22 Amendments of Annalisa TARDINO related to 2020/2071(INI)
Amendment 26 #
Motion for a resolution
Recital A
Recital A
A. whereas the increase in global demand has aggravated shortages of medicines in the EU, undermining health services in the Member States and exposing patients to considerable risks; whereas these include the progression of the disease and/or worsening of symptoms, increased exposure to falsified medicines, medication errors or adverse events which occur when the missing medicine is replaced by another, avoidable transmission of infectious diseases and significant psychological distress; whereas the Member States have a duty to find swift and effective solutions through closer European integration;
Amendment 70 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas medicine shortages may lead to delays in the treatment of patients, the need to use alternative therapies that could be less effective and, accordingly, to adverse effects and even a danger to life where a shortage concerns vital medicines;
Amendment 89 #
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 onlya way tof saveing money and maximising profit 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 135 #
Motion for a resolution
Recital F
Recital F
F. whereas there are no price harmonisation arrangements tocurrent internal market rules facilitate ‘parallel exports’ to countriMember States where the medicine in question is more expensive; whereas, however, in a market economy, price planning is inconceivable;
Amendment 154 #
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 imbalancesome Member States, stockpiling can further contribute to actual medicine shortages;
Amendment 166 #
Motion for a resolution
Recital H
Recital H
Amendment 172 #
Motion for a resolution
Recital I
Recital I
I. whereas the greater number, geographical spread and impact of epidemics is partly attributable to climate change, in combination with globalisation and increased travelglobalisation is a decisive factor as regards the increased geographical spread and impact of epidemics, not to mention the speed at which the infection spreads;
Amendment 181 #
Motion for a resolution
Recital J
Recital J
J. whereas the destruction of biodiversity, the proliferation of man-made habitats and damage to natural areas densely populated by humans are potentially facilitating the propagation of zoonoses, i.e. the transmission to humans and rapid spread of animal pathogens;
Amendment 185 #
Motion for a resolution
Recital J a (new)
Recital J a (new)
Ja. whereas health is not a commodity, and making it subject to internal market rules as if it were, has done nothing but discourage research and the production of new medicines, as well as promote the establishment of a parallel market in medicines and an oligopoly of multinationals;
Amendment 204 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses the geostrategic imperative that the UnionMember States regain itstheir sovereignty and independence with regard to health care and secure itstheir supply of medicines and medical equipment;
Amendment 285 #
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 sovereigntythe medical and pharmaceutical self-sufficiency of the Union 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 399 #
Motion for a resolution
Paragraph 8
Paragraph 8
8. Notes that procurement procedures with only one successful tenderer 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, in order to maintain market competition and reduce the risk of shortages, while guaranteeing high-quality and affordable treatment for patients;
Amendment 447 #
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; calls for medical research to be encouraged in Europe, to support the relocation and renewed competitiveness of the sector;
Amendment 490 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Recommends the introduction of centralised managementa European database 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 supplyan early warning system on shortages of existing and planned medicines to ensure that breaks in supply are better managed;
Amendment 530 #
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 harmonisedtailored to the purchasing power of each Member State, in a bid to counter recurrent shortages and ensure that patients have access to treatment;
Amendment 544 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls on the Commission to create, as part of the ‘RescEU’ mechanism, a European contingencystrategic reserve of medicines of strategic importance for health care, supplies of which are critical, along the lines of the ‘RescEU’ mechanism, in order to alleviate shortages outside crisis permajor therapeutic importance and at high risk of shortage, to act as a contingency stock for Member States in critical situatiodns;
Amendment 566 #
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 carmajor therapeutic importance’ 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 authority to be designated to carry out the task of setting quotas for the allocation of medicines from that reserve to the Member States;
Amendment 590 #
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; 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 staffat no additional cost to the Union budget;
Amendment 655 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to set up an innovative centralised digital platform, which can be consulted by the public, for sharing information provided by national agencies and all stakeholders regarding shortages of medicines and medical equipment; 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 difficulties, shortages and requirements in each Member State, with a view to preventing stockpiling;
Amendment 696 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls for the paper information notice to be supplemented by an electronic information notice to be drawn up in all the official Union languages for every medicine on the EU marketsold in the Union itself, in order to facilitate sales of medicines between Member States; recommends the provision of more comprehensive information on the origin of medicines;
Amendment 709 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Stresses the need to use state-of- the-art track-and-trace systems and technologies for medicines, from when the active ingredients are produced, in order to improve the reliability of the entire production, packaging and distribution chain and ensure a high quality of medicines;
Amendment 734 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Takes the view that the introduction of stress tests by the Member States to assess the resilience of respective health systems in emergencies would provide an effective means of countering shortages in the event of pandemics and of identifying structural risk factors which go to create shortages;