BETA

Activities of Katalin CSEH related to 2020/2071(INI)

Shadow opinions (1)

2020/06/16
Committee: ITRE
Dossiers: 2020/2071(INI)
Documents: PDF(175 KB) DOC(81 KB)
Authors: [{'name': 'Joëlle MÉLIN', 'mepid': 124765}]

Amendments (19)

Draft opinion
Recital A a (new)

A a. Whereas Article 81 of Directive 2001/83/EC1a calls for measures to prevent shortages or distributional issues of medicinal products in Member States; _________________ 1aDirective 2001/83/EC of the European Parliament and of the Council of November 6 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001. p. 67)

2020/05/19
Committee: ITRE

Draft opinion
Recital A b (new)

A b. Whereas the European Parliament in its resolution of 8 March 2011 and the Council in its Conclusions of 13 September 2010 stressed the need to introduce a common procedure for the joint procurement of medical countermeasures, and in particular of pandemic vaccines;

2020/05/19
Committee: ITRE

Draft opinion
Recital A c (new)

A c. Whereas Decision No 1082/2013 of the European Parliament and of the Council1b encourages Member States to take advantage of joint procurement procedures provided that such procedures are preceded by a Joint Procurement Agreement of participating Member States; _________________ 1bDecision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross- border threats to health (OJ L 293, 5.11.2013, p. 1–15)

2020/05/19
Committee: ITRE

Draft opinion
Recital A d (new)

A d. Whereas medicine shortages pose a serious threat to patients and undermine the resilience and efficiency of public healthcare systems across the Union;

2020/05/19
Committee: ITRE

Draft opinion
Recital A e (new)

A e. Whereas early detection, monitoring, and reporting of medicine shortages should be improved and underpinned by more transparent and available medicine shortages data;

2020/05/19
Committee: ITRE

Draft opinion
Recital A f (new)

A f. Whereas an effective coordination at EU level at times of crisis is essential to avoid unilateral border closures and export bans which exacerbate medicine shortages and jeopardise the resilience of supply chains and distribution channels;

2020/05/19
Committee: ITRE

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, and initiatives to mitigate risks to supply chains; calls on the Commission to propose ambitious and concrete actions to address these issues in its planned pharmaceutical strategy;

2020/05/19
Committee: ITRE

Draft opinion
Paragraph 1

1. Insists that the Commission urgently launches a multi-stakeholder consultation as well as market research in order to identify key supply chain issues that directly cause or increase the risk of medicine shortages; calls on the Commission to propose ambitious and concrete actions to address these issues in its planned pharmaceutical strategy;

2020/05/19
Committee: ITRE

Draft opinion
Paragraph 1 a (new)

1 a. 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 prepare and adopt a European pandemic preparedness plan, in order to ensure a coordinated and effective European pandemic response; emphasises 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

Draft opinion
Paragraph 2

2. Calls on the Commission to consider proposing requirements for the pharmaceutical industry to ensure that its supply chain is diversified and put in place a medicine shortage risk mitigation plan to manage any vulnerabilities in and risks to the supply chain; highlights that such plan should include transparent reporting mechanisms with permanent communication channels through which patients and healthcare professionals can report and anticipate shortages.

2020/05/19
Committee: ITRE

Draft opinion
Paragraph 3

3. Stresses the urgent need for the EU to reduce its over-reliance on a small number of third countries for medicine manufacturing and as sources of active pharmaceutical ingredients; calls on the Commission to foresee the creation of European common strategic reserves, building on rescEU stockpile's initiative, and to introduce new financial incentives to support the relocation of production sites from third countries to Europe, underpinned by more investment in research and development capabilities and infrastructure, including universities.

2020/05/19
Committee: ITRE

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 and innovation ecosystems.

2020/05/19
Committee: ITRE

Draft opinion
Paragraph 5 a (new)

5 a. Underlines the need to establish permanent joint procurement mechanisms for vaccines, antiviral drugs, and high- cost and essential medicines as increased cooperation in procurement shall facilitate sustainable access, more balanced pricing, and better information exchange regarding medicinal products.

2020/05/19
Committee: ITRE

Draft opinion
Paragraph 5 b (new)

5 b. Calls for the establishment of an interconnected early warning mechanism across the Union which require manufacturers to notify in advance the Commission as well as the European Medicines Agency about imminent medicine shortages and temporary or permanent disruptions in the supply and distribution of medicinal products.

2020/05/19
Committee: ITRE

Draft opinion
Paragraph 5 c (new)

5 c. Notes with concern that increased product demand during medicine shortages could increase the risk of unfair pricing practices occurring in regions affected by the shortage as well as in cases where alternative pharmaceutical products could replace those affected by the shortage.

2020/05/19
Committee: ITRE

Draft opinion
Paragraph 5 d (new)

5 d. Calls for measures to discourage unfair practices and business strategies in the pharmaceutical sector such as pay for delay and parallel trading while introducing public service obligations with a view to ensure supply resilience across Member States’ markets.

2020/05/19
Committee: ITRE

Draft opinion
Paragraph 5 e (new)

5 e. Calls for the establishment of preventive obligations for manufacturers and distributors to mitigate future medicine shortages more efficiently such as supply shortage risk assessments which includes information sharing on product development.

2020/05/19
Committee: ITRE

Draft opinion
Paragraph 5 f (new)

5 f. Recalls that an increasing number of Member States are seeking to establish national stockpiles of medical supplies; acknowledges that the subsequent increase in demand as a result of this would exceed current demand forecasts based on epidemiological need; also acknowledges that sudden large spikes in demand can place considerable strain on suppliers and lead to further challenges in meeting demand; therefore 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;

2020/05/19
Committee: ITRE

Draft opinion
Paragraph 5 g (new)

5 g. Calls upon the European Commission to maintain a robust European IP system under the forthcoming European Pharmaceutical Strategy, to encourage R&D and manufacturing in Europe, ensure that Europe remains an innovator and world leader, and ultimately to protect and strengthen Europe’s strategic autonomy in the field of public health.

2020/05/19
Committee: ITRE