10 Amendments of Izaskun BILBAO BARANDICA related to 2020/0321(COD)
Amendment 79 #
Proposal for a regulation
Recital 7
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 196 #
Proposal for a regulation
Article 9 – paragraph 1 – point a
Article 9 – paragraph 1 – point a
(a) specify the criteria and procedures for establishing the critical medicines lists;
Amendment 212 #
Proposal for a regulation
Article 9 – paragraph 3 – point d
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 215 #
Proposal for a regulation
Article 9 – paragraph 3 – point g
Article 9 – paragraph 3 – point g
(g) mitigation plans including enhanced production and, supply capacity; sourcing diversification and where applicable outsourcing plans;
Amendment 219 #
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 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 232 #
Proposal for a regulation
Article 12 – paragraph 1 – point f
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 276 #
Proposal for a regulation
Article 18 – paragraph 1 – point a
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 304 #
Proposal for a regulation
Article 23 – paragraph 3 – point d
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 #
Proposal for a regulation
Article 23 – paragraph 3 – point f
Article 23 – paragraph 3 – point f
(f) mitigation plans including enhanced production and, supply capacity, sourcing diversification and where applicable outsourcing plans;
Amendment 314 #
Proposal for a regulation
Article 26 – paragraph 1 – point e
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.