20 Amendments of Stanislav POLČÁK 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 90 #
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 onlprimary way to save money is to rely heavily, to a constantly growing extent, 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 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 131 #
Motion for a resolution
Recital E
Recital E
E. whereas stocks of ‘strategic’ medicines are inadequate, with chemicals that are cheap and easy to produce and mature medicines being in particularly short supply; whereas pharmaceutical firms operate on aaccording to the just-in-time basismethod;
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 226 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Points out that, while public health policies are a Member State matter, it is incumbent upon the EU to coordinate and complement national measures to guarantee affordable and high-quality health services for European citizens including those living in rural areas;
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 350 #
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 environmentally responsible 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 diversification;
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 436 #
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on the Commission and the Member States to create one or more European non-profit pharmaceutical undertakings which operate in the public interest to manufacturprovide priority medicines of strategic importance for health care; 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 510 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Recommends the introduction of centralisshared management to bring about greater transparency in the distribution chain and the creation of a European supply management unit tasked with developing a European strategy to prevent and resolve breaks in supply;
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;
Amendment 570 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls on the Commission and the Member States to adopt a joint definition of ‘medicines of strategic importance for health care’ and of ‘criticality’, emphasising the value of these medicines for public health, the lack of alternatives and the vulnerability of the production chain; calls for a European regulatory authorityEMA to be designated to carry out the task of setting quotas for the allocaa mechanism of just distribution of medicines from that reserve to the Member States affected by disruption or shortage of supply;
Amendment 596 #
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls on the Commission and Member States to develop innovative and coordinated strategies and to step up exchanges of good practice in the area of stock management with a view to preventing both insufficient stock and stockpiling; considers that the European Medicines Agency (EMA) could be designated as the regulatory authority tasked with preventing shortages of essential medicines, with a correspondingly wider remit and more staff;
Amendment 639 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to set up an innovative centralised digital platform for sharing more standardised information provided by national agencies and all stakeholders regarding shortages of medicines and medical equipmentany potential disruption or interruption of supply of medicines and medical equipment at a very early stage, in order to be able to anticipate when a potential disruption is likely to turn into a shortage with an actual impact on patients; welcomes the introduction by the EMA of the SPOC and i-SPOC systems; calls for existing information systems to be improved so as to provide a clear overview of problems, shortages and requirements in each Member State, with a view to preventing stockpiling;