Explanatory Memorandum to COM(2021)577 - Framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level

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dossier COM(2021)577 - Framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health ...
source COM(2021)577 EN
date 16-09-2021


1. CONTEXT OF THE PROPOSAL

• Reasons for and objectives of the proposal

This proposal for a Regulation aims to put in place a framework of measures to be activated in case of a public health emergency by enabling the Union to take the necessary measures for a sufficient and timely availability and supply of crisis-relevant medical countermeasures.

On 15 June 2021, the Commission presented a Communication on the early lessons from the COVID-19 pandemic 1 setting out the need for the Union to have special arrangements in place to better react in times of health crisis. In November 2020, the Commission had put forward proposals for a stronger European Health Union, and is now creating a new Union Health Emergency preparedness and Response Authority (HERA) within its services. This will provide an agile, robust and sustainable health security structure to improve the availability of medical countermeasures. It would operate during both preparedness and crisis situations.

The COVID-19 pandemic revealed significant vulnerabilities in the European health preparedness for and response to public health emergencies. The measures set out in this Regulation relate to the crisis response mode. They will complement the development of HERA as a new driver for Union action to address cross-border threats.

EU structures, Member States and the industrial sector involved in medical countermeasures were not sufficiently prepared to ensure the efficient development, manufacturing, procurement, and equitable distribution of key medical countermeasures 2 in response to the pandemic. The pandemic also revealed too many fragmented research activities across the Union, often rather limited in scope and limited manufacturing capacities for medical countermeasures, as well as vulnerability in related global supply chains. These limitations ultimately resulted in delays and inefficiencies in the response, which cost lives and harmed the economy.

In particular, the following problems related to crisis-relevant medical countermeasures were identified.

●Insufficient and scattered intelligence gathering and analysis, which is crucial for underpinning preparedness and response plans for crisis-relevant medical countermeasures as well as for ensuring that response interventions adequately ensure availability and accessibility of crisis-relevant medical countermeasures.

●Sub-optimal intervention tools and the absence of fully functional public-private ecosystems, which did not allow the Union to take a proactive approach with strategic and well-informed interventions, which are required to mobilise resources and accelerate the short timeframes for the process of research to final market product.

●Impediments to swift manufacturing of crisis-relevant medical countermeasures, which can be linked to vulnerabilities and difficulties experienced in manufacturing and supply chains, emergency funding and regulatory frameworks, research and data sharing as well as insufficient manufacturing capacities in particular at the beginning of the COVID-19 pandemic.

●Fragmented and dispersed efforts at the Union and national levels, aggravated by inadequate coordination and information sharing, which resulted in an inability to secure the availability of crisis-relevant medical countermeasures and to provide timely access to them.

Some steps to address these shortcomings come through better preparedness. But others require powers, instruments and actions which are only appropriate to cross border emergency situations. The Union did not have a specific emergency mandate for the coordination of Union activities able to ensure rapid availability and accessibility of crisis-relevant medical countermeasures for all Member States. Member States each had different capacities to prepare, respond with and manage crisis-relevant medical countermeasures. Neither national nor EU level had the capacity to respond as required already in place: the response had to be created from imperfect foundations. This situation is likely to be replicated: probably no single country can adequately address all the challenges associated with public health emergencies that have the ability to affect one or more Member States, such as COVID-19. Rapidly changing technological and competitive environments make country-specific responses still more difficult. Uncoordinated efforts may also lead to fragmentation of an already complex market and duplication of public funding.

Moreover, due to globalisation, climate change, natural and man-made disasters, biodiversity loss, habitat encroachment as well as armed conflicts and terrorism, the continuation, emergence and threat of public health emergencies remains a serious likelihood globally, requiring swift availability and accessibility of crisis-relevant medical countermeasures.

• Consistency with existing policy provisions in the policy area

This proposal for a Regulation forms one of the main pillars of the European Health Union by solidifying the Union’s capacity to support timely availability and accessibility for crisis-relevant medical countermeasures during a public health emergency. It is proposed in conjunction with the proposals put forward by the Commission in November 2020: the proposal for a Regulation on serious cross-border threats to health 3 and the extended mandates of the European Centre for Disease Prevention and Control (ECDC) 4 and the European Medicines Agency (EMA). 5 Overall, it reinforces the Union’s crisis management framework. With regard to the proposal for an extended EMA mandate, there will be a close link between the Commission and the EMA in order to ensure consistency and inform Commission decision making with regard to crisis-relevant medical countermeasures. This close link specifically pertains to the information and the recommendations of the Medicines Steering Group and the Commission’s role to take action to ensure mitigation of potential or actual shortages of medicinal products on the critical medicines list and the need for medical countermeasures, in line with Articles 12 and 26 of the proposal for a Regulation of the European Parliament and of the Council on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices. 6 .

2.

The proposed measures complement the following current Union measures in the fields of crisis response and health:


–Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014 7 ;

–the medical response envisaged under Decision No 1313/2013/EU of the European Parliament and of the Council on a Union Civil Protection Mechanism 8 ;

–the Union’s Emergency Support Instrument (Council Regulation (EU) 2016/369 on the provision of emergency support within the Union 9 ); and

–the proposed Pharmaceutical Strategy for Europe 10 .

The proposed measures also complement other policies and actions under the European Green Deal 11 in the field of climate and environment that will support enhanced environmental health, disease prevention and increased resilience.

These measures will support Member States, ensuring cooperation towards the availability and supply of crisis-relevant medical countermeasures and raw materials. The Commission, the European Parliament and the Council have strongly affirmed the Union’s commitment to scaling up global health emergency preparedness.

• Consistency with other Union policies

The proposed measures are in line with the overarching objectives of the Union. These include a stronger European Health Union, the smooth functioning of the internal market, fostering sustainable health systems including through the cohesion policy that supports regional authorities’ investments in public health and supporting cross-border cooperation notably in neighbouring regions, global health security preparedness, improved preparedness to protect workers 12 , and an ambitious research and innovation agenda. The proposal will also provide synergies with the Union’s Digital Single Market agenda and in the context of the future European Health Data Space, by encouraging innovation and research, facilitating the sharing of information and data (including of real world evidence), and supporting the development of a Union-level IT infrastructure for monitoring medical countermeasures.

The measures will also further strengthen the framework of preparedness and response to threats of biological, chemical, or unknown origin threats at Union level, as well as human, animal and environmental health in a coordinated One Health approach. This framework also includes the Union’s One Health Action Plan against antimicrobial resistance (AMR) 13 as well as the EU’s Action Plan to enhance preparedness against chemical, biological, radiological and nuclear security risks 14 .

Many EU policy areas are currently drawing the lessons from the crisis and the need for dedicated measures to be ready to be put in place in the event of a crisis.

2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

• Legal basis

Given that the proposal for this Regulation aims to ensure the supply and the timely availability and accessibility of crisis-relevant medical countermeasures addressing the economic impacts caused by public health emergencies, it is based on Article 122(1) of the Treaty on the Functioning of the European Union (TFEU). The Council may act pursuant to Article 122(1) TFEU to adopt measures that are appropriate to address the economic situation, in particular if severe difficulties arise in the supply of certain products.

• Subsidiarity (for non-exclusive competence)

Public health emergencies of the magnitude of the COVID-19 pandemic have an impact on all Member States. Actions by individual Member States could neither address the challenges resulting from such an emergency nor are they able to provide a sufficient response on their own. Unilateral action through Member State initiatives aiming to ensure the sufficient and timely availability and supply of crisis-relevant medical countermeasures runs the risk of increasing internal competition and sub-optimal Union level response. Such unilateral action can ultimately result in significant economic consequences and affect the health of Union citizens.

In particular, in a highly interconnected and interdependent world, people and goods move across borders and pathogens and contaminated products can circulate rapidly across the globe. Public health measures at national level therefore need to be coordinated across borders and in the area of crisis-relevant medical countermeasures, in order to contain further spread and minimise the consequences of such threats. Where appropriate to the economic situation, a coordinated response at Union-level to ensure the availability and accessibility of crisis-relevant medical countermeasures can help avoiding uncoordinated investments across Member States.

• Proportionality

The proposal constitutes a proportionate response to addressing the problems described in point 1, in particular by putting in place a framework in place that will enable the Union to take the necessary measures to ensure the sufficient and timely availability and supply of crisis-relevant medical countermeasures in case of a public health emergency at Union level where that is appropriate to the economic situation.

In accordance with the principle of proportionality, as set out in Article 5 of the Treaty on European Union, this proposal and the measures proposed do not go beyond what is necessary in order to achieve those objectives.

• Choice of the instrument

The proposal takes the form of a Council Regulation. This is considered to be the most suitable instrument as a key element of the proposal is to establish procedures and structures for cooperation on joint, Union-level work focussing on response to cross-border health emergencies. The measures do not require the implementation of national measures and can be directly applicable.

3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS

• Stakeholder consultations

The framework of measures to be activated to strengthen the response in the event of a public health emergency was not, as such, subject to consultation, but there has been a thorough consultation with relevant stakeholder groups about the setting up of HERA to ensure that their views were presented and considered in the policymaking process. That feedback gave insight in the emergency measures that are considered necessary for an effective response and informed the proposal for this Regulation.

3.

More specifically, the following consultation activities were carried out:


●a 4-week feedback period on the Inception Impact Assessment (27 January to 24 February 2021);

●a 6-week internet-based public consultation (31 March to 12 May 2021), which received contributions from 135 stakeholders 15 ; and

●targeted consultations with stakeholders, via the creation of a High Level Group with Member States, a ‘Sherpa’ group with the industry, as well as bilateral meetings with Member States, international actors, and the European Parliament.

Overall, the Commission has received support for the creation of HERA, with stakeholders noting the clear added value of this initiative as well as the need for the Union to increase its activities related to crisis-relevant medical countermeasures for preparedness and crisis management. Given the broadly shared view that there is a need for swift and effective response at Union level, the Commission proposes a set of emergency measures that can be activated in the event of health emergencies to ensure such a swift and effective response.

• Collection and use of expertise

Contents

1.

N/A


• Impact assessment

Due to the urgency of the matter to strengthen the emergency framework in preparation of a future public health emergency, this proposal is not accompanied by a formal impact assessment, as this could not have been delivered in the timeframe available prior to the adoption of the proposal. As regards medical devices and in vitro diagnostic medical devices, the proposal however takes into account the impact assessment carried out in preparation for the adoption of Regulation (EU) 2017/745 of the European Parliament and of the Council 16 and Regulation (EU) 2017/746 of the European Parliament and of the Council 17 . The proposal also draws on the recommendations contained in the joint opinion ‘Improving pandemic preparedness and management’ by the Group of Chief Scientific Advisors (GCSA) 18 , the European Group on Ethics in Science and New Technologies (EGE), and the Special Advisor to the President of the European Commission on the response to COVID-19.

• Fundamental rights

The proposal contributes to achieving a high level of human health protection as well as to upholding the highest standards in the protection of human rights and civil liberties, as enshrined in the Charter of Fundamental Rights of the European Union (‘the Charter’). The measures under this Regulation may limit the freedom to conduct business and the freedom of contract, which are protected by Article 16 of the Charter and the right to property, protected by Article 17 of the Charter. Any limitation of those rights will, in accordance with Article 52(1) of the Charter, be provided for by law, respect the essence of those rights and freedom, and comply with the principle of proportionality.

Where the activities to be carried out pursuant to this Regulation involve the processing of personal data, the lawfulness of that processing will be based on the acts assigning their tasks to the different actors involved, not this Regulation. Any such processing must comply with the relevant Union legislation on personal data protection, namely Regulation (EU) 2018/1725 of the European Parliament and of the Council 19 and Regulation (EU) 2016/679 of the European Parliament and of the Council 20 .

4. BUDGETARY IMPLICATIONS

In the event of a public health emergency at Union level, in order to ensure the necessary flexibility and rapidity in implementation, the Council could also trigger financing through the Emergency Support Instrument (ESI). 21 As ESI does not have an annual dedicated budget, when it is activated, the Commission will analyse the necessity of transferring funding from existing programmes or resort to Special Instruments. As foreseen under Article 4 of Council Regulation (EU) 2016/369, contributions could also be made by Member States (and by other public or private donors as external assigned revenue) in accordance with Article 21(5) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council. 22

5. OTHER ELEMENTS

• Implementation plans and monitoring, evaluation and reporting arrangements

The Commission plans to conduct a review in 2025, or at the latest after the first activation of the emergency measures, on the framework of measures related to medical countermeasures in event of a public health emergency. The main findings of the evaluation will be presented in a report to the European Parliament and the Council.

• Detailed explanation of the specific provisions of the proposal

4.

The proposal for a framework for ensuring the supply of medical countermeasures in the event of a public health emergency puts forward the following key measures:


●the establishment of a Health Crisis Board to ensure coordination and integration of approaches to crisis-relevant medical countermeasures at a Union level in the event of a public health emergency;

●the establishment of mechanisms for the monitoring, activation of emergency funding, procurement and purchase of crisis-relevant medical countermeasures and raw materials, including swift and solid assessment of supply chains and production capacity of manufacturers, possibly also by on-site visits ahead of the conclusion of advanced purchase agreement or innovation partnership;

●the activation of EU FAB facilities to make available reserved surge manufacturing capacities to ensure the delivery of the crisis-relevant medical countermeasures and raw materials;

●the activation of emergency research and innovation plans in dialogue with Member States, and the use of Union-wide clinical trial networks and provisions and platforms for the rapid sharing of data; and

●measures concerning the production of crisis-relevant medical countermeasures, including the establishment of an inventory of crisis-relevant medical countermeasures production and production facilities, raw materials, consumables, devices, equipment and infrastructure and including measures aiming at increasing their production in the EU.