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

Baroness Thornton Excerpts

Monday 30th September 2019 Lords Chamber

[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.