster rate than within medicines. That is what we need to address, and I do not feel we achieve it with this Bill.
This legislation will not help with the challenges of breast implants, vaginal mesh and spinal implants that crumble, because the registry that is to be created is within the constraints and confines of existing registries that, by and large, collect information about devices. They do not collect information about the journey of those devices through the patient experience, from implant through to removal and replacement, including where the device may be defective. That information, properly recorded, would enable us not only to recall devices that we knew were faulty, but to go to patients in whom we knew a device had been implanted to expedite dealing with a medical emergency.
More importantly, medicine is about innovation and creativity. Unless we have a mechanism to evaluate the progress of medical devices implanted in individuals, how can we know which ones work and which ones do not? If a patient does not re-present, and if there is nothing added to the record, we will never know. Such a registry is mission critical.
The Government should be brave and consider a new clause to create such a registry, and they need to consider how we can consolidate the existing registries. There are many national, European and international registries for particular disease areas, and a lot of thought has been given to what best practice and the ideal registry look like. The International Medical Device Regulators Forum set out in 2016 exactly what it thought that should look like, and it seems to me that the Government would be well advised to consider that. It suggests collecting information not just about the device but about the journey through and in the patient. It seems to me that only through a change to the Bill will we achieve what we want to achieve.
Things probably go beyond that. Indeed, some of my hon. Friends have explained the complexity of understanding what a “device” is—does it include lip fillers, artificial intelligence and so on? The list of new innovations grows and will, to be honest, grow beyond current human imagination and we need a regulatory system that enables us to take advantage of that and regulate appropriately and quickly. We therefore need the capacity to change the definition of a device, and right now we do not have that because we are effectively adopting the definitions in the rules we adopted from Europe. We are giving ourselves the ability to fiddle, but not to change them fundamentally, and that is actually quite important.
We need to create an international search database so that we can deliver on some of the challenges of urgent harm, which we can prevent and deal with once a defective device is identified, and so that we can create something that gives us the opportunity to be world leaders in not only medical devices but medicines. It seems to me that that is the opportunity. Why do we constrain ourselves to being a follower? Why do we always talk about keeping up with Europe? Why not be the leaders? The National Institute for Health and Care Excellence was always set out as the global standard that everybody looked to—as absolutely what we wanted in every country. Why not have exactly the right system, whatever the NICE or the Medicines and Healthcare Products Regulatory Agency of the future looks like? Why not set the standard that others then follow?
In the earlier part of the Bill, where it covers the regulation of medicine as opposed to medical devices, there are some changes that look to the future—that is certainly the case for the changes regarding medical trials. However, it seems to me that that is a missed opportunity not only to consider the sort of regulatory system we might want in the future, but—even though we have NICE, the MHRA and notified bodies for the lower levels of medical devices, which provide CE marks— to look at this all over again. As has been said, some things that seem to be harmless and very simple, and seem simply to merit a CE mark, can become very dangerous in how they are ultimately used by a practitioner. We might need to look at all this again, but the power to do that simply is not in the Bill.
There is also nothing in the medicines section, as far as I can see, about increasing the speed of access to new developments and new medicines. That has always been a mantra of this Government, but I cannot see any provision for it. If we had control to look at the MHRA and NICE, we could do that, but as the Minister well knows the reality is that she has no power. The power to deal with the regulatory system and the regulations set by the MHRA and NICE is in the gift of NHS England. Following the Lansley reforms, that power is not now in the gift of the Government and it seems to me that the Government, who have this proactive agenda, should be taking the initiative so that they can be more direct in ensuring that we have the regulatory system we need. At the moment, all we have is the ability to limit the money that is available.
For example, the Government have talked about an innovative medicines fund, but I see nothing in the Bill to provide for that. I understand that the idea is that it can be just an extension of the cancer drugs fund, but, I ask the Minister, is that actually right? There should be different criteria—there will be different tests and different needs. Simply extending the cancer drugs fund will muddy the water and not deliver what we are really looking for, which is something that looks specifically at innovative medicines, which need clearly defining and properly clarifying. If we are to cover both groups, we need to increase the pot, but there is no suggestion of doing so.
There is a lot still to be done. Earlier, one of my colleagues made the good point that if we are to be a global leader rather than just a follower, we ought perhaps to look at how our marketing authorisations could be adopted and accepted in other countries, effectively saving costs and getting medicines to market faster. The UK would therefore be seen as the place to come for one’s marketing authorisation, rather than Europe, despite the size differential, because we would be the market leader in the mechanism to develop that.
For me, the Government have made a good start, but there is much to do. I look forward very much to the Minister’s closing remarks and, more importantly, to her confirmation that the Government have an ambitious vision and will be working hard during the following stages of the Bill’s consideration, of which I would very much like to be part, to consider changes that will deliver opportunities that the as drafted Bill does not offer. That said, it is a good start and something we can build on.
I totally agree with the hon. Lady about the concerns and, we hope, the opportunity to ensure that any pack of sodium valproate that is dispensed carries the information. Does she share my concerns at the talk of having digital information, as many people are digitally excluded? Having actively to seek information about a drug is perhaps an additional barrier. We should be making this easier, simplifying the leaflets that are in with drugs, perhaps by having more infographics, to allow people with poor English or limited understanding to recognise what they should be doing around their medication.
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.