27 Amendments of Adam JARUBAS related to 2020/2071(INI)
Amendment 83 #
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 only way to save money is toEurope has a strong manufacturing footprint which should be incentivised, the supply chain still relyies heavily on subcontractors to produce pharmaceutical raw materials in Asia, where labour costs and environmental standards are lower, with the result that 8065% of active ingredients are manufactureding comes from outside the EU, mainly in China and India;
Amendment 110 #
Motion for a resolution
Recital D
Recital D
D. whereas the consequence of growing demand coupled with price suppression is thepressure, lack of market predictability and burdensome regulatory framework result in a concentration of supply, a reduction in the number of chemicals manufacturers and a lack of alternative solutions should problems arise;
Amendment 125 #
Motion for a resolution
Recital E
Recital E
E. whereas stocksing of ‘strategic’ medicines areis an inadequate strategy to prevent shortages, with chemicals that are cheap and easy to produce and mature medicines being in particularly short supply; whereas pharmaceutical firmsome hospitals operate on a just-in-time basis;
Amendment 136 #
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 expensiv‘parallel exports’ from countries with lower medicine prices to countries where the medicine in question is more expensive, the parallel trade is driven by more factors than the price differences alone;
Amendment 153 #
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 stockpiling in some Member States, without effective EU coordinating policies, is leading to a market imbalance, price rise and potential shortages;
Amendment 169 #
Motion for a resolution
Recital I
Recital I
Amendment 176 #
Motion for a resolution
Recital J
Recital J
Amendment 207 #
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 secure its supply of medicines and medical equipment, by among others building on the existing 400 generic and biosimilar medicines factories which supply the majority of medicines to European patients;
Amendment 248 #
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Calls on the Commission to coordinate a Pan-European response on medicines shortages to ensure equitable and sustainable access to medicines; a coordinated EU response is of utmost importance to avoid spillover effects of individual and uncoordinated national measures to address medicines shortages and ensure the right of patients to universal, equitable, affordable, effective, safe and timely access to essential medicines, as well as to guarantee the sustainability of the EU public healthcare systems; this Pan-European approach must focus on coordinating Member State policy measures to address the root causes of medicines shortages;
Amendment 260 #
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Urges the European Commission and relevant authorities to identify, assess and address the multifactorial root causes of medicines shortages, namely the economic causes, increasing regulatory burden, unforeseen surges in demand, supply chain interdependencies and manufacturing and quality challenges. Thereafter to propose an ambitious EU plan to prevent medicines shortages, articulated in short, mid and long term sustainable policies that stimulate competition and investment in manufacturing as well as strengthen security and resilience of supply to guarantee sustainable and equitable access to medicines;
Amendment 286 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission and the Member States to take whatever action is needednecessary actions to restore European health sovereignty and local pharmaceutical manufacturing, giving priority to essential and strategic medicines; calls on the Commission to map out existing and potential production sites in the EU;
Amendment 298 #
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. The EU shall support and coordinate Member States, using all necessary market and regulatory instruments, to secure the production of medicines and other necessary means of medical use, by EU manufacturers, at the levels meeting the needs of Member States for the duration of time period sufficient to adapt supplies from the third countries in the event of crisis, leaving the production above the level to free market;
Amendment 340 #
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 producers to locate their operations in Europe, from compound manufacturing to packaging and distribuAPI to medicines manufacturing; also urges the Member States to put in place sustainable market policies to secure existing operations; emphasises the strategic significance of this sector and the importance of investing in European companies, in the interests of resource diversification;
Amendment 408 #
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Recalls the existing evidence highlighting the role of sustainable procurement practices in preventing medicines shortages; calls on the Commission to support Member States in the prevention of shortages by developing ad hoc EU Guidelines on procurement of medicines, under the current public procurement directive, aimed at ensuring long-term sustainability, competition, security of supply and stimulating investments in manufacturing;
Amendment 413 #
Motion for a resolution
Paragraph 8 b (new)
Paragraph 8 b (new)
8b. Urges the Commission, in the context of the EU public procurement Directive 2014/24/EU, to promptly propose ad-hoc guidance for Member States to support sustainable tender practices for pharmaceuticals, where tender practices are used, notably on how to best implement the Most Economically Advantageous Tender (MEAT)criteria, looking beyond the lowest price criteria only and rewarding quality and security of supply investments;
Amendment 427 #
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 manufacture priority medicines of strategic importance for health careMember States, in the public interest, to create long-term commitments with manufacturers to ensure medicines of strategic importance for health care and in danger of being withdrawn are maintained in the European market; stresses the key contribution that can be made by new technologies ande.g. artificial intelligence applications, in enabling European laboratory researchers to form networks and share their objectives and findings;
Amendment 457 #
Motion for a resolution
Paragraph 11
Paragraph 11
11. Stresses the importance of research and innovation, including the off-patent segment, 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;
Amendment 496 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Recommends the introduction of centralised managementadvancing coordination in the EU 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 526 #
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 harmonisedstrengthening their strategic supply chains rather than creating further concentration, in a bid to counter recurrent shortages and ensure that patients have access to treatment;
Amendment 571 #
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 authoritymedicines supply committee to be designated to carry out the task of setting quotas for the allocation of medicines from that reserve to the Member States;
Amendment 585 #
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 thatto prevent shortages; considers that a European medicines supply committee, composed of National Authorities (CMDh) and 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; calls on the committee to ensure a close two way dialogue with the pharmaceutical supply chain to prevent shortages;
Amendment 603 #
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Following good practices of the Commission, of EMA and CMDh guidance to support availability of medicines used in the COVID-19 pandemic, calls on the Commission and relevant authorities to optimise the regulatory system and to simplify regulatory processes to ensure a reduction of the administrative burden of maintaining medicinal products on the market, to react quickly to patients’ needs and ensure prompt supply and access to high quality treatments; simplification can be achieved by amending the existing Regulation (EC) No 1234/2008 (Variations Regulation) and the Variations Classification Guidelines and making the most of the telematics tools at pan-European level;
Amendment 607 #
Motion for a resolution
Paragraph 16 b (new)
Paragraph 16 b (new)
16b. Calls on the Commission and relevant authorities to provide regulatory flexibility to mitigate medicines shortages when they occur, by allowing targeted measures such as more flexibility for multi-language packs, different pack size and e-leaflet, to ensure that patients are able to access high-quality and safe medicines faster;
Amendment 638 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to set up an single innovative centralised digital platform for sharingreporting and notifying harmonised information provided by national agencies and all stakeholders regarding shortages of medicines and medical equipment; such a platform should be efficient, easy to work with, transparent and avoid duplications; welcomes the introduction by the EMA of the SPOC and i-SPOC systems, which should be integrated in the EU telematics strategy; calls for existing information systems to be improved so as to provide a clear overview of problems, shortages and requirementdemand and shortages in each Member State, with a view to preventing stockpiling;
Amendment 692 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls for an electronic information notice to be drawn up in all the Union languages for every medicine on the EU market,to accompany the paper leaflet with the implementation of a parallel electronic product information leaflet in all EU languages in order to facilitate sales ofmoving medicines between Member States; recommends the provision of more comprehensive information on the origin of medicineswithin the Single Market to prevent and mitigate a shortage;
Amendment 714 #
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, longer expiry periods, use of veterinary medicinal products, etc.; calls on the Commission to monitor strictly the use and the requirements of these arrangements and to keep them available in the event of problems or shortages;, also non COVID- 19 related
Amendment 725 #
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Calls on the Commission, in the context of the upcoming Pharmaceutical Strategy, to propose and implement an ambitious agenda to optimise the current regulatory framework, in order to contribute to the prevention of medicines shortage by reducing the administrative burden both for the regulators and the industry, reflecting the evolution in technology, as well as fostering greater economic resilience and therefore access to and availability of affordable medicines for patients; in this context, encourages the Commission to make use and implement the digital and telematics tools at pan-European level, as well as to consider amending Regulation (EC) No 1234/2008 (Variations Regulation) and the Variations Classification Guidelines;