(1)

Pursuant to Articles 9 and 168 of the Treaty on the Functioning of the European Union (‘TFEU’) and Article 35 of the Charter of Fundamental Rights of the European Union (the ‘Charter’), the Union is to ensure a high level of human health protection in the definition and implementation of all Union policies and activities.

(2)

The COVID-19 pandemic has highlighted the interconnectedness of human, animal, and ecosystem health and the risks posed by the loss of biodiversity on Earth. As recognised by the World Health Organization, many of the same microbes infect animals and humans, so efforts that focus only on human health or only on animal health cannot prevent or eliminate the problem of disease transmission. Diseases may be transmitted from humans to animals or vice versa and therefore need to be tackled in both humans and animals, taking advantage of potential synergies in research and treatments. Approximately 70 % of emerging diseases, and almost all known pandemics, namely influenza, HIV/AIDS and COVID-19, are zoonoses. Those diseases have increased globally over the past 60 years. Changes in land use, deforestation, urbanisation, agricultural expansion and intensification, wildlife trafficking and consumption patterns are factors that have contributed to that increase. Zoonotic pathogens can be bacterial, viral or parasitic, and can include unconventional agents that are able to spread to humans through direct contact or through food, water or the environment. The COVID-19 pandemic is a clear example of the need to reinforce the application of the One Health approach in the Union to achieve better public health outcomes, since, as stated in Regulation (EU) 2021/522 of the European Parliament and of the Council (4), ‘human health is connected to animal health and to the environment and … actions to tackle threats to health must take into account those three dimensions’.

(3)

The unprecedented experience of the COVID-19 pandemic has also highlighted the difficulties of the Union and the Member States in addressing such a public health emergency. In that regard, it has demonstrated the need to strengthen the Union’s role in order to be more effective in managing the availability of medicinal products and the availability of medical devices and in vitro diagnostic medical devices and their respective accessories (collectively ‘medical devices’) and in developing medical countermeasures to address the threats posed to public health at an early stage in a harmonised way that ensures cooperation and coordination between Union, national and regional competent authorities, medicinal products and medical devices industry and other actors in the supply chains for medicinal products and medical devices, including healthcare professionals. While the Union needs to give a higher priority to health, its ability to ensure the continued provision of high quality healthcare services and to be prepared to address pandemics and other health threats has been severely impeded by the absence of a clearly defined legal framework for managing its response to pandemics and by the limited mandates and resources of its health agencies, as well as by the limited degree of Union and Member States preparedness for public health emergencies that impact a majority of the Member States.

(4)

Shortages of medicinal products and medical devices have different and complex root causes which need to be further mapped, understood and analysed together with the different stakeholders in order to be comprehensively addressed. A better understanding of those shortages should include identification of vulnerabilities in the supply chain. In the specific case of the COVID-19 pandemic, the shortage of treatments for the disease had a variety of causes, ranging from production difficulties in third countries to logistical or production difficulties within the Union, where the shortage of vaccines was due to inadequate manufacturing capacity.

(5)

Disruptions to the often complex supply chains for medicinal products and medical devices, national export restrictions and bans, border closures impeding the free movement of such goods, uncertainty related to the supply for and demand of such goods in the context of the COVID-19 pandemic, and the lack of production in the Union of certain medicinal products or active substances, have led to significant impediments to the smooth functioning of the internal market and to addressing the serious threats to public health across the Union, with serious consequences for the Union’s citizens.

(6)

Addressing the issue of shortages of medicinal products has been a long-standing priority for the Member States and European Parliament as illustrated by several reports from the European Parliament such as the European Parliament resolution of 17 September 2020 on the shortage of medicines – how to address an emerging problem (5), as well as by discussions within the Council of the European Union. However, that issue has remained, to date, unaddressed.

(7)

Shortages of medicinal products represent a growing threat to public health, with a serious impact on healthcare systems and on the right of patients to access appropriate medical treatment. Increased global demand for medicinal products, which was exacerbated by the COVID-19 pandemic, has led to further shortages of medicinal products, weakening the healthcare systems in Member States and posing significant risks to patients’ health and to the care of patients, particularly in terms of disease progression and worsening of symptoms, longer delays or interruptions in care or therapy, longer periods of hospitalisation, increased risk of exposure to falsified medicinal products, medication errors, adverse effects resulting from the substitution of unavailable medicinal products with alternative ones, significant psychological distress for patients and increased costs for healthcare systems.

(8)

The COVID-19 pandemic has exacerbated the problem of shortages of certain medicinal products considered to be critical to addressing the pandemic, and has highlighted the Union’s external dependence in terms of domestic production of medicinal products and medical devices, the lack of coordination and the structural limitations in the Union’s and Member States’ ability to rapidly and effectively react to such challenges during public health emergencies. It has also highlighted the need to support and strengthen the industrial capacities to produce those medicinal products and medical devices through appropriate policies, as well as the need for more active and extensive involvement of the Union institutions, bodies, offices and agencies in protecting the health of Union citizens.

(9)

The rapid evolution of COVID-19 and the spread of the virus led to a sharp increase in demand for medical devices such as ventilators, surgical masks, and COVID-19 test kits, while disruption of production or limited capacity to rapidly increase production and the complexity and global nature of the supply chain for medical devices led to severe supply difficulties and, at certain times, serious shortages of medical devices. It has also led Member States competing with each other when they respond to the legitimate needs of their citizens, thereby contributing to uncoordinated actions at national level, such as national hoarding and stockpiling. Those issues further resulted in new entities being involved in the expedited production of such medical devices, which subsequently resulted in delays in conformity assessments and the prevalence of medical devices that were over-priced, non-compliant, unsafe, and, in some cases, counterfeits. It is therefore appropriate and a matter of urgency that long-term structures be established within the European Medicines Agency (the ‘Agency’), established by Regulation (EC) No 726/2004 of the European Parliament and of the Council (6), to ensure more solid and effective monitoring of shortages of medical devices that can occur during a public health emergency and coordination of the management of those shortages, as well as increased and early dialogue with the medical devices industry and healthcare professionals to prevent and mitigate those shortages.

(10)

The COVID-19 pandemic and the subsequent public health emergency revealed the need for a more coordinated Union approach in crisis management. Although the lack of an impact assessment accompanying the Commission proposal for this Regulation was due to the emergency-like nature of the situation, sufficient allocation of resources in terms of staff and funding should be secured, taking into account the specificities of the health sector in the different Member States.

(11)

Uncertainty of supply and demand and the risk of shortages of medicinal products and medical devices during a public health emergency like the COVID-19 pandemic can trigger export restrictions among Member States and other national protective measures, which can seriously impact the functioning of the internal market, thereby exacerbating the consequences for public health, as well as leading to the need for temporary export transparency and export authorisation mechanisms. Furthermore, shortages of medicinal products can result in serious risks to the health of patients in the Union due to their lack of availability, which can result in medication errors, increased duration of hospital stays, adverse reactions and increased risk of fatalities caused by the administration of unsuitable medicinal products used as a substitute for unavailable medicinal products. With respect to medical devices, shortages can lead to a lack of diagnostic resources with negative consequences for public health measures or to a disease deteriorating or not being treated, and may also prevent health professionals from adequately carrying out their tasks or being protected when doing so, as evidenced during the COVID-19 pandemic, with serious consequences for their health. Such shortages, for example, insufficient supply of COVID-19 test kits, can also have a significant impact on control of the spread of a given pathogen. It is therefore important to have an appropriate framework at Union level to coordinate the Union response to shortages of medicinal products and medical devices and to reinforce and formalise the monitoring of critical medicinal products and medical devices in the most efficient way and in a way that avoids creating unnecessary burdens for stakeholders which can place a strain on resources and cause additional delays.

(12)

Safe and efficacious medicinal products that treat, prevent or diagnose diseases which cause public health emergencies, should be identified, developed, notably through joint efforts by public authorities, the private sector and academia, and made available to Union citizens as soon as possible during such emergencies. The COVID-19 pandemic has also highlighted the need to coordinate assessments and conclusions on multinational clinical trials, in line with what was done on a voluntary basis by clinical trials experts of Member States prior to the date of application of Regulation (EU) No 536/2014 of the European Parliament and of the Council (7), and the need for Union-level advice on the use of medicinal products in national compassionate use programmes or the use of medicinal products for indications that are not covered by the marketing authorisation in the Union, in order to avoid delays in the implementation of results of research and in the development and availability of new or repurposed medicinal products.

(13)

During the COVID-19 pandemic, ad hoc solutions, such as contingent arrangements between the Commission, the Agency, marketing authorisation holders, manufacturers or other actors in the supply chain for medicinal products, on the one side, and Member States, on the other, had to be found in order to make available safe and efficacious medicinal products to treat COVID-19 or prevent its spread, and in order to facilitate and speed up the development and marketing authorisation of treatments and vaccines.

(14)

In order to ensure the better functioning of the internal market for safe and efficacious medicinal products for the treatment of COVID-19 or prevention of its spread and to contribute to a high level of human health protection, it is therefore appropriate to approximate and strengthen the rules on monitoring of shortages of medicinal products and medical devices, and to facilitate the research and development of medicinal products which have the potential to treat, prevent or diagnose diseases that cause public health emergencies, with a view to strategically complementing the efforts of the Commission, including the Health Emergency Preparedness and Response Authority (‘HERA’), established by Commission Decision of 16 September 2021 (8), and Union agencies, to that end.

(15)

In order to support the assessment of the crisis-preparedness and crisis-management framework provided for in this Regulation with regard to shortages of medicinal products and medical devices, the Commission should be able to use the outcomes of targeted stress tests performed by the Commission, the Agency, Member States or other relevant actors. Such stress tests entail a simulation of a public health emergency or major event in which some or all segments of the processes and procedures laid down in this Regulation are tested.

(16)

This Regulation aims to ensure a high level of protection for human health by ensuring the smooth functioning of the internal market as regards medicinal products and medical devices. Moreover, this Regulation aims to ensure the quality, safety and efficacy of medicinal products that have the potential to address public health emergencies. Both objectives are being pursued simultaneously and are inseparably linked, without one being secondary to the other. As regards Article 114 TFEU, this Regulation establishes a framework for the monitoring and reporting of shortages of medicinal products and medical devices during public health emergencies and major events. As regards Article 168(4), point (c), TFEU, this Regulation should provide for a strengthened Union framework for ensuring the quality and safety of medicinal products and medical devices.

(17)

This Regulation should establish a framework to address the issue of shortages of medicinal products and medical devices during public health emergencies and major events. However, those shortages are a persistent problem that has been increasingly affecting the health and lives of Union citizens for decades. Therefore, this Regulation should be a first step towards improving the Union response to that persistent problem. The Commission should subsequently assess the expansion of that framework to ensure that the issue of shortages of medicinal products and medical devices is addressed.

(18)

In order to improve crisis preparedness and management with respect to medicinal products and medical devices and to increase resilience and solidarity across the Union, the procedures and the respective roles and obligations of the different entities concerned should be clarified. The framework established by this Regulation should build on the ad hoc solutions identified to date in the response to the COVID-19 pandemic that have proven effective, and should build on experience, best practices and examples from third countries, while remaining flexible enough to tackle any future public health emergency and major event in the most efficient way to the benefit of public health and patients.

(19)

A harmonised system of monitoring shortages of medicinal products and medical devices should be established. This would facilitate appropriate access to critical medicinal products and medical devices during public health emergencies and major events, which can have a serious impact on public health. That system should be complemented by improved structures for ensuring the appropriate management of public health emergencies and major events and for coordinating and providing advice on research and development relating to medicinal products which have the potential to mitigate public health emergencies or major events. In order to facilitate the monitoring and reporting of actual or potential shortages of medicinal products and medical devices, the Agency should be able to request and obtain information and data from the marketing authorisation holders concerned, manufacturers and Member States through designated single points of contact, while avoiding any duplication of the information requested and submitted. This should not interfere with the obligation on marketing authorisation holders under Article 23a of Directive 2001/83/EC of the European Parliament and of the Council (9) to notify a Member State when a product ceases to be placed on the market of that Member State or the obligation under Article 81 of that Directive on marketing authorisation holders and wholesale distributors to ensure appropriate and continued supplies of that medicinal product to persons and legal entities that are authorised or entitled to supply medicinal products, so that the needs of patients in the Member State in question are met.

(20)

In order to facilitate the prevention, monitoring and reporting of shortages of medicinal products, the Agency should set up an information technology (IT) platform, to be known as the European shortages monitoring platform (‘ESMP’), that is capable of processing information on the supply of and demand for critical medicinal products during public health emergencies or major events and, outside of those situations, to allow for reporting on shortages of medicinal products that are likely to lead to public health emergencies or major events. To facilitate the development of the ESMP, existing IT systems should be leveraged and used where possible. The ESMP should allow national competent authorities to submit and monitor information on unmet demand, including information received from marketing authorisation holders, wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products to the public, in order to anticipate shortages of medicinal products. The ESMP could also process additional information received from marketing authorisation holders, wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products to the public in order to avert a public health emergency or a major event. The ESMP, once it is fully implemented, should act as the sole portal for marketing authorisation holders to provide the information required during public health emergencies and major events, with a view to increasing efficiency and predictability during public health emergencies and major events, and to accelerating the decision-making process while avoiding duplication of efforts and unjustified burdens on stakeholders. In order to facilitate the coordination role of the Agency, the interoperability of data with existing Member States’ IT platforms for monitoring shortages and other systems, as appropriate, is essential to allow the sharing of relevant information with the ESMP, which should be managed by the Agency.

(21)

In the event that the actual future demand is unknown due to a public health emergency or major event, it is important to make pragmatic predictions as to demand for certain medicinal products on the basis of the best available information. In that context, information and data on available stocks and planned minimum stocks should be collected by Member States and the Agency and taken into account in identifying the demand as far as possible. Those information and data are essential for making correct adjustments in the manufacturing of medicinal products to avoid or at least mitigate the impact of shortages of medicinal products. However, when data on stocks are not available or cannot be provided due to national security interests, Member States should provide the Agency with estimated data on volumes of demand.

(22)

With respect to medicinal products, an executive steering group should be established within the Agency to ensure a robust response to major events and to coordinate urgent actions within the Union in relation to the management of issues relating to the supply of medicinal products (the ‘Medicine Shortages Steering Group – MSSG’). The MSSG should establish lists of critical medicinal products to ensure monitoring of those products and it should be able to provide advice and recommendations on the necessary action to take to safeguard the quality, safety and efficacy of medicinal products as well as to safeguard the supply of medicinal products and to ensure a high level of human health protection.

(23)

To facilitate appropriate communication between patients and consumers, on the one hand, and the MSSG, on the other, Member States could collect data on the impact of shortages of medicinal products on patients and consumers, and share relevant information with the MSSG in order to inform approaches to management of shortages of medicinal products.

(24)

In order to ensure the inclusivity and transparency of the work of the MSSG, there should be appropriate engagement between the MSSG and relevant third parties, including representatives of medicinal product interest groups, marketing authorisation holders, wholesale distributors, any other appropriate actors in the supply chain for medicinal products, and representatives of healthcare professionals, of patients and consumers.

(25)

The MSSG should benefit from the Agency’s extensive scientific expertise as regards the evaluation and supervision of medicinal products and should further develop the Agency’s leading role in coordinating and supporting the response to shortages of medicinal products during the COVID-19 pandemic.

(26)

In order to ensure that high quality, safe and efficacious medicinal products, which have the potential to address public health emergencies, can be developed and made available within the Union as soon as possible during public health emergencies, an emergency task force should be established within the Agency to provide advice on such medicinal products (the ‘Emergency Task Force – ETF’). The ETF should provide advice on scientific questions related to the development of treatments and vaccines and on clinical trial protocols free of charge to those entities involved in their development, such as marketing authorisation holders, clinical trial sponsors, public health bodies, and academia, irrespective of their role in the development of such medicinal products. Decisions on clinical trial applications should remain within the competence of the Member States, in accordance with Regulation (EU) No 536/2014.

(27)

The work of the ETF should be separate from the work of the scientific committees of the Agency and should be carried out without prejudice to the scientific assessments of those committees. The ETF should provide advice and recommendations with regard to the use of medicinal products in the fight to overcome public-health emergencies. The Committee for Medicinal Products for Human Use (‘CHMP’) established by Article 5 of Regulation (EC) No 726/2004 should be able to use those recommendations when preparing scientific opinions on compassionate or other early use of a medicinal product prior to marketing authorisation. The MSSG could also draw on the work of the ETF when developing the critical medicines lists.

(28)

The establishment of the ETFshould build on the support provided by the Agency during the COVID-19 pandemic, in particular as regards scientific advice on clinical trials design and product development as well as the ‘rolling’ review of emerging evidence, i.e. on an on-going basis, to allow a more efficient assessment of medicinal products including vaccines during public health emergencies, while guaranteeing a high level of human health protection.

(29)

In order to ensure the better functioning of the internal market for medicinal products and to contribute to a high level of human-health protection, it is appropriate for the ETF to coordinate and provide advice to developers involved in the research and development of medicinal products that have the potential to treat, prevent or diagnose diseases causing the public health emergency.

(30)

The ETF should provide advice on clinical trial protocols and to developers of clinical trials that are conducted in the Union, providing guidance on clinically relevant endpoints and targets for vaccines and treatments in order to facilitate clinical trial design meeting the criteria for effective public health interventions.

(31)

Experience with clinical trials during the COVID-19 pandemic revealed a tremendous amount of duplication of investigations on the same interventions, a high number of small trials, under-representation of important population subgroups, based on gender, age, ethnicity or medical comorbidities, and a lack of collaboration, leading to a risk that research will be wasted. International regulators pointed out the need to improve the clinical research agenda in order to generate robust evidence on quality, safety and efficacy of medicinal products. The main way of obtaining reliable evidence is through coordinated, well-designed, and adequately powered large randomised controlled trials. Clinical trial results and clinical data produced after the relevant marketing authorisation has been granted should be made publicly available in a timely manner. The publication of the trial protocol at the start of the clinical trial would allow public scrutiny.

(32)

Whenever necessary, considering that medicinal products for human use may impact the veterinary sector, a close liaison with the national competent authorities for veterinary medicinal products should be envisaged.

(33)

Although individual research entities may agree with each other or with another party to act as a sponsor in order to prepare a single harmonised Union-wide clinical trial protocol, experience during the COVID-19 pandemic has shown that initiatives to set up large multinational trials struggle to materialise due to the lack of a single entity that is able to take up all the responsibilities and activities of a sponsor within the Union as well as interact with multiple Member States. To address that problem, a new Union-wide and Union-funded vaccine trial network called VACCELERATE was launched following the Commission communication of 17 February 2021 entitled ‘HERA Incubator: Anticipating together the threat of COVID-19 variants’. The Agency should identify and facilitate such initiatives by giving advice on the possibilities for acting as a sponsor or, where applicable, for allocating respective responsibilities as co-sponsors in accordance with Article 72 of Regulation (EU) No 536/2014 and coordinate the development of clinical trial protocols. Such an approach would strengthen the research environment in the Union, would promote harmonisation and would avoid subsequent delays in availability of results of research for marketing authorisation files. A Union sponsor could benefit from Union research funding available at the time of the public health emergency as well as from existing clinical trial networks to facilitate the development, application, submission, and running of trials. This may be particularly valuable for trials established by Union or international public health or research organisations.

(34)

The Agency publishes European Public Assessment Reports (EPARs) for medicinal products authorised in accordance with Regulation (EC) No 726/2004 which provide information on the assessment of those medicinal products by describing the data assessed and the reasons for recommending whether a medicinal product should be authorised. The EPAR includes detailed information with regard to all relevant pre-submission activities under that Regulation, including the names of the coordinators and experts involved, and, where a medicinal product developer requests scientific advice during the pre-submission phase, an overview of the scientific topics discussed in view to that advice.

(35)

With respect to medical devices, an executive steering group on shortages of medical devices should be established to coordinate urgent actions within the Union in relation to the management of supply and demand issues of medical devices, and to establish a list of critical medical devices in the case of a public health emergency (the ‘Medical Device Shortages Steering Group – MDSSG’). To ensure such coordination, the MDSSG should also liaise with the Medical Devices Coordination Group (‘MDCG’) established by Article 103 of Regulation (EU) 2017/745 of the European Parliament and of the Council (10), where appropriate. In that respect, Member States should be able to appoint the same representatives to both the MDSSG and the MDCG.

(36)

The operational phase of the work of the MSSG, the MDSSG and the ETF should be triggered by the recognition of a public health emergency in accordance with Decision No 1082/2013/EU of the European Parliament and of the Council (11) and, as regards the MSSG, also by the recognition of a major event. The continuous monitoring of risks to public health from major events, including manufacturing issues, natural disasters and bioterrorism that have the potential to affect the quality, safety, efficacy, or supply of medicinal products should also be ensured. In addition, such monitoring should follow the One Health approach.

(37)

It is understood that all recommendations, advice, guidance and opinions provided for in this Regulation are inherently non-binding. Each of those instruments is intended to allow the Commission, the Agency, the MSSG, the MDSSG and the ETF to make their views known and to suggest a line of action without imposing any legal obligation on the addressees of those instruments.

(38)

It is imperative to have in place robust transparency measures and standards regarding the Agency’s regulatory activities in relation to medicinal products and medical devices that fall under the scope of this Regulation. Those measures should include the timely publication of all relevant information on approved medicinal products and medical devices and of clinical data, including clinical trial protocols. The Agency should be highly transparent as regards the membership, recommendations, opinions and decisions of the MSSG, the MDSSG and the ETF. Members of the MSSG, the MDSSG and the ETF should not have financial or other interests in the medicinal products or medical device industries which could affect their impartiality.

(39)

In order to establish the list of categories of critical medical devices and to facilitate the process of monitoring shortages, the manufacturers of those medical devices, or their authorised representatives and, where necessary, relevant notified bodies should provide information requested by the Agency. In specific situations, namely where a Member State considers the need to provide for temporary exemptions pursuant to Article 59(1) of Regulation (EU) 2017/745 or Article 54(1) of Regulation (EU) 2017/746 of the European Parliament and of the Council (12) with a view to mitigating actual or potential shortages of medical devices, the importer and distributor should also play a role in providing the requested information if the non-EU manufacturer has not designated an authorised representative.

(40)

This Regulation should provide the Agency with a role in supporting the expert panels on medical devices designated in accordance with Article 106(1) of Regulation (EU) 2017/745 (the ‘expert panels’) in providing independent scientific and technical assistance to the Member States, the Commission, the MDCG, notified bodies and manufacturers, while upholding maximum transparency as a condition for fostering trust and confidence in the Union regulatory system.

(41)

In addition to their role in clinical evaluation assessments and performance evaluations regarding certain high risk medical devices in accordance with Regulations (EU) 2017/745 and (EU) 2017/746, respectively, as well as in providing opinions in response to consultation by manufacturers and notified bodies, the expert panels are to provide scientific, technical, and clinical assistance to the Member States, the Commission and the MDCG. In particular, the expert panels are to contribute to the development of guidance on a number of points, including clinical and performance aspects of specific medical devices, categories, or groups of medical devices or specific hazards related to a category or group of medical devices, develop clinical evaluation and performance evaluation guidance in line with the state of the art, and contribute to the identification of concerns and emerging issues on safety and performance. In that context, the expert panels could play a relevant role in preparedness for and the management of public health emergencies relating to medical devices, particularly those of high risk including those medical devices which have the potential to address public health emergencies, without prejudice to tasks and obligations under Regulations (EU) 2017/745 and (EU) 2017/746.

(42)

Given the Agency’s long-standing and proven record of expertise in the field of medicinal products and considering the Agency’s experience from working with a multitude of groups of experts, it is appropriate to establish suitable structures within the Agency to monitor potential shortages of medical devices in the context of a public health emergency and provide that the Agency provide the secretariat for the expert panels. This would ensure that the expert panels operate sustainably in the long term and would provide clear synergies with related crisis-preparedness work in the area of medicinal products. Those structures would in no way change the regulatory system or decision-making procedures in the area of medical devices that are already in place in the Union, which should remain clearly distinct from those for medicinal products. To ensure a smooth transition to the Agency, the Commission should provide support for the expert panels until 1 March 2022.

(43)

In order to facilitate the work and exchanges of information under this Regulation, provision should be made for the establishment and management of IT infrastructures and to create synergies with other existing IT systems and IT systems under development, including the European database on medical devices (Eudamed) provided for in Article 33 of Regulation (EU) 2017/745, alongside enhanced protection of data infrastructure and deterrence from possible cyber attacks. Within Eudamed, the European Medical Device Nomenclature provided for in Article 26 of Regulation (EU) 2017/745 and in Article 23 of Regulation (EU) 2017/746 should be used to help the gathering of relevant information on categorisation of medical devices. That work could also be facilitated by, where appropriate, emerging digital technologies such as computational models and simulations for clinical trials, as well as by data from the Union Space Programme established by Regulation (EU) 2021/696 of the European Parliament and of the Council (13), such as from the Galileo geolocation services, and Copernicus Earth observation data.

(44)

In order to ensure the completeness of information and data obtained by the Agency and considering the specific characteristics of the medical device sector, until Eudamed is fully functional, it should be possible to constitute the list of single points of contact for monitoring the shortages of medical devices included on the public health emergency critical devices list using as a source of information the relevant databases or medical device associations at Union or national level.

(45)

Rapid access to and exchanges of health data, including real world data, i.e. health data generated outside of clinical studies, are essential to ensuring the effective management of public health emergencies and major events. This Regulation should allow the Agency to use and facilitate such exchanges and to be part of the establishment and operation of the European Health Data Space interoperable infrastructure, taking advantage of all the potential of supercomputing, artificial intelligence and big data science to develop predicting models and take better and more timely and effective decisions, without compromising privacy rights.

(46)

In order to facilitate the reliable exchange of information on medicinal products in a robust and consistent manner, the identification of medicinal products should be based on the standards developed by the International Organization for Standardization for the identification of medicinal products for human use.

(47)

The handling of sensitive data, crucial for dealing with potential public health emergencies, requires a high level of protection against cyber attacks. Healthcare organisations have also been facing heightened cybersecurity threats in the midst of the COVID-19 pandemic. The Agency itself was the target of a cyber attack that resulted in some documents related to COVID-19 medicinal products and vaccines belonging to third parties being illegally accessed and some of those documents then being leaked on the internet. It is therefore necessary for the Agency to be equipped with a high level of security controls and processes against cyber attacks to ensure that the Agency operates normally at all times and especially during public health emergencies and major events. To that end, the Agency should establish a plan to prevent, detect, mitigate and respond to cyber attacks so that its operations are secure at all times, while preventing any illegal access to documentation held by the Agency.

(48)

Due to the sensitive nature of health data, the Agency should safeguard its processing operations and ensure that they respect the data protection principles of lawfulness, fairness and transparency, purpose limitation, data minimisation, accuracy, storage limitation, integrity and confidentiality. Where the processing of personal data is necessary for the purposes of this Regulation, such processing should be done in accordance with Union law on the protection of personal data. Any processing of personal data under this Regulation should take place in accordance with Regulations (EU) 2016/679 (14) and (EU) 2018/1725 (15) of the European Parliament and of the Council.

(49)

The credibility of the Agency and public trust in its decisions depend on a high degree of transparency. Therefore, the use of adequate communication tools to proactively engage with the general public should be provided for. In addition, the rapid strengthening of transparency standards and measures regarding the Agency’s working bodies and clinical data that has been assessed for the evaluation and surveillance of medicinal products and medical devices are paramount to gain and uphold public trust. This Regulation should establish a framework for those strengthened transparency standards and measures, on the basis of the transparency standards and measures adopted by the Agency during the COVID-19 pandemic.

(50)

During public health emergencies or major events, the Agency should ensure cooperation with the European Centre for Disease Prevention and Control (‘ECDC’) established by Regulation (EC) No 851/2004 of the European Parliament and of the Council (16) and other Union agencies, as appropriate. Such cooperation should include the sharing of data, including data on epidemiological forecasting, regular communication at an executive level, and inviting representatives of the ECDC and other Union agencies to attend meetings of the ETF, the MSSG and the MDSSG, as appropriate. Such cooperation should also include strategic discussions with relevant entities of the Union that are in a position to assist research and development regarding appropriate solutions and technologies for mitigating the effects of the public health emergency or major event or preventing future similar public health emergencies or major events.

(51)

In cases of public health emergencies, or in relation to major events, it should be possible for the Agency to enable regular exchanges of information with Member States, marketing authorisation holders, relevant actors of the supply chain for medicinal products, and representatives of healthcare professionals, of patients and consumers, to ensure early discussions on potential shortages of medicinal products in the market and on supply constraints, so as to allow better coordination and synergies to mitigate and respond to the public health emergency or major event.

(52)

Given that the COVID-19 pandemic has not come to an end, and that the duration and evolution of public health emergencies, such as pandemics, are uncertain, provision should be made for a review of the effectiveness of the functioning of the structures and mechanisms established in accordance with this Regulation. In light of that review, those structures and mechanisms should be adjusted, if appropriate.

(53)

Since the objectives of this Regulation cannot be sufficiently achieved by the Member States alone due to the cross-border dimension of public health emergencies and major events but can rather, by reason of the scale or effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

(54)

In order to ensure that sufficient resources, including appropriate staffing and adequate expertise, are available for carrying out the tasks provided for under this Regulation, expenditure of the Agency should be covered by the contribution from the Union to the Agency’s revenue. That expenditure should include remuneration for rapporteurs who are appointed to provide scientific services in relation to the ETF and, in line with usual practice, reimbursement of travel, accommodation and subsistence expenses related to meetings of the MSSG, the MDSSG, the ETF and their working parties.

(55)

The EU4Health Programme established by Regulation (EU) 2021/522 or the Recovery and Resilience Facility established by Regulation (EU) 2021/241 of the European Parliament and of the Council (17) are some of the tools to provide additional support to national competent authorities in relation to shortages of medicinal products, including through the implementation of actions to mitigate shortages of medicinal products and improve the security of supply. Member States should be able to request financial support from the Union specifically for the implementation of their obligations set out in this Regulation.

(56)

The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 and delivered formal comments on 4 March 2021.

(57)

In accordance with Article 168(7) TFEU, this Regulation fully respects the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care as well as the fundamental rights and principles recognised by the Charter including the protection of personal data.

(58)

One of the aims of this Regulation is to ensure a strengthened framework for monitoring of and reporting on shortages of medicinal products during public health emergencies and major events. As announced in the communication of the Commission of 25 November 2020 entitled ‘Pharmaceutical Strategy for Europe’, the Commission will propose to revise the pharmaceutical legislation to enhance the security of supply and address shortages of medicinal products through specific measures. That legislation could cover a further coordinating role for the Agency in monitoring and managing shortages of medicinal products. If, as a result of that revision, strengthened measures regarding monitoring of and reporting on supply of and demand for medicinal products at Union level are required, the ESMP should be considered as a suitable system to facilitate any new provisions relating to monitoring of and reporting on shortages of medicinal products. As part of the reporting on this Regulation, the Commission should consider the need to extend the scope of this Regulation to include veterinary medicinal products and personal protective equipment, to amend definitions and to introduce measures at Union or national level to strengthen compliance with the obligations set out in this Regulation. That review should include consideration of the remit and functioning of the ESMP. The extension of the functioning of the ESMP and the need for national shortages monitoring systems should be considered if necessary. In order to prepare for shortages of medicinal products during public health emergencies and major events and to support the monitoring of such shortages, capacity building that is supported by Union funding mechanisms should be considered in order to enhance cooperation among Member States. This could include the exploration of best practices and the coordination of the development of IT tools for monitoring and managing shortages of medicinal products in Member States and for connecting to the ESMP. To ensure that the ESMP is used to its full potential and to identify and forecast problems relating to supply of and demand for medicinal products, where appropriate, the ESMP should facilitate the use of big data techniques and artificial intelligence.

(59)

In order to allow for the prompt application of the measures provided for in this Regulation, it should enter into force on the day following that of its publication in the Official Journal of the European Union,

(1)

In accordance with Decision 2010/465/EU of the Council and the Representatives of the Governments of the Member States of the European Union, meeting within the Council (2), the Protocol to amend the Air Transport Agreement between the United States of America and the European Community and its Member States, signed on 25 and 30 April 2007 (the ‘Protocol’), was signed on 24 June 2010, subject to its conclusion at a later date.

(2)

The Protocol has been ratified by all Member States, except for the Republic of Croatia. The Republic of Croatia is to accede to the Protocol in accordance with Article 6(2) of the 2012 Act of Accession.

(3)

The Protocol should be approved.

(4)

As Article 5 of Decision 2010/465/EU, on the provision of information by the Member States, is no longer necessary, that Article should cease to apply from the date of entry into force of this Decision,

(1)

To carry out its tasks under the Treaties, especially those related to the environment, sustainability and climate change, the Commission requires access to full, up-to-date and reliable information. Regulation (EU) No 691/2011 establishes a common framework for European environmental economic accounts, including lists of characteristics for which data are to be compiled and transmitted, and rules on the frequency and transmission deadlines for the compilation of the accounts.

(2)

The lists of characteristics of environmental accounts are essential to ensure comparability of statistical data across Member States. They now need to be updated to align to updates in the data sources for the accounts and to keep relevance for users.

(3)

To better monitor progress towards a green, competitive and resilient circular economy (2) and progress towards the sustainable development goals relevant to the EU, additional up-to-date data concerning the links of the environment and the economy is required.

(4)

The lists of characteristics of environmental accounts are essential to ensure comparability of statistical data across Member States.

(5)

The list of air pollutants in Annex I to Regulation (EU) No 691/2011 should be updated to align to the list of greenhouse gases that are reported under the United Nations Framework Convention on Climate Change (UNFCCC), which was revised after the second commitment period of the Kyoto Protocol, as well as to the guidelines for emission inventories under the Convention on long-range transboundary air pollution (CLRTAP) and definitions of Directive (EU) 2016/2284 of the European Parliament and of the Council on the reduction of national emissions of certain atmospheric pollutants (National Emissions Ceilings Directive) (3).

(6)

To better serve climate policies, Member States should be required to provide a breakdown of taxes recorded for government revenue arising from the EU Emissions Trading System (EU ETS) and other CO2 taxes. Those taxes should therefore be included in the list of characteristics in Annex II to Regulation (EU) No 691/2011.

(7)

The information in Tables C and E of Annex III to Regulation (EU) No 691/2011 is no longer necessary to produce Union aggregates, as Eurostat has developed a new method based on other readily available data. Those tables should therefore be deleted.

(8)

To better serve thematic environmental policies for the European Green Deal, the environmental accounts protection expenditure accounts must distinguish for all sectors the environmental purposes of Protection of ambient air and climate (Classification of environmental protection activities (CEPA) 1), Wastewater management (CEPA 2), Waste management (CEPA 3), Protection and remediation of soil, groundwater and surface water (CEPA 4), Noise and vibration abatement (CEPA 5), Protection of biodiversity and landscapes (CEPA 6), Protection against radiation, R & D and other environmental protection activities (CEPA 7–9). Annex IV to Regulation (EU) No 691/2011 should therefore be updated to reflect those changes.

(9)

Information on the marketed share of the environmental goods and services sector is not sufficient to serve environmental policies. Annex V to Regulation (EU) No 691/2011 should therefore be updated to require Member States to provide information on the total size of the sector.

(10)

To make it easier for users to interpret data and to allow Member States to assure quality during data compilation, Member States should provide information on all components of national expenditure on environmental protection. This includes estimates and information on the intermediate consumption of environmental protection services. Eurostat’s experience with validating Member States’ data demonstrates that, based on the accounting relations between other mandatory reporting categories, Eurostat cannot derive the data on the intermediate consumption of environmental protection services, such as costs of waste disposal or wastewater treatment services incurred by corporations, with sufficient quality for all Member States. Annex IV to Regulation (EU) No 691/2011 should therefore be updated so that Member States compile and report data for this item, undertaking all relevant quality assurance measures.

(11)

To accurately measure the total national expenditure on environmental protection, there is a need to identify all expenditure for environmental protection services that have been incurred for the purpose of producing other environmental protection services, and thus have already been covered in the value of relevant final products. Therefore, it is essential that Member States report all intermediate consumption of environmental protection services for the production of environmental protection services, whether by specialist producers or not.

(12)

Reporting deadlines for European environmental economic accounts should be reduced, to improve the usefulness of the accounts for policy making purposes.

(13)

To reduce the reporting burden for the Member States, the required level of detail of the classification NACE should be reduced for the environmental goods and services sector accounts and for the environmental protection expenditure accounts for NACE category ‘Manufacturing’. That is a cost-effective measure which also enhances data availability to users, by reducing the number of confidentiality flags and data disclosure restrictions. Annexes IV and V to Regulation (EU) No 691/2011 should therefore be updated.

(14)

To offset the additional burden imposed by shorter reporting deadlines and updated lists of characteristics, a burden reduction should be introduced in the form of a threshold of 1 % for breakdowns by economic activity in the environmental protection expenditure account.

(15)

The first reference year for the updated data must be established.

(16)

Regulation (EU) No 691/2011 should therefore be amended accordingly,

(1)

Regulation (EU) 2021/2115 lays down a new legal framework for the common agricultural policy (CAP) to improve its delivery on the Union’s objectives set out in the Treaty on the Functioning of the European Union. That Regulation further specifies these Union objectives to be achieved by the CAP and defines the types of intervention as well as the common Union requirements applicable to Member States, while leaving flexibility for Member States in the design of the interventions to be provided in their CAP Strategic Plans.

(2)

In order to ensure the common nature of the CAP and the internal market, Regulation (EU) 2021/2115 empowers the Commission to adopt additional requirements for the design of the interventions to be specified in the CAP Strategic Plans, in the area of direct payments, of certain agricultural sectors referred to in Regulation (EU) No 1308/2013 of the European Parliament and of the Council (2) and in the area of rural development as well as common rules for these areas as regards the ratio for the good agricultural and environmental condition (GAEC) standard 1. All those additional requirements have to be considered by Member States when designing their CAP Strategic Plans which cover all areas concerned and should therefore be all laid down in this Regulation.

(3)

As regards the interventions to be specified by Member States in their CAP Strategic Plans, in the area of direct payments, additional requirements for the interventions on hemp and cotton should be laid down. The granting of payments should be made conditional upon the use of certified seeds of certain hemp varieties.

(4)

In addition, the procedure for the determination of hemp varieties and the verification of their tetrahydrocannabinol content (THC content) referred to in Article 4(4) second subparagraph, of Regulation (EU) 2021/2115 should be laid down. The verification of the THC content is necessary to protect the financial interests of the Union, but is also strategic to preserve public health, and to ensure coherence with other legislative frameworks, namely criminal law in the field of illicit drug trafficking and the commitments under international obligations such as the Single Convention on Narcotic Drugs (3). It is therefore appropriate to lay down rules harmonising the methods and the procedures used by the Member States for the verification of hemp varieties and for the quantitative determination of the THC content in hemp, in order to ensure comparable results.

(5)

It is necessary to provide for a time period during which hemp grown for fibre may not be harvested after flowering, in order to enable the effective and reliable determination of the THC content in hemp.

(6)

In the interest of clarity and legal certainty, when a variety exceeds the THC content referred to in Article 4(4), second subparagraph, of Regulation (EU) 2021/2115 for 2 consecutive years, the Member States should take the necessary measures to inform timely the operators that the cultivation of that variety would not give the right to direct payments.

(7)

The rules for the verification of hemp varieties and the quantitative determination of the THC content should take into account that hemp may be cultivated either as main crop or as catch crop. In that context, it is appropriate to provide a definition of hemp cultivated as catch crop.

(8)

Title III, Chapter II, Section 3, Subsection 2, of Regulation (EU) 2021/2115 provides for a crop-specific payment for cotton. It is appropriate to lay down the rules and conditions for the authorisation of agricultural land and varieties for the purposes of that payment. Furthermore, additional conditions should be laid down to ensure a minimum activity in line with the support’s objective.

(9)

The Member States referred to in Article 36 of Regulation (EU) 2021/2115 should approve interbranch cotton producing organisations on the basis of objective criteria relating to their scale and internal organisation. The scale of an interbranch organisation should be fixed, taking into account the requirement for the ginner belonging to the organisation to be able to take delivery of sufficient quantities of unginned cotton.

(10)

Specific obligations with regard to the farmers, as members of interbranch organisations, should be laid down. These aim at facilitating the administration and control of farmers’ membership, as well as enhancing the organisations’ potential efficiency gain arising from the number and dedication of their members.

(11)

Additional requirements as regards investments, agri-environment-climate interventions, coaching, promotion, communication and marketing, mutual funds, replanting of orchards, olive groves or vineyards following mandatory grubbing-up, green harvesting and non-harvesting, harvest and production insurance, market withdrawals for destinations other than free distribution and collective storage should be set out for the interventions to be specified by Member States, in their CAP Strategic Plans, in the fruit and vegetables sector, in the apiculture sector, in the wine sector, in the hops sector, in the olive oil and table olives sectors as well as other sectors referred to in Article 42, point (f), of Regulation (EU) 2021/2115. In addition, provisions regarding forms of support and types of expenditure, including the use of flat-rates and scales of unit costs or lump sums, as well as administrative and personnel costs should be laid down. For reasons of sound financial management and legal certainty, a list of expenditure that may not be covered by the CAP Strategic Plans and a non-exhaustive list of expenditure that may be covered in the fruit and vegetables, the apiculture, the wine, the hops, the olive oil and table olives sectors as well as other sectors should be drawn up.

(12)

Furthermore, specific rules regarding certain sectoral types of intervention, namely, in the fruit and vegetables, the apiculture, the wine, the hops and the livestock sectors should be laid down in order to take into account certain specificities of those sectors.

(13)

Regarding sectoral types of intervention managed by producer organisations, associations of producer organisations, transnational producer organisations, transnational associations of producer organisations, or producer groups through operational programmes, in the fruit and vegetables, olive oil and table olives and other sectors, specific rules should be laid down as regards products coverage and market withdrawals for free distribution, namely transport and conditioning costs, taking into account the potential importance of that intervention. In particular, maximum levels of support for market withdrawals should be fixed in order to ensure that withdrawals do not become a permanent alternative outlet for products compared to placing them on the market. In all cases, for similar reasons, it is appropriate to set a quantitative limit of withdrawals per product per producer organisation. In addition, specific rules should be laid down regarding the destinations for withdrawn products, the conditions for the recipients of withdrawn products and relevant standards to be complied with by withdrawn products.

(14)

To facilitate the use of sectoral interventions through operational programmes, the method of calculation of the value of marketed production of producer organisations should be established, including the use of a flat rate for the purpose of calculating the value of fruit and vegetables intended for processing. The method of calculation of the value of marketed production should attenuate yearly fluctuations or insufficient data for newly recognised organisations or groups. To prevent misuse of the scheme, producer organisations should not be permitted in general to change the methodology for fixing the reference period within the duration of a programme.

(15)

To ensure a good functioning of the types of intervention in the fruit and vegetables sector, it would be appropriate to lay down specific objectives regarding agri-environment-climate interventions.

(16)

Rules should be laid down concerning the national financial assistance that Member States may grant in regions where the degree of organisation of producers of fruit and vegetables is particularly low, including rules on how the degree of organisation is calculated and a low degree of organisation is confirmed.

(17)

To ensure a good functioning of the types of intervention in apiculture sector, rules regarding beehives should be laid down.

(18)

To ensure a good functioning of the types of intervention in the wine sector, it is appropriate to draw up a non-exhaustive list of operators which may be the beneficiaries of the support for the different types of intervention. It is also necessary to provide for some specific eligibility requirements as regards beneficiaries of the types of intervention ‘restructuring and conversion of vineyards’, ‘green harvesting’ and ‘harvest insurance’, bodies governed by public law and private companies. It is further appropriate to exclude from Union support producers farming unlawful plantings or unauthorised planted areas.

(19)

To ensure that Union funds are spent properly, it is necessary to lay down rules on expenditure for the ‘replanting of vineyards for health or phytosanitary reasons’ in the wine sector. In particular, it is appropriate to provide for such expenditure not to exceed a certain amount of the total annual expenditure on restructuring and conversion of vineyards paid by the Member State concerned in any given financial year. It should be also clarified that the costs for grubbing-up and for compensating the income foregone should not constitute eligible expenditure under this intervention, which only aims at supporting the costs for replanting after mandatory phytosanitary measures.

(20)

For the purposes of the ‘restructuring and conversion of vineyards’ and ‘green harvesting’ interventions, it is appropriate to lay down rules on the measurement of areas, in particular to define what corresponds to the area planted with vines, which is of particular importance where support is paid on the basis of area-based standard scales of unit costs.

(21)

To ensure a good functioning of the types of intervention in the hops sector, it is appropriate to lay down rules on the Union financial assistance calculation.

(22)

To ensure a good functioning of the types of intervention in the livestock sector, it is appropriate to lay down rules on the restocking with livestock following compulsory slaughter or because of losses resulting from natural disasters.

(23)

The conditions applicable to commitments to preserve on farm endangered breeds and plant varieties under threat of genetic erosion, and to activities for the conservation, the sustainable use, and the development of genetic resources in agriculture and in forestry, should contribute to the specific environmental and climate-related objectives of the CAP set out in Article 6(1), points (d), (e) and (f), of Regulation (EU) 2021/2115. In particular, they should address the need to ensure the protection, the conservation, and the promotion of genetic diversity.

(24)

Levels of animal welfare should be improved by providing support to farmers who undertake to adopt higher standards of animal husbandry, which go beyond the relevant mandatory requirements. Where animal welfare commitments are made to provide for upgraded standards of production methods, the areas should be defined. In doing so, it should be avoided that those animal welfare commitments overlap with standard farming practices, in particular vaccination to prevent pathologies.

(25)

National recognised quality schemes can provide consumers with assurances on the quality and characteristics of the product or the production process. Criteria about the specificity of the final product, the access to the scheme, the verification of binding product specifications, the transparency of the scheme and the traceability of the products should be laid down with a view to optimising their support under rural development interventions. Given the special characteristics of cotton as a farm product, national quality schemes for cotton should also be covered.

(26)

With a view to supporting voluntary agricultural product certification schemes recognised by the Member States under rural development interventions and being aligned to sectoral interventions, certain objective criteria should be laid down.

(27)

With a view to ensure a level playing field as regards the ratio for the good agricultural and environmental condition (GAEC) standard 1 as referred to in Annex III to Regulation (EU) 2021/2115, rules should be provided for the method to determine both the reference ratio and the annual ratio of permanent grassland, as well as the level at which these can be established.

(28)

With a view to ensuring the protection of the share of permanent grassland, it is also appropriate to lay down that Member States should take steps to ensure reconversion of areas in the case where the share of permanent grassland has decreased below the 5 % limit. However, derogations should be provided for the cases where the absolute area of permanent grassland remain relatively stable or where the decrease of the share below the threshold is the result of conversions of area for environmentally- and climate-friendly objectives, in particular afforestation and rewetting of areas.

(29)

Since Member States need to take the rules laid down in this Regulation into account when developing their CAP Strategic Plans, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union,