2020/0321(COD) | [ParlTrack]

Proposal for a regulation
Recital 20

(20) Individual research entities may agree together, or with another party, to act as a sponsor in order to prepare one harmonised Union-wide clinical trial protocol, yet 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 can undertake all the responsibilities and activities of a sponsor within the Union, while interacting with multiple Member States. It is therefore appropriate for the Agency to identify and facilitate such initiatives by giving advice on the possibilities to act as a sponsor or, where applicable, to define respective responsibilities as co-sponsors in accordance with Article 72 of Regulation (EU) 536/2014 and coordinate the development of clinical trial protocols. Such an approach would strengthen the research environment in the Union, and promote harmonisation and avoid subsequent delays in integrating the results of research to a marketing authorisation. A Union sponsor could benefit from Union research funding available at the time of the public health emergency as well as existing clinical trial networks to facilitate the development, application, submission, and running of the trial. This may be particularly valuable for trials established by Union or international public health or research organisations or other non- commercial entities.

Amendment 101 #

Proposal for a regulation
Recital 20 a (new)

(20 a) The Emergency Task Force should review clinical trial protocols and advice developers on clinical trials that are conducted in the Union. The Emergency Task Force should define the most clinically relevant performance targets for vaccines and treatments to be measured in clinical trials, so that they can meet the criteria for effective public health interventions.

Amendment 102 #

Proposal for a regulation
Recital 21

(21) With respect to medical devices, an executive steering group on 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 devices infor the most probable cases of a public health emergencyies.

Amendment 103 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Recital 22

(22) This Regulation also provides the Agency with a role to support the expert panels on medical devices designated under Commission Implementing Decision (EU) 2019/139612 to provide independent scientific and technical assistance to the Member States, the Commission, the Medical Device Coordination Group (MDCG), notified bodies and manufacturers, while upholding maximum transparency as a condition for fostering trust and confidence in the EU regulatory system. _________________ 12Commission Implementing Decision (EU) 2019/1396 of 10 September 2019 laying down the rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the designation of expert panels in the field of medical devices OJ L 234, 11.9.2019, p. 23

Amendment 104 #

(23 a) Temporary exemption from the conformity assessment procedure for medical devices should only be considered in exceptional circumstances. Before allowing for such a derogation, the considerations should take into account both the safety of citizens using the device and the safety of the product. Only if both can be ensured even without a conformity assessment procedure, and the benefits for safeguarding supply outweigh the risks, a temporary exemption could be offered.

Amendment 105 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Alicia HOMS GINEL

Proposal for a regulation
Recital 24

(24) 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 the appropriate structures within the Agency to monitor potential shortages of medical devices in the context of a public health emergency and to provide the Agency with a mandate to host the expert panels on medical devices. In this regard, all national and, eventually, Union entities that are engaged in stockpiling of medical devices, should report their stocks to the Agency. This would allow for long-term sustainability for the functioning of the panels and provide clear synergies with related crisis preparedness work for medicinal products. Those structures would in no way change the regulatory system or the decision-making procedures in the area of medical devices already in place in the Union, which should remain clearly distinct from the one for medicinal products.

Amendment 106 #

Proposal for a regulation
Recital 25

(25) In order to facilitate the work and the exchange of information under this Regulation, provision should be made through further implementing acts with a view to outlining the roles of the actors involved in the processing of personal data for the establishment and management of IT infrastructures and synergies with other existing IT systems or systems under development, including the EUDAMED IT platform for medical devices and Data Analysis and Real World Interrogation Network - DARWIN. That work should also be facilitated by, where appropriate, emerging digital technologies such as computational models and simulations for clinical trials, as well as data from the EU Space Programme such as the Galileo geolocation services, and Copernicus earth observation data, while enabling data discoverability.

Amendment 107 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Maria da Graça CARVALHO

Proposal for a regulation
Recital 25

(25) In order to facilitate the work and the exchange of information under this Regulation, provision should be made for the establishment and management of IT infrastructures and synergies with other existing IT systems or systems under development, including the EUDAMED IT platform for medical devices. That work should also be facilitated by, where appropriate, emerging digital technologies such as computational models and simulations for clinical trials, as well as data from the EU Space Programme such as the Galileo geolocation services, and Copernicus earth observation use of the European Medicines Verification System (set up in the context of the Falsified Medicines FMD) data for preventing medicines shortages in an epidemiological crisis by enabling national regulators to assess the availability of products versus what has been consumed or parallel exported in their market, as well as the Substance, product, organisation and referential (SPOR) master management1a for human medicines and the EUDAMED IT platform for medical devices. _________________ 1ahttps://www.ema.europa.eu/en/human- regulatory/research-development/data- medicines-iso-idmp-standards/substance- product-organisation-referential-spor- master-data.

Amendment 108 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Josianne CUTAJAR, Alicia HOMS GINEL

Proposal for a regulation
Recital 25

(25) In order to facilitate the work and the exchange of information under this Regulation, provision should be made for the establishment and management of IT infrastructures and synergies with other existing IT systems or systems under development, including the EUDAMED IT platform for medical devices. That work should also be facilitated by, where appropriate, emerging digital technologies such as computational models and simulations for clinical trials, as well as data from the EU Space Programme such as the Galileo geolocation servicuse of including use of the European Medicines Verification System (set up in the context of the Falsified Medicines FMD) data for mapping consumption for human medicines and preventing medicines shortages, and of the Substance, product, organisation and referential (SPOR) master management1 for human medicines, and ~~Copernicus earth observation data~~the EUDAMED IT platform for medical devices.

Amendment 109 #

Proposal for a regulation
Recital 25 a (new)

(25 a) Underlines the potential of Big Data to complement the evidence from clinical trials and fill knowledge gaps on medicines, as well as to help to better characterise diseases, treatments and the performance of medicines in individual healthcare systems. The global pandemic has also shown how High Performance Computing, in combination with Big Data and AI, can be of critical importance in the global fight against COVID-19.

Amendment 110 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Alicia HOMS GINEL

Proposal for a regulation
Recital 25 a (new)

(25 a) Calling upon the NCAs to establish a reliable and harmonized pan- European interoperable and digital reporting system consisting of harmonized and common data fields and able to operate with other systems like SPOR, EMA systems and iSPOC and operate in a digital environment and having and effective alert system to discriminate between national and/or pan-European shortages and preventing duplication of shortages reporting.

Amendment 111 #

Proposal for a regulation
Recital 26

(26) Rapid access and exchange of health data, including real world data i.e. health data generated outside of clinical studies, such as electronic health records, insurance claims data and data from patient registries, is essential to ensure effective management of public health emergencies and other major events. This Regulation should allow the Agency to use and facilitate such exchange and be part of the establishment and operation of the European Health Data Space infrastructure, while ensuring the applicability of the GDPR and EUDPR, and the respect of the principles relating to the processing of personal data (as per Article 5 GDPR and 4 EUDPR).

Amendment 112 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Maria da Graça CARVALHO

Proposal for a regulation
Recital 26

(26) Rapid access and exchange of health data, including real world data i.e. health data generated outside of clinical studies, is essential to ensure effective management of public health emergencies and other major events. This Regulation should allow the Agency to use and facilitate such exchange and be part of the establishment and operation of the European Health Data Space infrastructure. It shall allow as well the definition of programs and data collection systems relating to outcomes, results, adverse and undesiderable events usable for all developers.

Amendment 113 #

Proposal for a regulation
Recital 26

(26) Rapid access and exchange of health data, including real world data i.e. health data generated outside of clinical studies, is essential to ensure effective management of public health emergencies and other major events. This Regulation should allow the Agency to use and facilitate such exchange and be part of the establishment and operation of the European Health Data Space infrastructure. It is of utmost importance to ensure that health data is used in full respect to the provisions of the GDPR on personal data protection.

Amendment 114 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Recital 26

(26) Rapid access and exchange of health data, including when generated with appropriate quality criteria, real world data i.e. health data generated outside of clinical studies, iscan be essential as supportive evidence or signal-eliciting evidence to ensure effective management of public health emergencies and other major events. This Regulation should allow the Agency to use and facilitate such exchange and be part of the establishment and operation of the European Health Data Space infrastructure.

Amendment 115 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Alicia HOMS GINEL

Proposal for a regulation
Recital 26 a (new)

(26 a) It is imperative to have in place robust transparency measures and standards regarding the Agency’s regulatory activities on treatments, vaccines and medical devices falling under the scope of this Regulation. These measures should include timely publication of all relevant information on approved products and clinical data, having taken due regard to protection of personal data protection and commercially confidential information. The Agency should make public the recommendations, opinions and decisions from the steering groups. The membership of the steering groups and working parties should be made public. Members of the steering groups and experts should not have financial or other interests in the pharmaceutical industry which could affect their impartiality;

Amendment 116 #

Proposal for a regulation
Recital 26 a (new)

(26 a) The handling of sensitive health data requires a high level of protection against cyber-attacks. The Agency was the target of a cyber-attack that resulted in some of the unlawfully accessed documents related to COVID-19 medicines and vaccines belonging to third parties. Highlights in this respect the need for a high level of security against cyber- attacks, and particularly cyber-espionage, at all times and especially during public health emergencies;

Amendment 117 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Alicia HOMS GINEL

Proposal for a regulation
Recital 26 a (new)

(26 a) Calls for the swift implementation of binding rules on security information and cybersecurity in line with the Security Union Strategy. Urges the Member States to accelerate the work towards completing the implementation of the main 5G Toolbox measures by the second quarter of 2021;

Amendment 118 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Antonio TAJANI, Maria da Graça CARVALHO

Proposal for a regulation
Recital 27

(27) During a public health emergency or in relation to a major event, the Agency should ensure cooperation with the European Centre for Disease Prevention – which should provide forecasts in a timely manner to relevant actor of the pharmaceutical supply chain - and Control and other Union Agencies as appropriate. Such cooperation should include data sharing, including data on epidemiological forecasting, regular communication at an executive level, and invitations to representatives of the European Centre for Disease Prevention and Control and other Union Agencies to attend meetings of the Emergency Task Force, the Medicines Steering Group, and the Medical Devices Steering Group, as appropriate. Regular two-way communication and exchange of information between regulators, industry and pertinent stakeholders of the pharmaceutical supply chain shall also be guaranteed to kick off prompt debates about estimated potential drug shortages in the market by way of sharing expected supply constraints which authorities become aware of via the notification process, allowing better coordination, interactions and proper response when required;

Amendment 119 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Antonio TAJANI, Maria da Graça CARVALHO

Proposal for a regulation
Recital 28

(28) SAs stressed out as well by EU4Health Programme recently adopted by the EU, 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 and can, therefore, 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.

Amendment 120 #

Proposal for a regulation
Recital 29 a (new)

(29 a) In order to ensure that the democratic oversight on EMA is maintained, especially in times of crisis, the Commission commits to answer questions asked by Members of the European Parliament before the deadline expires;

Amendment 121 #

Proposal for a regulation
Recital 31 a (new)

(31 a) To enable the Agency to be better prepared for the consequences of major events for human or veterinary medicinal products and public health emergencies, it is necessary to establish an European High Level Forum composed by health and pharmaceutical experts, Agency members and other interested parties with the purpose of sharing useful information, exchanging different points of view and finding appropriate solutions.

Amendment 122 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Antonio TAJANI, Maria da Graça CARVALHO

(31 a) Shortages consist of different and complex root causes which still need to be further mapped, understood and analysed together with all different stakeholders to be capable of addressing all the different root causes . A better understanding of the should include identification of bottlenecks in the supply chain;

Amendment 123 #

Proposal for a regulation
Recital 31 a (new)

(31 a) Recalls the applicability of the GDPR and EUDPR and the respect of the principles relating to the processing of personal data (as per Article 5 GDPR and 4EUDPR);

Amendment 124 #

Proposal for a regulation
Recital 31 b (new)

(31 b) Calling upon the National Competent Authorities (NCAs) to establish a reliable and harmonised pan- European interoperable and digital reporting system for shortages and preventing duplication of shortages reporting. The standardized reporting requirements for information on clearly defined shortages should be agreed, giving priority to critical products with high potential impact. For this the NCAs need to establish a uniform harmonized pan-European interoperable and digital NCAs reporting system consisting of harmonised and common data fields and interoperable with other systems like Substance, product, organisation and referential (SPOR) master management, EMA systems and Industry Single Point of Contact (iSPOC) and operating in a digital environment and having and effective alert system to discriminate between national and/or pan-European shortages;

Amendment 125 #

Proposal for a regulation
Recital 31 b (new)

(31 b) During COVID-19’s emergency, the regulatory flexibility allowed by the Commission has proven to be a tool for industry to prevent shortages. Such regulatory flexibilities should also be feasible outside of a crisis to help manufacturers to prevent shortages;

Amendment 126 #

Proposal for a regulation
Recital 31 c (new)

(31 c) In order to facilitate the reliable exchange of medicinal product information in a robust and consistent manner, identification of human medicinal products will be based on the standards of the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP);

Amendment 127 #

Proposal for a regulation
Recital 31 d (new)

(31 d) acknowledges the role of the pharmaceutical industry during the COVID-19 crisis and the fact that industry demonstrated resilience, through continued manufacturing, avoiding any major supply disruption for patients during the whole COVID-19 crisis;

Amendment 128 #

Proposal for a regulation
Recital 31 e (new)

(31 e) Shortages consist of different and complex root causes which still need to be further mapped, understood and analysed together with all different stakeholders to be capable of addressing all the different root causes. A better understanding of the root causes and drivers of shortages should include identification of bottlenecks in the supply chain via the European Medicines Verification System (set up in the context of the Falsified Medicines Directive) could readily be used for this purpose;

Amendment 129 #

Proposal for a regulation
Recital 31 f (new)

(31 f) During COVID-19 the regulatory flexibility allowed by the Commission has proven to be a tool for industry to prevent shortages. Such regulatory flexibilities, such as electronic product information (e- leaflet), should also be feasible outside of a crisis to help manufacturers to prevent shortages.

Amendment 130 #

Proposal for a regulation
Article 1 – paragraph 1 – point b

(b) monitor and report to prevent on shortages of medicinal products for human use and medical devices;

Amendment 131 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Antonio TAJANI, Maria da Graça CARVALHO

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

This Regulation shall not prejudice the potential expansion of this framework by subsequent legislation in order to be applicable on a permanent basis beyond public health emergencies and major events.

Amendment 132 #

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

(a) ‘public health emergency’ means a public health emergency at Union level recognised by the European Commission in accordance with Article 23(1) of Regulation (EU) 2020/[…]17 ;arising from a threat of human, animal, plant, food or environmental origin having a health dimension which requires urgent action by Authorities. _________________ 17[insert reference to the Regulation of the European Parliament and of the Council on serious cross-border threats to health and repealing Decision No 1082/2013/EU] OJ C […], […], p. […].

Amendment 133 #

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

(a) ‘public health emergency’ means a public health emergency at Union level recognised by the European Commission in accordance with Article 23(1) of Regulation (EU) 2020/[…]17 ;and the Agency will define upfront the actual criteria to capture the drivers of such an emergency in Article 3. _________________ 17[insert reference to the Regulation of the European Parliament and of the Council on serious cross-border threats to health and repealing Decision No 1082/2013/EU] OJ C […], […], p. […].

Amendment 134 #

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

(d) ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet ~~demand~~patients' demand plus appropriate buffer stock for that medicinal product or medical device at national level;

Amendment 135 #

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

(d) ‘shortage’ means that supply of a medicinal product for human or veterinary use or a medical device does not meet ~~deman~~patient need for that medicinal product or medical device at national level no matter the cause;

Amendment 136 #

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

(d) ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet demand patient and healthcare actors’ needs for that medicinal product or medical device at national level;

Amendment 137 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Antonio TAJANI, Maria da Graça CARVALHO

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

(d) ‘shortage’ means that supply of a medicinal product for human or veterinary use or a medical device does not meet demand for that medicinal product or medical device for patient need, no matter the cause;

Amendment 138 #

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

(d) ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet ~~demand for that medicinal product~~patient and healthcare actor’s needs at national level for a period orf m~~edical device;~~ore than two weeks.

Amendment 139 #

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

(d) ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet ~~demand~~patients' needs for that medicinal product or medical device at national level;

Amendment 140 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Antonio TAJANI, Maria da Graça CARVALHO

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

(e) ‘developer’ means any legal or natural person holding intellectual property rights for a medicinal product and who, as part of that product’s development, is seeking to generate scientific data with regard to the product's quality, safety and efficacy ~~of a medicinal product as part of that product’s development~~;

Amendment 141 #

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

(f) ‘major event’ means an event which is likely to pose a serious risk to public health in relation to medicinal products in more than one Member State. Such an event concerns a deadly threat or otherwise serious threat to health of biological, chemical, environmental or other origin or incident that can affect the demand and/or supply, or quality, safety, and efficacy of medicinal products. Such an event may lead to shortages of critical medicinal products in more than one Member State and necessitates urgent coordination at Union level in order to ensure a high level of human health protection.

Amendment 142 #

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

(f) ‘major event’ means an event which is likely to pose a serious risk to public health in relation to medicinal products in more than one Member State. Such an event concerns a deadly threat or otherwise serious threat to health of biological, chemical, environmental or other origin or incident that can affect the demand and/or supply or quality, safety, and efficacy of medicinal products. Such an event may lead to shortages of critical medicinal products in more than one Member State and necessitates urgent coordination at Union level in order to ensure a high level of human health protection.

Amendment 143 #

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

(f) ‘major event’ means an event which is likely to pose a serious risk to public health in relation to medicinal products in ~~more than on~~one or more Member States. Such an event concerns a deadly threat or otherwise serious threat to health of biological, chemical, environmental or other origin or incident that can affect the supply and availability or quality, safety, and efficacy of medicinal products. Such an event may lead to shortages of medicinal products ~~in more than on~~and/or medical devices in one or more Member State and necessitates urgent coordination at Union level in order to ensure a high level of human health protection.

Amendment 144 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Josianne CUTAJAR, Alicia HOMS GINEL

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

Amendment 145 #

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

(f) ‘major event’ means an event which is likely to pose a serious risk to public health in relation to medicinal products in more than one Member State. Such an event concerns a deadly threat or otherwise serious threat to health of biological, chemical, environmental or other origin or incident that can affect the manufacturing, supply or quality, safety, and efficacy of medicinal products. Such an event may lead to shortages of medicinal products in more than one Member State and necessitates urgent coordination at Union level in order to ensure a high level of human health protection.

Amendment 146 #

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

(f) ‘major event’ means an event which is likely to pose a serious risk to public health in relation to medicinal products in more than one Member State. Such an event concerns a deadly threat or otherwise serious threat to health of biological, chemical, environmental or other origin or incident that can affect the demand for, and/or supply or quality, safety, and efficacy of, medicinal products. Such an event may lead to shortages of medicinal products in more than one Member State and necessitates urgent coordination at Union level in order to ensure a high level of human health protection.

Amendment 147 #

Proposal for a regulation
Article 3 – paragraph 1

1. The Executive Steering Group on Shortages and Safety of Medicinal Products (‘the Medicines Steering Group’) is hereby established as part of the Agency. It shall meet either in person or remotely,. Meetings may be scheduled in preparation for or during a public health emergency or following a request for assistance referred to in Article 4(3) or to deal with a shortage that has been declared by at least one Member State. The Agency shall provide its secretariat.

Amendment 148 #

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

1 a. The Medicines Steering Group will be established for a fixed term and will cease its activities when the health emergency or the imminent major event has been declared to end.

Amendment 149 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Article 3 – paragraph 2

Amendment 150 #

Proposal for a regulation
Article 3 – paragraph 2 a (new)

2 a. The membership of the Medicines Steering Group shall be made public. Members of the Medicines Steering Group and experts shall not have financial or other interests in the pharmaceutical industry which could affect their impartiality. They shall undertake to act in the public interest and in an independent manner, and shall make an annual declaration of their financial interests. All indirect interests which could relate to the industry shall be entered in a register held by the Agency and shall be accessible to the public, on request.

Amendment 151 #

Proposal for a regulation
Article 3 – paragraph 3

3. The Medicines Steering Group shall be chaired by the Agency. The Chair ~~may~~should invite third parties, including representatives of medicinal product interest groups and marketing authorisation holders to attend its meetings. The chair shall ensure that a broad spectrum of opinions is taken into account. The chair shall ensure that the stakeholders in the medicines supply chain can give an informed opinion about the situation in the various Member States concerned;

Amendment 152 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Antonio TAJANI, Maria da Graça CARVALHO

Proposal for a regulation
Article 3 – paragraph 3

3. The Medicines Steering Group shall be chaired by the Agency. The Chair may invite third parties, including representatives of medicinal product interest groups and marketing authorisation holders ~~to attend its meeting~~, representatives of patients, consumers and healthcare professionals to attend its meetings. To avoid market distortions, the Medicines Steering Group shall ensure that data is evenly shared within or withheld from all marketing authorisation holders.

Amendment 153 #

Proposal for a regulation
Article 3 – paragraph 3

3. The Medicines Steering Group shall be chaired by the Agency. The Chair may invite third parties, including representatives of medicinal product interest groups and marketing authorisation holders, via the industry single point of contact (iSPOC), and other stakeholders in the medicines supply chain as well as interest groups representing patients and healthcare professionals, to attend its meetings.

Amendment 154 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Article 3 – paragraph 3

3. The Medicines Steering Group shall be chaired by the Agency. The Chair may ~~invite~~decide to hear third parties, including ~~representatives of medicinal product interest groups and marketing authorisation holders to attend its meeting~~marketing authorisation holders, developers of medicinal products, clinical trial experts, public-health advocacy groups, sectoral trade unions, consumer and patient organisations, as well as healthcare professionals.

Amendment 155 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Article 3 – paragraph 4

4. The Medicines Steering Group shall establish its rules of procedure including procedures relating to the working party referred to the paragraph 5 and on the adoption of lists, sets of information, and recommendations. The rules of procedure shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency. After being established, these rules shall be made publicly available.

Amendment 156 #

Proposal for a regulation
Article 3 – paragraph 4

4. The Medicines Steering Group shall establish its rules of procedure including the clarified mention of its competences, procedures relating to the working party referred to the paragraph 5 and on the adoption of lists, sets of information, and recommendations. The rules of procedure shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency.

Amendment 157 #

Proposal for a regulation
Article 3 – paragraph 5

5. The Medicines Steering Group shall be supported in its work by a working party comprised of single points of contact related to shortages from ~~national competent authorities for medicinal products established in accordance with Article 9(1)~~industry (iSPOC) and a two way communication line need to be established between the Medicines Steering Group and the iSPOC.

Amendment 158 #

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

5 a. The Medicines Steering Group shall be supported in its work by a working party comprised of industry single points of contact related to shortages (iSPOC) and a two way communication line need to be established between the Medicines Steering Group and the iSPOC.

Amendment 159 #

Proposal for a regulation
Article 3 – paragraph 6 a (new)

6 a. The Medicines Steering Group shall exercise its competencies in full compliance with the principles of proportionality and subsidiarity.

Amendment 160 #

Proposal for a regulation
Article 4 – paragraph 1

1. The Agency shall continuously monitor any event that ~~is likely~~has the potential to lead to a major event or a public health emergency. In this regard, the Agency shall cooperate closely with the European Centre for Disease Prevention and Control or other Union agencies, where relevant.

Amendment 161 #

Proposal for a regulation
Article 4 – paragraph 1

1. The Agency shall continuously monitor any event that is likely to lead to a major event or a public health emergency and it should be capable of establishing the necessary preventive mechanisms that are necessary-.

Amendment 162 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Antonio TAJANI, Maria da Graça CARVALHO

Proposal for a regulation
Article 4 – paragraph 1

1. The Agency, in coordination with the ECDC, shall continuously monitor any event that is likely to lead to a major event or a public health emergency.

Amendment 163 #

Proposal for a regulation
Article 4 – paragraph 2

Amendment 164 #

Proposal for a regulation
Article 4 – paragraph 2

Amendment 165 #

Proposal for a regulation
Article 4 – paragraph 2

Amendment 166 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Josianne CUTAJAR, Alicia HOMS GINEL

Proposal for a regulation
Article 4 – paragraph 2

Amendment 167 #

Proposal for a regulation
Article 4 – paragraph 5 – point a

(a) where the major event or public health emergency may affect the manufacturing, safety, quality, and efficacy of medicinal products, Article 5 shall apply;

Amendment 168 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Alicia HOMS GINEL

Proposal for a regulation
Article 5 – paragraph 1

Following the express recognition of a public health emergency or a request for assistance referred to in Article 4(3), the Medicines Steering Group shall evaluate the information related to the major event or the public health emergency and consider the need for urgent and coordinated action with regard to the safety, quality, and efficacy of the medicinal products concerned. The information evaluated shall become public in due time.

Amendment 169 #

Proposal for a regulation
Article 5 – paragraph 1

Following the recognition of a public health emergency or a request for assistance referred to in Article 4(3), the Medicines Steering Group shall evaluate the information related to the major event or the public health emergency and consider the need for urgent and coordinated action with regard to the manufacturing safety, quality, and efficacy of the medicinal products concerned.

Amendment 170 #

The Medicines Steering Group shall provide advice to the Commission and Member States on any appropriate action it believes should be taken at Union level on the medicinal products concerned in accordance with the provisions of Directive 2001/83/EC or Regulation (EC) No 726/2004.18This advice shall be made public, together with all the relevant information based on which the advice was compiled. If certain information can't be made available to the public, in order to respect confidentiality, the public health, commercial interests, grounds derived from Article 30 of this regulation, or the public order, it is mentioned. The Medicines Steering Group shall strive for the greatest transparency possible. _________________ 18 Regulation (EC) No 726/2004

Amendment 171 #

Proposal for a regulation
Article 6 – paragraph 1

1. Following a request for assistance referred to in Article 4(3) and after consultation of its working party, the Medicines Steering Group, after consulting the marketing authorisation holders and representatives of stakeholders in the sector, shall adopt a list of medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers as critical during the major event (‘the major event critical medicines list ’). The list shall be updated whenever necessary until the major event has been sufficiently addressed.

Amendment 172 #

Proposal for a regulation
Article 6 – paragraph 1

1. Following a request for assistance referred to in Article 4(3) and after consultation of its working party, the Medicines Steering Group, in consultation with marketing authorisation holders, shall adopt a list of medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers as critical during the major event (‘the major event critical medicines list ’). The list shall be updated whenever necessary until the major event has been sufficiently addressed.

Amendment 173 #

Proposal for a regulation
Article 6 – paragraph 3

3. The Medicines Steering Group shall adopt a set of information necessary to monitor the supply and demand of medicinal products included on the lists referred to in paragraphs 1 and 2 (‘the critical medicines lists’) and inform its working party thereof. Union or national entities that are engaged in stockpiling of medicinal products should be informed accordingly.

Amendment 174 #

Proposal for a regulation
Article 6 – paragraph 3

3. The Medicines Steering Group shall adopt a set of information necessary to monitor the supply and demand of medicinal products included on the lists referred to in paragraphs 1 and 2 (‘the critical medicines lists’) and inform its working party and the pharmaceutical operators concerned thereof.

Amendment 175 #

Proposal for a regulation
Article 6 – paragraph 4

4. ~~The Agency shall immediately publish~~Access to the critical medicines lists and any updates to those lists ~~on it~~should be granted to Member State representatives and the European Commission on a confidential basis, via the Agency’s web- portal referred to in Article 26 of Regulation (EC) No 726/2004.

Amendment 176 #

Proposal for a regulation
Article 6 – paragraph 4

4. The Agency shall ~~immediately publish the critical medicines lists and any updates to those lists on its web-portal referred to in Article 26 of Regulation (EC) No 726/2004.~~make available to the representatives of the Member States and the Commission the critical medicines lists and any updates to those lists;

Amendment 177 #

Proposal for a regulation
Article 6 – paragraph 4 a (new)

4 a. The Medicines Steering Group together with the industry (via the industry single points of contacts - iSPOCs) will determine the list of critical products and any future actions taken for the molecules included on the critical product list.

Amendment 178 #

Proposal for a regulation
Article 7 – paragraph 1

On the basis of the critical medicines lists and the information and data provided in accordance with Articles 10 and 11, the Medicines Steering Group shall monitor supply and demand of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products. Monitoring shall be conducted during health crises as well as before, after and outside these crises in order to identify potential shortages before they can affect health and lives of EU citizens. As part of that monitoring, the Medicines Steering Group shall liaise, where relevant, with the Health Security Committee established in Article 4 of Regulation (EU) 2020/[…]19 and, in the case of a public health emergency, the Advisory Committee on public health emergencies established pursuant to Article 24 of that Regulation. _________________ 19 [insert reference to adopted text referred to in footnote 4]

Amendment 179 #

Proposal for a regulation
Article 7 – paragraph 1

On the basis of the critical medicines lists, the establishment of two way communication line with industry and the information and data provided in accordance with Articles 10 and 11, the Medicines Steering Group shall monitor supply and demand, based on actual patient’s needs at national level, of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products. As part of that monitoring, the Medicines Steering Group shall liaise, where relevant, with the Health Security Committee established in Article 4 of Regulation (EU) 2020/[…]19 and, in the case of a public health emergency, the Advisory Committee on public health emergencies established pursuant to Article 24 of that Regulation. _________________ 19 [insert reference to adopted text referred to in footnote 4]

Amendment 180 #

Proposal for a regulation
Article 7 – paragraph 1

On the basis of the critical medicines lists and the information and data provided in accordance with Articles 10 and 11, the Medicines Steering Group shall monitor supply and demand with demand being based on actual patient need at the Member State level, as perArticle 2(f), of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products. As part of that monitoring, the Medicines Steering Group shall liaise, where relevant, with the Health Security Committee established in Article 4 of Regulation (EU) 2020/[…]19 and, in the case of a public health emergency, the Advisory Committee on public health emergencies established pursuant to Article 24 of that Regulation. _________________ 19 [insert reference to adopted text referred to in footnote 4]

Amendment 181 #

Proposal for a regulation
Article 7 – paragraph 1

On the basis of the critical medicines lists, the establishment of a two way communication line with industry via the industry single point of contacts (iSPOC) and the information and data provided in accordance with Articles 10 and 11, the Medicines Steering Group shall monitor supply and demand of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products. As part of that monitoring, the Medicines Steering Group shall liaise, where relevant, with the Health Security Committee established in Article 4 of Regulation (EU) 2020/[…]19 and, in the case of a public health emergency, the Advisory Committee on public health emergencies established pursuant to Article 24 of that Regulation. ~~_________________ 19 [insert reference to adopted text referred to in footnote 4]~~

Amendment 182 #

Proposal for a regulation
Article 7 – paragraph 1

On the basis of the critical medicines lists and the information and data provided in accordance with Articles 10 and 11, the Medicines Steering Group shall monitor supply and demand of medicinal products, based on the actual and potential needs of patients, included on those lists with a view to identifying any potential or actual shortages of those medicinal products. As part of that monitoring, the Medicines Steering Group shall liaise, where relevant, with the Health Security Committee established in Article 4 of Regulation (EU) 2020/[…]19 and, in the case of a public health emergency, the Advisory Committee on public health emergencies established pursuant to Article 24 of that Regulation. _________________ 19 [insert reference to adopted text referred to in footnote 4]

Amendment 183 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Antonio TAJANI, Maria da Graça CARVALHO

Proposal for a regulation
Article 7 – paragraph 1 a (new)

The Medicines Steering Group shall monitor supply and demand of medicinal products included on those across the entire value-chain, from resources to patient;

Amendment 184 #

Proposal for a regulation
Article 8 – paragraph 1

1. For the duration of a public health emergency or following a request for assistance referred to in Article 4(3) and until its closure, the Medicines Steering Group shall regularly report the results of its monitoring to the Commission, the pharmaceutical industry, relevant other stake-holders of the pharmaceutical supply chain and the sub-network referred to in Article 9(2), and, in particular, signal any potential or actual shortages of medicinal products included on the critical medicines lists.

Amendment 185 #

Proposal for a regulation
Article 8 – paragraph 1

1. For the duration of a public health emergency or following a request for assistance referred to in Article 4(3) and until its closure, the Medicines Steering Group shall regularly report the results of its monitoring to the Commission, Member States and the pharmaceutical industry and the sub-network referred to in Article 9(2), and, in particular, signal any potential or actual shortages of medicinal products included on the critical medicines lists.

Amendment 186 #

Proposal for a regulation
Article 8 – paragraph 2

2. Where requested by the Commission or the sub-network referred to in Article 9(2), the Medicines Steering Group shall provide aggregated data and forecasts of demand to substantiate its findings. In that regard, the Medicines Steering Group shall liaise with the European Centre for Disease Prevention and Control to obtain epidemiological data to help forecast medicinal product needs, and with the Executive Steering Group on Shortages of Medical Devices referred to in Article 19 where medicinal products included on the critical medicines lists are administered with a medical device. It shall share its findings and conclusions with Union and national entities engaged with stockpiling of medicinal products and medical devices.

Amendment 187 #

Proposal for a regulation
Article 8 – paragraph 3

3. As part of that reporting, the Medicines Steering Group may also provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities, including healthcare professionals, to prevent or mitigate potential or actual shortages. In that regard the Group shall liaise, as relevant, with the Health Security Committee and, in the case of a public health emergency, the Advisory Committee on public health emergencies.

Amendment 188 #

Proposal for a regulation
Article 8 – paragraph 4

4. The Medicines Steering Group may, on its own initiative or upon request from the Commission or Member states, provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities to ensure preparedness to deal with potential or actual shortages of medicinal products caused by public health emergencies or major events.

Amendment 189 #

Proposal for a regulation
Article 8 – paragraph 4 a (new)

4 a. Without prejudice to Article 30, reports and recommendations of the Medicines Steering Group will be made available to the public to their greatest extend.

Amendment 190 #

Proposal for a regulation
Article 8 – paragraph 5

5. The Medicines Steering Group may upon request from the Commission coordinate measures, where relevant, between the national competent authorities, the marketing authorisation holders and other entities, including healthcare professionals, to prevent or mitigate potential or actual shortages in the context of a major event or public health emergency.

Amendment 191 #

Proposal for a regulation
Article 8 – paragraph 5 a (new)

5 a. Measures recommended by the Medicines Steering Group to the Commission, Member States, marketing authorisation holders and other entities, should cover regulatory solutions for addressing potential shortages, e.g., measured aiming at minimizing regulatory administrate burden and facilitating flexible supply chains.

Amendment 192 #

Proposal for a regulation
Article 8 – paragraph 5 a (new)

5a. The measures recommended by the Steering Committee to the Commission, the Member States, the marketing authorisation holders and other stakeholders should include a relaxing of rules to deal with potential shortages.

Amendment 193 #

Proposal for a regulation
Article 9 – paragraph 1 – introductory part

1. In order to prepare for fulfilling the tasks referred to in Articles 4 to 8, and after consulting representatives of national authorities and marketing authorisation holders, as well as other stakeholders in the pharmaceutical sector, the Agency shall:

Amendment 194 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Alicia HOMS GINEL, Josianne CUTAJAR

Proposal for a regulation
Article 9 – paragraph 1 – introductory part

1. In order to prepare for fulfilling the tasks referred to in Articles 4 to 8 and also consulting representatives from national competent authorities and from industries representatives, as well as other stakeholders in the medicines supply chain, the Agency shall:

Amendment 195 #

Proposal for a regulation
Article 9 – paragraph 1 – point a

(a) specify the procedures and criteria for establishing the critical medicines lists;

Amendment 196 #

Ivars IJABS, Mauri PEKKARINEN, Christophe GRUDLER, Izaskun BILBAO BARANDICA

Proposal for a regulation
Article 9 – paragraph 1 – point a

(a) specify the criteria and procedures for establishing the critical medicines lists;

Amendment 197 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Antonio TAJANI, Maria da Graça CARVALHO

Proposal for a regulation
Article 9 – paragraph 1 – point c

(c) develop streamlined electronic monitoring and reporting systems; by implementing and building on existing regulatory infrastructure (EU telematics1a). This system will shall be interoperable with the national shortages reporting to prevent any duplication of the reporting process; the system should establish a two-way digital communication between the Agency and the National Competent Authorities, as well as a two way communication between the Agency and marketing authorisation holders. In case of public health emergency, aggregated information should be collected by the EMA from national competent authority shortages reporting systems in a harmonised and consolidated way, based on national harmonised data fields across Member States. The Agency can request additional information directly from the Marketing Authorisation Holders via the industry single point of contact (iSPOC), if this information has not been provided yet to the Member States; _________________ 1ahttps://www.ema.europa.eu/en/human- regulatory/overview/data-medicines-iso- idmp-standards- overview#:~:text=The%20ISO%20IDMP %20standards%20specify,a%20robust%2 0and%20consistent%20manner.

Amendment 198 #

Proposal for a regulation
Article 9 – paragraph 1 – point c

(c) develop streamlined electronic monitoring and reporting systems by implementing and building on existing regulatory infrastructure (EU telematics). This system shall be interoperable with the national shortages reporting to prevent any duplication of the reporting process; the system should establish a two-way digital communication between the Agency and the National Competent Authorities, as well as a two way communication between the Agency and marketing authorisation holders. In case of public health emergency, aggregated information should be collected by the EMA from national competent authority shortages reporting systems in a harmonised and consolidated way, based on harmonised data fields across Member States. The Agency can request additional information directly from the Marketing Authorisation Holders via the industry single point of contact (iSPOC), if this information has not been provided yet to the Member States;

Amendment 199 #

Proposal for a regulation
Article 9 – paragraph 1 – point c

(c) develop streamlined electronic monitoring and reporting systems, building upon EU telematics regulatory infrastructure, SPOR, into national shortage reporting interoperable system, preventing reporting duplication, using international standards (ISO IDMP) and supporting mutual cooperation of the Agency and National Competent Authorities and via iSPOC with Marketing Authorisation Holders;

Amendment 200 #

Proposal for a regulation
Article 9 – paragraph 1 – point c

(c) develop a streamlined and EU Harmonized electronic monitoring and reporting systems. The harmonised system prevent any duplication of the reporting process by industry;

Amendment 201 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Josianne CUTAJAR, Alicia HOMS GINEL

Proposal for a regulation
Article 9 – paragraph 1 – point c

(c) develop a streamlined electronic monitoring and reporting systems; accessible by Member State authorities and marketing authorization holders;

Amendment 202 #

Proposal for a regulation
Article 9 – paragraph 1 – point c

(c) develop streamlined electronic monitoring and reporting systems in coordination with the national competent authorities;

Amendment 203 #

Proposal for a regulation
Article 9 – paragraph 1 – point e

(e) ~~establish and maintain a list of~~update the Article 57(1)(l) of Regulation 726/2004 Data base by including the industry single points of contact ~~from marketing authorisation holders for all medicinal products for human use authorised in the Union, through the database provided for in Article 57(1)(l) of Regulation 726/2004;~~s (iSPOC), this database should be digital, regularly updated, and compliant with the standards of the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP)1a; _________________ 1ahttps://www.ema.europa.eu/en/human- regulatory/overview/data-medicines-iso- idmp-standards- overview#:~:text=The%20ISO%20IDMP %20standards%20specify,a%20robust%2 0and%20consistent%20manner.

Amendment 204 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Antonio TAJANI, Maria da Graça CARVALHO

Proposal for a regulation
Article 9 – paragraph 1 – point e

(e) establish and maintain a list of single points of contact from marketing authorisation holders for all medicinal products for human use authorised in the Union, through the database provided for in Article 57(1)(l) of Regulation 726/2004 after updating it by including the industry single point of contacts (iSPOC) maintaining compliance with ISO IDMP;

Amendment 205 #

Proposal for a regulation
Article 9 – paragraph 1 – point e

(e) ~~establish and maintain a list of~~update the Article 57(1)(l) of Regulation 726/2004 database by including the industry single points of contact ~~from marketing authorisation holders for all medicinal products for human use authorised in the Union, through the database provided for in Article 57(1)(l) of Regulation 726/2004;~~ (iSPOC); this database should be digital, regularly updated, and compliant with the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP)1a; _________________ 1ahttps://www.ema.europa.eu/en/human- regulatory/overview/data-medicines-iso- idmp-standards- overview#:~:text=The%20ISO%20IDMP %20standards%20specify,a%20robust%2 0and%20consistent%20manner.

Amendment 206 #

Proposal for a regulation
Article 9 – paragraph 2 – point a

(a) establish and maintain for the duration of the public health emergency or major event, a sub-network of single points of contact from marketing authorisation holders from the contacts established under Article 9(1) point (e), and of representatives of other relevant supply chain stakeholders involved in the distribution and supply of medicinal products to the public, based on the medicinal products included on the critical medicines lists;

Amendment 207 #

Proposal for a regulation
Article 9 – paragraph 2 – point a

(a) establish and maintain for the duration of the public health emergency or major event, a sub-network of single points of contact from marketing authorisation holders and of representatives of other relevant supply chain stakeholders involved in the distribution and supply of medicinal products to the public, based on the medicinal products included on the critical medicines lists;

Amendment 208 #

Proposal for a regulation
Article 9 – paragraph 2 – point a

(a) establish and maintain for the duration of the public health emergency or major event, a sub-network of single points of contact from marketing authorisation holders and wholesalers based on the medicinal products included on the critical medicines lists;

Amendment 209 #

Proposal for a regulation
Article 9 – paragraph 3 – introductory part

3. The information referred to in point (b) of paragraph 2 (as determined in Article 9(1)(c) and Article 11 shall not include a~~t least:~~ny information available to the Agency via collection of information submitted by industry to the national competent authority shortages systems in a harmonised and consolidated way by means of common data fields for each Member State. The system at the Agency will be interoperable with the national shortages reporting to prevent any duplication of the reporting process by industry via Industry Single Points of Contact (iSPOC).

Amendment 210 #

Proposal for a regulation
Article 9 – paragraph 3 – introductory part

3. The information referred to in point (b) of paragraph 2, without duplicating information available to the Agency via collection of information submitted by industry to the national competent authority shortages systems, shall include at least:

Amendment 211 #

Ivars IJABS, Mauri PEKKARINEN, Christophe GRUDLER, Izaskun BILBAO BARANDICA

Proposal for a regulation
Article 9 – paragraph 3 – point d

(d) details of the potential or actual shortage such as actual or estimated start and end dates and suspected or known cause as well as information on potential bottlenecks in the supply chain;

Amendment 212 #

Proposal for a regulation
Article 9 – paragraph 3 – point d

(d) details of the potential or actual shortage such as actual or estimated start and end dates and suspected or known cause at each stage of the supply chain;

Amendment 213 #

Ivars IJABS, Mauri PEKKARINEN, Christophe GRUDLER, Izaskun BILBAO BARANDICA

Proposal for a regulation
Article 9 – paragraph 3 – point d a (new)

(d a) information on active substance manufacturing sites, where relevant;

Amendment 214 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Article 9 – paragraph 3 – point e

(e) production, sales and market share data;

Amendment 215 #

Proposal for a regulation
Article 9 – paragraph 3 – point g

(g) mitigation plans including enhanced production ~~and~~, supply capacity; sourcing diversification and where applicable outsourcing plans;

Amendment 216 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Article 9 – paragraph 3 – point g

(g) mitigation plans including location- specific manufacturing, production and supply capacity;

Amendment 217 #

Proposal for a regulation
Article 9 – paragraph 3 – point h a (new)

(h a) update the format and content of the article 57 database to include the industry Single Point of contact (iSPOC) names as reported by industry. Industry should be able to digitally update the iSPOC names in the article 57 database if needed and compliant with the standards of the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP)1a; _________________ 1ahttps://www.ema.europa.eu/en/human- regulatory/overview/data-medicines-iso- idmp-standards- overview#:~:text=The%20ISO%20IDMP %20standards%20specify,a%20robust%2 0and%20consistent%20manner

Amendment 218 #

Ivars IJABS, Mauri PEKKARINEN, Christophe GRUDLER, Izaskun BILBAO BARANDICA

Proposal for a regulation
Article 9 – paragraph 3 a (new)

3 a. The information referred to in point (c) of paragraph 2 shall include at least details of (a) available alternative medicinal products; (b) information from the wholesale distributors and legal person entitled to supply the medicinal product to the public.

Amendment 219 #

Proposal for a regulation
Article 10 – paragraph 1

Amendment 220 #

Proposal for a regulation
Article 10 – paragraph 1

1. In order to facilitate the monitoring referred to in Article 7 and following a request from the Agency, marketing authorisation holders for medicinal products included on the critical medicines lists, and all distributors legally authorised to supply medicines to the public, shall submit the information referred to in Article 9(3) by the deadline set by the Agency. They shall submit the information through the points of contact designated in accordance with Article 9(2) and using the reporting methods and system established pursuant to Article 9(1). They shall provide updates where necessary.

Amendment 221 #

Proposal for a regulation
Article 10 – paragraph 1

Amendment 222 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Article 10 – paragraph 1

Amendment 223 #

Proposal for a regulation
Article 10 – paragraph 2

2. Marketing authorisation holders of medicinal products authorised in the Union shall, within ~~6 months~~12-24 from the date of application of this Regulation, provide the information required pursuant to Article 9(1)(e) in the form of an electronic submission in the database referred to in Article 57(1)(l) of Regulation (EC) No 726/2004 and compliant with the standards of the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP)5. Those marketing authorisation holders shall update their submission wherever necessary.

Amendment 224 #

Proposal for a regulation
Article 10 – paragraph 3

3. Marketing authorisation holders shall justify the absence of any requested information and any delays in providing it by the deadline set by the Agency after consultation and agreement with industry on a case by case scenario.

Amendment 225 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Article 10 – paragraph 4

4. Where marketing authorisation holders for medicinal products included on the critical medicines lists indicate that the submitted information might contains information of a commercially confidential nature, they shall identify the relevant parts ~~and~~, clarify the reasons for such an indication~~. The Agency shall assess the merits of each request and protect commercially confidential information against unjustified disclosure~~ and offer sufficient, actual and specific evidence of harm stemming from disclosure. The Agency shall assess the merits of each request, considering the benefits for public health of disclosure and act accordingly.

Amendment 226 #

Proposal for a regulation
Article 10 – paragraph 4

4. Where marketing authorisation holders for medicinal products included on the critical medicines lists indicate that the submitted information contains information of a commercially confidential nature, they shall identify the relevant parts and clarify the reasons for such an indication. The Agency shall assess the merits of each request and protect commercially confidential information against unjustified disclosure, unless the information is in the public interest. Marketing authorisation holders failing to comply with their reporting obligations shall be subject to sanctions to be determined by the Commission.

Amendment 227 #

Proposal for a regulation
Article 10 – paragraph 4

4. Where marketing authorisation holders for medicinal products included on the critical medicines lists indicate that the submitted information contains information of a commercially confidential nature, they shall identify the relevant parts and clarify the reasons for such an indication. TIt should be determined upfront what information is commercially confident, based on this the Agency shall assess the merits of each request and protect commercially confidential information against unjustified disclosure.

Amendment 228 #

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

Amendment 229 #

Proposal for a regulation
Article 11 – paragraph 1 – point a

(a) submit the set of information requested by the Agency in Chapter 2 Article 9(4) including available and estimated data on volume of demand, through its designated point of contact and using the reporting methods and system established pursuant to Article 9(1);

Amendment 230 #

Proposal for a regulation
Article 12 – paragraph 1 – point b

(b) consider the need for guidelines addressed to Member States, marketing authorisation holders, and other entities, including healthcare professionals;

Amendment 231 #

Ivars IJABS, Mauri PEKKARINEN, Christophe GRUDLER, Izaskun BILBAO BARANDICA

Proposal for a regulation
Article 12 – paragraph 1 – point c

(c) inform the Medicines Steering Group and industry (via the trade associations) of any measures taken and report on the results;

Amendment 232 #

Proposal for a regulation
Article 12 – paragraph 1 – point f

(f) liaise with third countries and relevant international organisations, as appropriate, to mitigate potential or actual shortages of medicinal products included on the critical medicines list or their active pharmaceutical ingredients, where those products or ingredients are imported into or exported from the Union and where such potential or actual shortages have international implications, including potential introduction of temporary export transparency and export authorisation mechanisms.

Amendment 233 #

Proposal for a regulation
Article 12 – paragraph 1 – point f a (new)

(f a) The Commission shall provide answers to (priority) written questions from Members of the European Parliament within the deadline.

Amendment 234 #

Proposal for a regulation
Article 13 – paragraph -1 (new)

-1 The Agency shall establish an early warning system to inform relevant stakeholders, including doctors and community and hospital pharmacists of any supply problems and potential or actual shortages of medicines included on the critical medicines lists.

Amendment 235 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Article 13 – paragraph 1

The Agency shall, via its web-portal and other appropriate means, in conjunction with national competent authorities, inform the public and interest groups with regard to the work ~~of the Medicines Steering Group.~~ and the data used and its sources based on which the recommendations of the Medicines Steering Group are taken. Proceedings and recommendations, including dissenting views, shall be documented and made publicly available.

Amendment 236 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Antonio TAJANI, Maria da Graça CARVALHO

Proposal for a regulation
Article 13 – paragraph 1

The Agency shall, via its web-portal and other appropriate means, in conjunction with national competent authorities, inform the public and interest groups in a timely manner with regard to the work of the Medicines Steering Group, including the recommendations, opinions and decisions made by the Medicines Steering Group as well as agendas and minutes of the Group’s meetings.

Amendment 237 #

Proposal for a regulation
Article 13 – paragraph 1

Amendment 238 #

Proposal for a regulation
Article 14 – paragraph 1

1. The permanent Emergency Task Force is hereby established as part of the Agency. It shall be convened ~~dur~~either ing p~~ublic health emergencies, either in p~~erson or remotely. The Agency shall provide its secretariat. The Emergency Task Force shall cooperate with EU bodies and agencies, the World Health Organisation, third countries and international scientific organisations in preparing timely and appropriate responses to health emergencies. The Agency, working together with the Member States, shall apply itself to developing the protocols and expertise necessary for a timely and appropriate response to health crises, including for sectors other than the health sector, in order to improve crisis response capacity.

Amendment 239 #

Proposal for a regulation
Article 14 – paragraph 1

Amendment 240 #

Proposal for a regulation
Article 14 – paragraph 1

1. The Emergency Task Force is hereby established as part of the Agency. It shall be convened in preparation for or during public health emergencies, either in person or remotely. The Agency shall provide its secretariat.

Amendment 241 #

Proposal for a regulation
Article 14 – paragraph 1

1. The Emergency Task Force is hereby established as part of the Agency. It shall be convened during the declared public health emergencies, either in person or remotely. The Agency shall provide its secretariat.

Amendment 242 #

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

(a a) The Emergency Task Force shall define the most clinically relevant performance targets for vaccines and treatments to be measured in clinical trials in order to guide the trials towards meeting the criteria for effective public health interventions.

Amendment 243 #

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

(b) reviewing clinical trial protocols and providing advice and guidance to developers on clinical trials to be conducted in the Union for medicinal products intended to treat, prevent, or diagnose the disease causing the public health emergency, in accordance with Article 15;

Amendment 244 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Antonio TAJANI, Maria da Graça CARVALHO

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

(c) providing scientific support to facilitate clinical trials to be conducted in the Union for medicinal products intended to treat, prevent, or diagnose the disease causing the public health emergency. Such support shall include advice to sponsors of similar or linked planned clinical trials on the establishment, in their place, of joint clinical trials and may include advice on establishing agreements to act as a sponsor or as co-sponsor in accordance with Articles 2(14) and 72 of Regulation (EU) 536/2014 and on developing suitable protocols;

Amendment 245 #

Marc BOTENGA, Manuel BOMPARD, Giorgos GEORGIOU, Marisa MATIAS, Sira REGO

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

(e) providing, by making publicly available, scientific recommendations with regard to the use of any medicinal product, which may have the potential to address public health emergencies, in accordance with Article 16;

Amendment 246 #

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

(e) providing scientific recommendations with regard to the use of any human and veterinary medicinal product, which may have the potential to address public health emergencies, in accordance with Article 16;.

Amendment 247 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Josianne CUTAJAR, Alicia HOMS GINEL

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

(f) cooperating with national competent authorities, Union bodies and agencies, the World Health Organization, third countries, and international scientific organisations on scientific and technical issues relating to the public health emergency and to medicinal products which may have the potential to address public health emergencies, as necessary.

Amendment 248 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Article 14 – paragraph 3

3. The Emergency Task Force shall be composed of representatives of the scientific committees, working parties, and staff members of the Agency, the coordination group established in accordance with Article 27 of Directive 2001/83/EC, and the Clinical Trials Coordination and Advisory Group established in accordance with Article 85 of Regulation (EU) 536/2014.21 External experts may be appointed and representatives of other Union bodies and agencies be invited on an ad hoc basis, as necessary. It shall be chaired by the Agency. Members of the Emergency Task Force, including external experts, shall not have financial or other interests in the health industry which could affect their independence and impartiality. They shall undertake to act in the public interest and in an independent manner, and shall make an annual declaration of their financial interests which shall be published. Members of the Emergency Task Force shall declare, at each meeting, any potential conflict of interest with respect to the items on the agenda. In the event of such a conflict of interest, the concerned member shall withdraw from the meeting. _________________ 21Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1

Amendment 249 #

Proposal for a regulation
Article 14 – paragraph 3 a (new)

3 a. The Emergency Task Force will be empowered to coordinate and exchange information and best practices with the health authorities of the Member States and the pharmaceutical industry in order to generate new synergies.

Amendment 250 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Article 14 – paragraph 4

4. The composition of the Emergency Task Force shall be approved by the Management Board of the Agency and made publicly available. The Executive Director of the Agency or their representative and representatives of the Commission shall be entitled to attend all meetings.

Amendment 251 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Article 14 – paragraph 5

5. The Chair may invite representatives of Member States, members of scientific committees of the Agency and working parties~~, and third parties, including representa~~ to attend its meetings, and decide to hear third partives ~~of medicinal product interest groups,~~, including marketing authorisation holders, developers of medicinal products, clinical trial ~~sponsors, representatives of clinical trial networks, and interest groups representing patients and~~experts, public health advocacy groups, sectoral trade unions, consumer and patient organisations, as well as healthcare professionals ~~to attend its meetings~~.

Amendment 252 #

Proposal for a regulation
Article 14 – paragraph 5

5. The Chair may invite representatives of Member States, members of scientific committees of the Agency and working parties, and third parties, including representatives of medicinal product interest groups, marketing authorisation holders, developers of medicinal products, clinical trial sponsors, representatives of clinical trial networks, researchers, and interest groups representing patients and healthcare professionals to attend its meetings.

Amendment 253 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Article 14 – paragraph 8

8. Article 63 of Regulation (EC) No 726/2004 shall apply to the Emergency Task Force as regards transparency and the independence of its members. Declarations of interest shall be made publicly available for all stakeholders and experts consulted. Stakeholders and experts with conflicts of interest shall not participate in the process.

Amendment 254 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Antonio TAJANI, Maria da Graça CARVALHO

Proposal for a regulation
Article 14 – paragraph 9

9. The Agency shall publish information about the medicinal products that the Emergency Task Force considers may have the potential to address public health emergencies and any updates on its web-portal. The Agency shall also publish clinical trials data on medicines and vaccines reviewed by the Emergency Task Force and clinical trials protocols on which the Emergency Task Force provided advise to developers, in line with the provisions of the Regulation (EU) No 536/2014.

Amendment 255 #

Proposal for a regulation
Article 14 – paragraph 9

9. The Agency shall rapidly publish all information about the medicinal products that the Emergency Task Force considers may have the potential to address public health emergencies and any updates on its web-portal.

Amendment 256 #

Proposal for a regulation
Article 15 – title

Advice and guidance on clinical trials

Amendment 257 #

Proposal for a regulation
Article 15 – paragraph -1 (new)

-1. The Emergency Task Force shall define the most clinically relevant performance targets for vaccines and treatments to be measured in clinical trials in order to ensure that these trials meet the criteria for effective public health interventions. These targets shall provide guidance for developers of medicinal products and underpin the scientific advice process outlined in this article.

Amendment 258 #

Proposal for a regulation
Article 15 – paragraph 1

1. During a public health emergency, the Emergency Task Force shall review clinical trial protocols submitted or intended to be submitted in a clinical trial application by developers of medicinal products as part of an accelerated scientific advice process based on targets referred to in Article 15.(-1). When providing scientific advice, a balance shall always be maintained between necessary facilitation in a crisis situation and patients’ safety.

Amendment 259 #

Proposal for a regulation
Article 15 – paragraph 2

2. Where a developer engages in an accelerated scientific advice process, the Emergency Task force shall provide such advice free of charge . The advice shall be endorsed by the Committee for Medicinal Products for Human Use at the latest 20 days following the submission to the Agency of a complete set of requested information and data by the developer. ~~The advice shall be endorsed by the Committee for Medicinal Products for Human Use.~~

Amendment 260 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Antonio TAJANI, Maria da Graça CARVALHO

Proposal for a regulation
Article 15 – paragraph 3

3. The Emergency Task Force shall establish and update procedures for the request and submission of the set of information and data required, in~~cluding inform~~ cooperation onwith the Member ~~State or~~ States where an application for authorisation of a clinical trial is submitted or is intended to be submitted in accordance with Article 4 of the Regulation 536/2014on clinical trials on medicinal products for human use. These procedures shall become public.

Amendment 261 #

Proposal for a regulation
Article 15 – paragraph 6

6. Where a developer is the recipient of scientific advice, the developer shall subsequently submit the data resulting from clinical trials to the Agency following a request made pursuant to Article 16 and awaiting the launch of the Clinical Trials Information System (CTIS) in accordance with Art. 80 and 81 of Regulation (EU) No 536/2014.

Amendment 262 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Alicia HOMS GINEL

Proposal for a regulation
Article 15 – paragraph 6

6. Where a developer is the recipient of scientific advice, the developer shall subsequently submit the data resulting from clinical trials to the Agency following a request made pursuant to Article 16. In order to ensure the protection of sensitive data a state-of-the-art pseudonymisation shall apply, including encryption.

Amendment 263 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Antonio TAJANI, Maria da Graça CARVALHO

Proposal for a regulation
Article 15 – paragraph 6

6. Where a developer is the recipient of scientific advice, the developer shall subsequently submit the data resulting from clinical trials to the Agency following a request made pursuant to Article 16. Due to the sensitive nature of this data, it shall be pseudonymised in line with the requirements of Article 89 of GDPR.

Amendment 264 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Article 15 – paragraph 6

6. Where a developer is the recipient of scientific advice, the developer shall subsequently and continuously submit all the data resulting from clinical trials to the Agency following a request made pursuant to Article 16.

Amendment 265 #

Proposal for a regulation
Article 16 – paragraph 1

1. Following the recognition of a public health emergency, the Emergency Task Force shall undertake a review of the available scientific data on human and veterinary medicinal products, which may have the potential to be used to address the public health emergency. The review shall be regularly updated and published during the public health emergency.

Amendment 266 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Article 16 – paragraph 2

2. In preparation of the review, the Emergency Task Force may request all relevant information and data from marketing authorisation holders and from developers and engage with them in preliminary discussions. The Emergency Task Force ~~may also, where available, make use of observational studies of health data generated outside of clinical studies taking into account their reliability~~shall use the results of comparative randomized controlled trials when available, but, if not, may also, when necessary, make use of real world data including pragmatic trials as in “close to everyday practice” taking into account their reliability as supportive evidence or signal-eliciting evidence.

Amendment 267 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Alicia HOMS GINEL

Proposal for a regulation
Article 16 – paragraph 2

2. In preparation of the review, the Emergency Task Force may request information and data from marketing authorisation holders and from developers and engage with them in preliminary discussions. The Emergency Task Force may also, where available, make use of observational studies of health data generated outside of clinical studies taking into account their reliability. The Emergency Task Force should liaise with agencies of third countries that authorise medicinal products for additional information and data.

Amendment 268 #

Proposal for a regulation
Article 16 – paragraph 2

2. In preparation of the review, the Emergency Task Force may request information and data from marketing authorisation holders and from developers and engage with them in preliminary discussions. The Emergency Task Force may also, where available, make use of observational studies of health data generated outside of clinical studies taking into account their reliability, while applying state-of-the-art pseudonymisation, including encryption.

Amendment 269 #

Proposal for a regulation
Article 16 – paragraph 2

2. In preparation of the re view, the Emergency Task Force mashall engage marketing authorisation holders and developers in preliminary discussions and may subsequently request information and data from marketing authorisation holders and from developers ~~and engage with them in preliminary discussions~~. The Emergency Task Force may also, where available, make use of observational studies of health data generated outside of clinical studies taking into account their reliability.

Amendment 270 #

Proposal for a regulation
Article 16 – paragraph 2

2. In preparation of the review, the Emergency Task Force ~~may~~shall request information and data from marketing authorisation holders and from developers and engage with them in preliminary discussions. The Emergency Task Force may also, where available, make use of observational studies of health data generated outside of clinical studies taking into account their reliability.

Amendment 271 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Article 16 – paragraph 3 – introductory part

3. Based on a request from one or more Member States, or the Commission, the Emergency Task Force shall provide independent recommendations, driven only by public-health needs and not by other interests, to the Committee for Medicinal Products for Human Use for an opinion in accordance with paragraph 4 on the following:

Amendment 272 #

Proposal for a regulation
Article 16 – paragraph 6

6. In the preparation of its recommendations provided pursuant to paragraphs 3, the Emergency Task Force may consult the concerned Member State and request it to provide any information and data, which inf~~orm~~luenced the Member State’s decision to make the medicinal product available for compassionate use. Following such a request, the Member State shall provide all of the requested information.

Amendment 273 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Josianne CUTAJAR, Alicia HOMS GINEL

Proposal for a regulation
Article 16 – paragraph 7 a (new)

7 a. Marketing Authorisation Holders or developers may suggest medicinal products which may have the potential to be used to address the public health emergency. The Emergency Taskforce shall take these suggestions into account and, given that the suggestion is accompanied with sufficient scientific data that the medicinal products have the potential to halt the public health emergency, give an appropriate reaction to the suggestion. The reaction shall be public.

Amendment 274 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Article 17 – paragraph 1

Amendment 275 #

Proposal for a regulation
Article 18 – paragraph 1 – point a

(a) develop and maintain electronic tools for the submission of information and data, including electronic health data generated outside the scope of clinical studies, while ensuring processing of patients' personal data is in compliance with the European data protection framework;

Amendment 276 #

Ivars IJABS, Mauri PEKKARINEN, Christophe GRUDLER, Izaskun BILBAO BARANDICA

Proposal for a regulation
Article 18 – paragraph 1 – point a

(a) develop and maintain highly secure and resilient electronic tools for the submission of information and data, including electronic health data generated outside the scope of clinical studies;

Amendment 277 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Josianne CUTAJAR, Alicia HOMS GINEL

Proposal for a regulation
Article 18 – paragraph 1 – point b

(b) coordinate independent vaccine effectiveness and safety monitoring studies using relevant data held by public authorities, while taking into consideration the priority recommendations of the HMA-EMA joint Big Data Task Force. Such coordination shall be conducted jointly with the European Centre for Disease Prevention and Control and notably through a new vaccine monitoring platform;

Amendment 278 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Alicia HOMS GINEL, Josianne CUTAJAR

Proposal for a regulation
Article 18 – paragraph 1 – point c

(c) as part of its regulatory tasks, make use of digital infrastructures or tools, to facilitate the rapid access to or analysis of available electronic health data generated outside the scope of clinical studies, and the exchange of such data between Member States, the Agency, and other Union bodies; underlines in this regard the need to speed up the deployment of a secure quantum communication infrastructure (QCI), which would allow the transmission of sensitive information, using an ultra-secure form of encryption to shield against cyberattacks;

Amendment 279 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Alicia HOMS GINEL

Proposal for a regulation
Article 18 – paragraph 1 – point c a (new)

(c a) The Agency shall be equipped with a high level of security against cyber- attacks and cyber-espionage at all times, especially during major events and public health emergencies at Union level. Binding rules on security information and cybersecurity shall apply in line with the Security Union Strategy.

Amendment 280 #

Proposal for a regulation
Article 18 – paragraph 1 – point d a (new)

(d a) develop IT tools interoperable with harmonized shortages reporting systems of National Competent Authorities (NCAs) by building on the existing digital regulatory infrastructure and ongoing projects on data management and implement AI technics to among others forecast crisis development, prepare responses and proactively initiate optimisation of resources management.

Amendment 281 #

Proposal for a regulation
Article 18 – paragraph 1 – point d a (new)

(d a) take urgent and appropriate measures to ensure the protection of health data from cyber intrusions. These measures should be built on combination of regular penetration testing, decentralised solutions and security by design principles.

Amendment 282 #

Proposal for a regulation
Article 18 – paragraph 1 – point d a (new)

Amendment 283 #

Proposal for a regulation
Article 19 – paragraph 1

1. The Executive Steering Group on Medical Devices (‘the Medical Devices Steering Group’) is hereby established as part of the Agency. It shall meet either in person or remotely, in preparation for or during a public health emergency, or upon request of a Member State affected by a shortage. The Agency shall provide its secretariat.

Amendment 284 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Article 19 – paragraph 2

Amendment 285 #

Proposal for a regulation
Article 19 – paragraph 2 a (new)

2 a. The membership of the Medical Devices Steering Group shall be made public. Members of the Medical Devices Steering Group and experts shall not have financial or other interests in the pharmaceutical industry which could affect their impartiality. They shall vow to act in the public interest and in an independent manner, and shall make an annual declaration of their financial interests. All indirect interests which could relate to the industry shall be entered in a register held by the Agency and shall be accessible to the public, on request.

Amendment 286 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Article 19 – paragraph 3

3. The Medical Devices Steering Group shall be chaired by the Agency. The Chair may ~~invite~~decide to hear third parties, including ~~representatives of medical device interest groups to attend its meeting~~developers and producers of medical devices, public-health advocacy groups, sectoral trade unions, consumer and patient organisations, as well as healthcare professionals.

Amendment 287 #

Proposal for a regulation
Article 19 – paragraph 3

3. The Medical Devices Steering Group shall be chaired by the Agency. The Chair may invite third parties, including representatives of medical device interest groups, healthcare professionals as well as representatives of patients and consumers to attend its meetings.

Amendment 288 #

Proposal for a regulation
Article 19 – paragraph 5 a (new)

5 a. The Medical Devices Steering Group will establish the basis for strengthened cooperation with national health authorities and the pharmaceutical industry.

Amendment 289 #

Proposal for a regulation
Article 20 – paragraph 1

1. Immediately following the recognition of a public health emergency and after consultation of its working party, the Medical Devices Steering Group, after consulting the marketing authorisation holders and representatives of stakeholders in the sector, shall adopt a list of medical devices which it considers as critical during the public health emergency (‘the public health emergency critical devices list’). The list shall be updated whenever necessary until the termination of the recognition of the public health emergency.

Amendment 290 #

Proposal for a regulation
Article 20 – paragraph 3

3. The Agency shall publish on an accessible way, the public health emergency critical devices list and any updates to that list on its web-portal.

Amendment 291 #

Proposal for a regulation
Article 20 – paragraph 3

3. The Agency shall publish the public health emergency critical devices list and any updates to that list in a timely manner on its web-portal.

Amendment 292 #

Proposal for a regulation
Article 21 – paragraph 1

1. On the basis of the public health emergency critical devices list and the information and data provided in accordance with Articles 24 and 25, the Medical Devices Steering Group shall monitor supply and demand of medical devices included on that list with a view to identifying any potential or actual shortages of those medical devices. As part of that monitoring, the Medical Devices Steering Group shall liaise, where relevant, with the Health Security Committee established in Article 4 of Regulation (EU) 2020/[…]22 and the Advisory Committee on public health emergencies established pursuant to Article 24 of that Regulation as well as with Union and national entities engaged with stockpiling of medical devices. _________________ 22 [insert reference to adopted text referred to in footnote 4]

Amendment 293 #

Proposal for a regulation
Article 22 – paragraph 2

2. Where requested by the Commission or the sub-network referred to in Article 23(2)(b), the Medical Devices Steering Group shall provide aggregated data and forecasts of demand to support its findings. In that regard, the Steering Group shall liaise with the European Centre for Disease Prevention and Control to obtain epidemiological data to help forecast medical device needs, and with the Medicines Steering Group referred to in Article 3 where medical devices included on the public health emergency critical devices list are used to jointly with a medicinal product as well as with Union and national entities engaged with stockpiling of medical devices.

Amendment 294 #

Proposal for a regulation
Article 22 – paragraph 4

4. The Medical Devices Steering Group may, on its own initiative or upon request from the Commission, provide recommendations on measures which may be taken by the Commission, Member States, medical device manufacturers, notified bodies and other entities, including healthcare professionals, to ensure preparedness to deal with potential or actual shortages of medical devices caused by public health emergencies.

Amendment 295 #

Proposal for a regulation
Article 22 – paragraph 5

5. The Medical Devices Steering Group may, upon request from the Commission coordinate measures, where relevant, between the national competent authorities, manufacturers of medical devices, notified bodies, and other entities, including healthcare professionals, to prevent or mitigate potential or actual shortages in the context of a public health emergency.

Amendment 296 #

Proposal for a regulation
Article 22 – paragraph 5 a (new)

Amendment 297 #

Marc BOTENGA, Manuel BOMPARD, Giorgos GEORGIOU, Marisa MATIAS, Sira REGO

Proposal for a regulation
Article 22 – paragraph 5 a (new)

5 a. All the recommendations made by the Medical Devices Steering Group shall be made publicly available.

Amendment 298 #

Proposal for a regulation
Article 23 – paragraph 1 – introductory part

1. In order to prepare for fulfilling the tasks referred to in Articles 20, 21, and 22, and after consulting the representatives of national authorities and marketing authorisation holders, as well as other stakeholders in the pharmaceutical sector, the Agency shall:

Amendment 299 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Alicia HOMS GINEL, Josianne CUTAJAR

Proposal for a regulation
Article 23 – paragraph 1 – point a

(a) after consultation with all relevant stakeholders specify the procedures for establishing the public health emergency critical devices list;

Amendment 300 #

Proposal for a regulation
Article 23 – paragraph 1 – point a

(a) specify the procedures and criteria for establishing the public health emergency critical devices list;

Amendment 301 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Alicia HOMS GINEL, Josianne CUTAJAR

Proposal for a regulation
Article 23 – paragraph 1 – point b

(b) develop streamlined electronic monitoring and reporting systems in coordination with the national competent authorities;

Amendment 302 #

Proposal for a regulation
Article 23 – paragraph 1 – point d

~~(d) establish and maintain a list of single points of contact from medical device manufacturers, authorised representatives and notified bodies;~~deleted

Amendment 303 #

Ivars IJABS, Mauri PEKKARINEN, Christophe GRUDLER, Izaskun BILBAO BARANDICA

Proposal for a regulation
Article 23 – paragraph 2 – point a

(a) establish and maintain for the duration of the public health emergency, a sub-network of single points of contact from medical device manufacturers and notified bodies based on the medical devices included on the public health emergency critical devices list based on single points of contact to be included for all medical device manufacturers in the database referred to in Article 33 of Regulation (EU) 2017/745 and Article 30 of Regulation (EU) 2017/746;

Amendment 304 #

Proposal for a regulation
Article 23 – paragraph 3 – point d

(d) details of the potential or actual shortage such as actual or estimated start and end dates, and the known or suspected cause at each level of the supply chain;

Amendment 305 #

Ivars IJABS, Mauri PEKKARINEN, Christophe GRUDLER, Izaskun BILBAO BARANDICA

Proposal for a regulation
Article 23 – paragraph 3 – point f

(f) mitigation plans including enhanced production ~~and~~, supply capacity, sourcing diversification and where applicable outsourcing plans;

Amendment 306 #

Proposal for a regulation
Article 23 – paragraph 3 – point i

(i) where conformity assessments are on-going, the status of the conformity assessment by the concerned notified bodies in relation to medical devices included in the public health emergency critical devices list and possible issues which need to be resolved in order to speedily complete the conformity assessment process.

Amendment 307 #

Proposal for a regulation
Article 24 – paragraph 1

1. In order to facilitate the monitoring referred to in Article 21 and following a request from the Agency, medical device manufacturers of the medical devices included on the public health emergency critical devices list and all distributors legally authorised to supply medical devices to the public, and, where necessary, concerned notified bodies, shall submit the information requested by the deadline set by the Agency. They shall submit the information requested through the points of contact designated in accordance with Article 23(2) and using the reporting methods and system established pursuant to Article 23(1). They shall provide updates wherever necessary.

Amendment 308 #

Proposal for a regulation
Article 24 – paragraph 3

3. Where manufacturers of medical devices included on the public health emergency critical devices list and concerned notified bodies indicate that the submitted information contains information of a commercially confidential nature, they shall identify the relevant parts and clarify the reasons for such an indication. The Agency shall assess the merits of each request and protect such commercially confidential information against unjustified disclosure unless the information is in the public interest.

Amendment 309 #

Proposal for a regulation
Article 25 – paragraph 2

2. Where necessary to fulfil their reporting obligations set out in paragraph 1, Member States shall gather information from manufacturers, importers, distributors, health care professionals and notified bodies on medical devices included on the public health emergency critical devices list.

Amendment 310 #

Proposal for a regulation
Article 25 – paragraph 4 – point a

(a) consider the need to provide for temporary exemptions at Member State level pursuant to Article 59(1) of Regulation (EU) 2017/745 or Article 54(1) of Regulation (EU) 2017/746 with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list while at the same time ensuring both patient and product safety;

Amendment 311 #

Proposal for a regulation
Article 26 – paragraph 1 – point a

(a) take all necessary action within the limits of the powers conferred on it, with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list, including, where necessary, granting temporary exemptions at Union level pursuant to Article 59(3) of Regulation (EU) 2017/745 or Article 54(3) of Regulation (EU) 2017/746 while at the same time ensuring both patient and product safety;

Amendment 312 #

Proposal for a regulation
Article 26 – paragraph 1 – point a a (new)

(a a) The Commission shall provide answers to (priority) written questions from Members of the European Parliament within the deadline.

Amendment 313 #

Ivars IJABS, Mauri PEKKARINEN, Christophe GRUDLER, Izaskun BILBAO BARANDICA

Proposal for a regulation
Article 26 – paragraph 1 – point b

(b) consider the need for guidelines addressed to Member States, medical device manufacturers, notified bodies, health care professionals and other entities;

Amendment 314 #

Proposal for a regulation
Article 26 – paragraph 1 – point e

(e) liaise with third countries and relevant international organisations, as appropriate, to mitigate potential or actual shortages of medical devices included on the critical devices list or their component parts, where those devices or parts are imported into or exported from the Union, and where such potential or actual shortages have international implications, including potential introduction of temporary export transparency and export authorisation mechanisms.

Amendment 315 #

Proposal for a regulation
Article 27 – paragraph 1

The Agency shall, via its web-portal and other appropriate means and, in conjunction with national competent authorities, inform the public and relevant interest groups with regard to the work of the Medical Devices Steering Group, including the recommendations, opinions and decisions made by the Medical Devices Steering Group as well as agendas and minutes of the Group’s meetings.

Amendment 316 #

Proposal for a regulation
Article 28 – paragraph 1 – point a

(a) provide administrative, scientific and technical support to the expert panels for the provision of scientific opinions, views and advice;

Amendment 317 #

Proposal for a regulation
Article 29 – paragraph 3 a (new)

3 a. The Commission shall carry out an impact assessment prior to the entry into force of this Regulation.

Amendment 318 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Alicia HOMS GINEL

Proposal for a regulation
Article 30 – paragraph 1 – introductory part

1. ~~Unless otherwise provided for in this Regulation and w~~Without prejudice to Regulation (EC) No 1049/200124 and existing national provisions and practices in the Member States on confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following: _________________ 24Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents, OJ L 145, 31.05.2001, p. 43

Amendment 319 #

Proposal for a regulation
Article 30 – paragraph 1 – point a

(a) personal data in accordance with Article 32 and Article 4(1) of Regulation (EU) 2016/679 (‘GDPR’) and Article 3(1) EUDPR;

Amendment 320 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Antonio TAJANI, Maria da Graça CARVALHO

Proposal for a regulation
Article 30 – paragraph 1 – point a

(a) personal data in accordance with ~~Article 32~~the definition contained in the Article 4 of GDPR and Article 3(1) EUDPR;

Amendment 321 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Alicia HOMS GINEL

Proposal for a regulation
Article 30 – paragraph 5

5. The Commission, the Agency, and Member States may exchange commercially confidential information and, where necessary to protect public health, personal data, with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements. Recalls that transfers of personal data to third countries or international organisations must comply with Chapter V of the EUDPR, relevant provisions of the GDPR, the LED and the Charter of Fundamental Rights and take into account the recommendations and guidelines of the EDPB.

Amendment 322 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Antonio TAJANI, Maria da Graça CARVALHO

Proposal for a regulation
Article 30 – paragraph 5

Amendment 65 #

Proposal for a regulation
Recital 1 a (new)

(1 a) According to Article 4(2) of the TFEU, common safety concerns in public health matters is amongst the shared competences of the EU;

Amendment 66 #

Aldo PATRICIELLO, Massimiliano SALINI, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Antonio TAJANI, Maria da Graça CARVALHO

Proposal for a regulation
Recital 2

(2) The unprecedented experience of the COVID-19 pandemic has demonstrated that the Union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health in a harmonised way between authorities, industry and other stakeholders of the pharmaceuticals supply chain. Europe needs to give a higher priority to health not with standing the competences of the Member States in the area of healthcare, to have health systems ready to provide state of the art care, and to be prepared to cope with epidemics and other unforeseeable health threats in line with the International Health Regulations. The Union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic, and also by the limited degree of Union preparedness in case of a public health emergency impacting a majority of Member States.

Amendment 67 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Josianne CUTAJAR, Alicia HOMS GINEL

Proposal for a regulation
Recital 2

(2) The unprecedented experience of the COVID-19 pandemic has demonstrated that the Union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health. The Union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic, and also by the limited degree of Union preparedness in case of a public health emergency impacting a majority of Member States. The pandemic has also shown the necessity of having an innovative and research based pharmaceutical industry that works closely with EMA in order to be better prepared for future health crisis and disruptions in the supply chain. COVID- 19 also underlined the need for more transparency on medicines pricing and EU marketing authorisation.

Amendment 68 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Recital 2

(2) The unprecedented experience of the COVID-19 pandemic has demonstrated that the Union should be more effective and transparent in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health. The Union’s ability to do so has been severely impeded by austerity measures affecting public health services, insufficient public control on production, and by the absence of a clearly defined legal framework for managing its response to the pandemic, and also by the limited degree of Union preparedness in case of a public health emergency impacting a majority of Member States.

Amendment 69 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Antonio TAJANI, Maria da Graça CARVALHO

Proposal for a regulation
Recital 2

(2) The unprecedented experience of the COVID-19 pandemic has demonstrated that the Union ~~should~~must be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health. The Union’s ability to do so 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 States preparedness in case of a public health emergency impacting a majority of Member States.

Amendment 70 #

Proposal for a regulation
Recital 3

(3) The ~~often complex supply chains of medicinal products and medical devices, national export restrictions and bans, border closures imped~~COVID-19 pandemic has exacerbated the already existing difficulty of shortages for certain medicinal products considered as critical in addressing the pandemic, and has highlighted the structural limitations ing the ~~free movement of those goods, and uncertainty related to their supply and demand in the context of the COVID-19 pandemic have led to significant~~Union’s ability to rapidly and effectively react to such challenges during public health crises, also due to the lack of implediment~~s to the smooth func~~ation~~ing~~ of ~~the single market and to addressing the serious threats to public health across the Union~~sustainable economic, regulatory and industrial policy reforms needed.

Amendment 71 #

Proposal for a regulation
Recital 3 a (new)

(3a) The COVID-19 crisis has revealed the complexity of the supply of raw materials and highlighted a highly fragmented production chain and complex distribution networks, which are factors that the manufacturers and their management controllers are struggling to deal with and which require real collaboration between states, as well as a clear stance to be taken by the EMA;

Amendment 72 #

Proposal for a regulation
Recital 3 b (new)

(3b) the essential free movement of goods must be possible with a revised border management;

Amendment 73 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Alicia HOMS GINEL

Proposal for a regulation
Recital 4

(4) Dealing with the issue of shortages of medicinal products has been a long- standing ~~priority~~but unresolved problem for the Member States and European Parliament as illustrated by several reports from the European Parliament11 as well as discussions under recent Presidencies of the Council of the European Union. _________________ 11European Parliament resolution of 17 September 2020 on the shortage of medicines – how to address an emerging problem (2020/2071(INI))

Amendment 74 #

Proposal for a regulation
Recital 4 a (new)

(4 a) The COVID-19 pandemic is a clear example of the need to reinforce the application of the One Health approach in the EU to achieve better public health outcomes, since, as stated in the EU4Health Programme, human health is connected to animal health and the environment and actions to tackle threats to health should take into account those three dimensions.

Amendment 75 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Antonio TAJANI, Maria da Graça CARVALHO

Proposal for a regulation
Recital 5

Amendment 76 #

Proposal for a regulation
Recital 6

(6) The rapid evolution of COVID-19 and the spread of the virus led to a sharp increase in demand for personal protective equipments and 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 a negative impact on supply. Those issues resulted in new entities being involved in the production of those products, which subsequently resulted in bottlenecks in conformity assessment, as well as the prevalence of non-compliant, unsafe, and in some cases counterfeit products. It is therefore appropriate to establish long-term structures within an appropriate Union body to ensure monitoring of shortages of medical devices resulting from a public health emergency.

Amendment 77 #

Proposal for a regulation
Recital 6

(6) 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 a negative impact on supply. Those issues resulted in new entities being involved in the production of those products, which subsequently resulted in bottlenecks in conformity assessment, as well as the prevalence of overpriced, non-compliant, unsafe, and in some cases counterfeit products. It is therefore appropriate to establish long-term structures within an appropriate Union body to ensure monitoring of shortages of medical devices resulting from a public health emergency.

Amendment 78 #

Ivars IJABS, Izaskun BILBAO BARANDICA, Mauri PEKKARINEN, Christophe GRUDLER

Proposal for a regulation
Recital 6 a (new)

(6 a) The COVID-19 pandemic has shown the need for increased cooperation of the European Medicines Agency with Member States and the pharmaceutical industry in order to improve the capacity of the EU and Member States to combat future health emergencies or serious events;

Amendment 79 #

Proposal for a regulation
Recital 7

(7) Uncertainty of supply and demand and the risk of shortages of essential medicinal products and medical devices during a public health emergency like the COVID-19 pandemic can trigger export restrictions amongst Member States and other national protective measures, which can seriously impact the functioning of the internal market as well as lead 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 cause, medication errors, increased duration of hospital stays, and adverse reactions caused by the administration of unsuitable products used as a substitute for unavailable ones. With respect to medical devices, shortages can lead to a lack of diagnostic resources with negative consequences for public health measures, a lack of treatment or deterioration of the disease and may also prevent health professionals from adequately carrying out their tasks. Those shortages can also have a significant impact on controlling the spread of a given pathogen caused by, for example, an insufficient supply of COVID- 19 test kits. It is therefore important to address the question of shortages and to reinforce and formalise monitoring of critical medicinal products and medical devices.

Amendment 80 #

Proposal for a regulation
Recital 7

(7) Uncertainty of supply and demand and the risk of shortages of essential medicinal products and medical devices during a public health emergency like the COVID-19 pandemic can trigger export restrictions amongst Member States and other national protective measures, which can seriously impact the functioning of the internal market. 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 cause fatalities, medication errors, increased duration of hospital stays, and adverse reactions caused by the administration of unsuitable products used as a substitute for unavailable ones. With respect to medical devices, shortages can lead to a lack of diagnostic resources with negative consequences for public health measures, a lack of treatment or deterioration of the disease and may also prevent health professionals from adequately carrying out their tasks or being protected doing so. Those shortages can also have a significant impact on controlling the spread of a given pathogen caused by, for example, an insufficient supply of COVID- 19 test kits. It is therefore important to address the question of shortages and to reinforce and formalise monitoring of critical medicinal products and medical devices.

Amendment 81 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Antonio TAJANI, Maria da Graça CARVALHO

Proposal for a regulation
Recital 8

(8) Safe and efficacious medicinal products that treat, prevent or diagnose diseases which cause public health emergencies, should be developed, if necessary, and made available within the Union as soon as possible during such emergencies. The COVID-19 pandemic has also highlighted ~~sub-optimal~~lacking coordination and decision- making as regards multinational clinical trials, and missing Union-level advice on the use of medicinal products in national compassionate use programmes or outside of their authorised indications in the Union, causing delays in the adoption of research outcomes and in the development and availability of new or repurposed medicines.

Amendment 82 #

Proposal for a regulation
Recital 9

(9) During the COVID-19 pandemic ad hoc solutions, including contingent arrangements between the Commission, the European Medicines Agency (‘the Agency’), marketing authorisation holders, manufacturers, other stakeholders of the pharmaceutical supply chain and Member States, had to be found to achieve the objective of making available safe and efficacious medicinal products to treat COVID-19 or prevent its spread, and to facilitate and speed up the development and marketing authorisation of treatments and vaccines.

Amendment 83 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Josianne CUTAJAR, Alicia HOMS GINEL

Proposal for a regulation
Recital 9 a (new)

(9 a) The outbreak of COVID-19 and the subsequent health crisis revealed the need for a more coordinated European approach in crisis management. Although the emergency of the situation explains the lack of an impact assessment, sufficient allocation of resources in terms of staff and funding needs to be secured, taking into account the specificities of the health sector in the different Member States.

Amendment 84 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Josianne CUTAJAR, Alicia HOMS GINEL

Proposal for a regulation
Recital 10

(10) In order to ensure a better functioning of the internal market of those products and contribute to a high level of human health protection, it is therefore appropriate to approximate the rules on monitoring of shortages of medicinal products and medical devices, and to facilitate the research and development of medicinal products, which may have the potential to treat, prevent, or diagnose diseases that cause public health crises. Highlights in this respect the necessity of developing analytics to predict emerging risks, including the use of alternative data sources.

Amendment 85 #

Proposal for a regulation
Recital 11

(11) This Regulation aims to ensure the smooth functioning of the internal market as regards medicinal products and medical devices, with a high level of human health protection being fundamental in those aims. Moreover, this Regulation aims to ensure the quality, safety and efficacy of medicinal products with the potential to address public health emergencies. Both objectives are being pursued simultaneously ~~and are inseparably linked whilst one not being secondary to the other~~, but quality, safety and efficacy of medical products should be a paramount priority. As regards Article 114 TFEU, this Regulation establishes a framework for the monitoring and reporting on shortages of medicinal products and medical devices during public health crises. As regards Article 168(4)(c) TFEU, this Regulation provides for a strengthened Union framework ensuring the quality and safety of medicinal products and medical devices.

Amendment 86 #

Proposal for a regulation
Recital 11 a (new)

(11 a) This Regulation establishes a framework to address the problem of shortages during public health emergencies and major events. However, shortages of medicinal products and medical devices is a persistent problem that affects health and lives of EU citizens between emergencies as well. Therefore, the Commission should subsequently propose the expansion of this framework to ensure that the problem of shortages is tackled on a permanent basis.

Amendment 87 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Antonio TAJANI, Maria da Graça CARVALHO

Proposal for a regulation
Recital 12

(12) In order to improve crisis preparedness and management for medicinal products and medical devices and increase resilience and solidarity across the Union, the procedures and the respective roles and obligations of different concerned entities involved should be clarified. The framework should build on the ad hoc solutions identified so far in the response to the COVID-19 pandemic and on experiences and examples in other countries.

Amendment 88 #

Proposal for a regulation
Recital 13

(13) A harmonised system, based on common data fields, of monitoring of shortages of medicinal products, personal protective equipments and medical devices should be established, which will facilitate appropriate access to for relevant national and EU authorities on markets situations for critical medicinal products and medical devices during public health emergencies and major events, which may have a serious impact on public health. That system should be complemented with improved telematic structures to ensure appropriate management of public health crises and coordinate and provide advice on the research and development of medicinal products which may have the potential to address public health emergencies. In order to facilitate the monitoring and reporting on potential or actual shortages of medicinal products and medical devices, as well as to avoid duplications of the information submitted, the Agency should be able to ask and obtain additional information and data, not already in the system, from the concerned marketing authorisation holders, manufacturers and Member States who all have the obligation to provide complete information and data through designated points of contact.

Amendment 89 #

Proposal for a regulation
Recital 13

(13) A harmonised system of monitoring of shortages of medicinal products and medical devices should be established, which will facilitate appropriate access to critical medicinal products and medical devices during public health emergencies and major events, which may have a serious impact on public health. That system should be complemented with improved structures to ensure appropriate management of public health crises and coordinate and provide advice on the research and development of medicinal products which may have the potential to ~~address~~mitigate public health emergencies. In order to facilitate the monitoring and reporting on potential or actual shortages of medicinal products and medical devices, the Agency should be able to ask and obtain information and data from the concerned marketing authorisation holders, manufacturers, wholesalers and Member States through designated points of contact.

Amendment 90 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Antonio TAJANI, Maria da Graça CARVALHO

Proposal for a regulation
Recital 15

Amendment 91 #

Proposal for a regulation
Recital 15

Amendment 92 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Recital 17

(17) In order to ensure that safe, high quality, 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 driven by public-health needs only should be established within the Agency to provide advice on such medicinal products. The Emergency Task Force should provide independent advice free of charge on scientific questions related to the development of treatments and vaccines and on clinical trial protocols, to those organisations involved in their development, such as marketing authorisation holders, clinical trial sponsors, public health bodies, and academia, irrespective of their exact role in the development of such medicinal products.

Amendment 93 #

Proposal for a regulation
Recital 17

(17) In order to ensure that safe, high quality, and efficacious medicinal products, which have the potential to address public health emergencies, can be developed, if necessary, 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 should provide advice free of charge on scientific questions related to the development of treatments and vaccines and on clinical trial protocols, to those organisations involved in their development, such as marketing authorisation holders, clinical trial sponsors, public health bodies, and academia, irrespective of their exact role in the development of such medicinal products.

Amendment 94 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Recital 18

(18) TWhile guaranteeing the independence of any subsequent evaluations, the work of the Emergency Task Force 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 Emergency Task Force should provide recommendations driven only by science and public-health needs and not by other interests, with regard to the use of medicinal products in the fight against the disease that is responsible for the public health crisis. The Committee for Medicinal Products for Human Use 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.

Amendment 95 #

Aldo PATRICIELLO, Ioan-Rareş BOGDAN, Cristian-Silviu BUŞOI, Massimiliano SALINI, Maria da Graça CARVALHO

Proposal for a regulation
Recital 18

(18) The work of the Emergency Task Force 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 Emergency Task Force should provide recommendations with regard to the use of medicinal products in the fight ~~against the disease that is responsible for~~to overcome the public health crisis. The Committee for Medicinal Products for Human Use 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.

Amendment 96 #

Proposal for a regulation
Recital 19

(19) The establishment of the Eemergency Ttask force is committed to overcome the divergencies among the individual regulatory frameworks, placing itself as guarantee and protection for EU citizens. The task Fforce should build on the support provided by the Agency during the COVID-19 pandemic, notably as regards scientific advice on clinical trials design and product development as well as the ‘rolling’ review i.e. on an on-going basis, of emerging evidence to allow a more efficient assessment of medicinal products including vaccines during public health emergencies.

Amendment 97 #

Marc BOTENGA, Marisa MATIAS, Manuel BOMPARD, Giorgos GEORGIOU, Sira REGO

Proposal for a regulation
Recital 19

(19) The establishment of the Emergency Task Force should build on the support provided by the Agency during the COVID-19 pandemic, notably as regards scientific advice on clinical trials design and product development, the transparency of related activities, including the rapid publishing clinical data for the products in question, as well as the ‘rolling’ review i.e. on an on-going basis, of emerging evidence to allow a more efficient assessment of medicinal products including vaccines during public health emergencies.

Amendment 98 #

Ivo HRISTOV, Nicolás GONZÁLEZ CASARES, Maria-Manuel LEITÃO-MARQUES, Lina GÁLVEZ MUÑOZ, Romana JERKOVIĆ, Carlos ZORRINHO, Robert HAJŠEL, Tsvetelina PENKOVA, Josianne CUTAJAR, Alicia HOMS GINEL

Proposal for a regulation
Recital 19 a (new)

(19 a) Experience with clinical trials during the COVID-19 pandemic revealed a tremendous amount of duplication, plethora of small trials, underrepresentation of important population groups and the lack of collaboration that increased the risk of research waste. To improve the clinical research agenda, there is a need for robust evidence on quality, efficacy and safety of medicinal products through well- designed, well-supported, large, randomised and controlled trials. Clinical results and data of trials need to be made public.

Amendment 99 #

Proposal for a regulation
Recital 20

(20) Individual research entities may agree together, or with another party, to act as a sponsor in order to prepare one harmonised Union-wide clinical trial protocol, yet 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 can undertake all the responsibilities and activities of a sponsor within the Union, while interacting with multiple Member States. It is therefore appropriate for the Agency to identify and facilitate such initiatives by giving advice on the possibilities to act as a sponsor or, where applicable, to define respective responsibilities as co-sponsors in accordance with Article 72 of Regulation (EU) 536/2014. Such an approach would strengthen the research environment in the Union, ~~and~~while encouraging the collaboration with external experts including academia, and target recruitment of data scientists, omics specialists, biostatisticians, epidemiologists, and experts in advanced analytics and AI, as well as to promote harmonisation and avoid subsequent delays in integrating the results of research to a marketing authorisation. A Union sponsor could benefit from Union research funding available at the time of the public health emergency as well as existing clinical trial networks to facilitate the development, application, submission, and running of the trial. This may be particularly valuable for trials established by Union or international public health or research organisations.

source: 691.131

2021/04/28 ENVI 626 amendments...

Amendment 112 #

Proposal for a regulation
Recital 1

(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 Union is to ensure a high level of human health protection in the definition and implementation of all Union policies and activities, within the strict limit defined by those two articles.

Amendment 113 #

Proposal for a regulation
Recital 1 a (new)

(1a) The COVID-19 pandemic has highlighted risks to human health posed by over-exploitation of wildlife and other natural resources and accelerated loss of biodiversity. As health of humans, animals and the environment are inextricably linked and similar medicines and medical devices are used for humans and animals, 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.

Amendment 114 #

Proposal for a regulation
Recital 2

(2) The unprecedented experience of the COVID-19 pandemic has demonstrated that the Union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public healthshown the difficulties of Member States to cope with a cross-border or global health emergency, and has therefore demonstrated the need to strengthen the competences of the Union in order to be more effective, efficient and expeditious in managing the availability of medicinal products and medical devices, in asserting supply chains of medicinal products and medical devices, and in developing medical countermeasures to address the threats posed to public health. The unprecedented experience of the COVID- 19 pandemic has also underlined the risks to human health posed by zoonotic spill- overs triggered by global biodiversity loss and wildlife over-exploitation. The Union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic, and also by the limited degree of Union preparedness in case of a public health emergency impacting a majority of Member States.

Amendment 115 #

Proposal for a regulation
Recital 2

(2) The unprecedented experience of the COVID-19 pandemic has demonstrated that the Union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health in a harmonised way between authorities, industry and other stakeholders of the pharmaceuticals supply chain. The Union needs to give a higher priority to health, to have health systems ready to provide state of the art care, and to be prepared to cope with epidemics and other unforeseeable health threats in line with the International Health. The Union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic, and also by the limited degree of Union preparedness in case of a public health emergency impacting a majority of Member States.

Amendment 116 #

Proposal for a regulation
Recital 2

(2) The unprecedented experience of the COVID-19 pandemic has demonstrated that the Union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health in a coordinated way between public authorities, industry and other entities of the pharmaceuticals' manufacturing, distribution and provision chains. A two- way dialogue between authorities and all the industry stakeholders is key and should be ensured to prevent and better manage medicines shortage. The Union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic, and also by the limited degree of Union preparedness in case of a public health emergency impacting a majority of Member States.

Amendment 117 #

Proposal for a regulation
Recital 2

(2) The unprecedented experience of the COVID-19 pandemic has demonstrated that, by strengthening its capacity and improving cooperation and coordination between the EU Member States, the Union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health. The Union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic, and also by the limited degree of Union preparedness in case of a public health emergency impacting a majority of Member States and by the lack of cooperation and coordination between the latter.

Amendment 118 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Nils TORVALDS, Susana SOLÍS PÉREZ, Andreas GLÜCK, Jan HUITEMA, Ondřej KNOTEK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Recital 2

Amendment 119 #

Proposal for a regulation
Recital 2

Amendment 120 #

Proposal for a regulation
Recital 2

(2) The unprecedented experience of the COVID-19 pandemic has demonstrated that, due to the significant risks posed by emerging zoonoses, the Union should be more effective in managing the availability of human or veterinary medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health. The Union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic, and also by the limited degree of Union preparedness in case of a public health emergency impacting a majority of Member States.

Amendment 121 #

Proposal for a regulation
Recital 2

Amendment 122 #

Proposal for a regulation
Recital 2 a (new)

(2a) As experienced during the COVID-19 crisis, regulatory capacity to adapt and activate exceptional measures to facilitate Marketing Authorisations for emergency medicines and medical devices is key for an effective and coordinated response to health emergencies at Union level. This capacity should be applied even beyond crisis situations, for example applying the Rolling Review procedures to critical medicinal products, covering procedures for changes in suppliers of APIs or for the designation of new manufacturing sites, leading to prevention and better mitigation of medicines shortage, in coherent and consistent coordination with Member States, avoiding fragmentation of the internal market and inefficient outcomes. The National Agencies should align their regulatory capacity to the EMA enhanced one, in terms of reduced times, efficiency and flexibility to prevent shortages and effectively respond to patients' clinical needs.

Amendment 123 #

Proposal for a regulation
Recital 2 a (new)

(2a) The COVID-19 crisis has shown that coordination and dialogue between European, national and regional authorities, industry, entities involved in the pharmaceutical supply chain, healthcare professionals and patients’ associations at European level are vital for countering health threats and should continue after the current health crisis ends so that the shortage of one-off and recurrent medicinal products can be tackled effectively. Ongoing dialogue between all such stakeholders should be assured.

Amendment 124 #

Proposal for a regulation
Recital 2 a (new)

(2a) The coronavirus pandemic has demonstrated that a pan-European coordination and dialogue among authorities, industry and relevant supply chain actors, is needed to fight against health threats, and should be continued beyond health crisis to tackle medicines shortage. A two-way communication between regulatory authorities and industry actors should be guaranteed to better mitigate and prevent medicines shortage.

Amendment 125 #

Proposal for a regulation
Recital 2 a (new)

(2a) It is therefore necessary that the Union be a full-fledged complementary component of European health systems, providing a guarantee or a last-resource stakeholder in case of serious cross- border health threats. For this reason, the know-how, expertise and capabilities of Union agencies should be strengthened accordingly.

Amendment 126 #

Proposal for a regulation
Recital 2 b (new)

(2b) Capitalizing on all pragmatic efforts made during the covid19 crisis, it is important to continue to allow regulatory flexibilities for Marketing Authorisations Holders even beyond crisis situations, for example covering procedures for changes in suppliers of APIs, the designation of new manufacturing sites, faster import authorisations, leading to better mitigation of medicines shortage. It is however crucial that those flexibilities are followed and applied in a coherent way by Member States avoiding fragmentation of the internal market and inefficient outcomes.

Amendment 127 #

Proposal for a regulation
Recital 2 c (new)

(2c) The root causes of medicines shortage should be assessed and tackled in the context of a strategy on medicines shortage. Root causes include economic causes, increasing regulatory burden, unforeseen surges in demand, supply chain interdependencies and manufacturing and quality challenges.

Amendment 128 #

Proposal for a regulation
Recital 2 d (new)

(2d) The combination of cost containment measures, lack of market predictability, combined with an onerous and rigid regulatory framework are challenging sustainable and equitable access to medicines, especially for very old inexpensive essential drugs, as well as the competitiveness of the European pharmaceutical industry.

Amendment 129 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Recital 3

(3) TDisruptions to the often complex supply chains of medicinal products and medical devices, national export restrictions and bans, border closures impeding the free movement of those goods, ~~and~~ uncertainty related to their supply and demand in the context of the COVID- 19 pandemic, and the lack of production in Europe of certain essential medicinal products or chemical active ingredients have led to significant impediments to the smooth functioning of the single market and to addressing the serious threats to public health across the Union.

Amendment 130 #

Proposal for a regulation
Recital 3

(3) The often complex supply chains of medicinal products and medical devices, national export restrictions and bans, border closures impeding the free movement of those goods, and uncertainty related to their supply and demand in the context of the COVID-19 pandemic have led to significant impediments to the smooth functioning of the single market and to addressing the serious threats to public health across the Union, with dire consequences for its citizens.

Amendment 131 #

Proposal for a regulation
Recital 3 a (new)

Amendment 132 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, Jan HUITEMA, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Recital 3 b (new)

(3b) The essential free movement of goods should be possible with revised border management.

Amendment 133 #

Proposal for a regulation
Recital 4

(4) ~~Dealing with t~~The issue of shortages of medicinal products has been a long- standing and insufficiently addressed priority for the Member States and European Parliament as illustrated by several reports from the European Parliament11 as well as discussions under recent Presidencies of the Council of the European Union. _________________ 11European Parliament resolution of 17 September 2020 on the shortage of medicines – how to address an emerging problem (2020/2071(INI))

Amendment 134 #

Proposal for a regulation
Recital 4

Amendment 135 #

Proposal for a regulation
Recital 4

(4) Dealing with 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 Parliament11 as well as discussions under recent Presidencies of the Council of the European Union. _________________ 11European Parliament resolution of 17 September 2020 on the shortage of medicines – how to address an emerging problem (2020/2071(INI)Does not affect English version.)

Amendment 136 #

Proposal for a regulation
Recital 4 a (new)

(4a) The long-standing issue of shortages of medicinal products within the Union has become significantly worse in recent years, and increased global demand exacerbated by the COVID-19 pandemic has led to further shortages, weakening the health systems of the Member States and posing significant risks to health and patient care, particularly in terms of disease progression or worsening of symptoms, longer delays or interruptions in care or treatment, longer periods of hospitalisation, increased exposure to fake medicinal products, medication errors or adverse reactions caused by substitutes for missing medicinal products, avoidable transmission of infectious diseases, significant psychological distress and increased costs for the healthcare systems.

Amendment 137 #

Proposal for a regulation
Recital 4 a (new)

(4a) The COVID-19 pandemic has clearly illustrated that human health is linked to animal health and the environment, and that action to tackle health threats should take account of all three dimensions.

Amendment 138 #

Proposal for a regulation
Recital 5

(5) The COVID-19 pandemic has exacerbated the problem of shortages for certain medicinal products considered as critical in addressing the pandemic, and has highlighted the structural limitations in the Union’s and Member States' ability to rapidly and effectively react to such challenges during public health crises. Effective communication among Member States about both anticipated and actual shortages and available stocks is essential. To ensure such information exchange, the Single Point of Contact Network (SPOC) should become an established monitoring system.

Amendment 139 #

Proposal for a regulation
Recital 5

(5) The COVID-19 pandemic has exacerbated the existing problem of shortages for certain medicinal products considered as essential and critical in addressing the pandemic, and has highlighted the Union’s dependence on third countries such as India or China, particularly in terms of the production of chemical active ingredients, the lack of coordination and cooperation between Member States, the structural limitations in the Union’s ability to rapidly and effectively react to such challenges during public health crises, and the need to support and strengthen the Union’s industrial fabric through appropriate policies.

Amendment 140 #

Proposal for a regulation
Recital 5

(5) The COVID-19 pandemic has exacerbated the problem of shortages for certain medicinal products considered as critical in addressing the pandemic, and has highlighted the structural limitations in the Union’s ability to rapidly and effectively react to such challenges during public health crises and the need for a more active and extended involvement of the European institutions addressing the health of the European citizens.

Amendment 141 #

Proposal for a regulation
Recital 5

(5) The COVID-19 pandemic has exacerbated the already existing problem of shortages for certain medicinal products considered as critical in addressing the pandemic, and has highlighted the structural limitations in the Union’s ability to rapidly and effectively react to such challenges during public health crises., also due to the lack of implementation of sustainable economic, regulatory and industrial policy reforms needed

Amendment 142 #

Proposal for a regulation
Recital 5

(5) The COVID-19 pandemic has exacerbated the problem of shortages for certain medicinal products, devices and services considered as critical in addressing the pandemic, and has highlighted the structural limitations in the Union’s ability to rapidly, efficiently and effectively react to such challenges during public health crises.

Amendment 143 #

Proposal for a regulation
Recital 5 a (new)

(5a) In order to tackle the Union’s dependence on third countries as well as production uncertainties and supply disruptions, emphasis must be placed on the importance of diversifying supplies and contracting practices for pharmaceutical products and on the need to offer prompt guidance to Member States, especially on the best way to apply the most economically advantageous tender criteria, without being confined to just the lowest price criterion. Investments in the manufacture of active ingredients and medicinal end products in the EU should also be retained as a criterion, as well as the number and location of production sites, the reliability of supply, the reinvestment of profits into R&D and the application of social, environmental, ethical and quality standards.

Amendment 144 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Nils TORVALDS, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Recital 5 a (new)

(5a) It is therefore necessary that the Agency assist the Commission in assessing the supply chain resilience of these products and devices in order to achieve a sufficient strategic autonomy of the Union in health products and devices. Ensuring supply chain resilience across the Union is not a primordial mission of the Agency, yet the European Medicines Agency (EMA) should provide data, knowledge, and skills, to the Commission and the ECDC in order to ensure supply chain resilience in Europe. Supply chain resilience is part of the four working groups of the COVID–19 taskforce of the EMA, alongside the therapeutic response, business continuity and impact, and human resources.

Amendment 145 #

Proposal for a regulation
Recital 6

(6) 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 a negative impact on supply and placed Member States in competition with each other to respond to the legitimate needs of their citizens, contributing to uncoordinated actions at national levels such as national hoarding and stockpiling. Those issues further resulted in new entities being involved in the rushed production of those products, which subsequently resulted in bottlenecks in conformity assessment, as well as the prevalence of non-compliant, unsafe, and in some cases counterfeit products. It is therefore appropriate to establish long-term structures within an appropriate Union body to ensure monitoring of shortages of medical devices resulting from a public health emergency, as well as increased and early dialogue with the industry to prevent and mitigate these shortages.

Amendment 146 #

Proposal for a regulation
Recital 6

(6) 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 a negative impact on supply. Those issues resulted in new entities being involved in the production of those products, which subsequently resulted in bottlenecks in conformity assessment, as well as the prevalence of non-compliant, unsafe, and in some cases counterfeit products. It is therefore appropriate to establish long-term structures within an appropriate Union body tohat will ensure monitoring of shortages of medical devices resulting from a public health emergency and to propose measures that can be agreed and implemented jointly across Europe.

Amendment 147 #

Proposal for a regulation
Recital 6

(6) 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 a negative impact on supply. Those issues resulted in new entities being involved in the production of those products, which subsequently resulted in bottlenecks in conformity assessment, as well as the prevalence of non-compliant, unsafe, and in some cases counterfeit products. It is therefore appropriate to establish long-term structures within an appropriate Union body to ensure monitoring of shortages of medical devices resulting from a public health emergency. These structures should, among other obligations, assess supply chain resilience and reliance.

Amendment 148 #

Proposal for a regulation
Recital 6

(6) 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 a negative impact on supply and stock shortages. Those issues resulted in new entities being involved in the production of those products, which subsequently resulted in bottlenecks in conformity assessment, as well as the prevalence of non-compliant, unsafe, and in some cases counterfeit products. It is therefore appropriate to establish long-term structures within an appropriate Union body to ensure monitoring of shortages of medical devices resulting from a public health emergency and the necessary coordination within the Union.

Amendment 149 #

Proposal for a regulation
Recital 6

(6) 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 a negative impact on supply. Those issues resulted in new entities being involved in the production of those products, which subsequently resulted in bottlenecks in conformity assessment, as well as the prevalence of over-priced, non-compliant, unsafe, and in some cases counterfeit products. It is therefore appropriate to establish long-term structures within an appropriate Union body to ensure monitoring of shortages of medical devices resulting from a public health emergency.

Amendment 150 #

Proposal for a regulation
Recital 6 a (new)

(6a) During the first stages of the COVID-19 pandemic, uncoordinated actions at national level, such as national hoarding and stockpiling, undermined industry ability to deliver equitable supply in all markets. This represents a lesson learned to avoid in any future crisis situations and highlights the urgent need for a more solid and effective coordination at Union level.

Amendment 151 #

Proposal for a regulation
Recital 6 a (new)

(6a) The Covid-19 pandemic has shown the need for increased cooperation of the European Medicines Agency with Member States and the pharmaceutical industry in order to improve the capacity of the Union and Member States to combat future health emergencies or serious events.

Amendment 152 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS, Jan HUITEMA

Proposal for a regulation
Recital 7

(7) Uncertainty of supply and demand and the risk of shortages of essential medicinal products and medical devices during a public health emergency like the COVID-19 pandemic can trigger export restrictions or bans amongst Member States and other national protective measures, such as inappropriate stockpiling, which can seriously impact the functioning of the internal market. 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 cause, medication errors, increased duration of hospital stays, and adverse reactions caused by the administration of unsuitable products used as a substitute for unavailable ones. With respect to medical devices, shortages can lead to a lack of diagnostic resources with negative consequences for public health measures, a lack of treatment or deterioration of the disease and may also prevent health professionals from adequately carrying out their tasks. Those shortages can also have a significant impact on controlling the spread of a given pathogen caused by, for example, an insufficient supply of COVID- 19 test kits or suitable PPE such as masks, gloves and protective clothing. It is therefore important to address the question of shortages ~~and to~~, reinforce and formalise monitoring of critical medicinal products and medical devices, and improve coordination within the Union.

Amendment 153 #

Proposal for a regulation
Recital 7

(7) Uncertainty of supply and demand and the risk of shortages of essential medicinal products and medical devices during a public health emergency like the COVID-19 pandemic can trigger export restrictions amongst Member States and other national protective measures, which can seriously impact the functioning of the internal market. 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 cause, medication errors, increased duration of hospital stays, and adverse reactions caused by the administration of unsuitable products used as a substitute for unavailable ones. With respect to medical devices, shortages can lead to a lack of diagnostic resources with negative consequences for public health measures, a lack of treatment or deterioration of the disease and may also prevent health professionals from adequately carrying out their tasks. Those shortages can also have a significant impact on controlling the spread of a given pathogen caused by, for example, an insufficient supply of COVID- 19 test kits. It is therefore important to address the question of shortages and to reinforce and formalise monitoring of critical medicinal products and medical devices in the most efficient way and so as to avoid creating unnecessary burdens for stakeholders which may strain resources and cause additional delays.

Amendment 154 #

Proposal for a regulation
Recital 7

(7) Uncertainty of supply and demand and the risk of shortages of essential medicinal products and medical devices during a public health emergency like the COVID-19 pandemic can trigger export restrictions amongst Member States and other national protective measures, which can seriously impact the functioning of the internal market. 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 cause, medication errors, increased duration of hospital stays, and adverse reactions caused by the administration of unsuitable products used as a substitute for unavailable ones. With respect to medical devices, shortages can lead to a lack of diagnostic resources with negative consequences for public health measures, a lack of treatment or deterioration of the disease and may also prevent health professionals from adequately carrying out their tasks. Those shortages can also have a significant impact on controlling the spread of a given pathogen caused by, for example, an insufficient supply of COVID- 19 test kits. It is therefore important to address the question of shortages and to reinforce and formalise monitoring of critical human and veterinary medicinal products and medical devices.

Amendment 155 #

Proposal for a regulation
Recital 7

(7) Uncertainty of supply and demand and the risk of shortages of essential medicinal products and medical devices during a public health emergency like the COVID-19 pandemic can trigger export restrictions amongst Member States and other national protective measures, which can seriously impact the functioning of the internal market. 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 cause fatalities, medication errors, increased duration of hospital stays, and adverse reactions caused by the administration of unsuitable products used as a substitute for unavailable ones. With respect to medical devices, shortages can lead to a lack of diagnostic resources with negative consequences for public health measures, a lack of treatment or deterioration of the disease and may also prevent health professionals from adequately carrying out their tasks. Those shortages can also have a significant impact on controlling the spread of a given pathogen caused by, for example, an insufficient supply of COVID- 19 test kits. It is therefore important to address the question of shortages and to reinforce and formalise monitoring of critical medicinal products and medical devices.

Amendment 156 #

Proposal for a regulation
Recital 8

(8) Safe and efficacious medicinal products that treat, prevent or diagnose diseases which cause public health emergencies, should be developed, if necessary through joint undertakings by public authorities, the private sector and academia, and made available within the Union as soon as possible during such emergencies. The COVID-19 pandemic has also highlighted sub-optimal coordination and decision- making as regards multinational clinical trials, and Union-level advice on the use of medicinal products in national compassionate use programmes or outside of their authorised indications in the Union, causing delays in the adoption of research outcomes and in the development and availability of new or repurposed medicines.

Amendment 157 #

Proposal for a regulation
Recital 8 a (new)

(8a) Experience with clinical trials during the Covid-19 pandemic revealed a tremendous amount of duplication of investigations on the same interventions, many small trials, under-representation of important population subgroups, based on gender, age, ethnicity or medical comorbidities, and a lack of collaboration, posing a risk of research waste. To improve the clinical research agenda, international regulators pointed out the need for robust evidence on quality, efficacy and safety of medicinal products. The main way to obtain reliable evidence is through co-ordinated, well-designed, well-powered large randomised controlled trials. Clinical trial results and data should be made public.

Amendment 158 #

Proposal for a regulation
Recital 8 a (new)

(8a) Experience with clinical trials during the Covid-19 pandemic revealed a tremendous amount of duplication of investigations on the same interventions, many small trials, underrepresentation of important population groups and a lack of collaboration putting a risk of research waste. To improve the clinical research agenda, international regulators pointed out the need for robust evidence on quality, efficacy and safety of medicinal products. The main way to obtain reliable evidence is through co-ordinated, well- designed, well powered large randomised controlled trials. Clinical trial results and data should be made public.

Amendment 159 #

Proposal for a regulation
Recital 8 b (new)

(8b) To accelerate, facilitate and coordinate the launch and development of clinical trials in Europe, the Agency should make full use of existing networks, including the Heads of Medicines Agencies (HMA), the Clinical Trials Facilitation and Coordination Group (CTFG), and the European Clinical Research Infrastructure Network (ECRIN).

Amendment 160 #

Proposal for a regulation
Recital 8 b (new)

(8b) To speed up, facilitate and coordinate the development and launch of clinical trials in Europe, the Agency should make full use of existing networks like the Heads of Medicines Agencies (HMA), the Clinical Trials Facilitation and Coordination Group (CTFG), and the European Clinical Research Infrastructure Network (ECRIN).

Amendment 161 #

Proposal for a regulation
Recital 9

(9) During the COVID-19 pandemic ad hoc solutions, including contingent arrangements between the Commission, the European Medicines Agency (‘the Agency’), marketing authorisation holders, manufacturers and Member States, had to be found to achieve the objective of making available safe and efficacious medicinal products to treat COVID-19 or prevent its spread, and to facilitate and speed up the development and marketing authorisation of treatments and vaccines. These ad-hoc solutions should be taken into account as well as all the lessons learned during the pandemic in order to better use the Agency’s potential to face future outbreaks.

Amendment 162 #

Proposal for a regulation
Recital 9

(9) During the COVID-19 pandemic ad hoc solutions, including contingent arrangements between the Commission, the European Medicines Agency (‘the Agency’), marketing authorisation holders, manufacturers or other entities in the pharmaceutical supply chain and Member States, had to be found to achieve the objective of making available safe and efficacious medicinal products to treat COVID-19 or prevent its spread, and to facilitate and speed up the development and marketing authorisation of treatments and vaccines.

Amendment 163 #

Proposal for a regulation
Recital 9

(9) During the COVID-19 pandemic ad hoc solutions, including contingent arrangements between the Commission, the European Medicines Agency (‘the Agency’), marketing authorisation holders, manufacturers, other entities of the pharmaceutical supply chain and Member States, had to be found to achieve the objective of making available safe and efficacious medicinal products to treat COVID-19 or prevent its spread, and to facilitate and speed up the development and marketing authorisation of treatments and vaccines.

Amendment 164 #

Proposal for a regulation
Recital 9

(9) During the COVID-19 pandemic ad hoc solutions, including contingent arrangements between the Commission, the European Medicines Agency (‘the Agency’), marketing authorisation holders, manufacturers and Member States, had to be found to achieve the objective of making available to the Member States safe and efficacious medicinal products to treat COVID-19 or prevent its spread, and to facilitate and speed up the development and marketing authorisation of treatments and vaccines.

Amendment 165 #

Proposal for a regulation
Recital 9 a (new)

(9a) In order to facilitate the supply of medicinal products during the COVID-19 pandemic, marketing authorisation holders were granted regulatory flexibility in relation to, for example, existing procedures for changing suppliers of active ingredients, designation of new production sites and faster processing of import permits, so that shortages of medicinal products could be addressed. Those solutions should remain in place to assist with future situations and those flexibilities should be applied consistently across the Member States to prevent fragmentation of the internal market and ineffective outcomes.

Amendment 166 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS, Jan HUITEMA

Proposal for a regulation
Recital 10

(10) In order to ensure a better functioning of the internal market of those products and contribute to a high level of human health protection, it is therefore appropriate to approximate the rules on monitoring of shortages of medicinal products and medical devices, and to facilitate the research and development of medicinal products, which may have the potential to treat, prevent, or diagnose diseases that cause public health crises. The Union's actions should be consistent with the WHO’s One Health approach, as well as with the Health in All Policies principle, recognising the interconnections between human and animal health and the environment and the cross-sectoral character of health policies.

Amendment 167 #

Proposal for a regulation
Recital 10

(10) In order to ensure a better functioning of the internal market of those products and contribute to a high level of human health protection, it is therefore appropriate to approximate the rules on monitoring of shortages of medicinal products and medical devices, and to facilitate the research and development of medicinal products, which may have the potential to treat, prevent, or diagnose diseases that cause public health crises, with a view to strategically complement the efforts of the Commission and other existing Agencies to that end, as well as that of future key agencies such as the proposed European Health Emergency Preparedness and Response Authority (HERA).

Amendment 168 #

Proposal for a regulation
Recital 10

(10) In order to ensure a better functioning of the internal market of those products and contribute to a high level of human health protection, it is therefore appropriate to approximate the rules on monitoring of shortages of medicinal products and medical devices, and to facilitate the research and development of medicinal products, which may have the potential to treat, prevent, or diagnose diseases that cause public health crises. Requirements could be defined in close cooperation between authorities, industry and relevant entities of the pharmaceutical supply chain.

Amendment 169 #

Proposal for a regulation
Recital 10

(10) In order to ensure a better functioning of the internal market of those products and contribute to a high level of human health protection, it is therefore appropriate to approximate and better coordinate the rules on monitoring of shortages of medicinal products and medical devices, and, through increased support for research and innovation, to facilitate the research and development of medicinal products, which may have the potential to treat, prevent, or diagnose diseases that cause public health crises.

Amendment 170 #

Proposal for a regulation
Recital 10

Amendment 171 #

Proposal for a regulation
Recital 10 a (new)

(10a) In order to ensure a better functioning of the internal market of those products and contribute to a high level of human health protection, it is therefore appropriate to facilitate the research and development of human and veterinary medicinal products, which may have the potential to treat, prevent, or diagnose diseases that cause serious public health events, including emerging zoonoses that particularly stem from human and animal environmental changes.

Amendment 172 #

Proposal for a regulation
Recital 10 a (new)

(10a) In order to ensure effective health systems, stress tests should be introduced to assess the resilience of health systems in emergencies with a view to providing an effective means of countering shortages in the event of pandemics and identifying structural risk factors that create shortages.

Amendment 173 #

Proposal for a regulation
Recital 11

(11) This Regulation aims to ensure the smooth functioning of the internal market as regards human and veterinary medicinal products and medical devices, with a high level of human health protection being fundamental in those aims. Moreover, this Regulation aims to ensure the quality, safety and efficacy of medicinal products with the potential to address public health emergencies. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other. As regards Article 114 TFEU, this Regulation establishes a framework for the monitoring and reporting on shortages of human and veterinary medicinal products and medical devices during public health crises. As regards Article 168(4)(c) TFEU, this Regulation provides for a strengthened Union framework ensuring the quality and safety of medicinal products and medical devices.

Amendment 174 #

Proposal for a regulation
Recital 11

(11) This Regulation aims to ensure the smooth functioning of the internal market as regards medicinal products and medical devices, ~~with~~as well as a high level of human health protection being fundamental in those aims. Moreover, this Regulation aims to ensure the quality, safety and efficacy of medicinal products with the potential to address public health emergencies. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other. As regards Article 114 TFEU, this Regulation establishes a framework for the monitoring and reporting on shortages of medicinal products and medical devices during public health crises. As regards Article 168(4)(c) TFEU, this Regulation provides for a strengthened Union framework ensuring the quality and safety of medicinal products and medical devices.

Amendment 175 #

Proposal for a regulation
Recital 11 a (new)

(11a) This Regulation aims at establishing a pan-European coordination and information system to tackle all medicines shortage which is in place and functional also under normal circumstances to be able to better manage a crisis. In this respect, this regulation sets the basis for the creation of an harmonised pan-European interoperable and digitalized shortages reporting and notification system, interconnecting national reporting systems, with data collected in digital and harmonised fields, and based on a common definition, covering both Centralised and National Marketing Authorisations. The knowledge of digital reporting systems used already in some Member States should be used as best practices to develop a pan-European harmonized system. Such harmonized and digital system should be supported by a two-way communication between industry and authorities as a prerequisite to pro- actively address medicines shortage and to use the two-months reporting lead time to try to avoid them. The combination of such information and communication systems would provide the transparency needed to take actions to prevent and mitigate cross border shortages, ultimately ensuring that public health is not impacted and patients access their medicines with no disruption. It would also enable coordination and solidarity, increase efficiency, better visibility and predictability during crisis situations, speed-up the decision-making process, while avoiding duplications of efforts, red tapes and miss communication.

Amendment 176 #

Proposal for a regulation
Recital 11 a (new)

(11a) This Regulation establishes a framework to address the problem of shortages during public health emergencies and major events. However, shortages of medicinal products and medical devices are a persistent problem that has been increasingly affecting health and lives of EU citizens for decades. Therefore, this Regulation should be a first step towards improving the EU response to this long-lasting issue. The Commission should subsequently propose the expansion of this framework to ensure that the issue of shortages is broadly and permanently tackled in the upcoming revision of Regulation (EC) 726/2004 and Directive 2001/83/EC.

Amendment 177 #

Proposal for a regulation
Recital 11 a (new)

(11a) This Regulation aims at establishing the foundations of a European Union of Health coordination and early-warning digitalized interoperable system, to monitor and report medicines shortage, based on shared definitions and procedures, in order to be prepared and better react during a crisis. The existing best practices of digital reporting systems at national level should be shared and taken into account after a common evaluation.

Amendment 178 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Nils TORVALDS, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Recital 12

(12) In order to improve crisis preparedness and management for medicinal products and medical devices and increase resilience and solidarity across the Union, the procedures and the respective roles and obligations of different concerned entities involved should be clarified. The framework should build on the ad hoc solutions identified so far in the response to the COVID-19 pandemic that have proven effective and operative and that can provide foundational protocols on which to build upon.

Amendment 179 #

Proposal for a regulation
Recital 12

(12) In order to improve crisis preparedness and management for medicinal products and medical devices and increase resilience and solidarity across the Union, the procedures and the respective roles and obligations of different concerned entities involved should be clarified. The framework should build on the ad hoc solutions identified so far in the response to the COVID-19 pandemic, while remaining flexible enough to tackle any future health crisis in the most efficient way to the benefit of public health and patients.

Amendment 180 #

Proposal for a regulation
Recital 12

(12) In order to improve crisis preparedness and management for human and veterinary medicinal products and medical devices and increase resilience and solidarity across the Union, the procedures and the respective roles and obligations of different concerned entities involved should be clarified. The framework should build on the ad hoc solutions identified so far in the response to the COVID-19 pandemic.

Amendment 181 #

Proposal for a regulation
Recital 13

(13) A harmonised system, based on common data fields, of monitoring of shortages of medicinal products, personal protective equipment and medical devices should be established, which will facilitate appropriate access tofor relevant national and Union authorities on markets situations for critical medicinal products and medical devices during public health emergencies and major events, which may have a serious impact on public health. That system should be complemented with improved telematics structures to ensure appropriate management of public health crises and coordinate and provide advice on the research and development of medicinal products which may have the potential to address public health emergencies. In order to facilitate the monitoring and reporting on potential or actual shortages of medicinal products and medical devices, as well as to avoid duplications of the information submitted, the system should be interoperable with the national shortages reporting system, the Agency should be able to ask and obtain additional any information and data – not already in the system - from the concerned marketing authorisation holders, manufacturers and Member States who should all have the obligation to provide complete information and data through designated points of contact (iSPOC and SPOC).

Amendment 182 #

Proposal for a regulation
Recital 13

(13) A harmonised system of monitoring of shortages of medicinal products and medical devices should be established, which will facilitate appropriate access to critical medicinal products and medical devices during public health emergencies and access to critical medicinal products, devices and applications in major events, which may have a serious impact on public health. That system should be complemented with improved structures to ensure appropriate management of public health crises and coordinate and provide advice on the research, innovation and development of medicinal products which may have the potential to address public health emergencies. In order to facilitate the monitoring and reporting on potential or actual shortages of medicinal products and medical devices, the Agency should be able to ask demand and obtain information and data from the concerned marketing authorisation holders, manufacturers and Member States through designated points of contact. Should any of the aforementioned stakeholders not give information to the Agency in the time lapse established by the Agency, the Commission should assist the Agency in obtaining such information, with the prospect of an eventual sanction, which should also be duly made available to the public.

Amendment 183 #

Proposal for a regulation
Recital 13

Amendment 184 #

Proposal for a regulation
Recital 13

(13) A harmonised ~~system of monitoring~~European Union of Health digitalized and interoperable early-warning system of shortages of medicinal products and medical devices should be established, which will facilitate appropriate access to critical medicinal products and medical devices during public health emergencies and major events, which may have a serious impact on public health. That system should be complemented with improved structures to ensure appropriate management of public health crises and coordinate and provide advice on the research and development of medicinal products which may have the potential to address public health emergencies. In order to facilitate the monitoring and reporting on potential or actual shortages of medicinal products and medical devices, the Agency should be able to a~~sk and obtain~~ccess information and data from the concerned marketing authorisation holders, manufacturers ~~and Member States through designated points of contact~~, relevant entities of the pharmaceuticals' supply chain and Member States' national agencies, directly via the uploaded information at national level available in the European Union of Health early-warning, interoperable and digitalized system, avoiding duplications of reporting requirements at different levels.

Amendment 185 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Recital 13

(13) A harmonised system of monitoring of shortages of medicinal products and medical devices should be established, which will facilitate appropriate access to critical medicinal products and medical devices during public health emergencies and major events, which may have a serious impact on public health. That system should be complemented with improved structures to ensure appropriate management of public health crises and coordinate and provide advice on the research and development of medicinal products which may have the potential to address public health emergencies. In order to facilitate the monitoring and reporting on potential or actual shortages of human or veterinary medicinal products and medical devices, the Agency should be able to ask and obtain information and data from the concerned marketing authorisation holders, manufacturers and Member States through designated points of contact.

Amendment 186 #

Proposal for a regulation
Recital 13 a (new)

(13a) However, in order to facilitate the prevention, monitoring and reporting of shortages of medicinal products, it would be necessary for the Union and Member States to set up an electronic platform capable of determining the volume of stocks and detecting, predicting and preventing shortages of medicinal products. To facilitate the development of such a system, lessons could be learnt from projects such as CISMED, funded by the Union through Horizon Europe. The platform should provide the national competent authorities with real-time access to unmet demands from wholesale distributors, community pharmacies and hospital pharmacies, providing accurate data in order to understand the functioning of the supply chain and anticipate potential shortages of medicinal products. The platform should also act as the sole portal for marketing authorisation holders and wholesale distributors to provide the information required during major events and public health emergencies once fully implemented, with a view to increase efficiency, predictability during crises, and speed-up the decision making process while avoiding duplication of efforts and unjustified burden on all stakeholders. In order to facilitate the coordination role of the Agency, Member States' supply monitoring platforms should be interoperable and replicate their information in a Union database managed by the Agency. To accelerate the implementation of the system at Union and national level, its development and implementation should be supported by Union funding from, inter alia, the EU4Health Programme or the Recovery and Resilience Facility established by Regulation (EU) 2021/241 of the European Parliament and of the Council1a. _________________ 1a1a Regulation (EU) 2021/241 of the European Parliament and of the Council of 12 February 2021 establishing the Recovery and Resilience Facility (OJ L 57, 18.2.2021, p. 17).

Amendment 187 #

Proposal for a regulation
Recital 13 a (new)

(13a) In order to ensure that Member State strategies, particularly in terms of stock management, are correctly implemented and coordinated, the Agency should become the regulatory authority responsible for preventing shortages of medicinal products within the Union, not only during crises but also in normal times, and its mandate and resources should also be strengthened.

Amendment 188 #

Proposal for a regulation
Recital 13 a (new)

(13a) The Agency, together with the Commission, should also do its upmost to counterbalance smear campaigns and disinformation on medicines, medical products, devices or applications, in order to ensure proper information to the public.

Amendment 189 #

Proposal for a regulation
Recital 15

(15) 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 Steering Group should establish a European lists of essential and critical medicinal products, in cooperation with all stakeholders, to ensure monitoring of those products and it should be able to provide advice on the necessary action to take to safeguard the quality, safety, and efficacy of medicinal products and ensure a high level of human health protection as well as adequate supplies. Priorities should be established for the different types of medicinal product by drawing a distinction in particular between ‘medicinal products of major therapeutic interest’ (MITMs), i.e. medicines for which an interruption of treatment is likely to jeopardise the vital prognosis of patients in the short or medium term or significantly diminishes the patient’s chances with regard to the progressive potential of the disease, or for which there are no suitable therapeutic alternatives available in sufficient quantity, and ‘medicinal products of health and strategic importance’ (MISSs), for which the interruption of treatment causes an immediate threat to the patient’s life.

Amendment 190 #

Proposal for a regulation
Recital 15

(15) 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 Steering Group 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 and ensure a high level of human health protection. The Steering Group should take into account and integrate in its works the outcomes of the ongoing discussions in the context of the European Commission Structured Dialogue on manufacturing and supply chain among institutions, national authorities and stakeholders, in order to achieve the best results in preventing and responding to shortage of medicines.

Amendment 191 #

Proposal for a regulation
Recital 15

(15) 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 Steering Group should establish a single pan-European lists of critical medicinal products, in close cooperation with industry, to ensure monitoring of those products and it should be able to provide advice on the necessary action to take to safeguard the quality, safety, and efficacy of medicinal products and ensure a high level of human health protection. during public health emergencies and major events. Such a list should take into account and integrate the outcomes of the ongoing discussions in the context of the EC structured dialogue on manufacturing and supply chain among institutions, national authorities and stakeholders, in order to avoid duplications of work and contradicting results

Amendment 192 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Nils TORVALDS, María Soraya RODRÍGUEZ RAMOS, Martin HOJSÍK, Andreas GLÜCK, Susana SOLÍS PÉREZ

Proposal for a regulation
Recital 15

Amendment 193 #

Proposal for a regulation
Recital 15

Amendment 194 #

Proposal for a regulation
Recital 15

Amendment 195 #

Proposal for a regulation
Recital 16

(16) The Executive Steering Group on Shortages and Safety of Human and Veterinary Medicinal Products 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 during the COVID-19 pandemic.

Amendment 196 #

Proposal for a regulation
Recital 16 a (new)

(16a) In order to facilitate the prevention, monitoring and reporting of shortages of medicinal products, devices and applications, the Agency and the Commission should establish an electronic platform to track and follow medicinal products, devices and applications throughout the supply chain. This platform should also be a one-stop shop for marketing authorisation holders and wholesale distributors to provide required information during major health events. This platform should use the distributed ledger technology (DLT) and include data from national and regional competent authorities. The platform should, among other duties, determine the volume of stock, the capabilities of all stakeholders linked in the supply chain or chains, the actual, current and foreseeable level of demand. This platform should also obtain, record and share information.

Amendment 197 #

Proposal for a regulation
Recital 16 b (new)

(16b) Finally, this platform should also be linked to the Health data space and managed by the Agency and the Commission.

Amendment 198 #

Proposal for a regulation
Recital 17

(17) In order to ensure that safe, high quality, 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 should provide advice free of charge on scientific questions related to the development of treatments and vaccines and on clinical trial protocols, to those organisations involved in their development, such as marketing authorisation holders, clinical trial sponsors, public health bodies, and academia, irrespective of their exact role in the development of such medicinal products. The lessons learned during the COVID pandemic should be taken into account in order to better use the Agency’s potential to face future health crises.

Amendment 199 #

Proposal for a regulation
Recital 17

(17) In order to ensure that safe, high quality, 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 should provide advice free of charge on scientific questions related to the development of treatments and vaccines and on clinical trial protocols, as well as existing minimum stock levels needed to manage the crisis adequately, to those organisations involved in their development, such as marketing authorisation holders, clinical trial sponsors, public health bodies, and academia, irrespective of their exact role in the development of such medicinal products.

Amendment 200 #

Proposal for a regulation
Recital 17

(17) In order to ensure that safe, high quality, and efficacious human and veterinary 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 should provide advice free of charge on scientific questions related to the development of treatments and vaccines and on clinical trial protocols, to those organisations involved in their development, such as marketing authorisation holders, clinical trial sponsors, public health bodies, and academia, irrespective of their exact role in the development of such medicinal products.

Amendment 201 #

Proposal for a regulation
Recital 18

(18) The work of the Emergency Task Force 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, although communication between these two bodies should be guaranteed. The Emergency Task Force should provide recommendations with regard to the use of medicinal products in the fight against the disease that is responsible for the public health crisis. The Committee for Medicinal Products for Human Use 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.

Amendment 202 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Recital 18

Amendment 203 #

Proposal for a regulation
Recital 19

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

Amendment 204 #

Simona BALDASSARRE, Silvia SARDONE, Marco DREOSTO, Joëlle MÉLIN, Gianantonio DA RE, Lucia VUOLO

Proposal for a regulation
Recital 19 a (new)

(19a) In order to ensure the full application of Article 35 of Regulation (EU) no.536/2014 of the European Parliament and of the Council 1a, with regard to emergency clinical trials on subjects unable to provide informed consent, a special independent monitoring committee for emergency clinical trials is setup, in order to avoid the duplication of similar studies that could harm the human dignity and to ensure closer pharmacovigilance due to the particularity of the trial in question. _________________ 1a Regulation (EU) no 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Official Journal of the European Union L 158/1, p. 34. https://ec.europa.eu/health/sites/health/fil es/files/eudralex/vol- 1/reg_2014_536/reg_2014_536_en.pdf

Amendment 205 #

Proposal for a regulation
Recital 20

(20) Individual research entities may agree together, or with another party, to act as a sponsor in order to prepare one harmonised Union-wide clinical trial protocol, yet 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 can undertake all the responsibilities and activities of a sponsor within the Union, while interacting with multiple Member States. It is therefore appropriate for the Agency to identify and facilitate such initiatives by giving advice on the possibilities to act as a sponsor or, where applicable, to define respective responsibilities as co-sponsors in accordance with Article 72 of Regulation (EU) 536/2014 and coordinate the development of clinical trial protocols. The Emergency Task Force should define the most clinically relevant performance targets for vaccines and treatments to be measured in clinical trials, so that they can meet the criteria for effective public health interventions. Such an approach would strengthen the research environment in the Union, and promote harmonisation and avoid subsequent delays in integrating the results of research to a marketing authorisation. A Union sponsor could benefit from Union research funding available at the time of the public health emergency as well as existing clinical trial networks to facilitate the development, application, submission, and running of the trial. This may be particularly valuable for trials established by Union or international public health or research organisations.

Amendment 206 #

Proposal for a regulation
Recital 20 a (new)

(20a) The Emergency Task Force should build on the trial networks to ensure that adequate data on new medicinal products, devices and applications, and it could build also upon the HERA Incubator, presented by Communication of 17 February 2021 “HERA Incubator: Anticipating together the threat of COVID-19 variants” [COM(2021) 78 final].

Amendment 207 #

Proposal for a regulation
Recital 21

(21) With respect to medical devices, an executive steering group on 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 devices in the case of a public health emergency. The executive steering group on medical devices should be managed by the Commission and the Agency.

Amendment 208 #

Proposal for a regulation
Recital 21

(21) With respect to medical devices, an executive steering group on 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 devices and minimum stock levels required in the case of a public health emergency.

Amendment 209 #

Proposal for a regulation
Recital 24

(24) 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 the appropriate structures within the Agency to monitor potential shortages of medical devices in the context of a public health emergency and to provide the Agency with a mandate to host the expert panels on medical devices. In this regard, all national and, eventually, Union entities engaged in stockpiling of medical devices, should report their stocks to the Agency. This would allow for long-term sustainability for the functioning of the panels and provide clear synergies with related crisis preparedness work for medicinal products. Those structures would in no way change the regulatory system or the decision- making procedures in the area of medical devices already in place in the Union, which should remain clearly distinct from the one for medicinal products.

Amendment 210 #

Proposal for a regulation
Recital 25

(25) In order to facilitate the work and the exchange of information under this Regulation, provision should be made for the establishment and management of IT infrastructures and synergies with other existing IT systems or systems under development, including ~~the EUDAMED IT platform for medical devices. That work should also be facilitated by, where appropriate, emerging di~~use of the European Medicines Verification System (set up in the context of the Falsified Medicines FMD) data for preventing medicines shortages in an epidemiologitcal ~~technologies such as computational models and simulations for clinical trials, as well as data from the EU Space Programme such as the Galileo geolocation servic~~crisis by enabling national regulators to assess the availability of products versus what has been consumed or parallel exported in their market, as well as the Substance, product, organisation and referential (SPOR) master management for human medicines, and ~~Copernicus earth observation data~~the EUDAMED IT platform for medical devices.

Amendment 211 #

Proposal for a regulation
Recital 25

(25) In order to facilitate the work and the exchange of information under this Regulation, provision should be made for the establishment and management of IT infrastructures and synergies with other existing IT systems or systems under development, including the use of the European Medicines Verification System (set up in the context of the Falsified Medicines FMD) data for mapping consumption for human medicines and preventing medicines shortages, and of the Substance, product, organisation and referential (SPOR) master management for human medicines and the EUDAMED IT platform for medical devices. That work should also be facilitated by, where appropriate, emerging digital technologies such as computational models and simulations for clinical trials, as well as data from the EU Space Programme such as the Galileo geolocation services, and Copernicus earth observation data.

Amendment 212 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Recital 25

Amendment 213 #

Proposal for a regulation
Recital 25

Amendment 214 #

Proposal for a regulation
Recital 26

(26) Rapid access and exchange of health data, including real world data i.e. health data generated outside of clinical studies, is essential to ensure effective management of public health emergencies and other major events. This Regulation should allow the Agency to use and facilitate such exchange and be part of the establishment and operation of the European Health Data Space in~~frastructure.~~ teroperable infrastructure, taking advantage of all the potential of the supercomputing, the Artificial Intelligence and the Big Data science to develop predicting models and take better and more timely-effective decisions, without compromising the privacy rights.

Amendment 215 #

Proposal for a regulation
Recital 26

(26) Rapid access and exchange of health data, including real world data i.e. health data generated outside of clinical studies, is essential to ensure effective management of public health emergencies and other major events. This Regulation should allow the Agency to use and facilitate such exchange and be part of the establishment and operation of the European Health Data Space infrastructure, but with clear rules on controlling access to the data (users with access, data retention period) and ensuring adequate protection of the data.

Amendment 216 #

Proposal for a regulation
Recital 26 a (new)

(26a) Due to the sensitive nature of health data, the Agency 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. The Agency should strictly respect the principles of data protection as defined in Article 27 of Regulation (EU)2018/1725 EUDPR, while also determining appropriate technical and organisational security measures in accordance with Article 33 EUDPR.

Amendment 217 #

Petar VITANOV

Proposal for a regulation
Recital 26 a (new)

(26a) Where it is necessary for the purposes of this Regulation to process personal data, this should be done in accordance with Union law on the protection of personal data. Any processing of personal data based on this Regulation should take place in accordance with Regulations (EU)2016/679 and (EU) 2018/1725.

Amendment 218 #

Proposal for a regulation
Recital 26 a (new)

(26a) In order to facilitate the reliable exchange of medicinal product information in a robust and consistent manner, identification of human medicinal products will be based on ISO IDMP standards.

Amendment 219 #

Proposal for a regulation
Recital 26 b (new)

(26b) Where processing of personal data is not necessary to perform the activities of the Agency, measures should be put in place to ensure use of anonymous data in line with the principle of data minimisation. Where anonymisation would not allow to achieve the specific purpose of the processing, the data should be pseudonymised. Where it is necessary for the purposes of this Regulation to process personal data, this should be carried out in accordance with Union law on the protection of personal data. Any processing of personal data based on this Regulation shall take place in accordance with Regulation 2018/1725 (EUDPR).

Amendment 220 #

Proposal for a regulation
Recital 26 c (new)

(26c) It is imperative to have in place robust transparency measures and standards regarding the Agency’s regulatory activities on medicinal products and medical devices falling under the scope of this Regulation. These measures should include timely publication of all relevant information on approved products and clinical data, including full clinical trial protocols. The Agency should apply high degree of transparency on the membership, recommendations, opinions and decisions of the newly established Steering Groups and the Emergency Task Force. Members of the Steering Groups and the Emergency Task Force should have no financial or other interests in the pharmaceutical or medical device industry which could affect their impartiality.

Amendment 221 #

Proposal for a regulation
Recital 26 d (new)

(26d) Credibility of the Agency and public trust in its decisions relies on a high degree of transparency. Therefore, proactive engagement of adequate communication tools with the general public should be foreseen. In addition, strengthened and accelerated transparency standards and measures regarding the Agency’s working bodies and clinical data assessed for the evaluation and surveillance of medicinal products and medical devices are paramount to gain and upheld public trust. This Regulation establishes a framework for these strengthened transparency standards and measures, based on the EMA’s efforts, standards and measures put in place during the Covid-19 pandemic.

Amendment 222 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Nils TORVALDS, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS, Jan HUITEMA

Proposal for a regulation
Recital 27

Amendment 223 #

Proposal for a regulation
Recital 27

(27) During a public health emergency or in relation to a major event, the Agency should ensure cooperation with the European Centre for Disease Prevention and Control and other Union Agencies as appropriate. Such cooperation should include data sharing, including data on epidemiological forecasting, regular communication at an executive level, and invitations to representatives of the European Centre for Disease Prevention and Control and other Union Agencies to attend meetings of the Emergency Task Force, the Medicines Steering Group, and the Medical Devices Steering Group, as appropriate. This cooperation should also include strategic discussions with relevant entities of the Union in a position to boost the research and development of appropriate solutions and technologies to mitigate the effects of the public health emergency or major event, or prevent future similar public health emergencies or major events, such as the proposed European Health Emergency Preparedness and Response Authority (HERA).

Amendment 224 #

Proposal for a regulation
Recital 27

(27) During a temporary public health emergency or in relation to a major event, the Agency should ensure cooperation with the European Centre for Disease Prevention and Control and other Union Agencies as appropriate. Such cooperation should include data sharing, including data on epidemiological forecasting, regular communication at an executive level, and invitations to representatives of the European Centre for Disease Prevention and Control and other Union Agencies to attend meetings of the Emergency Task Force, the Medicines Steering Group, and the Medical Devices Steering Group, as appropriate.

Amendment 225 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ

Proposal for a regulation
Recital 27 a (new)

(27a) Public trust relies on full transparency. Pro-active engagement with adequate communication tools with the general public should be foreseen. Strengthened and accelerated transparency standards and measures regarding the Agency working bodies and clinical data assessed for the evaluation and surveillance of medicinal products and medical devices are paramount to gain and upheld public trust. The EMA has put in place strengthened and accelerated transparency standards and measures during the Covid-19 pandemic. This Regulation establishes a framework for these strengthened transparency standards and measures.

Amendment 226 #

Proposal for a regulation
Recital 27 a (new)

(27a) During a public health emergency or in relation to a major event, the Agency should enable regular exchanges of information with the industry, relevant entities of the pharmaceutical supply chain, representatives of healthcare professionals, patients and consumers, to guarantee early discussions on potential drug shortages in the market and supply constraints, so as to allow better coordination and synergies to mitigate and respond to the public health emergency or major event.

Amendment 227 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS, Jan HUITEMA, Ondřej KNOTEK

Proposal for a regulation
Recital 29

(29) In order to ensure that sufficient resources, including appropriate staffing and adequate expertise, are available for the work provided for under this Regulation, expenditure of the Agency should be covered by the contribution from the Union to the Agency’s revenue.

Amendment 228 #

Proposal for a regulation
Recital 29 a (new)

(29a) The Commission retains the right to adjust the Agency's proposed resources and staffing allocation following the upcoming publication of the legislative proposal to establish a European Biomedical Research and Development Agency (BARDA) / European Health Emergency Preparedness and Response Authority (HERA).

Amendment 229 #

Proposal for a regulation
Recital 31 a (new)

(31a) National Competent Authorities (NCAs) should establish a reliable and harmonised pan-European interoperable and digital reporting system for shortages and preventing duplication of shortages reporting. The standardized reporting requirements for information on clearly defined shortages should be agreed, giving priority to critical products with high potential impact. For this the NCAs should establish a uniform harmonized pan-European interoperable and digital NCAs reporting system consisting of harmonised and common data fields and interoperable with other systems like Substance, product, organisation and referential (SPOR) master management, EMA systems and Industry Single Point of Contact (iSPOC) and operating in a digital environment and having and effective alert system to discriminate between national and/or pan-European shortages.

Amendment 230 #

Proposal for a regulation
Recital 31 a (new)

Amendment 231 #

Proposal for a regulation
Recital 31 a (new)

(31a) In the specific case of the COVID- 19 epidemic, the shortage of adjuvant treatments for the disease had a variety of causes, ranging from production difficulties in third countries to logistical or production difficulties, whilst the shortage of vaccines was due to a rarer cause, namely an unexpectedly high and rising demand.

Amendment 232 #

Proposal for a regulation
Recital 31 a (new)

(31a) It is important to acknowledge the role of the pharmaceutical industry during the COVID-19 crisis and the fact that the industry demonstrated its resilience, through continuous manufacturing, avoiding any major disruption of supply to patients throughout the COVID-19 crisis.

Amendment 233 #

Proposal for a regulation
Recital 31 b (new)

(31b) In order to facilitate the reliable exchange of information on medicinal products in a robust and consistent manner, identification of human medicinal products should be based on the standards of the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP).

Amendment 234 #

Proposal for a regulation
Recital 31 b (new)

(31b) Shortages consist of different and complex root causes which still need to be further mapped, understood and analysed together with all different stakeholders to be capable of addressing all the different root causes.

Amendment 235 #

Proposal for a regulation
Recital 31 b (new)

(31b) The establishment of an interoperable electronic platform between Member States and the Union is necessary for the prevention, monitoring and reporting of shortages of medicines and medical devices.

Amendment 236 #

Proposal for a regulation
Recital 31 b (new)

(31b) It is important to take into account, in the assessment of potential health emergencies, the contribution of zoonoses and the role of veterinary services where they are involved.

Amendment 237 #

Proposal for a regulation
Recital 31 c (new)

(31c) Shortages consist of different and complex root causes which still need to be further mapped, understood and analysed together with all different stakeholders to be capable of addressing all the different root causes. A better understanding of the root causes and drivers of shortages should include identification of bottle necks in the supply chain via the European Medicines Verification System (set up in the context of the Falsified Medicines Directive) could readily be used for this purpose.

Amendment 238 #

Proposal for a regulation
Recital 31 c (new)

(31c) It is important to acknowledge the role of the pharmaceutical industry during the Covid-19 crisis and the fact that industry demonstrated resilience, through continued manufacturing, avoiding any major supply disruption for patients during the whole Covid-19 crisis.

Amendment 239 #

Proposal for a regulation
Recital 31 d (new)

(31d) Shortages consist of different and complex root causes which still need to be further mapped, understood and analysed together with all different stakeholders to be capable of addressing all the different root causes. A better understanding of the root causes and drivers of shortages should include identification of bottlenecks in the supply chain via the European Medicines Verification System (setup in the context of the Falsified Medicines Directive) could readily be used for this purpose.

Amendment 240 #

Proposal for a regulation
Recital 31 e (new)

(31e) During Covid-19 the regulatory flexibility allowed by the Commission has proven to be a tool for industry to prevent shortages. Such regulatory flexibilities, such as electronic product information (e- leaflet), should also be feasible outside of a crisis to help manufacturers to prevent shortages.

Amendment 241 #

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

(a) prepare for and manage the impact of major events on medicinal products for human and veterinary use and of public health emergencies on medicinal products for human and veterinary use and on medical devices;

Amendment 242 #

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

(a) pre~~pare for and manage~~vent, prepare for, manage and coordinate at European level the impact of major events on medicinal products for human use and of public health emergencies on medicinal products for human use and on medical devices;

Amendment 243 #

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

(a) prepare for ~~and manage~~, coordinate and manage at European level the impact of major events on medicinal products for human use and of public health emergencies on medicinal products for human use and on medical devices;

Amendment 244 #

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

(a) prepare for and manage the impact of major events in order to limit urgently that impact on medicinal products for human use and of public health emergencies on medicinal products for human use and on medical devices;

Amendment 245 #

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

(a) prepare ~~for~~ and manage (at a pan- European level) the impact of major events on medicinal products for human use and of public health emergencies on medicinal products for human use and on medical devices;

Amendment 246 #

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

(a) prevent, prepare for and manage the impact of major events on medicinal products for human use and of public health emergencies on medicinal products for human use and on medical devices;

Amendment 247 #

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

i) Set up the relevant harmonised pan-European interoperable and digitalized infrastructure and information systems in place and functional also under normal circumstances to monitor and report on shortages, as a basis to better manage crisis situations;

Amendment 248 #

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

(aa) Set up the European Union of Health digitalized and interoperable early-warning system of shortages of medicinal products and medical devices, interconnecting national reporting systems, with common definitions and data collection procedures, as a basis to better prevent, manage and coordinate health emergencies at Union level;

Amendment 249 #

Proposal for a regulation
Article 1 – paragraph 1 – point b

(b) monitor and report on shortages of medicinal products for human use and medical devices, and adopt all adequate and necessary measures to ensure that shortages of essential medicinal products can be avoided and patients have access to safe medicinal products and treatments at accessible prices;

Amendment 250 #

Proposal for a regulation
Article 1 – paragraph 1 – point b

(b) prevent, monitor and report on shortages of medicinal products for human use and medical devices;

Amendment 251 #

Proposal for a regulation
Article 1 – paragraph 1 – point b

(b) monitor and report to prevent on shortages of medicinal products for human use and medical devices;

Amendment 252 #

Proposal for a regulation
Article 1 – paragraph 1 – point b

(b) prevent, monitor and report on shortages of medicinal products for human use and medical devices;

Amendment 253 #

(b) prevent, monitor and report on shortages of medicinal products for human use and medical devices;

Amendment 254 #

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

(ba) set up an interoperable and digital database at Union level to track, monitor, report and share information on shortages of medicinal products, devices and applications;

Amendment 255 #

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

(c) provide advice on medicinal products for human and veterinary use with the potential to address public health emergencies;

Amendment 256 #

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

(a) ‘public health emergency’ means a public health emergency at Union level recognised by the European Commission in accordance with Article 23(1) of Regulation (EU) 2020/[…]17 and the Agency will define upfront the actual criteria to capture the drivers of such and emergency in Article 3; _________________ 17[insert reference to the Regulation of the European Parliament and of the Council on serious cross-border threats to health and repealing Decision No 1082/2013/EU] OJ C […], […], p. […].

Amendment 257 #

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

(a) ‘public health emergency’ means a public health emergency at Union level recognised by the European Commission in accordance with Article 23(1) of Regulation (EU) 2020/[…]17 ; _________________ 17[insert reference to the Regulation of the European Parliament and of the Council on serious cross-border threats to health and repealing Decision No 1082/2013/EU] OJ C […], […], p. […] and the Agency will define upfront the actual criteria to capture the drivers of such an emergency in Article 3.

Amendment 258 #

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

(a) ‘public health emergency’ means a temporary public health emergency at Union level recognised by the European Commission in accordance with Article 23(1) of Regulation (EU) 2020/[…]17; _________________ 17[insert reference to the Regulation of the European Parliament and of the Council on serious cross-border threats to health and repealing Decision No 1082/2013/EU] OJ C […], […], p. […].

Amendment 259 #

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

(a) ‘public health emergency’ means a public health emergency at Union level rdec~~ognis~~lared by the European Commission in accordance with Article 23(1) of Regulation (EU) 2020/[…]17; _________________ 17[insert reference to the Regulation of the European Parliament and of the Council on serious cross-border threats to health and repealing Decision No 1082/2013/EU] OJ C […], […], p. […].

Amendment 260 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS, Ondřej KNOTEK

Proposal for a regulation
Article 2 – paragraph 1 – point c a (new)

(ca) 'supply' means total volume of stock of an individual medicinal product or medical device that is made available on the national market by a marketing authorisation holder or a manufacturer either distributors, or any other actor in the distribution chain respectively;

Amendment 261 #

Proposal for a regulation
Article 2 – paragraph 1 – point c a (new)

(ca) 'supply' means total volume of stock of an individual medicinal product or medical device that is placed on the national market by a marketing authorisation holder, a manufacturer, a distributor, or any other actor in the distribution chain respectively;

Amendment 262 #

Proposal for a regulation
Article 2 – paragraph 1 – point c a (new)

(ca) 'supply' means total volume of stock of an individual medicinal product or medical device that is made available on the national market by a marketing authorisation holder, a manufacturer, a distributors, or any other actor in the distribution chain respectively;

Amendment 263 #

Proposal for a regulation
Article 2 – paragraph 1 – point c a (new)

(ca) ‘veterinary medicinal product’ means a veterinary medicinal product as defined in paragraph 1(b) of Article 1 of Directive 2004/28/EC of the European Parliament and of the Council;

Amendment 264 #

Proposal for a regulation
Article 2 – paragraph 1 – point c b (new)

(cb) 'demand' means total volume of an individual medicinal product or medical device that is requested in the national market in response to a clinical need, including the necessary buffer stock at wholesale level;

Amendment 265 #

Proposal for a regulation
Article 2 – paragraph 1 – point c b (new)

(cb) 'demand' means total volume of an individual medicinal product or medical device that is requested in the national market in response to treatments need;

Amendment 266 #

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

(d) ‘shortage’ means that supply of a medicinal product for human or veterinary use or a medical device does not meet demand, i.e. patient needs plus appropriate buffer stocks, for that medicinal product or medical device, no matter the cause;

Amendment 267 #

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

(d) ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet demand for that medicinal product or medical device for patient and healthcare actors' needs;

Amendment 268 #

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

Amendment 269 #

Cyrus ENGERER

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

(d) ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet demand, that is patient demand together with appropriate buffer stocks, for that medicinal product or medical device;

Amendment 270 #

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

(d) ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet patients' demand for that medicinal product or medical device at national level for a period of more than two weeks;

Amendment 271 #

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

Amendment 272 #

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

(d) ‘'shortage’ means that supply of a medicinal product for human use or a medical device does not meet ~~demand for that medicinal produ~~patient and healthcare act or ~~medical device~~s’ needs;

Amendment 273 #

Petar VITANOV

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

(d) ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet ~~demand~~patient demand plus the appropriate buffer stocks for that medicinal product or medical device;

Amendment 274 #

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

(d) ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet the anticipated demand for that medicinal product or medical device, no matter the cause;

Amendment 275 #

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

(d) ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet ~~demand for that medicinal product or medical device~~the needs of patients or healthcare professionals;

Amendment 276 #

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

d) ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet ~~demand~~patients’ needs for that medicinal product or medical device at national level;

Amendment 277 #

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

(d) ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet demand for that medicinal product or medical device, regardless the cause;

Amendment 278 #

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

(d) ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet demand for that medicinal product or medical device, no matter the cause;

Amendment 279 #

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

(d) ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet demand for that medicinal product or medical device, no matter the cause;

Amendment 280 #

Proposal for a regulation
Article 2 – paragraph 1 – point d a (new)

(da) 'supply' means total volume of stock of an individual medicinal product or medical device that is made available on the national market by a marketing authorisation holder, a manufacturer, a distributors, or any other actor in the distribution chain respectively;

Amendment 281 #

Proposal for a regulation
Article 2 – paragraph 1 – point d b (new)

(db) 'demand' means total volume of an individual medicinal product or medical device that is requested in the national market in response to treatments need;

Amendment 282 #

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

(e) ‘developer’ means any legal or natural person holding intellectual property rights for a medicinal product and who, as part of that product’s development, is seeking to generate scientific data with regard to the product’s quality, safety and efficacy of a medicinal product as part of that product’s development;

Amendment 283 #

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

(e) ‘developer’ means any legal or natural person holding intellectual property rights for a medicinal product who is seeking to generate scientific data with regard to the quality, safety and efficacy of athat medicinal product as part of thate product’s development;

Amendment 284 #

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

Amendment 285 #

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

(f) ‘major event’ means an event which is likely to pose a serious risk to public health in relation to medicinal products in more than one Member State. Such an event concerns a deadly threat or otherwise serious threat to health of biological, chemical, environmental or other origin or incident that can affect the demand and / or supply, or quality, safety, and efficacy of medicinal products. Such an event may lead to shortages of critical medicinal products in more than one Member State and necessitates urgent coordination at Union level in order to ensure a high level of human health protection.

Amendment 286 #

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

(f) ‘major event’ means an event which is likely to pose a serious risk to public health in relation to human and veterinary medicinal products in more than one Member State. Such an event concerns a deadly threat or otherwise serious threat to health of biological, chemical, environmental or other origin or incident that can affect the supply or quality, safety, and efficacy of medicinal products. Such an event may lead to shortages of medicinal products in more than one Member State and necessitates urgent coordination at Union level in order to ensure a high level of human health protection.

Amendment 287 #

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

(f) ‘major event’ means an event which is likely to pose a serious risk to public health in relation to medicinal products in more than one Member State. Such an event concerns a deadly threat or otherwise serious threat to health of biological, chemical, environmental or other origin or incident that can affect the supply or demand, quality, safety, and efficacy of medicinal products. Such an event may lead to shortages of critical medicinal products in more than one Member State and necessitates urgent coordination at Union level in order to ensure a high level of human health protection.

Amendment 288 #

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

f) ‘major event’ means an event which is likely to pose a serious risk to public health in relation to medicinal products in more than one Member State. Such an event concerns a deadly threat or otherwise serious threat to health of biological, chemical, environmental or other origin or incident that can affect the demand and/or supply or quality, safety, and efficacy of medicinal products. Such an event may lead to shortages of medicinal products in more than one Member State and necessitates urgent coordination at Union level in order to ensure a high level of human health protection.

Amendment 289 #

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

(f) ‘major event’ means an event which is likely to pose a serious risk to public health in relation to medicinal products in ~~more than on~~one or more Member State. Such an event concerns a deadly threat or otherwise serious threat to health of biological, chemical, environmental or other origin or incident that can affect the supply or quality, safety, and efficacy of medicinal products. Such an event may lead to shortages of medicinal products in more than one Member State and necessitates urgent coordination at Union level in order to ensure a high level of human health protection.

Amendment 290 #

Proposal for a regulation
Article 2 – paragraph 1 – point f a (new)

(fa) ‘demand’ relates to the request for a medicinal product or a medical device by a healthcare professional or patient in response to a clinical need. For demand to be satisfactorily met, the medicinal product will need to be acquired in time and sufficient quantity to allow continuity of best care of patients, while following real, adequate prescription needs.

Amendment 291 #

Proposal for a regulation
Article 2 – paragraph 1 – point f a (new)

(fa) ‘critical medicinal product’ means any medicinal product for human and veterinary use within the meaning of Article 1(2) of Directive 2001/83/EC of the European Parliament and of the Council, or a constituent thereof, that is considered necessary for the management of a public health emergency and until such time as the emergency is resolved.

Amendment 292 #

Proposal for a regulation
Article 2 – paragraph 1 – point f a (new)

(fa) ‘major non-communicable disease’ means a chronic disease which tends to be of long duration and is the result of a combination of genetic, physiological, environmental and behavioural factors, such as a cardiovascular disease, cancer, respiratory disease, diabetes or mental illness, and which affects a significant number of people in the Union.

Amendment 293 #

Proposal for a regulation
Article 2 – paragraph 1 – point f a (new)

Amendment 294 #

Proposal for a regulation
Article 2 – paragraph 1 – point f a (new)

Amendment 295 #

Proposal for a regulation
Article 2 – paragraph 1 – point f a (new)

(fa) ‘demand’ relates to the request for a medicinal product or a medical device by a healthcare professional or patient in response to a clinical need. For demand to be satisfactorily met, the medical product will need to be acquired in time and sufficient quantity to allow continuity of best care of patients.

Amendment 296 #

Proposal for a regulation
Article 2 – paragraph 1 – point f a (new)

(fa) 'demand' means total volume of an individual medicinal product or medical device that is requested in the national market in response to a clinical need

Amendment 297 #

Proposal for a regulation
Article 2 – paragraph 1 – point f a (new)

(fa) ‘Health in all policies’ means health in all policies as defined in Regulation (EU) .../... EU 4 Health [OJ: ...]

Amendment 298 #

Proposal for a regulation
Article 2 – paragraph 1 – point f b (new)

(fb) ‘supply’ refers to the total volume of stock of an individual medicinal product or a medical device that is placed on the market by the Marketing Authorisation Holder or the producer, including situations in which a product is withdrawn from the market for commercial reasons.

Amendment 299 #

Proposal for a regulation
Article 2 – paragraph 1 – point f b (new)

Amendment 300 #

Proposal for a regulation
Article 2 – paragraph 1 – point f b (new)

(fb) ‘One Health approach’ means One health approach as defined in Regulation(EU) .../... EU 4 Health [OJ: ...]

Amendment 301 #

Proposal for a regulation
Article 2 – paragraph 1 – point f c (new)

(fc) ‘zoonosis’ means an infectious disease that has jumped from a non- human animal to humans through zoonotic spill-over;

Amendment 302 #

Proposal for a regulation
Article 2 – paragraph 1 – point f d (new)

(fd) ‘zoonotic spill-over’ is the spread of a non-human disease to humans resulting in zoonosis;

Amendment 303 #

Proposal for a regulation
Article 2 – paragraph 1 – point f e (new)

(fe) 'veterinary medicinal product' means a medicinal product as defined in point (1) of Article 4 of Regulation (EU) 2019/6 of the European Parliament and the Council;

Amendment 304 #

(ff) 'supply' means total volume of stock of a medicinal product, a medical device, or a medical application, that is placed on the market by a marketing authorisation holder or a manufacturer;

Amendment 305 #

Proposal for a regulation
Article 2 – paragraph 1 – point f g (new)

(fg) ‘supply chain’ is a steps-based network of activities, information and resources between a manufacturer company and its suppliers willing to produce and distribute a specific product to the final buyer;

Amendment 306 #

Proposal for a regulation
Article 2 – paragraph 1 a (new)

'supply' means total volume of stock of an individual medicinal product or medical device that is made available on the national market by a marketing authorisation holder or a manufacturer either distributors, or any other actor in the distribution chain respectively; 'demand' means total volume of an individual medicinal product or medical device that is requested in the national market in response to a clinical need;

Amendment 307 #

Proposal for a regulation
Article 2 a (new)

Article 2 a The setting of a European Union of Health digitalized and interoperable early-warning system 1. In order to better manage health crisis, a European Union of Health digitalized and interoperable early-warning system to monitor and report all medicines shortage is hereby established, through an infrastructure which is in place and functional also under normal circumstances. 2. Through such a harmonized, digitalized and interoperable system, the reporting shall be based on collecting data at the national level, with data collected on common definitions and procedures, covering both Centralised and National Marketing Authorisations. The Agency shall receive, when relevant, aggregated data from national databases to monitor any potential cross-border shortages.

Amendment 308 #

Proposal for a regulation
Article 3 – paragraph 1

1. The Executive Steering Group on Shortages and Safety of Human and Veterinary Medicinal Products (‘the Medicines Steering Group’) is hereby established as part of the Agency. It shall meet either in person or remotely, in preparation for or during a public health emergency or following a request for assistance referred to in Article 4(3). The Agency shall provide its secretariat.

Amendment 309 #

Proposal for a regulation
Article 3 – paragraph 1

1. The Executive Steering Group on Shortages and Safety of Medicinal Products (‘the Medicines Steering Group’) is hereby established as part of the Agency. It shall meet as often as needed, either in person or remotely, in preparation for or during a public health emergency or following a request for assistance referred to in Article 4(3). The Agency shall provide its secretariat.

Amendment 310 #

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

1 a. The Medicines Steering Group will be established for a fixed term and will cease its activities when the health emergency or the imminent major event has been declared to end;

Amendment 311 #

Proposal for a regulation
Article 3 – paragraph 2

2. The Medicines Steering Group shall be composed of a representative of the Agency, a representative of the Commission and one senior representative per Member State. Each Member State shall appoint their representative. ~~Members may be accompanied by experts in specific scientific or technical field~~Those Member States with devolved competences in health may appoint a representative from a regional competent authority who will represent the whole Member State. Members may be accompanied by experts in specific scientific or technical fields. The Steering Group shall also include a representative of the Patients’ and Consumers’ Working Party as well as a representative of the Healthcare Professionals’ Working Party as observers.

Amendment 312 #

Proposal for a regulation
Article 3 – paragraph 2

2. The Medicines Steering Group shall be composed of a representative of the Agency, a representative of the Commission ~~and~~, one senior representative per Member State, a representative of the Patients' and Consumers' Working Party (PCWP) and a representative of the Healthcare Professionals' Working Party (HCPWP). Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields. The list of members of the Steering Group shall be made public on the EMA web-portal.

Amendment 313 #

Proposal for a regulation
Article 3 – paragraph 2

2. The Medicines Steering Group shall be composed of a representative of the Agency, a representative of the Commission, a representative of the Patients' organizations, a representative of the Healthcare Professionals' organizations and one senior representative per Member State. Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields. The list of the members of the Steering Group shall be transparent and made public on the EMA web-portal.

Amendment 314 #

Proposal for a regulation
Article 3 – paragraph 2

2. The Medicines Steering Group shall be composed of a representative of the Agency, a representative of the Commission, and one senior representative per Member State. Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields. The Steering Group shall also include a representative of the Patients’ and Consumers’ Working Party and a representative of the Healthcare Professionals’ Working Party.

Amendment 315 #

Proposal for a regulation
Article 3 – paragraph 2

Amendment 316 #

Proposal for a regulation
Article 3 – paragraph 2

2. The Medicines Steering Group shall be composed of a representative of the Agency, a representative of the Commission and one senior representative per Member State, as well as one alternate for unforeseen circumstances. Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields.

Amendment 317 #

Proposal for a regulation
Article 3 – paragraph 2

2. The Medicines Steering Group shall be composed of a representative of the Agency, a representative of the Commission and one authorised senior representative per Member State. Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields.

Amendment 318 #

Proposal for a regulation
Article 3 – paragraph 2 a (new)

2 a. Members of the Medicines Steering Group 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 industry shall be entered in a register held by the Agency and be accessible to the public, upon request.

Amendment 319 #

Proposal for a regulation
Article 3 – paragraph 3

3. The Medicines Steering Group shall be chaired by the Agency. The Chair may invite third parties, including representatives of medicinal product interest groups ~~and~~, marketing authorisation holders ~~to attend its meeting~~or any other entity in the relevant pharmaceutical supply chain, healthcare professionals and patients’ associations, to attend its meetings to ensure transparent and effective dialogue between all stakeholders in the supply chain and the relevant authorities.

Amendment 320 #

Proposal for a regulation
Article 3 – paragraph 3

3. The Medicines Steering Group shall be chaired by the Agency. The Chair may invite third parties, including representatives of medicinal product interest groups and marketing authorisation holders to attend its meetings. The Chair shall ensure that a broad spectrum of opinions is taken into account. The chair shall ensure that the stakeholders in the medicines supply chain can give an informed opinion about the situation in the various Member States concerned;

Amendment 321 #

Proposal for a regulation
Article 3 – paragraph 3

3. The Medicines Steering Group shall be chaired by the Agency. TAll members of the Medicines Steering Group may propose to the Chair ~~may~~to invite third parties, including representatives of medicinal product interest groups ~~and marketing authorisation holders to attend its meetings~~, representatives of healthcare professionals, patients and consumers, and marketing authorisation holders to attend its meetings when their contribution may inform the discussions of the Steering Group.

Amendment 322 #

Proposal for a regulation
Article 3 – paragraph 3

3. The Medicines Steering Group shall be chaired by the Agency. ~~The Chair may~~All members of the Medicines Steering Group may propose to the Chair to invite third parties, including representatives of medicinal product interest groups ~~and marketing authorisation holders to attend its meetings~~, in particular healthcare professionals, patients, consumers and marketing authorisation holders to attend its meetings when their contribution may inform the discussions of the Steering Group.

Amendment 323 #

Proposal for a regulation
Article 3 – paragraph 3

3. The Medicines Steering Group shall be chaired by the Agency. TOn a regular basis, the Chair ~~may~~shall invite third parties, including representatives of medicinal product interest groups and marketing authorisation holders to attend its meetings. In the event of an actual or imminent major event, the Chair shall invite relevant entities from the pharmaceutical supply chain to attend its meetings.

Amendment 324 #

Proposal for a regulation
Article 3 – paragraph 3

3. The Medicines Steering Group shall be chaired by the Agency. The Chair may invite third parties, including representatives of medicinal product interest groups ~~and~~, marketing authorisation holders ~~to attend its meetings~~, representatives of healthcare professionals, and of patients to attend its meetings, when their contribution may inform the discussions of the Steering Group.

Amendment 325 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS, Ondřej KNOTEK

Proposal for a regulation
Article 3 – paragraph 3

3. The Medicines Steering Group shall be chaired by the Agency. The Chair ~~may~~shall invite third parties, including representatives of medicinal product interest groups ~~and~~, marketing authorisation holders ~~to attend its meeting~~and other representatives of the pharmaceutical supply chain to attend its meetings and actively participate in the dialog with the authorities.

Amendment 326 #

Proposal for a regulation
Article 3 – paragraph 3

Amendment 327 #

Proposal for a regulation
Article 3 – paragraph 3

Amendment 328 #

Proposal for a regulation
Article 3 – paragraph 3

Amendment 329 #

Proposal for a regulation
Article 3 – paragraph 3

Amendment 330 #

Proposal for a regulation
Article 3 – paragraph 3

3. The Medicines Steering Group shall be chaired by the Agency. The Chair ~~may~~shall invite third parties, including representatives of medicinal product interest groups and marketing authorisation holders to attend its meetings.

Amendment 331 #

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

3a. The Medicines Steering Group shall regularly invite representatives of interest groups in the field of medicinal products and marketing authorisation holders, as well as other stakeholders in the pharmaceutical industry to exchange regularly on the situation of medicine production in Europe and worldwide. On the basis of these exchanges, the Medicines Steering Group shall draw up strategic recommendations which it shall address to the Member States during the public health emergency period.

Amendment 332 #

Proposal for a regulation
Article 3 – paragraph 4

4. The Medicines Steering Group shall establish its rules of procedure including procedures relating to the working party referred to the paragraph 5 and on the adoption of lists, sets of information, and recommendations. The rules of procedure shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency. The agenda and minutes of the Steering Group as well as the rules of procedure and recommendations shall be made available to the public via the EMA web-portal.

Amendment 333 #

Proposal for a regulation
Article 3 – paragraph 4

4. The Medicines Steering Group shall establish its rules of procedure including procedures relating to the working party referred to the paragraph 5 and on the adoption of lists, sets of information, and recommendations. The rules of procedure shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency. Agendas and minutes of the Steering Group as well as the rules of procedure and recommendations shall be made available to the public via the EMA web-portal.

Amendment 334 #

Proposal for a regulation
Article 3 – paragraph 4

4. The Medicines Steering Group shall establish its rules of procedure including procedures relating to the working party referred to the paragraph 5 and on the adoption of lists, sets of information, and recommendations. The rules of procedure shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency. The agenda, minutes and recommendations of the Medicines Steering Group shall be made available to the public through the Agency's online portal.

Amendment 335 #

Proposal for a regulation
Article 3 – paragraph 4

Amendment 336 #

Proposal for a regulation
Article 3 – paragraph 5

5. The Medicines Steering Group shall be supported in its work by a working party comprised of single points of contact related to shortages from national, and where applicable regional, competent authorities for medicinal products established in accordance with Article 9(1).

Amendment 337 #

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

Amendment 338 #

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

Amendment 339 #

Proposal for a regulation
Article 3 – paragraph 6

6. The Medicines Steering Group shall be responsible for fulfilling the tasks referred to in Article 4(3), 4 (4) and Articles 5 to 8.

Amendment 340 #

Proposal for a regulation
Article 3 – paragraph 6 a (new)

6a. All members of the Medicines Steering Group shall comply with the usual rules in force in the Union on conflicts of interest, in accordance with Article 107 of Regulation (EU) 2017/745 of the European Parliament and of the Council.

Amendment 341 #

Proposal for a regulation
Article 3 – paragraph 6 a (new)

6 a. The Medicines Steering Group together with the industry (via the industry single points of contacts - iSPOCs) shall determine the list of critical products and any future actions taken for the molecules included on the critical product list.

Amendment 342 #

Proposal for a regulation
Article 3 – paragraph 6 a (new)

6 a. The members of the Medicines Steering Group must have no financial or other interests that could affect their impartiality. The list of members shall be published on the EMA’s website.

Amendment 343 #

Margarita DE LA PISA CARRIÓN, Joanna KOPCIŃSKA

Proposal for a regulation
Article 3 – paragraph 6 a (new)

6 a. The members of the Medicines Steering Group must have no financial or other interests that could affect their impartiality. The list of members shall be published on the EMA’s website.

Amendment 344 #

Proposal for a regulation
Article 3 – paragraph 6 a (new)

6 a. The Medicines Steering Group shall exercise its competencies in full compliance with the principles of proportionality and subsidiarity;

Amendment 345 #

Proposal for a regulation
Article 4 - title

Monitoring of events and preparedness for temporary major events and public health emergencies

Amendment 346 #

Proposal for a regulation
Article 4 – paragraph 1

Amendment 347 #

Proposal for a regulation
Article 4 – paragraph 1

1. The Agency shall continuously monitor any event that is likely to lead to a major event or a public health emergency and it shall be capable of establishing the necessary preventive mechanisms that are necessary.

Amendment 348 #

Proposal for a regulation
Article 4 – paragraph 1

1. The Agency shall continuously monitor any event that is likely to lead to a major event or a public health emergency in coordination with the relevant national or regional authorities.

Amendment 349 #

Proposal for a regulation
Article 4 – paragraph 1

1. The Agency shall continuously monitor any event that is likely to lead to a major event or a public health emergency in coordination with the national and regional competent authorities.

Amendment 350 #

Proposal for a regulation
Article 4 – paragraph 1

1. The Agency shall continuously monitor any event in the Union or in third countries that is likely to lead to a major event or a public health emergency.

Amendment 351 #

Proposal for a regulation
Article 4 – paragraph 1

1. The Agency, in coordination with the ECDC, shall continuously monitor any event that is likely to lead to a major event or a public health emergency.

Amendment 352 #

Proposal for a regulation
Article 4 – paragraph 2

2. To facilitate the monitoring task referred to in paragraph 1, the national competent authorities, through the single points of contact referred to in Article 3(5), shall, based on the reporting criteria specified by the Agency pursuant to Article 9(1)(b), ~~report to the Agency on~~upload in the harmonised pan- European interoperable and digitalized shortages reporting and notification system, any event, including a shortage of a medicinal product in a given Member State, that is likely to lead to a major event or a public health emergency. Where a national competent authority ~~informs the Agency~~uploads the information of a shortage of a medicinal product in a given Member State on the pan-European harmonized system, it shall provide the Agency with any information received from the marketing authoriszation holder pursuant to Article 23a of Directive 2001/83/EC. The information uploaded in the pan-European system are directly accessible for the Agency and national competent authorities and while avoiding duplications of reporting, it shall support a two-way communication between authorities and industry to provide the transparency needed to take actions to prevent and mitigate cross border shortages. Based on a report of an event from a national competent authority and in order to understand the impact of the event in other Member States, the Agency may request information from the national competent authorities, through the working party referred to in Article 3(5).

Amendment 353 #

Proposal for a regulation
Article 4 – paragraph 2

2. To facilitate the monitoring task referred to in paragraph 1, the national competent authorities, through the single points of contact referred to in Article 3(5), shall, based on the reporting criteria specified by the Agency pursuant to Article 9(1)(b), report to the Agency on any event, including a shortage of a human or veterinary medicinal product in a given Member State, that is likely to lead to a major event or a public health emergency in other Member States. Where a national competent authority informs the Agency of a shortage of a medicinal product in a given Member State, it shall provide the Agency with any information received from the marketing authorisation holder pursuant to Article 23a of Directive 2001/83/EC, as well as any relevant additional information provided by stakeholders and actors in the pharmaceutical industry, with due regard for confidentiality and privacy, as provided for in Regulation (EU) 2016/769 of the European Parliament and of the Council (General Data Protection Regulation – GDPR). Based on a report of an event from a national competent authority and in order to understand and, in particular, anticipate the impact of the event in other Member States, the Agency may request information from the national competent authorities, through the working party referred to in Article 3(5).

Amendment 354 #

Proposal for a regulation
Article 4 – paragraph 2

2. To facilitate the monitoring task referred to in paragraph 1, the national, and where applicable regional, competent authorities, through the single points of contact referred to in Article 3(5) or the digital interoperable database referred to in Article 1(b) and Article 12(g), shall, based on the reporting criteria specified by the Agency pursuant to Article 9(1)(b), report to the Agency on any event, including a shortage of a medicinal product in a given Member State, that is likely to lead to a major event or a public health emergency. Where a national, and where applicable regional, competent authority informs the Agency of a shortage of a medicinal product in a given Member State, it shall provide the Agency with any information received from the marketing authorisation holder pursuant to Article 23a of Directive 2001/83/EC. Based on a report of an event from a national or regional competent authority and in order to understand the impact of the event in other Member States, the Agency may request information from the national and where applicable regional, competent authorities, through the working party referred to in Article 3(5).

Amendment 355 #

Proposal for a regulation
Article 4 – paragraph 2

2. To facilitate the monitoring task referred to in paragraph 1, the national competent authorities, through the single points of contact referred to in Article 3(5), shall, based on the reporting criteria specified by the Agency pursuant to Article 9(1)(b), report to the Agency, in due time, in an interoperable and digitalized platform for reporting and notifying shortages, on any event, including a shortage of a medicinal product in a given Member State, that is likely to lead to a major event or a public health emergency. Where a national competent authority informs the Agency of a shortage of a medicinal product in a given Member State, it shall provide the Agency with any information received from the marketing authorisation holder pursuant to Article 23a of Directive 2001/83/EC. Based on a report of an event from a national competent authority and in order to understand the impact of the event in other Member States, the Agency may request information from the national competent authorities, through the working party referred to in Article 3(5).

Amendment 356 #

Proposal for a regulation
Article 4 – paragraph 2

Amendment 357 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Article 4 – paragraph 2

Amendment 358 #

Proposal for a regulation
Article 4 – paragraph 2

Amendment 359 #

Proposal for a regulation
Article 4 – paragraph 2

Amendment 360 #

Proposal for a regulation
Article 4 – paragraph 3

3. Where the Agency considers that an actual or imminent major event needs to be addressed, it shall inform the Commission and the Member States thereof. The Commission, on its own initiative or following a request from one or more Member States, or the Executive Director of the Agency may request the assistance of the Medicines Steering Group to address the major event. Where requested to do so by at least two Member States or the Executive Director of the Agency, the Commission shall request the assistance of the Steering Group.

Amendment 361 #

Proposal for a regulation
Article 4 – paragraph 3

3. Where the Agency considers that an actual or imminent major event needs to be addressed, it shall inform the Commission and the Member States thereof. The Commission~~, on its own initiative or following a request from one or more Member States, or the Executive Director of the Agency may~~ shall then request the assistance of the Medicines Steering Group to address the major event.

Amendment 362 #

Proposal for a regulation
Article 4 – paragraph 3

Amendment 363 #

Proposal for a regulation
Article 4 – paragraph 3

Amendment 364 #

Proposal for a regulation
Article 4 – paragraph 3

3. Where the Agency considers that an actual or imminent major event needs to be addressed, it shall inform the Commission and the Member States thereof. The Commission, ~~on its own initiative or following a request from one or more Member States,~~ or the Executive Director of the Agency ~~may~~shall request the assistance of the Medicines Steering Group to address the major event.

Amendment 365 #

Proposal for a regulation
Article 4 – paragraph 5 – point a

(a) where the major event or public health emergency may affect the production, manufacturing, safety, quality, distribution and efficacy of medicinal products, devices and applications Article 5 shall apply;

Amendment 366 #

Proposal for a regulation
Article 5 – title

Evaluation of information and the provision of advice on action in relation to the production, manufacturing, safety, quality, distribution and efficacy of medicinal products, devices and applications related to public health emergencies and major events

Amendment 367 #

Proposal for a regulation
Article 5 – title

~~Evaluation of information and the provision of advice on action in relation to the safety, quality, and efficacy of medicinal products related to public health emergencies and major events~~(Does not affect English version.)

Amendment 368 #

Proposal for a regulation
Article 5 – paragraph 1

Following the recognition of a public health emergency or a request for assistance referred to in Article 4(3), the Medicines Steering Group shall evaluate the information related to the major event or the public health emergency and consider the need for urgent and coordinated action with regard to the production, manufacturing, safety, quality, distribution and efficacy of ~~the~~ medicinal products, devices and applications concerned.

Amendment 369 #

Proposal for a regulation
Article 5 – paragraph 1

Amendment 370 #

Proposal for a regulation
Article 5 – paragraph 2

The Medicines Steering Group shall provide advice and recommendations to the Commission and Member States on any appropriate action it believes should be taken at Union level on the medicinal products concerned in accordance with the provisions of Directive 2001/83/EC or Regulation (EC) No 726/200418. _________________ 18 Regulation (EC) No 726/2004

Amendment 371 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Nils TORVALDS, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Article 6 – paragraph 1

1. Following a request for assistance referred to in Article 4(3) and after consultation of its working party, the Medicines Steering Group, after consulting the marketing authorisation holders and representatives of stakeholders in the sector, shall adopt a list of human and veterinary medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers as critical during the major event (‘the major event critical medicines list’). The list shall be updated whenever necessary until the major event has been sufficiently addressed, and shall cease to apply at the end of the major event.

Amendment 372 #

Proposal for a regulation
Article 6 – paragraph 1

1. Following a request for assistance referred to in Article 4(3) and after consultation of its working party, the Medicines Steering Group shall adopt a list of medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers as critical during the major event (‘the major event critical medicines list ’). The list shall be updated whenever necessary until the major event has been sufficiently addressed and it is confirmed that the assistance of the Medicines Steering group is no longer needed as per Article 4(4).

Amendment 373 #

Proposal for a regulation
Article 6 – paragraph 1

1. Following a request for assistance referred to in Article 4(3) and after consultation of its working party, ~~the~~medicinal product interest groups and supply chain stakeholders, in time adequate to the major event, Medicines Steering Group shall adopt a list of medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers as critical during the major event (‘the major event critical medicines list ’). The list shall be updated whenever necessary until the major event has been sufficiently addressed.

Amendment 374 #

Proposal for a regulation
Article 6 – paragraph 1

Amendment 375 #

Proposal for a regulation
Article 6 – paragraph 1

1. Following a request for assistance referred to in Article 4(3) and after consultation of its working party, the Medicines Steering Group, in coordination with stakeholders in the sector, shall adopt a list of medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers as critical during the major event (‘the major event critical medicines list’). The list shall be updated whenever necessary until the major event has been sufficiently addressed.

Amendment 376 #

Proposal for a regulation
Article 6 – paragraph 1

Amendment 377 #

Proposal for a regulation
Article 6 – paragraph 2

2. Immediately following the recognition of a public health emergency and after consultation of its working party, the Medicines Steering Group shall adopt a list of medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers as critical during the public health emergency (‘the public health emergency critical medicines list’). The World Health Organization Model List of Essential Medicines for adults and for children shall be used as the base for its identification of critical medicinal products at Union level. The Agency shall make the public health emergency critical medicines list within 12 months after the entry into force of this Regulation. The list shall be updated whenever necessary until the termination of the recognition of the public health emergency as well as with the Commission and the European Centre for Disease Prevention and Control.

Amendment 378 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Nils TORVALDS, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS, Ondřej KNOTEK

Proposal for a regulation
Article 6 – paragraph 2

2. Immediately following the recognition of a public health emergency and after consultation of its working party, the Medicines Steering Group shall adopt a list of human and veterinary medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers as critical during the public health emergency (‘the public health emergency critical medicines list’). The list shall be updated whenever necessary until the termination of the recognition of the public health emergency, and shall cease to apply at the end of the public health emergency.

Amendment 379 #

Proposal for a regulation
Article 6 – paragraph 2

2. Immediately following the recognition of a public health emergency and after consultation of its working party, the industry and representatives of health professionals, the Medicines Steering Group shall adopt a list of medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers as critical during the public health emergency (‘the public health emergency critical medicines list’). The list shall be updated whenever necessary until the termination of the recognition of the public health emergency.

Amendment 380 #

Proposal for a regulation
Article 6 – paragraph 2

2. Immediately following the recognition of a public health emergency and after consultation of its working party, the Medicines Steering Group, in coordination with stakeholders in the sector, shall adopt a list of medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers as critical during the public health emergency (‘the public health emergency critical medicines list’). The list shall be updated whenever necessary until the termination of the recognition of the public health emergency.

Amendment 381 #

Proposal for a regulation
Article 6 – paragraph 2 a (new)

2 a. In case of an eventual zoonotic spill-over, the Medicines Steering Group shall work with the other relevant bodies of the Agency in order to counter it as soon as possible.

Amendment 382 #

Proposal for a regulation
Article 6 – paragraph 3

3. The Medicines Steering Group shall adopt a set of information and actions necessary to monitor the supply and demand of medicinal products included on the lists referred to in paragraphs 1 and 2 (‘the critical medicines lists’) and inform its working party thereof. The Medicines Steering Group shall report the Agency and the Commission in due time on the monitoring and shall notify immediately on any major event or shortage in the supply.

Amendment 383 #

Proposal for a regulation
Article 6 – paragraph 3

Amendment 384 #

Proposal for a regulation
Article 6 – paragraph 3

3. The Medicines Steering Group shall adopt a set of information necessary to monitor the supply and demand of human and veterinary medicinal products included on the lists referred to in paragraphs 1 and 2 (‘the critical medicines lists’) and inform its working party thereof.

Amendment 385 #

Proposal for a regulation
Article 6 – paragraph 4

4. The Agency shall immediately publish the critical medicines lists and any updates to those lists on its web-portal referred to in Article 26 of Regulation (EC) No 726/2004. This list shall be published in a clear and accessible way so that Member States, actors in the pharmaceutical supply chain and all stakeholders can easily access this information and, where appropriate, can easily report possible changes or publication problems.

Amendment 386 #

Proposal for a regulation
Article 6 – paragraph 4

4. ~~The Agency shall immediately publish~~Access to the critical medicines lists and any updates to those lists ~~on it~~shall be granted to Member State representatives and the European Commission on a confidential basis, via the Agency’s web- portal referred to in Article 26 of Regulation (EC) No 726/2004.

Amendment 387 #

Proposal for a regulation
Article 6 – paragraph 4

4. ~~The Agency shall immediately publish~~Member State representatives and the European Commission shall on a confidential basis be granted access to the critical medicines lists and any updates to those lists ~~on its~~via the web-portal referred to in Article 26 of Regulation (EC) No 726/2004.

Amendment 388 #

Proposal for a regulation
Article 6 – paragraph 4

4. The Agency shall ~~immediately publish~~make available the critical medicines lists and any updates to those lists ~~on its web-portal referred to in Article 26 of Regulation (EC) No 726/2004~~to the representatives of the Member States and the Commission.

Amendment 389 #

Proposal for a regulation
Article 6 – paragraph 4 a (new)

4 a. The Agency, under its own assessment, shall establish an open, digital and interoperable database with information on expected and actual shortages of critical medical products, devices and applications. The database shall contain information on but not limited to: a. Trade name and international non- proprietary name; b. Indication; c. Reason for the shortage; d. Start and end dates; e. Member States and/or regions affected, especially cross-border regions; f. Possible consequences to non- communicable diseases or conditions, such as mental health and possible medical solutions and other measures; g. Information for healthcare professionals and patients, including information on alternative treatments. This database shall be accessible to the public. The Agency shall include the national, and where applicable regional, registries on medicine shortages on its web-portal.

Amendment 390 #

Proposal for a regulation
Article 6 – paragraph 4 a (new)

4 a. The Agency shall establish a publicly accessible database with information on expected and actual shortages of critical medicines. Reference to national shortage registries shall also be linked on the web portal. The database shall contain information on, but not limited to: (a) Trade name and international non- proprietary name; (b) Indication; (c) Reason for the shortage; (d) Start and end dates; (e) Member States affected; (f) Information for healthcare professionals and patients, including information on alternative treatments.

Amendment 391 #

Proposal for a regulation
Article 6 – paragraph 4 a (new)

4 a. The Agency shall establish a database with information on expected and actual shortages of critical medicines. The database shall contain information on but not limited to: (a) Trade name and international non- proprietary name; (b) Indication; (c) Reason for the shortage; (d) Start and end dates; (e) Member States affected; (f) Information for healthcare professionals and patients, including information on alternative treatments.

Amendment 392 #

Proposal for a regulation
Article 6 – paragraph 4 a (new)

Amendment 393 #

Proposal for a regulation
Article 6 – paragraph 4 a (new)

4a. The Agency, in cooperation with the Commission and the national competent authorities of the Member States, shall work with representatives of the European medicinal product industry to ensure that medicinal products included on the critical medicines list made available in one Member State are equally available in all Member States, in one form or another, and in particular in smaller Member States.

Amendment 394 #

Proposal for a regulation
Article 6 – paragraph 4 a (new)

Amendment 395 #

Proposal for a regulation
Article 6 – paragraph 4 b (new)

4 b. The database shall be accessible to the public.

Amendment 396 #

Proposal for a regulation
Article 6 – paragraph 4 b (new)

4 b. The database shall be accessible to the public.

Amendment 397 #

Proposal for a regulation
Article 6 – paragraph 4 c (new)

4 c. The Agency shall list on its web- portal the national registries on medicine shortages.

Amendment 398 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ

Proposal for a regulation
Article 6 – paragraph 4 c (new)

4 c. The Agency shall list on its web- portal the national registries on medicine shortages.

Amendment 399 #

Proposal for a regulation
Article 7 – paragraph 1

On the basis of the single European critical medicines lists and the information and data provided in accordance with Articles 10 and 11, , and the database established in accordance with Article 12a once fully operational, the Medicines Steering Group shall monitor supply and demand of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products. As part of that monitoring, the Medicines Steering Group shall liaise, where relevant, with the Health Security Committee established in Article 4 of Regulation (EU) 2020/[…]19 and, in the case of a public health emergency, the Advisory Committee on public health emergencies established pursuant to Article 24 of that Regulation, as well as with the European Centre for Disease Prevention and Control. The Medicines Steering Group shall also guarantee an open communication and close cooperation with the industry, relevant entities of the pharmaceutical supply chain, and representatives of healthcare professionals, patients and consumers with a view to enable early notification or identification of potential or actual shortages of critical medicines. _________________ 19 [insert reference to adopted text referred to in footnote 4]

Amendment 400 #

Proposal for a regulation
Article 7 – paragraph 1

On the basis of the critical medicines lists and the information and data provided in accordance with Articles 10 and 11 of this Regulation, the Medicines Steering Group shall meet regularly throughout the major event or public health emergency with the working group of designated national contact points for medicines shortages within the national competent authorities for medicines and with representatives of the medicines production and distribution sectors in order to monitor supply and demand of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products and to adapt the list as well as possible throughout the major event or emergency. As part of that monitoring, the Medicines Steering Group shall liaise, where relevant, with the Health Security Committee established in Article 4 of Regulation (EU) 2020/[…]19 and, in the case of a public health emergency, the Advisory Committee on public health emergencies established pursuant to Article 24 of that Regulation. _________________ 19 [insert reference to adopted text referred to in footnote 4]

Amendment 401 #

Proposal for a regulation
Article 7 – paragraph 1

On the basis of the critical medicines lists , the establishment of a two way communication line with industry via the industry single point of contacts (iSPOC) and the information and data provided in accordance with Articles 10 and 11, the Medicines Steering Group shall monitor supply and demand, with demand being based on actual patient need at the Member State level, as per Article 2(f), of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products. As part of that monitoring, the Medicines Steering Group shall liaise, where relevant, with the Health Security Committee established in Article 4 of Regulation (EU) 2020/[…]19 and, in the case of a public health emergency, the Advisory Committee on public health emergencies established pursuant to Article 24 of that Regulation. _________________ 19 [insert reference to adopted text referred to in footnote 4]

Amendment 402 #

Proposal for a regulation
Article 7 – paragraph 1

On the basis of the critical medicines lists and the information and data provided in accordance with Articles 10 and 11, the Medicines Steering Group shall monitor supply and demand of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products. As part of that monitoring, the Medicines Steering Group shall liaise, where relevant, with the Health Security Committee established in Article 4 of Regulation (EU) 2020/[…]19 and, in the case of a public health emergency, the Advisory Committee on public health emergencies established pursuant to Article 24 of that Regulation. The Medicines Steering Group shall provide the aggregated data and demand forecasts from the digital interoperable platform referred to in Article1(b) and Article 12(g). _________________ 19 [insert reference to adopted text referred to in footnote 4]

Amendment 403 #

Proposal for a regulation
Article 7 – paragraph 1

On the basis of the critical medicines lists , the establishment of a two way communication line with industry via the industry single point of contacts (iSPOC)and the information and data provided in accordance with Articles 10 and 11, the Medicines Steering Group shall monitor supply and demand of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products. As part of that monitoring, the Medicines Steering Group shall liaise, where relevant, with the Health Security Committee established in Article 4 of Regulation (EU) 2020/[…]19 and, in the case of a public health emergency, the Advisory Committee on public health emergencies established pursuant to Article 24 of that Regulation. ~~_________________ 19 to in footnote 4]~~[insert reference to adopted text referred

Amendment 404 #

Proposal for a regulation
Article 7 – paragraph 1

On the basis of the critical medicines lists and the information and data provided in accordance with Articles 10 and 11, the Medicines Steering Group ~~shall monitor supply and demand of medicinal products~~, based on patients’ actual and potential needs, included on those lists with a view to identifying any potential or actual shortages of those medicinal products. As part of that monitoring, the Medicines Steering Group shall liaise, where relevant, with the Health Security Committee established in Article 4 of Regulation (EU) 2020/[…]19 and, in the case of a public health emergency, the Advisory Committee on public health emergencies established pursuant to Article 24 of that Regulation. _________________ 19 [insert reference to adopted text referred to in footnote 4]

Amendment 405 #

Proposal for a regulation
Article 7 – paragraph 1 a (new)

There should also be regular structured dialogue with industry, entities involved in the pharmaceutical supply chain, healthcare professionals and patients’ associations so that any potential or actual shortages of those medicinal products in a public health emergency and/or major event can be managed as effectively as possible.

Amendment 406 #

Proposal for a regulation
Article 7 – paragraph 1 a (new)

The Medicines Steering Group shall monitor supply and demand of medicinal products included on those across the entire value-chain, from resources to patient;

Amendment 407 #

Proposal for a regulation
Article 7 – paragraph 1 a (new)

The Single Point of Contact Network (SPOC) shall be extended to become a reliable monitoring system for shortages of medicines and other medical counter.

Amendment 408 #

Proposal for a regulation
Article 7 – paragraph 1 b (new)

As shortage of medicines outside of the critical lists established in a public health emergency or a major event are outside of the scope of this Regulation and yet pose a persistent challenge that has been increasingly affecting health and well- being of EU citizens for the past decades, this Regulation should be a first step towards improving the EU response to this long-lasting issue. The Commission shall subsequently propose the expansion of this framework to ensure that the issue of shortages is broadly and permanently tackled in the upcoming revision of Regulation (EC) 726/2004 and Directive 2001/83/EC.

Amendment 409 #

Proposal for a regulation
Article 8 – paragraph 1

1. For the duration of a public health emergency or following a request for assistance referred to in Article 4(3) and until its closure, the Medicines Steering Group shall regularly report the results of its monitoring to the Commission, the pharmaceutical industry and the sub- network referred to in Article 9(2), and, in particular, signal any potential or actual shortages of medicinal products included on the critical medicines lists.

Amendment 410 #

Proposal for a regulation
Article 8 – paragraph 1

1. For the duration of a public health emergency or following a request for assistance referred to in Article 4(3) and until its closure, the Medicines Steering Group shall regularly report the results of its monitoring to the Commission, national public health authorities and the sub- network referred to in Article 9(2), and, in particular, signal any potential or actual shortages of medicinal products included on the critical medicines lists.

Amendment 411 #

Proposal for a regulation
Article 8 – paragraph 1

1. For the duration of a public health emergency or following a request for assistance referred to in Article 4(3) and until its closure, the Medicines Steering Group shall regularly report the results of its monitoring to the Commission, Member States, the pharmaceutical industry and the sub-network referred to in Article 9(2), and, in particular, signal any potential or actual shortages of medicinal products included on the critical medicines lists.

Amendment 412 #

Proposal for a regulation
Article 8 – paragraph 1

1. For the duration of a public health emergency or following a request for assistance referred to in Article 4(3) and until it is c~~losure~~onfirmed that its assistance is no longer needed under Article 4(4), the Medicines Steering Group shall regularly report the results of its monitoring to the Commission and the sub-network referred to in Article 9(2), and, in particular, signal any potential or actual shortages of medicinal products included on the critical medicines lists.

Amendment 413 #

Proposal for a regulation
Article 8 – paragraph 1

1. For the duration of a public health emergency or following a request for assistance referred to in Article 4(3) and until its closure, the Medicines Steering Group shall re~~gularly report~~port on a systematic, structured, and timely basis the results of its monitoring to the Commission and the sub-network referred to in Article 9(2), and, in particular, signal any potential or actual shortages of medicinal products included on the critical medicines lists.

Amendment 414 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Article 8 – paragraph 1

1. For the duration of a public health emergency or following a request for assistance referred to in Article 4(3) and until its closure, the Medicines Steering Group shall regularly report the results of its monitoring to the Commission, the pharmaceutical industry and the sub- network referred to in Article 9(2), and, in particular, signal any potential or actual shortages of medicinal products included on the critical medicines lists.

Amendment 415 #

Proposal for a regulation
Article 8 – paragraph 1 a (new)

1 a. Reports of any potential or actual shortages of medicinal products included on the critical medicines lists shall also be made available to industry and other entities of the pharmaceutical supply chain, where relevant.

Amendment 416 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Article 8 – paragraph 2

2. Where requested by the Commission or the sub-network referred to in Article 9(2), the Medicines Steering Group shall provide aggregated data and forecasts of demand to substantiate its findings. In that regard, the Medicines Steering Group shall liaise with the European Centre for Disease Prevention and Control to obtain epidemiological data to help forecast medicinal product needs, and with the Executive Steering Group on Shortages of Medical Devices referred to in Article 19 where medicinal products included on the critical medicines lists are administered with a medical device. The aggregated data and forecasts of demand shall also be made available to industry and other entities of the pharmaceutical supply chain, where relevant, with the view to better prevent or mitigate potential or actual shortages.

Amendment 417 #

Proposal for a regulation
Article 8 – paragraph 2

Amendment 418 #

Proposal for a regulation
Article 8 – paragraph 2

2. Where requested by the Commission or the sub-network referred to in Article 9(2), the Medicines Steering Group shall provide aggregated data and forecasts of demand to substantiate its findings. In that regard, the Medicines Steering Group shall use data from its interoperable and digitalized platform for reporting and notifying shortages and shall liaise with the European Centre for Disease Prevention and Control to obtain epidemiological data to help forecast medicinal product needs, and with the Executive Steering Group on Shortages of Medical Devices referred to in Article 19 where medicinal products included on the critical medicines lists are administered with a medical device.

Amendment 419 #

Proposal for a regulation
Article 8 – paragraph 2

2. Where requested by the Commission, one or more national public health authorities or the sub-network referred to in Article 9(2), the Medicines Steering Group shall provide aggregated data and forecasts of demand to substantiate its findings. In that regard, the Medicines Steering Group shall liaise with the European Centre for Disease Prevention and Control to obtain epidemiological data to help forecast medicinal product needs, and with the Executive Steering Group on Shortages of Medical Devices referred to in Article 19 where medicinal products included on the critical medicines lists are administered with a medical device.

Amendment 420 #

Proposal for a regulation
Article 8 – paragraph 3

3. As part of that reporting, the Medicines Steering Group may also provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities, including healthcare professionals and patient organisations, to prevent or mitigate potential or actual shortages. In that regard the Group shall liaise, as relevant, with the Health Security Committee and, in the case of a public health emergency, the Advisory Committee on public health emergencies.

Amendment 421 #

Proposal for a regulation
Article 8 – paragraph 3

3. As part of that reporting, the Medicines Steering Group may also provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities, including healthcare professionals, consumers and patients, to prevent or mitigate potential or actual shortages. In that regard the Group shall liaise, as relevant, with the Health Security Committee and, in the case of a public health emergency, the Advisory Committee on public health emergencies.

Amendment 422 #

Proposal for a regulation
Article 8 – paragraph 3

3. As part of that reporting, the Medicines Steering Group may also provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities, including healthcare professionals or patients, to prevent or mitigate potential or actual shortages. In that regard the Group shall liaise, as relevant, with the Health Security Committee and, in the case of a public health emergency, the Advisory Committee on public health emergencies.

Amendment 423 #

Proposal for a regulation
Article 8 – paragraph 3

3. As part of that reporting, the Medicines Steering Group may also provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities, including healthcare professionals and patients, to prevent or mitigate potential or actual shortages. In that regard the Group shall liaise, as relevant, with the Health Security Committee and, in the case of a public health emergency, the Advisory Committee on public health emergencies.

Amendment 424 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS, Ondřej KNOTEK

Proposal for a regulation
Article 8 – paragraph 3

3. As part of that reporting, the Medicines Steering Group may also provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities, including healthcare professionals and patients, to prevent or mitigate potential or actual shortages. In that regard the Group shall liaise, as relevant, with the Health Security Committee and, in the case of a public health emergency, the Advisory Committee on public health emergencies.

Amendment 425 #

Proposal for a regulation
Article 8 – paragraph 3

3. As part of that reporting, the Medicines Steering Group may also provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities, including healthcare professionals and patients, to prevent or mitigate potential or actual shortages. In that regard the Group shall liaise, as relevant, with the Health Security Committee and, in the case of a public health emergency, the Advisory Committee on public health emergencies.

Amendment 426 #

Proposal for a regulation
Article 8 – paragraph 3

3. As part of that reporting, the Medicines Steering Group may also provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities, including healthcare professionals and patients, to prevent or mitigate potential or actual shortages. In that regard the Group shall liaise, as relevant, with the Health Security Committee and, in the case of a public health emergency, the Advisory Committee on public health emergencies.

Amendment 427 #

Proposal for a regulation
Article 8 – paragraph 4

4. The Medicines Steering Group may, on its own initiative or upon request from the Commission, provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities to ensure preparedness to deal with potential or actual shortages of medicinal products caused by public health emergencies or major events. These recommendations may include measures to minimize unnecessary administrative burdens or facilitate flexible supply chains.

Amendment 428 #

Proposal for a regulation
Article 8 – paragraph 4

4. The Medicines Steering Group may, on its own initiative or upon request from the Commission, provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities, including healthcare professionals, to ensure preparedness to deal with potential or actual shortages of medicinal products caused by public health emergencies or major events.

Amendment 429 #

Proposal for a regulation
Article 8 – paragraph 4

4. The Medicines Steering Group may, on its own initiative or upon request from the Commission, provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities to ensure preparedness to deal with potential or actual shortages of human and veterinary medicinal products caused by public health emergencies or major events.

Amendment 430 #

Proposal for a regulation
Article 8 – paragraph 4 a (new)

4 a. Without prejudice to Article 30, reports and recommendations of the Medicines Steering Group will be made available to the public to their greatest extent.

Amendment 431 #

Proposal for a regulation
Article 8 – paragraph 5

5. The Medicines Steering Group may upon request from the Commission coordinated measures, where relevant, between the national competent authorities, the marketing authorisation holders and other entities, including healthcare professionals and patient organisations, to prevent or mitigate potential or actual shortages in the context of a major event or public health emergency.

Amendment 432 #

Proposal for a regulation
Article 8 – paragraph 5

5. The Medicines Steering Group may upon request from the Commission coordinate measures, where relevant, between the national competent authorities, the marketing authorisation holders and other entities, including healthcare professionals and patients, to prevent or mitigate potential or actual shortages in the context of a major event or public health emergency.

Amendment 433 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Nils TORVALDS, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS, Ondřej KNOTEK

Proposal for a regulation
Article 8 – paragraph 5

Amendment 434 #

Proposal for a regulation
Article 8 – paragraph 5

Amendment 435 #

Proposal for a regulation
Article 8 – paragraph 5

Amendment 436 #

Proposal for a regulation
Article 8 – paragraph 5

5. The Medicines Steering Group may upon request from the Commission coordinate measures, where relevant, between the national, and where applicable regional, competent authorities, the marketing authorisation holders and other entities to prevent or mitigate potential or actual shortages in the context of a major event or public health emergency.

Amendment 437 #

Proposal for a regulation
Article 8 – paragraph 5

Amendment 438 #

Joëlle MÉLIN, Danilo Oscar LANCINI

Proposal for a regulation
Article 8 – paragraph 5 a (new)

5 a. In case any of the aforementioned stakeholders does not give information to the Agency in the time lapse established by the Agency, the Commission shall assist the Agency in obtaining such information, with the prospect of an eventual sanction, which should also be duly informed to the public. This sanction shall be established in an implementing regulation.

Amendment 439 #

Proposal for a regulation
Article 8 – paragraph 5 a (new)

5a. The measures recommended by the Steering Group to the Commission, Member States, marketing authorisation holders and other stakeholders should include a relaxing of rules to deal with potential shortages.

Amendment 440 #

Proposal for a regulation
Article 8 – paragraph 5 b (new)

5 b. The Agency, together with the Commission, shall also present recommendations to the Commission to counterbalance smear campaigns and disinformation on medicines, medical products, devices or applications, in order to ensure proper information to the public.

Amendment 441 #

Joëlle MÉLIN, Danilo Oscar LANCINI

Proposal for a regulation
Article 9 – paragraph 1 – introductory part

1. In order to prepare for fulfilling the tasks referred to in Articles 4 to 8 and after having consulted representatives from national competent authorities and from marketing authorisation holder representatives, as well as other stakeholders in the medicines supply chain, the Agency shall:

Amendment 442 #

Proposal for a regulation
Article 9 – paragraph 1 – introductory part

Amendment 443 #

Proposal for a regulation
Article 9 – paragraph 1 – point a

(a) specify the procedures for establishing the critical medicines lists, , ensuring adequate consultation with healthcare professionals, consumers, patients a high level of transparency in decision-making;

Amendment 444 #

Proposal for a regulation
Article 9 – paragraph 1 – point a

(a) specify the procedures for establishing the critical medicines lists, ensuring adequate consultation with patients, consumers and healthcare professionals and a high level of transparency;

Amendment 445 #

Proposal for a regulation
Article 9 – paragraph 1 – point a

(a) specify the procedures for establishing the critical medicines lists; , ensuring adequate consultation with consumers, patients and healthcare professionals and a high level of transparency;

Amendment 446 #

Proposal for a regulation
Article 9 – paragraph 1 – point a

(a) specify the procedures for establishing the critical medicines lists, ensuring adequate consultation with consumers, patients and healthcare professionals and a high level of transparency;

Amendment 447 #

Proposal for a regulation
Article 9 – paragraph 1 – point a

(a) specify the procedures for establishing the critical medicines lists and the minimum stock levels required to ensure continuity of medical care;

Amendment 448 #

Proposal for a regulation
Article 9 – paragraph 1 – point a

(a) specify the procedures and criteria for establishing the critical medicines lists;

Amendment 449 #

Proposal for a regulation
Article 9 – paragraph 1 – point a

(a) specify the procedures for establishing and reviewing the critical medicines lists;

Amendment 450 #

Proposal for a regulation
Article 9 – paragraph 1 – point b

(b) specify the methods of and criteria for the monitoring, data collection and reporting through the European Union of Health digitalized and interoperable early-warning system of shortage of medicines, established in Article 2bis(new), and provided for in Articles 4, 7 and 8;

Amendment 451 #

Proposal for a regulation
Article 9 – paragraph 1 – point c

(c) develop streamlined electronic monitoring and reporting systems by implementing and building on existing regulatory infrastructure (EU telematics[1]). This system shall be interoperable with the national shortages reporting to prevent any duplication of the reporting process; the system shall establish a two-way digital communication between the Agency and the national competent authorities, as well as a two way communication between the Agency and marketing authorisation holders. In case of public health emergency, aggregated information shall be collected by the Agency from national competent authority shortages reporting systems in a harmonised and consolidated way, based on national harmonised data fields and definitions across Member States. The Agency can request additional information directly from the marketing authorisation holders via the industry single point of contact (iSPOC), if this information has not been provided yet to the Member States through the system;

Amendment 452 #

Proposal for a regulation
Article 9 – paragraph 1 – point c

(c) develop streamlined electronic monitoring and reporting systems; by implementing and building on existing regulatory infrastructure (EU telematics[1]). This system shall be interoperable with the national shortages reporting to prevent any duplication of the reporting process; the system should establish a two-way digital communication between the Agency and the national competent authorities, as well as a two way communication between the Agency and marketing authorisation holders. In case of public health emergency, aggregated information should be collected by the Agency from national competent authority shortages reporting systems in a harmonised and consolidated way, based on harmonised data fields across Member States. The Agency can request additional information directly from the marketing authorisation holders via the industry single point of contact (iSPOC), if this information has not been provided yet to the Member States.

Amendment 453 #

Proposal for a regulation
Article 9 – paragraph 1 – point c

(c) develop streamlined electronic monitoring and reporting systems; , by implementing and building on existing regulatory infrastructure (EU telematics). This system shall be interoperable with the national shortages reporting to prevent any duplication of the reporting process; the system should establish a two-way digital communication between the Agency and the national competent authorities, as well as a two way communication between the Agency and marketing authorisation holders. In case of public health emergency, aggregated information should be collected by the Agency from national competent authority shortages reporting systems in a harmonised and consolidated way, based on harmonised data fields across Member States. The Agency can request additional information directly from the marketing authorisation holders via the industry single point of contact (iSPOC), if this information has not been provided yet to the Member States.

Amendment 454 #

Proposal for a regulation
Article 9 – paragraph 1 – point c

(c) develop streamlined electronic monitoring and reporting systems; by implementing and building on existing regulatory infrastructure (EU telematics). This system shall be interoperable with the national shortages reporting to prevent any duplication of the reporting process; the system should establish a two-way digital communication between the Agency and the national competent authorities, as well as a two way communication between the Agency and marketing authorisation holders. In case of public health emergency, aggregated information should be collected by the Agency from national competent authority shortages reporting systems in a harmonised and consolidated way, based on harmonised data fields across Member States. The Agency can request additional information directly from the marketing authorisation holders via the industry single point of contact (iSPOC), if this information has not been provided yet to the Member States.

Amendment 455 #

Proposal for a regulation
Article 9 – paragraph 1 – point c

(c) develop streamlined electronic monitoring and reporting systems, building upon EU telematics regulatory infrastructure, SPOR, into national shortage reporting interoperable system, based on national harmonised data fields and definitions across Member States, preventing reporting duplication, using international standards (ISO IDMP) and supporting mutual cooperation of the Agency and national competent authorities and via iSPOC with marketing authorisation holders;

Amendment 456 #

Proposal for a regulation
Article 9 – paragraph 1 – point c

(c) develop ~~streamlined electronic~~an interoperable and digitalized platform for monitoring ~~and~~, reporting ~~systems~~and notifying;

Amendment 457 #

Proposal for a regulation
Article 9 – paragraph 1 – point d

(d) establish and maintain membership of the working party referred to in Article 3(5) comprised of single points of contacts from national, and where applicable regional, competent authorities for medicinal products;

Amendment 458 #

Proposal for a regulation
Article 9 – paragraph 1 – point e

Amendment 459 #

Proposal for a regulation
Article 9 – paragraph 1 – point e

(e) ~~establish and maintain a list of~~update the Article 57(1)(l) of Regulation 726/2004 Data base by including the industry single points of contact ~~from marketing authorisation~~ s (iSPOC), this database should~~ers for all medicinal products for human use authorised in the Union, through the database provided for in Article 57(1)(l) of Regulation 726/2004~~ be digital, regularly updated, and compliant with the standards of the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP)2;

Amendment 460 #

Proposal for a regulation
Article 9 – paragraph 1 – point e

(e) ~~establish and maintain a list of~~update the Article 57(1)(l) of Regulation 726/2004 Data base by including the industry single points of contact ~~from marketing authorisation~~ s (iSPOC), this database should~~ers for all medicinal products for human use authorised in the Union, through the database provided for in Article 57(1)(l) of Regulation 726/2004~~ be digital, regularly updated, and compliant with the standards of the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP);

Amendment 461 #

Proposal for a regulation
Article 9 – paragraph 1 – point e

(e) ~~establish and maintain a list of~~update the Article57(1)(l) of Regulation 726/2004 database by including the industry single points of contact ~~from marketing authorisation~~ (iSPOC); this database should~~ers for all medicinal products for human use authorised in the Union, through the database provided for in Article 57(1)(l) of Regulation 726/2004;~~ be digital, regularly updated, and compliant with the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP)

Amendment 462 #

Proposal for a regulation
Article 9 – paragraph 1 – point f a (new)

(fa) update the format and content of the Article 57 database to include the industry Single Point of contact (iSPOC) names as reported by industry. Industry should be able to digitally update the iSPOC names in the article 57 database if needed and compliant with the standards of the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP);

Amendment 463 #

Proposal for a regulation
Article 9 – paragraph 1 – point f a (new)

(fa) The Agency shall publish information referred to in paragraph (1) (a), (b), (f) on its web-portal.

Amendment 464 #

Proposal for a regulation
Article 9 – paragraph 1 – point f a (new)

(fa) publish information referred to in paragraph (1) (a), (b) and (f) on its web- portal.

Amendment 465 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Article 9 – paragraph 1 – point f b (new)

(fb) Include the use of including use of the European Medicines Verification System data for shortages in an epidemiological crisis by enabling national regulators to assess the availability of products versus what has been consumed or parallel exported in their market;

Amendment 466 #

Proposal for a regulation
Article 9 – paragraph 1 a (new)

1 a. The Agency shall publish the information referred to in paragraph 1 (a), (b), (f) on its web portal without delay.

Amendment 467 #

Proposal for a regulation
Article 9 – paragraph 2 – point a

(a) establish and maintain for the duration of the public health emergency or major event, a sub-network of single points of contact from marketing authorisation holders who can be different from the contacts established under Article 9(1) point (e), and of representatives of other relevant supply chain stakeholders involved in the distribution and supply of medicinal products to the public, based on the medicinal products included on the critical medicines lists;

Amendment 468 #

Proposal for a regulation
Article 9 – paragraph 2 – point b

(b) request information, including on the supply of the list of critical medicinal products, from the points of contact included in the sub-network referred to in point (a) and set a deadline for its submission in the platform;

Amendment 469 #

Proposal for a regulation
Article 9 – paragraph 2 – point c

(c) request information, including on the supply of the list of critical medicinal products, from the single points of contact from Member States’ national competent authorities based on the set of information agreed on by the Medicines Steering Group and set a deadline for its submission in the platform.

Amendment 470 #

Proposal for a regulation
Article 9 – paragraph 2 – point c

(c) request information from the single points of contact from Member States’ national, and where applicable regional, competent authorities based on the set of information agreed on by the Medicines Steering Group and set a deadline for its submission.

Amendment 471 #

Proposal for a regulation
Article 9 – paragraph 3 – introductory part

3. The information referred to in point (b) of paragraph 2 (as determined in Article 9(1) (c) and Article 11 (a) shall not include a~~t least:~~ny information available to the Agency via collection of information submitted by industry to the national competent authority shortages systems in a harmonised and consolidated way by means of common data fields for each Member State. The system at the Agency shall be interoperable with the national shortages reporting to prevent any duplication of the reporting process by industry via Industry Single Points of Contact (iSPOC).

Amendment 472 #

Proposal for a regulation
Article 9 – paragraph 3 – introductory part

3. The scope of the information referred to in point (b) of paragraph 2 shall ~~include at least~~be discussed with representatives of the relevant marketing authorisation holders, including to avoid overlaps with information already submitted following Directive 2001/83/EC. Requested information may include:

Amendment 473 #

Proposal for a regulation
Article 9 – paragraph 3 – introductory part

Amendment 474 #

Proposal for a regulation
Article 9 – paragraph 3 – point d

(d) details of the potential or actual shortage such as actual or estimated start and end dates and suspected or known cause as well as information on potential bottlenecks in the supply chain;

Amendment 475 #

Proposal for a regulation
Article 9 – paragraph 3 – point d a (new)

(da) information on active substance manufacturing sites, where relevant;

Amendment 476 #

Proposal for a regulation
Article 9 – paragraph 3 – point e

~~(e) sales and market share data;~~deleted

Amendment 477 #

Proposal for a regulation
Article 9 – paragraph 3 – point e

(e) sales, available stock, where relevant, and market share data;

Amendment 478 #

Proposal for a regulation
Article 9 – paragraph 3 – point f

(f) details of available alternative medicinal products where known by the marketing authorisation holder;

Amendment 479 #

Proposal for a regulation
Article 9 – paragraph 3 – point g

(g) prevention and mitigation plans including ~~production and supply capacity~~but not limited to information on production and supply capacity, production sites of finished pharmaceutical products and active pharmaceutical ingredients and raw materials, potential alternative production sites, minimum stock levels;[PA1] such plans shall contain preventative measures that help ensure the continued supply of critical medicines, such as diversification of supply chains;

Amendment 480 #

Proposal for a regulation
Article 9 – paragraph 3 – point g

(g) prevention and mitigation plans including information on production and supply capacity; production sites of the finished pharmaceutical product and of active pharmaceutical ingredients, potential alternative production sites, minimum stock levels, etc.;

Amendment 481 #

Proposal for a regulation
Article 9 – paragraph 3 – point g

Amendment 482 #

Proposal for a regulation
Article 9 – paragraph 3 – point g

Amendment 483 #

Proposal for a regulation
Article 9 – paragraph 3 – point g

(g) mitigation plans including production and supply capacity; these plans shall contain preventative measures that help ensure the continued supply of critical medicines, such as diversification of supply chains;

Amendment 484 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Nils TORVALDS, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Article 9 – paragraph 3 – point g

(g) mitigation plans containing preventative measures that help ensure the continued supply of critical medicines, such as diversification of supply chains, as well as including production and supply capacity;

Amendment 485 #

Proposal for a regulation
Article 9 – paragraph 3 – point g

(g) mitigation plans, including production and supply capacity, with a view to guarantee continued supply and prevent shortages of medicinal products included on the critical medicines lists;

Amendment 486 #

Proposal for a regulation
Article 9 – paragraph 3 – point g

(g) prevention and mitigation plans including production and supply capacity;

Amendment 487 #

Proposal for a regulation
Article 9 – paragraph 3 – point g

(g) mitigation plans ~~including production and supply capacity~~;

Amendment 488 #

Proposal for a regulation
Article 9 – paragraph 3 – point g a (new)

(ga) update the format and content of the Article 57 database to include the industry Single Point of contact (iSPOC) names as reported by industry. Industry should be able to digitally update the iSPOC names in the Article 57 database if needed and compliant with the standards of the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP)3;

Amendment 489 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS, Jan HUITEMA

Proposal for a regulation
Article 9 – paragraph 3 – point h

~~(h) information from the wholesale distributors and legal person entitled to supply the medicinal product to the public.~~deleted

Amendment 490 #

Proposal for a regulation
Article 9 – paragraph 3 – point h

~~(h) information from the wholesale distributors and legal person entitled to supply the medicinal product to the public.~~deleted

Amendment 491 #

Proposal for a regulation
Article 9 – paragraph 3 – point h

(h) information on stock levels from the wholesale distributors and legal person entitled to supply the medicinal product to the public, via their representatives who are part of the sub-network referred to in point (a) of paragraph 2.

Amendment 492 #

Sirpa PIETIKÄINEN

Proposal for a regulation
Article 9 – paragraph 3 a (new)

3 a. Following the recognition of a public health emergency or a request for assistance referred to in Article 4 (3), the Agency shall establish: (a) a minimum stock level for wholesale distributors and other legal entities entitled to supply the public with medicinal products included on the critical medicines lists; (b) an emergency preparedness plan to fast track an increase in the production capacity so that it is sufficient to fulfil Union needs for the medicinal products included on the critical medicines lists.

Amendment 493 #

Proposal for a regulation
Article 9 – paragraph 3 a (new)

Amendment 494 #

Proposal for a regulation
Article 9 – paragraph 3 a (new)

Amendment 495 #

Sirpa PIETIKÄINEN

Proposal for a regulation
Article 9 – paragraph 3 b (new)

3 b. In normal circumstances the Agency shall establish a minimum stock level for wholesale distributors and other legal entities entitled to supply the public with medicinal products.

Amendment 496 #

Proposal for a regulation
Article 10 – title

Obligations on marketing authorisation holders and other actors in the supply chain

Amendment 497 #

Proposal for a regulation
Article 10 – paragraph 1

1. In order to facilitate the monitoring referred to in Article 7 and following a request from the Agency, marketing authorisation holders for medicinal products included on the critical medicines lists shall submit ~~the~~upload the additional information referred to in Article 9(3) ~~by the deadline set by the Agency. They shall submit the~~in the harmonised pan-European interoperable and digitalized shortages reporting and notification system by the a reasonable deadline set by the Agency in concertation with industry. They shall submit upload the additional information in the harmonised pan-European interoperable and digitalized shortages reporting and notification system through the points of contact designated in accordance with Article 9(2) and using the reporting methods and system established pursuant to Article 9(1). They shall provide updates where necessary. Once uploaded, the information is accessible to the Agency and national competent authorities, ensuring transparency and avoiding duplications of reporting at different levels and enabling the two-way communication with industry and entities of the pharmaceutical supply chain .

Amendment 498 #

Proposal for a regulation
Article 10 – paragraph 1

Amendment 499 #

Joëlle MÉLIN, Danilo Oscar LANCINI

Proposal for a regulation
Article 10 – paragraph 1

Amendment 500 #

Proposal for a regulation
Article 10 – paragraph 1

1. In order to facilitate the monitoring referred to in Article 7 and following a request from the Agency, marketing authorisation holders for medicinal products included on the critical medicines lists, and all distributors legally authorised to supply medicines to the public, shall submit the information referred to in Article 9(3) by the deadline set by the Agency. They shall submit the information through the points of contact designated in accordance with Article 9(2) and using the reporting methods and system established pursuant to Article 9(1). They shall provide updates where necessary.

Amendment 501 #

Proposal for a regulation
Article 10 – paragraph 2

2. Marketing authorisation holders of medicinal products authorised in the Union shall, within 612-24 months from the date of application of this Regulation, provide the information required pursuant to Article 9(1)(e) in the form of an electronic submission in the database referred to in Article 57(1)(l) of Regulation (EC) No 726/2004 and compliant with the standards of the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). Those marketing authorisation holders shall update their submission wherever necessary.

Amendment 502 #

Proposal for a regulation
Article 10 – paragraph 2

2. Marketing authorisation holders of medicinal products authorised in the Union shall, within 6 months from the date of application of this Regulation, provide the information required pursuant to Article 9(1)(e) in the form of an electronic submission in the database referred to in Article 57(1)(l) of Regulation (EC) No 726/2004 and compliant with ISO IDMP standards for the identification of human medicines. Those marketing authorisation holders shall update their submission wherever necessary.

Amendment 503 #

Proposal for a regulation
Article 10 – paragraph 3

~~3. Marketing authorisation holders shall justify the absence of any requested information and any delays in providing it by the deadline set by the Agency.~~deleted

Amendment 504 #

Proposal for a regulation
Article 10 – paragraph 3

3. Marketing authorisation holders ~~shall justify the absence of any requested information and any delays in providing it by~~of medicinal products authorised in the Union shall, within 6 months from the date of application of this Regulation, provide the information required pursuant to Article 9(1)(e) in the form of an electronic submission in the database referred to in Article 57(1)(l) of Regulation (EC)No 726/2004 and compliant with ISO IDMP standards for the ide~~adline set by the Agenc~~ntification of human medicines. Those marketing authorisation holders shall update their submission wherever necessary.

Amendment 505 #

Proposal for a regulation
Article 10 – paragraph 3

3. Marketing authorisation holders shall justify the absence of any requested information and any delays in providing it by the deadline set by the Agency. Marketing authorisation holders failing to comply with their reporting obligations shall be subject to proportionate sanctions set by the Commission in a delegated act.

Amendment 506 #

Proposal for a regulation
Article 10 – paragraph 3

Amendment 507 #

Proposal for a regulation
Article 10 – paragraph 3

Amendment 508 #

Proposal for a regulation
Article 10 – paragraph 4

Amendment 509 #

Proposal for a regulation
Article 10 – paragraph 4

4. Where marketing authorisation holders for medicinal products included on the critical medicines lists indicate that the submitted information contains information of a commercially confidential nature, they shall identify the relevant parts and clarify the reasons for such an indication. TIt should be determined upfront what information is commercially confident, based on this the Agency shall assess the merits of each request and protect commercially confidential information against unjustified disclosure.

Amendment 510 #

Proposal for a regulation
Article 10 – paragraph 4

4. Where marketing authorisation holders for medicinal products included on the critical medicines lists indicate that the submitted information requested by the Agency and the national competent authorities contains information of a commercially confidential nature, they shall identify the relevant parts and clarify the reasons for such an indication. The Agency shall assess the merits of each request and protect commercially confidential information against unjustified disclosure.

Amendment 511 #

Proposal for a regulation
Article 10 – paragraph 5

5. Where marketing authorisation 5. holders for medicinal products included on the critical medicines lists are in possession of any additional information, which provides evidence of a potential or actual shortage they shall immediately provide such information to the Agency. National, or where applicable regional, competent authorities shall facilitate patient and consumer reporting of medicine shortages through the digital interoperable database referred to in Article 1(b) and Article 12(g). Aggregated data from these reports shall be shared by the sub-network of single points of contact from national, or where applicable regional, competent authorities referred to in Article 3(5) with the Steering Group to inform recommendations on medicine shortage management.

Amendment 512 #

Proposal for a regulation
Article 10 – paragraph 5

5. Where marketing authorisation holders for medicinal products included on the critical medicines lists are in possession of any additional information, which provides evidence of a potential or actual shortage they shall immediately provide such information to the Agency. In the absence of notification of essential information, the Agency, the Commission and Member States should enact sanctions, e.g. financial penalties, extending compulsory license or removing intellectual property rights to allow that other actors can minimise the shortage.

Amendment 513 #

5. Where marketing authorisation holders for medicinal products included on the critical medicines lists and /or other relevant entities of the pharmaceutical supply chain, are in possession of any additional information, which provides evidence of a potential or actual shortage they shall immediately provide such information to the Agency.

Amendment 514 #

Proposal for a regulation
Article 10 – paragraph 6 – point a

(a) provide any comments they have to the Agency, in accordance with Article 30 of this Regulation;

Amendment 515 #

Proposal for a regulation
Article 10 – paragraph 6 – point c

(c) inform the Medicines Steering Group of any measures taken and report on the monitoring and results of those measures, including information on the resolution of the potential or actual shortage.

Amendment 516 #

Proposal for a regulation
Article 10 – paragraph 6 a (new)

6 a. In order to supplement the shortage prevention and mitigation plans of critical products, the Agency and national competent authorities may request additional information from wholesale distributors and other relevant actors regarding any logistical challenges incurred by the wholesale supply chain.

Amendment 517 #

Proposal for a regulation
Article 10 – paragraph 6 a (new)

6 a. 6 a. The Commission and Member States shall lay down rules on sanctions for non-compliance with the obligations established under this Article. These sanctions shall be dissuasive.

Amendment 518 #

Proposal for a regulation
Article 10 – paragraph 6 a (new)

6 a. The Commission and Member States shall lay down rules on sanctions for non-compliance with the obligations established under this Article. These sanctions shall be dissuasive.

Amendment 519 #

Proposal for a regulation
Article 10 – paragraph 6 b (new)

6 b. The Commission shall exercise its power to lay down rules on sanctions for non-compliance with the obligations established under this Article in a delegated act.

Amendment 520 #

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

1. In order to facilitate the monitoring referred to in Article 7 and following a request from the Agency, Member States shall, by the deadline set by the Agency: , where relevant, following the creation of a harmonized pan-European interoperable and digital National Competent Authorities (NCAs) shortages reporting system based on common data fields (a) submit the set of information requested by the Agency in Chapter 2 Article 9 (4) including available and estimated data on volume of demand, through its designated point of contact and using the reporting methods and system established pursuant to Article 9(1);

Amendment 521 #

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

1. In order to facilitate the monitoring referred to in Article 7 and following a request from the Agency, Member States shall, by the deadline set by the Agency, submit the following, if not already available in the harmonised pan- European interoperable and digitalized shortages reporting and notification system :

Amendment 522 #

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

1. In order to facilitate the monitoring referred to in Article 7 and following a request from the Agency, Member States or any national competent authority shall, by the deadline set by the Agency:

Amendment 523 #

Proposal for a regulation
Article 11 – paragraph 1 – point a

(a) In order to facilitate the monitoring referred to in Article 7 and following a request from the Agency, Member States shall, by the deadline set by the Agency, where relevant, following the creation of a harmonized pan- European interoperable and digital National Competent Authorities (NCAs) shortages reporting system based on common data fields (a) submit the set of information requested by the Agency in Chapter 2 Article 9 (4) including available and estimated data on volume of demand, through its designated point of contact and using the reporting methods and system established pursuant to Article 9(1);

Amendment 524 #

Proposal for a regulation
Article 11 – paragraph 1 – point a

(a) submit the set of additional information requested by the Agency in Chapter 2 Article 9 (3) including available and estimated data on volume of demand, through its designated point of contact and using the reporting methods and system established pursuant to Article 9(1);

Amendment 525 #

Proposal for a regulation
Article 11 – paragraph 1 – point a

(a) submit the set of available information to Member States requested by the Agency including ~~available and~~ estimated data on volume of demand, through its designated point of contact and using the reporting methods and system established pursuant to Article 9(1);

Amendment 526 #

Proposal for a regulation
Article 11 – paragraph 1 – point a

(a) submit the set of information requested by the Agency including available and estimated data on volume of demand, through its designated point of contact and using the reporting methods ~~and~~, system and platform established pursuant to Article 9(1);

Amendment 527 #

Proposal for a regulation
Article 11 – paragraph 2

2. Where necessary to fulfil their reporting obligations set out in paragraph 1, Member States, with the support of the Agency, shall gather information and data on stock levels from wholesale distributors and other legal entities entitled to supply the public with medicinal products included on the critical medicines lists.deleted

Amendment 528 #

Proposal for a regulation
Article 11 – paragraph 2

Amendment 529 #

Proposal for a regulation
Article 11 – paragraph 2

2. Where necessary to fulfil their reporting obligations set out in paragraph 1, Member States, with the support of the Agency, shall gather information and data on stock levels from ~~wholesale distributors~~marketing authorisation holders, wholesale distributors, community and hospital pharmacies, and other legal entities entitled to supply the public with medicinal products included on the critical medicines lists.

Amendment 530 #

Proposal for a regulation
Article 11 – paragraph 2 a (new)

2a. Where necessary to fulfil their reporting obligations set out in paragraph 1, Member States, with the support of the Agency, shall gather information and data on unmet demands from wholesale distributors, community and hospital pharmacies, and other legal entities entitled to supply the public with medicinal products included on the critical medicines lists.

Amendment 531 #

Proposal for a regulation
Article 11 – paragraph 3

3. Where Member States are in possession of any additional information on volume of sales and volumes of prescriptions, including data based on Article 23a of Directive 2001/83/EC, which provides evidence of a potential or actual shortage of a medicinal product included on the critical medicines lists, they shall immediately provide such information to the Medicines Steering Group through their designated points of contact via the harmonised pan-European interoperable and digitalized shortages reporting and notification system.

Amendment 532 #

Proposal for a regulation
Article 11 – paragraph 4 – point a

(a) ~~take into account~~acknowledge any recommendations and guidelines and comply with any measures taken at Union- level pursuant to Article 12;

Amendment 533 #

Proposal for a regulation
Article 11 – paragraph 4 – subparagraph 1 (new)

Member States shall facilitate patient and consumer reporting of medicine shortages through the provision of alternative reporting formats in addition to web- based formats. Aggregated data from these reports shall be shared by the sub- network of single points of contact from national competent authorities referred to in Article 3 (5) with the Steering Group to inform recommendations on medicine shortage management.

Amendment 534 #

Proposal for a regulation
Article 11 – paragraph 4 a (new)

4 a. National medicines agencies in Member States shall facilitate patient and consumer reporting of medicine shortages through the provision of alternative reporting formats in addition to web- based formats. Aggregated data from these reports shall be shared by the sub- network of single points of contact from national competent authorities referred to in Article 3 (5) with the Medicines Steering Group to inform recommendations on medicine shortage impact and management.

Amendment 535 #

Proposal for a regulation
Article 11 – paragraph 4 a (new)

4 a. Member States shall facilitate patient and consumer reporting of medicine shortages through the provision of alternative reporting formats in addition to web-based formats. Aggregated data from these reports shall be shared by the sub-network of single points of contact from national competent authorities referred to in Article 3 (5) with the Steering Group to inform recommendations on medicine shortage management.

Amendment 536 #

Proposal for a regulation
Article 12 – paragraph 1 – introductory part

The Commission shall take into account the aggregated data from the harmonised pan-European interoperable and digitalized shortages reporting and notification system, as well as information from and recommendations of the Medicines Steering Group and shall:

Amendment 537 #

Proposal for a regulation
Article 12 – paragraph 1 – point a a (new)

(aa) The European Commission shall facilitate the coordination between manufacturers and other relevant stakeholders to address demand surges adapting with relevant European legislation including competition, internal market and pharmaceutical regulation.

Amendment 538 #

Proposal for a regulation
Article 12 – paragraph 1 – point b

(b) consider the need for guidelines addressed to Member States, marketing authorisation holders, and other entities, including healthcare professionals, to support them in their work and in the communication with patients;

Amendment 539 #

Proposal for a regulation
Article 12 – paragraph 1 – point b

(b) consider the need for guidelines addressed to Member States, marketing authorisation holders, and other entities, including healthcare professionals to support them in their work and in the communication with patients;

Amendment 540 #

Proposal for a regulation
Article 12 – paragraph 1 – point b

Amendment 541 #

Proposal for a regulation
Article 12 – paragraph 1 – point b

(b) consider the need for guidelines addressed to Member States, marketing authorisation holders, and other entities; , including healthcare professionals to support them in their work and in the communication with patients;

Amendment 542 #

Proposal for a regulation
Article 12 – paragraph 1 – point b

(b) consider the need for guidelines addressed to Member States, marketing authorisation holders, and other entities, including healthcare professionals, in order to support their work and communication with patients;

Amendment 543 #

Proposal for a regulation
Article 12 – paragraph 1 – point b

(b) consider the need for guidelines addressed to Member States, marketing authorisation holders, and other entities where this is proportionate, justified and necessary;

Amendment 544 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS, Ondřej KNOTEK

Proposal for a regulation
Article 12 – paragraph 1 – point b

(b) consider the need for guidelines addressed to Member States, marketing authorisation holders, and other entities including from the pharmaceutical supply chain;

Amendment 545 #

Proposal for a regulation
Article 12 – paragraph 1 – point b

(b) consider the need for guidelines addressed to Member States, marketing authorisation holders, and other entities, including healthcare professionals;

Amendment 546 #

Proposal for a regulation
Article 12 – paragraph 1 – point b

(b) consider the need for guidelines addressed to Member States, marketing authorisation holders, and other entities; of the pharmaceuticals supply chain

Amendment 547 #

Proposal for a regulation
Article 12 – paragraph 1 – point b

(b) consider the need for guidelines and recommendations addressed to Member States, marketing authorisation holders, and other entities;

Amendment 548 #

Proposal for a regulation
Article 12 – paragraph 1 – point c

(c) inform the Medicines Steering Group and industry (via the trade associations) of any measures taken and report on the results;

Amendment 549 #

Proposal for a regulation
Article 12 – paragraph 1 – point c

Amendment 550 #

Proposal for a regulation
Article 12 – paragraph 1 – point f a (new)

(fa) assist the Agency in building the digital and interoperable database referred to in Article 1(b) and Article12(g), with the following main tasks: i. facilitate the prevention, monitoring and reporting of shortages of medicinal products, devices and applications, ii. track and follow medicinal products, devices and applications throughout the supply chain, iii. determine the volume of stock, the capabilities of all stakeholders linked in the supply chain or chains, the actual, current and foreseeable level of demand obtain, iv. record and share information about innovative medicinal products, devices, applications or developments that are still not harmonised throughout the Union, such as plasma-derived products.

Amendment 551 #

Proposal for a regulation
Article 12 – paragraph 1 – point f b (new)

(fb) sanction those marketing authorisation holders, manufacturers or Member States that do not comply with the demands of information by the Agency;

Amendment 552 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Article 12 – paragraph 1 a (new)

The Commission shall provide answers to (priority) written questions from Members of the European Parliament within the deadline;

Amendment 553 #

Proposal for a regulation
Article 12 a (new)

Article 12 a European medicines supply database 1. The Agency shall, in collaboration with the Commission and Member States, set up, maintain and manage the European medicines supply database (EUMSD) for the following purposes: (a) to enable the monitoring of supply and demand of medicinal products at Union and Member State level; (b) to enable the monitoring and reporting of shortages of medicinal products at Union and Member State level; (c) to enable marketing authorisation holders and wholesale distributors to comply with the information obligations laid down in Article 10; (d) to enable the Commission, the national competent authorities and the Agency to carry out their tasks relating to this Regulation on a well-informed basis and to enhance the cooperation between them. The EUMSD, which shall be functional not only during public health emergencies and major events but also under normal circumstances, shall function as an interoperable and harmonised Union database, based on the data reported through the national electronic platforms established pursuant to paragraph 2. The database shall allow the national competent authorities and the Agency to simultaneously access and share the information provided in the database. 2. Each Member State shall develop an electronic platform for real-time monitoring of the supply of medicinal products, capable of determining the volume of supply existing at any given moment, and detecting, predicting and preventing shortages of medicinal products. Those platforms, which shall be managed by the national competent authorities, shall be fully operational at Member State level by... [30 months after the date of entry into force of this Regulation]. Data on supply and demand shall be reported at Member State level by the following entities: (a) marketing authorisation holders (b) wholesale distributors (c) community and hospital pharmacies 3. In addition to paragraph 2, the electronic platforms shall provide the national competent authorities with real- time access to unmet demands from wholesale distributors, community pharmacies and hospital pharmacies at national level. Those platforms shall also allow marketing authorisation holders to report any medicinal products supply problems, including manufacturing problems. 4. Member State platforms shall be interoperable and shall replicate their information in the EUMSD managed by the Agency, thus preventing any duplication of the reporting process by the single points of contact established in Article 9(2). 5. The data generated by the Member State platforms and consequently by the EUMSD shall make it possible to identify any supply problems along the supply chain and, through the application of big data techniques and, where appropriate, artificial intelligence, shall be able to forecast supply problems in advance. 6. The data submitted shall be compliant with the International Organization for Standardization for the identification of medicinal products standards for the identification and description of medicinal products for human use and be based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organisation and referential data. 7. The Agency shall, in collaboration with the Commission and Member States , draw up the functional specifications for the database, together with a plan for the implementation of the EUMSD and the Member State platforms by... [6 months after the entry into force of this Regulation] . That plan shall seek to ensure that the EUMSD is fully functional by ...[48 months after the date of entry into force of this Regulation] . 8. Where a national competent authority indicates that the submitted information contains information of a commercially confidential nature, it shall identify the relevant parts and clarify the reasons for such an indication. The Agency shall assess the merits of each request and protect commercially confidential information against unjustified disclosure. 9. Considering the commercially sensitive data provided in the EUMSD, access to the database shall be limited to the Commission, the Agency, national competent authorities reporting the data to the database and the Medicines Steering Group.

Amendment 554 #

Proposal for a regulation
Article 13 – paragraph -1 (new)

Amendment 555 #

Proposal for a regulation
Article 13 – paragraph 1

The Agency shall, via its web-portal and other appropriate means, in conjunction with national competent authorities, inform the public and interest groups in a timely manner with regard to the work of the Medicines Steering Group, and ensure adequate consultation with the Patients’ and Consumers’ Working Party (PCWP) and the Healthcare Professionals’ Working Party (HCPWP). The list of the members of the Medicines Steering Group, the rules of procedure, agendas and minutes of the meetings and recommendations shall be published on the Agency’s web-portal.

Amendment 556 #

Proposal for a regulation
Article 13 – paragraph 1

The Agency shall, via its web-portal and other appropriate means, in conjunction with national, or where applicable regional, competent authorities, inform the public and interest groups with regard to the work of the Medicines Steering Group, ensuring the sharing of information by the Patients’ and Consumers’ Working Party as well as a representative of the Healthcare Professionals’ Working Party as observers. The Agency shall assess the transparency of the undertakings of the Medicines Steering Group, taking into account principles of transparency and accountability.

Amendment 557 #

Proposal for a regulation
Article 13 – paragraph 1

The Agency shall, via its web-portal and other appropriate means, in conjunction with national competent authorities, inform the public and interest groups with regard to the work of the Medicines Steering Group, and ensure adequate consultation with the Patients’ and Consumers’ Working Party and the Healthcare Professionals’ Working Party.

Amendment 558 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Article 13 – paragraph 1

The Agency shall, via its web-portal and other appropriate means, in conjunction with national competent authorities, inform the public and interest groups with regard to the work of the Medicines Steering Group., and ensure adequate consultation with the Patients’ and Consumers’ Working Party and the Healthcare Professionals’ Working Party

Amendment 559 #

The Agency shall, via its web-portal and other appropriate means, in conjunction with national competent authorities, inform without delay the public and interest groups with regard to the work of the Medicines Steering Group, and respond to disinformation as appropriate.

Amendment 560 #

Proposal for a regulation
Article 14 – paragraph 1

1. The Emergency Task Force is hereby established as a permanent structure as part of the Agency. It shall be convened during public health emergencies, either in person or remotely. The Agency shall provide its secretariat. The Emergency Task Force shall work with scientific committees, working parties and scientific advisory groups of the Agency in the area of pandemic preparedness and response. It shall cooperate with Union bodies and agencies, the World Health Organization, third countries, and international scientific organisations on scientific and technical issues related to pandemic preparedness. The Agency, in collaboration with the Member States, shall, in parallel, proactively foster expertise building to avoid a shortage of expertise due to a public health emergency, in areas which are unrelated to the public health emergency.

Amendment 561 #

Proposal for a regulation
Article 14 – paragraph 1

1. The permanent Emergency Task Force is hereby established as part of the Agency. It shall be convened during public health emergencies, either in person or remotely. The Agency shall provide its secretariat. The Emergency Task Force shall cooperate with EU bodies and agencies, the World Health Organization, third countries and international scientific organisations in preparing timely and appropriate responses to health emergencies. The Agency, working together with the Member States, shall undertake to develop the protocols and expertise necessary for a timely and appropriate response to health crises, including for sectors other than the health sector, in order to improve crisis response capacity.

Amendment 562 #

Proposal for a regulation
Article 14 – paragraph 1

1. The Emergency Task Force is hereby established as part of the Agency. It shall be convened as often as needed during public health emergencies, either in person or remotely. The Agency shall provide its secretariat.

Amendment 563 #

Proposal for a regulation
Article 14 – paragraph 1

1. The Emergency Task Force is hereby established as part of the Agency. It shall be convened in preparation for and during public health emergencies, either in person or remotely. The Agency shall provide its secretariat.

Amendment 564 #

Proposal for a regulation
Article 14 – paragraph 1

1. The Emergency Task Force is hereby established as part of the Agency. It shall be convened only during public health emergencies, either in person or remotely. The Agency shall provide its secretariat.

Amendment 565 #

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

(a) providing scientific advice and reviewing the available scientific data on human and veterinary medicinal products with the potential to address the public health emergency, including requesting data from developers and engaging with them in preliminary discussions;

Amendment 566 #

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

(b) reviewing clinical trial protocols and providing advice to developers on clinical trials to be conducted in the Union, in particular on large multicentre clinical trials, for medicinal products intended to treat, prevent, or diagnose the disease causing the public health emergency, in accordance with Article 15;

Amendment 567 #

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

(b) reviewing clinical trial protocols and providing advice to developers on clinical trials to be conducted in the Union, in particular on large multi-centre trials, for medicinal products intended to treat, prevent, or diagnose the disease causing the public health emergency, in accordance with Article 15;

Amendment 568 #

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

Amendment 569 #

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

(e) providing scientific recommendations with regard to the use of any medicinal product, and in particular alternative medicinal products, which may have the potential to address public health emergencies, in accordance with Article 16;

Amendment 570 #

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

(e) providing scientific recommendations with regard to the use of any human or veterinary medicinal product, which may have the potential to address public health emergencies, in accordance with Article 16;

Amendment 571 #

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

(ea) collecting information from national competent authorities and defining a pan-European list of alternative products for use to address public health emergencies. Such list shall be accessible for relevant healthcare stakeholders;

Amendment 572 #

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

(f) cooperating with national and regional competent authorities, Union bodies and agencies, the World Health Organization, third countries, and international scientific organisations on scientific and technical issues relating to the public health emergency and to medicinal products which may have the potential to address public health emergencies, as necessary.

Amendment 573 #

Proposal for a regulation
Article 14 – paragraph 3

3. The Emergency Task Force shall be composed of representatives of the scientific committees, working parties, including a representative of the Patients’ and Consumers’ Working Party and a representative of the Healthcare Professionals’ Working Party, and staff members of the Agency, the coordination group established in accordance with Article 27 of Directive 2001/83/EC, and the Clinical Trials Coordination and Advisory Group established in accordance with Article 85 of Regulation (EU) 536/2014 .21 External experts may be appointed and representatives of other Union bodies and agencies be invited on an ad hoc basis, as necessary. It shall be chaired by the Agency. _________________ 21Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1

Amendment 574 #

Proposal for a regulation
Article 14 – paragraph 3

3. The Emergency Task Force shall be composed of representatives of the scientific committees, working parties, including a representative of the Patients’ and Consumers’ Working Party and a representative of the Healthcare Professionals’ Working Party, and staff members of the Agency, the coordination group established in accordance with Article 27 of Directive 2001/83/EC, and the Clinical Trials Coordination and Advisory Group established in accordance with Article 85 of Regulation (EU) 536/2014.21 External experts may be appointed and representatives of other Union bodies and agencies be invited on an ad hoc basis, as necessary. It shall be chaired by the Agency. _________________ 21Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1

Amendment 575 #

Proposal for a regulation
Article 14 – paragraph 3

3. The Emergency Task Force shall be composed of representatives of the Member States, of the scientific committees, working parties, and staff members of the Agency, the coordination group established in accordance with Article 27 of Directive 2001/83/EC, and the Clinical Trials Coordination and Advisory Group established in accordance with Article 85 of Regulation (EU) 536/2014.21 External experts may be appointed and representatives of other Union bodies and agencies be invited on an ad hoc basis, as necessary. It shall be chaired by the Agency. _________________ 21Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1under Heads of Medicines Agencies. Each Member State may appoint one representative. A Member State may delegate its tasks in the Emergency Task Force to another Member State. External experts may be appointed and representatives of other Union bodies and agencies be invited on an ad hoc basis, as necessary. It shall be chaired by the Agency.

Amendment 576 #

Proposal for a regulation
Article 14 – paragraph 3

3. The Emergency Task Force shall be composed of representatives of the scientific committees, working parties, namely representatives of the Patients’ and Consumers’ Working Party and the Healthcare Professionals’ Working Party, and staff members of the Agency, the coordination group established in accordance with Article 27 of Directive 2001/83/EC, and the Clinical Trials Coordination and Advisory Group established in accordance with Article 85 of Regulation (EU) 536/2014.21 External experts may be appointed and representatives of other Union bodies and agencies be invited on an ad hoc basis, as necessary. It shall be chaired by the Agency. _________________ 21Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1

Amendment 577 #

Proposal for a regulation
Article 14 – paragraph 3 a (new)

3 a. The Emergency Task Force shall be empowered to coordinate and exchange information and best practices with the health authorities of the Member States and the pharmaceutical industry in order to generate new synergies.

Amendment 578 #

5. The Chair ~~may~~shall invite, to Emergency Task Force meetings throughout the public health emergency, representatives of Member States, members of scientific committees of the Agency and working parties, and third parties, including representatives of medicinal product interest groups, marketing authorisation holders, developers of medicinal products, clinical trial sponsors, representatives of clinical trial networks, and interest groups representing patients and healthcare professionals ~~to attend its meetings~~, in order to provide the Emergency Task Force with the broadest and most detailed view of the situation at all times throughout the public health emergency.

Amendment 579 #

Proposal for a regulation
Article 14 – paragraph 5

5. The Chair may invite representatives of Member States, members of scientific committees of the Agency and working parties, and third parties, including representatives of medicinal product interest groups, marketing authorisation holders, developers of medicinal products, clinical trial sponsors, representatives of clinical trial networks, independent clinical trial experts and researchers, and interest groups representing patients and healthcare professionals to attend its meetings.

Amendment 580 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Nils TORVALDS, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS, Ondřej KNOTEK

Proposal for a regulation
Article 14 – paragraph 5

5. The Chair may invite representatives of Member States, members of scientific committees of the Agency and working parties, and third parties, including representatives of medicinal product interest groups, marketing authorisation holders, developers of medicinal products, clinical trial sponsors, representatives of clinical trial networks, independent clinical trials experts and researchers, and interest groups representing patients and healthcare professionals to attend its meetings.

Amendment 581 #

Proposal for a regulation
Article 14 – paragraph 5

5. The Chair may invite representatives of Member States, members of scientific committees of the Agency and working parties, and third parties, including representatives of medicinal product interest groups, marketing authorisation holders, developers of medicinal products, clinical trial sponsors, representatives of clinical trial networks, independent clinical trial experts and researchers, and interest groups representing patients and healthcare professionals to attend its meetings.

Amendment 582 #

Proposal for a regulation
Article 14 – paragraph 5

5. The Chair may invite representatives of Member States, members of scientific committees of the Agency and working parties, and third parties, including representatives of medicinal product interest groups, marketing authorisation holders, developers of medicinal products, clinical trial sponsors, representatives of clinical trial networks, independent clinical trial experts and researchers, and interest groups representing patients and healthcare professionals to attend its meetings.

Amendment 583 #

Proposal for a regulation
Article 14 – paragraph 6

6. The Emergency Task Force shall establish its rules of procedure including rules on the adoption of recommendations. The rules of procedure shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency. The rules of procedure including rules on the adoption of recommendations as well as the opinions should be made public on the Agency web-portal. The agenda and minutes of the Task Force shall be made public via the Agency web-portal.

Amendment 584 #

Proposal for a regulation
Article 14 – paragraph 6

6. The Emergency Task Force shall establish its rules of procedure including rules on the adoption of recommendations. The rules of procedure shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency. The rules of procedure including rules on the adoption of recommendations, as well as the opinions meeting minutes and agendas should be made public on the Agency web-portal.

Amendment 585 #

Proposal for a regulation
Article 14 – paragraph 6

6. The Emergency Task Force shall establish its rules of procedure ~~including~~, which shall include rules relating to its formation, structure and confidentiality, including potential conflicts of interest. These rules of procedure shall also include rules on the adoption of recommendations. The rules of procedures shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency.

Amendment 586 #

Proposal for a regulation
Article 14 – paragraph 6

6. The Emergency Task Force shall establish its rules of procedure including rules on the adoption of recommendations. The rules of procedure shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency. The agenda and minutes of the Task Force shall be made public through the Agency's online portal.

Amendment 587 #

9a. The Agency shall use traditional and social media to issue periodic communications, agreed by all Member States, to keep the general public informed, using accessible language and providing explanations that can be understood by all;

Amendment 588 #

Proposal for a regulation
Article 15 – paragraph 1

1. During a public health emergency, the Emergency Task Force shall review clinical trial protocols submitted or intended to be submitted in a clinical trial application by developers of medicinal products as part of an accelerated scientific advice process, taking into account possible innovative medicinal products, devices, applications or developments that are still not harmonised throughout the Union, such as plasma-derived products.

Amendment 589 #

Proposal for a regulation
Article 15 – paragraph 3

3. The Emergency Task Force shall establish procedures for the request and submission of the set of information and data required, in~~cluding inform~~ cooperation onwith the Member ~~State or~~ States where an application for authorisation of a clinical trial is submitted or is intended to be submitted in accordance with Article 4 of the Regulation 536/2014 on clinical trials on medicinal products for human use.

Amendment 590 #

Proposal for a regulation
Article 15 – paragraph 4

4. TFor the purposes of this Article, the Emergency Task Force shall involve representatives of the Member State or States where an application for authorisation of a clinical trial is submitted or is intended to be submitted in the preparation of the scientific advice.

Amendment 591 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Nils TORVALDS, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS, Jan HUITEMA

Proposal for a regulation
Article 15 – paragraph 5

5. When authorising a clinical trial application for which scientific advice has been given, Member States shall take that advice duly into account. The scientific advice provided by the Emergency Task Force and endorsed by the Committee for Medicinal Products for Human Use referred to in paragraph 2 shall have no binding force on the opinion of an independent Ethics Committee issued within authorisation of a clinical trial application.

Amendment 592 #

Proposal for a regulation
Article 15 – paragraph 5 a (new)

5 a. Where a clinical trial reviewed as part of an accelerated scientific advice process is authorised, the developer of the clinical trial shall: (a) publish the study protocol at the start of the trial through the European Union clinical trials register; (b) publish the summary of the results of the trial through the European Union clinical trials register by a deadline set by the Agency shorter than that laid down in Article 37 of Regulation (EU) No 536/2014, taking into consideration the public interest and nature of the health emergency.

Amendment 593 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ

Proposal for a regulation
Article 15 – paragraph 5 b (new)

5 b. Where a clinical trial took part in an accelerated scientific advice process and the related medicinal product receives a marketing authorisation, the Agency shall: (a) publish the European Public Assessment Reports in full within 7 days of authorisation by the Commission; (b) publish the clinical data submitted to the Agency in support of the application within two months of authorisation by the Commission, and after personal data have been anonymised and commercially confidential information redacted; (c) publish the Risk Management Plan in full, and any updated version.

Amendment 594 #

Proposal for a regulation
Article 16 – paragraph 1

1. Following the recognition of a public health emergency, the Emergency Task Force shall undertake a review of the available scientific data on human or veterinary medicinal products, which may have the potential to be used to address the public health emergency. The review shall be regularly updated during the public health emergency.

Amendment 595 #

Proposal for a regulation
Article 16 – paragraph 2

2. In preparation of the review, the Emergency Task Force may request information and data from marketing authorisation holders and from developers and engage with them in preliminary discussions. The Emergency Task Force may also, where available, make use of observational studies of health data generated outside of clinical studies taking into account their reliability. The Emergency Task Force shall liaise with medicine agencies of third countries for additional information and data exchange.

Amendment 596 #

Proposal for a regulation
Article 16 – paragraph 2

Amendment 597 #

Proposal for a regulation
Article 16 – paragraph 3 – introductory part

3. Based on a request from one or more Member States, or the Commission, the Emergency Task Force shall provide recommendations to the Committee for Medicinal Products for Human and Veterinary Use for an opinion in accordance with paragraph 4 on the following:

Amendment 598 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Article 16 – paragraph 3 – point a

(a) the compassionate use of medicinal products falling under the scope of Directive 2001/83/EC or Regulation (EC) No 726/2004 and the whole production and distribution chain, as well as the adapted prescription by carers in accordance with Article 83(8) of Regulation (EC) No 726/2004;

Amendment 599 #

4. Following receipt of the recommendation, the Committee for Medicinal Products for Human Use shall adopt an opinion on the conditions for use, the conditions for distribution and the patients targeted. The opinion shall be updated where necessary, and made public on the Agency's web-portal.

Amendment 600 #

Proposal for a regulation
Article 16 – paragraph 6

6. In the preparation of its recommendations provided pursuant to paragraphs 3, the Emergency Task Force may consult the concerned Member State and request it to provide any information and data, which informed the Member State’s decision to make the medicinal product available for compassionate use. Following such a request, the Member State shall provide all of the best available requested information.

Amendment 601 #

Proposal for a regulation
Article 16 – paragraph 7

7. The Agency shall publish the recommendations provided pursuant to paragraph 3 and the opinions adopted pursuant to paragraph 4 including any updates on its web-portal.

Amendment 602 #

Proposal for a regulation
Article 16 – paragraph 7

7. The Agency shall publish the recommendations provided pursuant to paragraph3 and opinions adopted pursuant to paragraph 4 including any updates on its web-portal.

Amendment 603 #

Proposal for a regulation
Article 16 – paragraph 7 a (new)

7 a. Marketing authorisation holders or developers may suggest medicinal products which may have the potential to be used to address the public health emergency. The Emergency Taskforce shall take these suggestions into account and, given that the suggestion is accompanied with sufficient scientific data that the medicinal products have the potential to halt the public health emergency, give an appropriate reaction to the suggestion. The reaction shall be public.

Amendment 604 #

Proposal for a regulation
Article 17 – paragraph 1

The Agency shall, via its web-portal and other appropriate means and, in conjunction with national competent authorities, inform the public and relevant interest groups with regard to the work of the Emergency Task Force, and ensure adequate consultation with the Patients’ and Consumers’ Working Party and the Healthcare Professionals’ Working Party. The list of the members of the Emergency Task Force, the rules of procedure, agendas and minutes of the meetings and recommendations shall be published on the Agency’s web-portal.

Amendment 605 #

Proposal for a regulation
Article 17 – paragraph 1

Amendment 606 #

Proposal for a regulation
Article 17 – paragraph 1

Amendment 607 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Article 17 – paragraph 1

The Agency shall, via its web-portal and other appropriate means and, in conjunction with national competent authorities, inform the public and relevant interest groups with regard to the work of the Emergency Task Force, as well as its decisions, proposals and recommendations to the national and European authorities.

Amendment 608 #

Proposal for a regulation
Article 17 – paragraph 1

The Agency shall, via its web-portal and other appropriate means and, in conjunction with national competent authorities, inform without delay the public and relevant interest groups with regard to the work of the Emergency Task Force, and respond to disinformation as appropriate.

Amendment 609 #

Proposal for a regulation
Article 18 – paragraph 1 – introductory part

To prepare for and support the work related to the reporting and notification obligations defined in this Regulation, as well as the tasks of the Agency bodies established, including of the Emergency Task Force during public health emergencies, the Agency shall:

Amendment 610 #

Proposal for a regulation
Article 18 – paragraph 1 – point a

(a) develop and maintain pan- European interoperable and digitalized electronic tools for the submission of information and data, including electronic health data generated outside the scope of clinical studies, as well as for the harmonised pan-European interoperable and digitalized shortages reporting and notification system, based on ISO IDMP standards for the identification of human medicines and based on a harmonized data collection model with interoperability with SPOR data, as well as on the EUDAMED IT platform for medical devices. Those platforms shall be accessible to relevant authorities at EU and national level to ensure the transparency needed to take actions to prevent and mitigate cross border shortages, as well as to avoid duplications of reporting at different levels;

Amendment 611 #

Proposal for a regulation
Article 18 – paragraph 1 – point a

(a) develop and maintain European- designed electronic tools for the submission of information and data, including electronic health data generated outside the scope of clinical studies, in strict compliance with Union law on personal data and the GDPR;

Amendment 612 #

Proposal for a regulation
Article 18 – paragraph 1 – point a

(a) develop and maintain electronic tools, including an interoperable and digitalized platform, for the submission of information and data, including electronic health data generated outside the scope of clinical studies;

Amendment 613 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Nils TORVALDS, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Article 18 – paragraph 1 – point a

(a) develop and maintain electronic tools for the submission of information and data, including electronic health data generated outside the scope of interventional clinical studies;

Amendment 614 #

Proposal for a regulation
Article 18 – paragraph 1 – point b

(b) coordinate independent ~~vaccine~~utilisation, effectiveness and safety monitoring studies of medicinal products intended to treat, prevent or diagnose a disease using relevant data held by public authorities~~. S~~; for vaccines, such coordination shall be conducted jointly with the European Centre for Disease Prevention and Control and notably through a new vaccine monitoring platform;

Amendment 615 #

Proposal for a regulation
Article 18 – paragraph 1 – point c

Amendment 616 #

Proposal for a regulation
Article 18 – paragraph 1 – point c

(c) as part of its regulatory tasks, make use of digital infrastructures or tools, as referred to in point (a), to facilitate the rapid access to or analysis of available electronic health data generated outside the scope of clinical studies, and the exchange of such data between Member States, the Agency, and other Union bodies;

Amendment 617 #

Proposal for a regulation
Article 18 – paragraph 1 – point c

Amendment 618 #

Proposal for a regulation
Article 18 – paragraph 1 – point c

Amendment 619 #

Proposal for a regulation
Article 18 – paragraph 1 – point d a (new)

(da) develop IT tools interoperable with harmonized shortages reporting systems of National Competent Authorities (NCAs) by building on the existing digital regulatory infrastructure and ongoing projects on data management and implement AI technics to among others forecast crisis development, prepare responses and proactively initiate optimisation of resources management.

Amendment 620 #

Proposal for a regulation
Article 18 – paragraph 1 – point d a (new)

(da) take urgent and appropriate measures to ensure the protection of health data from attacks against information systems. These measures should be built on combination of regular penetration testing, decentralised solutions and security by design principles.

Amendment 621 #

Proposal for a regulation
Article 18 – paragraph 1 – point d a (new)

(da) develop, implement and coordinate an online European platform where consumers, pharmacists, medical professionals and all other European citizens can report shortages of medicinal products or medical devices in any of the Member States;

Amendment 622 #

Proposal for a regulation
Article 18 – paragraph 1 – point d a (new)

Amendment 623 #

Proposal for a regulation
Article 18 – paragraph 1 – point d a (new)

Amendment 624 #

Proposal for a regulation
Article 18 – paragraph 1 – point d a (new)

(da) ensure that it has the necessary resources to secure and protect the data flow within the Agency, and in particular to resist and/or counter cyberattacks and human leaks of documentation;

Amendment 625 #

Proposal for a regulation
Article 18 – paragraph 1 – point d a (new)

(da) build the digital and interoperable database as referred to in Article1(b) and Article 12(g).

Amendment 626 #

Proposal for a regulation
Article 18 – paragraph 1 a (new)

ensure enhanced protection of electronic tools and disseminated data against cyberattacks, deciding in conjunction with the Member States how the data in question can be accessed (users with access, data access period, data retention period);

Amendment 627 #

Proposal for a regulation
Article 18 a (new)

Article 18 a Public information about clinical trials and marketing authorisation decisions 1. For the duration of a public health emergency, the sponsors of clinical trials conducted in the EU shall: (a) publish the study protocol at the start of the trial through the EU clinical trials register; (b) publish the summary of the results through the EU clinical trials register within a timeline set by the Agency that is shorter than the timeline laid down in Article 37 of Regulation (EU) No 536/2014. 2. The Agency shall publish: (a) the European Public Assessment Reports as soon as possible and ideally within seven days of marketing authorisation; (b) the full body of the Risk Management Plan and any updated versions.

Amendment 628 #

Proposal for a regulation
Article 18 a (new)

Article 18 a new Article 19 1. For the duration of a public health emergency, the sponsors of clinical trials conducted in the EU shall: (a) publish the study protocol at the start of the trial through the EU clinical trials register; (b) publish the summary of the results through the EU clinical trials register within a timeline set by the Agency that is shorter than the timeline laid down in Article 37 of Regulation (EU) No 536/2014. 2. The Agency shall publish: (a) the European Public Assessment Reports as soon as possible and ideally within seven days of marketing authorisation; (b) the full body of the Risk Management Plan and any updated versions.

Amendment 629 #

Proposal for a regulation
Article 19 – paragraph 1

1. The Executive Steering Group on Medical Devices (‘the Medical Devices Steering Group’) is hereby established as part of the Agency. It shall meet as often as needed, either in person or remotely, in preparation for or during a public health emergency. The Agency shall provide its secretariat.

Amendment 630 #

Proposal for a regulation
Article 19 – paragraph 2

2. The Medical Devices Steering Group shall be composed of a representative of the Agency, a representative of the Commission and one senior representative per Member State. Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields. The Steering Group shall also include a representative of the Patients’ and Consumers’ Working Party as well as a representative of the Healthcare Professionals’ Working Party as observers. The Agency shall assess the transparency of the undertakings of the Executive Steering Group on Medical Devices, taking into account principles of transparency and accountability.

Amendment 631 #

Proposal for a regulation
Article 19 – paragraph 2

2. The Medical Devices Steering Group shall be composed of a representative of the Agency, a representative of the Commission ~~and~~, one senior representative per Member State, a representative of the Patients' and Consumers' Working Party (PCWP) and a representative of the Healthcare Professionals' Working Party (HCPWP). Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields. The list of members of the Steering Group shall be made public on the Agency web-portal.

Amendment 632 #

Proposal for a regulation
Article 19 – paragraph 2

2. The Medical Devices Steering Group shall be composed of a representative of the Agency, a representative of the Commission and one senior representative per Member State. Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields. The Steering Group shall also include a representative the Patients’ and Consumers’ Working Party and a representative of the Healthcare Professionals’ Working Party.

Amendment 633 #

Proposal for a regulation
Article 19 – paragraph 2

2. The Medical Devices Steering Group shall be composed of a representative of the Agency, a representative of the Commission and one senior representative per Member State. Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields. The Steering Group shall also include a representative the Patients’ and Consumers’ Working Party and a representative of the Healthcare Professionals’ Working Party.

Amendment 634 #

Proposal for a regulation
Article 19 – paragraph 2

2. The Medical Devices Steering Group shall be composed of a representative of the Agency, a representative of the Commission and one senior representative per Member State, including one alternate in case of unforeseen circumstances. Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields.

Amendment 635 #

Proposal for a regulation
Article 19 – paragraph 2 a (new)

2 a. Members of the Medical Devices Steering Group 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 industry shall be entered in a register held by the Agency and be accessible to the public, upon request.

Amendment 636 #

Proposal for a regulation
Article 19 – paragraph 3

3. The Medical Devices Steering Group shall be chaired by the Agency. The Chair may invite third parties, including representatives of medical device interest groups ~~to attend its meeting~~, any other entity in the relevant pharmaceutical supply chain, healthcare professionals and patients’ associations, to attend its meetings to ensure transparent and effective dialogue between all stakeholders in the supply chain and the relevant authorities.

Amendment 637 #

Proposal for a regulation
Article 19 – paragraph 3

3. The Medical Devices Steering Group shall be chaired by the Agency. The Chair may invite third parties, including representatives of medical device interest groups to attend its meetings ensuring the sharing of information by the Patients’ and Consumers’ Working Party as well as a representative of the Healthcare Professionals’ Working Party as observers.

Amendment 638 #

Proposal for a regulation
Article 19 – paragraph 3

3. The Medical Devices Steering Group shall be chaired by the Agency. ~~The Chair may~~All members of the Medicines Steering Group may propose to the Chair to invite third parties, including representatives of medical device interest groups ~~to attend its meetings~~, in particular healthcare professionals, consumers and patients, to attend its meetings when their contribution may inform the discussions of the Steering Group.

Amendment 639 #

Proposal for a regulation
Article 19 – paragraph 3

3. The Medical Devices Steering Group shall be chaired by the Agency. The Chair may invite third parties, including representatives of medical device interest groups and representatives of patients, consumers and healthcare professionals to attend its meetings.

Amendment 640 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS, Ondřej KNOTEK

Proposal for a regulation
Article 19 – paragraph 3

Amendment 641 #

Proposal for a regulation
Article 19 – paragraph 3

3. The Medical Devices Steering Group shall be chaired by the Agency. The Chair may invite third parties, including representatives of medical device interest groups, representatives of patients and healthcare professionals, to attend its meetings.

Amendment 642 #

Proposal for a regulation
Article 19 – paragraph 3 a (new)

3a. The Medical Devices Steering Group shall regularly invite representatives of medicinal product interest groups and marketing authorisation holders, as well as other stakeholders in the pharmaceutical industry, to discuss the situation of drug production in Europe and worldwide. On the basis of these exchanges, the Medical Devices Steering Group shall draw up strategic recommendations which it shall address to the Member States during the public health emergency period.

Amendment 643 #

Proposal for a regulation
Article 19 – paragraph 4

4. The Medical Devices Steering Group shall establish its rules of procedure including procedures relating to the working party referred to in paragraph 5, and on the adoption of lists, sets of information and recommendations. The rules of procedures shall enter into force after receiving a favourable opinion from the Commission and the Management Board of the Agency. Agendas and minutes of the Steering Group as well as the rules of procedure and recommendations should be made available to the public via the Agency web-portal.

Amendment 644 #

Proposal for a regulation
Article 19 – paragraph 5

5. The Medical Devices Steering Group shall be supported in its work by a working party comprised of single points of contact from national, and where applicable regional, competent authorities for medical devices established in accordance with Article 23(1).

Amendment 645 #

Proposal for a regulation
Article 19 – paragraph 5

5. The Medical Devices Steering Group ~~shall~~may be supported in its work by a working party comprised of single points of contact from national competent authorities for medical devices established in accordance with Article 23(1).

Amendment 646 #

Proposal for a regulation
Article 19 – paragraph 5 a (new)

5 a. The Medical Devices Steering Group will establish the basis for strengthened cooperation with national health authorities and the pharmaceutical industry.

Amendment 647 #

Proposal for a regulation
Article 19 – paragraph 6 a (new)

6 a. The members of the Medicines Steering Group must have no financial or other interests that could affect their impartiality. The list of members shall be published on the Agency website.

Amendment 648 #

Proposal for a regulation
Article 19 – paragraph 6 a (new)

6 a. The members of the Medicines Steering Group must have no financial or other interests that could affect their impartiality. The list of members shall be published on the Agency website.

Amendment 649 #

Proposal for a regulation
Article 20 – paragraph 1

1. Immediately following the recognition of a public health emergency and after consultation of its working party, the Medical Devices Steering Group, after consulting marketing authorisation holders and representatives of stakeholders in the sector, shall adopt a list of medical devices which it considers as critical during the public health emergency (‘the public health emergency critical devices list’). The list shall be updated whenever necessary until the termination of the recognition of the public health emergency, and shall cease to apply at the end of the public health emergency.

Amendment 650 #

Proposal for a regulation
Article 20 – paragraph 1

1. Immediately following the recognition of a public health emergency and after consultation of its working party, the Medical Devices Steering Group, in coordination with stakeholders in the sector, shall adopt a list of medical devices which it considers as critical during the public health emergency (‘the public health emergency critical devices list’). The list shall be updated whenever necessary until the termination of the recognition of the public health emergency.

Amendment 651 #

Proposal for a regulation
Article 20 – paragraph 1

1. Immediately following the recognition of a public health emergency and after consultation of its working party, the Medical Devices Steering Group shall adopt a list of medical devices which it considers as critical during the public health emergency (‘the public health emergency critical devices list’) as well as minimum necessary stock levels. The list shall be updated whenever necessary until the termination of the recognition of the public health emergency.

Amendment 652 #

Proposal for a regulation
Article 20 – paragraph 2

2. The Medical Devices Steering Group shall adopt a set of information necessary to only monitor ~~the supply and demand~~data for the long-term safety assessment of medical devices included on the public health emergency critical devices list ~~and inform its working party thereof~~.

Amendment 653 #

Proposal for a regulation
Article 20 – paragraph 3

3. The Agency shall publish the public health emergency critical devices list and any updates to that list on its web-portal. This list shall be published in a clear and accessible way so that Member States, actors in the pharmaceutical supply chain and all stakeholders can easily access this information and, where appropriate, can easily report possible changes or publication problems.

Amendment 654 #

Proposal for a regulation
Article 20 – paragraph 3 a (new)

3a. The Agency, in cooperation with the Commission and the national competent authorities of the Member States, shall work with representatives of the European medical device industry to ensure that medical devices included on the critical devices list made available in one Member State are equally available in all Member States, in one form or another, and in particular in smaller Member States.

Amendment 655 #

Proposal for a regulation
Article 20 – paragraph 3 a (new)

3 a. The Agency shall report about the shortage of public health emergency critical devices through the database referred to in Article 6 (4a).

Amendment 656 #

Proposal for a regulation
Article 20 – paragraph 3 a (new)

3 a. The Agency shall report about the shortage of public health emergency critical devices through the database referred to in Article 6(5).

Amendment 657 #

Proposal for a regulation
Article 20 – paragraph 3 a (new)

3 a. The Agency shall report about the shortage of public health emergency critical devices through the database referred to in Article 6(5).

Amendment 658 #

Proposal for a regulation
Article 21 – paragraph 1

1. On the basis of the public health emergency critical devices list and the information and data provided in accordance with Articles 24 and 25 of this Regulation, the Medical Devices Steering Group shall meet regularly throughout the major event or public health emergency with the working group of designated national contact points for medicines shortages within the national competent authorities for medicines and with representatives of the medicines production and distribution sectors in order to monitor supply and demand of medical devices included on that list with a view to identifying any potential or actual shortages of those medical devices and to adapt the list as best as possible throughout the major event or emergency. As part of that monitoring, the Medical Devices Steering Group shall liaise, where relevant, with the Health Security Committee established in Article 4 of Regulation (EU) 2020/[…]22[1] and the Advisory Committee on public health emergencies established pursuant to Article 24 of that Regulation. _________________ 22[1] [insérert r~~efe~~éférence ~~to adopted text referred to in footnot~~au texte adopté mentionné à la note de bas de page 4]

Amendment 659 #

Proposal for a regulation
Article 21 – paragraph 1

1. On the basis of the public health emergency critical devices list and the information and data provided in accordance with Articles 24 and 25, the Medical Devices Steering Group shall ~~monitor supply and demand of~~update the medical devices included on thate list compiled by the Medical Device Coordination Group (MDCG) with a view to identifying any potential or actual shortages of those medical devices. As part of that monitoring, the Medical Devices Steering Group shall liaise, where relevant, with the Health Security Committee established in Article 4 of Regulation (EU) 2020/[…]22 and the Advisory Committee on public health emergencies established pursuant to Article 24 of that Regulation. _________________ 22 [insert reference to adopted text referred to in footnote 4]

Amendment 660 #

Proposal for a regulation
Article 21 – paragraph 2

2. As part of the monitoring, the Medical Devices Steering Group may also make use of data from device registries and databanks where such data is available to the Agency. In so doing, the Medical Devices Steering Group shall take into account the data generated pursuant to Article 108 of Regulation (EU) 2017/745 and Article 101 of Regulation (EU) 2017/746.deleted

Amendment 661 #

Proposal for a regulation
Article 22 – paragraph 1

1. For the duration of the public health emergency, the Medical Devices Steering Group shall regularly report the results of its monitoring to the Commission, national public health authorities and the sub- network referred to in Article 23(1)(b), and, in particular, signal any potential or actual shortages of medical devices included on the public health emergency critical devices list.

Amendment 662 #

Proposal for a regulation
Article 22 – paragraph 2

2. Where requested by the Commission, one or more national public health authorities or the sub-network referred to in Article 23(2)(b), the Medical Devices Steering Group shall provide aggregated data and forecasts of demand to support its findings. In that regard, the Steering Group shall liaise with the European Centre for Disease Prevention and Control to obtain epidemiological data to help forecast medical device needs, and with the Medicines Steering Group referred to in Article 3 where medical devices included on the public health emergency critical devices list are used to jointly with a medicinal product.

Amendment 663 #

Proposal for a regulation
Article 22 – paragraph 3

3. As part of the reporting referred to in paragraphs 1 and 2, the Medical Devices Steering Group may also provide recommendations on measures, which may be taken by the Commission, Member States, medical device manufacturers, notified bodies and other entities to prevent or mitigate potential or actual shortages. In that regard the Group shall liaise, where relevant, with the Health Security Committee and the Advisory Committee on public health emergencies.deleted

Amendment 664 #

Proposal for a regulation
Article 22 – paragraph 4

4. The Medical Devices Steering Group may, on its own initiative or upon request from the Commission, provide recommendations on measures which may be taken by the Commission, Member States, medical device manufacturers, notified bodies and other entities to ensure preparedness to deal with potential or actual shortages of medical devices caused by public health emergencies.deleted

Amendment 665 #

Proposal for a regulation
Article 22 – paragraph 5

5. The Medical Devices Steering 5. Group may, upon request from the Commission coordinate measures, where relevant, between the national, and where applicable regional, competent authorities, manufacturers of medical devices, notified bodies, and other entities to prevent or mitigate potential or actual shortages in the context of a public health emergency.

Amendment 666 #

Proposal for a regulation
Article 22 – paragraph 5 a (new)

Amendment 667 #

Proposal for a regulation
Article 23 – paragraph 1 – introductory part

1. In order to prepare for fulfilling the tasks referred to in Articles 20, 21, and 22, and after consulting representatives of national authorities and marketing authorisation holders, as well as other stakeholders in the pharmaceutical sector, the Agency shall:

Amendment 668 #

Proposal for a regulation
Article 23 – paragraph 1 – point a

(a) specify the procedures for establishing the public health emergency critical devices list, ensuring adequate consultation with healthcare professionals, consumers, patients and a high level of transparency indecision- making;

Amendment 669 #

Proposal for a regulation
Article 23 – paragraph 1 – point a

(a) specify the procedures for establishing the public health emergency critical devices list, ensuring adequate consultation with consumers, patients and healthcare professionals and a high level of transparency;

Amendment 670 #

Proposal for a regulation
Article 23 – paragraph 1 – point a

Amendment 671 #

Proposal for a regulation
Article 23 – paragraph 1 – point a

Amendment 672 #

Proposal for a regulation
Article 23 – paragraph 1 – point a

(a) specify the procedures and criteria for establishing the public health emergency critical devices list;

Amendment 673 #

Proposal for a regulation
Article 23 – paragraph 1 – point b

(b) develop streamlined electronic monitoring and reporting systems, including for existing or potential stock levels;

Amendment 674 #

Proposal for a regulation
Article 23 – paragraph 1 – point c

(c) establish and maintain membership of the working party referred to in Article 19(5) comprised of single points of contact from Member States’ national, and where applicable regional, competent authorities for medical devices;

Amendment 675 #

Proposal for a regulation
Article 23 – paragraph 1 – point d

~~(d) establish and maintain a list of single points of contact from medical device manufacturers, authorised representatives and notified bodies;~~deleted

Amendment 676 #

Proposal for a regulation
Article 23 – paragraph 2 – point a

Amendment 677 #

Proposal for a regulation
Article 23 – paragraph 2 – point c

(c) request information from the single points of contact from Member States’ national, and where applicable regional, competent authorities based on the set of information agreed on by the Medical Devices Steering Group and set a deadline for its submission.

Amendment 678 #

Proposal for a regulation
Article 23 – paragraph 3 – point e

~~(e) sales and market share data;~~deleted

Amendment 679 #

Proposal for a regulation
Article 23 – paragraph 3 – point e

(e) sales, stock, where relevant, and market share data;

Amendment 680 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Nils TORVALDS, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Article 23 – paragraph 3 – point f

(f) prevention and mitigation plans including production and supply capacity; such plans shall contain preventative measures that help ensure the continued supply of critical medical devices;

Amendment 681 #

Proposal for a regulation
Article 23 – paragraph 3 – point f

(f) mitigation plans including production and supply capacity, with a view to guarantee continued supply and prevent shortages of medicinal products included on the critical medicines lists;

Amendment 682 #

Proposal for a regulation
Article 23 – paragraph 3 – point f

(f) mitigation plans including production and supply capacity; these plans shall contain preventative measures that help ensure the continued supply of critical medical devices;

Amendment 683 #

Proposal for a regulation
Article 23 – paragraph 3 – point f

(f) mitigation plans including production and supply capacity; these plans shall contain preventative measures that help ensure the continued supply of critical medical devices;

Amendment 684 #

Proposal for a regulation
Article 23 – paragraph 3 – point f

(f) mitigation plans, containing preventative measures to ensure the continued supply of critical medical devices as well as including production and supply capacity;

Amendment 685 #

Proposal for a regulation
Article 23 – paragraph 3 – point f

(f) mitigation plans including production and supply capacity, so as to ensure the minimum stock levels required;

Amendment 686 #

Proposal for a regulation
Article 23 – paragraph 3 – point f

(f) prevention and mitigation plans including production and supply capacity;

Amendment 687 #

Proposal for a regulation
Article 24 – paragraph 1

1. In order to facilitate the monitoring referred to in Article 21 and following a request from the Agency, medical device manufacturers of the medical devices included on the public health emergency critical devices list, and all distributors legally authorised to supply medical devices to the public and, where necessary, concerned notified bodies, shall submit the information requested by the deadline set by the Agency. They shall submit the information requested through the points of contact designated in accordance with Article 23(2) and using the reporting methods and system established pursuant to Article 23(1). They shall provide updates wherever necessary.

Amendment 688 #

Proposal for a regulation
Article 24 – paragraph 4

4. Where manufacturers of medical devices included on the public health emergency critical devices list and concerned notified bodies are in possession of any additional information, which provides evidence of a potential or actual shortage, they shall immediately provide such information to the Agency.deleted

Amendment 689 #

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

6 a. The Commission and Member States shall lay down rules on sanctions for non-compliance with the obligations established under this Article. These sanctions shall be dissuasive.

Amendment 690 #

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

6 a. The Commission and Member States shall lay down rules on sanctions for non-compliance with the obligations established under this Article. These sanctions shall be dissuasive.

Amendment 691 #

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

6 a. The Commission shall exercise its power to lay down rules on sanctions for non-compliance with the obligations established under this Article in a delegated act.

Amendment 692 #

Proposal for a regulation
Article 25 – paragraph 1 – introductory part

1. In order to facilitate the monitoring referred to in Article 21 and following a request from the Agency, Member States or any national competent authority shall, by the deadline set by the Agency:

Amendment 693 #

Proposal for a regulation
Article 25 – paragraph 1 – point b

(b) indicate the existence of any commercially confidential information, and, clarify the reasons for such an indication, in accordance with Article 30 of this Regulation;

Amendment 694 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS, Ondřej KNOTEK

Proposal for a regulation
Article 25 – paragraph 1 – point c a (new)

(ca) regional authorities with devolved health policy competences shall also comply with Article 25 and provide this information both to the national competent authority and to the Agency.

Amendment 695 #

Proposal for a regulation
Article 25 – paragraph 4 – point a

(a) consider the need to provide for temporary exemptions at Member State level pursuant to Article 59(1) of Regulation (EU) 2017/745 or Article 54(1) of Regulation (EU) 2017/746 with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list, while at the same time ensuring a high level of patient and product safety;

Amendment 696 #

Proposal for a regulation
Article 25 – paragraph 4 – point a

(a) consider the need to provide for temporary exemptions at Member State level pursuant to Article 59(1) of Regulation (EU) 2017/745 or Article 54(1) of Regulation (EU) 2017/746 with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list, while at the same time ensuring both patient and product safety;

Amendment 697 #

Proposal for a regulation
Article 25 – paragraph 4 – point a

(a) consider the need to provide for temporary exemptions at Member State level pursuant to Article 59(1) of Regulation (EU) 2017/745 or Article 54(1) of Regulation (EU) 2017/746 with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list, while at the same time ensuring both patient and product safety;

Amendment 698 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS, Ondřej KNOTEK

Proposal for a regulation
Article 25 – paragraph 4 – point a

Amendment 699 #

Proposal for a regulation
Article 26 – paragraph 1 – point a

(a) take all necessary action within the limits of the powers conferred on it, with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list, including, where necessary, granting temporary exemptions at Union level pursuant to Article 59(3) of Regulation (EU) 2017/745 or Article 54(3) of Regulation (EU) 2017/746, while at the same time ensuring a high level of patient and product safety;

Amendment 700 #

Proposal for a regulation
Article 26 – paragraph 1 – point a

(a) take all necessary action within the limits of the powers conferred on it, with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list, including, where necessary, granting temporary exemptions at Union level pursuant to Article 59(3) of Regulation (EU) 2017/745 or Article 54(3) of Regulation (EU) 2017/746, while at the same time ensuring both patient and product safety;

Amendment 701 #

Proposal for a regulation
Article 26 – paragraph 1 – point a

(a) take all necessary action within the limits of the powers conferred on it, with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list, including, where necessary, granting temporary exemptions at Union level pursuant to Article 59(3) of Regulation (EU) 2017/745 or Article 54(3) of Regulation (EU) 2017/746, while at the same time ensuring both patient and product safety;

Amendment 702 #

Proposal for a regulation
Article 26 – paragraph 1 – point a

Amendment 703 #

Proposal for a regulation
Article 26 – paragraph 1 – point b

(b) consider the need for guidelines addressed to Member States, medical device manufacturers, notified bodies and other entities where this is proportionate, justified and necessary;

Amendment 704 #

Proposal for a regulation
Article 26 – paragraph 1 – point d a (new)

(da) work in conjunction with the European Centre for Disease Prevention and Control (ECDC) to categorise and establish different priority levels for the medicinal products identified as critical.

Amendment 705 #

Proposal for a regulation
Article 27 – paragraph -1 (new)

-1 The Agency shall establish an early warning system to inform relevant stakeholders, including healthcare professionals of any supply problems and potential or actual shortages of medicinal products included on the critical products list.

Amendment 706 #

Proposal for a regulation
Article 27 – paragraph 1

The Agency shall, via its web-portal and other appropriate means and, in conjunction with national competent authorities, inform the public and relevant interest groups with regard to the work of the Medical Devices Steering Group, and ensure adequate consultation with the Patients’ and Consumers’ Working Party and the Healthcare Professionals’ Working Party. The list of the members of the Medical Devices Steering Group, the rules of procedure, agendas and minutes of the meetings and recommendations shall be published on the Agency’s web-portal.

Amendment 707 #

Proposal for a regulation
Article 27 – paragraph 1

Amendment 708 #

Proposal for a regulation
Article 27 – paragraph 1

Amendment 709 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Article 27 – paragraph 1

Amendment 710 #

Proposal for a regulation
Article 27 – paragraph 1

The Agency shall, via its web-portal and other appropriate means and, in conjunction with national competent authorities, inform without delay the public and relevant interest groups with regard to the work of the Medical Devices Steering Group, and respond to disinformation.

Amendment 711 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Article 28 – paragraph 1 – introductory part

The Agency shall, on behalf of the Commission, ~~from 1 March 2022 onwards,~~ provide the secretariat of the expert panels designated in accordance with Implementing Decision (EU) 2019/1396 and provide the support necessary to ensure that those panels can efficiently perform their tasks as set out in Article 106(9) and (10) of Regulation (EU) 2017/745. The Agency shall:

Amendment 712 #

Amendment 713 #

Proposal for a regulation
Article 28 – paragraph 1 – point a

(a) provide administrative, scientific and technical support to the expert panels for the provision of scientific opinions, views and advice;

Amendment 714 #

1 a. The purpose of this Regulation is to increase cooperation between the European Medicines Agency, the European Commission, the Member States and stakeholders. Highlights that under no circumstances this Regulation should establish a sanctions regime.

Amendment 715 #

Margarita DE LA PISA CARRIÓN, Joanna KOPCIŃSKA

Proposal for a regulation
Article 29 – paragraph 3

3. In agreement with the Chairs, ~~joint meetings of~~ the Medicines and Medical Devices Steering Groups ~~may be held~~shall be maintained and deployed beyond crisis situations for the management of medicines shortage, ensuring proportionality of their actions compared to emergency situations.

Amendment 716 #

Proposal for a regulation
Article 29 – paragraph 3 a (new)

3 a. The Commission shall carry out an impact assessment prior to the entry into force of this Regulation.

Amendment 717 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Article 29 a (new)

Article 29 a Transparency and publication of clinical data 1. For the duration of a public health emergency, the sponsors of clinical trials related to products linked to the disease in question, shall: (a) publish the study protocol at the start of the trial through the EU clinical trials register; (b) publish the summary of the results through the EU clinical trials register within two months after marketing authorisation. 2. The Agency shall implement exceptional measures with regard to medicinal products, including vaccines, and medical devices falling under the scope of this Regulation, strengthening transparency measures and speeding up standard publication timelines and providing more information. These measures include: (a) Publication of the product information with details of the conditions of use at the time of marketing authorisation; (b) Expedited publication of the full European Public Assessment Reports (EPAR), within 7days after marketing authorisation. The EPARs should include a description of received scientific advice; (c) Expedited publication, within a period of 2 months after marketing authorisation, of clinical data submitted to the Agency in support of the applications for medicines, after personal data have been anonymised and any commercially confidential information redacted. Access shall be provided to all independent individual participant level data along with protocols and analytic codes; (d) Publication of the full risk management plan for authorised medicines; (e) Publication of news announcements within 1 day of the start of initial rolling reviews or the evaluation of new evidence or applications for extension of indication. 3. The Agency shall make agendas and minutes of all meetings public, as well as the recommendations, opinions and decisions from the Steering Groups and the Emergency Task Force on its web- portal. 4. The membership of the Emergency Task Force, Steering Groups and Working Parties shall be made public. Members of the Emergency Task Force, Steering Groups and experts shall not have financial or other interests in the pharmaceutical or medical device industry which could affect their impartiality. They shall act in the public interest in an independent manner and shall make an annual declaration of their financial interests. All indirect interests which could relate to the industry shall be entered in a register held by the Agency, which is accessible to the public, upon request. Members of the Emergency Task Force, Steering Groups and Working Parties, and experts who participate in meetings or working groups of the Agency shall declare, at each meeting, any specific interests which could be considered to be prejudicial to their independence with respect to the items on the agenda. These declarations shall be made available to the public.

Amendment 718 #

Proposal for a regulation
Article 29 a (new)

Article 29 a Protection against cyber-attacks The Agency shall be equipped with a high level of security controls and processes against cyber-attacks to ensure the normal functioning of the Agency at all time, and especially during public health emergencies and major events at Union level. To that end, the Agency shall actively pursue and implement best cybersecurity practices within Union institutions and bodies to prevent, detect, mitigate, and respond to cyber-attacks.

Amendment 719 #

Proposal for a regulation
Article 30 – title

Confidentiality and data privacy

Amendment 720 #

Proposal for a regulation
Article 30 – paragraph 1 – introductory part

1. Unless otherwise provided for in this Regulation and without prejudice to Regulation (EC) No 1049/200124 and on the legal protection of persons who report breaches of Union law, and existing national provisions and practices in the Member States on confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following: _________________ 24Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents, OJ L 145, 31.05.2001, p. 43

Amendment 721 #

Proposal for a regulation
Article 30 – paragraph 1 – introductory part

1. Unless otherwise provided for in this Regulation and without prejudice to Regulation (EC) No 1049/200124 and all existing national provisions and practices in the Member States on confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following: _________________ 24Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents, OJ L 145, 31.05.2001, p. 43

Amendment 722 #

Proposal for a regulation
Article 30 – paragraph 1 – point a

(a) personal data in accordance with ~~Article 32~~the definitions contained in Article 4(1) of Regulation (EU) 2016/679 (GDPR) and Article3(1) of Regulation (EU) 2018/1725 (EUDPR);

Amendment 723 #

Proposal for a regulation
Article 30 – paragraph 1 – point a

(a) personal data ~~in accordance with Article 32~~as defined in Article 4(1) of the GDPR;

Amendment 724 #

Proposal for a regulation
Article 30 – paragraph 1 – point b

(b) commercially confidential information and trade secrets of a natural or legal person, in~~cluding intellectual property rights~~ accordance with Directive 2016/943 and without prejudice to Directive 2019/1937, as well as intellectual property rights, unless there is an overriding public interest in disclosure;

Amendment 725 #

Proposal for a regulation
Article 30 – paragraph 1 – point b

(b) commercially confidential information and trade secrets of a natural or legal person, including intellectual property rights, unless there is an overriding public interest in disclosure.;

Amendment 726 #

Proposal for a regulation
Article 30 – paragraph 1 – point b

(b) commercially confidential information and trade secrets of a natural or legal person, including intellectual property rights, unless there is an overriding public interest in disclosure;

Amendment 727 #

Proposal for a regulation
Article 30 – paragraph 5

5. The Commission, the Agency, and the Member States may exchange commercially confidential information and, where necessary to protect public health, anonymised and aggregated personal and sensitive personal data, with regulatory authorities of the third countries with which they have concluded bilateral or multilateral confidentiality arrangements.

Amendment 728 #

Proposal for a regulation
Article 30 – paragraph 5

5. The Commission, the Agency, and Member States may, in compliance with Chapter V of the EUDPR, exchange commercially confidential information and, where necessary to protect public health, personal data, with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.

Amendment 729 #

Proposal for a regulation
Article 30 – paragraph 5

5. The Commission, the Agency, and Member States may exchange commercially confidential information and, where necessary to protect public health, anonymised and aggregated sensitive personal data, with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.

Amendment 730 #

Proposal for a regulation
Article 30 – paragraph 5 a (new)

5 a. All parties involved in the application of this Regulation shall ensure that the concept of commercially confidential information is interpreted narrowly, and information of public interest is, to the extent possible, proactively disclosed.

Amendment 731 #

Proposal for a regulation
Article 30 – paragraph 5 a (new)

Amendment 732 #

Proposal for a regulation
Article 30 – paragraph 5 a (new)

Amendment 733 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Article 30 – paragraph 5 b (new)

5 b. 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 the Agency and the Commission relating to their processing of personal data under Regulation (EU) No 2018/1725, when fulfilling their responsibilities.

Amendment 734 #

Proposal for a regulation
Article 31 – title

31 Entry into Force and date of application

Amendment 735 #

Frédérique RIES, Véronique TRILLET-LENOIR, Nicolae ŞTEFĂNUȚĂ, Susana SOLÍS PÉREZ, Andreas GLÜCK, Martin HOJSÍK, María Soraya RODRÍGUEZ RAMOS

Proposal for a regulation
Article 31 – title

31 Entry into Force and application

Amendment 736 #

Proposal for a regulation
Article 31 – paragraph 1 a (new)

Chapters IV shall apply from… [date of entry into force + 12 months].

Amendment 737 #