11 Amendments of Patrizia TOIA related to 2020/0321(COD)
Amendment 110 #
Proposal for a regulation
Recital 25 a (new)
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 122 #
(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 125 #
Proposal for a regulation
Recital 31 b (new)
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 136 #
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 patient and healthcare actors’ needs for that medicinal product or medical device at national level;
Amendment 144 #
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 157 #
Proposal for a regulation
Article 3 – paragraph 5
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 179 #
Proposal for a regulation
Article 7 – paragraph 1
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 194 #
Proposal for a regulation
Article 9 – paragraph 1 – introductory part
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 200 #
Proposal for a regulation
Article 9 – paragraph 1 – point c
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 207 #
Proposal for a regulation
Article 9 – paragraph 2 – point a
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 239 #
Proposal for a regulation
Article 14 – paragraph 1
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.