22 Amendments of Biljana BORZAN related to 2020/2071(INI)
Amendment 6 #
Draft opinion
Paragraph 1
Paragraph 1
1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms the vital role played by functioning global supply chains for medical products, and in particular for medicines; emphasises that an fair, open, rules-based trading system is fundamental to ensuring the global availability of medicines;
Amendment 16 #
Draft opinion
Paragraph 2
Paragraph 2
2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over- reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of medicines in the EU; calls on the Commission to present a long-term strategy focused on ensuring the EU’s open strategic autonomy in health, and the diversification of its supply chains;
Amendment 22 #
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Underlines that a complete repatriation of medical supply chains is not possible in a global economy; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains i.a. by establishing a global catalogue of essential emergency healthcare products in order to limit the resort to protectionist measures;
Amendment 33 #
Draft opinion
Paragraph 3
Paragraph 3
3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments; underlines that the flexibilities provided in the TRIPS agreement canshould be used to address potential supply shortages in exceptional circumstances;
Amendment 34 #
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
Amendment 51 #
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Notes that the whole world is fighting the COVID-19 pandemic, as no available medication that can fight the disease has been found yet; calls upon the Commission to coordinate with the WTO and the WHO that all countries, and in particular the developing countries, have equal access in case of any breakthrough drugs; encourages all member states to make efforts to establish a pool of patent rights for COVID-19 technologies at the WHO;
Amendment 53 #
Draft opinion
Paragraph 6
Paragraph 6
Amendment 64 #
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Calls upon the Commission and the Member States to make sure that there is a constant and reliable supply of medical products; stresses that the development of medical products has to be in line with the international standards of human rights, in compliance with the Paris agreement, and that labour rights are in compliance with the ILO conventions; calls on the Commission that to maintain a level playing field in the internal market a common European approach for binding supply chain law is urgently needed;
Amendment 67 #
Draft opinion
Paragraph 6 b (new)
Paragraph 6 b (new)
6 b. Emphasises the importance of European safety standards for medical products; urges the Commission to check medical products entering our internal market that they uphold to the European safety standards; calls upon the Commission to ensure that consumer protection is prioritised in the WTO negotiations on e-commerce in negotiation;
Amendment 196 #
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, vaccines, and medical equipment; proposes obligations for the Union’s pharmaceutical industry to have a diversified supply chain and a medicine shortage risk mitigation plan for managing any vulnerabilities and risks to their supply chain; stresses the importance of ensuring that all Member States especially those which are vulnerable from a public health and economic perspective due to their location or size have fair and affordable access to the supply chain;
Amendment 289 #
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; points out that a complete repatriation of medical supply chains is not possible in a global economy; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains;
Amendment 311 #
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’ dependence on third countries; believes that the strategies must include legislative measures, policies and incentives to encourage production of essential active pharmaceutical ingredients and medicines in Europe;
Amendment 314 #
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’ dependence on third countries; calls on the Commission to pay special attention to the possibility of a no- deal Brexit and the ramifications it can cause in medical trade and supply; calls on the Commission to propose ambitious and concrete actions to address these issues in its planned pharmaceutical strategy;
Amendment 386 #
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 tenderEuropean joint procurement 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 key criterion;
Amendment 407 #
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Calls on the Commission to expand its joint European response to include joint procurement actions and procedures for all developed vaccines, medication, medical equipment and medical technology; insists that this joint response be a priority post-pandemic, and be easily accessible for citizens in every Member State especially those that are particularly vulnerable from a public health and economic perspective due to their remote location or small size;
Amendment 430 #
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 in all Union countries irrespective of economic or spatial differences; stresses the key contribution that can be made by new technologies and artificial intelligence with proper data protection safeguards in enabling European laboratory researchers to form networks and share their objectives and findings;
Amendment 452 #
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 on the Commission to provide increased financial resources under Horizon Europe and other EU programmes to strengthen support for rare diseases through increased research, clinical trials, best practices sharing, and medication development; insists that best practices, clinical trials, and medication pertaining to rare diseases be available to all citizens regardless of their Member State;
Amendment 549 #
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, along the lines of the ‘RescEU’ mechanism, in order to alleviate shortages outside crisis periods; insists that the use of such a reserve be transparent, accountable, and fair for all Member States;
Amendment 592 #
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls on the Commission and Member States to ensure the setting up of common, European medical stocks; calls on the Commission and the Member States to develop innovative and coordinated joint strategies and to step up exchanges of good practice in the area of stock management; stresses that ensuring all Member States have fair and transparent access to these stocks through joint European coordination is crucial to managing vulnerabilities and risks to the supply chain; 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 staff;
Amendment 604 #
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Points out that the EU has no equivalent of the US Biomedical Advanced Research and Development Authority (BARDA), which is responsible for procurement and development of countermeasures against bioterrorism, chemical, nuclear and radiological threats as well as pandemic influenza and emerging diseases; believes that the creation of an EU equivalent to BARDA should be considered;
Amendment 624 #
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Calls on the Commission and Member States to revisit the idea of transparency of net pricing and reimbursement of different treatments, to allow Member States equal footing when negotiating with pharmaceutical companies for treatments that are not jointly procured;
Amendment 651 #
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; insists that such a digital platform be in strict compliance with the most recent data protection legislation; 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 problems, shortages and requirements in each Member State, with a view to preventing stockpiling;