Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

Lord Bethell Excerpts

Wednesday 2nd December 2020 Lords Chamber

Moved by

[Lord Bethell]

That the draft Regulations laid before the House on 20 October be approved.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

My Lords, we all believe that we must protect the safety of patients, while preserving their access to new and innovative medicines. The instruments that we are discussing today, on the UK’s regulation of medicines and medical devices, will ensure that there is a functioning statute book at the end of the transition period. This could not be more important in the context of the Government’s Covid-19 response.

The instruments are generally technical in nature and broadly achieve three things: first, they make minor amendments to existing regulations to take account of the implementation period agreed under the withdrawal agreement; secondly, they implement the Northern Ireland protocol; and, thirdly, they implement certain changes to the regulatory regime in Great Britain to ensure that the regulatory framework is up to date and functioning correctly at the end of the transition period.

These regulations do not prevent the need for future changes but they do preserve the solid foundation of the UK regulatory environment to protect patient safety and to allow the UK to remain a world leader in science and innovation. I will set out some of the key changes in the medical devices SI and then the medicines SI. However, as the SIs are long and technical, I trust that noble Lords will understand that I will not address all elements in the time we have available.

The medical devices instrument will allow CE-marked medical devices to be placed on the Great Britain market for a period of two and a half years. This will ensure continued access to medical devices for patients, while providing time for industry to adapt to future regulations. The Government have created their own new product safety marking—the UK conformity assessed, or UKCA, marking—which will be used across goods regulation in Great Britain. The SI sets out that the UKCA marking can be used for devices certified in accordance with the regulations and placed on the market in Great Britain from the end of the transition period.

The instrument makes a change to the 2019 medical devices SI, which would have inserted into domestic law provisions of the EU medical device regulation, or MDR, and the in vitro diagnostic medical devices regulation, the IVDR. By not including these provisions, we can develop our own system based on patient access, international standards and public health considerations.

The report of the Independent Medicines and Medical Devices Safety Review, led by my noble friend Lady Cumberlege, has made it clear that we must do more to protect patient safety. The Government wholeheartedly agree. We will use the opportunity of leaving the EU to develop a robust, world-leading regulatory regime which prioritises patient safety, innovation and international best practice, using the powers of the Medicines and Medical Devices Bill.

Throughout recent constructive debates on the Bill, I have listened carefully to my noble friend Lady Cumberlege and other noble Lords. We listened to concerns and have incorporated the medical devices information system into the framework for a future regulatory system. We are also in discussion on a number of other important regulatory issues, the details of which I will not go into now for the sake of brevity. I look forward greatly to the public consultation on this future regime next year and to working closely with the life sciences and healthcare sectors on these important considerations.

I now turn to the human medicines SI. From 1 January 2021, the Northern Ireland protocol will apply, so marketing authorisations granted by the EU will continue to apply in Northern Ireland. However, medicines placed on the market in Great Britain must be authorised through the UK national route.

The human medicines SI allows the MHRA to have “regard to” decisions made by EU member states on products approved via decentralised and mutual recognition procedures when considering whether to authorise those products in Great Britain. This policy will ensure that the MHRA can continue to take effective regulatory and safety action on these products.

The medicines SI will ensure that new and existing medicines continue to be on the UK market after the end of the transition period, so that patients are still able to access them in a timely manner. This will be achieved by allowing recognition of decisions by the EU Commission to grant marketing authorisations for centrally authorised products. These products will receive a GB marketing authorisation.

Both the SIs we are discussing today uphold the Prime Minister’s commitment to unfettered access for Northern Ireland’s businesses to the whole of the UK market. The SIs include transparency requirements for medicines and medical devices moving from Northern Ireland to Great Britain, which will allow the MHRA to maintain oversight of products on the GB market and thus protect patient safety.

For medical devices, the transparency requirements mean that non-UK manufacturers placing devices on the UK market will be required to appoint a UK responsible person. The UK responsible person will be required to register devices with the MHRA in accordance with a transitional timetable set out in the regulations. Registration requirements will also apply to GB and Northern Ireland-based manufacturers. Both SIs make changes to ensure that the relevant EU laws will continue to apply in Northern Ireland after the end of the transition period, fulfilling the requirements of the Northern Ireland protocol. I reassure noble Lords that this Government will continue to regulate medicines and medical devices in a way which works for the whole United Kingdom, including, of course, Northern Ireland.

The MHRA will continue to regulate medicines and devices in Northern Ireland. This will ensure continuity for patients and for businesses. Moreover, the Medicines and Medical Devices Bill, currently passing through this House, will provide the powers for future changes to the UK’s regulatory system. Within this, and having tabled an amendment in my name, what is now Clause 43 requires a public consultation on regulatory change before making use of the relevant designated powers in the Bill. The consultation process will help to ensure that the interests of the all interested parties, including devolved Administrations such as Northern Ireland, continue to be fully considered. Officials have kept the devolved Administrations informed of the drafting of this instrument and I am grateful for their continued collaborative approach. In particular, I thank the Minister of Health in Northern Ireland, Robin Swann, who agreed—despite policy for human medicines being a devolved matter—to the human medicines SI being signed solely by the Secretary of State for the Department of Health and Social Care.

To inform the industry, we have published a number of guidance documents which go into further detail on the changes included in the SIs on GOV.UK. In addition, an accompanying series of webinars were held where officials engaged directly with 11,500 industry representatives and provided them with an opportunity to ask questions. My officials also meet regularly with top industry companies and key trade associations, including the Association of the British Pharmaceutical Industry, the BioIndustry Association and the Association of British HealthTech Industries.

It is important to note that these instruments amend pre-existing EU exit legislation made in 2019. A full consultation process was conducted for this pre-existing legislation. Moreover, full impact assessments were conducted for this underlying legislation. As the nature of the changes in the instruments that we are discussing today are in many instances technical, the impacts of these SIs above and beyond the existing legislation do not meet the threshold for further impact assessments and hence these are not provided for. These instruments will ensure that the UK’s exceptional standards of safety and quality regulation of human medicines and medical devices are maintained and enhanced. At a time when we have never been more reliant on all the elements of our public healthcare system for our survival, we must support this. I beg to move.

--- Later in debate ---

[Lord Bethell (Con)]

My Lords, I am enormously grateful for the penetrating and thoughtful questions on this important set of SIs. There were far too many for me to be able to cover them in all the detail they deserve this afternoon, but I will undertake to write to noble Lords if I have failed to address any specific questions.

I start by sharing with the noble Lord, Lord Blunkett, the very positive vibe he gave out about the vaccine. He is entirely right that I have been at this Dispatch Box answering questions on PPE, test and trace and all manner of government challenges, but today is a great day. I do not want to bang on about it, but it is a huge relief to see the authorisation of this vaccine: it is a huge triumph for medical science and a massive breakthrough for humanity. I cannot help emoting so positively on it.

On the precise procedures used, I reassure the noble Lord that, in fact, the procedures used for the authorisation of this vaccine were exactly the same as those we could have used, and do use, under current EU regulations—as he probably knows. Those will change at the end of the month, but, as he probably knows, in October, we brought in specific regulations to allow us to have this opt-out procedure. I pay tribute to the EMA, which is a fantastic regulator with which we intend to work extremely closely. I pay enormous tribute to the MHRA, which has worked with phenomenal diligence, enormous scientific insight and great precision and confidence in order to get this authorisation done so promptly. Dr June Raine, who runs the MHRA, has done a fantastic job, and we should be extremely proud of the role of British regulation in this matter.

On a serious point, this incident demonstrates some of the benefits that will come to Britain’s life sciences industries from the transition. As noble Lords will know very well, we are not planning a massive divergence from either the EMA or the cohort of other regulators—the FDA and others—on a large number of matters. In fact, we have a huge amount of respect for our partners in other countries, especially the EMA. However, in the areas of innovative medicine, where there are new techniques and novel science, and where thoughtful, rapid processing makes a huge impact on the velocity of innovation and where expertise and scientific insight are particularly important, Britain can make a difference. This is where the MHRA will help not only British industry but all of humanity. I very much look forward to reporting back to the House on the progress that we can make in that area.

There have been a large number of questions from noble Lords on whether we are ready for these changes. I assure all noble Lords that we are in great shape. We are in constant liaison with industry and I have regular phone calls, meetings, webinars and bilaterals with industry to ensure that things are in good shape. When it comes to batch testing, which was raised by the noble Baroness, Lady Wheeler, the stockpiling of medicines, and the other matters raised, I can assure noble Lords that we are indeed in good shape. The noble Baroness asked specifically about our conversations with the DPRRC; I cannot give precise answers to her detailed and very reasonable questions, but I will write to her.

I am particularly abreast of the matter of stockpiles, having presented to the Project Defend board earlier today for three hours. I assure noble Lords that the Government are considering the resilience of the country as we approach not only the transition, but also the ongoing pandemic and the winter, simultaneously. We are in very good shape. There is a nationwide, government-wide project to ensure that we are truly resilient. In terms of health provisions, this means not only having stockpiles, but also strengthening our relationships with our suppliers, ensuring the provenance of those supplies and, where necessary—I emphasise that—building up domestic supply. Phenomenal progress has been made regarding medicines and devices, as well as PPE, which typically one associates with production in Asia. We are currently producing more than half our PPE in the UK, and it is possible that we will be producing more than that.

The noble Baroness, Lady Wheeler, is entirely right about the MHRA. We have a winning organisation there, but the emphasis and pressure on it going forward will be extremely important. I assure her that I have regular meetings with the MHRA through the spending review, and its financial plans have been gone through with a fine-toothed comb. Both the MHRA management and the policymakers at the department are reassured that the budgets and the human resources are in place for the MHRA to step up to that challenge.

These are important regulations. I am extremely grateful for the scrutiny that noble Lords have given them and, in that spirit, I commend them to the House.

Motion agreed.