20 Amendments of Jan HUITEMA related to 2020/2071(INI)
Amendment 12 #
Motion for a resolution
Citation 19 a (new)
Citation 19 a (new)
- having regard to the newly created platforms in light of the current COVID- 19 crisis, such as the European Medicines Agency (EMA) Industry Single Point of Contact (I-SPOC) system, which is streamlining the process of reporting potential medicine shortages in order to prevent them and to flag these shortages as early as possible; having regard that these platforms have enabled and facilitated a dialogue on shortages between stakeholders in the pharmaceutical supply chain and regulators,
Amendment 60 #
Motion for a resolution
Recital A g (new)
Recital A g (new)
Ag. whereas the COVID-19 crisis has exacerbated the EU’s long-existing structural problems related to the supply of medicines, and the dependency on third-country import for medicines and medical materials;
Amendment 198 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses the geostrategic imperative that the Union regain its sovereignty and independence with regard to health care and secure its supply of medicines, diagnostic tools, vaccines, medical devices and medical equipment;
Amendment 246 #
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses the need for health policies to focus on patients’ health and interests and for closer cooperation between Member States;
Amendment 264 #
Motion for a resolution
Paragraph 3 e (new)
Paragraph 3 e (new)
3e. Calls for the launch of a Joint Action on the prevention of shortage of medicines which would be funded by the future Health Program; considers that this Joint Action would allow an exchange of good practices between the Member States and the development of common prevention measures;
Amendment 325 #
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. calls on the Commission to present a specific strategy for managing shortages of medicines and medical products in Europe;
Amendment 339 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Urges the Commission and the Member States to introduce tax and financial incentives in return for appropriate commitments and to authorise state aid to encourage producers to locate their operations in Europe, from compound manufacturing to packaging and distribution; emphasises the strategic significance of this sector and the importance of investing in European companies, in the interests of resource diversificationorder to diversify resources and encourage the development of innovative production technologies capable of enhancing the responsiveness of production lines, in particular the continuous manufacturing process;
Amendment 365 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Stresses that the pharmaceutical sector remains an important industrial pillar as well as a driving force in terms of job creation;
Amendment 368 #
Motion for a resolution
Paragraph 6 b (new)
Paragraph 6 b (new)
6b. Recalls that Articles 81 and 23a of Directive 2001/83/EC establishing a Community Code relating to medicinal products for human use have laid down general obligations for the supply of medicinal products to be borne by marketing authorization holders (MAHs) and distributors, as well as a notification obligation for MAHs in the event of a temporary or permanent supply interruption;
Amendment 455 #
Motion for a resolution
Paragraph 11
Paragraph 11
11. Stresses the importance of research and innovation, and calls for the establishment of a genuine European network, given that the price of relocation must not be a deterioration in the quality of medical research; highlights the role of European projects and SMEs in improving access to medicines in the Union; underlines the crucial role of the Horizon Europe program in this respect;
Amendment 484 #
Motion for a resolution
Paragraph 11 e (new)
Paragraph 11 e (new)
11e. Calls on the Member States to adopt a common position and start negotiations on the proposal for a Regulation of the Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU;
Amendment 511 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Recalls that the EMA and the National Medicines Agencies have agreed on the following definition of a shortage: "a shortage of a medicinal product for human or veterinary use occurs when supply does not meet demand at a national level"; calls on the Commission, the EMA and the National Medicines Agencies, the Member States and the pharmaceutical supply chain actors to come up with a common definition of a shortage to better take into account patients' needs while avoiding different national definitions and approaches;
Amendment 514 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Welcomes the recent creation green lanes, set up to facilitate the transport of all goods, in order to allow the smooth running of the transport not only of medicines but also of raw materials, intermediate products and related materials, including packaging;
Amendment 519 #
Motion for a resolution
Paragraph 12 d (new)
Paragraph 12 d (new)
12d. Encourages the development of shortage prevention and management plans across all Member States; believes that these plans could result from an analysis of manufacturing and distribution risks and include measures on building up stocks, diversifying sources of supply for raw materials and creating other manufacturing sites to ensure resilience from production;
Amendment 579 #
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Calls for the adoption of common definitions of 'supply disruption' and 'stock-out' of medicines as well as a grid of criteria for assessing the risk associated with each of these situations;
Amendment 633 #
Motion for a resolution
Paragraph 17 b (new)
Paragraph 17 b (new)
17b. Notes that the differences in the price of a medicine from one Member State to another have led to the development of parallel exports, which can increase the risk of supply stress and cause of shortages; recalls that the free movement of goods within the Union allows certain wholesaler-distributors called "short-liners" to buy medicines in one Member State and to resell them more expensive in neighbouring countries; calls for the adoption of preventive measures to limit the parallel trade of medicines within the Union;
Amendment 688 #
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Recalls that misinformation can lead to inappropriate use of medicines and the creation of unnecessary stockpiling;
Amendment 728 #
Motion for a resolution
Paragraph 21 c (new)
Paragraph 21 c (new)
21c. Recalls that its resolution also calls for the competences, budget and staffing of EMA to be substantially increased in order to allow it to coordinate medical responses in times of crisis; considers it essential that EMA has solid governance to meet future challenges such as monitoring and responding to shortages in coordination with the Member States; underlines that, in the long term, EMA should be able to make conditional marketing authorizations upon guarantees of supply and accessibility from manufacturers; hopes that the reinforcement of the staff of EMA will enable it to carry out inspections of production sites established in third countries;
Amendment 730 #
Motion for a resolution
Paragraph 21 e (new)
Paragraph 21 e (new)
21e. Considers that in the event of a health crisis the closure of borders and customs controls cannot constitute an obstacle to cross-border movement of medicinal products of major interest within the Union; calls on the Commission and the Member States to set up secure and rapid procedures for checking products at the border during a health crisis in compliance with EU law;
Amendment 736 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Welcomes, following the onset of the COVID-19 crisis, the introduction of more flexible rules in a bid to mitigate shortages and facilitate the circulation of medicines between Member States: acceptance of different packaging formats, reuse procedure to enable marketing authorisation holders to obtain approval in another Member State, longer expiry periods, use of veterinary medicinal products, etc.; calls on the Commission to monitor strictly the use of these arrangements and to keep them available in the event of problems or shortages;