25 Amendments of Danilo Oscar LANCINI related to 2020/2071(INI)
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 80 #
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 to rely heavilyEurope manufacturing operations, from active ingredients to finished products, are numerous and sustainable policies should be encouraged to maintain and secure them; however the supply chain still relies 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 manufactured outside the EU, mainly in China and India, especially for off patent pharmaceutical, manufacturing come from outside the EU;
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 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 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 421 #
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 care; sStresses 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 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 501 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Recommends the introduction of centralised management to bring about greater transparency and more interaction between competent authorities and industry about potential disruption or interruption of supply 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 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 563 #
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 Statdetermine together with Member States the demand, to align and commit with the industry on the available capacity and lead times, and in case of gap between demand and capacity to support remediation actions via relevant regulatory flexibilities;
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 612 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. CRecalls 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;
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;