Explanatory Memorandum to COM(2020)725 - Reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices - Main contents
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| dossier | COM(2020)725 - Reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical ... |
|---|---|
| source | COM(2020)725  |
| date | 11-11-2020 |
1. CONTEXTOFTHE PROPOSAL
• Reasons for and objectives of the proposal
The unprecedented experience of the COVID-19 pandemic has demonstrated that the Union’s ability to coordinate work to ensure the availability of medicinal products and medical devices and facilitate their development is currently limited.
During the COVID-19 crisis, ad hoc solutions needed to be found to contain the risk of shortages of medicines and medical devices such as ventilators, surgical masks and COVID-19 test kits. The operation of these mechanisms during the emergency was made possible by contingent arrangements between the actors involved (the Member States, the Commission, the European Medicines Agency (‘the Agency’), the medicinal product marketing authorisation holders, and the medical device manufacturers and authorised representatives). This has in some cases required the Commission and the Agency to take on tasks requiring ad hoc working methods. For these solutions to become efficient and predictable, the respective roles and obligations of the different entities should be clarified and anchored in the relevant legislative framework.
Moreover, for, when a number of medicines purported to treat or prevent COVID-19, the Agency did not always have access to sufficient health data to formulate coordinated recommendations across the Union. The Agency provided scientific advice on their development and ability to fight COVID-19 to the utmost of its ability, but outside of a formal crisis management structure and without the benefit of fast-track scientific advice procedures and obligations on Member States and developers to cooperate. In particular, developers indicated a lack of harmonisation on aspects related to clinical trials, stemming mainly from the fact that each trial needs to be authorised separately in each Member State.
A suitable framework to support the work of the Expert Panels on medical devices as provided for in Regulation (EU) 2017/7451 should also be provided for in order to ensure that those panels can efficiently and effectively provide scientific advice relevant for crisis preparedness and management, in addition to their core function to provide opinions on the verification by notified bodies of the clinical and performance assessments for certain high-risk medical devices, including certain in vitro diagnostic devices. This type of advice is essential for crisis preparedness and management, for example in the context of the COVID-19 pandemic, repurposing production lines for fast production of ventilators with the associated minimal technical and safety specifications.
Therefore, a clear framework for the activities to be deployed by the Agency in preparation for and during public health emergencies and other major events should be established in order to enhance the Union's capacity to react quickly, efficiently, and in a coordinated manner to such emergencies. To be effective and operational in
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC OJ L 117, 5.5.2017, p. 1 as amended by Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions, OJ L 130, 24.4.2020, p. 18.
times of public health emergencies, the approach should be based on strong preparedness. This preparedness can be achieved with the development of common tools and agreed methods for monitoring, reporting and data collection. Gathering data on key medicines and medical devices considered the most likely to be impacted by a health emergency or other major event is also a key priority. In doing so, the proposed Regulation builds on experience from the COVID-19 pandemic so far and on ad hoc solutions set up over the last months as well as the management of previous major events in the context of the established incident management plan. As part of this plan the EU Regulatory Network Incident Management Plan for medicines for human use was developed (Incident Review Network/IRN). 2 This structure is used to continuously monitor events and new information, to review their public health impact and to take the necessary routine measures to remedy the situation. The Incident Review Network will continue its activities taking into account the new management structure in times of crisis provided by the Medicines Steering Group established by the proposed Regulation. The proposed Regulation will complement and further develop the core tasks already given to the Agency in its founding Regulation3, notably to provide scientific advice and to assess the quality, safety and efficacy of medicinal products as part of their authorisation process.
1. ensure a high level of human health protection by strengthening the Union’s
ability to manage and respond to public health emergencies, which have an impact on medicinal products and medical devices;
contribute to ensuring the smooth functioning of the internal market for such products during public health emergencies.
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monitor and mitigate potential and actual shortages of medicinal products and medical devices considered as critical in order to address a given public health emergency or, for medicinal products, other major events which may have a serious impact on public health;
ensure timely development of high quality, safe and efficacious medicinal products with a particular focus on addressing a given public health emergency;
ensure smooth functioning of expert panels for the assessment of some high-risk medical devices and avail of essential advice in crisis preparedness and management with regard to the use of medical devices.
Consistency with existing policy provisions in the policy area
As part of a package of closely associated measures, the proposal will form part of the Union’s overall health response to the COVID-19 pandemic and enhanced crisis management framework. The recognition of a public health emergency in accordance
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Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, OJ L 136, 30.4.2004, p. 1.
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with the proposed Regulation on Cross-Border Health Threats would trigger the activation of the structures provided for within this proposal. The proposed monitoring of potential and actual shortages of medicines and medical devices would provide a clear evidence base, which would inform decisions on the need for medical countermeasures as provided for in that proposed Regulation.
The proposed measures would also complement the considerable body of current Union legislation in the fields of medicinal products and medical devices by supporting the continued implementation of that legislation during times of crisis. By facilitating the development of medicines, which have the potential to treat, prevent or diagnose a disease causing a public health crisis, the proposal will support the implementation of the current legislation on clinical trials. The Agency and Member States can use opinions and recommendations on such medicines in regulatory procedures leading to their authorisation for use within the EU. By providing a permanent structure within the Agency for the functioning of expert panels, the proposal will create the ability to quickly provide scientific advice and technical support on demand in case of crisis and to support the assessment of certain high-risk medical devices.
While not a central component of the proposed Regulation, it shall also contribute indirectly to the EU’s international cooperation priorities in the area of global health. Through the work of the Emergency Task Force, the proposed Regulation will not only support Member States but also partner countries, to develop and access potential treatments and vaccines during public health crises, thus supporting the strengthening of health systems and global health security preparedness and response.
Consistency with other Union policies
This proposal is in line with the obligations set out in the Union’s Charter of Fundamental Rights and the EU's overarching objectives, including a stronger Health Union, a smooth functioning of the internal market, sustainable and resilient health systems, and an ambitious research and innovation agenda. In addition, the proposal will provide useful input to and synergies with the EU Digital Single Market agenda and in the context of the planned European Health Data Space, encouraging and supporting innovation and research, facilitating access to and analysis of data and information, including real world data (health data generated outside the scope of clinical studies), and by including the Agency in the European Health Data Space IT infrastructure, with the purpose, inter alia, of monitoring use and shortages of medicinal products and medical devices. While this proposal provides for a role for the Agency in the European Health Data Space, the details and procedures for processing personal data through that IT infrastructure, including the role of the Agency as a data controller and/or processor will be set out in the planned legislative proposal on that data space.
The proposal contributes to achieving a high level of human health protection and is thus consistent with the Charter of Fundamental Rights in this regard. Where personal data is processed to fulfil the provisions of the proposed Regulation, this will be done in line with the relevant Union legislation on personal data protection, namely Regulation (EU) 2018/17254 and Regulation (EU) 2016/6795 (the General
Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions,
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Data Protection Regulation (GDPR)) and build on existing procedures and processes within the Agency which are used to meet such requirements.
The proposal is a tailored approach for medicine and medical device management focusing on public health emergency preparedness. These measures will be complemented by additional actions under the Pharmaceutical Strategy for Europe to address structural challenges.
2. LEGALBASIS, SUBSIDIARITYAND PROPORTIONALITY
• Legal basis
The proposed Regulation would be based on Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union. Such an approach is based on the general and specific objectives of the proposal, namely to ensure the smooth functioning of the internal market, also during times of crisis, and to ensure the quality and safety of medicinal products and medical devices developed during such periods. This approach is also consistent with the legal basis generally used for Union legislation on medicinal products and medical devices6.
• Subsidiarity
Public health emergencies of the magnitude of COVID-19 have an impact on all Member States, which, on their own are unable to provide a sufficient response. Potential or actual shortages of (nationally and centrally authorised) medicines and medical devices in times of crises can lead to the risk of disproportionate national stockpiling or restrictions to single market movements being placed on such goods. Such measures can have a negative impact on the free movement of goods. A coordinated response at Union-level to monitoring and mitigating the risk of shortages can help the Member States to be better prepared for a sudden increase in demand, avoid export restrictions within the EU or excessive and uncoordinated stockpiling, resulting in an effective allocation of resources at national and Union level, maintaining the smooth functioning of the single market and ensuring an overall positive impact on public health.
Providing scientific advice on medicinal products which have the potential to address public health emergencies at Union-level can facilitate their market entry, ensure a harmonised approach to their use across Member States, and help to ensure such products meet harmonised EU standards for their quality, safety and efficacy. Scientific advice can eliminate duplication of efforts and unnecessary research.
An uncoordinated approach to the development of medicines, which have the potential to treat, prevent, or diagnose diseases causing public health emergencies can cause delays in their development during periods where time is of the essence. Moreover, a lack of clear, Union-level advice on the use of medicines in national compassionate use programmes or outside of their authorised indications can lead to
bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No
45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
protection of natural persons with regard to the processing of personal data and on the free movement of
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a fragmented approach across the Union. In addition, regulators’ access to EU-wide health data is limited and scattered across different partners leading to complex and slow analysis, undermining the optimal time window for certain interventions.
• Proportionality
The proposal constitutes a proportionate response to address the problems described in section 1. In particular, the proposed requirement of more structured monitoring at Union level will avoid duplication and provide a better overview of shortage issues of a Union-wide interest.
The proposal does not interfere with Member States’ competences in decisions on the organisation of health care. The proposal does not interfere with notifications sent by marketing authorisation holders to the competent authorities when a product ceases to be on the market according to Article 23a of Directive 2001/83/EC7.
• Choice of the instrument
The proposal takes the form of a new Regulation. This type of instrument is considered to be the most suitable considering that a key element of the proposal is the establishment of a framework at Union-level providing for coordinated action to address public health emergencies and major events and gives a number of tasks to the Agency. The measures do not require the implementation of national measures and can be directly applicable.
3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER
Contents
- CONSULTATIONS
- Regulation (EU) 2016/769 of the European Parliament and of the Council of 27 April 2016 on the
- The general objectives of the proposal are to:
- The specific objectives of the proposal are to:
- bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No
- protection of natural persons with regard to the processing of personal data and on the free movement of
- such data, and repealing Directive 95/46/EC, OJ L 119, 4.5.2016, p. 1
- For example: Directive 2001/83/EC, Regulation (EC) No 726/2004, Regulation (EU) 2017/745, and
- Regulation (EU) 2017/746
- Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, p.67
- The budgetary implications are mainly related to:
ANDIMPACTASSESSMENTS
• Ex-post evaluations/fitness checks of existing legislation
As part of a package of urgent measures based on lessons learnt so far from COVID-19, the initiative will be supported by an assessment of data collected and exchanges held with public and private stakeholders in the framework of the COVID-19 pandemic on issues encountered and possible means to address them. Considering that the initiative will enlarge the scope of existing legislation, it will not be based on an ex post evaluation, as the needs identified were not addressed by the existing framework.
Stakeholder
consultations
Shortages of medicines have been a priority for the Member States and European Parliament for many years as illustrated by several reports from the European Parliament as well as Council conclusions and discussions under recent Council Presidencies.
Following the COVID-19 pandemic, coordinating EU health policies, strengthening crisis management and increasing EU production of essential medicinal products and medical devices have also been identified as a priority by the Council. In addition, several Member States have called for coordination to ensure availability of critical medicines, including vaccines and medical devices during the COVID-19 and potential future health crises.
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, p.67
In its resolution on shortages of medicines of 17 September 20208, the European Parliament calls on the Commission to implement fast-track and innovative solutions to mitigate medicines shortages and calls on the Commission, the Agency and the national regulatory authorities to build on all the pragmatic efforts made during the COVID-19 crisis. The proposed Regulation would allow the Agency, to achieve part of the vision outlined in the European Parliament’s resolution.
Medicinal product interest groups including associations representing respectively hospital pharmacists, community pharmacists, consumer associations, wholesale distributors, and medical doctors, have expressed concerns in relation to the recurrent problems of shortages of medicines in the EU. Such interest groups have renewed long-standing calls for action on this during the COVID-19 pandemic given the acute impact it has had on the supply of certain medicinal products during the current crisis.The COVID-19 pandemic has been extremely challenging for the medical devices industry, which has had to adapt to a sharp increase on demand in a climate of lack of coordination. Medical Device interest groups have recurrently requested a clearer view of EU demand in order to ensure that production capacity will meet the needs of Member States, which is essential to avoid shortages. The lack of EU-wide scientific advice on medical devices during the current crisis has also been highlighted as an area that the expert panels can contribute to in future crises.
• Impact assessment
Due to its urgent nature this proposal is not accompanied by an impact assessment. The initiative will enlarge the scope of the existing legislation. These changes are mainly based on an assessment of the data collected during the first months of the pandemic and exchanges held with public and private stakeholders in the framework of the COVID-19 pandemic on issues encountered and possible means to address them. As regards medical devices, the proposal takes into account the impact assessment undertaken in preparation for Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
• Fundamental rights
The proposed Regulation contributes to achieving a high level of human health protection as set out in Article 35 of the EU Charter of Fundamental Rights. Where personal data is processed based on this proposal it will be done in line with the relevant Union legislation on personal data protection namely, Regulation (EU) 2018/1725 and Regulation (EU) 2016/679 (the General Data Protection Regulation (GDPR)).
4. BUDGETARYIMPLICATIONS
The implementation of this proposal has no impact on the current Multiannual Financial Framework 2014-2020.
The financial impact on the EU budget post-2020 will be part of the next Multiannual Financial Framework.
European Parliament resolution of 17 September 2020 on the shortage of medicines – how to address an emerging problem (2020/2071(INI))
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– administrative support (e.g. to ensure the secretariat of the Executive Steering
Groups for medicinal products and medical devices, and the Emergency Task Force, establish and maintain networks of single points of contacts, provide the secretariat for the medical device expert panels, coordinate independent vaccines effectiveness and safety monitoring studies using relevant data held by public authorities);
– scientific support (e.g. provide scientific advice on medicines which have the
potential to treat, prevent or diagnose diseases and technical assessments and advice on medical devices by expert panels;
– IT support (e.g. establish, host, and maintain streamlined electronic monitoring
and reporting tools);
– remuneration in the form of a special allowance to national experts involved in
expert panels on medical devices.
5. OTHERELEMENTS
• Detailed explanation of the specific provisions of the proposal
The proposal aims to complement the measures directed at improving the overall EU crisis management framework by addressing the specific issues related to medicinal product and medical device sectors and the tasks of the Agency. It would thus introduce new rules for the Agency with the objective to provide mechanisms within the Agency to:
– Monitor and mitigate potential and actual shortages of medicinal products and
medical devices considered as critical in order to address a given public health emergency or, for medicinal products, major event;
– Provide advice on medicinal products, which have the potential to treat,
prevent or diagnose the disease in question. Such advice would cover both medicinal products under development, those used under national compassionate use programmes, and those already authorised for a different indication but with the potential to also treat, prevent or diagnose the disease in question (repurposed medicines).
– Provide a well-managed and sustainable structure to coordinate the expert
panels on medical devices, which will be involved in the assessment of specific high-risk medical devices and device types relevant for health crisis management and provide scientific advice essential in crisis preparedness and crisis management.
The proposal also seeks to ensure inter-Agency cooperation during such emergencies, most notably with the European Centre for Disease Prevention and Control (ECDC).