11 Amendments of Csaba MOLNÁR related to 2020/2071(INI)
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 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 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 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 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 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 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;