Activities of Nathalie COLIN-OESTERLÉ related to 2020/0321(COD)
Plenary speeches (1)
European Medicines Agency (continuation of debate)
Amendments (41)
Amendment 117 #
Proposal for a regulation
Recital 2
Recital 2
(2) The unprecedented experience of the COVID-19 pandemic has demonstrated that, by strengthening its capacity and improving cooperation and coordination between the EU Member States, the Union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health. The Union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic, and also by the limited degree of Union preparedness in case of a public health emergency impacting a majority of Member States and by the lack of cooperation and coordination between the latter.
Amendment 123 #
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2a) The COVID-19 crisis has shown that coordination and dialogue between European, national and regional authorities, industry, entities involved in the pharmaceutical supply chain, healthcare professionals and patients’ associations at European level are vital for countering health threats and should continue after the current health crisis ends so that the shortage of one-off and recurrent medicinal products can be tackled effectively. Ongoing dialogue between all such stakeholders should be assured.
Amendment 129 #
Proposal for a regulation
Recital 3
Recital 3
(3) TDisruptions to the often complex supply chains of medicinal products and medical devices, national export restrictions and bans, border closures impeding the free movement of those goods, and uncertainty related to their supply and demand in the context of the COVID- 19 pandemic, and the lack of production in Europe of certain essential medicinal products or chemical active ingredients have led to significant impediments to the smooth functioning of the single market and to addressing the serious threats to public health across the Union.
Amendment 135 #
Proposal for a regulation
Recital 4
Recital 4
(4) Dealing with the issue of shortages of medicinal products has been a long- standing priority for the Member States and European Parliament as illustrated by several reports from the European Parliament11 as well as discussions under recent Presidencies of the Council of the European Union. _________________ 11European Parliament resolution of 17 September 2020 on the shortage of medicines – how to address an emerging problem (2020/2071(INI)Does not affect English version.)
Amendment 136 #
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
Amendment 139 #
Proposal for a regulation
Recital 5
Recital 5
(5) The COVID-19 pandemic has exacerbated the existing problem of shortages for certain medicinal products considered as essential and critical in addressing the pandemic, and has highlighted the Union’s dependence on third countries such as India or China, particularly in terms of the production of chemical active ingredients, the lack of coordination and cooperation between Member States, the structural limitations in the Union’s ability to rapidly and effectively react to such challenges during public health crises, and the need to support and strengthen the Union’s industrial fabric through appropriate policies.
Amendment 143 #
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5a) In order to tackle the Union’s dependence on third countries as well as production uncertainties and supply disruptions, emphasis must be placed on the importance of diversifying supplies and contracting practices for pharmaceutical products and on the need to offer prompt guidance to Member States, especially on the best way to apply the most economically advantageous tender criteria, without being confined to just the lowest price criterion. Investments in the manufacture of active ingredients and medicinal end products in the EU should also be retained as a criterion, as well as the number and location of production sites, the reliability of supply, the reinvestment of profits into R&D and the application of social, environmental, ethical and quality standards.
Amendment 148 #
Proposal for a regulation
Recital 6
Recital 6
(6) The rapid evolution of COVID-19 and the spread of the virus led to a sharp increase in demand for medical devices such as ventilators, surgical masks, and COVID-19 test kits while disruption of production or limited capacity to rapidly increase production and the complexity and global nature of the supply chain for medical devices, led to a negative impact on supply and stock shortages. Those issues resulted in new entities being involved in the production of those products, which subsequently resulted in bottlenecks in conformity assessment, as well as the prevalence of non-compliant, unsafe, and in some cases counterfeit products. It is therefore appropriate to establish long-term structures within an appropriate Union body to ensure monitoring of shortages of medical devices resulting from a public health emergency and the necessary coordination within the Union.
Amendment 152 #
Proposal for a regulation
Recital 7
Recital 7
(7) Uncertainty of supply and demand and the risk of shortages of essential medicinal products and medical devices during a public health emergency like the COVID-19 pandemic can trigger export restrictions or bans amongst Member States and other national protective measures, such as inappropriate stockpiling, which can seriously impact the functioning of the internal market. Furthermore, shortages of medicinal products can result in serious risks to the health of patients in the Union due to their lack of availability, which can cause, medication errors, increased duration of hospital stays, and adverse reactions caused by the administration of unsuitable products used as a substitute for unavailable ones. With respect to medical devices, shortages can lead to a lack of diagnostic resources with negative consequences for public health measures, a lack of treatment or deterioration of the disease and may also prevent health professionals from adequately carrying out their tasks. Those shortages can also have a significant impact on controlling the spread of a given pathogen caused by, for example, an insufficient supply of COVID- 19 test kits or suitable PPE such as masks, gloves and protective clothing. It is therefore important to address the question of shortages and to, reinforce and formalise monitoring of critical medicinal products and medical devices, and improve coordination within the Union.
Amendment 162 #
Proposal for a regulation
Recital 9
Recital 9
(9) During the COVID-19 pandemic ad hoc solutions, including contingent arrangements between the Commission, the European Medicines Agency (‘the Agency’), marketing authorisation holders, manufacturers or other entities in the pharmaceutical supply chain and Member States, had to be found to achieve the objective of making available safe and efficacious medicinal products to treat COVID-19 or prevent its spread, and to facilitate and speed up the development and marketing authorisation of treatments and vaccines.
Amendment 165 #
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) In order to facilitate the supply of medicinal products during the COVID-19 pandemic, marketing authorisation holders were granted regulatory flexibility in relation to, for example, existing procedures for changing suppliers of active ingredients, designation of new production sites and faster processing of import permits, so that shortages of medicinal products could be addressed. Those solutions should remain in place to assist with future situations and those flexibilities should be applied consistently across the Member States to prevent fragmentation of the internal market and ineffective outcomes.
Amendment 169 #
Proposal for a regulation
Recital 10
Recital 10
(10) In order to ensure a better functioning of the internal market of those products and contribute to a high level of human health protection, it is therefore appropriate to approximate and better coordinate the rules on monitoring of shortages of medicinal products and medical devices, and, through increased support for research and innovation, to facilitate the research and development of medicinal products, which may have the potential to treat, prevent, or diagnose diseases that cause public health crises.
Amendment 172 #
Proposal for a regulation
Recital 10 a (new)
Recital 10 a (new)
(10a) In order to ensure effective health systems, stress tests should be introduced to assess the resilience of health systems in emergencies with a view to providing an effective means of countering shortages in the event of pandemics and identifying structural risk factors that create shortages.
Amendment 187 #
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) In order to ensure that Member State strategies, particularly in terms of stock management, are correctly implemented and coordinated, the Agency should become the regulatory authority responsible for preventing shortages of medicinal products within the Union, not only during crises but also in normal times, and its mandate and resources should also be strengthened.
Amendment 189 #
Proposal for a regulation
Recital 15
Recital 15
(15) With respect to medicinal products, an executive steering group should be established within the Agency to ensure a robust response to major events and to coordinate urgent actions within the Union in relation to the management of issues relating to the supply of medicinal products. The Steering Group should establish a European lists of essential and critical medicinal products, in cooperation with all stakeholders, to ensure monitoring of those products and it should be able to provide advice on the necessary action to take to safeguard the quality, safety, and efficacy of medicinal products and ensure a high level of human health protection as well as adequate supplies. Priorities should be established for the different types of medicinal product by drawing a distinction in particular between ‘medicinal products of major therapeutic interest’ (MITMs), i.e. medicines for which an interruption of treatment is likely to jeopardise the vital prognosis of patients in the short or medium term or significantly diminishes the patient’s chances with regard to the progressive potential of the disease, or for which there are no suitable therapeutic alternatives available in sufficient quantity, and ‘medicinal products of health and strategic importance’ (MISSs), for which the interruption of treatment causes an immediate threat to the patient’s life.
Amendment 243 #
Proposal for a regulation
Article 1 – paragraph 1 – point a
Article 1 – paragraph 1 – point a
(a) prepare for and manage, coordinate and manage at European level the impact of major events on medicinal products for human use and of public health emergencies on medicinal products for human use and on medical devices;
Amendment 250 #
Proposal for a regulation
Article 1 – paragraph 1 – point b
Article 1 – paragraph 1 – point b
(b) prevent, monitor and report on shortages of medicinal products for human use and medical devices;
Amendment 275 #
Proposal for a regulation
Article 2 – paragraph 1 – point d
Article 2 – paragraph 1 – point d
(d) ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet demand for that medicinal product or medical devicethe needs of patients or healthcare professionals;
Amendment 319 #
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. The Medicines Steering Group shall be chaired by the Agency. The Chair may invite third parties, including representatives of medicinal product interest groups and, marketing authorisation holders to attend its meetingor any other entity in the relevant pharmaceutical supply chain, healthcare professionals and patients’ associations, to attend its meetings to ensure transparent and effective dialogue between all stakeholders in the supply chain and the relevant authorities.
Amendment 348 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The Agency shall continuously monitor any event that is likely to lead to a major event or a public health emergency in coordination with the relevant national or regional authorities.
Amendment 370 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
The Medicines Steering Group shall provide advice and recommendations to the Commission and Member States on any appropriate action it believes should be taken at Union level on the medicinal products concerned in accordance with the provisions of Directive 2001/83/EC or Regulation (EC) No 726/200418. _________________ 18 Regulation (EC) No 726/2004
Amendment 375 #
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Following a request for assistance referred to in Article 4(3) and after consultation of its working party, the Medicines Steering Group, in coordination with stakeholders in the sector, shall adopt a list of medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers as critical during the major event (‘the major event critical medicines list’). The list shall be updated whenever necessary until the major event has been sufficiently addressed.
Amendment 380 #
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. Immediately following the recognition of a public health emergency and after consultation of its working party, the Medicines Steering Group, in coordination with stakeholders in the sector, shall adopt a list of medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers as critical during the public health emergency (‘the public health emergency critical medicines list’). The list shall be updated whenever necessary until the termination of the recognition of the public health emergency.
Amendment 405 #
Proposal for a regulation
Article 7 – paragraph 1 a (new)
Article 7 – paragraph 1 a (new)
There should also be regular structured dialogue with industry, entities involved in the pharmaceutical supply chain, healthcare professionals and patients’ associations so that any potential or actual shortages of those medicinal products in a public health emergency and/or major event can be managed as effectively as possible.
Amendment 422 #
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. As part of that reporting, the Medicines Steering Group may also provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities, including healthcare professionals or patients, to prevent or mitigate potential or actual shortages. In that regard the Group shall liaise, as relevant, with the Health Security Committee and, in the case of a public health emergency, the Advisory Committee on public health emergencies.
Amendment 433 #
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. The Medicines Steering Group may upon request from the Commission coordinate measures, where relevant, between the national competent authorities, the marketing authorisation holders and other entities, including healthcare professionals, to prevent or mitigate potential or actual shortages in the context of a major event or public health emergency.
Amendment 448 #
Proposal for a regulation
Article 9 – paragraph 1 – point a
Article 9 – paragraph 1 – point a
(a) specify the procedures and criteria for establishing the critical medicines lists;
Amendment 477 #
Proposal for a regulation
Article 9 – paragraph 3 – point e
Article 9 – paragraph 3 – point e
(e) sales, available stock, where relevant, and market share data;
Amendment 486 #
Proposal for a regulation
Article 9 – paragraph 3 – point g
Article 9 – paragraph 3 – point g
(g) prevention and mitigation plans including production and supply capacity;
Amendment 522 #
Proposal for a regulation
Article 11 – paragraph 1 – introductory part
Article 11 – paragraph 1 – introductory part
1. In order to facilitate the monitoring referred to in Article 7 and following a request from the Agency, Member States or any national competent authority shall, by the deadline set by the Agency:
Amendment 529 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. Where necessary to fulfil their reporting obligations set out in paragraph 1, Member States, with the support of the Agency, shall gather information and data on stock levels from wholesale distributorsmarketing authorisation holders, wholesale distributors, community and hospital pharmacies, and other legal entities entitled to supply the public with medicinal products included on the critical medicines lists.
Amendment 530 #
Proposal for a regulation
Article 11 – paragraph 2 a (new)
Article 11 – paragraph 2 a (new)
2a. Where necessary to fulfil their reporting obligations set out in paragraph 1, Member States, with the support of the Agency, shall gather information and data on unmet demands from wholesale distributors, community and hospital pharmacies, and other legal entities entitled to supply the public with medicinal products included on the critical medicines lists.
Amendment 547 #
Proposal for a regulation
Article 12 – paragraph 1 – point b
Article 12 – paragraph 1 – point b
(b) consider the need for guidelines and recommendations addressed to Member States, marketing authorisation holders, and other entities;
Amendment 569 #
Proposal for a regulation
Article 14 – paragraph 2 – point e
Article 14 – paragraph 2 – point e
(e) providing scientific recommendations with regard to the use of any medicinal product, and in particular alternative medicinal products, which may have the potential to address public health emergencies, in accordance with Article 16;
Amendment 572 #
Proposal for a regulation
Article 14 – paragraph 2 – point f
Article 14 – paragraph 2 – point f
(f) cooperating with national and regional competent authorities, Union bodies and agencies, the World Health Organization, third countries, and international scientific organisations on scientific and technical issues relating to the public health emergency and to medicinal products which may have the potential to address public health emergencies, as necessary.
Amendment 636 #
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
3. The Medical Devices Steering Group shall be chaired by the Agency. The Chair may invite third parties, including representatives of medical device interest groups to attend its meeting, any other entity in the relevant pharmaceutical supply chain, healthcare professionals and patients’ associations, to attend its meetings to ensure transparent and effective dialogue between all stakeholders in the supply chain and the relevant authorities.
Amendment 650 #
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
1. Immediately following the recognition of a public health emergency and after consultation of its working party, the Medical Devices Steering Group, in coordination with stakeholders in the sector, shall adopt a list of medical devices which it considers as critical during the public health emergency (‘the public health emergency critical devices list’). The list shall be updated whenever necessary until the termination of the recognition of the public health emergency.
Amendment 672 #
Proposal for a regulation
Article 23 – paragraph 1 – point a
Article 23 – paragraph 1 – point a
(a) specify the procedures and criteria for establishing the public health emergency critical devices list;
Amendment 679 #
Proposal for a regulation
Article 23 – paragraph 3 – point e
Article 23 – paragraph 3 – point e
(e) sales, stock, where relevant, and market share data;
Amendment 686 #
Proposal for a regulation
Article 23 – paragraph 3 – point f
Article 23 – paragraph 3 – point f
(f) prevention and mitigation plans including production and supply capacity;
Amendment 692 #
Proposal for a regulation
Article 25 – paragraph 1 – introductory part
Article 25 – paragraph 1 – introductory part
1. In order to facilitate the monitoring referred to in Article 21 and following a request from the Agency, Member States or any national competent authority shall, by the deadline set by the Agency: