Activities of Aldo PATRICIELLO related to 2020/0321(COD)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices
Amendments (64)
Amendment 65 #
Proposal for a regulation
Recital 1 a (new)
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 #
Proposal for a regulation
Recital 2
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 70 #
Proposal for a regulation
Recital 3
Recital 3
(3) The often complex supply chains of medicinal products and medical devices, national export restrictions and bans, border closures impedCOVID-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 significantUnion’s ability to rapidly and effectively react to such challenges during public health crises, also due to the lack of implediments to the smooth funcationing of the single market and to addressing the serious threats to public health across the Unionsustainable economic, regulatory and industrial policy reforms needed.
Amendment 76 #
Proposal for a regulation
Recital 6
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 82 #
Proposal for a regulation
Recital 9
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 88 #
Proposal for a regulation
Recital 13
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 91 #
Proposal for a regulation
Recital 15
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 shouldall establish 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.
Amendment 96 #
Proposal for a regulation
Recital 19
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 107 #
Proposal for a regulation
Recital 25
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 112 #
Proposal for a regulation
Recital 26
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 115 #
Proposal for a regulation
Recital 2
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 118 #
Proposal for a regulation
Recital 27
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 #
Proposal for a regulation
Recital 28
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 123 #
Proposal for a regulation
Recital 31 a (new)
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 2 a (new)
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 126 #
Proposal for a regulation
Recital 2 b (new)
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)
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)
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 132 #
Proposal for a regulation
Article 2 – paragraph 1 – point a
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 138 #
Proposal for a regulation
Article 2 – paragraph 1 – point d
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 productpatient and healthcare actor’s needs at national level for a period orf medical device;ore than two weeks.
Amendment 141 #
Proposal for a regulation
Article 2 – paragraph 1 – point f
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 141 #
Proposal for a regulation
Recital 5
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 153 #
Proposal for a regulation
Article 3 – paragraph 3
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 163 #
Proposal for a regulation
Article 4 – paragraph 2
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) pro-actively and with the shortest delay, 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 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 163 #
Proposal for a regulation
Recital 9
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 168 #
Proposal for a regulation
Recital 10
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 175 #
Proposal for a regulation
Recital 11 a (new)
Recital 11 a (new)
Amendment 181 #
Proposal for a regulation
Recital 13
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 184 #
Proposal for a regulation
Article 8 – paragraph 1
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 191 #
Proposal for a regulation
Recital 15
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 197 #
Proposal for a regulation
Article 9 – paragraph 1 – point c
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 205 #
Proposal for a regulation
Article 9 – paragraph 1 – point e
Article 9 – paragraph 1 – point e
(e) establish and maintain a list ofupdate 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 210 #
Proposal for a regulation
Recital 25
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 diuse 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 serviccrisis 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 datathe EUDAMED IT platform for medical devices.
Amendment 218 #
Proposal for a regulation
Recital 26 a (new)
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 222 #
Proposal for a regulation
Recital 27
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 237 #
Proposal for a regulation
Article 13 – paragraph 1
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, advices and findings of the Medicines Steering Group.
Amendment 245 #
Proposal for a regulation
Article 1 – paragraph 1 – point a
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 14 – paragraph 2 – point e
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 #
Proposal for a regulation
Article 1 – paragraph 1 – point a – point i (new)
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 255 #
Proposal for a regulation
Article 14 – paragraph 9
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 261 #
Proposal for a regulation
Article 15 – paragraph 6
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 265 #
Proposal for a regulation
Article 16 – paragraph 1
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 272 #
Proposal for a regulation
Article 2 – paragraph 1 – point d
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 produpatient and healthcare act or medical devices’ needs;
Amendment 296 #
Proposal for a regulation
Article 2 – paragraph 1 – point f a (new)
Article 2 – paragraph 1 – point f a (new)
Amendment 306 #
Proposal for a regulation
Article 2 – paragraph 1 a (new)
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 320 #
Proposal for a regulation
Article 30 – paragraph 1 – point a
Article 30 – paragraph 1 – point a
(a) personal data in accordance with Article 32the definition contained in the Article 4 of GDPR and Article 3(1) EUDPR;
Amendment 352 #
Proposal for a regulation
Article 4 – paragraph 2
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 onupload 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 Agencyuploads 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 451 #
Proposal for a regulation
Article 9 – paragraph 1 – point c
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 461 #
Proposal for a regulation
Article 9 – paragraph 1 – point e
Article 9 – paragraph 1 – point e
(e) establish and maintain a list ofupdate the Article57(1)(l) of Regulation 726/2004 database by including the industry single points of contact from marketing authorisation (iSPOC); this database shoulders 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 497 #
Proposal for a regulation
Article 10 – paragraph 1
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 theupload the additional information referred to in Article 9(3) by the deadline set by the Agency. They shall submit thein 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 502 #
Proposal for a regulation
Article 10 – paragraph 2
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 504 #
Proposal for a regulation
Article 10 – paragraph 3
Article 10 – paragraph 3
3. Marketing authorisation holders shall justify the absence of any requested information and any delays in providing it byof 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 ideadline set by the Agencntification of human medicines. Those marketing authorisation holders shall update their submission wherever necessary.
Amendment 521 #
Proposal for a regulation
Article 11 – paragraph 1 – introductory part
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 524 #
Proposal for a regulation
Article 11 – paragraph 1 – point a
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 528 #
Proposal for a regulation
Article 11 – paragraph 2
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., when not yet available or accessible in the harmonised pan-European interoperable and digitalized shortages reporting and notification system
Amendment 531 #
Proposal for a regulation
Article 11 – paragraph 3
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 536 #
Proposal for a regulation
Article 12 – paragraph 1 – introductory part
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 546 #
Proposal for a regulation
Article 12 – paragraph 1 – point b
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 549 #
Proposal for a regulation
Article 12 – paragraph 1 – point c
Article 12 – paragraph 1 – point c
(c) inform the Medicines Steering Group and industry of any measures taken and report on the results;
Amendment 571 #
Proposal for a regulation
Article 14 – paragraph 2 – point e a (new)
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 609 #
Proposal for a regulation
Article 18 – paragraph 1 – introductory part
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
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 616 #
Proposal for a regulation
Article 18 – paragraph 1 – point c
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 715 #
Proposal for a regulation
Article 29 – paragraph 3
Article 29 – paragraph 3
3. In agreement with the Chairs, joint meetings of the Medicines and Medical Devices Steering Groups may be heldshall be maintained and deployed beyond crisis situations for the management of medicines shortage, ensuring proportionality of their actions compared to emergency situations.