11 Amendments of Nathalie COLIN-OESTERLÉ related to 2021/2013(INI)
Amendment 126 #
Motion for a resolution
Paragraph -1 (new)
Paragraph -1 (new)
-1. Stresses the geostrategic imperative for the Union to regain its independence with regard to healthcare, to secure rapidly and efficiently its supply of affordable medicines, medical equipment, medical devices, active substances, diagnostic tools and vaccines, and to prevent shortages thereof, prioritising the interest and safety of patients;
Amendment 130 #
Motion for a resolution
Paragraph -1 a (new)
Paragraph -1 a (new)
-1a. Points out that while the Member States are responsible for the definition and organisation of their health policies, the Union is responsible for pharmaceutical legislation as well as various public health policies, and it is incumbent on the EU to coordinate and complement national measures to guarantee access to affordable and high- quality health services for all EU citizens and residents;
Amendment 362 #
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Emphasises that joint European procurement procedures can make it possible to counter shortages, especially in times of health crises, as was the case with the procedure launched following the onset of the COVID-19 epidemic, with simplified and transparent procedures in the interests of improved response times; calls, in particular, for the establishment of EU joint procurement for medicines to treat rare diseases in order to ensure that these medicines are available in all Member States;
Amendment 392 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Calls on the Commission to develop European health strategies on the basis of a common basket of medicines for the treatment of cancer, infections, rare diseases and other areas particularly affected by shortages; calls on the Commission to consider the option of harmonised pricing criteria to make such medicines affordable;
Amendment 402 #
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
11b. Calls on the Commission consider creating a European contingency reserve for medicinal products of health and strategic importance (MISSs) that are at high risk of shortage, along the lines of the ‘RescEU’ mechanism, in order to alleviate recurrent shortages;
Amendment 410 #
Motion for a resolution
Paragraph 11 c (new)
Paragraph 11 c (new)
11c. Urges the Commission and the Member States to introduce financial incentives, in line with State aid rules, to preserve and expand the EU’s pharmaceutical industrial base, from the production of active pharmaceutical ingredients to medicine manufacturing, packaging and distribution; emphasises the strategic significance of this sector and the importance of investing in European companies in order to diversify resources and encourage the development of innovative production technologies capable of enhancing the responsiveness of entire production lines; recalls that all public funding must be made conditional on the transparency and traceability of investments, on supply obligations on the European market, and on facilitating the best outcome for patients, including in terms of accessibility of manufactured medicines;
Amendment 571 #
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Calls on the Commission, the EMA and the competent authorities to capitalise on all the pragmatic efforts made during the COVID-19 crisis, in particular as regards regulatory flexibility with a view to tackling medicine shortages more effectively;
Amendment 597 #
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Emphasises that security of supply is an essential factor and must be used as a qualitative criterion in connection with the award of public pharmacy contracts and calls for tender for the supply of medicines; emphasises the importance of diversified supplies and procurement practices for pharmaceuticals; urges the Commission, in the context of Directive 2014/24/EU, to act swiftly in proposing guidelines for the Member States, to look beyond the lowest price criterion, and to ensure that investments in the manufacture of active ingredients and medicinal end products in the EU are also retained as an essential criterion;
Amendment 608 #
Motion for a resolution
Paragraph 19 b (new)
Paragraph 19 b (new)
19b. Calls on the Commission and the Member States to develop innovative and coordinated strategies and to step up exchanges of good practice in the area of stock management; takes the view that the EMA is the body best suited to be designated as the regulatory authority tasked with preventing shortages of medicines at EU level during emergencies and beyond;
Amendment 610 #
Motion for a resolution
Paragraph 19 c (new)
Paragraph 19 c (new)
19c. Calls on the Commission to set up an innovative, user-friendly, transparent and centralised digital platform for reporting and notifying information provided by national agencies and all stakeholders regarding available stocks and shortages of medicines and medical equipment; calls for existing information systems to be evaluated and improved so as to provide a clear overview of difficulties, shortages and requirements in each Member State to prevent overstocking;
Amendment 628 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Welcomes the introduction of a structured dialogue with all stakeholders to identify weak links in the global supply chain for critical medicines, pharmaceutical raw materials, intermediate products and active pharmaceutical ingredients; with that in mind, urges the Commission, the Member States and stakeholders to draw up, as soon as possible, a clear and ambitious policy roadmap to secure and modernise Europe’s existing manufacturing capacity for medicines, technology and active pharmaceutical ingredients;