31 Amendments of Łukasz KOHUT 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 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 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 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 127 #
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Notes with concern market failure in several Members States where patients' access to effective and affordable medicines and medical devices remains threatened by very high and often unsustainable price levels, market withdrawal of products that are out-of- patent or a failure to introduce new products to national markets due to business strategies; recognises that access to medicines and medical devices in the Member States with smaller markets requires particular consideration in the new EU Pharmaceutical Strategy;
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 137 #
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5 b. Taking into account that timely notification of shortage of medicines is essential for ensuring alternative treatments for patient care and for mitigating negative effects on the security of supply, calls on the Commission to introduce obligation for marketing authorization holders to notify shortage of medicines to the competent authorities at a minimum two months in advance;
Amendment 144 #
Draft opinion
Paragraph 5 c (new)
Paragraph 5 c (new)
5 c. Calls on the Commission to expand its joint European response to include joint procurement actions 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 economical perspective due to their remote location or small size;
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;
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 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 573 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls on the Commission and the Member States to adopt a joint definition of ‘medicines of strategic importance for health care’ and of ‘criticality’, emphasising the value of these medicines for public health, the lack of alternatives and the vulnerability of the production chain; calls for a European regulatory authority to be designated to carry out the task of setting quotas for the allocation of medicines from that reserve to the Member States; calls for scheduled, independent and transparent reviews from the European regulatory authority so as to make sure designated medicinal quotas are quantifiable and puts all Member States on a level playing field and not give any advantage to one Member State over another;
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 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;