Activities of Joanna KOPCIŃSKA related to 2020/2071(INI)
Shadow reports (1)
REPORT on the shortage of medicines – how to address an emerging problem
Amendments (24)
Amendment 6 #
Motion for a resolution
Citation 11 a (new)
Citation 11 a (new)
- having regard to the Regulation 2020/561 amending Regulation 2017/745 on medical devices, as regards the dates of application of certain of its provisions,
Amendment 17 #
Motion for a resolution
Citation 24 a (new)
Citation 24 a (new)
- having regard to the Court's Judgments C-468/06-C-478/06 of 16 September 2008,
Amendment 30 #
Motion for a resolution
Recital A
Recital A
A. whereas the increase in global demand within the pharmaceutical supply chain, which has been exacerbated by the COVID-19 pandemic, has aggravated shortages of medicines in the EU, which has serious consequences, 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 integration;
Amendment 34 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas the causes underlying medicine shortages are complex and multi-factorial, and include manufacturing challenges, industry quotas, legal parallel trade, as well as economic elements, such as the pricing of medicinal products, which is a competence of the Member States;
Amendment 101 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas the EU-based manufacturers of generics have an important role to play in satisfying the growth in the demand for affordable medicines in the Member States;
Amendment 119 #
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas the relocation of production to sites outside the EU to maximise profits combined with excessive reliance on individual drugs for certain health conditions and insufficient incentives to invest in new innovative medicines might have contributed to rise and spread of antimicrobial resistance;
Amendment 126 #
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 a just-in-time basis which can leave manufacturers vulnerable to supply shocks where there are unanticipated production and supply chain interruptions, and market demand fluctuations;
Amendment 140 #
Motion for a resolution
Recital F
Recital F
F. whereas there are no price harmonisation arrangements todifferential pricing between Member States facilitates ‘parallel exports’ to countries where the medicine in question is more expensive;
Amendment 151 #
Motion for a resolution
Recital G
Recital G
G. whereas, in the absshortage of medicine supplies, experienced of a regulatory authority,r anticipated, can lead to inappropriate stockpiling in some Member States is leadingand therefore to a market imbalance;
Amendment 167 #
Motion for a resolution
Recital H
Recital H
Amendment 179 #
Motion for a resolution
Recital J
Recital J
J. whereas there is an increasing correlation between the destruction of biodiversity, the proliferation of man-made habitats and damage to natural areas densely populated by humans are facilitating, and the propagation of zoonoses, i.e. the transmission to humans and rapid spread of animal pathogens; whereas further research is needed to establish a clear causal link;
Amendment 202 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses the geostrategic imperative that the Union regain its sovereignty and independence with regard to health care and secensure itsthe supply of affordable medicines and medical equipment;
Amendment 218 #
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, complement and encourage cooperation among national measures to guarantee affordable and high-quality health services for European citizens, prevent and manage diseases, mitigate sources of danger to human health, and promote investment in research;
Amendment 280 #
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;Member States to map out, in cooperation with the Commission, potential production sites in the EU; underlines that this analysis should only be used for advisory purposes.
Amendment 306 #
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 manufacturers’s well as industry’s dependencey on third countries for manufacturing capacity, the supply of active pharmaceutical ingredients (APIs) and starting materials;
Amendment 398 #
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, including joint tenderers, in order to maintain market competition and reduce the risk of shortages, while guaranteeing high-quality treatment for patients;
Amendment 429 #
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on the Commission and the Member States to create one or moreonsider establishing European non-profit pharmaceutical undertakings which operate in the public interest to manufacture priority medicines of strategic importance for health care; underlines the necessity of increased diversification at the European level by establishing several new manufacturing businesses to satisfy the EU’s high demand, where every product should have at least two alternative sources of production; 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 527 #
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; emphasises that any attempt at price harmonisation must be adjusted for purchasing power parity in all Member States;
Amendment 546 #
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, albased ong the lines of the ‘RescEU’ mechanismMember States’ reserves of strategic medicines, in order to alleviate shortages outside crisis periods;
Amendment 565 #
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 the Member Staton the Commission to accompany the joint definition with rules on the distribution of these strategic reserves;
Amendment 586 #
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 authorhave increased resources and responsibilities to help Member States, working in conjunction wityh tasked withhe European Centre for Disease Prevention and Control, better preventing shortages of essential medicines, with a correspondingly wider rlife-saving medicines and commonly used drugs in light of possible future epidemitcs and more staffpandemics;
Amendment 642 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to set up an innovative centralised digital platform 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 intensify market surveillance and to provide a clear overview of problems, shortages and requirements in each Member State, with a view to preventing stockpiling;ensuring a well-designed supply chain from the manufacturer, to the wholesaler to the healthcare entity.
Amendment 715 #
Motion for a resolution
Paragraph 21
Paragraph 21
21. Welcomes, following the onset of the COVID-19 crisis, the introduction of more flexible rules in a bid to mitigate shortages and facilitate the circulation of medicines between Member States: acceptance of different packaging formats, reuse procedure to enable marketing authorisation holders to obtain approval in another Member State, extension of validity of Good Manufacturing Practices certificates, longer expiry periods, use of veterinary medicinal products, etc.; calls on the Commission, the EMA and national regulatory authorities to monitor strictly the use of these arrangements, ensure that patient safety is not compromised and to keep them available in the event of problems or shortages; welcomes in this regard also the extension of the date of application of the Medical Devices Regulation.
Amendment 733 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Takes the view that the introduction of stress tests to assess the resilience of health systems in emergencies would provide an effective means of countering shortages in the event of pandemics and of identifyingform the basis of an early warning system that identifies the structural risk factors which go to create shortages;