11 Amendments of Ljudmila NOVAK related to 2020/2071(INI)
Amendment 45 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas medicine shortages are a growing public health threat with a serious impact on health care systems and public health;
Amendment 91 #
Motion for a resolution
Recital C
Recital C
C. whereas the loss of European sovereignty and independence in the health sector is linked to the relocation of production, with 40% of medicinal end products marketed in the EU now originating in third countries; whereas the onlyone way to save money is to rely heavily on subcontractors to produce pharmaceutical raw materials in Asia, where labour costs and environmental standards are lower, with the result that 80% of active ingredients are manufactured outside the EU, mainly in China and India;
Amendment 157 #
Motion for a resolution
Recital G
Recital G
G. whereas, in the absence of a regulatory authority, stockpiling in some Member States is leading to a market imbalance excessive stockpiling can lead to a market imbalance if cooperation between Member States is insufficient;
Amendment 187 #
Motion for a resolution
Recital J a (new)
Recital J a (new)
Ja. whereas a strong, innovative and competitive pharmaceutical industry in Europe is in the vital interest of the EU and its Member States;
Amendment 190 #
Motion for a resolution
Recital J b (new)
Recital J b (new)
Jb. whereas the pharmaceutical industry needs the right legal framework to do research, development and production of pharmaceuticals within the EU;
Amendment 213 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Points out that, while public health policies are a Member State matter,the "Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care" it is very clear that pharmaceutical legislation needs to be done by the European Union and partly exercised by the EMA and it is incumbent upon the EU to coordinate and complement national measures to guarantee affordable and high- quality health services for the European citizens;
Amendment 275 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission and the Member States to take whatever action is needed to restore European health sovereignty and local pharmaceutical manufacturing, giving priority to essential and strategic medicines; calls on the Commission to map out potential production sites in the EU;
Amendment 397 #
Motion for a resolution
Paragraph 8
Paragraph 8
8. Notes that procurement procedures with only one successful tenderer with only one production site of the basic substance may exacerbate vulnerability should supplies be disrupted; calls on the Commission and the Member States to introduce procurement procedures under which contracts may be awarded to a number of successful tenderers where each has at least more than one production site in different countries (including one within the EU) for the tendered medicinal product, in order to maintain market competition and reduce the risk of shortages, while guaranteeing high-quality treatment for patients;
Amendment 406 #
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Ask the Commission to examine if it is possible to create a legislative framework that encourage and enables healthcare systems to do tenders that award pharmaceutical companies that guarantee the supply of pharmaceuticals in difficult circumstances by focussing on production inside the EU and guarantee at least two different sources for the basic substance; ask the Commission to examine if legislative requirements to ensure more sustainable delivery of pharmaceuticals can be mandated under EU law;
Amendment 423 #
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on the Commission and the Member States to to make concreate one or more European non-profitproposals how models of public private pharmaceutical undertakings which operate in the public interest to manufacture priority medicines of strategic importance for health caretnership like the US Biomedical Advanced Research and Development Authority can be established in the EU to operate in the public interest; stresses the key contribution that can be made by new technologies and artificial intelligence in enabling European laboratory researchers to form networks and share their objectives and findings;
Amendment 529 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls on the Commission to develop European health strategies on the basis of a common basket of drugs for the treatment of cancer and infections whose prices are harmonised, in a bid to counter recurrent shortages and ensure that patients have access to treatment; calls on the Commission to also examine, whether a harmonised price for those drugs may solve the problems of shortages for those life-saving drugs;