Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 — House of Lords, 2020-12-02
Topic: Health
James Bethell (Conservative, Centre-right): 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.