These EU documents are politically important because:
3.1Recognising that the Covid-19 pandemic has demonstrated the need for stronger EU-level provisions to tackle serious cross-border health threats, the European Commission tabled three draft Regulations as well as an over-arching Communication on a “European Health Union”. Once adopted, the legislation will not apply to the United Kingdom, but elements of it relating to the placing on the market of medicinal products and medical devices have implications for Northern Ireland due to the terms of the Ireland/Northern Ireland Protocol to the UK/EU Withdrawal Agreement. Furthermore, the Commission’s proposed approach to tackling serious cross-border threats to health—including those between the EU and third countries—dovetails with the health security provisions in the EU-UK Trade and Cooperation Agreement.
3.2The current EU health security arrangements provide a limited legal framework for EU level coordination, based on the Early Warning and Response System (EWRS) and the exchange of information and cooperation within the EU’s Health Security Committee (HSC). The proposed new health security legal framework would allow the EU to react more rapidly and comprehensively. Based on lessons learnt from combatting the Covid-19 pandemic, the new framework will extend the role of EU agencies in the coordination of preparedness and response measures.
3.3Particular features of the proposed framework include:
3.4The Secretary of State for Health and Social Care (Rt Hon. Matt Hancock MP) submitted his (EM) shortly before the UK-EU Trade and Cooperation Agreement was agreed. He noted that the pandemic had underlined the importance of international cooperation on health security. The UK was working closely with international partners, including the EU, to support international efforts to combat the virus and provide global leadership. He indicated that this cooperation with the EU would continue.
3.5In addition, the UK would ensure the highest standards of health protection were upheld, in line with its obligations under the International Health Regulations. The UK would continue to receive critical information on public health risks and incidents through its existing access to international surveillance systems, such as the Event Information System (EIS) operated by the WHO. The Minister added that, in England, a new National Institute for Health Protection would ensure the best capability to control infectious disease and deal with pandemics or health protection crises.
3.6The Minister offered substantial comment on the proposed Regulation reinforcing the role of the European Medicines Agency as it links to the Ireland/Northern Ireland Protocol annexed to the Withdrawal Agreement. While the EMA should be in a stronger position to identify, and advise on, crisis-relevant medicinal products and medical devices in a timely manner, such products and devices would still be subject to robust assessment procedures. The Minister noted that the Regulation would enable certain products to be brought to market quicker and those products would automatically be licenced in Northern Ireland under the terms of the Protocol. In the event of any risk to patient safety from any of these products, however, the Minister stated that the UK’s regulator (MHRA) would still have the power to withdraw these products from the Northern Ireland market.
3.7The Minister did not expect that the EU was likely to propose that the new Regulation be added to the list of EU legislation which must be applied in Northern Ireland as the current EU legislation in the fields of medicinal products and medical devices—with which Northern Ireland must comply—would not be affected by the new Regulation.
3.8It is anticipated, he added, that the package would contribute indirectly to international cooperation priorities by supporting the development of, and access to, potential treatments and vaccines during public health crises.
3.9This legislation could enable EU Member States and drug manufacturers to benefit from the scientific advice given on clinical trial protocols and their recommendations on the use of such medicines in national indications, also known as ‘off-label use’, as a result of this legislation. The UK would only benefit from this, noted the Minister, if the UK were to have a binding bilateral or multilateral confidentiality agreement with the European Commission, EMA and EU Member States.
3.10The EU-UK Trade and Cooperation Agreement includes a section on health security, providing mostly for cooperation on serious cross-border threats to health affecting the UK and at least one EU Member State. In particular, it gives the UK access to the EU’s Early Warning and Response System (EWRS) in respect of a specific serious cross-border threat to health to enable the EU and UK to exchange relevant information, to assess public health risks, and to coordinate the measures that could be required to protect public health. The EU may also invite the UK to participate in a EU-level committee composed of Member State representatives for the purposes of supporting the exchange of information and of coordination in relation to the serious cross-border threat to health.
3.11The EU and UK should respectively designate a “focal point” with a view to exchanging information in the event of a serious cross-border threat to health and to facilitating understanding as to whether or not a threat is a serious cross-border threat to health.
3.12Finally, the TCA provides for EU-UK cooperation in international forums on health security and for a memorandum of understanding between the European Centre for Disease Prevention and Control and the relevant body in the United Kingdom responsible for surveillance, epidemic intelligence and scientific advice on infectious diseases.
3.13For the most part, this package of legislation is of indirect interest only to the UK. The EU recognises that it needs to be nimbler in responding to serious cross-border threats to health than has been the case with the Covid-19 pandemic. Clearly, a more effective EU response to a serious cross-border threat to health that also affects the UK is positive for the UK and may also contribute helpfully to the UK’s own response to any such crisis. For that reason alone, this package of legislation is to be welcomed.
3.14We note that Northern Ireland is potentially affected if speedier EU procedures lead to the placing on the Northern Ireland market of medicinal products or medical devices that have not also been authorised in Great Britain. While the MHRA may be able to suspend the use of medicinal products and medical devices in Northern Ireland, we note that these arrangements are caveated by EU law. Where a medicinal product has been centrally-authorised (by the EMA), EU law gives Member States—including the UK in respect of Northern Ireland for the purposes of laws applicable under the Northern Ireland Protocol—the right to suspend the use of that product to protect human health or the environment, pending the outcome of a review by the EMA and the Commission. The final decision concerning the availability of the product would, ultimately, be a matter for the EU itself. For those products authorised under the decentralised procedure (by one Member State acting as a reference for other Member States), the MHRA would only be able to suspend the use of a product if one of the 27 Member States had triggered a review of the product. The MHRA would be obliged to withdraw a product found to be harmful or ineffective. For medical devices, the MHRA could withdraw a medical device from the market if it was considered to represent an unacceptable risk to health and safety, although that assessment would be subject to challenge by EU Member States and the Commission and could be overturned by the Commission.
3.15Furthermore, we also observe that—since the Minister submitted his EM—the EU and UK have agreed arrangements for future cooperation on health security, including ad hoc UK access to the EWRS to deal with specific serious cross-border threats to health. In that context, it is relevant that the Commission has proposed not only the continuation of the EWRS but with an extended capability for it to be used to notify an urgent need or shortage of medical countermeasures and to make requests and offers for cross-border emergency assistance.
3.16Also of relevance to the provisions in the TCA is the proposed extension of the remit of the European Centre for Disease Prevention and Control (ECDC), given that the TCA provides for a Memorandum of Understanding between the ECDC and the relevant UK body. Logically, a wider ECDC remit should add greater value to that avenue of EU-UK cooperation, particularly as regards surveillance. We note too that provision is made in the legislation for third country access to the ECDC’s surveillance monitoring digital platform
3.17We have no further queries but we highlight:
3.18On that basis, we report the documents to the House as politically important and draw them to the particular attention of the Health and Social Care Committee and the Northern Ireland Affairs Committee.
11 (a) Proposal for a Regulation amending Regulation (EC) No 851/2004 establishing a European Centre for disease prevention and control (b) Proposal for a Regulation on serious cross-border threats to health and repealing Decision No 1082/2013/EU (c) Proposal for a Regulation on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (d) Commission Communication—Building a European Health Union: Reinforcing the EU’s resilience for cross-border health threats; COM number: (a) (b) (c) (d) ; Legal base: (a) Article 168(5) TFEU, QMV, Ordinary legislative procedure (b) Article 168(5) TFEU, QMV, Ordinary legislative procedure (c) Articles 114 and 168(4)(c) TFEU, QMV, Ordinary legislative procedure (d)—; Department: Health and Social Care; Devolved Administrations: Consulted; ESC numbers: (a) 41652 (b) 41653 (c) 41654 (d) 41655.
12 on serious cross-border threats to health and repealing Decision No 2119/98/EC.
13 Article 20 (4),
14 Article 31(3) of
15 Article 117 of Directive 2001/83/EC as implemented by Regulations 68 and 69 of the Human Medicines Regulations 2012
16 Articles 95 and 96 of on medical devices (applicable from 26 Mary 2021).