BETA

Activities of Margrete AUKEN related to 2020/0322(COD)

Plenary speeches (2)

2021/09/13
Dossiers: 2020/0322(COD)

2022/10/03
Dossiers: 2020/0322(COD)

Shadow reports (1)

2021/07/22
Committee: ENVI
Dossiers: 2020/0322(COD)
Documents: PDF(486 KB) DOC(229 KB)
Authors: [{'name': 'Véronique TRILLET-LENOIR', 'mepid': 197593}]

Amendments (50)

Proposal for a regulation
Recital -1 (new)

(-1) The COVID-19 pandemic has highlighted the risks to human health posed by the over-exploitation of wildlife and other natural resources and the accelerated loss of biodiversity. As the health of humans, animals and the environment are inextricably linked, it is crucial to take the ‘One Health’ approach to address current and emerging crises. This is paramount as the majority (72%) of emerging diseases of humans, including COVID-19, influenza and HIV/AIDS, are caused by zoonotic pathogens.

2021/04/30
Committee: ENVI

Proposal for a regulation
Recital -1 a (new)

(-1 a) The Union’s ability to adequately respond to COVID-19 has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic, insufficient mandates of its health agencies and also by the limited degree of Union and Member State preparedness in case of a public health emergency impacting a majority of Member States.

2021/04/30
Committee: ENVI

Proposal for a regulation
Recital 2

(2) In light of the lessons learnt during the ongoing COVID-19 pandemic and in order to facilitate adequate Union-wide preparedness and response to all cross- border threats to health, the legal framework for epidemiological surveillance, monitoring, early warning of, and combating serious cross-border threats to health, as set out in Decision No 1082/2013/EU, needs to be broadened with regard to additional reporting requirements and analysis on health systems indicators, and cooperation byetween Member States ~~with~~, and Union agencies, particularly the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA), and international organisations, namely the World Health Organization (WHO). Moreover, in order to ensure effective Union response to novel cross- border threats to health, the legal framework to combat serious cross-border threats to health should enable to immediately adopt case definitions for the surveillance of novel threats and should provide for the establishment of a network of EU reference laboratories and a network to support monitoring of disease outbreaks that are relevant to substances of human origin. ~~The capacity for contact tracing should be strengthened via the creation of an automated system, using modern technologies.~~

2021/04/30
Committee: ENVI

Proposal for a regulation
Recital 5

(5) This Regulation should apply without prejudice to other binding measures concerning specific activities or quality and safety standards for certain goods, which provide for special obligations and tools for monitoring, early warning and combatting specific threats of a cross-border nature. Those measures include, in particular, relevant Union legislation in the area of common safety concerns in public health and environmental matters, covering goods such as pharmaceutical products, medical devices ~~and~~, foodstuffs, substances of human origin (blood, tissues and cells, organs), and exposure to ionising radiation.

2021/04/30
Committee: ENVI

Proposal for a regulation
Recital 6

(6) TIn line with the One Health and Health in All Policies approach, the protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous Union policies and activities. In order to achieve a high level of human health protection, and to avoid any overlap of activities, duplication or conflicting actions, the Commission, in liaison with the Member States, should ensure coordination and exchange of information between the mechanisms and structures established under this Regulation, and other mechanisms and structures established at Union level and under the Treaty establishing the European Atomic Energy Community (the Euratom Treaty), the activities of which are relevant to the preparedness and response planning, monitoring, early warning of, and combating serious cross-border threats to health. In particular, the Commission should ensure that relevant information from the various rapid alert and information systems at Union level and under the Euratom Treaty is gathered and communicated to the Member States through the Early Warning and Response System (‘EWRS’) set up by Decision No 2119/98/EC.

2021/04/30
Committee: ENVI

Proposal for a regulation
Recital 7

(7) Preparedness and response planning are essential elements for effective monitoring, early warning of and combatting serious cross-border threats to health. As such, a Union health crisis and pandemic preparedness plan needs to be established by the Commission and approved by the HSC. This should be coupled with updates to Member States’ preparedness and response plans so as to ensure they are compatible within the regional level structures. To support Member States in this endeavour, targeted training and knowledge exchange activities for healthcare staff and public health staff should be provided knowledge and necessary skills should be provided by the Commission and Union Agencies. To ensure the putting into operation and the running of these plans, the Commission should conduct stress tests, exercises and in-action and after-action reviews with Member States. These plans should include recommendations for policy interventions related to mitigation of the impact of communicable diseases on health services and care, including for non-communicable diseases (NCDs). The plans should be coordinated, be functional and updated, and have sufficient resources for their operationalisation. Following stress tests and reviews of the plans, corrective actions should be implemented and the Commission should be kept informed of all updates.

2021/04/30
Committee: ENVI

Proposal for a regulation
Recital 8

(8) Access to timely and complete data is a precondition for a rapid risk assessments and crisis mitigation. To this end, Member States should provide the Commission with an update on the latest situation with regard to their preparedness and response planning and implementation at national level. Information provided by the Member States should include the elements that Member States are obliged to report to the World Health Organization (WHO) in the context of the International Health Regulations (IHR)15 . To avoid duplication of efforts and diverging recommendations, standardised definitions and fluid information exchange should take place between Union agencies, the WHO and national agencies. In turn, the Commission should report to the European Parliament and to the Council on the state of play and progress with preparedness, response planning and implementation at Union level, including on corrective actions, every 2 years to ensure that national preparedness and response plans are adequate. In order to support the assessment of these plans, EU audits in Member States should be conducted, in coordination with the ECDC and Union agencies. Such planning should include in particular adequate preparedness of critical sectors of society, such as agriculture, energy, transport, communication or civil protection, which rely, in a crisis situation, on well-prepared gender-sensitive public health systems that are also in turn dependent on the functioning of those sectors and on maintenance of essential services at an adequate level. In the event of a serious cross-border threat to health originating from a zoonotic infection, it is important to ensure the interoperability between health and veterinary sectors for preparedness and response planning. _________________ 15World Health Organization. International Health Regulation (IHR, 2005) https://www.who.int/ihr/publications/9789 241596664/en/

2021/04/30
Committee: ENVI

Proposal for a regulation
Recital 8 a (new)

(8 a) Building on lessons learnt from the COVID-19 pandemic, this Regulation should create a more robust mandate for coordination at EU-level. The declaration of an EU emergency situation would trigger increased coordination and allow for timely development, stockpiling and joint procurement of medical countermeasures.

2021/04/30
Committee: ENVI

Proposal for a regulation
Recital 9

(9) As serious cross-border threats to health are not limited to Union borders, joint procurement of medical countermeasures should be extended to include European Free Trade Association States and Union candidate countries, in accordance with the applicable Union legislation. Joint procurement of medical countermeasures will strengthen the purchasing power of participating countries, improve the security of supply and ensure equitable access to medical countermeasures against serious cross- border threats to health. The Joint Procurement Agreement, determining the practical arrangements governing the joint procurement procedure established under Article 5 of Decision No 1082/2013/EU, should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure, to allow for better coordination within the EU. All Joint Procurement Agreements should adhere to the highest level of transparency to allow public scrutiny of the contracts. The Commission should ensure coordination and information exchange between the entities organizing any action under different mechanisms established under this Regulation and other relevant Union structures related to procurement and stockpiling of medical countermeasures, such as the strategic rescEU reserve under Decision No 1313/2013/EU of the European Parliament and of the Council16 . The Union should, in a spirit of solidarity, pre-allocate part of jointly procured products to low-and middle-income countries. _________________ 16Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924).

2021/04/30
Committee: ENVI

Proposal for a regulation
Recital 9 a (new)

(9 a) Other mechanisms should be used to enable global response and crises mitigation. These include enhanced cooperation agreements on production of medical countermeasures, both voluntary and compulsory technology know-how pools and licensing agreements between companies. Triggering such mechanisms should guarantee equitable access to necessary counter-measures to global populations, including those in low-and middle-income countries.

2021/04/30
Committee: ENVI

Proposal for a regulation
Recital 11

(11) The Commission should strengthen cooperation and activities with the Member States, the ECDC, the European Medicines Agency (‘EMA’), other Union Agencies, research infrastructures and the WHO to improve, through the One Health approach, the prevention of communicable diseases, such as vaccine preventable diseases, as well as other health issues, such as antimicrobial resistance.

2021/04/30
Committee: ENVI

Proposal for a regulation
Recital 14

(14) In order to ensure that the assessment of risks to public health at the Union level from serious cross-border threats to health is consistent as well as comprehensive from a public health perspective, the available scientific expertise should be mobilised in a coordinated and multidisciplinary manner, through appropriate channels or structures depending on the type of threat concerned. That assessment of risks to public health should be developed by means of a fully transparent process and should be based on principles of science, excellence, independence, impartiality and transparency. The involvement of Union agencies in these risk assessments needs to be broadened according to their speciality in order to ensure an all hazard approach, via a permanent network of agencies and relevant Commission services to support the preparation of risk assessments.

2021/04/30
Committee: ENVI

Proposal for a regulation
Recital 14 a (new)

(14 a) Member States, the Commission and Union agencies should identify recognised public health organisations and experts, both in the area of communicable and non-communicable diseases, and other relevant stakeholders across sectors, applying the One Health approach, available to assist in Union responses to health threats. Such experts and stakeholders, including civil society organisations, should be structurally engaged throughout all crisis response activities and contribute to the decision- making processes. Full compliance with transparency and conflict of interest rules for stakeholder engagement should be ensured.

2021/04/30
Committee: ENVI

Proposal for a regulation
Recital 17

(17) Inconsistent communication with the public and stakeholders such as healthcare professionals can have a negative impact on the effectiveness of the response from a public health perspective as well as on economic operators. In addition to the recommendations targeted at Member States and healthcare professionals, the ECDC should broaden its communication activities to provide key information available in all EU languages to the general public and serve as a point of reference and reliable source of information. The coordination of the response within the HSC, assisted by relevant subgroups, should, therefore, encompass rapid information exchange concerning communication messages and strategies and addressing communication challenges with a view to coordinating risk and crisis communication, based on robust and independent evaluation of public health risks, to be adapted to national needs and circumstances. Such exchanges of information are intended to facilitate the monitoring of the clarity and coherence of messages to the public and to healthcare professionals. Given the cross-sectoral nature of this type of crises, coordination should also be ensured with other relevant constituencies, such as the Union Civil Protection Mechanism established by Decision (EU) 2019/420 of the European Parliament and of the Council17 . _________________ 17Decision (EU) 2019/420 of the European Parliament and of the Council of 13 March 2019 amending Decision No 1313/2013/EU on a Union Civil Protection Mechanism (OJ L 77I , 20.3.2019, p. 1).

2021/04/30
Committee: ENVI

Proposal for a regulation
Recital 18

(18) The recognition of public health emergency situations and the legal effects of this recognition provided by Decision No 1082/2013/EU should be broadened. To this end, this Regulation should allow for the Commission to formally recognise a public health emergency at Union level. In order to recognise such an emergency situation, the Commission should establish an independent advisory committee that will provide expertise on whether a threat constitutes a public health emergency at Union level, and advise on public health response measures and on the termination of this emergency recognition. The advisory committee should consist of independent experts, and representatives of civil society, selected by the Commission from the fields of expertise and experience most relevant to the specific threat that is occurring, representatives of the ECDC, of the EMA, and of other Union bodies or agencies as observers. Recognition of a public health emergency at Union level will provide the basis for introducing operational public health measures for medical products and medical devices, flexible mechanisms to develop, procure, manage and deploy medical countermeasures as well as the activation of support from the ECDC to mobilise and deploy outbreak assistance teams, known as ‘EU Health Task Force’.

2021/04/30
Committee: ENVI

Proposal for a regulation
Recital 22

(22) Due to the sensitive nature of the health data, Member States, the Commission and Union agencies should safeguard and guarantee that their processing operations respect the data protection principles of lawfulness, fairness, transparency, purpose limitation, data minimisation, accuracy, storage limitation, integrity and confidentiality. The processing of personal data for the purpose of implementing this Regulation should comply with Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 of the European Parliament and of the Council19 . In particular, the operation of the EWRS should provide for specific safeguards for the safe and lawful exchange of personal data for the purpose of contact tracing measures implemented by Member States at national level. In this regard, the EWRS includes a messaging function in which personal data, including contact and health data, can be communicated to relevant authorities involved in contact tracing measures. Article 27 of Regulation (EU) 2018/1725 EUDPR should be strictly respected and appropriate technical and organisational security measures in accordance with Article 33 EUDPR should be put in place. _________________ 19Regulation (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, 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).

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 2 – paragraph 1 – point a – point i

(i) communicable diseases, including of zoonotic origin;

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 3 – paragraph 1 – point 5 a (new)

(5 a) ‘One Health’ is a collaborative, multi-sectoral, and transdisciplinary approach to designing and implementing programmes, policies, legislation and research in which multiple sectors communicate and work together to achieve better public health outcomes, recognising the interconnection between people, animals, plants, and their shared environment;

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 4 – paragraph 1 a (new)

1 a. Representatives of the European Centre for Disease Prevention and Control (ECDC), the European Medicines Agency (EMA), and the European Environment Agency (EEA) shall participate in HSC meetings as observers.

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 4 – paragraph 2 – point b

(b) coordination in liaison with the Commission and relevant Union agencies of the preparedness and response planning of the Member States in accordance with Article 10;

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 4 – paragraph 2 – point c

(c) coordination in liaison with the Commission and relevant Union agencies of the risk and crisis communication and responses of the Member States to serious cross-border threats to health, in accordance with Article 21;

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 4 – paragraph 5 a (new)

5 a. Members of the Committee and the Commission shall ensure thorough consultation with relevant Union agencies, public health experts, international organisations and stakeholders, including healthcare professionals.

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 4 – paragraph 7 a (new)

7 a. The list of members of the Health Security Committee at both the political and technical levels shall be made public on the Commission and Council websites. Members of the Committee must have no financial or other interests that could affect their impartiality. They shall act in the public interest and in an independent manner and make an annual declaration of their financial interests. All indirect interests which could relate to the medical or other relevant industry shall be entered in a register held by the Commission and be accessible to the public, upon request.

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 4 – paragraph 7 b (new)

7 b. The rules of procedure, guidance, agendas and minutes of the meetings of the HSC shall be published on the Commission’s web-portal. To allow further public scrutiny by the European Parliament, the Commission shall be invited for an annual exchange of view regarding the work of the HSC with the Committee on the Environment, Public Health and Food Safety (ENVI).

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 5 – paragraph 4

4. The Union preparedness and response plan shall include interregional preparedness elements to establish coherent, multi-sectoral, cross-border public health measures, in particular considering capacities for testing, contact tracing, laboratories, and specialised treatment or intensive care across neighbouring regions. The plan should include recommendations for policy interventions related to mitigation of the impact of communicable diseases on health services and care, including for non-communicable diseases (NCDs). The plans shall include preparedness and response means to address the situation of those citizens with higher risks.

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – introductory part

That report shall be based on set indicators and cover the following:

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 2

The report shall include, whenever relevant, interregional preparedness and response elements in line with the Union and national plans, covering in particular the existing capacities, resources and coordination mechanisms across neighbouring regions. Union or national entities that are engaged in stockpiling of medical products shall engage with the Commission and Member States in reporting of available stocks and taken into account in both Union and national preparedness and response planning.

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 3

The recommendations of the report shall be published on at the websites of the Commission and the ECDC.

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 8 – paragraph 1

1. Every 32 years, the ECDC shall conduct audits in the Member States aimed at ascertaining the state of implementation of the national plans and their coherence with the Union plan. Such audits shall be based on a set of agreed indicators and implemented with the relevant Union agencies, aiming at the assessment of preparedness and response planning at national level with regard to the information referred to in Article 7(1).

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 10 – paragraph 1 – introductory part

1. The Commission, relevant Union agencies and the Member States shall work together within the HSC to coordinate their efforts to develop, strengthen and maintain their capacities for the monitoring, early warning and assessment of, and response to serious cross-border threats to health.

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 11 – paragraph 1 – introductory part

1. The Commission or relevant Union agencies may organise training activities for healthcare staff and public health staff in the Member States, including preparedness capacities under the International Health Regulations.

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 12 – paragraph 1

1. The Commission and any Member States which so desire may engage in a joint procurement procedure as contracting parties conducted pursuant to Article 165(2) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council29 with a view to the advance purchase of medical countermeasures for serious cross-border threats to health. _________________ 29Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 12 – paragraph 2 – point c a (new)

(c a) the joint procurement shall start only if at least four Member States and the Commission vote in favour and participate in the procurement process as contracting parties;

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 12 – paragraph 2 – point c b (new)

(c b) the joint procurement shall be conducted in such a way so as to strengthen the purchasing power of participating countries, improve the security of supply and ensure equitable access to medical countermeasures against serious cross-border threats to health;

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 12 – paragraph 2 – point d a (new)

(d a) a high degree of transparency shall be applied to all joint procurement activities and related purchase agreements; The European Court of Auditors shall have full access to all relevant documents to provide accurate annual scrutiny of signed contracts and public investment;

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 12 – paragraph 3 a (new)

3 a. The Commission must ensure all joint procurement contracts are made available to the public and accessible on Commission’s website within 30 days after signing of the contract.Information disclosed for public scrutiny shall include: (a) the amount of public investment paid to the contractor, broke down by cost structure of the product; (b) price per unit of the product; (c) number of product units to be delivered per quarter; (d) number and locations of the product’s manufacturing sites; (e) arrangements related to product donations, intellectual property and technology transfer within the Union and with third countries; (f) product liability clauses and compensation for any damage caused by the product; (g) terms and conditions related to the breach of the contracts and their termination.

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 12 – paragraph 3 b (new)

3 b. Joint procurement contracts for medical countermeasures essential for the mitigation of the duration of the health threat and wellbeing of populations, including vaccines and other medicinal products and medical devices. The contract shall include clauses according to which the suppliers shall make freely available the technologies, know-how and trade secrets underpinning the above- mentioned products under global non- exclusive licences on reasonable terms. Those licences shall be made available to patent pools and other multilateral technology transfers mechanisms aiming at disseminating innovations and scaling-up global production of these products.

2021/04/30
Committee: ENVI

(e) contribute to the assessment of the burden of communicable diseases on health systems, care delivery, including for non-communicable diseases (NCDs), and the population using such data as disease prevalence, complications, hospitalisation and mortality;

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 14 – paragraph 2 – point a

(a) enable the automated collection of surveillance and laboratory data, make use of information from electronic health records, media monitoring, and apply artificial intelligence for data validation, analysis and ~~automated reporting~~statistical reporting in accordance to Article 22 of the GDPR;

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 14 – paragraph 2 – point b a (new)

(b a) include specific measures for minimising risks that may emerge from the transfer of bias or incomplete data from multiple sources, as well as establish procedures for data quality review to provide quality assurance of surveillance activities.

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 14 – paragraph 6 a (new)

6 a. Digital platforms and applications supporting epidemiological surveillance at Union and Member State level shall be implemented with in compliance with the principle of data protection by design pursuant to Art. 27(1) of Regulation (EU) 2018/1725.

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 16 – paragraph 1

1. A network of Member States’ services supporting transfusion, and transplantation ~~and medically assisted reproduction~~ is established to allow for the continuous and rapid access to sero- epidemiological data, including assessment of donor population exposure and immunity, and to monitor, assess and help address disease outbreaks that are relevant to substances of human origin.

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 16 – paragraph 3

3. Each Member State shall designate the competent authorities responsible within their territory for the services supporting transfusion, and transplantation ~~and medically assisted reproduction~~ as referred to in paragraph 1.

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 18 – paragraph 2 – subparagraph 1

The ECDC shall continuously update the EWRS allowing for the use of modern technologies, such as digital mobile applications, artificial intelligence models, space enabled applications, or other technologies for automated contact tracing, building upon the contact tracing technologies developed by the Member States. taking into account lessons learned by the Member States. Digital platforms and applications supporting the EWRS shall be implemented in compliance with the principle of data protection by design pursuant to Article 27(1) of Regulation (EU) 2018/1725. Due to the sensitive nature of health data, Member States, the Commission and Union agencies should safeguard and guarantee its processing operations respect the data protection principles of lawfulness, fairness, transparency, purpose limitation, data minimisation, accuracy, storage limitation, integrity and confidentiality. Article 27 of Regulation (EU) 2018/1725 EUDPR should be strictly respected and appropriate technical and organisational security measures in accordance with Article 33 EUDPR should be put in place.

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 20 – paragraph 1 – point f a (new)

(f a) Union or national entities engaged in stockpiling of medical products.

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 20 – paragraph 3 – subparagraph 2

The risk assessment shall take into account, if available, relevant information provided by public health experts and other entities, in particular by the WHO in the case of a public health emergency of international concern.

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 24 – paragraph 1 – point c – point ii

(ii) identification and mitigation of significant gaps, inconsistencies or inadequacies in measures taken or to be taken to contain and manage the specific threat and overcome its impact, including in clinical management and treatment, ~~non-pharmaceut~~stability of supply chains and production capacity of medical countermeasures and public health research needs;

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 24 – paragraph 2

2. The Advisory Committee shall be composed of independent experts, selected by the Commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. The Committee should have multidisciplinary membership so it can advise on biomedical, behavioural, social, economic, cultural and international aspects. The representatives of the ECDC and of the EMA ~~participate as observers~~take an active part in the Advisory Committee. The representatives of other Union bodies or agencies relevant to the specific threat shall participate as observers in this Committee as necessary. The Commission may invite experts with specific expertise with respect to a subject matter on the agenda to take part in the work of the Advisory Committee on an ad- hoc basis.

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 24 – paragraph 6 a (new)

6 a. The list of members of the Advisory Committee shall be made public on the Commission website. Members of the Committee must have no financial or other interests that could affect their impartiality. They shall act in the public interest and in an independent manner and make an annual declaration of their financial interests. All indirect interests which could relate to the medical or other relevant industry shall be entered in a register held by the Commission and be accessible to the public, upon request.

2021/04/30
Committee: ENVI

Proposal for a regulation
Article 26 – paragraph 6 a (new)

6 a. This Regulation shall be without prejudice to the obligations of Member States relating to their processing of personal data under Regulation (EU) No 2016/679 and Directive 2002/58/EC on privacy and electronic communications, or the obligations of Union agencies and the Commission relating to their processing of personal data under Regulation (EU)No 2018/1725, when fulfilling their responsibilities.

2021/04/30
Committee: ENVI