9 Amendments of Maria SPYRAKI related to 2021/2013(INI)
Amendment 98 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
C a. Whereas the strategy highlights the importance of removing barriers to access for generic and biosimilar medicines and the encouragement of their rapid uptake;
Amendment 102 #
Motion for a resolution
Recital C b (new)
Recital C b (new)
C b. Whereas for the Pharmaceutical Strategy to be fully effective it is necessary that it incorporates lessons learnt from the COVID-19 crisis and takes into consideration the resilience demonstrated by the off-patent medicines industry during the COVID-19 outbreak, so as to build on in the existing European manufacturing capacity;
Amendment 114 #
Motion for a resolution
Recital C c (new)
Recital C c (new)
C c. whereas it is important to recognise that cooperation is required between the Commission and Member States so as to set out ambitious implementation agendas with clear timelines and the necessary long-term financing to implement concrete actions that follow from the Pharmaceutical Strategy for Europe;
Amendment 173 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Welcomes the intention of the European Commission to assess and review the existing incentives framework; calls on the Commission to stimulate competition by adapting a regulatory framework and stimulating investments in off-patent orphan and paediatric medicines, including for oncology, paediatric cancers, and neurological diseases;
Amendment 305 #
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Welcomes the Commission's recognition of the importance of full clarification of the provision for the conduct of trials on patented products to support generic and biosimilar medicines marketing authorization applications (so called Bolar provision); calls for an urgent European harmonization and enlargement of the Bolar exemption, including all the processes needed to launch off-patent medicine at the expiry of patents including administrative actions to enable generic and biosimilar medicines to be on the market on day-1; urges a clear ban on all forms of patent linkage in the EU legislation, which are anti-competitive and delay generic and biosimilar market entry, frustrating the objectives of the Bolar exemption;
Amendment 551 #
17. Urges the Commission, based on the experience with the authorisation of COVID-19 vaccines, to work with the EMA to consider extending the application of rolling reviews to other emergency medicines; further calls on the Commission to work with the EMA, to develop the use of electronic product information for all medicines in the EUhe industry and all relevant stakeholders accelerate the development and adoption of electronic product information for all medicines in the EU by defining timelines and harmonised standards within a common European interoperable information exchange network;
Amendment 594 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; calls on the Commission to develop an early warning system for drug shortages, based on a European information exchange network on supply problems, to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;
Amendment 623 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20 a. Call on the Commission, in the context of the medicines manufacturing structured dialogue, to propose reforms and incentives to stimulate investments in medicines manufacturing and resilience of the pharmaceutical supply chain by introducing market reforms that make markets sustainable via smart procurement to reduce industrial consolidation pressure and create a level playing field, including digital transformation of the regulatory system that would maintain high EU scientific standards while dramatically reducing administrative burdens and vastly improve the EU crisis response to shortages as well as to stimulate investments in manufacturing technology (greening, digital, process technology, automation) that are needed to enable EU manufacturers to upgrade their technology to compete and to meet societal expectations for security, value added innovation and the environment;
Amendment 645 #
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21 a. Recalls the role of sustainable procurement practices in preventing medicines shortage and that, as recognised in the EU industrial strategy public procurement can lead to market consolidation and increases the risk of shortages; calls on the Commission to support Member States in the prevention of shortages by developing EU rules 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; considers that these 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, ensure timely procurement processes to ensure the plurality of manufacturers and competition of multi- source medicines as soon as they are available;