Activities of Tiemo WÖLKEN related to 2020/2071(INI)
Shadow opinions (1)
Opinion on "Shortage of medicines: how to address an emerging problem"
Amendments (32)
Amendment 8 #
Motion for a resolution
Citation 13 a (new)
Citation 13 a (new)
- having regard to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and to the Doha Declaration on the TRIPS Agreement and Public Health,
Amendment 16 #
Motion for a resolution
Citation 24 a (new)
Citation 24 a (new)
- having regards to the 2016 Report of the United Nations Secretary General's High-Level Panel on Access to Medicine "Promoting innovation and access to health technologies",
Amendment 21 #
Motion for a resolution
Recital A
Recital A
A. whereas the increase inshortages of medicines within the EU have worsened exponentially in recent years and global demand has further aggravated shortages of medicines in the EU, undermining health services in the Member States and exposing patients to considerable riskntailing considerable risks for the health and care of patients, including disease progression and/or worsening of symptoms, increased exposure to falsified medicines, medication errors or adverse events occurring when the missing medicine is substituted by another one, avoidable transmission of infectious diseases, significant psychological distress; whereas the Member States have a duty to find swift and effective solutions through closer European integration;
Amendment 118 #
Motion for a resolution
Recital D
Recital D
D. whereas the consequence of growing demand coupled with price suppression is the concentration of active pharmaceutical ingredients supply, a reduction in the number of chemicals manufacturers and a lack of alternative solutions should problems arise;
Amendment 129 #
Motion for a resolution
Recital E
Recital E
E. whereas stocks of ‘strategic’ medicines are inadequate, with chemicals that are cheap and easy to produce and mature, yet essential medicines being in particularly short supply; whereas pharmaceutical firms operate on a just-in- time basis;
Amendment 148 #
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas profit-oriented decision making on the part of the pharmaceutical industry such as products’ discontinuations and withdrawals from particular (less profitable) Member States’ markets can often lead to medicine shortages;
Amendment 221 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Points out that, while public health policies are a Member State matter, it is incumbent upon the EU to coordinate and complement national measures to guarantee the protection of public health and equal access to affordable and high- quality health services for all European citizens;
Amendment 227 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Emphasizes that patent protection and enforcement should have due regard for the interests of society, namely the safeguard of human rights and public health priorities; in the same vein, recalls that patent protection should not interfere with the right to health and should not contribute to widening the gap between wealthier and poorer citizens when it comes to access to medicines; considers that the Union's approach to this question should ensure harmonisation and coherence among the different measures at the disposal of Member States;
Amendment 236 #
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses the need for health policies to focusimportance of always putting the interest and safety onf patients’ interests at the centre of European health policy and for closer cooperation between Member States;
Amendment 324 #
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls on the Commission to draw up a comprehensive study on root causes of shortages of medicines including economic, supply chain, manufacturing and/or quality related factors;
Amendment 328 #
Motion for a resolution
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Underlines that marketing authorizations files already contain all the information on the supply chain concerning pharmaceuticals; calls on the Commission and Member States to empower regulatory agencies to make better use of the existing information by using all telematics tools available to identify vulnerabilities and risks unknown to manufacturers in a timely manner, whilst also respecting commercially confidential information;
Amendment 354 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Calls on the Commission to introduce obligations for pharmaceutical companies to notify drug shortages according to Article 23a of Directive 2001/83/EC: underlines that other stakeholders involved in the supply chain such as wholesale distributors, pharmacists, hospitals and patients should also be included in the notification procedure of shortages ;
Amendment 391 #
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 tender 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 to increase supply resilience should also be a criterion;
Amendment 409 #
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Highlights the role that public procurement procedures by Member States’ authorities could have in reducing the risk of shortage of medicines, namely with regard to the number of production sites requested in the call for Tenders and the kind of contractual sanctions envisaged for failure to supply;
Amendment 414 #
Motion for a resolution
Paragraph 8 b (new)
Paragraph 8 b (new)
8b. Calls on the Commission to publish targeted public procurement guidelines for the pharmaceutical sector including the contribution to the security of EU supply and sufficient manufacturing lead-time to guarantee the supply of medicines for patients; underlines that these guidelines should clarify recommendations for Member States on what to consider specifically for the pharmaceutical sector whilst awarding bids; whereas the guidelines should be based on the principle of the Most economically Advantageous Tender (‘MEAT’) criteria, which aims to ensure the best value for money rather than simply the cheapest product;
Amendment 432 #
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; stresses the key contribution that can be made by new technologies and artificial intelligence in enabling European laboratory researchers to form networks and share their objectives and findings, whilst fully respecting the General Data Protection Regulation;
Amendment 454 #
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; stresses that when research is wholly or partially funded by EU funding and other public funds, the results need to stay within the public domain and have clear affordability and accessibility conditions attached to them;
Amendment 460 #
Motion for a resolution
Paragraph 11
Paragraph 11
11. Stresses the importance of high quality medical 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;
Amendment 466 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Contends that, especially during global health emergencies, publicly- funded scientific research should not be constrained by patent protection since it may constitute an undue and disproportionate obstacle to a quicker achievement of results and be in contradiction with the purpose of public financial support, in particular tackling the urgent medicine needs of EU citizens;
Amendment 474 #
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
11b. Stresses the need to ensure adequate provisions for medicine supply chains across the EU-UK borders are included in the future relationship agreement with the United Kingdom, as well as ensuring contingency plans are in place in case of a ‘no deal’;
Amendment 500 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Recommends the introduction of centralised management to bring about greater transparency in the distribution chain and the creation of a European supply management unit tasked with developing a European strategy to prevent and resolve breaks in supply; underlines that full transparency must be ensured about the causes of shortages including the market withdrawal of a medicine due to economic reasons:
Amendment 504 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Recommends the introduction of centralised management coordinated by the European Medicine Agency to bring about greater transparency in the distribution chain and the creation of a European supply management unit tasked with developing a European strategy to prevent and resolve breaks in supply;
Amendment 516 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Calls on the Commission and Member States to introduce mandatory shortage preventions plans for pharmaceutical companies;
Amendment 577 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls on the Commission and the Member States to adopt a joint definition of ‘medicine shortages’ relevant for all stakeholders and ‘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;
Amendment 598 #
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls on the Commission and Member States to develop innovative and coordinated strategies and to step up exchanges of good practice in the area of stock management; consideremphasizes that the European Medicines Agency (EMA) cshould be designated as the regulatory authority tasked with preventing shortages of essential medicines, with a correspondingly wider remit and more staff;
Amendment 619 #
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Calls on the Commission to consider measures such as expedient compulsory licensing of essential medicinal products on legitimate grounds of public health needs and fundamental rights as a way to allow Member States to more easily respond to shortage of medicines, including when it results from or is caused by public health crisis; recalls that this is one of the public health flexibilities in the field of patent protection already included in the World Trade Organisation’s TRIPS Agreement, further reaffirmed by the 2001 Doha Declaration; similarly, calls on the Commission to reflect on how increasing the level of transparency of voluntary licensing agreements could improve this response strategy;
Amendment 635 #
Motion for a resolution
Paragraph 17 b (new)
Paragraph 17 b (new)
17b. Calls on the Commission to assess whether, for the specific purpose of safeguarding public health against the risk of essential medicines shortage, reducing the time of patent protection, as well as secondary patents, or conditioning the granting of such protection in view of the amount of production that takes place with the Union could help achieve that objective;
Amendment 647 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to set up an innovative centralised digital platform for reporting and notifying information in a harmonised way, as well as sharing information provided by national agencies and all stakeholders regarding shortages of medicines and medical equipment; points out that such a platform should be efficient, easy to work with, transparent and avoid duplications; welcomes the introduction by the EMA of the SPOC and i-SPOC systems; calls for existing information systems to be evaluated and if needed improved so as to provide a clear overview of problems, shortages and requirements in each Member State, with a view to preventing stockpiling;
Amendment 654 #
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 including manufacturers, wholesalers and pharmacists regarding shortages of medicines and medical equipment; 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;
Amendment 676 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Considers it essential to improve early communication with healthcare professionrelevant stakeholders such as healthcare professionals, consumer organisations, pharmacist, hospitals and patients on medicine availability through the use of innovative digital tools providing real-time data on the availability, location, quantity and price of a given medicine, in compliance with dData pProtection legislation; stresses that for better uptake and usage the digital tool need to be barrier-free and available in all official Union languages;
Amendment 700 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls for an electronic information notice to be drawn up in all the Union languages and in a barrier-free way for every medicine on the EU market, in order to facilitate and fast-track sales of medicines between Member States in order to ensure faster patients' accessibility to high-quality and safe medicines; recommends the provision of more comprehensive information on the origin of medicines;
Amendment 718 #
Motion for a resolution
Paragraph 21
Paragraph 21
21. Welcomes, following the onset of the COVID-19 crisis, the introduction of more flexible rules in a bid to mitigate shortages and facilitate the circulation of medicines between Member States: acceptance of different packaging formats, reuse procedure to enable marketing authorisation holders to obtain approval in another Member State, longer expiry periods, use of veterinary medicinal products, etc.; calls on the Commission to monitor strictly the use of these arrangements and to keep them available in the event of problems or shortages also for non COVID-19 related medicines;