Products | UK Regulatory Outlook February 2023
Published on 28th Feb 2023
Medical Technology Strategy | UK to introduce regulatory framework for point of care manufacturing | Commission launches call for evidence for its proposal on ecodesign for sustainable products
New 'Windsor Framework' agreed to amend Northern Ireland Protocol
On 27 February, the UK prime minister, Rishi Sunak, and European Commission president, Ursula Von der Leyen, reached an agreement to change the original Northern Ireland Protocol by introducing the new Windsor Framework which amends the text and provisions of the protocol.
Under the new framework, a new "Green Lane" for goods travelling from Great Britain into Northern Ireland will be introduced. Businesses will be able to access the green lane via the new UK Internal Market scheme, which will replace the current UK Trader Scheme.
The green lane will also be open to food retail products that will come under the Northern Ireland Retail Movement scheme, and which will come into force in autumn 2023. Within the food sector, they have also agreed, among other things, to remove health certificates for individual food products and remove bans on British products moving to Northern Ireland, including products such as chilled Lincolnshire sausages.
In regards to medicines, it has been agreed that those medicines approved by the MHRA will be able to be placed on the market in Northern Ireland. This means manufacturers of medicines will only need approval from the MHRA to supply medicines to Northern Ireland and not the European Medicines Agency. Medicines going from Great Britain to Northern Ireland will also travel via the new green lane referred to above, meaning a reduction in the customs paperwork.
Other agreements made in the framework include: changes to alcohol duties, cut on VAT on energy saving materials, and a new "Stormont Brake".
The government has noted that businesses do not need to take any action right now and should move goods in the same away as they do now. It will be consulting with businesses in due course ahead of implementing any changes introduced by the arrangements under the new framework.
Medical Technology Strategy
On 3 February, the Department of Health and Social Care published its first medical technology (medtech) strategy. This encompasses a vision focused on three objectives: right product, right price, right place. It aims to ensure health and care systems and patients have access to innovative medical technologies. The strategy builds on and supports the Life Sciences Vision with the aim to secure the UK's position as a "global science superpower."
Four priority areas for action are set out in the strategy:
- Resilience and continuity of supply – including increasing UK medtech manufacturing capability and capacity.
- Innovative and dynamic markets – enhancing clear demand signalling for industry and streamlined, class-based, product evaluation.
- Enabling infrastructure – ensuring collaboration between industry, government and the clinical and commercial communities of the health and care system.
- Specific market focusses – increase the focus on medtech within the community.
The government's focus will also be on educating clinicians on medtech products and increasing benefits to the life sciences sector, such as the upskilling of workers and boosting focus and investment in research and development.
An implementation plan for the strategy will be published in early 2023, and the government expects to see an increased focus of the strategy over the next five to 10 years.
UK to introduce regulatory framework for point of care manufacturing
The Medicines and Healthcare products Regulatory Agency (MHRA) announced at the end of January that the UK will be the first country to introduce a tailored framework for the regulation of innovative point of care (POC) products, following a consultation that ran from August to September 2021. Examples of POC products are blood glucose analysers and pregnancy tests.
The new framework will ensure that there are no regulatory barriers to innovative manufacturing and that products made have the same assurances of safety, quality, and effectiveness as those for traditional medicinal products. The aim of this framework is to bring a range of benefits to:
- Patients and carers – by providing access to new and more personalised treatments in a timely and more convenient manner with the potential for less travel and time spent in hospitals.
- Healthcare professionals – by providing a greater range and more effective treatment options and improve patients’ adherence to those treatments.
- Innovators – by providing clear regulatory expectations and enabling easier product development.
The framework will apply to all POC products manufactured in the UK once implemented, including a range of advanced therapy medicinal products, such as cell therapy, gene therapy and tissue-engineered products, 3D-printed products, blood products and medicinal gases.
Legislation will be introduced to Parliament later this year to amend the UK’s legislation on human medicines and clinical trials in order to implement the new framework.
Commission launches call for evidence for its proposal on ecodesign for sustainable products
The European Commission has opened a call for evidence for its ecodesign for sustainable products proposal, which aims to make products sold in the EU subject to performance and information-related requirements to ensure greater sustainability (see our Insight for more on the proposal). The consultation is focusing on what the new product priorities under the proposed Ecodesign for Sustainable Products Regulation should be.
The Commission is seeking views on the categories of new products and measures to address so that it can set priorities transparently and inclusively. The accompanying consultation document outlines that a number of new products and horizontal measures were identified as potentially suitable for action under the proposal:
- End-use products. Textiles and footwear, furniture, ceramic products, tyres, detergents, mattresses, lubricants, paints and varnishes, cosmetics, toys, fishing nets and gears, and absorbent hygiene products.
- Intermediary products. Iron and steel, non-ferrous metals, aluminium, chemicals, plastic and polymers, paper, pulp paper and boards, and glass.
- Horizontal measures. Durability, recyclability, post-consumer recycled content.
The call for evidence closes on 25 April 2023. The Commission is aiming to adopt a communication in the first quarter of 2024.
Government publishes response to Regulatory Horizons Council report on medical devices
In 2021, the Regulatory Horizon Council (RHC) published its report on medical devices regulation that addressed the overarching question: “How can the UK encourage international investment, innovation and improve safety in the medical devices area through regulatory and non-regulatory changes?”
At the end of last month, the government published its full response to the report. The government noted its plans to amend the regulatory framework in order to "increase patient safety and promote innovation, thereby growing the life sciences sector in the UK". Additionally, the government states that it will increase the number of UK designation approved bodies to assist with the transition to the UKCA mark, increase international engagement and amend in-vitro diagnostics (IVD) regulation to ensure the fast-tracking evaluation of new IVDs can occur in response to pandemics.
While the government's response does not provide us with an exact timeline of when it will be implementing these changes, it gives businesses a clear indication of what is coming down the line.
CTIS mandatory since 31 January for all new clinical trial applications
The European Medicines Agency recently announced that from 31 January 2023 the use of the Clinical Trials Information System (CTIS) would become mandatory for new clinical trial applications.
CTIS is the information system supporting the implementation of the Clinical Trials Regulation in the EU, which changes the way that applications for authorisation of clinical trials in the EU are submitted, how the clinical trials are authorised and supervised. Further details on CTIS can be read here.
Registration for Scottish Deposit Return Scheme closes next month
With the start of the Scottish Deposit Return Scheme approaching in August, the deadline to be a part of the scheme for businesses that wish to manufacture or sell drinks in Scotland to register with the Scottish Environment Protection Agency (SEPA) is 1 March 2023. Failure to register may result in businesses not being able to sell drinks in Scotland after August 2023.
Government confirms the introduction of legislation to tackle illegal deforestation in supply chains
Please see ESG.