21 Amendments of Patrizia TOIA related to 2020/2071(INI)
Amendment 8 #
Draft opinion
Recital A a (new)
Recital A a (new)
A a. whereas the Treaties and the European Charter of Fundamental Rights state that everyone shall have access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices; whereas this right should be enforced for all citizens, including those living in the smaller Member States and in the most peripheral areas of the Union;
Amendment 10 #
Draft opinion
Recital A a (new)
Recital A a (new)
A a. whereas uncoordinated initiatives at national level, such as stockpiling and penalties, could lead to an increased risk of medicines shortage, while a pan- European coordinated approach and a close dialogue among all actors concerned is crucial to mitigate and prevent medicines shortage, as the covid- 19 crisis has demonstrated;
Amendment 10 #
Draft opinion
Recital B
Recital B
B. whereas transport and logistics management are of crucial importance for the supply of medicine, pharmaceutical products, medical equipment, personal protective equipment, other medical supplies and raw materials, not least given the increasing degree of complexity of the transport chain, and whereas it is important to have efficient crossing green lane borders with fast track lanes in order to ensure the unobstructed flow of medicines;
Amendment 20 #
Draft opinion
Recital A b (new)
Recital A b (new)
A b. Whereas is fundamental to prevent medicine shortages, as well as to mitigate them in case they occur; shortages of medicines are a symptom of unsustainable policies, abundant scientific evidence demonstrates that medicines shortages have numerous root causes: specifically economic causes, increasing regulatory burden, unforeseen surges in demand, supply chain interdependencies and manufacturing and quality challenges;
Amendment 29 #
Draft opinion
Recital A c (new)
Recital A c (new)
A c. Whereas after the pandemic a global economic crisis is expected, this will challenge even more equitable access to medicines and competitiveness of industrial sector;
Amendment 41 #
Draft opinion
Paragraph 2
Paragraph 2
2. Stresses that boosting the industrial production of the Member States through favourable economic conditions in the context of national fiscal policie, social and environmental conditions would lead to a more efficient and sustainable logistics network, while reducing the length of transport routes, thereby reducing emissions, mitigating the impact on the environment, and improving the functioning of the internal market;
Amendment 48 #
Draft opinion
Paragraph -1 (new)
Paragraph -1 (new)
-1. Calls on the Commission to publish without any further delays the roadmap on EU Pharmaceutical Strategy which will identify root causes of medicine shortages; urges the Commission to propose ambitious and specific regulatory measures with an objective of making medicines available, affordable, sustainable and equally accessible; calls on the Commission to promote measures which will increase EU security of supply of medicines and reduce dependency on third countries;
Amendment 52 #
Draft opinion
Paragraph 4
Paragraph 4
4. Highlights the importance of IT systems in facilitating the exchange of information between the various actors involved in the transport logistics chain, including the customs authorities, with a view to optimising the distribution of medicines in the Member States and planning supply times more efficiently; calls on the Commission to develop mechanisms in cooperation with Member States in order to ensure a fast and safe transport of medicines; notes also the importance of having contingency plans that ensure the unobstructed transport of medicines when the transport sector is conditioned;
Amendment 53 #
Draft opinion
Paragraph 1
Paragraph 1
1. Insists that the Commission urgently launches a multi-stakeholder consultation to identify keyevidence-based drivers within the supply chain issuesand beyond that directly cause or increase the risk of medicine shortages; calls on the Commission to propose ambitious and concrete actions to address these issues in its planned pharmaceutical strategy;
Amendment 56 #
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Calls on the Commission to coordinate a Pan-European response, with European Medicines Agency (EMA), National Competent Authorities (NCAs), Member States, the pharmaceutical industry and all players in the pharmaceutical supply chain; a coordinated EU response is of utmost importance to coordinate Members States policy measures to individual and uncoordinated national measures to address medicines shortages root causes and prevent them in the long term as well as to 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;
Amendment 70 #
Draft opinion
Paragraph 2
Paragraph 2
2. Calls on the Commission to consider proposing requirements for the pharmaceutical industry to ensure that its supply chain is diversified andincentivize the pharmaceutical industry to put in place a medicine shortage risk mitigation plan for essential medicines to manage any vulnerabilities in and risks to the supply chain;
Amendment 74 #
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. 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 90 #
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Stresses the importance of ensuring the smooth functioning of the Internal Market in order to eliminate barriers to the access of medicines, medical devices and protective equipment to all citizens, especially those living in Member States that, due to their small size or to their remote position, heavily rely on imports and do not have easy access to the supply chain;
Amendment 93 #
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3 b. Whereas the coronavirus pandemic has highlighted Europe’s dependency on third countries for the production of essential medicines and medical devices, including active pharmaceutical ingredients(APIs), calls on the Commission to provide adequate financial resources under Horizon Europe and other EU programs to strengthen Union’s R&I activities supporting manufacturing in key industrial sectors, such as the pharmaceutical industry; calls on the Commission to reduce the R&I divide within the Union by ensuring broad geographical coverage and participation of low R&I performing Member States in collaborative projects; underlines that Horizon Europe and other EU programs need to support rare diseases through increased research, clinical trials, best practices sharing, and medication development; insists that research, best practices, clinical trials, and medication pertaining to rare diseases be made accessible for the benefit of citizens of all the Member States;
Amendment 103 #
4. Encourages the Commission to propose measures, including financial incentives, to promote investments in green manufacturing for medicines value chain, 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 107 #
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Having regard to the European Strategy for Data and the digital transformation of healthcare, urges the Commission to promote implementation of interoperable technologies in the Member State’s health sector which will facilitate delivery of innovative health solutions to patients; encourages the creation of a fully operational European Health Data Space with a governance framework which fosters creation of an innovative data-driven ecosystem and which encourages sharing of information and critical data across the Union; asks the Commission to promote next generation standards, tools and infrastructure to store and process data suitable for research and the development of innovative products and services, while ensuring processing of patients personal data is in compliance with European data protection framework;
Amendment 109 #
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Underlines that ensuring a fit for purpose regulatory environment is a key element to protect public health, provide access to high quality medicines and contribute to the prevention of shortages. The adequate use of Information Technology systems will improve regulatory efficiency across Europe; therefore, the Commission should optimize the European regulatory framework by harmonising regulatory telematics projects with a focus on data quality, interoperability and interdependency;
Amendment 115 #
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4 b. Calls on the Commission to take stock of the impact of coronavirus on industry and SMEs and to present a renewed EU industrial strategy; considers that the industrial recovery of Europe needs to prioritize twin digital and ecological transformation of our societies and building of resilience to external shocks; stresses the importance of promoting private-public partnerships in high value-added and innovative sectors, such as the pharmaceutical industry; stresses the importance of manufacturing for jobs, growth and competitiveness;
Amendment 129 #
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. In order to support Member States in the prevention of medicine shortages, calls on the Commission to develop targeted EU Guidelines on procurement of medicines by putting in place the right economic framework, under the EU public procurement Directive 2014/24/EU, aimed at ensuring long term sustainability, competition, security of supply and stimulating investments in manufacturing;
Amendment 135 #
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
Amendment 147 #
Draft opinion
Paragraph 5 c (new)
Paragraph 5 c (new)
5 c. Calls on the Commission and relevant authorities, in the mitigation of shortages of medicines, when they occur, to provide regulatory flexibility 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;