Activities of Alessandra MORETTI related to 2020/2071(INI)
Shadow reports (1)
REPORT on the shortage of medicines – how to address an emerging problem
Amendments (37)
Amendment 44 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas shortages of medicines is a growing public health threat with a serious negative impact on health care systems and the right of every patient in the EU to access appropriate medical treatment;
Amendment 69 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas medicine shortages can lead to possible delays in patients’ treatment, the need to switch to alternative therapies that could be less effective, adverse effects and adherence problems or even a threat to life;
Amendment 82 #
Motion for a resolution
Recital C
Recital C
C. whereas the loss of European sovereignty and independence in the health sector is linked to the relocation of production, with 40% of medicinal end products marketed in the EU now originating in third countries; whereas the only way to save money is to relan important role is played in the EU by theavily on subcontractors to produce pharmaceutical raw materials in Asia, manufacturing footprint already in place; whereas labour costs and environmental standards areoutside the EU are often lower, with the result that 80% of active ingredients are manufactured outside the EU, mainly in China and India;
Amendment 97 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas the health crisis linked to COVID-19 will likely be followed by an economic crisis in Europe, challenging the sustainability of healthcare systems, access to treatment for patients, as well as the competitiveness of the sector on a global scale;
Amendment 142 #
Motion for a resolution
Recital F
Recital F
F. whereas there are no price harmonisation arrangements to facilitate ‘parallel exports’ to countries where the medicine in question is more expensive; whereas parallel exports have determined in some cases the unintended consequence of creating disruptions in supply across Member States;
Amendment 146 #
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas profit-oriented decision making, discontinuations of products and withdrawals from particular Member States’ markets, which are less profitable, are common reasons for medicine shortages; whereas there are several other root causes of medicines shortage, amongst them economic causes, regulatory burden, unforeseen surges in demand, supply chain interdependencies and manufacturing and quality challenges;
Amendment 158 #
Motion for a resolution
Recital G
Recital G
G. whereas, in the absence of a regulatory authority, stockpiling in some Member States is leadingcoordination and regulatory measures at EU level, stockpiling in some Member States is leading to reduced access to treatments for patients in the EU and to a market imbalance;
Amendment 180 #
Motion for a resolution
Recital J
Recital J
J. whereas the destruction of biodiversity, the proliferation of man-made habitats and damage to natural areas densely populated by humans and unsustainable food production methods are facilitating the propagation of zoonoses, i.e. the transmission to humans and rapid spread of animal pathogens;
Amendment 197 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses the geostrategic imperative thatfor the Union to regain its sovereignty and independence with regard to health care and with the objective of rapidly and efficiently secureing its supply of medicines and medical equipment;
Amendment 216 #
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 tothe running of health care systems are a Member State matter, the EU has an important role in public health, including coordinateing and complementing national measures to guarantee affordable and high-quality health services for European citizens;
Amendment 251 #
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Stresses that shortage of medicine is a serious threat to the right to essential medical treatments for patients in the EU, generating inequalities between patients depending on their country of residence and also creating possible disruption of the single market;
Amendment 257 #
Motion for a resolution
Subheading 1
Subheading 1
Securing supplies in the interests of patients and, restoring health sovereignty and ensuring access to medical treatment to all patients in the EU;
Amendment 276 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission and the Member States to take whatever action is neededaction to restore European health sovereignty and local pharmaceutical manufacturing, giving priority to essential and strategic medicines to be defined and identified by public authorities at EU level in close cooperation with Member States and to preserve an attractive ecosystem for R&D in the pharmaceutical sector; calls on the Commission to map out existing and potential production sites in the EU;
Amendment 310 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to address in its nextupcoming pharmaceutical and industrial strategies issues relating to the availability and accessibility of medicines and manufacturers’ dependence on third countries; stresses the importance of pan- European coordination and dialogue and asks the Commission to evaluate in its upcoming strategies the inclusion of dialogue platforms with the participation of the relevant stakeholders;
Amendment 334 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Urges the Commission and the Member States to introducAcknowledges that the pharmaceutical industry plays an important role for quality manufacturing and supply of medicines to reach all patients in need, to contribute to future innovation, support the resilience, responsiveness and readiness of healthcare systems and help address future challenges including pandemics; Asks the Commission and the Member States, if needed for public interest, to evaluate economic sustainable policies, such as for example tax and financial incentives, in return for appropriate commitments and to authorise state aid to encourage producers to re-locate their operations in Europe, fromin the EU the production of active pharmaceutical ingredients (APIs), medicine and 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 diversificationobserves that any incentive should incorporate public safeguards, such as transparency regarding public contributions and clauses on accessibility and affordability of manufactured medicines to ensure they are equally available at a fair price; emphasises the strategic significance of this sector and the importance to protect the public interest and affordable access to treatment;
Amendment 353 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Calls on the Commission and Member States to ensure that market authorisation holders and wholesale distributors comply with the requirement of Directive 2001/83/EC to ensure appropriate and continued supplies of medicines; recalls the public responsibility of marketing authorisation holders and wholesale distributors to ensure an appropriate and prompt marketization and distribution of medicine in order to guarantee the right to equal treatment to all patients in the EU, regardless of their country of residence; calls on the Commission to clarify the marketing authorisation holder’s obligations under the Directive 2001/83/EC and highlights the need to ensure that market authorization holders report about all medicines shortages within the established timeframes; stresses the need to apply dissuasive sanctions for non-compliance with these legal obligations; calls on the Commission to explore how the requirement to ensure continued supplies could be strengthened;
Amendment 371 #
Motion for a resolution
Paragraph 6 b (new)
Paragraph 6 b (new)
6b. Calls on Member States to require market authorisation holders to submit medicines shortage prevention plans for risk mitigation, as part of their obligation to ensure continuous supply as foreseen by Directive 2001/83; stresses the need to make such prevention plans mandatory by EU law; calls for ensuring proactive monitoring of medicines at risk of shortage at EU and national level;
Amendment 411 #
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Notes that procurement practices focusing solely on price have resulted in manufacturers withdrawing from national markets leading to market consolidation and an increasing risk of medicines shortages; calls on the Commission and Member States to engage in a structured exchange to apply criteria other than price in tendering procedures such as reliability of supply;
Amendment 422 #
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 findingaddress the issue of medicine shortages and contribute to the availability of medicines on the markets of different Member States;
Amendment 439 #
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. 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; urges the Commission and the Member States to ensure that algorithm- based technologies used to address medicines shortages are effective and compliant with the European Data Protection framework;
Amendment 449 #
Motion for a resolution
Paragraph 11
Paragraph 11
11. Stresses the importance of research and innovation, and calls for the estincluding off-patent research, in order to achieve secure and appropriate availabilishment of a genuine European network, given that the price of relocation must not be a deterioration in the quality of medicalty of medicines thus guaranteeing the right to equal treatment to all patients in the EU, and calls for appropriate funding to be allocated by EU and national budgets; urges the European Commission and Member States to include availability and affordability related conditions in research funds;
Amendment 499 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Recommends the introduction of centralised managementCalls on Member States, in close collaboration with the Commission and other affected stakeholders, to explore alternative approaches to ensuring adequate stocks, such as the effective enforcement of existing regulatory requirements on all actors in the supply chain at national level, as well as measures to increase transparency within the supply chain; recommends the introduction of centralised management under the leadership of the European Medicines Agency (EMA) 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 542 #
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, alalong the lines of the ‘RescEU’ mechanism, in order to alleviate shortages outside crisis periods, and to require marketing authorization holders to ensure stocks of medicine in the form of finished product, particularly for those medicines for which no or only limited alternatives are available, and where discontinuation of supply will result in a potential risk for public health; calls ong the lines of the ‘RescEU’ mechanism, in order to alleviate shortages outside crisis periods; Commission to ensure transparency around the functioning of this mechanism and the criteria to distribute stocks; urges the Commission to develop guidance and a monitoring system to ensure that national initiatives on stockpiling are proportionate to the needs; in this regard welcomes the Commission proposal for the EU4Health Programme;
Amendment 576 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls on the Commission and the Member States to adopt a joint definition of 'shortage of medicines', ‘medicines of strategic importance for health care’ and of ‘criticality’ while taking into account patients' needs, 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 589 #
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; recognizes the European Medicines Agency (EMA) as the body best suited to take the responsibility of the European response to medicines shortages; considers that the European Medicines Agency (EMA) cshould be designated as the regulatory authority coordinating and monitoring medicines shortages at EU level during emergencies and beyond, tasked also with preventing shortages of essential medicines, with a correspondingly wider remitstronger mandate, wider remit, better infrastructures, and more staff;
Amendment 609 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls for further invitations to tenderjoint procurements to be issued at European level in an effort to counter shortages, as has been done following the onset of the COVID-19 virus, with simplified procedures in the interests of improved response times; calls for EU joint procurement to be used more routinely to ensure supply and access to medicines and medical devices when considered appropriate; in this regard calls on the Commission to propose a Regulation to revise the Cross Border Health Threats Decision, which establishes Joint Procurement Mechanism;
Amendment 620 #
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Recognises the importance of drawing lessons from the COVID-19 crisis in order to be better prepared for and deal with future pandemics more effectively; therefore calls on the Commission, in close collaboration with Member States, to launch a EU pandemic preparedness plan, in order to ensure a coordinated and effective European pandemic response, with appropriate response mechanisms already in place;
Amendment 634 #
Motion for a resolution
Paragraph 17 b (new)
Paragraph 17 b (new)
17b. Calls on the Commission and Member States to take action against the distortive effects caused by parallel imports in some Member States in order to ensure that medicines reach all patients in the EU in a timely way;
Amendment 648 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the CommissionMember States to set up interoperable databases to foresee and report on shortages; calls on the Commission together with the EMA to set up an innovative centralised digital platform for sharing information provided by national agencies and all stakeholders regarding current or expected 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 and further developed so as to provide a clear overview of problems, shortages, available stocks and requirements in each Member State, also with a view to preventing stockpiling;
Amendment 665 #
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Calls on the Commission together with the EMA to setup a comprehensive and user-friendly database informing on expected or current medicines shortages and for it to be available to health care authorities at all levels, together with appropriate information about existing alternatives; stresses the need to ensure transparency about the causes of medicines shortages;
Amendment 678 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Considers it essential to improve 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; recalls that health care professionals must have access to up- to-date information to be able to adequately respond to arising and existing shortages given that early awareness of a supply problem and early identification of potential therapeutic alternatives may mitigate possible adverse reactions which endanger patient safety;
Amendment 702 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls for an electronic information notice to be drawn up in all the Union languages for every medicine on the EU market, in order to facilitate sales of medicines between Member States, without replacing the paper Patient Information Leaflet; recommends the provision of more comprehensive information on the origin of medicines;
Amendment 721 #
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Welcomes the creation by the Commission of a Clearing House for medical equipment on COVID-19, which aims to support Member States in matching supply and demand of medical equipment at EU level, identify and overcome bottlenecks in the supply chain and exchange information on supply and demand in view of actions to be implemented by the Emergency Support Instrument;
Amendment 739 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Believes that EU healthcare systems need more common standards and better interoperability in order to avoid medicines shortages and provide quality healthcare for all in society, therefore calls on the Commission to propose a directive setting minimum standards for quality healthcare systems, based on the findings of stress tests;
Amendment 742 #
Motion for a resolution
Paragraph 22 b (new)
Paragraph 22 b (new)
22b. Highlights with concern the shortages of some medicines that have occurred during the COVID19 crisis, including shortages of medicines used in intensive care; underlines the importance of maintaining the production, supply, distribution, development and equal access to high-quality medicines, coordinated by EMA; notes with concern the export bans placed on some medicines globally and welcomes the engagement by the Commission to secure the supply of medicines; underlines that experimental use of medicines to treat COVID-19 must not lead to shortages for patients with other conditions, who depend on these medicines;
Amendment 744 #
Motion for a resolution
Paragraph 22 c (new)
Paragraph 22 c (new)
22c. Insists that, in preparation of a safe and efficacious vaccine or treatment against COVID-19 being developed and authorised, all steps must be taken to ensure rapid production and distribution is possible in Europe and globally, ensuring fair and equal access to the vaccine or treatment;
Amendment 746 #
Motion for a resolution
Paragraph 22 d (new)
Paragraph 22 d (new)
22d. Welcomes the World Health Assembly resolution of 18 May 2020 which calls for the universal, timely and equitable access to and fair distribution of all quality, safe, efficacious and affordable essential health technologies and products including their components and precursors required in the response to the COVID-19 pandemic as a global priority, and the urgent removal of unjustified obstacles thereto consistent with the provisions of relevant international treaties including the provisions of the TRIPS agreement and the flexibilities as confirmed by the Doha Declaration on the TRIPS Agreement and Public Health;