26 Amendments of Pietro FIOCCHI related to 2020/2071(INI)
Amendment 16 #
Draft opinion
Recital A a (new)
Recital A a (new)
A a. whereas uncoordinated measures at national level have demonstrated to be ineffective to fight against the covid19 crisis, while a pan-European coordination and dialogue is needed;
Amendment 22 #
Draft opinion
Recital A b (new)
Recital A b (new)
A b. whereas the combination of cost containment measures, lack of market predictability, combined with an onerous and rigid regulatory framework create an unsustainable environment for the European pharmaceutical industry to operate and to continue to act as a catalyst to enable sustainable access to medicines for patients;
Amendment 25 #
Draft opinion
Recital A c (new)
Recital A c (new)
A c. 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 33 #
Draft opinion
Recital A d (new)
Recital A d (new)
A d. whereas an efficient strategy should cover measures to mitigate medicines shortage, but also to prevent them from happening;
Amendment 36 #
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 79 #
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 98 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas, an economic crisis will likely result from the COVID-19 pandemic in Europe, and this will challenge even further the competitiveness of the European pharmaceutical industry and sustainable access to medicines for patients;
Amendment 105 #
Draft opinion
Paragraph 4
Paragraph 4
4. Encourages the Commission to propose measures, including financial incentives, to promote greeinvestments in manufacturing, within the EU, of strategically important chemicals used in medicine production; urges the Commission to also propose measures to incentivise the greater inclusion of EU small and medium-sized enterprises in the medicine supply chain given their key role in research and innovation and inherent ability to quickly adapt their production focus, with a view to coping better with unexpected shocks;
Amendment 111 #
Motion for a resolution
Recital D
Recital D
D. whereas the consequence of growing demand coupled with price suppressionpressure, lack of market predictability and an onerous and burdensome regulatory framework is the concentration of supply, a reduction in the number of chemicals manufacturers and a lack of alternative solutions should problems arise;
Amendment 130 #
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. 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 150 #
Motion for a resolution
Recital G
Recital G
G. whereas, in the absence of a regulatory authority,implementation of stockpiling in some Member States is leading to a market imbalance and increased possibility of medicines shortage, illustrating the absence of coordination at EU level in addressing medicines shortages;
Amendment 162 #
Motion for a resolution
Recital G a (new)
Recital G a (new)
Ga. whereas the 2009 financial crisis forced European countries to introduce unsustainable cost-containment measures - such as clawbacks and inefficient procurement mechanisms - to reduce pharmaceutical expenditure, which has led to withdrawals of products and companies from the market;
Amendment 164 #
Motion for a resolution
Recital G b (new)
Recital G b (new)
Gb. whereas uncoordinated measures at national level have demonstrated to be ineffective to fight against the COVID-19 crisis, while a pan-European coordination and dialogue is needed;
Amendment 188 #
Motion for a resolution
Recital J a (new)
Recital J a (new)
Ja. whereas the combination of cost containment measures, lack of market predictability, combined with an onerous and rigid regulatory framework create an unsustainable environment for the EU pharmaceutical industry to operate and to continue to act as a catalyst to enable sustainable access to medicines for patients;
Amendment 191 #
Motion for a resolution
Recital J b (new)
Recital J b (new)
Jb. whereas the 2009 financial crisis forced European countries to introduce unsustainable cost-containment measures - such as clawbacks and inefficient procurement mechanisms - to reduce pharmaceutical expenditure, which has led to withdrawals of products and companies from the market;
Amendment 192 #
Motion for a resolution
Recital J c (new)
Recital J c (new)
Jc. whereas an efficient strategy should cover measures to mitigate medicines shortage, but also to prevent them from happening;
Amendment 208 #
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 building on the existing 400 generic and biosimilar medicines factories which supply the majority of medicines to European patients;
Amendment 291 #
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 existing and potential production sites in the EU;"
Amendment 387 #
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 criterionto increase supply resilience should also be a criterion; urges the Commission, in the context of Directive 2014/24/EU on public procurement, to promptly propose ad-hoc guidelines for Member States to support sustainable tenders practices for pharmaceuticals;
Amendment 392 #
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Notes that targeted guidelines should cover clarifications and recommendations to Member States on how to implement multi-winner framework agreements, apply Most Economically Advantageous Tender (MEAT) criteria, recognise investments in security of supply for Europe; introduce sufficient manufacturing lead times that guarantee a continuous supply of medicines to patients; proportionally apply penalties that do not offset the prospective rewards for tender awardees; investigate and consider exclusion of abnormally low bids to the tender process ; ensure timely procurement processes to ensure competition of multi-source medicines as soon as they are available;
Amendment 425 #
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; 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 findingsMember 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;
Amendment 459 #
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 525 #
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 637 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to set up ana 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,demand and shortages and requirements in each Member State, with a view to preventing stockpiling; 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 to amend the Regulation (EC) No.1234/2008 (Variations Regulation) and the Variations Classification Guidelines;
Amendment 661 #
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Calls on the Commission to coordinate a Pan-European response on medicines shortages to ensure equitable and sustainable access to medicines; considers that 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; stresses that this Pan-European approach must focus on coordinating Member State policy measures to address the root causes of medicines shortages;
Amendment 691 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls for an electronic information notice to be drawn upto replace the paper leaflet with the implementation of an electronic product information leaflet in all the Union languages for everyall the countries where the medicine on the EUis marketed, in order to facilitate sales ofmoving medicines between Member States; recommends the provision of more comwithin the Single Market to prehvensive information on the origin of medicinest and mitigate a shortage;