Activities of Luisa REGIMENTI related to 2020/2071(INI)
Shadow reports (1)
REPORT on the shortage of medicines – how to address an emerging problem
Amendments (33)
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 37 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas shortages of medicines are a symptom of unsustainable policies, and there is abundant scientific evidence that demonstrates that medicines shortages have multi factorial root causes: namely economic causes, increasing regulatory burden, unforeseen surges in demand, supply chain interdependencies and manufacturing and quality challenges;
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 104 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas the EU has an important existing manufacturing footprint and it is important to secure it through sustainable economic, regulatory and industrial incentives and policies;
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 163 #
Motion for a resolution
Recital G a (new)
Recital G a (new)
Ga. whereas the combination of cost containment measures, lack of market predictability, combined with an onerous and rigid regulatory framework are challenging sustainable and equitable access to medicines, especially for very old inexpensive essential drugs, as well as the competitiveness of the EU pharmaceutical industry;
Amendment 165 #
Motion for a resolution
Recital G b (new)
Recital G b (new)
Gb. whereas the coronavirus pandemic has demonstrated that a pan-European coordination and dialogue is needed between authorities, industry and relevant stakeholders of the healthcare supply chain;
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 212 #
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Urges Member States to avoid to take measures such as artificial stockpiling, as recommended by the Commission in its Guidelines on the optimal and rational supply of medicines of 8 April 2020 in the context of the COVID-19 crisis; also discourages Member States to apply unproportioned and unnecessary penalties, which create even further unsustainability and increase the possibility to generate medicines shortage;
Amendment 230 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Urges the Commission to propose in the upcoming Pharmaceutical Strategy the creation of a High Level pharmaceutical Forum, together with policy-makers, regulators, payers, patients, industry representatives and other actors of the healthcare supply chain to set a clear plan to address pharmaceutical sustainability issues, and ensure the competitiveness of the pharmaceutical industry sector in Europe;
Amendment 232 #
Motion for a resolution
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Calls on the Commission to preserve a competitive research-based pharmaceutical industry taking into account that EU remains by far the world leader manufacturing region of active ingredients for on patent medicines;
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 346 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Urges the Commission and the Member States to define and propose sustainable, economic, industrial and regulatory policies to maintain and secure existing manufacturing operations, to introduce tax and financial incentives in return for appropriate commitments and to authorise state aid to encourage producers to maintain or 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 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 622 #
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Calls on the Commission to encourage producers, on a voluntary basis, to introduce a labelling system - visible to and identifiable by patients / consumers - concerning the place of origin and production of medical products and active ingredients, in order to avoid the risks of falsified medicines and to meet consumers' expectations;
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 724 #
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Calls on the Commission, EMA and relevant regulatory authorities to ensure that regulatory flexibilities continue to be applied in the efforts to mitigate medicines shortage from occurring;
Amendment 727 #
Motion for a resolution
Paragraph 21 b (new)
Paragraph 21 b (new)
21b. Calls on the Commission and EMA to optimise the regulatory framework by implementing its telematics strategy and amending Regulation (EC) No 1234/2008 (Variations Regulation) and the Variations Classification Guidelines; this will contribute to the prevention of medicines shortage and align with the progress in technology;
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;