Activities of Sara CERDAS related to 2020/2071(INI)
Shadow opinions (1)
OPINION on shortage of medicines – how to address an emerging problem
Amendments (30)
Amendment 5 #
Draft opinion
Recital A
Recital A
A. whereas the problem of medicine shortages in the Member States is gettrowing ever more severe on account ofdue the lack of production capacity in the EU and the relocation of our industries in the sector to other markets in third countries;
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 31 #
Draft opinion
Paragraph 1
Paragraph 1
1. Calls on the Member States to enhance theirComission to coordinate with Member States a strategy for a cooperation in order to improve the distribution chain through better visibility and efficient monitoring, particularly on cross-border routes, and to establish corridors where medical supplies have priority of delivery;
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 45 #
Draft opinion
Paragraph 3
Paragraph 3
3. Calls on the Commission to work in coordination with the Member States in order to adopt strategic plans to upgrade their existing infrastructure for an efficient supply of medicines with a better use of all transport modes; deems it necessary to remove bottlenecks, boost intermodality (while favouring the shift to rail), finance the main hubs (ports, airports and intermodal platforms), and enhance the delivery of various types of goods, including dangerous goods crucial for the production of the chemical and pharmaceutical industry;
Amendment 46 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas medicine shortages are a growing public health threat with a serious impact on health care systems and public health;
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 #
Motion for a resolution
Recital A b (new)
Recital A b (new)
Ab. whereas the reason of medicine shortages is multifactorial, patient consumption does not always follow a trend and could change rapidly in a crisis;
Amendment 57 #
Draft opinion
Paragraph 5
Paragraph 5
5. Notes the importance of guaranteeing high safety standards for both transport infrastructure and employees, making it possible to manage significant volumes in the supply chain without disruptions or posing risks to health; underlines the importance of having good conditions for drivers in order to respect the resting time and good working conditions; further derogations of rest time rules should become more harmonised and limited to what is strictly necessary;
Amendment 62 #
Motion for a resolution
Recital B
Recital B
B. whereas medicines to treat cancer, infections and disorders of the nervous system account for more than half of those in short supply and the postponement or any interruption of the treatment could lead to worse health outcomes, increasing the burden of the disease and the healthcare expenditure;
Amendment 67 #
Draft opinion
Paragraph 6
Paragraph 6
6. Stresses the importance of catering to specific transport needs at local and regional levels, particularly in rural, mountain and insular, insular and outermost regions areas that are more difficult to access and involve higher delivery costs; notes that there are new automated delivery tools, such as via drones, available on the market that could help operators to access these areas;
Amendment 68 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas medicine shortages can lead to possible delays in patients’ treatment, to the need to switch to alternative therapies that could be less effective, to adverse effects and adherence problems or even life threat when a shortage concerns essential medicines
Amendment 71 #
Draft opinion
Paragraph 7
Paragraph 7
7. Notes that the COVID-19 outbreak has laid bare the weaknesses of the European production system,is highlighting the importance of delivering medicines swiftly in urgent and exceptional circumstances that could arise in the future; calls on the European Commission to prepare an agreement with drug- producing third countries, to ensure the transport of medicines overcoming any constraints that may occur, such as this case of the COVID pandemic.
Amendment 117 #
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 128 #
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 matureolder, yet essential, medicines being in particularly short supply; whereas pharmaceutical firms operate on a just-in- time basis;
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 287 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission and the Member States to take whatevernecessary actions is needed to restore European health sovereignty and local pharmaceutical manufacturing, giving priority to essential and strategic medicines; calls on the Commission to map out potential production sites in the EU;
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 342 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Urges the Commission and the Member States to introduce tax and financial incentivescentives supporting the diversification of supply in return for appropriate commitments and to authorise state aid to encourage producers to locate their operations in Europe, from compound manufacturing to packaging and distribution; emphasises the strategic significance of this sector and the importance of investing in European companies, in the interests of resource diversification;
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 509 #
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 supplysupply disruptions;
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 616 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls for further invitations to tender to be issued at European level in an effort to counter shortages during a time of crisis, as has been done following the onset of the COVID-19 virus, with simplified procedures in the interests of improved response times;
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;
Amendment 680 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Considers it essential to improve an early communication with healthcare professionals 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 data protection legislation; recommends the inclusion of information for healthcare professionals on available alternatives.