33 Amendments of Cristian-Silviu BUŞOI related to 2020/2071(INI)
Amendment 13 #
Motion for a resolution
Citation 20 a (new)
Citation 20 a (new)
- having regard to the platforms that have been set up under the current COVID-19 crisis in order to prevent medicine shortages and to flag them as early as possible, including the European Medicines Agency (EMA) Industry Single Point of Contact (I-SPOC) system, which streamlines the process for reporting potential shortages,
Amendment 24 #
Motion for a resolution
Recital A
Recital A
A. whereas the increase in global demand has aggravated shortages of medicines in the EU, undermining health services in the Member States and exposing patients to considerable risksshortages of medicines have worsened exponentially in recent years in the EU, undermining health services in the Member States entailing considerable risks for the health and safety of patients, including disease progression or avoidable adverse events occurring when the missing medicine is substituted by another one; whereas the Member States have a duty to find swift and effective solutions through closer European integration;
Amendment 77 #
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 end76,6% of active principle ingredients for on-patent products are sourced from within the EU-27 and the UK, with 11,9% from the US and only 9% from Asia (including Japan and South Korea); whereas 61,5% of active pharmaceutical ingredients for off-patent products marketed in the EU now originating in thire sourced from the EU-28, 7,2% from the US and 26,8% from Asia, (including Japan and cSountriesth Korea); whereas the only way to save money for some products is to rely heavily on subcontractors to produce pharmaceutical raw materials in Asia, where labour costs and environmental standards are lower, with the result that 80% of active ingredients are manufactured outside the EU, mainly in China and India;
Amendment 99 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas, following the COVID-19 health crisis, the EU will face an economic crisis which will challenge even further the access to medicines and the competitiveness of the EU pharmaceutical industry;
Amendment 107 #
Motion for a resolution
Recital D
Recital D
D. whereas the consequence of growing demand coupled with price suppression is the concentration of supply, a reduction in the number of chemicals manufacturers and a lack of alternative solutions should problems ariseroot causes of shortages are multifactorial (e.g. growing demand, limitations of approved raw materials or intermediate products for APIs, limited accurate visibility of demand-supply situation through the entire supply chain at local level); whereas despite various supply security strategies implemented by the pharmaceutical sector there are still disruptions;
Amendment 121 #
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 medicines being in particularly short supply; wheensuring adequate safety and readiness stocks of critical medicines within Europe, ensuring quality manufacturing with safe components and ensuring effective, solid and long term shortage prevention measureas pharmaceuare essentical firms operate on a just-in-time basior EU citizens and governments;
Amendment 138 #
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 ques‘parallel exports’ have proven to give inaccurate visibility in the supply chain and thus creating disruptions is more expensiven supply across Member States;
Amendment 159 #
Motion for a resolution
Recital G
Recital G
G. whereas, in the absence of a regulatory authority, stockpiling in some Member States is leading to a market imbalance and evidence gathered has shown an allocation challenge of supplies among Member States which are competing in their demand for stockpiling, not commensurate to their short and medium-term patient needs;
Amendment 161 #
Motion for a resolution
Recital G a (new)
Recital G a (new)
Ga. whereas an increasing number of Member States are seeking to establish national stockpiles of medical supplies, and the subsequent increase in demand as a result of this would exceed current demand forecasts based on epidemiological need; whereas sudden large spikes in demand can place considerable strain on suppliers and, as a result, lead to challenges in meeting demand in other countries;
Amendment 183 #
Motion for a resolution
Recital J a (new)
Recital J a (new)
Ja. recalls the importance of the European Centre for Disease Control's (ECDC) modelling data about the likely progression of the pandemic in each country for preventing shortages, as it can be crucial for governments and manufacturers to forecast demand for medical supplies and therefore carry out the necessary planning to increase manufacturing capacity and ensure adequate distribution arrangements;
Amendment 203 #
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 maintaining a secure its supply of medicines and medical equipment;
Amendment 229 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Calls on the Commission, in the context of the upcoming Pharmaceutical Strategy, to set up a High Level pharmaceutical Forum, putting around the table policy-makers, regulators, payers, patients, industry representatives and other relevant stakeholders of the healthcare supply chain to address pharmaceutical sustainability issues;
Amendment 250 #
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Acknowledges that the research- based pharmaceutical industry is an essential sector and contributor to ensuring quality manufacturing and supply of medicines, to ensuring future innovation to address outstanding, unmet needs, and to supporting the resilience, responsiveness and readiness of healthcare systems to address future challenges including pandemics;
Amendment 305 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to address in its next pharmaceutical and industrial strategies issues relating tomeasures focused on ensuring that Europe “remains an innovator and world leader”, measure ensuring the competitiveness of the pharma sector worldwide, on the availability and accessibility of medicines and, on manufacturers’ dependence on third countries;
Amendment 366 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Calls on the Commission to issue guidelines on procurement of medicines to incentivise Member States to improve their procurement practices;
Amendment 388 #
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 should also be a criterion; in this context, urges the Commission to propose targeted guidelines for Member States to implement sustainable tenders practices for pharmaceuticals, aimed at ensuring long term sustainability, competition, security of supply and stimulating investments in manufacturing;
Amendment 396 #
Motion for a resolution
Paragraph 8
Paragraph 8
8. Notes that procurement procedures with only one successful tenderer may exacerbate vulnerability should supplies be disrupted; calls on the Commission and the Member States to introduceacknowledges that procurement procedures under which contracts may be awarded to a number of successful tenderers could be considered in some specific cases, in order to maintain market competition and reduce the risk of shortages, while guaranteeing high-quality treatment for patients;
Amendment 419 #
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; sStresses 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;
Amendment 442 #
Motion for a resolution
Paragraph 10
Paragraph 10
Amendment 451 #
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 to support high quality of medical research in Europe with an emphasis on innovation;
Amendment 463 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Stresses the importance of ensuring in times of health crisis, outbreaks and pandemics, that therapies and vaccines can become rapidly available to wider populations, particularly those with the greatest needs; acknowledges the importance of further strengthening dialogue in order to achieve this; therefore calls on the Commission to further strengthen dialogue with relevant stakeholders, with international actors to assess new treatments and vaccines as well as with the European Medicines Agency, in order to find ways to rapidly align scientific assessments between national agencies, including on collaboration in the pre-assessment phase prior to availability of critical clinical data, on the alignment of post-approval data generation, and on flexible approaches to upscaling manufacturing of treatments and vaccines;
Amendment 487 #
Motion for a resolution
Paragraph 12
Paragraph 12
Amendment 521 #
Motion for a resolution
Paragraph 13
Paragraph 13
Amendment 543 #
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; emphasises that such mechanism should be proportionate and appropriate, and therefore should allow sufficient time to build up (e.g. manufacturing lead times could be greater than 36 months for certain vaccines), be subject to close consultation with supply chain stakeholders before being set up, and any medicines purchased through EU mechanisms should carefully be managed with respect to shelf lives and avoidance of wastage;
Amendment 554 #
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Calls on Member States, in close collaboration with the Commission and other affected stakeholders, to simultaneously 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;
Amendment 558 #
Motion for a resolution
Paragraph 14 b (new)
Paragraph 14 b (new)
14b. Recalls that EMA and National Medicines Agencies have agreed on the following definition of a shortage: “a shortage of a medicinal product for human or veterinary use occurs when supply does not meet demand at a national level”; calls on EMA and National Medicines Agencies to revise their definition of shortages to better take into account patient need, as follows: “a shortage of a medicinal product for human use occurs when supply does not meet patient need at national level for a period of more than two weeks”;
Amendment 560 #
Motion for a resolution
Paragraph 15
Paragraph 15
Amendment 593 #
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; considers that the European Medicines Agency (EMA) could also be designated as the regulatory authority tasked with supporting the preventingon of shortages of essential medicines through coordination across Member States, with a correspondingly wider remit and more staff; also acknowledges that the ultimate decision about what is "essential" would need to remain with Member States, due to the national therapeutic environment; ;
Amendment 631 #
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Stresses that, in addition to the underlying vulnerabilities that have been exposed by the COVID-19 crisis, there are also other factors that increase the risk of shortages; notes that one of these is parallel trade, whereby wholesalers are allowed to buy medical products in one Member States, and sell them in other Member States; recognises that parallel trade may be one of the reasons for the occurrence of shortages because it hinders the visibility on medicine stocks to relevant authorities; therefore, calls on the Commission and Member States to abolish the distortive effects of national schemes incentivising parallel imports from lower income to higher income Member States or imposing significant national stockpiling obligations limiting supply for other EU markets in order to ensure that medicines reach all EU patients in a timely manner;
Amendment 646 #
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; 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; in particular, calls for the Commission to evaluate current projects improving information systems(including the European Medicines Agency's substance, product, organisation and referential (SPOR) data) and thereby ensure that drug shortage related use cases are prioritised;
Amendment 668 #
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Calls on the ECDC to release modelling data about the likely progression of the COVID-19 pandemic in each Member State as well as patient need data and hospital capacity data in the Member States;
Amendment 684 #
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; recommends the inclusion of information for healthcare professionals on available alternatives;
Amendment 737 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Emphasises that a European pandemic preparedness plan should include the coordination of information about medicinal product distribution and consumption in Member States, and the adequate definition of regulatory flexibilities to address supply tensions; should also include the wide use of cooperative EU-level crisis mechanisms directed towards serious cross-border threats to health, such as rescEU and the Joint Procurement Agreement, to efficiently assist Member State response capabilities;