Medicines and Medical Devices Bill

Ben Everitt 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

[Matt Hancock]

It is almost as though the hon. Gentleman has read my speech. That is the broad intent of that part of the Bill. I will come to it in more detail in a moment, and I am glad about the constructive tone that has been adopted across the House when discussing the Bill.

As I said, the fourth purpose of the Bill is to get innovation while not compromising patient safety—indeed, I would argue that we will enhance patient safety by being able to use modern techniques. It will do that by requiring the Secretary of State to have regard to the safety of medicines and medical devices; to the availability of medicines and devices, because sometimes getting availability as fast as possible is crucial for both innovation and patient safety; and to the attractiveness of the UK as a place to conduct clinical trials and bring medicines and medical devices to market. I will come on to clinical trials in more detail.

Let me turn to the main parts of the Bill. The first part, covering clauses 1 to 7, gives us the ability to update the law relating to human medicines—for example, to reflect changes in manufacturing methods or new types of product. We need that ability because coming down the track are cutting-edge personalised medicines that a hospital might literally have to assemble at the patient’s bedside. Those include gene therapies, medical gases and 3D-printed tablets—bespoke treatments so tailored to the individual that they will only be produced once, with a shelf life that might be measured in minutes. It is just not appropriate to regulate those kinds of treatment in the same way as a mass-produced factory drug, with mandatory batch numbers and packaging information. The Bill gives us the flexibility to respond to those developments. It also allows us to make changes to the regulation of clinical trials, ensuring that we are a globally attractive market to test new drugs and treatments.

But the Bill is not just about the latest science and innovation. It also means that we can update the rules on things such as labelling requirements—for instance, whether the leaflet in a pill packet should have a digital equivalent; rules on how online pharmacies ensure that medicines reach their intended customer; and rules on how the medicine brokerage market works.

We have said that we want to do more to boost the role of our brilliant community pharmacists, and the Bill helps us to do exactly that. It will allow us to remove the barriers to hub-and-spoke dispensing once EU rules no longer apply. Large companies such as Boots already do that, but the law as it stands prevents small, independent pharmacies from joining this kind of arrangement if the hub is not part of the same retail business as the spokes. That is an unnecessary barrier for smaller businesses in the pharmacy sector, and the Bill means that we can remove those barriers.

It also allows us to continue to add to the range of healthcare professionals who can prescribe medicines, which will relieve pressure on the frontline NHS, and it gives us the ability to make rapid changes to regulations to ensure the availability of and access to medicines in an emergency; I am sure we can all understand right now why that is important. Nothing in the Bill changes all the regulations immediately. Instead, it is about getting ahead of the game and giving us the power to make these changes as and when we need to, suitably scrutinised by Parliament.

The next part of the Bill concerns veterinary medicines. It broadly replicates the first part, giving us the ability to amend or supplement the Veterinary Medicines Regulations 2013. Changes could include, for instance, how veterinary medicines are supplied and the information that must be supplied with them. It sets out that, in making new regulations, we have an obligation to consider the safety of the medicines in relation to animals, humans and the environment. These are important matters, not least for me as the Newmarket MP. The Bill will ensure that we have a veterinary medicine system that is fit for purpose.

The third part of the Bill deals with the medical devices regulatory framework, covering everything from MRI scanners to embolisation coils and pacemakers to prophylactics. Like the first part, it allows us to fast-track a new diagnostic test in response to an emerging disease.

[Ben Everitt (Milton Keynes North) (Con)]

Is this not an example of how, having left the EU, we can now move at a much faster pace on a lot of regulatory things that are really important to our constituents?

[Matt Hancock]

Yes, that is right. This Bill empowers us to be able to move faster. Essentially, it empowers the UK to build a life sciences regulatory framework that is the best in the world—of course, working with EU partners, but also with partners from right around the world—and all with the intention of getting the most innovative products, as quickly as possible and as cost-effectively as possible, into the NHS. That is the goal of the entire Bill. It is a benefit of Brexit, but it is also worth doing in its own right.

The measures to strengthen innovation with respect to diagnostic tests again strengthen patient safety, because they strengthen the role of the Medicines and Healthcare Products Regulatory Agency. This includes, for instance, allowing us to legislate to create a comprehensive statutory register of medical devices in the UK. Such a register could be held by the MHRA, and we would make it compulsory to register a device along with information such as who manufactures and supplies it. This would mean that the MHRA could conduct post-market surveillance of devices in the UK, making it easier to trigger device recalls where a safety concern arises.

Indeed, we will enhance patient safety by giving the MHRA a new power to disclose to members of the public any safety concerns about a device. This was not possible while we were part of the EU. Previously, if an NHS trust raised a concern about a device and asked if similar reports had been received elsewhere, too often the MHRA was restricted in sharing that information; nor could it always routinely share information with the Care Quality Commission or other NHS national bodies. This Bill gives us the ability to share vital information about reporting patterns with the NHS family, and where necessary with the public, with enforcement powers that will be proportionate, transparent and suitably safeguarded.

--- Later in debate ---

[Dr Evans]

I am grateful for the hon. Lady’s point, but I would simply say that the NHS is going that way and will be providing those tests. My simple point is that whoever goes through such a test must have counselling afterwards to tell them what to do with the information. We could put that in law. It does not matter if the testing is done by the NHS or by a private testing facility. If an individual makes the choice to have the test, it must be incumbent on the person doing the test to inform them completely and counsel them throughout the test and of course afterwards when they are given the result. That duty should fall on the NHS, if the NHS has done the test, and on the private provider if the private provider has done it.

[Ben Everitt]

This is a brave new world for medical science and for the NHS, and we should not let ideology get in the way of getting the data that we need or of trialling things and accepting good ideas when they come our way, while of course taking on board what my hon. Friend is saying about getting it right at the GP end and ensuring that we look after the people who are involved in this pioneering work.