Activities of Andrey KOVATCHEV related to 2020/2071(INI)
Opinions (1)
OPINION on shortage of medicines – how to address an emerging problem
Amendments (6)
Amendment 9 #
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 such as export restrictions 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; notes that such protectionist measures are likely to backfire and undermine global productive capacity as a whole; underlines that maintaining a stable and predictable trade and investment environment is the best way to leverage global manufacturing capacity when there is a surge in the demand for medicines; calls on the Commission to present a long-term strategy focused on ensuring the EU’s open strategic autonomy in health including through concrete measures that support diversification, security of supply and domestic manufacturing of critical products;
Amendment 24 #
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Urges the Commission and Member States to conduct an in-depth mapping and analysis of the global supply chains for medicines; demands that, if such a mapping reveals substantial vulnerabilities and risks of supply disruption, remedial action be taken;
Amendment 31 #
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 and for maintaining EU's global competitive advantage in innovation; underlines that the flexibilities provided in the TRIPS agreement can be used to address potential supply shortages in exceptional circumstances;
Amendment 38 #
Draft opinion
Paragraph 4
Paragraph 4
4. Emphasises that a broad network of FTAs together with a functioning multilateral trading system constitute the best way of guaranteeing that multiple sources of manufacturing for essential medicines are available and regulatory standards converge globally; recalls that difference in regulatory frameworks and standards for medicinal products can create an obstacle to trade; encourages the adoption of international standards to ensure the quality and safety of imported final or intermediate medicinal products and the inclusion of strong regulatory cooperation provisions in EU bilateral trade agreements to ensure that all medicinal products destined for the European market fulfill the applicable quality standards;
Amendment 47 #
5. Strongly encourages all countries to join the WTO’s Pharmaceutical Tariff Elimination Agreement; calls for its scope to be extended to all pharmaceutical and medicinal products; stresses that medical products and medicines, including in their intermediate forms, should be exempted from retaliation in trade disputes;
Amendment 65 #
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Calls on the Commission and the Member States to ensure the swift and full implementation - and if needed a revision - of the regulation on FDI screening, in which health care should be included as a strategic sector;