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Activities of Sara SKYTTEDAL related to 2020/2071(INI)

Shadow opinions (1)

OPINION on shortage of medicines - how to address an emerging problem
2020/06/16
Committee: ITRE
Dossiers: 2020/2071(INI)
Documents: PDF(175 KB) DOC(81 KB)
Authors: [{'name': 'Joëlle MÉLIN', 'mepid': 124765}]

Amendments (41)

Amendment 3 #
A. whereas the problem of medicine shortages in the Member States is getting ever more severe on account of the lack of production capacity in the EU and the relocation of our industries in the sector to other markets in third countries; whereas fostering medical innovation and research in the EU is required to benefit patients and to ensure the EU pharmaceutical industry remains globally competitive;
2020/05/19
Committee: TRAN
Amendment 5 #
Draft opinion
Recital A
A. whereas the coronavirus pandemic has exacerbated the growing problem of medicine shortages across the EU; whereas the ensuing disruption of the global supply chain has highlighted the EU’s dependency on third countries for medicines and, active pharmaceutical ingredients, starting materials and other components entering into medicines manufacturing; whereas the novel coronavirus pandemic revealed also shortages on medical devices, medical products and protective equipment;
2020/05/19
Committee: ITRE
Amendment 11 #
Draft opinion
Recital A a (new)
A a. whereas a European coordination and dialogue is needed to address medicine shortages, and whereas it is known that medicine shortages have multi factorial root causes: economic causes, regulatory burden, unforeseen surges in demand, supply chain interdependencies, including on third countries, and manufacturing challenges;
2020/05/19
Committee: ITRE
Amendment 24 #
Draft opinion
Recital A b (new)
A b. whereas the coronavirus pandemic has demonstrated that a European coordination and cooperation is needed to fight against health threats, as opposed to individual and uncoordinated measures at national level;
2020/05/19
Committee: ITRE
Amendment 27 #
Draft opinion
Recital A c (new)
A c. whereas two key trends strongly affect the continuity of supply in times of crisis more than the location of the production of Active Pharmaceutical Ingredient (API) these are, closure of boarders within the EU and overstocking at different levels, patients, pharmacies and distributors;
2020/05/19
Committee: ITRE
Amendment 30 #
Draft opinion
Recital A d (new)
A d. whereas manufacturing of medicines and other medical products are challenging and require highly sophisticated facilities, procedures and highly trained staff to ensure quality, safety and efficiency of medicines;
2020/05/19
Committee: ITRE
Amendment 35 #
Draft opinion
Recital A e (new)
A e. whereas the quality of medicines and other medical products must conform to strict EU regulatory standards, which are amongst the highest of existing standards worldwide;
2020/05/19
Committee: ITRE
Amendment 39 #
Draft opinion
Recital A f (new)
A f. whereas the economic root causes of shortages which include but are not limited to, the fact that European markets are frequently a monopoly where the buyer is also the price setter;
2020/05/19
Committee: ITRE
Amendment 40 #
Draft opinion
Recital A g (new)
A g. whereas the complexity of the supply chain, the economic relations of the different actors involved and the complexity of manufacturing, storage, distribution and dispensing medicines, it is possible that medicine shortages arise due to any failure related to these factors;
2020/05/19
Committee: ITRE
Amendment 42 #
Draft opinion
Recital A h (new)
A h. whereas, following the coronavirus pandemic, Europe will have to face an economic crisis which will challenge even further access to medicines and the competitiveness of the European pharmaceutical industry;
2020/05/19
Committee: ITRE
Amendment 45 #
Draft opinion
Recital A i (new)
A i. whereas it is of utmost importance to prevent shortage of medicines, as well as to mitigate them in case they occur;
2020/05/19
Committee: ITRE
Amendment 47 #
Draft opinion
Recital A j (new)
A j. whereas the pharmaceutical industry employs 765,000 people in Europe, and supports around 2.7 million jobs in the EU;
2020/05/19
Committee: ITRE
Amendment 49 #
Draft opinion
Paragraph 1
1. Insists that the Commission urgently launches a multi-stakeholder consultation to identify key supply chain issues that directly cause or increase the risk of medicine shortages; establishes a permanent, concrete and action-oriented dialogue with the EMA, National Competent Authorities (NCAs), Member States, the pharmaceutical industry and all actors in the pharmaceutical supply chain, establishes a European and effective policy framework to prevent shortages in the long-term, by sharing information, reporting anticipated shortages, by improving the transparency of the supply chain; calls on the Commission to propose ambitious and concrete actions to address these issues in its planned pharmaceutical strategy;
2020/05/19
Committee: ITRE
Amendment 53 #
Draft opinion
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; stresses that medical supply chains can be improved through investments in skills, health data infrastructure, supporting regulatory framework and intellectual property policies that foster innovation;
2020/05/19
Committee: TRAN
Amendment 59 #
Draft opinion
Paragraph 1 a (new)
1 a. Calls on the Commission to ensure a European coordination to tackle medicines shortage and to create a single pan European harmonised reporting and notification system, initially focusing on the pan European critical list of products, covering both Centralised and National Marketing Authorisations;
2020/05/19
Committee: ITRE
Amendment 61 #
Draft opinion
Paragraph 1 b (new)
1 b. Calls on the Commission and Member States to put in place the financial incentives which rewards investments in medicines quality and security of supply; in particular, in the context of the EU public procurement Directive 2014/24/EU, urges the Commission to develop specific guidance to support sustainable procurement practices for pharmaceuticals, notably on how to best implement the MEAT (Most Economic Advantageous Criteria) criteria, as defined by the Directive, for the markets where tender practices are used;
2020/05/19
Committee: ITRE
Amendment 63 #
Draft opinion
Paragraph 1 c (new)
1 c. Calls for remedies against single winner, price-only tenders that cause severe price erosion, reducing the number of suppliers on the market and often results in short lead times and apply harsh penalties on companies which in turn increase the risk of shortages of medical products;
2020/05/19
Committee: ITRE
Amendment 64 #
Draft opinion
Paragraph 1 d (new)
1 d. Supports the Commission's call on all Member States to lift export bans on medicines within the internal market, export bans are damaging the availability of medicines for European patients, furthermore, measures leading to requisitioning of medicines, intermediates or APIs, or their production, should not be considered as an option, especially as far as they are applied to APIs or intermediates, because they are critical to medical industry output;
2020/05/19
Committee: ITRE
Amendment 66 #
Draft opinion
Paragraph 2
2. Calls on the Commission to consider proposing requirementprovide incentives for the pharmaceutical industry to ensure that its supply chain is diversified and sufficient at the EU level and put in place a medicine shortage risk mitigation plan for essential medicines to manage any vulnerabilities in and risks to the supply chain; a risk mitigation plan should include solutions for strategic storage of medicine to ensure supply for a reasonable period of time; highlights the importance of R&D investments for ensuring the pharmaceutical industry can respond to tomorrow’s needs;
2020/05/19
Committee: ITRE
Amendment 72 #
Draft opinion
Paragraph 7
7. Notes that the COVID-19 outbreak has laid bare the weaknesses of the European production system, highlighting the importance of delivering medicines swiftly in urgent and exceptional circumstances that could arise in the future; highlights the importance of R&D investments to ensure that the pharmaceutical industry can respond to tomorrow’s needs.
2020/05/19
Committee: TRAN
Amendment 73 #
Draft opinion
Paragraph 2 a (new)
2 a. Highlights examples of shortages are associated with the time necessary to fulfil the regulatory requirements including regulatory time lag and national requirements; calls on the Commission to coordinate a European response on medicines shortages to ensure equitable and sustainable access to medicines;
2020/05/19
Committee: ITRE
Amendment 76 #
Draft opinion
Paragraph 2 b (new)
2 b. Emphasises that pharmaceutical pricing policies that are solely containing expenditure do not allow for price adjustments to reflect the changes in cost of goods, manufacturing, regulatory procedures and distribution and have a negative effect on supply reliability;
2020/05/19
Committee: ITRE
Amendment 80 #
Draft opinion
Paragraph 2 c (new)
2 c. Highlights that the due to parallel trade there is a discrepancy between the volume manufactures release on a given market, the volume of exports and imports and the actual patients’ needs from the said market which can give rise to shortages; acknowledges that supply quotas applied by marketing authorisation holders on healthcare product distribution are set on several parameters including estimates of national patient needs;
2020/05/19
Committee: ITRE
Amendment 83 #
Draft opinion
Paragraph 3
3. Stresses the urgent need for the EU to protect its strong pharmaceutical industrial basis while rethinking the security of its supply to reduce its over- reliance on a small number of third countries for medicine manufacturing and as sources of active pharmaceutical ingredients; calls on stakeholders to diversify their supply chains in order to reduce vulnerability; to this end, calls on the Commission to closely examine the impact of European import dependency for, inter alia, medical equipment, artificial respiratory equipment, chemicals and raw materials from third countries, notably China and other countries where the state exercises significant influence on the market, and include in the planned pharmaceutical strategy measures to cope with any disruption in global value chains, specifically by means of increased EU coordination and strategic global partnerships;
2020/05/19
Committee: ITRE
Amendment 89 #
Draft opinion
Paragraph 3 a (new)
3 a. Calls on Commission to assist Member States to develop national stockpile strategies to increase EU preparedness while at the same time minimize costs associated with national stockpiles, acknowledges that the issue of inventory of important medicines, and possibility to increase manufacturing readiness for a few particularly important medicines, must be viewed from a longer time perspective;
2020/05/19
Committee: ITRE
Amendment 94 #
Draft opinion
Paragraph 3 b (new)
3 b. Calls on the Commission to assist Member States develop stockpiles of important medicines as a shared public- private responsibility, emphasizes that designing a system for such an emergency inventory should be part of the planned pharmaceutical strategy and should include how inventory keeping can be kept up to date with medical development, calls on the Commission to explore the possibilities to stockpile at the EU level through RescEU, stresses that shortage of medicines is a matter of national security, by improving the resilience of Member States critical health care infrastructure the overall perseverance of the EU is increased;
2020/05/19
Committee: ITRE
Amendment 97 #
Draft opinion
Paragraph 3 c (new)
3 c. Calls on the Commission to ensure that EU level stockpiling is synchronized with Member States in order to guarantee that stockpiling by Member States at the national level is coordinated in order guarantee the resilience and perseverance of European societies in times of crisis and/or conflict;
2020/05/19
Committee: ITRE
Amendment 98 #
Draft opinion
Paragraph 3 d (new)
3 d. Calls on the Commission, in close collaboration with Member States, to prepare and adopt a European pandemic preparedness plan, in order to ensure a coordinated and effective European pandemic response; emphasizes that this should include measures ensuring open borders in order to protect the free movement of goods, and in particular medicines;
2020/05/19
Committee: ITRE
Amendment 100 #
Draft opinion
Paragraph 3 e (new)
3 e. Calls on the Commission to preserve an active research-based pharmaceutical industry in Europe, also taking into account that EU remains the world leader manufacturing region of active ingredients for on patent medicines as stated in President Von Der Leyen's mission letter to Commissioner Kyriakides;
2020/05/19
Committee: ITRE
Amendment 106 #
Draft opinion
Paragraph 4
4. Encourages the Commission to propose measures, including financial incentives, to promote green manufacturing, 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;
2020/05/19
Committee: ITRE
Amendment 108 #
Draft opinion
Paragraph 4 a (new)
4 a. Calls the Commission to introduce a centralised and harmonized definition of shortages for reporting and monitoring from manufacturing authorisation holders (MAHs) to the national competent authorities and/or EMA in order to facilitate communication of shortages amongst Member States and in order to facilitate EU level monitoring; furthermore, a clearly definition “risk of shortage” is essential to support the notification process to Competent Authorities; furthermore, to assess the possibility to use the EMVS (European Medicines Verification System) data repositories at aggregated level as a tool to over see shortages;
2020/05/19
Committee: ITRE
Amendment 116 #
Draft opinion
Paragraph 4 b (new)
4 b. Stresses the need to coordinate amongst Members States, regardless of the type of product registration procedure, especially a definition of “essential” medicines products should be established and given priority when addressing shortages; furthermore, there is a need to ensure a tailored approach with reasonable and appropriate security measures, incentives and appropriate penalties in case of failure to supply;
2020/05/19
Committee: ITRE
Amendment 117 #
Draft opinion
Paragraph 4 c (new)
4 c. Calls on the Commission to establish a cooperation mechanism to coordinate EU, national policies to address medicine shortages, strong cooperation amongst institutions and Member States are necessary to reduce the risk of shortages, and to avoid spill over effects where one Member States policy could create supply issues in another Member State, moreover, monitoring shortages at EU level is essential to streamline efforts to collaboratively tackle the issue;
2020/05/19
Committee: ITRE
Amendment 118 #
Draft opinion
Paragraph 4 d (new)
4 d. Acknowledges that the movement of medicines throughout Member States are not only controlled by the pharmaceutical companies due to parallel trade;
2020/05/19
Committee: ITRE
Amendment 119 #
Draft opinion
Paragraph 4 e (new)
4 e. Highlights that parallel trade sometimes cover up to 80 or 90% of some Member States demand, which creates a fragile supply chain; furthermore, despite providing up to 1,5 to 2 times the amount of medicines needed to cover the market, some patients still do not receive access to essential medicines because they are diverted by parallel traders to other parts of the European market;
2020/05/19
Committee: ITRE
Amendment 120 #
Draft opinion
Paragraph 4 f (new)
4 f. Stresses the importance that the Commission addresses the issue of legal parallel trade in order to prevent shortages due to exports caused by high differences in terms of prices of a medicine, between Member States;
2020/05/19
Committee: ITRE
Amendment 121 #
Draft opinion
Paragraph 4 g (new)
4 g. Calls on the Commission to create a real time alert system on shortage of medicines in each Member State, based on EMA single point of contact network, in order to collect data from all EU for essential life-saving medicines shortages and to temporary restrict parallel trade until the respective shortage is restored;
2020/05/19
Committee: ITRE
Amendment 123 #
Draft opinion
Paragraph 5
5. Highlights the fact that Horizon 2020 has already financed a significant number of health-related research and innovation activities; calls for more funding to be provided through Horizon Europe to create and support medicine- focused research ecosystems.; stresses that a leading medical research ecosystem requires skills, networks and academic connections, health data infrastructure, functioning regulatory framework and intellectual property policies that foster innovation;
2020/05/19
Committee: ITRE
Amendment 128 #
Draft opinion
Paragraph 5 a (new)
5 a. Encourages the Commission to make the most of the digital and telematics tools at European level for regulatory processes in order to contribute to the prevention of medicines shortage (ex. eLeaflet), reducing the administrative burden for the industry and for the regulators, as well as fostering greater economic resilience and therefore access to and availability of affordable medicines for patients;
2020/05/19
Committee: ITRE
Amendment 141 #
Draft opinion
Paragraph 5 b (new)
5 b. Calls on the Commission to amend the EC Variations Regulations 1234/20081c and Variations Classification Guideline in order to modernise the current variations system and to reflect the evolution in technology and regulatory needs of all actors involved; _________________ 1cCommission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ L 334, 12.12.2008, p. 7)
2020/05/19
Committee: ITRE
Amendment 145 #
Draft opinion
Paragraph 5 c (new)
5 c. Calls for the Commission to provide an environment where the research-based pharmaceutical industry is incentivized to develop solutions for unmet medical needs, such fight against antimicrobial resistance; calls on the Commission to maintain a robust European IP system under the forthcoming European Pharmaceutical Strategy, to encourage R&D and manufacturing in Europe to ensure that Europe remains an innovator and world leader;
2020/05/19
Committee: ITRE