28 Amendments of Jessica POLFJÄRD related to 2020/2071(INI)
Amendment 32 #
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 the Member States have a duty to find swift and effective solutions through closer European integrcoordination;
Amendment 35 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas the problem of medicine shortages has multifactorial root causes, including but not limited to regulatory requirements, pressure to reduce production and distribution costs, supply chain interdependencies, including on third countries, unforeseen surges in demand as well as inadequate demand and supply data, and the concentration of production to a narrower set of production sites;
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 50 #
Motion for a resolution
Recital A b (new)
Recital A b (new)
Ab. whereas medicine shortages impose significant costs on both public and private health stakeholders;
Amendment 54 #
Motion for a resolution
Recital A c (new)
Recital A c (new)
Ac. whereas medicine shortages could pose a risk to the success of Union and Member State health initiatives, such as Europe's Beating Cancer Plan;
Amendment 56 #
Motion for a resolution
Recital A d (new)
Recital A d (new)
Ad. whereas it is imperative to prevent medicine shortages, and mitigate their effects in case they occur;
Amendment 75 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas the COVID-19 pandemic has highlighted the importance of a well- functioning internal market and robust supply chains for medicines and medical equipment; whereas a European dialogue on how to ensure this is needed;
Amendment 81 #
Motion for a resolution
Recital C
Recital C
C. whereas the loss of European sovereignty and independence in theone of the factors affecting the availability and accessibility of medicines in the European health sector is linked to the relocation of production, with 40% of medicinal end products marketed in the EU now originating in to third countries; whereas the only way to save money for certain products 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%a substantial part of active ingredients are manufactured outside the EU, mainly in China and India;
Amendment 113 #
Motion for a resolution
Recital D
Recital D
D. whereas thone consequence of growing demand coupled with price suppression is the concentration of supply, a reduction in the number of chemicals manufacturers and a less diversified supply chain and therefore a lack of alternative solutions should problems arise;
Amendment 137 #
Motion for a resolution
Recital F
Recital F
F. whereas there are no price harmonisation arrangements to facilitate ‘parallel exports’ to countries where the medicine in question is more expensive can add to the lack of clarity of supply and demand and thereby contributes to or exacerbates market imbalances;
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 195 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses the geostrategic imperative that the Union regain its sovereignty and independence with regard tostrengthen its health care and secure its supply of medicines and medical equipment;
Amendment 253 #
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Welcomes the Commission’s proposal for a new European health programme “EU4Health”; notes that one of its stated objectives is to promote the availability and accessibility of medicines and medical equipment;
Amendment 271 #
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 andappropriate action to ensure European availability and accessibility of medicines and consider the need for local pharmaceutical manufacturing, giving priority to essential and strategic medicines; calls on the Commission to map out potential production sites in the EU; invites the Commission to launch a consultation with Member States, relevant Union authorities and other key stakeholders in order to identify the factors causing or contributing to medicine shortages; calls on the Commission to propose initiatives to address these issues in its forthcoming strategies;
Amendment 317 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to address in its next pharmaceutical and industrial strategies issues relating to the availability and accessibility of medicines and, including manufacturers’ dependence on third countries;
Amendment 338 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. UrgInvites 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,consider incentives for the pharmaceutical industry in return for appropriate commitments to diversify their supply chains from compound manufacturing to packaging and distribution; emphasises the strategic significance of this sector and the importance of invespromoting in European companies, in the interests of resource diversificationetitiveness;
Amendment 385 #
Motion for a resolution
Paragraph 7
Paragraph 7
7. Notes that security of supply is an essential factor in combating shortages 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, as recommended in Article 67 of Directive 2014/24/EU; proposes that investments in the manufacture of active ingredients and medicinal end products in the EU should also be a criterionemphasises the importance of diversified supplies and sustainable procurement practices;
Amendment 402 #
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 consider introduceing 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 treatment for patients;
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 443 #
Motion for a resolution
Paragraph 10
Paragraph 10
10. Calls for links to be establishedan enhanced dialogue between the pharmaceutical industry and other productionkey stakeholders and strategic sectors, such as farming, in a bid to develop the production of active ingredients in the EU; calls for efforts to counter over-specialisation in certain sectors andensure the availability and accessibility of active ingredients in the EU; calls for substantial investment in research, the bioeconomy and biotechnology, for the purposes of resource diversification;
Amendment 450 #
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 bemedical research network, in order to avoid a deterioration in the quality of European medical research;
Amendment 493 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Recommends the introduction of centralised managementgreater coordination and information sharing practices to bring about greater transparency in the distribution chain and the creation of a European supply management unit tasked with; notes the importance of developing a European strategy to prevent and resolve breaks in supply;
Amendment 524 #
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 forthat take into particular consideration the treatment of cancer and infections whose prices are harmonised, in a biand the need to counter recurrent shortages and ensure that patients have access to treatment;
Amendment 551 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls on the Commission to create a European contingency 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 periods; acknowledges that such reserves must be proportionate to their objective;
Amendment 564 #
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 authority to be designated to carry out the task of setting quotas for the allocation of medicines from that reserve to theacknowledges that the particular medicines falling under these categories may differ between Member States;
Amendment 610 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. CallsNotes that it may be necessary for further invitations to tender to be issued at European level in an effort to counter shortages, as has been done following the onset of the COVID-19 virus, with simplified procedures in the interests of improved response times; acknowledges that such measures should primarily be considered to alleviate future Union-wide health crises, such as pandemics;
Amendment 704 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls for an electronic information notice to be drawn up in all the Union languagesn accessible manner for every medicine on the EU market, in order to facilitate sales of medicines between Member States; recommends the provision of more comprehensive information on the origin of medicines;