12 Amendments of Carlo CALENDA related to 2020/0321(COD)
Amendment 139 #
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 demandpatients' needs for that medicinal product or medical device at national level;
Amendment 146 #
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 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 164 #
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 on any event, including apotential shortage of a medicinal product in a given Member State, that is likely to leadjeopardise a timely and appropriate response 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 176 #
Proposal for a regulation
Article 6 – paragraph 4
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 182 #
Proposal for a regulation
Article 7 – paragraph 1
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 238 #
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The permanent Emergency Task Force is hereby established as part of the Agency. It shall be convened dureither ing 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 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 276 #
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 demandpatients’ needs for that medicinal product or medical device at national level;
Amendment 288 #
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 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 356 #
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 on any event, including apotential shortage of a medicinal product in a given Member State, that is likely to leadjeopardise a timely and appropriate response 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 388 #
Proposal for a regulation
Article 6 – paragraph 4
Article 6 – paragraph 4
4. The Agency shall immediately publishmake available the critical medicines lists and any updates to those lists on its web-portal referred to in Article 26 of Regulation (EC) No 726/2004to the representatives of the Member States and the Commission.
Amendment 404 #
Proposal for a regulation
Article 7 – paragraph 1
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 561 #
Proposal for a regulation
Article 14 – paragraph 1
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.