Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Lord Bethell Excerpts

Monday 30th September 2019 Lords Chamber

Moved by

[Lord Bethell]

That the draft Regulations laid before the House on 24 July be approved.

[Lord Bethell (Con)]

My Lords, I am confident that all noble Lords have a shared intention to protect and improve the safety of patients using medicines, while enabling their access to the most innovative treatments. As my noble friend Lady Manzoor stated previously:

“Our regulator, the Medicines and Healthcare products Regulatory Agency, MHRA, has over 30 years’ experience as a leading regulator in the EU. This expertise and experience is globally recognised and respected; we want to ensure that this continues, to the benefit of UK patients. It is with this at the forefront of our minds that the UK’s plans for the regulation of medicines … in a no-deal scenario have been developed”.


As my noble friend set out on 7 March 2019, it is important to reiterate our aim to retain a recognised regulatory system, which ensures that,

“patients in the UK and the EU continue to have timely access to safe and effective medicines”.—[Official Report, 7/3/19; col. 758.]

The system for regulating medicines is currently set out in EU legislation, and we have made legislation to ensure that our national regulatory system continues to function without any detriment to our ability to protect the public health in the event of the UK leaving the EU without a deal. We will then be considered a third country by the EU and, in this scenario, the UK regulator will take on the functions currently carried out by the EU. Additional changes are now being made through the SI in areas the Department of Health and Social Care has identified would benefit from further clarification. This is being done in response to comments from stakeholders, including industry and the life sciences sectors, and from internal review.

The changes proposed do not in any way represent changes in any underlying policy; rather, they are technical in nature, correcting minor drafting errors and omissions, and seek to ensure only that the original policy intention is delivered in legislation. The amendments proposed by this SI continue to be based on the department’s priority to ensure timely availability of safe, effective medicines and medical devices, while minimising disruption to patients and businesses, and to ensure that the regulator can continue to protect public health.

Noble Lords will note that the original regulations were developed through close consultation and co-operation with stakeholders, and that the department has published an impact assessment. After a period of informal consultation in August last year, the MHRA published an initial proposal for the UK’s medicines regulation framework and followed this up through a four-week public consultation in October. The feedback from that consultation—which received about 170 responses—led to revised proposals, which were published in January, and informed the development of the system that will come into place in the event of no deal. Noble Lords will have seen the published impact assessment, which was developed by experts at the MHRA and influenced by responses to the consultation. Noble Lords will want to be reassured that none of the proposed amendments change this impact assessment.

I will now give some specific detail of the arrangements set out in this SI. The majority of the changes being made are technical in nature and have arisen as we have reviewed the legislation and identified areas requiring changes to the legal text to ensure that it gives effect to the published policy. There are no new policy changes introduced in this SI.

This SI makes the following amendments for medicines specifically. First, it makes clear the requirements for a responsible person for import and RPI and for a wholesaler’s licence to hospitals importing human medicines directly from a country on an approved list for their own use. Secondly, it clarifies that UK generic applications can rely on data supplied in relation to medicinal products whose EU marketing authorisations were cancelled pre-exit on grounds other than safety, quality and efficacy. Thirdly, it gives additional detail in relation to the process by which companies may make representations to the Commission on Human Medicines about decisions on rare disease medicines and paediatric matters. Fourthly, it provides for a temporary exemption, subject to a specified condition, from the obligation to maintain a UK pharmacovigilance system master file for companies whose UK authorisations are included in an EU file. This also includes the condition that information required by the licensing authority be provided by the marketing authorisation holders on request. Fifthly, it clarifies that the temporary exemption as to the geographical location of an appropriately qualified person for pharmacovigilance applies to all marketing authorisations and herbal registrations that a company holds, whether granted before or after exit day. This is provided that they are covered by a single pharmacovigilance system in respect of which there is the same qualified person. Lastly, it adds the Republic of Korea to the approved list of countries with equivalent regulatory standards for the manufacturing of active substances on exit day. This is to reflect the updates to the EU list since the no deal SI was made.

For medical devices, there are some changes resulting from amendments made by the EU to the underlying medical devices regulations since the no-deal SI was made via the recently published corrigendum. The changes range from grammatical and reference corrections to a change concerning what is included in the transitional arrangements. Two further changes are inserted to ensure that products mainly used for cosmetic purposes are required to comply with common specifications and to require the information registered with the MHRA about medical devices to be updated by the manufacturer.

In conclusion, in the event of no deal these regulations will put in place technical changes that will ensure that the UK’s medicines regulations legislation continues to function effectively after exit day. These provisions will minimise any impact on patients and businesses and will ensure the timely availability of safe, effective medicines in the UK market.

[Baroness Thornton (Lab)]

I thank the Minister and welcome him to the world of EU health statutory instruments and their amendments—whether it is just for today or for a longer period. I also thank him for his explanation. I really hope that the Government have managed to get it right this time—I am not quite sure whether I have visited this twice or three times in the last year or so.

This statutory instrument comes into force immediately before exit day to correct the defects and omissions in the Human Medicines (Amendment) Regulations 2019 and the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019. They come into force on exit day and, as the Minister described, amend our various regulations to ensure that they are fit for purpose in the case of the UK crashing out of the European Union without a deal.

As noble Lords know, EU law provides that the EU medicines regulatory system—of which the UK is currently a part—ensures, for example, the recognition of prescriptions across the EU and EEA, provides for the monitoring of the safety of medicines and incentivises the development of medicines to treat rare diseases and children. EU law also provides for an EU regulatory system for medical devices and in vitro diagnostic devices. This provides a conformity and safety before these things can be placed on the European Union market—so they are very important.

I have a few questions. First, it is said:

“The new Medical Devices Regulations … and in-vitro Diagnostics Regulations … have been applied directly in UK law since May 2017 and will be fully implemented in the EU from May 2020 and May 2022 respectively”.


So my question is: what is happening to them in the meantime? If we leave the European Union in six weeks’ time, will these things still be implemented or not? I just want to know whether my reading of that—from the Explanatory Notes in this case—is right.

--- Later in debate ---

[Lord Bethell]

My Lords, I thank noble Lords for a stimulating debate in the exciting area of medical SIs. I also thank noble Lords for the warm welcome they have given me. It is a thrill to be here.

The noble Baroness, Lady Thornton, put it very well: this SI is technical but vital. It is vital for those who depend on these medicines and devices for their health and well-being. It is also important for the businesses in Britain that the noble Lord, Lord Rennard, referred to, which have exciting, innovative and important inventions that they are trying to sell on a world stage. Getting this right is a big priority for the Government.

When I look through the SI and the detailed changes it includes, I must admit I have a slightly different sensation. As a neophyte, what I find remarkable is how small and detailed the changes are, and how much hard work must have gone in to getting this right—or more or less right—in the first place. I commend the House for the contribution it made to the scrutiny of these important SIs when they came before us earlier this year and also the officials who have turned an incredibly difficult challenge of Brexit into something that is clearly workable and has passed the scrutiny of a large number of organisations.

Safety and security are massive priorities for the Government; I very much want to convey that to the House. The Government are fully committed to a system of medicines and medical device regulation that intelligently balances patient access to new, innovative, world-leading products on the one hand with an assurance of acceptable safety. The MHRA will have in place a suite of licensing routes for medicines and vigilant systems for medicines and devices. We are committed to offering a competitive regulatory environment to ensure that the UK has access to medicines and devices meeting high standards of safety and efficacy. This SI makes technical amendments to achieve these aims, which are important and necessary.

I will take a moment to answer a couple of the questions that came up. The noble Baroness, Lady Thornton, asked about resources and regulations taking effect. I reassure her that, as I stated, this SI makes minor changes to the SI made earlier this year. The Government are confident that the hard work put in by the MHRA has made it ready for this challenge. It has an impressive roster of staff in place to step up to the work.

The noble Baroness also asked about EU legislation currently in force and what will happen when we leave the EU. The noble Lord, Lord Rennard, asked similar questions. I reassure noble Lords that all relevant EU law will be retained EU law for the purposes of the European Union (Withdrawal) Act 2018. Much of it has already been transposed, including the human medicines regulations and the medical devices regulations.

Questions were raised about the important NAO report, which the Government take very seriously. I reassure the House that the Government are taking every possible step to ensure the uninterrupted supply of medicines in the event of a no-deal Brexit so that patients continue to receive the medicines they need. We are working closely with suppliers to put in place stockpiles, reroute supply chains and ensure medical freight companies are ready for any changes to customs procedures.

Our guidance to suppliers is that there should be at least six weeks’ stock of prescription-only medicines, pharmacy medicines and medical devices. However, stockpiling is only one part of our approach, as some medicines have short shelf-lives or are tailored to individual patients. An example of the kind of measure we are putting in place is that we have supported suppliers to test and secure new routes. We are working closely with the Department for Transport on precuring our own dedicated health channels for critical products needed within a 24 to 48-hour timeframe.

The noble Lord, Lord Rennard, asked particularly about duplication. The UK has put in place an innovative licensing route to ensure that companies, particularly innovative companies, have a route to market that is efficient, cost-effective, speedy, effective and trusted. This allows them to produce their products on to the UK market at the same time as the EU. They will simply have to provide the MHRA with the same information as they do to the EU. The architecture for this was designed specifically to avoid duplication.

The MHRA intends to provide free scientific advice for UK-based small and medium-sized enterprises and to introduce a new targeted assessment, as well as an accelerated assessment route to enable licensing more quickly than the EU. It is very much part of the principle of the Government’s approach to Brexit that we want to have a competitive regulatory environment, particularly in life sciences, that gives companies the chance to compete effectively on the world stage.

My noble friend Lord Lansley reminds us that huge changes in this exciting industry have nothing to do with Brexit at all. In fact, Brexit is not the only challenge. There are massive regulatory innovations across the industry. He makes a strong argument to delay the implementation by the EU of new medical device regulations. I reassure my noble friend that I will certainly pass this up the line and ensure that the MHRA is made aware of his concerns.

This SI is detailed and was put before the House promptly before the summer. I believe that we all agree that it is important in its intent. For that reason, I beg to move.

Motion agreed.