2020/2071(INI) Shortage of medicines - how to address an emerging problem
Next event: Commission response to text adopted in plenary 2021/02/11 more...
Lead committee dossier:
Next event: Commission response to text adopted in plenary 2021/02/11 more...
- Results of vote in Parliament 2020/09/17
- Decision by Parliament 2020/09/17
- End of procedure in Parliament 2020/09/17
Progress: Procedure completed
EPP
S&D
Renew
Verts/ALE
ID
ECR
GUE/NGL
PPE
RELead committee dossier:
Legal Basis:
RoP 54
Legal Basis:
RoP 54Events
2021/02/11
EC - Commission response to text adopted in plenary
Documents
2020/09/17
EP - Results of vote in Parliament
Documents
2020/09/17
EP - Decision by Parliament
Details
The European Parliament adopted by 663 votes to 23, with 10 abstentions, a resolution on shortage of medicines - how to address an emerging problem.
The long-standing problem of shortages of medicines within the EU has worsened during the COVID-19 pandemic, with direct negative consequences for the health and safety of patients and the continuation of their treatment.
Parliament called for the establishment of a genuine pharmaceutical industrial strategy to enable the EU to regain its health sovereignty and called for better coordination between EU countries to address the drug shortage.
The European response to the shortage of medicines shall be based on four pillars:
(1) Restoring the EU's independence in health matters by securing supply
With 40% of medicines marketed in the EU today coming from third countries and between 60-80% of chemical active substances being produced in China and India, Parliament considered it geostrategically imperative for the EU to regain its independence in the field of healthcare, to ensure a rapid and efficient supply of medicines, medical equipment, diagnostic tools and vaccines at affordable prices and to prevent shortages in these areas, giving priority to the interests and safety of patients.
Members called on the Commission and Member States to:
- take the necessary measures to guarantee the security of supply of medical products, reduce the EU's dependence on third countries and support the local manufacture of medicines of major therapeutic interest, giving priority to medicines of health and strategic interest;
- establish a precise mapping of potential production sites within the European Union in order to be able to preserve, modernise and strengthen their capacity where necessary;
- make the shortage of medicines one of the pillars of the Commission's forthcoming pharmaceutical strategy and create a Pharmaceutical Forum, overseen by the European Medicines Agency, bringing together relevant stakeholders in the healthcare supply chain to prevent shortages;
- introduce financial measures and incentives in line with state aid rules in order to encourage the industry to locate its activities in Europe, from the production of active ingredients to the manufacturing, packaging and distribution of medicines;
- consider setting up harmonised shortage prevention and management plans that require manufacturers to identify drugs of major therapeutic interest that require the introduction of measures to avoid supply disruptions;
- make security of supply a priority criterion in drug-related tendering procedures;
- create one or more non-profit European pharmaceutical undertakings capable of producing certain medicines of strategic importance for health care in emergencies, in the absence of existing industrial production, in order to prevent possible shortages of medicines in case of emergency;
- assess foreign direct investment in pharmaceutical production sites, which are part of Europe's essential health infrastructure;
- creating an environment to ensure that Europe continues to be an attractive location for R&D investment to encourage research, development and manufacturing in Europe and to ensure that Europe remains the leading region in the world for the manufacture of active ingredients for patent medicines.
Members called for joint action on the prevention of shortage of medicines, to be funded by the future health programme.
(2) Strengthen European action to better coordinate and complement Member States' health policies
Parliament recommended:
- greater transparency in the production and distribution chain of medicines and the creation of a European unit for the prevention and management of shortages;
- the development of health strategies at European level with a common basket of drugs against cancer, infectious diseases, rare diseases and in other areas particularly affected by shortages, as well as examining the possibility of setting harmonised criteria for pricing to make these medicines affordable;
- the creation of a European contingency reserve for medicinal products of health and strategic importance (MISSs) that are at high risk of shortage, along the lines of the ‘RescEU’ mechanism, in order to alleviate recurrent shortages and create an emergency European pharmacy;
- the development of innovative and coordinated strategies and the strengthening of the exchange of best practices in stock management;
- the introduction of new European joint procurement procedures to combat shortages, particularly in times of health crises, with simplified and transparent procedures for greater responsiveness.
(3) Strengthening cooperation among Member States
Members considered it essential to improve early communication to both health professionals and patients on the availability of medicines through innovative digital tools. Member States shall share information such as epidemiological forecasts with all relevant stakeholders to help them plan their activities better in the face of rising demand and respond better to needs at times of shortages.
Members pointed out that misinformation can lead to the inappropriate use of medicines and the creation of unnecessary stockpiling.
(4) Preventing and responding to shortages in the event of health crises
Parliament called on the Commission, in close collaboration with the Member States, to adopt a European pandemic preparedness plan in order to ensure a coordinated and effective response. It also called for simplified legislation and more flexible regulatory measures in times of crisis to alleviate shortages and facilitate the movement of medicines between Member States, such as the acceptance of different packaging formats, extended expiry dates or the use of veterinary medicines.
Documents
2020/09/17
EP - End of procedure in Parliament
2020/07/22
EP - Committee report tabled for plenary
Details
The Committee on the Environment, Public Health and Food Safety adopted an own-initiative report by Nathalie COLIN-OESTERLÉ (EPP, FR) on the shortage of medicines - how to address an emerging problem.
The long-standing problem of shortages of medicine in the EU has worsened during the COVID-19 health crisis, with direct negative consequences on the health and safety of patients and their continued treatment.
The report called for the establishment of a genuine pharmaceutical industrial strategy to enable the European Union to regain its health sovereignty and called for better coordination among EU countries to address the shortage of medicines.
Members believe that the European response to the shortage of medicines should be based on four pillars:
1) Restoring the EU's independence in health matters by securing supply
Recalling that 40% of medicinal end products marketed in the EU originate in third countries and 80% of active pharmaceutical ingredients are produced in China and India, Members called on the Commission and Member States to:
- take the necessary measures to guarantee the security of supply of medical products, reduce the EU's dependence on third countries and support the local manufacture of medicines of major therapeutic interest, giving priority to medicines of health and strategic interest;
- establish a precise mapping of potential production sites within the European Union in order to be able to preserve, modernise and strengthen their capacity where necessary;
- make the shortage of medicines one of the pillars of the Commission's forthcoming pharmaceutical strategy and create a Pharmaceutical Forum, overseen by the European Medicines Agency, bringing together relevant stakeholders in the healthcare supply chain to prevent shortages;
- introduce financial measures and incentives in line with state aid rules to protect the EU pharmaceutical industrial base and encourage the industry to locate its activities in Europe, from the production of active ingredients to the manufacturing, packaging and distribution of medicines;
- consider setting up harmonised shortage prevention and management plans that require manufacturers to identify drugs of major therapeutic interest that require the introduction of measures to avoid supply disruptions;
- make security of supply a priority criterion in drug-related tendering procedures;
- create one or more non-profit European pharmaceutical undertakings capable of producing certain medicines of strategic importance for health care in emergencies, in the absence of existing industrial production, in order to prevent possible shortages of medicines in case of emergency;
- create an environment to ensure that Europe remains an attractive location for R&D investment and maintain a strong European intellectual property system in the context of the forthcoming pharmaceutical strategy, in order to encourage research, development and manufacturing in Europe, to ensure that Europe remains a world-class innovator and ultimately to protect and strengthen Europe's strategic autonomy in the field of public health.
Members called for joint action to prevent drug shortages, to be funded by the future health programme.
2) Strengthen European action to better coordinate and complement Member States' health policies
The committee recommended:
- greater transparency in the production and distribution chain of medicines and the creation of a European unit for the prevention and management of shortages;
- the development of health strategies at European level with a common basket of drugs against cancer, infectious diseases, rare diseases and in other areas particularly affected by shortages, as well as examining the possibility of setting harmonised criteria for pricing to make these medicines affordable;
- the creation of a European contingency reserve for medicinal products of health and strategic importance (MISSs) that are at high risk of shortage, along the lines of the ‘RescEU’ mechanism, in order to alleviate recurrent shortages and create an emergency European pharmacy;
- the development of innovative and coordinated strategies and the strengthening of the exchange of best practices in stock management;
- the introduction of new European joint procurement procedures to combat shortages, particularly in times of health crises, with simplified and transparent procedures for greater responsiveness.
3) Strengthening cooperation among Member States
- set up an innovative, transparent and centralised digital platform to report harmonised information provided by national agencies and all stakeholders on available stocks and shortages of medicines and medical equipment;
- improve early communication with healthcare professionals and patients on the availability of medicines through the use of innovative digital tools;
- share with all the actors involved information such as epidemiological forecasts to help them plan their activities better in the face of rising demand and respond better to needs at times of shortage.
4) Preventing and responding to shortages in the event of health crises
Members called on the Commission, in close collaboration with the Member States, to adopt a European pandemic preparedness plan in order to ensure a coordinated and effective response. They also called for simplified legislation and more flexible regulatory measures in times of crisis to alleviate shortages and facilitate the movement of medicines between Member States, such as the acceptance of different packaging formats, extended expiry dates or the use of veterinary medicines.
Documents
2020/07/14
EP - Vote in committee
2020/06/17
EP - Committee opinion
Documents
2020/06/16
EP - Committee opinion
Documents
2020/06/15
EP - Specific opinion
Documents
2020/06/11
EP - Committee opinion
Documents
2020/06/08
EP - Amendments tabled in committee
Documents
2020/06/08
EP - Amendments tabled in committee
Documents
2020/06/08
EP - Amendments tabled in committee
Documents
2020/05/28
EP - Committee opinion
Documents
2020/05/27
EP - Committee referral announced in Parliament
2020/05/27
EP - Referral to associated committees announced in Parliament
2020/05/13
EP - KEMPA Beata (ECR) appointed as rapporteur in DEVE
2020/05/04
EP - LEBRETON Gilles (ID) appointed as rapporteur in JURI
2020/04/30
EP - Committee draft report
Documents
2020/04/28
EP - CAMPOMENOSI Marco (ID) appointed as rapporteur in TRAN
2020/04/23
EP - MÉLIN Joëlle (ID) appointed as rapporteur in ITRE
2020/04/15
EP - KOVATCHEV Andrey (EPP) appointed as rapporteur in INTA
2020/03/25
EP - COLIN-OESTERLÉ Nathalie (EPP) appointed as rapporteur in ENVI
Documents
- Commission response to text adopted in plenary: SP(2020)597
- Results of vote in Parliament: Results of vote in Parliament
- Decision by Parliament: T9-0228/2020
- Committee report tabled for plenary: A9-0142/2020
- Committee opinion: PE653.840
- Committee opinion: PE650.634
- Specific opinion: PE652.652
- Committee opinion: PE650.657
- Amendments tabled in committee: PE652.627
- Amendments tabled in committee: PE652.628
- Amendments tabled in committee: PE652.629
- Committee opinion: PE650.551
- Committee draft report: PE650.394
- Committee draft report: PE650.394
- Committee opinion: PE650.551
- Amendments tabled in committee: PE652.627
- Amendments tabled in committee: PE652.628
- Amendments tabled in committee: PE652.629
- Committee opinion: PE650.657
- Specific opinion: PE652.652
- Committee opinion: PE650.634
- Committee opinion: PE653.840
- Commission response to text adopted in plenary: SP(2020)597
| Amendments | Dossier |
| 1068 |
2020/2071(INI)
2020/05/18
INTA
69 amendments...
Amendment 1 #
Draft opinion Paragraph 1 1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms the vital role played by functioning global supply chains for medical products, and in particular for medicines and treatments; emphasises that an open, transparent, rules-based trading system is fundamental to ensuring the global availability of medicines and guaranteeing an easy distribution and use;
Amendment 10 #
Draft opinion Paragraph 2 2. Recognises th
Amendment 11 #
Draft opinion Paragraph 2 2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over- reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of medicines in the EU; calls on the Commission
Amendment 12 #
Draft opinion Paragraph 2 2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that the lack of strategic autonomy and the high dependence of the European Union in a key sector such as health and the production of medicines is the concrete expression of the exacerbated free trade as promoted by the European Commission for decades; stresses that this over-
Amendment 13 #
Draft opinion Paragraph 2 2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over- reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of medicines in the EU; calls on the Commission to present a long-term strategy focused on ensuring the EU’s open strategic autonomy in health; asks for a prior European or Member State allowance to any project of outsourcing health-related or pharmaceutical productions outside the EU;
Amendment 14 #
Draft opinion Paragraph 2 2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical
Amendment 15 #
Draft opinion Paragraph 2 2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over- reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of medicines in the EU; calls on the Commission to present a long-term strategy focused on ensuring the EU’s open strategic autonomy in health, incorporating exploration into new trading partners for diversification of supply chains;
Amendment 16 #
Draft opinion Paragraph 2 2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over- reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of medicines in the EU; calls on the Commission to present a long-term strategy focused on ensuring the EU’s open strategic autonomy in health, and the diversification of its supply chains;
Amendment 17 #
Draft opinion Paragraph 2 2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over- reliance
Amendment 18 #
Draft opinion Paragraph 2 2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over- reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of medicines in the EU; calls on the Commission to present a long-term strategy focused on ensuring the EU’s open strategic autonomy
Amendment 19 #
Draft opinion Paragraph 2 2.
Amendment 2 #
Draft opinion Paragraph 1 1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms the vital role played by functioning global supply chains for medical products, and in particular for medicines; emphasises that the implementation of an open, rules- based trading system is fundamental to ensuring the global availability of medicines and that our vulnerability is not repeated in future emergencies;
Amendment 20 #
Draft opinion Paragraph 2 2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of low technology medical supplies, active pharmaceutical ingredients and chemical raw materials; stresses that this over-
Amendment 21 #
Draft opinion Paragraph 2 2. Recognises that the EU depends on a narrow set of countries, mainly China and India, for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over-
Amendment 22 #
Draft opinion Paragraph 2 a (new) 2 a. Underlines that a complete repatriation of medical supply chains is not possible in a global economy; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains i.a. by establishing a global catalogue of essential emergency healthcare products in order to limit the resort to protectionist measures;
Amendment 23 #
Draft opinion Paragraph 2 a (new) 2 a. Insists that the measures proposed in the Commission's upcoming Pharmaceutical Strategy should ensure Europe's central role as an "innovator and world leader", as underlined in President von der Leyen's mission letter to Commissioner Stella Kyriakides, recognising that the start of any EU policy aimed at bringing the production of medicines and active ingredients back into Europe starts by strengthening research;
Amendment 24 #
Draft opinion Paragraph 2 a (new) 2 a. Urges the Commission and Member States to conduct an in-depth mapping and analysis of the global supply chains for medicines; demands that, if such a mapping reveals substantial vulnerabilities and risks of supply disruption, remedial action be taken;
Amendment 25 #
Draft opinion Paragraph 3 3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of well-balanced IP rights in free trade agreements (FTAs) and at the WTO
Amendment 26 #
Draft opinion Paragraph 3 3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that
Amendment 27 #
3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments; underlines
Amendment 28 #
Draft opinion Paragraph 3 3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments; underlines that the flexibilities provided in the TRIPS agreement can be used to address potential supply shortages in exceptional circumstances; asks for an European Health Exception notified to the WTO and included in all trade agreements, past and future, keeping a zero tariff on pharmaceutical products but allowing parties to provide state aid to their domestic health-related and pharmaceutical sector; asks for a regulation on the disqualification of any future dispute raised by our FTA partners on the health issue;
Amendment 29 #
Draft opinion Paragraph 3 3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments; underlines that the flexibilities provided in the TRIPS agreement can be used to address potential supply shortages in exceptional circumstances and solve the current problems related to the use of compulsory licencing;
Amendment 3 #
Draft opinion Paragraph 1 1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms the vital role played by functioning
Amendment 30 #
Draft opinion Paragraph 3 3. Emphasises that the EU is a leading global exporter of pharmaceutical products and one of the most research intensive region in this area in the world; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments; underlines that the flexibilities provided in the TRIPS agreement can be used to address potential supply shortages in exceptional circumstances;
Amendment 31 #
Draft opinion Paragraph 3 3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments and for maintaining EU's global competitive advantage in innovation; underlines that the flexibilities provided in the TRIPS agreement can be used to address potential supply shortages in exceptional circumstances;
Amendment 32 #
Draft opinion Paragraph 3 3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments and EU's competitive position in innovation; underlines that the flexibilities provided in the TRIPS agreement can be used to address potential supply shortages in exceptional circumstances;
Amendment 33 #
Draft opinion Paragraph 3 3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments; underlines that the flexibilities provided in the TRIPS agreement
Amendment 34 #
Draft opinion Paragraph 3 a (new) Amendment 35 #
Draft opinion Paragraph 3 a (new) 3 a. Welcomes the commitment of the Commission to ensuring that emergency measures designed to tackle COVID-19 effects must be targeted, proportionate, transparent, temporary and consistent with WTO rules;
Amendment 36 #
Draft opinion Paragraph 4 4. Emphasises that a broad network of FTAs together with a functioning multilateral trading system constitute the best way of guaranteeing that multiple sources of manufacturing for essential medicines are available and regulatory standards converge globally; stresses the importance that the future agreement between the United Kingdom and the EU allows both sides to respond to emerging health threats, whilst also ensuring the supply of medicines and medical products in the best possible manner;
Amendment 37 #
Draft opinion Paragraph 4 4. Emphasises that a broad network of FTAs together with a functioning multilateral trading system
Amendment 38 #
Draft opinion Paragraph 4 4. Emphasises that a broad network of FTAs together with a functioning multilateral trading system constitute the best way of guaranteeing that multiple sources of manufacturing for essential medicines are available and regulatory standards converge globally; recalls that difference in regulatory frameworks and standards for medicinal products can create an obstacle to trade; encourages the adoption of international standards to ensure the quality and safety of imported final or intermediate medicinal products and the inclusion of strong regulatory cooperation provisions in EU bilateral trade agreements to ensure that all medicinal products destined for the European market fulfill the applicable quality standards;
Amendment 39 #
Draft opinion Paragraph 4 4.
Amendment 4 #
Draft opinion Paragraph 1 1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms the vital role played by functioning global supply chains for medical products, and in particular for medicines; emphasises that an open,
Amendment 40 #
Draft opinion Paragraph 4 4. Emphasises that a broad network of FTAs that take into account components of intellectual property, together with a functioning multilateral trading system constitute the best way of guaranteeing that multiple
Amendment 41 #
Draft opinion Paragraph 4 4. Emphasises that a
Amendment 42 #
Draft opinion Paragraph 4 4. Emphasises that a broad network of FTAs together with a fully functioning multilateral trading system with the World Trade Organisation and an operational Appellate Body at its core constitute the best way of guaranteeing that multiple sources of manufacturing for essential medicines are available and regulatory standards converge globally;
Amendment 43 #
Draft opinion Paragraph 4 4. Emphasises that
Amendment 44 #
Draft opinion Paragraph 4 4. Emphasises that a broad network of fair and well implemented FTAs together with a functioning multilateral trading system constitute the best way of guaranteeing that multiple sources of manufacturing for essential medicines are available and regulatory standards converge globally;
Amendment 45 #
Draft opinion Paragraph 4 a (new) 4 a. Emphasizes the need for a broader trade and health initiative within the WTO that aims to enhance cooperation and develop guidance to ensure a coordinated response in the event of shortage of essential medical supplies;
Amendment 46 #
Draft opinion Paragraph 5 5.
Amendment 47 #
5. Strongly encourages all countries to join the WTO’s Pharmaceutical Tariff Elimination Agreement; calls for its scope to be extended to all pharmaceutical and medicinal products; stresses that medical products and medicines, including in their intermediate forms, should be exempted from retaliation in trade disputes;
Amendment 48 #
Draft opinion Paragraph 5 5. Strongly encourages all countries to join the WTO’s Pharmaceutical Tariff Elimination Agreement; calls for its scope to be extended to all pharmaceutical and medicinal products; stresses that medical products and pharmaceuticals, including in their intermediate forms, should be exempted from retaliation in trade disputes;
Amendment 49 #
Draft opinion Paragraph 5 5. Strongly encourages all countries to join the WTO’s Pharmaceutical Tariff Elimination Agreement; calls for its scope to be extended to all pharmaceutical and
Amendment 5 #
Draft opinion Paragraph 1 1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms the vital role played by functioning global
Amendment 50 #
Draft opinion Paragraph 5 5. Strongly encourages all countries to join the WTO’s Pharmaceutical Tariff Elimination Agreement;
Amendment 51 #
Draft opinion Paragraph 5 a (new) 5 a. Notes that the whole world is fighting the COVID-19 pandemic, as no available medication that can fight the disease has been found yet; calls upon the Commission to coordinate with the WTO and the WHO that all countries, and in particular the developing countries, have equal access in case of any breakthrough drugs; encourages all member states to make efforts to establish a pool of patent rights for COVID-19 technologies at the WHO;
Amendment 52 #
Draft opinion Paragraph 5 a (new) 5 a. Calls also for the EU to unilaterally and temporarily eliminate tariffs on medical and pharmaceutical products to facilitate imports of these goods;
Amendment 53 #
Draft opinion Paragraph 6 Amendment 54 #
Draft opinion Paragraph 6 6. Underlines that a complete repatriation of medical supply chains is not possible in a global economy;
Amendment 55 #
Draft opinion Paragraph 6 6. Underlines that whereas - a complete repatriation of medical supply chains is not possible in a global economy; a gradual repatriation of strategic medicine production secures the stock of medical products within the EU, also during times of crisis, and strengthens the EUs independence from foreign producers who might impose protectionist measures; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to protectionist measures during health crises.
Amendment 56 #
Draft opinion Paragraph 6 6. Underlines that a complete repatriation of medical supply chains is n
Amendment 57 #
Draft opinion Paragraph 6 6. Underlines that a complete repatriation of medical supply chains is not possible in a global economy nor is it desirable; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to protectionist measures during health crises; calls on the Commission to explore the creation of a common European strategic reserve of medicines, building on the rescEU stockpile initiative.
Amendment 58 #
Draft opinion Paragraph 6 6. Underlines that a complete repatriation of medical supply chains is not possible in a global economy; urges the Commission and the Member States to work with the EU’s multilateral partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit individual states from resorting to protectionist measures, such as import and/or export restrictions during health crises.
Amendment 59 #
Draft opinion Paragraph 6 6. Underlines that a complete repatriation of all medical supply chains is not possible in a global economy; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to protectionist measures during health crises.
Amendment 6 #
Draft opinion Paragraph 1 1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms the vital role played by functioning global supply chains for medical products, and in particular for medicines; emphasises that a
Amendment 60 #
6. Underlines that a complete repatriation of medical supply chains is not possible in a global economy; urges the Commission and the Member States to work more closely between each other, with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to protectionist measures during health crises.
Amendment 61 #
Draft opinion Paragraph 6 6. Underlines that a complete repatriation of medical supply chains is not possible neither should be the aim in a global economy; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to protectionist measures during health crises.
Amendment 62 #
Draft opinion Paragraph 6 6. Underlines that a complete repatriation of medical supply chains is not possible in a global economy; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to
Amendment 63 #
Draft opinion Paragraph 6 6. U
Amendment 64 #
Draft opinion Paragraph 6 a (new) 6 a. Calls upon the Commission and the Member States to make sure that there is a constant and reliable supply of medical products; stresses that the development of medical products has to be in line with the international standards of human rights, in compliance with the Paris agreement, and that labour rights are in compliance with the ILO conventions; calls on the Commission that to maintain a level playing field in the internal market a common European approach for binding supply chain law is urgently needed;
Amendment 65 #
Draft opinion Paragraph 6 a (new) 6 a. Calls on the Commission and the Member States to ensure the swift and full implementation - and if needed a revision - of the regulation on FDI screening, in which health care should be included as a strategic sector;
Amendment 66 #
Draft opinion Paragraph 6 a (new) 6 a. Highlights the importance that the European Commission takes all necessary measures to combat speculation, fraud and price abuses in the trade of essential medical substances;
Amendment 67 #
Draft opinion Paragraph 6 b (new) 6 b. Emphasises the importance of European safety standards for medical products; urges the Commission to check medical products entering our internal market that they uphold to the European safety standards; calls upon the Commission to ensure that consumer protection is prioritised in the WTO negotiations on e-commerce in negotiation;
Amendment 68 #
Draft opinion Paragraph 6 b (new) 6 b. Calls on the Commission to exercise leadership at global level to ensure that developing countries have guaranteed access to and supply of essential medicines, especially in emergencies;
Amendment 69 #
Draft opinion Paragraph 6 c (new) 6 c. Stresses the importance of ensuring universal access to vaccines and medical treatment, especially in cases of emergency and for new diseases for which no treatment exists, as in the case of Covid-19; urges a close collaboration between the WHO and the WTO to ensure the supply of the vaccine once it is found; at the same time, calls on the Commission to strengthen its mechanisms for the joint procurement of medicines in order to guarantee universal access to treatment for all citizens regardless of their place of residence.
Amendment 7 #
Draft opinion Paragraph 1 a (new) 1 a. Recalls the need to step up medicine production capacities in Europe ensuring the adequate availability of needed pharmaceuticals and limiting delivery bottlenecks;
Amendment 8 #
Draft opinion Paragraph 1 b (new) 1 b. Asks the Commission and Member States to allocate resources to support the reconversion of chemical plants in the EU for the production of active pharmaceutical ingredients in order to decrease dependency on third countries;
Amendment 9 #
Draft opinion Paragraph 2 2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over- reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures such as export restrictions threaten the proper functioning of global supply chains and potentially undermine the availability of medicines in the EU;
source: 652.313
2020/05/19
ITRE
254 amendments...
Amendment 1 #
Draft opinion Recital -A (new) -A. whereas the problem of medicines shortages in the EU is long-standing and the number of incidents relating to medicines shortages has been growing in the EU Member States in recent years;
Amendment 1 #
Draft opinion Recital A A. whereas the problem of
Amendment 10 #
Draft opinion Recital A a (new) A a. whereas uncoordinated initiatives at national level, such as stockpiling and penalties, could lead to an increased risk of medicines shortage, while a pan- European coordinated approach and a close dialogue among all actors concerned is crucial to mitigate and prevent medicines shortage, as the covid- 19 crisis has demonstrated;
Amendment 10 #
Draft opinion Recital B B. whereas transport and logistics management are of crucial importance for the supply of medicine, pharmaceutical products, medical equipment, personal protective equipment, other medical supplies and raw materials, not least given the increasing degree of complexity of the transport chain, and whereas it is important to have efficient crossing green lane borders with fast track lanes in order to ensure the unobstructed flow of medicines;
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;
Amendment 101 #
Draft opinion Paragraph 4 4.
Amendment 102 #
Draft opinion Paragraph 4 4. Encourages the Commission to propose measures, including financial incentives and targeted guidelines on public procurements, to promote green manufacturing, within the EU, of strategically important chemicals used in medicine production, particularly APIs and intermediates; 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; notes that currently SMEs suffer, in particular, from disproportionate costs stemming from inefficient mechanisms of implementation of regulations;
Amendment 103 #
4. Encourages the Commission to propose measures, including financial incentives, to promote investments in green manufacturing for medicines value chain, 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;
Amendment 104 #
Draft opinion Paragraph 4 4. Encourages the Commission to propose measures, including financial incentives, to promote green manufacturing, within the EU, of medicines and 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;
Amendment 105 #
Draft opinion Paragraph 4 4. Encourages the Commission to propose measures, including financial incentives, to promote
Amendment 106 #
Draft opinion Paragraph 4 4. Encourages the Commission to propose measures, including financial incentives, to promote
Amendment 107 #
Draft opinion Paragraph 4 a (new) 4 a. Having regard to the European Strategy for Data and the digital transformation of healthcare, urges the Commission to promote implementation of interoperable technologies in the Member State’s health sector which will facilitate delivery of innovative health solutions to patients; encourages the creation of a fully operational European Health Data Space with a governance framework which fosters creation of an innovative data-driven ecosystem and which encourages sharing of information and critical data across the Union; asks the Commission to promote next generation standards, tools and infrastructure to store and process data suitable for research and the development of innovative products and services, while ensuring processing of patients personal data is in compliance with European data protection framework;
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;
Amendment 109 #
Draft opinion Paragraph 4 a (new) 4 a. Underlines that ensuring a fit for purpose regulatory environment is a key element to protect public health, provide access to high quality medicines and contribute to the prevention of shortages. The adequate use of Information Technology systems will improve regulatory efficiency across Europe; therefore, the Commission should optimize the European regulatory framework by harmonising regulatory telematics projects with a focus on data quality, interoperability and interdependency;
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;
Amendment 11 #
Draft opinion Recital B a (new) B a. whereas any EU strategy to address medicine shortages should be a wholesome approach that takes into consideration the root causes of medicines shortages and that addresses concrete actions for their prevention. The Union needs to focus on ways to increase production of medicines in Europe avoiding any future recurrence of shortages during a crisis and avoiding dependency on third countries for pharmaceutical ingredients.
Amendment 110 #
Draft opinion Paragraph 4 a (new) 4 a. Acknowledges that parallel trade may cause medicines shortages; calls on the Commission and Member States to adequately tackle problems related to parallel trade in medicines in the EU adopting measures based on the highest human rights standards in order to guarantee full availability and accessibility for all medicines, with particular attention to those needed for serious diseases;
Amendment 111 #
Draft opinion Paragraph 4 a (new) 4 a. Calls on the Commission to optimise regulatory processes, whilst maintaining its high scientific standards, in order to enable simplified administrative tasks associated with “variations”, improved access to information for patients and health care professionals, and simplified flow of medicines from one Member State to another in case of a shortage;
Amendment 112 #
Draft opinion Paragraph 4 a (new) 4 a. Highlights the importance of assessing the impact of parallel trade and export bans from the perspective of patient access; calls on the Commission to develop additional guidance as necessary for Member States on parallel exports; stresses the need to include the perspective and experiences of patient and consumer groups;
Amendment 113 #
Draft opinion Paragraph 4 a (new) 4 a. Urges the Commission to enable the Member States to make every necessary effort to ensure that small and medium-sized pharmaceutical companies continue or resume their research activities and help ensure the diversity of our production and the maintenance of the jobs that go with it;
Amendment 114 #
Draft opinion Paragraph 4 a (new) 4 a. 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;
Amendment 115 #
Draft opinion Paragraph 4 b (new) 4 b. Calls on the Commission to take stock of the impact of coronavirus on industry and SMEs and to present a renewed EU industrial strategy; considers that the industrial recovery of Europe needs to prioritize twin digital and ecological transformation of our societies and building of resilience to external shocks; stresses the importance of promoting private-public partnerships in high value-added and innovative sectors, such as the pharmaceutical industry; stresses the importance of manufacturing for jobs, growth and competitiveness;
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;
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;
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;
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;
Amendment 12 #
Draft opinion Recital A a (new) A a. whereas with the Covid-19 outbreak has emerged that many national governments of Member States have been victims of fraud and have been supplied with defective medical equipment and supplies coming from third countries companies, in particular Chinese ones;
Amendment 12 #
Draft opinion Recital B a (new) B a. whereas free competition in the road transport sector, the absence of administrative barriers and easy access to transport services, including cabotage, play a crucial role in ensuring an adequate level of supply of medicines and medical devices and preventing their shortages;
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;
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;
Amendment 122 #
Draft opinion Paragraph 5 5. Highlights the fact that Horizon 2020 has already financed a significant number of health-related research and innovation activities; underlines that the funding of coronavirus-related research should not affect other health priorities of Horizon 2020; calls for making funding conditional on ensuring wide availability and affordability of R&D products vital in health emergencies, including the possibility to require non- exclusive licensing; calls for more funding to be provided through Horizon Europe to create and support medicine-
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
Amendment 124 #
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
Amendment 125 #
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.
Amendment 126 #
Draft opinion Paragraph 5 a (new) 5 a. Considers that the relocation of the activities of the European pharmaceutical industries, on the one hand, and their willingness to continue to invest in their European units on the other, will depend in part on our ability to develop advanced authentication and traceability technologies that will ensure the reliability of the entire chain of manufacture, packaging and distribution of their products; this could possibly be achieved by making more appropriate use of the data from the EMVS (European Medicines Verification System) directory to obtain complete serialisation of each box of medicines;
Amendment 127 #
Draft opinion Paragraph 5 a (new) 5 a. Notes with concern market failure in several Members States where patients' access to effective and affordable medicines and medical devices remains threatened by very high and often unsustainable price levels, market withdrawal of products that are out-of- patent or a failure to introduce new products to national markets due to business strategies; recognises that access to medicines and medical devices in the Member States with smaller markets requires particular consideration in the new EU Pharmaceutical Strategy;
Amendment 128 #
Draft opinion Paragraph 5 a (new) Amendment 129 #
Draft opinion Paragraph 5 a (new) 5 a. In order to support Member States in the prevention of medicine shortages, calls on the Commission to develop targeted EU Guidelines on procurement of medicines by putting in place the right economic framework, under the EU public procurement Directive 2014/24/EU, aimed at ensuring long term sustainability, competition, security of supply and stimulating investments in manufacturing;
Amendment 13 #
Draft opinion Recital A a (new) A a. whereas 60 % to 80 % of the active ingredients of medicinal products, i.e. the substance which gives the therapeutic effect, are manufactured outside Europe, mainly in China and India; whereas this proportion was 20 % 30 years ago;
Amendment 13 #
Draft opinion Recital C C. whereas high safety standards and preservation of working conditions for transport workers should be guaranteed and whereas pharmaceutical regulation should ensure the quality, safety and efficiency of the supply of medicines between Member States;
Amendment 130 #
Draft opinion Paragraph 5 a (new) 5 a. Calls on the Commission and relevant authorities to provide regulatory flexibility to mitigate medicines shortages when they occur, by allowing targeted measures such as more flexibility for multi-language packs, different pack size and e-leaflet, to ensure that patients are able to access high-quality and safe medicines faster;
Amendment 131 #
Draft opinion Paragraph 5 a (new) 5 a. Recalls the detrimentally high level of public dependency on the will of private companies to develop life-saving products; calls for a review of the incentives put in place to encourage research on ‘orphan medicines’ in order to determine whether they are successful, and calls for new incentives should this not be the case;
Amendment 132 #
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.
Amendment 133 #
Draft opinion Paragraph 5 a (new) 5 a. Welcomes the initiative of Commissioner Reynders to propose a due diligence law for companies in 2021; calls on the Commission to incorporate measures for the pharmaceutical sector into this proposal;
Amendment 134 #
Draft opinion Paragraph 5 a (new) 5 a. Calls on the Commission to take the first steps to enhance transparency of research and development costs of medicines;
Amendment 135 #
Draft opinion Paragraph 5 b (new) Amendment 136 #
Draft opinion Paragraph 5 b (new) 5 b. Calls on the Commission, in close cooperation with the Member States, to promote andf acilitate greater public transparency, information and best practice sharing and cooperation in regard to pricing, reimbursement and procurement of medicines; calls for a new Transparency Directive to replace Directive 89/105/EEC with the aim of ensuring effective controls and full transparency on the procedures used to determine the prices and the reimbursement of medicinal products in the Member States;
Amendment 137 #
Draft opinion Paragraph 5 b (new) 5 b. Taking into account that timely notification of shortage of medicines is essential for ensuring alternative treatments for patient care and for mitigating negative effects on the security of supply, calls on the Commission to introduce obligation for marketing authorization holders to notify shortage of medicines to the competent authorities at a minimum two months in advance;
Amendment 138 #
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.
Amendment 139 #
Draft opinion Paragraph 5 b (new) 5 b. 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;
Amendment 14 #
Draft opinion Recital A a (new) A a. A. Whereas causes underlying medicines shortages are complex and multi-dimensional and are linked to manufacturing problems, industry quotas, legal parallel trade, but also to economic aspects, such as pricing;
Amendment 14 #
Draft opinion Recital C C. whereas high safety standards should be guaranteed and whereas pharmaceutical regulation should ensure the quality, quantity, safety and efficiency of the supply of medicines between Member States;
Amendment 140 #
Draft opinion Paragraph 5 b (new) 5 b. States that the current COVID-19 crisis shows the need for more European cooperation in the health sector, calls for more EU competences in the sector; demands an increased rescEU budget to facilitate future common European procurement of medicine, vaccines, medical devices and protective gear;
Amendment 141 #
Draft opinion Paragraph 5 b (new) Amendment 142 #
Draft opinion Paragraph 5 b (new) 5 b. Invites the Commission, therefore, to introduce incentives for manufacturers or a system of labelling - visible and identifiable by patients/customers - concerning the origin and place of production of medicinal products and active ingredients;
Amendment 143 #
Draft opinion Paragraph 5 c (new) 5 c. Highlights the dangers of neglecting environmental standards in production, as e.g. possible unlawful disposal of waste water containing toxic substances does not only harm the environment but can also lead to serious health threats; recalls the serious danger of growing antimicrobial resistance (AMR) through uncontrolled release of antibiotics in the environment both through factory farming and through API production without proper waste (water) treatment; reminds of the “EU One Health Action Plan against Antimicrobial Resistance”; stresses that Europe has a global responsibility in containing AMR and that non-compliance to environmental standards should be a knock-out criterion for API and chemicals providers;
Amendment 144 #
Draft opinion Paragraph 5 c (new) 5 c. Calls on the Commission to expand its joint European response to include joint procurement actions for all developed vaccines, medication, medical equipment and medical technology; insists that this joint response be a priority post-pandemic, and be easily accessible for citizens in every Member State especially those that are particularly vulnerable from a public health and economical perspective due to their remote location or small size;
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;
Amendment 146 #
Draft opinion Paragraph 5 c (new) 5 c. Calls on the Commission to promote and include in the future pharmaceutical strategy for the EU the paradigm of sovereignty in the production of medicines and active ingredients; calls, in this regard, for a coordinated and concerted plan with the Member States to provide for the urgent relocation within the EU of production lines for all essential and strategic medicines and active ingredients;
Amendment 147 #
Draft opinion Paragraph 5 c (new) 5 c. Calls on the Commission and relevant authorities, in the mitigation of shortages of medicines, when they occur, to provide regulatory flexibility by allowing targeted measures such as more flexibility for multi-language packs, different pack size and e-leaflet, to ensure that patients are able to access high- quality and safe medicines faster;
Amendment 148 #
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.
Amendment 149 #
Draft opinion Paragraph 5 c (new) Amendment 15 #
Draft opinion Recital A a (new) A a. whereas parallel trade and export bans could affect the availability of medicines in some Member States; whereas the Commission launched a study on the impact of the parallel trade;
Amendment 15 #
Draft opinion Recital C a (new) C a. Whereas the Treaties and the European Charter of Fundamental Rights state that everyone shall have access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices, and whereas this right should be enforced for all citizens, including those living in the most peripheral areas of the Union;
Amendment 150 #
Draft opinion Paragraph 5 d (new) 5 d. Calls on the Commission to strengthen border controls on the conformity of imported medicinal products or active ingredients, particularly where such imports drive down internal market prices, distort competition, and lead to the relocation of production lines outside the EU;
Amendment 151 #
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.
Amendment 152 #
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.
Amendment 153 #
Draft opinion Paragraph 5 e (new) 5 e. Calls on the Commission and the Member States to carry out stress tests on the availability and production capacity of medicines and active ingredients in order to protect against future pandemic health crises;
Amendment 154 #
Draft opinion Paragraph 5 f (new) Amendment 155 #
Draft opinion Paragraph 5 f (new) 5 f. Calls on the Commission to plan investment measures for innovative research projects and for the development of cutting-edge pharmaceutical technologies; encourages, in this respect, the Commission to direct these investments as a matter of priority towards laboratories of excellence and European small and medium-sized enterprises in the pharmaceutical sector, in order to restore a form of capacity equity in the face of the giants of the pharmaceutical industry.
Amendment 156 #
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.
Amendment 16 #
Draft opinion Recital A a (new) A a. whereas uncoordinated measures at national level have demonstrated to be ineffective to fight against the covid19 crisis, while a pan-European coordination and dialogue is needed;
Amendment 16 #
Draft opinion Recital C a (new) C a. whereas ensuring full patient access is one of the core objectives of the Union and the WHO, and one of the Sustainable Development Goals, and whereas patients rely on equitable and efficient access to medicines based on a sustainable, competitive, multi-source and well-functioning Single Market, including the Single European Transport Area;
Amendment 17 #
Draft opinion Recital A a (new) A a. Recognizes that drug shortages are sometimes artificially created by pharmaceutical companies that choose to produce more profitable drugs while neglecting less profitable ones;
Amendment 17 #
Draft opinion Recital C a (new) C a. whereas ensuring patient access is one of the core objectives of the Union and the WHO, and of the Sustainable Development Goals, and whereas patients rely on equitable and sustainable access to medicines based on a sustainable, competitive, multi-source and well- functioning single market;
Amendment 18 #
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)
Amendment 18 #
Draft opinion Recital C a (new) C a. whereas stocks are often not in the right storage location, even if available in the supply chain, and patients are unable to get them at the delivery point due to a lack of information, giving a false sign of a shortage of medicines;
Amendment 19 #
Draft opinion Recital A a (new) A a. Whereas it is of outmost importance to prevent shortages of medicines and, in case they occur, mitigate their consequences;
Amendment 19 #
Draft opinion Recital C a (new) C a. whereas the coronavirus pandemic highlighted the importance of coordinated action between EU institutions, Member States and industry in order to mitigate supply disruptions of medicines.
Amendment 2 #
Draft opinion Recital -A a (new) -A a. whereas the dependency on suppliers from a small number of third countries – the overwhelming majority of chemical raw and starting materials and active pharmaceutical ingredients (API) used for manufacturing of medicinal products for the EU market come from India and China – leads to the vulnerability of the EU health systems; whereas causes of most incidents relating to medicines shortages can be traced to disruption in the early stages of supply chains;
Amendment 2 #
Draft opinion Recital A 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 and the artificial shortage created by pharmaceutical companies which choose to focus on profitability ;
Amendment 20 #
Draft opinion Recital A b (new) A b. Whereas is fundamental to prevent medicine shortages, as well as to mitigate them in case they occur; shortages of medicines are a symptom of unsustainable policies, abundant scientific evidence demonstrates that medicines shortages have numerous root causes: specifically economic causes, increasing regulatory burden, unforeseen surges in demand, supply chain interdependencies and manufacturing and quality challenges;
Amendment 20 #
Draft opinion Recital C b (new) C b. whereas the COVID-19 pandemic outbreak demonstrated the importance of coordination between EU policies and departments to promptly and efficiently react to emergencies as well as to prevent medicines shortages, and to mitigate them in case they occur;
Amendment 21 #
Draft opinion Recital A b (new) A b. whereas the Commission has issued guidelines for an optimal and rational supply of medicines in order to avoid shortages during the COVID-19 pandemic; whereas, in these guidelines, the Commission recognises that no country is self-sufficient in either raw materials or Active Pharmaceutical Ingredient (APIs), intermediate products or finished medicines needed for the proper functioning of the health system;
Amendment 21 #
Draft opinion Recital C b (new) C b. whereas the COVID-19 pandemic demonstrated the importance of coordination between EU policies and department to promptly and efficiently react to emergencies as well as to prevent medicines shortages, and to mitigate them in case they occur;
Amendment 22 #
Draft opinion Recital A b (new) A b. whereas the combination of cost containment measures, lack of market predictability, combined with an onerous and rigid regulatory framework create an unsustainable environment for the European pharmaceutical industry to operate and to continue to act as a catalyst to enable sustainable access to medicines for patients;
Amendment 22 #
Draft opinion Recital C b (new) C b. whereas the COVID-19 exacerbated the existing situation, and highlighted that the pharmaceutical supply chain is interconnected within EU Members States and externally;
Amendment 23 #
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;
Amendment 23 #
Draft opinion Recital C c (new) C c. whereas the COVID-19 pandemic outbreak stressed that European coordination among EU Institutions, regulators and pharmaceutical supply chain experts is vital to respond in real- time to health crisis and to supply disruption, including shortages of medicines, in all relevant policy areas;
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;
Amendment 24 #
Draft opinion Recital C c (new) C c. whereas the COVID-19 pandemic stressed that European coordination among the EU institutions, the Member States, regulators and pharmaceutical supply chain experts is vital to respond to health crisis and to supply disruption such as shortages of medicines in all policy areas;
Amendment 25 #
Draft opinion Recital A c (new) A c. whereas shortages of medicines are a symptom of unsustainable policies, and there is abundant scientific evidence that demonstrates that medicines shortages have multi factorial root causes: namely economic causes, increasing regulatory burden, unforeseen surges in demand, supply chain interdependencies and manufacturing and quality challenges;
Amendment 25 #
Draft opinion Recital C d (new) C d. whereas the COVID-19 pandemic outbreak exacerbated the existing situation, it emerged that the pharmaceutical supply chain is interconnected within EU Members States and externally, and relies heavily on fully and properly functioning Single European Transport Area;
Amendment 26 #
Draft opinion Recital A c (new) A c. whereas, according to the Commission, the COVID-19 pandemic crisis has justified and still justifies a significant increase in the production of both active ingredients and medicinal products in the EU, and whereas this situation requires a reorganisation of supply chains and production lines;
Amendment 26 #
Draft opinion Recital C e (new) C e. whereas the COVID-19 pandemic outbreak demonstrated the importance of prioritising the circulation of essential goods, such as medicines and medical goods, including their undisrupted flow between Member States;
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;
Amendment 27 #
Draft opinion Paragraph 1 1. Calls on the Member States to enhance their cooperation
Amendment 28 #
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)
Amendment 28 #
Draft opinion Paragraph 1 1. Calls on the Member States to enhance their cooperation in order to improve the medical supply and distribution chain through
Amendment 29 #
Draft opinion Recital A c (new) A c. Whereas after the pandemic a global economic crisis is expected, this will challenge even more equitable access to medicines and competitiveness of industrial sector;
Amendment 29 #
Draft opinion Paragraph 1 1. Calls on the Member States to enhance their cooperation in order to improve the distribution chain through better visibility and efficient monitoring, particularly on cross-border routes, and to establish corridors where medical supplies have priority of delivery; calls on the Commission to maintain the green lanes to address future unexpected events;
Amendment 3 #
Draft opinion Recital -A b (new) -A b. whereas production of chemical raw and starting materials and active pharmaceutical ingredients in the EU has been affected by the tendering system based on the criterion of lowest price, which incentivises the outsourcing of such production to third countries and therefore harming European companies with higher standards; whereas some facilities in these third countries often lack the capacity to enforce adherence to adequate standards of sustainable and ethical production of these materials and ingredients; whereas single winner tender systems are endangering the diversification of sources and leading to possible shortages;
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;
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;
Amendment 30 #
Draft opinion Paragraph 1 1. Calls on the Member States to enhance their cooperation in order to improve the distribution chain through better visibility and efficient monitoring, planning and timely exchange information regarding important deliveries, particularly on cross-border routes, and to
Amendment 31 #
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;
Amendment 31 #
Draft opinion Paragraph 1 1. Calls on the
Amendment 32 #
Draft opinion Recital A d (new) A d. whereas the Commission has announced its intention to publish, by the end of 2020, recommendations for a future EU pharmaceutical strategy;
Amendment 32 #
Draft opinion Paragraph 1 1. Calls on the Member States to enhance their cooperation and coordination between them in order to improve the distribution chain through better visibility and efficient monitoring, particularly on cross-border routes, and to establish corridors where medical supplies have priority of delivery;
Amendment 33 #
Draft opinion Recital A d (new) A d. whereas an efficient strategy should cover measures to mitigate medicines shortage, but also to prevent them from happening;
Amendment 33 #
Draft opinion Paragraph 1 a (new) 1 a. Calls on the Commission to coordinate a pan-European response to medicines shortages in order to ensure equitable and sustainable access to medicines; believes that a coordinated EU response is of utmost importance to avoid spill-over effects of individual and uncoordinated national measures addressing local medicines shortages, and to ensure the patients' right to universal, equitable, affordable, effective, safe and timely access to essential medicines, as well as to guarantee the sustainability of the EU public healthcare systems; is of the opinion that this pan-European approach should focus on coordinating Member States' policy measures to address the root causes of medicines shortages;
Amendment 34 #
Draft opinion Recital A e (new) A e. whereas, in her statements made during a meeting with the members of the European Parliament’s Environment, Public Health and Food safety (ENVI) committee, on April 22, Commissioner Stella Kyriakides highlighted the need to increase the production of medicines and the level of innovation within the UE;
Amendment 34 #
Draft opinion Paragraph 1 a (new) 1 a. Highlights that the air freight is a crucial part of the pharmaceutical supply chain; and therefore calls on the Commission and the Member States to create dedicated hubs in the Union to build receiving points of air freight of medicines, active pharmaceutical ingredients and medical equipment insufficient capacity in order to cover needs of the supply chain as well as creating open routes between the Union and third countries for these essential goods; calls on the Member States to encourage cargo and express airlines to apply reasonable shipping rates for medical and emergency supplies;
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;
Amendment 35 #
Draft opinion Paragraph 1 a (new) 1 a. Calls on the Commission to coordinate a European response to medicines shortages to ensure equitable and sustainable access to medicines; believes that a coordinated EU response is of utmost importance to avoid spillover effects of individual and uncoordinated national measures to address medicines shortages and ensure the right of patients to universal, equitable, affordable, effective, safe and timely access to essential medicines, as well as to guarantee the sustainability of the EU public healthcare systems;
Amendment 36 #
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;
Amendment 36 #
Draft opinion Paragraph 1 a (new) 1 a. notes with concern that climate change being one of the factors behind the multiplication of epidemics, their number will grow in future; underlines that globalisation and the intensification of travel also results in the aggravation of epidemics and their geographical spread;
Amendment 37 #
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;
Amendment 37 #
Draft opinion Paragraph 1 b (new) 1 b. Notes that in times of epidemics, the few countries responsible for most of the production of active substances for medicines can become unable to meet demand; remarks that long supply chains for medicines can therefore pose a risk to human life;
Amendment 38 #
Draft opinion Recital A f (new) A f. whereas, to date, no compulsory label or labelling - visible by patients/customers - is required for medicinal products and active ingredients concerning their origin and country of manufacture;
Amendment 38 #
Draft opinion Paragraph 1 c (new) 1 c. Notes that the security of supply is central to fight against medicine shortages and that problems with cross border transport and controls make it even more important to uphold the Schengen agreement;
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;
Amendment 39 #
Draft opinion Paragraph 2 2.
Amendment 4 #
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; whereas the limited access to Active Pharmaceutical Ingredients (APIs) required for the production of generic medicines poses a particular challenge with around 70% of APIs used in Europe being imported from third countries;
Amendment 4 #
Draft opinion Recital A A. whereas the problem of medicine shortages in the Member States was highlighted during the COVID-19 crisis, demonstrating that the problem is getting ever more severe on account of the lack of production capacity in the EU and
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;
Amendment 40 #
Draft opinion Paragraph 2 2. Stresses that boosting the industrial production of the Member States through favourable economic conditions in the context of national fiscal policies would ensure a more efficient supply of stocks of medicines and medical equipment, and would lead to a more efficient and sustainable logistics network, while reducing the length of transport routes, thereby reducing emissions, mitigating the impact on the
Amendment 41 #
Draft opinion Recital A g (new) A g. whereas existing tax mechanisms and incentives can be implemented at European and Member States level for strategic industrial sectors;
Amendment 41 #
Draft opinion Paragraph 2 2. Stresses that boosting the industrial production of the Member States through favourable economic
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;
Amendment 42 #
Draft opinion Paragraph 3 3. Calls on the Member States
Amendment 43 #
Draft opinion Recital A h (new) A h. whereas there is a high level of control in force in the EU over the quality of drug production;
Amendment 43 #
Draft opinion Paragraph 3 3. Calls on the
Amendment 44 #
Draft opinion Recital A i (new) A i. whereas all small and medium- sized pharmaceutical laboratories constitute a wealth to be preserved and a breeding ground for research and discoveries to be supported, as they can participate in the prevention of drug shortages;
Amendment 44 #
Draft opinion Paragraph 3 3. Calls on the Member States to adopt a strategic plan
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;
Amendment 45 #
Draft opinion Paragraph 3 3. Calls on the Commission to work in coordination with the Member States in order to adopt strategic plans to upgrade their existing infrastructure for an efficient supply of medicines with a better use of all transport modes; deems it necessary to remove bottlenecks, boost intermodality (while favouring the shift to rail), finance the main hubs (ports, airports and intermodal platforms), and enhance the delivery of various types of goods, including dangerous goods crucial for the production of the chemical and
Amendment 46 #
Draft opinion Recital A j (new) A j. whereas the relocation of production units for medicinal products is likely to be accompanied by an increase in the cost of manufacturing said products; whereas purchasers, in particular hospital pharmacies, are subject to budgetary restrictions which very often require them to consider only financial criteria and not quality or origin;
Amendment 46 #
Draft opinion Paragraph 3 3. Calls on the Member States to adopt strategic plans to upgrade their existing infrastructure for an efficient supply of medicines, including inexpensive, essential medicines; deems it necessary to remove bottlenecks, boost intermodality (while favouring the shift to rail), finance the main hubs (ports, airports and intermodal platforms), and enhance the delivery of various types of goods, including dangerous goods crucial for the production of the chemical and pharmaceutical industry;
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;
Amendment 47 #
Draft opinion Paragraph 3 3. Calls on the Member States to adopt strategic plans to upgrade their existing infrastructure for an efficient supply of medicines and for the reduction of delivery time; deems it necessary to remove bottlenecks, boost intermodality (while favouring the shift to rail), finance the main hubs (ports, airports and
Amendment 48 #
Draft opinion Paragraph -1 (new) -1. Calls on the Commission to publish without any further delays the roadmap on EU Pharmaceutical Strategy which will identify root causes of medicine shortages; urges the Commission to propose ambitious and specific regulatory measures with an objective of making medicines available, affordable, sustainable and equally accessible; calls on the Commission to promote measures which will increase EU security of supply of medicines and reduce dependency on third countries;
Amendment 48 #
Draft opinion Paragraph 3 3. Calls on the Member States to adopt strategic plans to upgrade their existing infrastructure for an efficient supply of medicines; deems it necessary to remove bottlenecks, boost intermodality (while favouring the shift to rail), finance the main hubs (ports, airports and intermodal platforms), and
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;
Amendment 49 #
Draft opinion Paragraph 3 a (new) 3 a. Welcomes the contribution of the armed forces of Member States to the supply chain of medicines and protective equipment during the COVID-19 outbreak; therefore, calls on the Commission and the Member States, in close cooperation with the European Medicines Agency, to enhance the cooperation for the use of national military resources, where available and necessary, to assist the supply chain of medicines and protective equipments among Member States, as part of PESCO cooperation framework;
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
Amendment 5 #
Draft opinion Recital A A. whereas the problem of medicine shortages in the Member States is g
Amendment 50 #
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; calls on the Commission to propose ambitious and concrete actions to address these issues in its planned pharmaceutical strategy with, among others, a mechanism to oblige the companies owning the patents to produce the needed medicines even if they are less profitable, and the possibility to impose compulsory licences in order to facilitate, without constraint, the increase of the production of the most needed drugs or vaccines;
Amendment 50 #
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, and of completion of the proposal for a regulation of the European Parliament and of the Council establishing the ‘Customs’ programme for cooperation in the field of customs and of the proposal for a regulation of the European Parliament and of the Council establishing, as part of the Integrated Border Management Fund, the instrument for financial support for customs control equipment , with a view to optimising the distribution of medicines in the Member States and planning supply times more efficiently;
Amendment 51 #
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;
Amendment 51 #
Draft opinion Paragraph 4 4. Highlights the importance of IT systems in facilitating the trackability, supervision and timely delivery of transported medicines as well as the exchange of information between the various actors involved in the transport logistics chain,
Amendment 52 #
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;
Amendment 52 #
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; calls on the Commission to develop mechanisms in cooperation with Member States in order to ensure a fast and safe transport of medicines; notes also the importance of having contingency plans that ensure the unobstructed transport of medicines when the transport sector is conditioned;
Amendment 53 #
Draft opinion Paragraph 1 1. Insists that the Commission urgently launches a multi-stakeholder consultation to identify
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;
Amendment 54 #
Draft opinion Paragraph 1 – subparagraph 1 (new) In particular, calls on the Commission to propose a comprehensive strategy to promote the medical European self- sufficiency and that of its Member States;
Amendment 54 #
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
Amendment 55 #
Draft opinion Paragraph 1 a (new) 1 a. Calls for an overhaul of the EU- wide early warning system that would provide a comprehensive picture and issue regular and timely alerts on potential shortages of medicines; insists that within this system, all stakeholders in the supply chain, including parallel traders and wholesalers, should have an obligation to report in a timely manner on potential disruptions; states that the deadline of two months for the current reporting obligation doesn´t leave enough time to act, calls for better enforcement of legal reporting obligations; calls for a more central role for the European Medicine Agency in an EU-wide early warning system that includes, in addition to the aforementioned stakeholders, hospital pharmacists and patient associations;
Amendment 55 #
Draft opinion Paragraph 4 a (new) 4 a. Highlights the importance of safe, reliable and clear data for both the transport and health sector; welcomes the EC Data Strategy, in particular the projects for a mobility and health data space; invites the Commission to work on creating synergies between the two data spaces, with the objective of maximising efficiency in transporting medicines, avoiding shortages and allowing for expedient crisis management; invites the Commission to explore the possibility of a European digital platform to facilitate logistical coordination between medicine distributors and transport operators;
Amendment 56 #
Draft opinion Paragraph 1 a (new) 1 a. Calls on the Commission to coordinate a Pan-European response, with European Medicines Agency (EMA), National Competent Authorities (NCAs), Member States, the pharmaceutical industry and all players in the pharmaceutical supply chain; a coordinated EU response is of utmost importance to coordinate Members States policy measures to individual and uncoordinated national measures to address medicines shortages root causes and prevent them in the long term as well as to ensure the right of patients to universal, equitable, affordable, effective, safe and timely access to essential medicines, as well as to guarantee the sustainability of the EU public healthcare systems;
Amendment 56 #
Draft opinion Paragraph 5 5. Notes the importance of guaranteeing high safety standards for both transport infrastructure, for transport workers and employees, making it possible to manage significant volumes in the supply chain without disruptions o
Amendment 57 #
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;
Amendment 57 #
Draft opinion Paragraph 5 5. Notes the importance of guaranteeing high safety standards for both transport infrastructure and employees, making it possible to manage significant volumes in the supply chain without disruptions or posing risks to health; underlines the importance of having good conditions for drivers in order to respect the resting time and good working conditions; further derogations of rest time rules should become more harmonised and limited to what is strictly necessary;
Amendment 58 #
Draft opinion Paragraph 1 a (new) 1 a. Calls on the Commission, in cooperation with the stakeholders of the sector, to finally develop a shortage alert mechanism that will be both responsive and easily activated, so that in the future countries facing this problem can react and turn to other markets if necessary; insists that this mechanism be extended, as far as possible, to the entire supply chain, so that distributors can also trigger the alert;
Amendment 58 #
Draft opinion Paragraph 5 5. Notes the importance of guaranteeing high safety standards for both transport infrastructure and employees, making it possible to manage significant volumes in the supply chain without disruptions or posing risks to health; stresses the need to preserve the working conditions established before the crisis in terms of working time and rest and to privilege branch agreements for any modification of the working conditions required by the supply continuity;
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;
Amendment 59 #
Draft opinion Paragraph 5 5. Notes the importance of guaranteeing non-discriminatory high safety standards for both transport infrastructure and
Amendment 6 #
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
Amendment 6 #
Draft opinion Recital A a (new) A a. whereas climate change is one of the factors behind the multiplication of epidemics, both in terms of geographic spread and severity, that are linked to globalisation and the intensification of travel, and whereas the destruction of biodiverse habitats and industrial farming creates favourable conditions for the spread of 'zoonoses' by allowing pathogens and animal origin to reach humans and spread rapidly;
Amendment 60 #
Draft opinion Paragraph 1 a (new) 1 a. Calls the Commission and Member States to provide an environment that ensures Europe continues to be an attractive location for R&D investment and industrial development in the pharmaceutical industry to respond to potential needs;
Amendment 60 #
Draft opinion Paragraph 5 a (new) 5 a. Calls on the Commission to provide financial and organisational support to the Member States and transport operators in urgent cases, to prioritise and provide reserved space in all cargoes for essential goods (such as medicines, active pharmaceutical ingredients, medical equipment, etc.)
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;
Amendment 61 #
Draft opinion Paragraph 5 a (new) 5 a. Calls on the Commission to support Member States, also financially, during emergency events, such as pandemic outbreaks, to give priority and ensure reserved space in all cargo to essential goods, such as medicines, active pharmaceutical ingredients, medical equipment, etc.;
Amendment 62 #
Draft opinion Paragraph 1 b (new) 1 b. Stresses the need to maintain open borders via Green Lanes, facilitating crossing borders to those pharmaceutical or medical companies distributing and supplying medicines and/or personal protection equipment (PPE), to avoid possible shortages of medicines;
Amendment 62 #
Draft opinion Paragraph 5 a (new) 5 a. Call on the Commission to support Member States, in extraordinary circumstances in order to ensure reserved space in all cargo to essential goods (such as medicines, active pharmaceutical ingredients, medical equipment, etc).
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;
Amendment 63 #
Draft opinion Paragraph 5 b (new) 5 b. calls for the efficiency enhancement of regulatory procedures and swift implementation of fast-track processes to timely mitigate the medicines shortage;
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;
Amendment 64 #
Draft opinion Paragraph 6 6. Stresses the importance of catering to specific transport needs at local and regional levels, particularly in rural, mountain, sparsely populated and insular areas that are more difficult to access and involve higher delivery costs; notes th
Amendment 65 #
Draft opinion Paragraph 2 2. Calls on the Commission to consider proposing
Amendment 65 #
Draft opinion Paragraph 6 6. Stresses the importance of catering to specific transport needs at local and regional levels, particularly in rural, mountain and insular areas and outermost regions that are more difficult to access and involve higher delivery costs; believes that the strategic plans to upgrade Member States infrastructure should deliver concrete actions for these areas and regions; notes that there are new automated delivery tools, such as via drones, available on the market that could help operators to access these areas;
Amendment 66 #
Draft opinion Paragraph 2 2. Calls on the Commission to
Amendment 66 #
Draft opinion Paragraph 6 6. Stresses the importance of catering to specific transport needs at local and regional levels, particularly in rural, mountain and insular areas, but also in outermost regions that are more difficult to access and involve higher delivery costs; notes that there are new automated delivery tools, such as via drones, available on the market that could
Amendment 67 #
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.
Amendment 67 #
Draft opinion Paragraph 6 6. Stresses the importance of catering to specific transport needs at local and regional levels, particularly in rural, mountain
Amendment 68 #
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; notes the importance for the industry to have the capacity of increasing its production to be able to meet with the sudden surge in the demand due to critical situations;
Amendment 68 #
Draft opinion Paragraph 6 6. Stresses the importance of catering to specific transport needs at local and regional levels, particularly in peripheral, rural, mountain and insular areas that are more difficult to access and involve higher delivery costs; notes that
Amendment 69 #
Draft opinion Paragraph 2 2. Calls on the Commission to
Amendment 69 #
Draft opinion Paragraph 6 a (new) 6 a. Underlines that restricting the supply of transport services by creating market or administrative barriers poses a serious threat to the continuity of supply of medicines, medical devices and other medical products and may be a reason for their shortage in the common market;
Amendment 7 #
Draft opinion Recital A A. whereas the coronavirus pandemic has
Amendment 7 #
Draft opinion Recital A a (new) A a. Where as access to medicines is a growing problem within the Union, usually associated with the high price of medicines and hindering European citizens' right to access to health care, and whereas it is expected for the socio-economic situation to decline as a consequence of coronavirus pandemic and to worsen the living conditions for vulnerable citizens;
Amendment 70 #
Draft opinion Paragraph 2 2. Calls on the Commission to
Amendment 70 #
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
Amendment 71 #
Draft opinion Paragraph 2 a (new) 2 a. Calls on the Commission to reflect, together with stakeholders from the pharmaceutical industry, on the volumes of stock of medicines available; recalls in this respect that the quotas of stock volumes put in place by distributors are often tight and cause slowdowns and shortages, and that at all levels there is a lack of stock transparency;
Amendment 71 #
Draft opinion Paragraph 7 7. Notes that the COVID-19 outbreak
Amendment 72 #
Draft opinion Paragraph 2 a (new) 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.
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;
Amendment 73 #
Draft opinion Paragraph 7 7. Notes that the COVID-19
Amendment 74 #
Draft opinion Paragraph 2 a (new) 2 a. Calls on the Commission to preserve a competitive research-based pharmaceutical industry taking into account that EU remains by far the world leader manufacturing region of active ingredients for on patent medicines;
Amendment 74 #
Draft opinion Paragraph 7 7. Notes that the COVID-19 outbreak h
Amendment 75 #
Draft opinion Paragraph 2 a (new) 2 a. Insists that the Commission establishes shortage of medicines as one of the pillars of its new planned pharmaceutical strategy;
Amendment 75 #
Draft opinion Paragraph 7 7. Notes that the COVID-19 outbreak
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;
Amendment 76 #
Draft opinion Paragraph 7 7. Notes that the COVID-19 outbreak h
Amendment 77 #
Draft opinion Paragraph 2 b (new) 2 b. Stresses the need to establish proper pandemic preparedness plans under medical supervision for critical medicines at EU level based on solidarity between Member States, and ensuring that non-pandemic related medicines continue to reach the patients in need;
Amendment 77 #
Draft opinion Paragraph 7 7. Notes that the COVID-19 outbreak
Amendment 78 #
Draft opinion Paragraph 2 b (new) 2 b. Calls on the Commission to organise the revision of the European legislative framework through the future pharmaceutical strategy to enable the Member States to put transparency measures into practice;
Amendment 78 #
Draft opinion Paragraph 7 – point 1 (new) (1) Calls on the Commission to extend the competences of the ECDC in the area of public health; notes that in the future ECDC should be the centre of coordination and evaluation of the Union in situations of health crises, which can lead to medicines shortages, such as the one we have experienced;
Amendment 79 #
Draft opinion Paragraph 2 b (new) 2 b. Calls on the Commission to reinforce the harmonized definition of medicine shortage, proposed by the EMA and HMA joint task force in 2019;
Amendment 79 #
Draft opinion Paragraph 7 a (new) 7 a. Calls on the Commission to immediately activate European and global cooperation during crisis events, to prioritise the intra-EU or extra-EU circulation of essential goods, such as medicines, active pharmaceutical ingredients, intermediates, key starting materials ingredients, etc., to maintain road, ports, rail, airport traffic flowing by creating priority “Green lanes” between Member States and between EU and relevant third countries, and within those countries, for these essential goods;
Amendment 8 #
Draft opinion Recital A a (new) A a. whereas the Treaties and the European Charter of Fundamental Rights state that everyone shall have access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices; whereas this right should be enforced for all citizens, including those living in the smaller Member States and in the most peripheral areas of the Union;
Amendment 8 #
Draft opinion Recital A a (new) A a. whereas the problem of the shortage of medicines in the Member States is increasingly observed, due to economic and regulatory burdens, unforeseen surges of demand and supply chain bottlenecks in manufacturing and quality insurance.
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;
Amendment 80 #
Draft opinion Paragraph 7 a (new) 7 a. Calls on the Commission to immediately activate European and global cooperation, during crisis events, to prioritise the circulation intra-EU or extra-EU of essential goods, such as medicines, active pharmaceutical ingredients, intermediates, key starting materials ingredients, etc, to maintain road, ports, airport traffic flowing by creating priority “Green lanes” within Member States and between EU and third countries, and within those countries, for these essential goods.
Amendment 81 #
Draft opinion Paragraph 2 c (new) 2 c. Encourages the Commission to create a fair pricing model for essential medicines, taking into account that prices should be more in line with the costs of research and development and considering the added therapeutic value;
Amendment 81 #
Draft opinion Paragraph 7 a (new) 7 a. Underlines that flexibility in the approach to rules on working and rest time in road transport had played an essential role in making the distribution chain for medicines and medical devices more efficient when the COVID-19 pandemic erupted; stresses that European rules in this area should take greater account of such emergencies and provide for flexibility in the approach to working time issues;
Amendment 82 #
Draft opinion Paragraph 2 d (new) 2 d. Calls on the Commission to address supply quotas imposed by pharmaceutical manufacturers, which are a contributing factor to medicines shortages;
Amendment 82 #
Draft opinion Paragraph 7 a (new) 7 a. Stresses the need to reduce transport costs, while preserving the level of service, minimising the number of kilometres of the routes, having ready and effective response tools to changes, both in ordinary operations and in exceptional periods of crisis, such as for COVID-19;
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;
Amendment 83 #
Draft opinion Paragraph 7 a (new) 7 a. Insists that the Commission establishes shortage of medicines as one of the pillars of its new planned pharmaceutical strategy;
Amendment 84 #
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.
Amendment 84 #
Draft opinion Paragraph 7 b (new) 7 b. Emphasis the importance of implementing specific measures to maintain, first and foremost, fully functioning and healthy European multi- supplier market with the full enforcement of „Green lanes” for medicine products transportation, as well as facilitation of the fastest modes of transport to carry especially time sensitive cargo, such as medicines;
Amendment 85 #
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 therefore the EU to enable the creation of a European public pharmaceutical hub which will have the responsibility to ensure the production of essential drugs and vaccines and make them available at cost price to the health departments of Member States;
Amendment 85 #
Draft opinion Paragraph 7 b (new) 7 b. Calls for the implementation of innovative solutions to enable the safe transport of temperature-sensitive drugs, tracing the products through a constant remote monitoring in real time of medicines and their temperature from production to the final customer;
Amendment 86 #
Draft opinion Paragraph 3 3. Stresses the urgent need for the EU to reduce its over-reliance on a small number of
Amendment 86 #
Draft opinion Paragraph 7 b (new) 7 b. Encourages the Commission to create a fair pricing model for essential medicines, taking into account that prices should be more in line with the costs of research and development and considering the added therapeutic value;
Amendment 87 #
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 key starting materials, intermediate materials and active pharmaceutical ingredients;
Amendment 87 #
Draft opinion Paragraph 7 c (new) 7 c. Calls for a revision of the EU Guidelines on Good Distribution Practice (GDP) of medicinal products for human use, taking into account the need to improve the efficiency of the supply chain, to reduce the products losses, and to implement innovative solutions, also in light of the recent COVID-19 outbreak;
Amendment 88 #
Draft opinion Paragraph 3 a (new) 3 a. Stresses the urgent need to ensure that patents are not a barrier to securing supplies during any epidemic outbreak; stresses the need to override patents for drugs, vaccines, and medical equipment as needed to secure critical supplies during any epidemic outbreak, present and future, by licensing public laboratories and industries to make generic copies of brand-name products without having to negotiate with patent holders;
Amendment 88 #
Draft opinion Paragraph 7 c (new) 7 c. Believes it is important 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;
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;
Amendment 89 #
Draft opinion Paragraph 7 c (new) 7 c. Calls on the Commission and the Member States to ensure that healthcare workers, including pharmaceutical employees, are authorised to cross internal borders if they work in a neighbouring country;
Amendment 9 #
Draft opinion Recital A a (new) A a. Whereas access to medicines is a growing problem within EU, usually associated with the high price of medicines and hindering European citizens` right to access to health care; whereas it is expected for the socio- economic situation to decline as a consequence of coronavirus pandemic and to worsen the living conditions for vulnerable citizens;
Amendment 9 #
Draft opinion Recital A a (new) A a. whereas the European Commission's response to the COVID-19 pandemic was late and insufficient, and the burden of fighting the coronavirus was mainly on the Member States;
Amendment 90 #
Draft opinion Paragraph 3 a (new) 3 a. Stresses the importance of ensuring the smooth functioning of the Internal Market in order to eliminate barriers to the access of medicines, medical devices and protective equipment to all citizens, especially those living in Member States that, due to their small size or to their remote position, heavily rely on imports and do not have easy access to the supply chain;
Amendment 90 #
Draft opinion Paragraph 7 d (new) 7 d. Calls on the Member States to implement strategies improving prevention and management of shortages caused by disruptions in the supply chain, to develop guidance for companies on reporting of shortages, and to favour the exchange of best practices among regulatory authorities to better coordinate actions between Member States;
Amendment 91 #
Draft opinion Paragraph 3 a (new) 3 a. Highlights the need for a joint, pan-European, coordinated approach in introducing measures to tackle root causes of medicinal shortages, as ad-hoc solutions such as stock piling requirements could contribute to increased disparities between Member States given the low manufacturing capacity of the EU and economic differences between Member States;
Amendment 91 #
Draft opinion Paragraph 7 e (new) 7 e. Calls on the Commission to revise Directive 2008/68/EC on the inland transport of dangerous goods adopting specific measures for the supply of dangerous goods in support of the chemical and pharmaceutical industry;
Amendment 92 #
3 a. Calls on the Commission and Member States to re-balance stocks based on patients’ and hospitals´ needs instead of stockpiling; notes that to ensure a fair allocation at European level, it is necessary to have an equitable distribution of medicines based on shared protocols on the use of medicines to give priority to those who urgently require it;
Amendment 92 #
Draft opinion Paragraph 7 f (new) 7 f. Calls on the Commission to revise Directive 92/106/EEC on the establishment of common rules for certain types of combined transport of goods between Member States assessing possible provisions aimed at improving the logistics chain for the transport of medicines;
Amendment 93 #
Draft opinion Paragraph 3 b (new) 3 b. Whereas the coronavirus pandemic has highlighted Europe’s dependency on third countries for the production of essential medicines and medical devices, including active pharmaceutical ingredients(APIs), calls on the Commission to provide adequate financial resources under Horizon Europe and other EU programs to strengthen Union’s R&I activities supporting manufacturing in key industrial sectors, such as the pharmaceutical industry; calls on the Commission to reduce the R&I divide within the Union by ensuring broad geographical coverage and participation of low R&I performing Member States in collaborative projects; underlines that Horizon Europe and other EU programs need to support rare diseases through increased research, clinical trials, best practices sharing, and medication development; insists that research, best practices, clinical trials, and medication pertaining to rare diseases be made accessible for the benefit of citizens of all the Member States;
Amendment 93 #
Draft opinion Paragraph 7 g (new) 7 g. Calls on the Commission to address the problem of the shortage of medicines in the work programmes adopted within the Multi-Annual Financial Framework 2021-2027, in particular by increasing the focus on aspects linked to research and innovation under Horizon Europe and other programmes;
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;
Amendment 94 #
7 h. Calls on the Commission to implement an observatory, monitoring and coordinating actions at European- level, about the shortages of medicines, without any increase of the EU's budget.
Amendment 95 #
Draft opinion Paragraph 3 b (new) 3 b. Stresses that the urgent need for medicines and medical equipment cannot mean, nor be at the expense of the quality, safety, efficacy and cost-effectiveness of medicines for human use and health products, including medical devices and products cosmetics and body hygiene;
Amendment 95 #
Draft opinion Paragraph 7 i (new) 7 i. Calls on the Commission and Member States to closely coordinate to protect the resilience and sustainability of the healthcare supply chain, which ensures the continuous availability of medicines, as well as their safe distribution and fair allocation to all dispensing points within Member States.
Amendment 96 #
Draft opinion Paragraph 3 c (new) 3 c. Recalls that compliance with the rules applicable to the authorization of clinical trials with medicines, as well as the control of observance of good clinical practices in their performance, must continue to be regulated and supervised according to the highest standards of public health protection, to guarantee the access of health professionals and citizens to quality, effective and safe medicines and health products;
Amendment 96 #
Draft opinion Paragraph 7 j (new) 7 j. Calls for transparency at EU level through the introduction of a Europe- wide medicines shortages database and an early warning system involving the main supply chain stakeholders, from manufacturers, full-service healthcare distributors / pharmaceutical full-line wholesalers, pharmacists to prescribers and the national competent authorities, about existing and anticipated shortages, providing their root causes in a harmonised, comparable manner.
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;
Amendment 97 #
Draft opinion Paragraph 7 k (new) 7 k. Calls on the Member States to ensure that all main stakeholders of the healthcare supply chain (manufacturers, full-service healthcare distributors /pharmaceutical full-line wholesalers, pharmacists) to be recognised as critical infrastructure to maintain the continuous and safe supply of medicines in extraordinary circumstances, such as the ones currently experienced in the COVID- 19 crisis or even taking into account the distribution of an upcoming vaccine.
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;
Amendment 98 #
Draft opinion Paragraph 7 l (new) 7 l. 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, thereby stressing the importance and availability of existing and established infrastructure, including logistical hubs, warehouses and networks, for the safe and efficient distribution of medical supplies, including also the possibility for keeping stocks of medicines for emergency use.
Amendment 99 #
Draft opinion Paragraph 3 d (new) 3 d. Recalls the words of the United Nations Secretary-General who recently declared that the future treatment for Covid-19 is "a public good" that should be made available to all; warns that the defense of public health does not match the presumption of profit, which will always be obtained at the expense of the suffering of the peoples;
source: 652.374
2020/06/08
ENVI
745 amendments...
Amendment 1 #
Motion for a resolution Citation 7 — having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use and Article 81 thereof concerning an adequate and uninterrupted supply of medicinal products, and Article 23a thereof on notifying the competent authority if a product ceases to be placed on the market on a temporary or permanent basis,
Amendment 10 #
Motion for a resolution Citation 14 b (new) - having regard to Commission communication of 27 May 2020 on "The EU budget powering the recovery plan for Europe",
Amendment 100 #
Motion for a resolution Recital C a (new) Ca. whereas the EU dependency on third countries in production and supply of medicines place the EU in risk of shortages; whereas its consequences have been showed during the pandemic;
Amendment 101 #
Motion for a resolution Recital C a (new) Ca. whereas the EU-based manufacturers of generics have an important role to play in satisfying the growth in the demand for affordable medicines in the Member States;
Amendment 102 #
Motion for a resolution Recital C a (new) Ca. whereas existing manufacturing capabilities are numerous in the EU and it is crucial to secure them through sustainable economic, regulatory and industrial policies;
Amendment 103 #
Motion for a resolution Recital C a (new) Ca. whereas it is equally important to protect and foster the existing production sites in the EU and strengthen the European research landscape;
Amendment 104 #
Motion for a resolution Recital C a (new) Ca. whereas the EU has an important existing manufacturing footprint and it is important to secure it through sustainable economic, regulatory and industrial incentives and policies;
Amendment 105 #
Motion for a resolution Recital C b (new) Cb. whereas, the EU has an important existing manufacturing footprint and it is important to secure it through sustainable economic, regulatory and industrial incentives;
Amendment 106 #
Motion for a resolution Recital C b (new) Cb. whereas the price to be paid to secure the EU’s supply of medicines and meet basic needs of the population is far from insurmountable, since active ingredients account for around 10% of the price of a medicine protected by a patent and 40% of that of a generic;
Amendment 107 #
Motion for a resolution Recital D D. whereas the
Amendment 108 #
Motion for a resolution Recital D D. whereas
Amendment 109 #
Motion for a resolution Recital D D. whereas the
Amendment 11 #
Motion for a resolution Citation 15 a (new) - having regard to the Commission communication of 20 May 2020 on the EU Biodiversity Strategy for 2030,
Amendment 110 #
Motion for a resolution Recital D D. whereas the
Amendment 111 #
Motion for a resolution Recital D D. whereas the consequence of
Amendment 112 #
Motion for a resolution 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 arise, such as the current COVID-19 crisis and the closure of EU borders;
Amendment 113 #
Motion for a resolution Recital D D. whereas
Amendment 114 #
Motion for a resolution Recital D D. whereas the consequence of growing demand coupled with price suppression is the concentration of active pharmaceutical ingredients supply, a reduction in the number of chemicals manufacturers and a lack of alternative solutions should problems arise;
Amendment 115 #
Motion for a resolution Recital D D. whereas the consequence of growing demand coupled with price suppression is the concentration of active pharmaceutical ingredients supply, a reduction in the number of chemicals manufacturers and a lack of alternative solutions should problems arise;
Amendment 116 #
Motion for a resolution Recital D D. whereas the consequence of growing demand coupled with price suppression is the concentration of active pharmaceutical ingredients supply, a reduction in the number of chemicals manufacturers and a lack of alternative solutions should problems arise;
Amendment 117 #
Motion for a resolution Recital D D. whereas the consequence of growing demand coupled with price suppression is the concentration of active pharmaceutical ingredients supply, a reduction in the number of chemicals manufacturers and a lack of alternative solutions should problems arise;
Amendment 118 #
Motion for a resolution Recital D D. whereas the consequence of growing demand coupled with price suppression is the concentration of active pharmaceutical ingredients supply, a reduction in the number of chemicals manufacturers and a lack of alternative solutions should problems arise;
Amendment 119 #
Motion for a resolution Recital D a (new) Da. whereas the relocation of production to sites outside the EU to maximise profits combined with excessive reliance on individual drugs for certain health conditions and insufficient incentives to invest in new innovative medicines might have contributed to rise and spread of antimicrobial resistance;
Amendment 12 #
Motion for a resolution Citation 19 a (new) - having regard to the newly created platforms in light of the current COVID- 19 crisis, such as the European Medicines Agency (EMA) Industry Single Point of Contact (I-SPOC) system, which is streamlining the process of reporting potential medicine shortages in order to prevent them and to flag these shortages as early as possible; having regard that these platforms have enabled and facilitated a dialogue on shortages between stakeholders in the pharmaceutical supply chain and regulators,
Amendment 120 #
Motion for a resolution Recital D a (new) Da. whereas there are no harmonised rules in the Union for generic prescription and generic substitution, which leads to considerable imbalances of possible remedies in Member States in cases of shortages of medicines;
Amendment 121 #
Motion for a resolution Recital E E. whereas
Amendment 122 #
Motion for a resolution Recital E E. whereas stocks of ‘strategic’ medicines are inadequate, with
Amendment 123 #
Motion for a resolution Recital E E. whereas stocks of
Amendment 124 #
Motion for a resolution Recital E E. whereas stocks of
Amendment 125 #
Motion for a resolution Recital E E. whereas stock
Amendment 126 #
Motion for a resolution 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; whereas pharmaceutical firms operate on a just-in-time basis which can leave manufacturers vulnerable to supply shocks where there are unanticipated production and supply chain interruptions, and market demand fluctuations;
Amendment 127 #
Motion for a resolution Recital E E. whereas stocks of ‘strategic’ medicines are inadequate at European level, with chemicals that are cheap and easy to produce and mature medicines being in particularly short supply; whereas pharmaceutical firms operate on a just-in- time basis;
Amendment 128 #
Motion for a resolution Recital E E. whereas stocks of ‘strategic’ medicines are inadequate, with chemicals that are cheap and easy to produce and
Amendment 129 #
Motion for a resolution Recital E E. whereas stocks of ‘strategic’ medicines are inadequate, with chemicals that are cheap and easy to produce and mature, yet essential medicines being in particularly short supply; whereas pharmaceutical firms operate on a just-in- time basis;
Amendment 13 #
Motion for a resolution 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 130 #
Motion for a resolution Recital E E. whereas stocks of ‘strategic’
Amendment 131 #
Motion for a resolution 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; whereas pharmaceutical firms operate
Amendment 132 #
Motion for a resolution Recital E a (new) Ea. whereas the lack of essential medicines is becoming increasingly common at national and global level, increasing the burden on health services, incurring additional costs and jeopardising patients unable to obtain the medicines they need;
Amendment 133 #
Motion for a resolution Recital E a (new) Ea. whereas the Commission made 63 demands to individual Member States that governments cut spending on healthcare and/or outsource or privatise health services between 2011-2018 through the European Semester;
Amendment 134 #
Motion for a resolution Recital F F. whereas the
Amendment 135 #
Motion for a resolution Recital F F. whereas
Amendment 136 #
Motion for a resolution Recital F F. whereas there are
Amendment 137 #
Motion for a resolution Recital F F. whereas
Amendment 138 #
Motion for a resolution Recital F F. whereas
Amendment 139 #
Motion for a resolution Recital F F. whereas
Amendment 14 #
Motion for a resolution Citation 23 — having regard to Report No 737 of 27 September 2018 entitled ‘Shortages of medicines and vaccines: focusing more closely on public health issues in the medicine supply chain’, drawn up by Jean- Pierre Decool on behalf of the French Senate fact-finding mission on the shortage of medicines and vaccines,
Amendment 140 #
Motion for a resolution Recital F F. whereas
Amendment 141 #
Motion for a resolution 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 trade of pharmaceuticals is related to the free movement of goods in the internal market, fostering competition and lowering the cost of patented pharmaceuticals and therapeutics; whereas agreements to restrict parallel trade are prohibited under Article 101 (1) TFEU;
Amendment 142 #
Motion for a resolution 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 143 #
Motion for a resolution Recital F a (new) Fa. whereas parallel trade can lead to a severe lack of access to medicines in some Member States while benefitting others;
Amendment 144 #
Motion for a resolution Recital F a (new) Fa. whereas in its resolution of 2 March 2017 (2016/2057 (INI) the European Parliament called on the Commission and the Council to better define the concept of a shortage of medicines - and to analyse its causes - and, in this regard, to assess the impact of the parallel trade and supply quotas;
Amendment 145 #
Motion for a resolution Recital F a (new) Fa. whereas profit-oriented decision making by the pharmaceutical industry and Market Authorisation Holders MAHs such as the discontinuation and withdrawal of medicines supplies solely on what is profitable;
Amendment 146 #
Motion for a resolution 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 147 #
Motion for a resolution Recital F a (new) Fa. whereas profit-oriented decision making on the part of the pharmaceutical industry such as products’ discontinuations and withdrawals from particular, less profitable Member States’ markets is often the reason for medicine shortages;
Amendment 148 #
Motion for a resolution Recital F a (new) Fa. whereas profit-oriented decision making on the part of the pharmaceutical industry such as products’ discontinuations and withdrawals from particular (less profitable) Member States’ markets can often lead to medicine shortages;
Amendment 149 #
Motion for a resolution Recital F a (new) Fa. whereas profit-oriented decision making on the part of the pharmaceutical industry such as products’ discontinuations and withdrawals from less profitable markets is often the reason for medicine shortages;
Amendment 15 #
Motion for a resolution Citation 23 a (new) - having regard to the Commission Guidance concerning foreign direct investment and free movement of capital from third countries, and the protection of Europe’s strategic assets in the context of the COVID-19 emergency, ahead of the application of Regulation (EU) 2019/452 (FDI Screening Regulation), which will be fully operational as from 11 October 2020,
Amendment 150 #
Motion for a resolution Recital G G. whereas,
Amendment 151 #
Motion for a resolution Recital G G. whereas
Amendment 152 #
Motion for a resolution Recital G G. whereas, in the absence of
Amendment 153 #
Motion for a resolution Recital G G. whereas
Amendment 154 #
Motion for a resolution Recital G G. whereas, in
Amendment 155 #
Motion for a resolution Recital G G. whereas, in the absence of
Amendment 156 #
Motion for a resolution Recital G G. whereas
Amendment 157 #
Motion for a resolution Recital G G. whereas
Amendment 158 #
Motion for a resolution Recital G G. whereas, in the absence of
Amendment 159 #
Motion for a resolution 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 16 #
Motion for a resolution Citation 24 a (new) - having regards to the 2016 Report of the United Nations Secretary General's High-Level Panel on Access to Medicine "Promoting innovation and access to health technologies",
Amendment 160 #
Motion for a resolution Recital G G. whereas, in the absence of a regulatory authority, stockpiling in some Member States is leading to a market imbalance and could, in the event of a health crisis, question the principle of solidarity;
Amendment 161 #
Motion for a resolution 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 162 #
Motion for a resolution Recital G a (new) Ga. whereas the 2009 financial crisis forced European countries to introduce unsustainable cost-containment measures - such as clawbacks and inefficient procurement mechanisms - to reduce pharmaceutical expenditure, which has led to withdrawals of products and companies from the market;
Amendment 163 #
Motion for a resolution Recital G a (new) Ga. whereas the combination of cost containment measures, lack of market predictability, combined with an onerous and rigid regulatory framework are challenging sustainable and equitable access to medicines, especially for very old inexpensive essential drugs, as well as the competitiveness of the EU pharmaceutical industry;
Amendment 164 #
Motion for a resolution Recital G b (new) Gb. whereas uncoordinated measures at national level have demonstrated to be ineffective to fight against the COVID-19 crisis, while a pan-European coordination and dialogue is needed;
Amendment 165 #
Motion for a resolution Recital G b (new) Gb. whereas the coronavirus pandemic has demonstrated that a pan-European coordination and dialogue is needed between authorities, industry and relevant stakeholders of the healthcare supply chain;
Amendment 166 #
Motion for a resolution Recital H Amendment 167 #
Motion for a resolution Recital H Amendment 168 #
Motion for a resolution Recital H a (new) Ha. whereas medicine shortage notification mechanisms for supply chain operators and pharmacists in particular are currently very fragmented in the Member States; whereas this could prevent adequate monitoring and communication between Member State authorities regarding medicine shortages;
Amendment 169 #
Motion for a resolution Recital I Amendment 17 #
Motion for a resolution Citation 24 a (new) - having regard to the Court's Judgments C-468/06-C-478/06 of 16 September 2008,
Amendment 170 #
Motion for a resolution Recital I Amendment 171 #
Motion for a resolution Recital I I. whereas
Amendment 172 #
Motion for a resolution Recital I I. whereas
Amendment 173 #
Motion for a resolution Recital I I. whereas the greater number, geographical spread and impact of epidemics is partly attributable to climate change, in combination with globalisation and increased travel; whereas European surveillance has been strengthened on vector-borne diseases such as Malaria, Dengue, Chikungunya, Zika and West Nile viruses;
Amendment 174 #
Motion for a resolution Recital I I. whereas the greater number, geographical spread and impact of epidemics is partly attributable to climate change, in combination with globalisation, urbanisation and increased travel;
Amendment 175 #
Motion for a resolution Recital I a (new) Ia. whereas generic and biosimilar medicines industry supply the majority of medicines to EU patients (almost 70% of dispensed pharmaceuticals);
Amendment 176 #
Motion for a resolution Recital J Amendment 177 #
Motion for a resolution Recital J J. whereas the destruction of biodiversity, the proliferation of man-made habitats and damage to natural areas densely populated by humans are facilitating the propagation of zoonoses, i.e. the transmission to humans and rapid spread of animal pathogens; whereas human and animal health are interdependent and both depend on environmental health and the good condition of the ecosystems in which they interact; whereas in order to minimise future risks there is a need for a collaborative approach to tackle anthropogenic changes to ecosystems and the link to the increased risk of infectious diseases emerging and of their dissemination;
Amendment 178 #
Motion for a resolution Recital J J. whereas the destruction of biodiversity, the illegal trade in wildlife, the proliferation of man-made habitats and damage to natural areas densely populated by humans are facilitating the propagation of zoonoses, i.e. the transmission to humans and rapid spread of animal pathogens; whereas biodiversity is an important source for existing medicines and potential future drug development;
Amendment 179 #
Motion for a resolution Recital J J. whereas there is an increasing correlation between the destruction of biodiversity, the proliferation of man-made habitats and damage to natural areas densely populated by humans
Amendment 18 #
Motion for a resolution Citation 24 a (new) - having regard to the Commission communication of 11 December 2019 on ‘The European Green Deal’,
Amendment 180 #
Motion for a resolution 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 181 #
Motion for a resolution Recital J J. whereas the destruction of biodiversity, the proliferation of man-made habitats and damage to natural areas densely populated by humans are potentially facilitating the propagation of zoonoses, i.e. the transmission to humans and rapid spread of animal pathogens;
Amendment 182 #
Motion for a resolution Recital J a (new) Ja. whereas a lack of information around medicine shortages remains one of the most problematic issues for patients, as they are often the last group to be informed about a medicine shortage, if they are told at all; whereas this issue is also experienced in in-patient hospital settings, where patients are not told when they are not receiving the preferred treatment and are instead being given an alternative;
Amendment 183 #
Motion for a resolution 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 184 #
Motion for a resolution Recital J a (new) Ja. whereas the COVID-19 outbreak has highlighted the importance of countries having sovereignty and a reasonable capacity for ensuring their own supplies of medicines and medical equipment, especially in view of the restricted intra-Community movement of goods and the arbitrary retention of equipment in the wake of the outbreak;
Amendment 185 #
Motion for a resolution Recital J a (new) Ja. whereas health is not a commodity, and making it subject to internal market rules as if it were, has done nothing but discourage research and the production of new medicines, as well as promote the establishment of a parallel market in medicines and an oligopoly of multinationals;
Amendment 186 #
Motion for a resolution Recital J a (new) Ja. whereas the COVID-19 emergency has highlighted the increased risk of attempts to acquire healthcare capacities via foreign direct investment and the need to preserve and enhance the sharing of such precious capacities within the single market;
Amendment 187 #
Motion for a resolution Recital J a (new) Ja. whereas a strong, innovative and competitive pharmaceutical industry in Europe is in the vital interest of the EU and its Member States;
Amendment 188 #
Motion for a resolution Recital J a (new) Ja. whereas the combination of cost containment measures, lack of market predictability, combined with an onerous and rigid regulatory framework create an unsustainable environment for the EU pharmaceutical industry to operate and to continue to act as a catalyst to enable sustainable access to medicines for patients;
Amendment 189 #
Motion for a resolution Recital J a (new) Ja. whereas an efficient strategy should cover measures to mitigate medicines shortage, but also to prevent them from happening, looking at the multiple root causes of shortages ;
Amendment 19 #
Motion for a resolution Citation 24 b (new) - having regard to its resolution of 15 January 2020 on the European Green Deal,
Amendment 190 #
Motion for a resolution Recital J b (new) Jb. whereas the pharmaceutical industry needs the right legal framework to do research, development and production of pharmaceuticals within the EU;
Amendment 191 #
Motion for a resolution Recital J b (new) Jb. whereas the 2009 financial crisis forced European countries to introduce unsustainable cost-containment measures - such as clawbacks and inefficient procurement mechanisms - to reduce pharmaceutical expenditure, which has led to withdrawals of products and companies from the market;
Amendment 192 #
Motion for a resolution Recital J c (new) Jc. whereas an efficient strategy should cover measures to mitigate medicines shortage, but also to prevent them from happening;
Amendment 193 #
Motion for a resolution Paragraph 1 1. Stresses the
Amendment 194 #
Motion for a resolution Paragraph 1 1. Stresses the
Amendment 195 #
Motion for a resolution Paragraph 1 1. Stresses the
Amendment 196 #
Motion for a resolution Paragraph 1 1. Stresses the geostrategic imperative that the Union
Amendment 197 #
Motion for a resolution Paragraph 1 1. Stresses the geostrategic imperative
Amendment 198 #
Motion for a resolution Paragraph 1 1. Stresses the geostrategic imperative that the Union regain its sovereignty and independence with regard to health care and secure its supply of medicines, diagnostic tools, vaccines, medical devices and medical equipment;
Amendment 199 #
Motion for a resolution Paragraph 1 1. Stresses the geostrategic imperative that the Union regain its sovereignty and independence with regard to health care and secure its supply of medicines and medical equipment to meet the needs of European citizens;
Amendment 2 #
Motion for a resolution Citation 7 — having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use and the obligations set out in Article 81 thereof concerning an a
Amendment 20 #
Motion for a resolution Recital -A (new) -A. whereas a shortage of a medicinal product occurs when supply of an already marketed medicine does not meet demand at a national level from healthcare professionals or patients in response to clinical needs; whereas shortages of medicines are part of the wider problem of ensuring equitable access, affordability and availability of medicines in all EU;
Amendment 200 #
Motion for a resolution Paragraph 1 1. Stresses the geostrategic imperative that the Union and the Member States regain
Amendment 201 #
Motion for a resolution Paragraph 1 1. Stresses the geostrategic imperative that the Union and its Member States regain
Amendment 202 #
Motion for a resolution Paragraph 1 1. Stresses the geostrategic imperative that the Union regain its sovereignty and independence with regard to health care and
Amendment 203 #
Motion for a resolution Paragraph 1 1. Stresses the geostrategic imperative that the Union regain its sovereignty and independence with regard to health care and maintaining a secure
Amendment 204 #
Motion for a resolution Paragraph 1 1. Stresses the geostrategic imperative that the
Amendment 205 #
Motion for a resolution Paragraph 1 1. Stresses the
Amendment 206 #
Motion for a resolution Paragraph 1 1. Stresses the geostrategic imperative that the Union regain its sovereignty and independence with regard to health care and secure its supply of medicines and medical equipment; stresses the need to boost European manufacture of key products such as health products, medicines and active ingredients;
Amendment 207 #
Motion for a resolution Paragraph 1 1. Stresses the geostrategic imperative that the Union regain its sovereignty and independence with regard to health care and secure its supply of medicines and medical equipment, by among others building on the existing 400 generic and biosimilar medicines factories which supply the majority of medicines to European patients;
Amendment 208 #
Motion for a resolution Paragraph 1 1. Stresses the geostrategic imperative that the Union regain its sovereignty and independence with regard to health care and secure its supply of medicines and medical equipment; by building on the existing 400 generic and biosimilar medicines factories which supply the majority of medicines to European patients;
Amendment 209 #
Motion for a resolution Paragraph 1 1. Stresses the importance of putting the patient at the centre when addressing the problem of medicines shortages and the geostrategic imperative that the Union regain its sovereignty and independence with regard to health care and secure its supply of medicines and medical equipment;
Amendment 21 #
Motion for a resolution Recital A A. whereas
Amendment 210 #
Motion for a resolution Paragraph 1 a (new) 1a. Points out the necessity to develop a single pan-European harmonised reporting and notification system for medicines shortage to ensure coordination within the single market, and a close dialogue with industry and other relevant actors of the supply chain; considers that such a system should focus on a pan-European critical list of products, covering both Centralised and National Marketing Authorisations; in this context, a single pan-European Definition for Critical List of Medicines should be defined in coordination with relevant stakeholders;
Amendment 211 #
Motion for a resolution Paragraph 1 a (new) 1a. Recalls that shortage of medicines is a global challenge; stresses that developing countries, such as a number of African countries, are the most affected by these shortages; urges that access to medicines in developing countries be tackled in a wider context in the WHO framework ; calls on the Commission and the Member States to increase their support to developing countries, in particular through the rescUE strategic reserve;
Amendment 212 #
Motion for a resolution Paragraph 1 a (new) 1a. Urges Member States to avoid to take measures such as artificial stockpiling, as recommended by the Commission in its Guidelines on the optimal and rational supply of medicines of 8 April 2020 in the context of the COVID-19 crisis; also discourages Member States to apply unproportioned and unnecessary penalties, which create even further unsustainability and increase the possibility to generate medicines shortage;
Amendment 213 #
Motion for a resolution Paragraph 2 2. Points out that, while
Amendment 214 #
Motion for a resolution Paragraph 2 2. Points out that, that while public health policies are a Member State matter,
Amendment 215 #
Motion for a resolution Paragraph 2 2. Points out that, while
Amendment 216 #
Motion for a resolution Paragraph 2 2. Points out that, while
Amendment 217 #
Motion for a resolution Paragraph 2 2. Points out that
Amendment 218 #
Motion for a resolution Paragraph 2 2. Points out that, while public health policies are a Member State matter, it is incumbent upon the EU to coordinate
Amendment 219 #
Motion for a resolution Paragraph 2 2. Points out that, while public health policies are a responsibility of Member State
Amendment 22 #
Motion for a resolution Recital A A. whereas
Amendment 220 #
Motion for a resolution Paragraph 2 2. Points out that, that while public health policies are a Member State matter, it is the incumbent upon the EU to coordinate and complement national measures to guarantee affordable and high- quality health services for European citizens; underlines that the current crisis has highlighted the divergences in matters of health between Member States in areas such as minimum health standards and the provision of medical devices and medicines; considers it necessary to increase the competence of the European Union in health matters through the creation of an EU Health Union which would address subjects such as joint procurement or minimum standards for the quality of health systems;
Amendment 221 #
Motion for a resolution Paragraph 2 2. Points out that, while public health policies are a Member State matter, it is incumbent upon the EU to coordinate and complement national measures to guarantee the protection of public health and equal access to affordable and high- quality health services for all European citizens;
Amendment 222 #
Motion for a resolution Paragraph 2 2. Points out that, while public health policies are a Member State matter, it is incumbent upon the EU to coordinate and complement national measures to guarantee the protection of public health and access to affordable and high-quality health services for European citizens;
Amendment 223 #
Motion for a resolution Paragraph 2 2. Points out that, while public health policies
Amendment 224 #
Motion for a resolution Paragraph 2 2. Points out that, while public health policies are a Member State matter, it is incumbent upon the EU to co
Amendment 225 #
Motion for a resolution Paragraph 2 2. Points out that, that while public health policies are primarily a Member State matter, it is incumbent upon the EU to coordinate and complement national measures to guarantee affordable and high- quality health services for European citizens;
Amendment 226 #
Motion for a resolution Paragraph 2 2. Points out that, while public health policies are a Member State matter, it is incumbent upon the EU to coordinate and complement national measures to guarantee affordable and high-quality health services for European citizens including those living in rural areas;
Amendment 227 #
Motion for a resolution Paragraph 2 a (new) 2a. Emphasizes that patent protection and enforcement should have due regard for the interests of society, namely the safeguard of human rights and public health priorities; in the same vein, recalls that patent protection should not interfere with the right to health and should not contribute to widening the gap between wealthier and poorer citizens when it comes to access to medicines; considers that the Union's approach to this question should ensure harmonisation and coherence among the different measures at the disposal of Member States;
Amendment 228 #
Motion for a resolution Paragraph 2 a (new) 2a. Recalls the shortages of female hormonal drugs used for contraception and hormone replacement therapy (HRT); notes with concern the threats they pose to women and girls' sexual and reproductive health and rights; stresses the importance to enhance control and management of the manufacturing, stockpiling and marketing of those medicines to ensure continuity in supply chains, fair pricing and availability for women;
Amendment 229 #
Motion for a resolution 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 23 #
Motion for a resolution Recital A A. whereas
Amendment 230 #
Motion for a resolution Paragraph 2 a (new) 2a. Urges the Commission to propose in the upcoming Pharmaceutical Strategy the creation of a High Level pharmaceutical Forum, together with policy-makers, regulators, payers, patients, industry representatives and other actors of the healthcare supply chain to set a clear plan to address pharmaceutical sustainability issues, and ensure the competitiveness of the pharmaceutical industry sector in Europe;
Amendment 231 #
Motion for a resolution Paragraph 2 a (new) 2a. Insists that the Commission establishes shortage of medicines as one of the pillars of its new planned pharmaceutical strategy;
Amendment 232 #
Motion for a resolution Paragraph 2 b (new) 2b. Calls on the Commission to preserve a competitive research-based pharmaceutical industry taking into account that EU remains by far the world leader manufacturing region of active ingredients for on patent medicines;
Amendment 233 #
Motion for a resolution Paragraph 2 b (new) 2b. Encourages the Commission to create a fair pricing model for essential medicines, taking into account that prices should be more in line with the costs of research and development and considering the added therapeutic value;
Amendment 234 #
Motion for a resolution Paragraph 2 c (new) 2c. Calls on the Commission to address supply quotas imposed by pharmaceutical manufacturers, which are a contributing factor to medicines shortages;
Amendment 235 #
Motion for a resolution Paragraph 3 3. Stresses the
Amendment 236 #
Motion for a resolution Paragraph 3 3. Stresses
Amendment 237 #
Motion for a resolution Paragraph 3 3. Stresses the need for health policies to focus on patients’ interests and for closer cooperation between Member States; calls on the Commission and Member States to closely coordinate to protect the resilience and sustainability of the healthcare supply chain and ensure the continuous availability of medicines as well as their safe distribution and fair allocation to all dispensing points throughout Member States;
Amendment 238 #
Motion for a resolution Paragraph 3 3. Stresses the need for health policies to focus on patients’ interests and for closer cooperation between Member States; stresses the need for health policies to focus on patients’ interests and for closer cooperation between Member States; notes that the interest and safety of patients should be at the heart of European health policy;
Amendment 239 #
Motion for a resolution Paragraph 3 3. Stresses the need for health policies to focus on patients’ interests and for closer cooperation between Member States; Notes that the interest and safety of patients should be at the heart of European health policy;
Amendment 24 #
Motion for a resolution Recital A A. whereas
Amendment 240 #
Motion for a resolution Paragraph 3 3. Stresses the need for health policies to focus on patients' interests and for closer cooperation between Member States and for promoting greater dialogue between the main stakeholders in order to facilitate the exchange of best practices;
Amendment 241 #
Motion for a resolution Paragraph 3 3. Stresses the need for health policies to focus on patients’ interests without allowing any discrimination in the access to medicines and treatments, such as the age of the patient, and for closer cooperation between Member States;
Amendment 242 #
Motion for a resolution Paragraph 3 3. Stresses the need for health policies to focus on patients’ interests and for closer cooperation between Member States
Amendment 243 #
Motion for a resolution Paragraph 3 3. Stresses the need for health policies to focus on patients’ interests and for closer cooperation between Member States; highlights the potential harm to patients from shortages of medicines and medical devices;
Amendment 244 #
Motion for a resolution Paragraph 3 3. Stresses the need for health policies to focus on patients' interests and for closer cooperation and coordination between Member States;
Amendment 245 #
Motion for a resolution Paragraph 3 3. Stresses the need for health policies to focus on patients' interests and safety for closer cooperation between Member States;
Amendment 246 #
Motion for a resolution Paragraph 3 3. Stresses the need for health policies to focus on patients’ health and interests and for closer cooperation between Member States;
Amendment 247 #
Motion for a resolution Paragraph 3 a (new) 3a. Calls on the Commission to set up a platform bringing together health ministers and policy makers at European level, paying agencies, patient associations, industry and other relevant stakeholders in the healthcare supply chain, with the aim of establishing a pan- European political framework to prevent shortages, improve sustainable access to medicines for patients and boost the competitiveness of the European pharmaceutical industry; recommends that this platform be one of the practical proposals for the Commission's forthcoming pharmaceutical strategy;
Amendment 248 #
Motion for a resolution Paragraph 3 a (new) 3a. Calls on the Commission to coordinate a Pan-European response on medicines shortages to ensure equitable and sustainable access to medicines; a coordinated EU response is of utmost importance to avoid spillover effects of individual and uncoordinated national measures to address medicines shortages and ensure the right of patients to universal, equitable, affordable, effective, safe and timely access to essential medicines, as well as to guarantee the sustainability of the EU public healthcare systems; this Pan-European approach must focus on coordinating Member State policy measures to address the root causes of medicines shortages;
Amendment 249 #
Motion for a resolution Paragraph 3 a (new) 3a. Insists on the importance of a definition harmonised between Member States of ‘shortages’, ‘tensions’, ‘supply disruptions’ and ‘overstocking’; calls on the Commission to work on harmonising these concepts in conjunction with all the players concerned; calls for a distinction to be made between ‘medicinal products of major therapeutic interest’ (MITMs) and ‘medicines of health and strategic interest’(MISS);
Amendment 25 #
Motion for a resolution Recital A A. whereas
Amendment 250 #
Motion for a resolution 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 251 #
Motion for a resolution 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 252 #
Motion for a resolution Paragraph 3 a (new) 3a. Underlines that exclusively relying on profit-oriented decision-making is never going to solve the problem of medicines shortages, that market failures should be addressed and alternative drug manufacturing models should be explored;
Amendment 253 #
Motion for a resolution Paragraph 3 a (new) 3a. Welcomes the Commission’s proposal for a new European health programme “EU4Health”; notes that one of its stated objectives is to promote the availability and accessibility of medicines and medical equipment;
Amendment 254 #
Motion for a resolution Paragraph 3 a (new) 3a. Stresses residence for the elderly have been the most affected by the pandemic; regrets the lack of access to medicines they had in many cases to treat patients in the first stage of the illness;
Amendment 255 #
Motion for a resolution Paragraph 3 a (new) 3a. Stresses the need for each health system to have assured access to a continuous supply of high-quality and affordable essential medicines;
Amendment 256 #
Motion for a resolution Subheading 1 Securing supplies in the interests of patients
Amendment 257 #
Motion for a resolution Subheading 1 Securing supplies in the interests of patients
Amendment 258 #
Motion for a resolution Subheading 1 Securing supplies in the interests of patients and restoring
Amendment 259 #
Motion for a resolution Paragraph 3 a (new) 3a. Recalls that medicines shortages have a direct impact on patients' health, safety and the continuation of their treatment; stresses that for patients, the consequences of drug shortages include: progression of the disease and / or worsening of symptoms due to delay in treatment, avoidable transmission of infectious diseases, increased risk of exposure to falsified medicines and significant psychological distress for patients and their families;
Amendment 26 #
Motion for a resolution 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 risks; whereas these include the progression of the disease and/or worsening of symptoms, increased exposure to falsified medicines, medication errors or adverse events which occur when the missing medicine is replaced by another, avoidable transmission of infectious diseases and significant psychological distress; whereas the Member States have a duty to find swift and effective solutions through closer European integration;
Amendment 260 #
Motion for a resolution Paragraph 3 b (new) 3b. Urges the European Commission and relevant authorities to identify, assess and address the multifactorial root causes of medicines shortages, namely the economic causes, increasing regulatory burden, unforeseen surges in demand, supply chain interdependencies and manufacturing and quality challenges. Thereafter to propose an ambitious EU plan to prevent medicines shortages, articulated in short, mid and long term sustainable policies that stimulate competition and investment in manufacturing as well as strengthen security and resilience of supply to guarantee sustainable and equitable access to medicines;
Amendment 261 #
Motion for a resolution Paragraph 3 b (new) 3b. Notes that the risks are particularly high amongst vulnerable populations such as children, the elderly, pregnant women, people affected by a disability, patients with chronic diseases or cancer or people in intensive care unit (ICU);
Amendment 262 #
Motion for a resolution Paragraph 3 c (new) 3c. Underlines that a higher price of the substitute medicine proposed to the patient, a lower reimbursement rate or the lack of reimbursement constitute in several Member States major obstacles to access to medicines for populations with low incomes or suffering from chronic conditions ; calls on the Member States to guarantee access to a substitute medicine at an equivalent price or subject to a similar reimbursement in the event of a supply shortage;
Amendment 263 #
Motion for a resolution Paragraph 3 d (new) 3d. Welcomes the publication of the call for tenders launched by DG SANTE for a study on the causes of shortage of medicines in the Union; calls, however, for another study to be carried out on the impacts of drug shortages on patient care, treatment and health;
Amendment 264 #
Motion for a resolution Paragraph 3 e (new) 3e. Calls for the launch of a Joint Action on the prevention of shortage of medicines which would be funded by the future Health Program; considers that this Joint Action would allow an exchange of good practices between the Member States and the development of common prevention measures;
Amendment 265 #
Motion for a resolution Paragraph 3 f (new) 3f. Stresses that patient associations should be more involved in defining research strategies for public and private clinical trials, in order to ensure that they meet the unmet needs of European patients;
Amendment 267 #
Motion for a resolution Paragraph 3 k (new) 3 k. Recalls that no Member State is self-sufficient with regard to raw materials, intermediates, active pharmaceutical ingredients (APIs) and finished medicines necessary to guarantee the proper functioning of the health system;
Amendment 268 #
Motion for a resolution Paragraph 4 4. Calls on the Commission
Amendment 269 #
Motion for a resolution Paragraph 4 4. Calls on the Commission
Amendment 27 #
Motion for a resolution 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 risks; whereas in France, 1 450 cases of unavailability of medicines were noted in 2019 compared to 44 cases in 2008; whereas in the Netherlands, the number of drug stock-out cases almost doubled in 2019, with 1,492 cases recorded, compared to 769 in 2018; whereas in the Czech Republic, 2,208 products suffered from a supply disruption in 2019, compared to 1,630 in 2018 and 19 in 2008; whereas the Member States have a duty to find swift and effective solutions through closer European integration;
Amendment 270 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the Member States to
Amendment 271 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the
Amendment 272 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the Member States to
Amendment 273 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the Member States to take
Amendment 274 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the Member States to take whatever action is needed to restore European health sovereignty and local pharmaceutical manufacturing, giving priority to essential and strategic medicines;
Amendment 275 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the Member States to take whatever action is needed to restore European health sovereignty and local pharmaceutical manufacturing, giving priority to essential and strategic medicines;
Amendment 276 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the Member States to take
Amendment 277 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the Member States to take whatever action is needed to
Amendment 278 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the Member States to take whatever action is needed to restore European health sovereignty and local pharmaceutical manufacturing, giving priority to
Amendment 279 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the Member States to take
Amendment 28 #
Motion for a resolution Recital A A. whereas the increase in global demand has aggravated
Amendment 280 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the Member States to take whatever action is needed to restore European health sovereignty and local pharmaceutical manufacturing, giving priority to essential and strategic medicines; calls on
Amendment 281 #
Motion for a resolution Paragraph 4 4. Calls on the Commission
Amendment 282 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the Member States to take
Amendment 283 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the Member States to take whatever action is needed to restore
Amendment 284 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the Member States to take
Amendment 285 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the Member States to take whatever action is
Amendment 286 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the Member States to take
Amendment 287 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the Member States to take
Amendment 288 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the Member States to take whatever action is needed to restore European health
Amendment 289 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the Member States to take whatever action is needed to restore European health sovereignty and local pharmaceutical manufacturing, giving priority to essential and strategic medicines; calls on the Commission to map out potential production sites in the EU; points out that a complete repatriation of medical supply chains is not possible in a global economy; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains;
Amendment 29 #
Motion for a resolution Recital A A. whereas
Amendment 290 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the Member States to take whatever action is needed to restore European health sovereignty and local pharmaceutical manufacturing, giving priority to essential and strategic medicines; calls on the Commission to map out potential production sites in the EU; calls the EU to enable the creation of a European public pharmaceutical hub which will have the responsibility to ensure the production of essential drugs and vaccines and make them available at cost price to the health departments of Member States;
Amendment 291 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the Member States to take whatever action is needed to restore European health sovereignty and local pharmaceutical manufacturing, giving priority to essential and strategic medicines; calls on the Commission to map out existing and potential
Amendment 292 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the Member States to take whatever action is needed to restore European health sovereignty and local pharmaceutical manufacturing, giving priority to essential and strategic medicines; calls on the Commission to map out potential and existing production sites in the EU;
Amendment 293 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the Member States to take whatever action is needed to restore European health sovereignty and local pharmaceutical manufacturing, giving priority to essential and strategic medicines; calls on the Commission to map out available and potential production sites in the EU;
Amendment 294 #
Motion for a resolution Paragraph 4 4. Calls on the Commission and the Member States to take whatever action is needed to restore European health sovereignty and to support local pharmaceutical manufacturing, giving priority to essential and strategic medicines; calls on the Commission to map out potential production sites in the EU;
Amendment 295 #
Motion for a resolution Paragraph 4 a (new) 4a. Calls on the Commission and the Member States to set up a Task Force responsible for ensuring a constant inventory of the origin and production capacities of manufacturers in terms of active pharmaceuticals ingredients (APIs) and finished medicines,; considers that this independent body could establish and manage a database to prevent and steer European actions to avoid tensions or shortages on medicinal products of major therapeutic interest; stresses that this Task Force could ultimately assess the specific needs of medicinal products of major therapeutic interest of each Member State;
Amendment 296 #
Motion for a resolution Paragraph 4 a (new) 4a. Calls on the Commission to come forward with clear traceability rules on medicines both in regard to the final product and also any other pharmaceutical components used in medicines, including active and inactive ingredients; considers that transparent traceability of pharmaceutical components to be of the upmost importance in regard to a prevention framework; suggests that the traceability of pharmaceuticals should be similar in concept to the general tracing requirements found in Articles 18,19 and 20 of the Regulation (EC) No 178/2002 laying down the general principles and requirements of food law (General Food Law Regulation);
Amendment 297 #
Motion for a resolution Paragraph 4 a (new) 4a. Calls on the Commission and the Member States to jointly identify, assess and eliminate the causes of drug shortages; calls for an ambitious EU plan to prevent drug shortages, expressed in short-, medium- and long-term strategies, which will aim to stimulate competition and investment in production, and will strengthen security of supply in order to guarantee sustainable and equal access to medicines;
Amendment 298 #
Motion for a resolution Paragraph 4 a (new) 4a. The EU shall support and coordinate Member States, using all necessary market and regulatory instruments, to secure the production of medicines and other necessary means of medical use, by EU manufacturers, at the levels meeting the needs of Member States for the duration of time period sufficient to adapt supplies from the third countries in the event of crisis, leaving the production above the level to free market;
Amendment 299 #
Motion for a resolution Paragraph 4 a (new) 4a. Notes the importance for the industry to have the capacity of increasing its production to be able to meet with the sudden surge in the demand due to critical situations, understanding demand as the total of patients in need, without any kind of discrimination, especially by age;
Amendment 3 #
Motion for a resolution Citation 7 a (new) - having regard to the assessment report from the Commission to the European Parliament and the Council in accordance with Article 59(4) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use,
Amendment 30 #
Motion for a resolution Recital A A. whereas the increase in global
Amendment 300 #
Motion for a resolution Paragraph 4 a (new) 4a. 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 between Member States in terms of prices of a medicine;
Amendment 301 #
Motion for a resolution Paragraph 4 a (new) Amendment 302 #
Motion for a resolution Paragraph 4 b (new) 4b. Considers that the Commission should proactively disclose all documents related to the pharmaceutical supply network, including the work and meetings of the European Medicines Agency (EMA);
Amendment 303 #
Motion for a resolution Paragraph 4 b (new) 4b. Points out that, since the beginning of the health crisis, community pharmacists have displayed commitment and determination to ensure that patients have ongoing access to necessary medicines 24 hours a day and seven days a week; recognises that community pharmacists, due to their proximity to patients, have been the first line of counselling, treatment and referral for many patients suffering from common ailments, helping to ease the pressure on the emergency services and other levels of health care;
Amendment 304 #
Motion for a resolution Paragraph 5 5. Calls on the Commission to address in its next pharmaceutical and industrial strategies issues relating to the availability and accessibility of medicines
Amendment 305 #
Motion for a resolution Paragraph 5 5. Calls on the Commission to address in its next pharmaceutical and industrial strategies
Amendment 306 #
Motion for a resolution Paragraph 5 5. Calls on the Commission to address in its next pharmaceutical and industrial strategies issues relating to the availability and accessibility of medicines, a
Amendment 307 #
Motion for a resolution Paragraph 5 5. Calls on the Commission to
Amendment 308 #
Motion for a resolution Paragraph 5 5. Calls on the Commission to address in its next pharmaceutical and industrial strategies issues relating to the availability and accessibility of medicines and
Amendment 309 #
Motion for a resolution Paragraph 5 5. Calls on the Commission to address in its next pharmaceutical and industrial strategies issues relating to the availability
Amendment 31 #
Motion for a resolution Recital A A. whereas the increase in global demand
Amendment 310 #
Motion for a resolution Paragraph 5 5. Calls on the Commission to address in its
Amendment 311 #
Motion for a resolution Paragraph 5 5. Calls on the Commission to address in its next pharmaceutical and industrial strategies issues relating to the availability and accessibility of medicines and manufacturers’ dependence on third countries; believes that the strategies must include legislative measures, policies and incentives to encourage production of essential active pharmaceutical ingredients and medicines in Europe;
Amendment 312 #
Motion for a resolution Paragraph 5 5. Calls on the Commission to address in its next pharmaceutical and industrial strategies issues relating to the availability and accessibility of medicines and
Amendment 313 #
Motion for a resolution Paragraph 5 5. Calls on the Commission to take all necessary action to ensure that the adequate manufacturing of active pharmaceutical ingredients is guaranteed in the EU, and to study the possibility of establishing a regulation to create a remunerated obligation for the manufactures to bring the production of these active ingredients to Europe; to address in its next pharmaceutical and industrial strategies issues relating to the availability and accessibility of medicines and manufacturers’ dependence on third countries;
Amendment 314 #
Motion for a resolution Paragraph 5 5. Calls on the Commission to address in its next pharmaceutical and industrial strategies issues relating to the availability and accessibility of medicines and manufacturers’ dependence on third countries; calls on the Commission to pay special attention to the possibility of a no- deal Brexit and the ramifications it can cause in medical trade and supply; calls on the Commission to propose ambitious and concrete actions to address these issues in its planned pharmaceutical strategy;
Amendment 315 #
Motion for a resolution Paragraph 5 5. Calls on the Commission to address in its next pharmaceutical and industrial strategies issues relating to the availability and accessibility of medicines and manufacturers’ dependence on third countries; shortage mitigation strategies should be included and health economic analysis should be considered;
Amendment 316 #
Motion for a resolution Paragraph 5 5. Calls on the Commission to address in its next pharmaceutical and industrial strategies issues relating to the availability and accessibility of medicines, including unmet needs, and manufacturers’ dependence on third countries;
Amendment 317 #
Motion for a resolution Paragraph 5 5. Calls on the Commission to address in its next pharmaceutical and industrial strategies issues relating to the availability and accessibility of medicines
Amendment 318 #
Motion for a resolution Paragraph 5 a (new) Amendment 319 #
Motion for a resolution Paragraph 5 a (new) 5a. Calls on the Commission to propose ambitious and concrete actions to address these issues in its planned pharmaceutical strategy with, among others, a mechanism to oblige the companies owning the patents to produce the needed medicines even if they are less profitable, and the possibility to impose compulsory licences in order to facilitate, without constraint, the increase of the production of the most needed drugs or vaccines;
Amendment 32 #
Motion for a resolution Recital A A. whereas the increase in global demand has aggravated shortages of medicines in the EU, undermining health
Amendment 320 #
Motion for a resolution Paragraph 5 a (new) 5a. Calls on the Commission to publish without any further delays the EU Pharmaceutical Strategy which will identify root causes of medicine shortages; urges the Commission to propose ambitious and specific regulatory measures with an objective of making medicines available, affordable, sustainable and equally accessible; calls on the Commission to promote measures which will increase EU security of supply of medicines and reduce dependency on third countries;
Amendment 321 #
Motion for a resolution Paragraph 5 a (new) 5a. Calls on the Commission to draft an analysis on why medicine shortages occur before suggesting any regulatory measures and only subsequently present a strategy for preventing shortages of medicines and medical products in Europe and mitigate them where they occur;
Amendment 322 #
Motion for a resolution Paragraph 5 a (new) 5a. Calls on the Commission to address the issue of the dependence of non-EU countries in the production of medicines, bearing in mind that the innovative industry already sources a large part of its active substances from Europe;
Amendment 323 #
Motion for a resolution Paragraph 5 a (new) 5a. Considers it essential to ensure universal access to health insurance, first-rate essential services and safe, effective, good quality and affordable medicines and vaccines;
Amendment 324 #
Motion for a resolution Paragraph 5 a (new) 5a. Calls on the Commission to draw up a comprehensive study on root causes of shortages of medicines including economic, supply chain, manufacturing and/or quality related factors;
Amendment 325 #
Motion for a resolution Paragraph 5 a (new) 5a. calls on the Commission to present a specific strategy for managing shortages of medicines and medical products in Europe;
Amendment 326 #
Motion for a resolution Paragraph 5 a (new) 5a. 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;
Amendment 327 #
Motion for a resolution Paragraph 5 b (new) 5b. Calls on the Commission, in the context of the upcoming Pharmaceutical Strategy, to propose and implement an ambitious agenda to optimise the current regulatory framework in order to contribute to the prevention of medicine shortages by reducing the administrative burden both for the regulators and the industry, reflecting the evolution in technology as well as fostering greater economic resilience and therefore access to and availability of affordable medicines for patients;
Amendment 328 #
Motion for a resolution Paragraph 5 b (new) 5b. Underlines that marketing authorizations files already contain all the information on the supply chain concerning pharmaceuticals; calls on the Commission and Member States to empower regulatory agencies to make better use of the existing information by using all telematics tools available to identify vulnerabilities and risks unknown to manufacturers in a timely manner, whilst also respecting commercially confidential information;
Amendment 329 #
Motion for a resolution Paragraph 5 b (new) 5b. Calls on the Commission to include in the EU Statistics on Income and Living Conditions(EU-SILC) data on self-reported unmet needs regarding access to medicines, as so far access to medicines in not measured in the EU- SILC;
Amendment 33 #
Motion for a resolution Recital A a (new) Aa. whereas the causes underlying medicines shortages are complex and multi-dimensional, including industrial factors, such as manufacturing difficulties and supply-chain disruptions, industry quotas, quality defects, parallel trade by distributors, logistical inefficiencies, economic factors, such as pricing and reimbursement policies, unsustainable tenders, commercial withdrawals, regulatory time lag and national requirements, geopolitical factors, such as the dependency on active pharmaceutical ingredients (APIs) and chemical raw materials from third countries and the possible implications from the withdrawal agreement with the UK, unexpected pandemics, accidents, natural disasters or other force majeure issues;
Amendment 330 #
Motion for a resolution Paragraph 6 Amendment 331 #
Motion for a resolution Paragraph 6 6. Urges the Commission and the Member States to
Amendment 332 #
Motion for a resolution Paragraph 6 6. Urges the Commission and the Member States to introduce
Amendment 333 #
Motion for a resolution Paragraph 6 6.
Amendment 334 #
Motion for a resolution Paragraph 6 6.
Amendment 335 #
Motion for a resolution Paragraph 6 6. Urges the Commission and the Member States to introduce measures to support competitiveness and tax and financial incentives in return for appropriate commitments and to authorise, with due respect for international and EU legislation, state aid to encourage producers to locate their operations in Europe, from 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 diversification, with any public incentive having as a counterpart the transparency and traceability of investments, as well as the obligation to supply the European market;
Amendment 336 #
Motion for a resolution Paragraph 6 6. Urges the Commission and the Member States to introduce
Amendment 337 #
Motion for a resolution Paragraph 6 6. Urges the Commission and the Member States to introduce
Amendment 338 #
Motion for a resolution Paragraph 6 6.
Amendment 339 #
Motion for a resolution Paragraph 6 6. Urges the Commission and the Member States to introduce tax and financial incentives in return for appropriate commitments and to authorise state aid to encourage producers to locate their operations in Europe, from compound manufacturing to packaging and distribution; emphasises the strategic significance of this sector and the importance of investing in European companies
Amendment 34 #
Motion for a resolution Recital A a (new) Aa. whereas the causes underlying medicine shortages are complex and multi-factorial, and include manufacturing challenges, industry quotas, legal parallel trade, as well as economic elements, such as the pricing of medicinal products, which is a competence of the Member States;
Amendment 340 #
Motion for a resolution Paragraph 6 6. Urges the Commission and the Member States to introduce tax and financial incentives in return for appropriate commitments and to authorise state aid to encourage producers to locate their operations in Europe, from
Amendment 341 #
Motion for a resolution Paragraph 6 6. Urges the Commission and the Member States to introduce
Amendment 342 #
Motion for a resolution Paragraph 6 6. Urges the Commission and the Member States to in
Amendment 343 #
Motion for a resolution Paragraph 6 6. Urges the Commission and the Member States to in
Amendment 344 #
Motion for a resolution Paragraph 6 6. Urges the Commission and the Member States to introduce tax and financial incentives in return for appropriate commitments and to authorise state aid to encourage producers to locate their operations in Europe, from 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 diversification; notes that all incentives should include explicit safeguards, such as information on the level of public contribution, and accessibility clauses to ensure equal access to medicines at a fair price;
Amendment 345 #
Motion for a resolution Paragraph 6 6. Urges the Commission and the Member States to introduce tax and financial incentives in return for appropriate commitments and to authorise state aid to encourage producers to locate their operations in Europe, from compound manufacturing to packaging and distribution; emphasises the strategic significance of this sector and the
Amendment 346 #
Motion for a resolution Paragraph 6 6. Urges the Commission and the Member States to define and propose sustainable, economic, industrial and regulatory policies to maintain and secure existing manufacturing operations, to introduce tax and financial incentives in return for appropriate commitments and to authorise state aid to encourage producers to maintain or locate their operations in Europe, from 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 diversification;
Amendment 347 #
Motion for a resolution Paragraph 6 6. Urges the Commission and the Member States to introduce incentives supporting the diversification of supply, such as tax and financial incentives in return for appropriate commitments and to authorise state aid to encourage producers to locate their operations in Europe, from 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 diversification;
Amendment 348 #
Motion for a resolution Paragraph 6 6. Urges the Commission and the Member States to introduce tax and financial incentives in return for appropriate commitments and to authorise state aid to encourage producers to locate their operations in Europe, from compound manufacturing to packaging and distribution; and urges Member States to secure existing operations; emphasises the strategic significance of this sector and the importance of investing in European companies, in the interests of resource diversification;
Amendment 349 #
Motion for a resolution Paragraph 6 6. Urges the Commission and the Member States to introduce, as a priority, tax and financial incentives in return for appropriate commitments and to authorise, on an exceptional and temporary basis, state aid to encourage producers to locate their operations in Europe, from 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 diversification;
Amendment 35 #
Motion for a resolution Recital A a (new) Aa. whereas the problem of medicine shortages has multifactorial root causes, including but not limited to regulatory requirements, pressure to reduce production and distribution costs, supply chain interdependencies, including on third countries, unforeseen surges in demand as well as inadequate demand and supply data, and the concentration of production to a narrower set of production sites;
Amendment 350 #
Motion for a resolution Paragraph 6 6. Urges the Commission and the Member States to introduce tax and financial incentives in return for appropriate commitments and to authorise state aid to encourage environmentally responsible producers to locate their operations in Europe, from 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 diversification;
Amendment 351 #
Motion for a resolution Paragraph 6 a (new) 6a. Calls on the Commission and Member States to ensure that, if incentives are offered to the medicines industry, these do not affect medicine affordability; stresses the need to make incentives conditional on medicines being available and affordable;
Amendment 352 #
Motion for a resolution Paragraph 6 a (new) Amendment 353 #
Motion for a resolution 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 354 #
Motion for a resolution Paragraph 6 a (new) 6a. Calls on the Commission to introduce obligations for pharmaceutical companies to notify drug shortages according to Article 23a of Directive 2001/83/EC: underlines that other stakeholders involved in the supply chain such as wholesale distributors, pharmacists, hospitals and patients should also be included in the notification procedure of shortages ;
Amendment 355 #
Motion for a resolution Paragraph 6 a (new) 6a. Recalls that Article 81 of Directive 2001/83/EC stipulates measures to prevent pharmaceutical shortages by means of a so-called public service obligation (PSO), which obligates manufacturers and distributors to safeguard supplies to national markets; recalls further that, in many cases, the PSO is not applied to manufacturers supplying the distributors, as indicated in a study commissioned by the Commission; stresses that Article 23a requires a holder of the marketing authorisation who ceases production to report all data relating to the volume of sales and prescriptions of the medicinal product to the competent authorities so that they may notify any potential shortages in advance; calls, in this regard, for the effective implementation of the existing regulatory requirements by all actors in the supply chain at national and European level, along with measures to increase transparency in the supply chain;
Amendment 356 #
Motion for a resolution Paragraph 6 a (new) 6a. Notes that current legislation does not ensure the stable supply of medicines; calls on the Commission to clarify the marketing authorisation holder’s obligations under the Directive 2001/83/EC and develop an enforcement mechanism including sanctions to hold companies accountable
Amendment 357 #
Motion for a resolution Paragraph 6 a (new) 6a. Notes that the current legislation does not ensure the stable supply of medicines; calls on the Commission to clarify the marketing authorisation holder’s obligations under the Directive 2001/83/EC and develop an enforcement mechanism including sanctions to hold companies accountable;
Amendment 358 #
Motion for a resolution Paragraph 6 a (new) 6a. Calls on Member States to ensure that pharmaceutical companies and whole sale distributors comply with the requirement in Directive 2001/83/EC to ensure appropriate and continued supplies of medicines; highlights the need to ensure that pharmaceutical companies 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 359 #
Motion for a resolution Paragraph 6 a (new) 6a. Calls on the Commission to work together with Member States’ national authorities and the relevant stakeholders with a view to reinforcing the obligation for continuous supply to tackle the problem of shortages of medicines, including through a revision of Directive 2001/83/EC addressing earlier notification by companies in all Member States, consumer reporting and effective public communication;
Amendment 36 #
Motion for a resolution Recital A a (new) Aa. whereas shortages of medicines are a symptom of unsustainable policies, and there is abundant scientific evidence that demonstrates that medicines shortages have multi factorial root causes: namely economic causes, increasing regulatory burden, unforeseen surges in demand, supply chain interdependencies and manufacturing and quality challenges;
Amendment 360 #
Motion for a resolution Paragraph 6 a (new) 6a. Calls on the Commission to ensure that its pharmaceutical strategy is guaranteed to combat inadmissible business practices anywhere on the medicines circuit that might undermine transparency and balanced relations between the various public and private entities directly or indirectly involved in ensuring access to medicines, fulfilling an essential public service;
Amendment 361 #
Motion for a resolution Paragraph 6 a (new) 6a. Underlines that a complete repatriation of medical supply chains is not feasible in a global economy; emphasises the importance of Free Trade Agreements to ensure the diversification of supply chains; urges the Commission to work closely together with the WHO and WTO to establish an international framework to prevent a future breakdown of medical supply chains;
Amendment 362 #
Motion for a resolution Paragraph 6 a (new) 6a. Urges the Commission and Member States to put the right economic framework in place to secure and modernise existing manufacturing capabilities of medicines, technology and APIs in Europe, for example by rewarding investments in medicines quality and security of supply;
Amendment 363 #
Motion for a resolution Paragraph 6 a (new) 6a. Stresses the need for full transparency and traceability of public investments in research for medicines in order to reflect these public investments in the availability and price setting for the general public;
Amendment 364 #
Motion for a resolution Paragraph 6 a (new) 6a. Calls on the Commission and Member States to provide an environment that ensures Europe as an attractive location for R&D investment and industrial development in the pharmaceutical industry;
Amendment 365 #
Motion for a resolution Paragraph 6 a (new) 6a. Stresses that the pharmaceutical sector remains an important industrial pillar as well as a driving force in terms of job creation;
Amendment 366 #
Motion for a resolution 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 367 #
Motion for a resolution Paragraph 6 b (new) 6b. Calls on the Commission and Member States to reflect on the need for manufacturers to diversify their sources of supply for raw materials and the manufacture of health products, including the relocation of production in Europe;
Amendment 368 #
Motion for a resolution Paragraph 6 b (new) 6b. Recalls that Articles 81 and 23a of Directive 2001/83/EC establishing a Community Code relating to medicinal products for human use have laid down general obligations for the supply of medicinal products to be borne by marketing authorization holders (MAHs) and distributors, as well as a notification obligation for MAHs in the event of a temporary or permanent supply interruption;
Amendment 369 #
Motion for a resolution Paragraph 6 b (new) 6b. Calls on the Commission and the Member States to review existing legislation to ensure effective early notification requirements to marketing authorisation holders regarding supply interruptions in order to prevent shortages;
Amendment 37 #
Motion for a resolution Recital A a (new) Aa. whereas shortages of medicines are a symptom of unsustainable policies, and there is abundant scientific evidence that demonstrates that medicines shortages have multi factorial root causes: namely economic causes, increasing regulatory burden, unforeseen surges in demand, supply chain interdependencies and manufacturing and quality challenges;
Amendment 370 #
Motion for a resolution Paragraph 6 b (new) 6b. Acknowledges that the EU`s recent trade agreements include clear rules on commercial aspects of intellectual property rights, which generally acknowledge the issuing of compulsory licences in line with the TRIPS agreement; calls upon the Commission to ensure that the implementation of the EU free trade agreements does not interfere with the possibilities of invoking flexibilities provided by the TRIPS agreement, and to provide guidance to Member States in order to encourage voluntary licencing over immediate compulsory licencing;
Amendment 371 #
Motion for a resolution 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 372 #
Motion for a resolution Paragraph 6 b (new) 6b. Calls on the Commission to monitor compliance with Article 81 of Directive 2001/83/EC on supply shortages and to take action to remedy the shortcomings resulting from failure to comply with legislative obligations such as, for example, the imposition of financial penalties for failure to report on the interruption of supply or failure to comply with the public service obligation;
Amendment 373 #
Motion for a resolution Paragraph 6 b (new) 6b. Calls on the Commission and Member States to establish a standardised, early warning system at national and EU level enhancing pharmaceutical companies’ obligations to immediately notify any interruptions of supply of medicines;
Amendment 374 #
Motion for a resolution Paragraph 6 c (new) 6c. Calls on the Commission and Member States to strengthen their work on the responsibilities of Market Authorisation Holders (MAHs) in relation to the continuous supply obligations set out in Directive 2001/83/EC (Article 81); calls on the Commission and the European Medicines Agency (EMA) to clarify these obligations into enforceable guidelines and encourage Member States ensure compliance, provide sanctions and to explore all options to ensure that continuous supplies are strengthened, particularly in relation to a European network of pharmaceutical suppliers to promote increased competition and security of supply;
Amendment 375 #
Motion for a resolution Paragraph 6 c (new) 6c. Regrets, however, the disparities observed by the EMA in the transposition of these obligations into national legislations;
Amendment 376 #
Motion for a resolution Paragraph 6 c (new) 6c. Calls on the Commission to develop a clear definition of medicine shortages or scarcities and to address all the causes of shortages together with the Member States; calls on the Commission, in this regard, to submit a report on the impact of parallel trade and supply quotas, to explore mechanisms to address the withdrawal of effective medicines from the market for purely commercial reasons and to establish a mechanism for reporting annually on shortages of medicines across the EU;
Amendment 377 #
Motion for a resolution Paragraph 6 d (new) 6d. Urges the Commission to establish and update together with the Member States, the EMA and the relevant stakeholders a list of essential/critical medicines in line with the WHO list, for which there should be a mandatory supply reserve to meet the needs of patients and which it should not be possible to export (e.g. vaccines) provided that the export restriction is necessary in the interest of public health and to mitigate the risk of medicine shortages; calls in this regard for the establishment of procedures for prior notification/export authorisation by wholesalers on a pre-defined list;
Amendment 378 #
Motion for a resolution Paragraph 6 d (new) 6d. Calls on the Commission and Member States to establish requirements to oblige pharmaceutical companies to submit medicine shortage prevention plans for risk mitigation; stresses the need to make such prevention plans mandatory in EU law; calls for the proactive monitoring at national and EU level of medicines that are at risk of shortage;
Amendment 379 #
Motion for a resolution Paragraph 6 d (new) 6d. Considers that the European Green Deal constitutes a major opportunity to encourage pharmaceutical manufacturers to participate to the green recovery plan by producing in compliance with environmental and ecological standards;
Amendment 38 #
Motion for a resolution Recital A a (new) Aa. whereas there are important lessons to be learned from experiences during the COVID-19 pandemic; whereas some shortages resulted from restrictions imposed by other countries and an increased global demand; whereas shortages of some medicines in the intensive care setting resulted from significant unanticipated increased demand and issues at manufacturing sites within Europe, alongside restrictions on movement at EU internal borders, with imports from outside the EU in some cases helping to address shortages; whereas some Member States experienced issues relating to available stocks being in the wrong location at the wrong time, nationally and across the EU, rather than shortages of the medicines in question;
Amendment 380 #
Motion for a resolution Paragraph 6 e (new) 6e. Calls for the revision of Directive 2001/83/EC establishing a Community code relating to medicinal products for human use in order to ensure the notification of shortages, to strengthen the obligations incumbent on marketing authorization holders (MAHs) and to be able to ensure compliance with all of the obligations of actors in the drug supply chain;
Amendment 381 #
Motion for a resolution Paragraph 6 f (new) 6f. Calls on the Commission and the Member States to encourage marketing authorisation holders (MAHs) to build up and manage rolling stocks of medicines of major therapeutic interest in the form of finished products; considers that several months of rolling stocks would make it possible to absorb the supply shortfalls and avoid the losses linked to the expiry of the medicines;
Amendment 382 #
Motion for a resolution Paragraph 6 g (new) Amendment 383 #
Motion for a resolution 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;
Amendment 384 #
Motion for a resolution 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
Amendment 385 #
Motion for a resolution 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;
Amendment 386 #
Motion for a resolution 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
Amendment 387 #
Motion for a resolution 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
Amendment 388 #
Motion for a resolution 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
Amendment 389 #
Motion for a resolution 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 as well as the number, location of production sites, and the application of social, environmental, ethical and quality standards;
Amendment 39 #
Motion for a resolution Recital A a (new) Aa. whereas medicine shortages may be due to manufacturing problems, such as standards regarding good manufacturing practice, insufficient stocks available for a given market or economic reasons; whereas in certain cases medicine shortages can occur either because of illegitimate business strategies, such as ‘pay for delay’ in the pharmaceutical sector, or political, manufacturing or distribution issues, or parallel trade;
Amendment 390 #
Motion for a resolution 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; other essential factors are the reinvestment of profits into R&D and promotion of affordability and accessibility; proposes that investments in the manufacture of active ingredients and medicinal end products and to increase resilience in the EU should also be a criterion;
Amendment 391 #
Motion for a resolution 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 to increase supply resilience should also be a criterion;
Amendment 392 #
Motion for a resolution Paragraph 7 a (new) 7a. Notes that targeted guidelines should cover clarifications and recommendations to Member States on how to implement multi-winner framework agreements, apply Most Economically Advantageous Tender (MEAT) criteria, recognise investments in security of supply for Europe; introduce sufficient manufacturing lead times that guarantee a continuous supply of medicines to patients; proportionally apply penalties that do not offset the prospective rewards for tender awardees; investigate and consider exclusion of abnormally low bids to the tender process ; ensure timely procurement processes to ensure competition of multi-source medicines as soon as they are available;
Amendment 393 #
Motion for a resolution Paragraph 7 a (new) 7a. Notes that for certain biological medicinal products such as blood and plasma derived medicinal products, enabling Europe to increase its capacity to collect blood and plasma will be key to reduce its dependence on plasma imports from third countries; calls on the Commission to accelerate the revision of the Blood, Tissues and Cells legislation [Directive 2002/98/EC and Directive 2004/23/EC] in order to reduce the risk of shortages of these essential life-saving medicinal products;
Amendment 394 #
Motion for a resolution Paragraph 7 a (new) 7a. Urges the Commission, in the context of the EU public procurement Directive 2014/24/EU, to promptly propose ad-hoc guidance for Member States to support sustainable tenders practices for pharmaceuticals, where tender practices are used, notably on how to best implement the Most Economically Advantageous Tender (MEAT) criteria, looking beyond the lowest price criteria only, such as rewarding quality and security of supply investments;
Amendment 395 #
Motion for a resolution Paragraph 7 a (new) 7a. Stresses that the urgent need for medicines and medical equipment must not mean compromising the quality, safety, efficacy and cost-effectiveness of medicines for human use and health products;
Amendment 396 #
Motion for a resolution Paragraph 8 8. Notes that procurement procedures with only one successful tenderer may exacerbate vulnerability should supplies be disrupted;
Amendment 397 #
Motion for a resolution Paragraph 8 8. Notes that procurement procedures with only one successful tenderer with only one production site of the basic substance may exacerbate vulnerability should supplies be disrupted; calls on the Commission and the Member States to introduce procurement procedures under which contracts may be awarded to a number of successful tenderers where each has at least more than one production site in different countries (including one within the EU) for the tendered medicinal product, in order to maintain market competition and reduce the risk of shortages, while guaranteeing high-quality treatment for patients;
Amendment 398 #
Motion for a resolution 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 introduce procurement procedures under which contracts may be awarded to a number of successful tenderers, including joint tenderers, in order to maintain market competition and reduce the risk of shortages, while guaranteeing high-quality treatment for patients;
Amendment 399 #
Motion for a resolution 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 introduce procurement procedures under which contracts may be awarded to a number of successful
Amendment 4 #
Motion for a resolution Citation 7 b (new) - having regard to the Council Conclusions of 8 June 2010 on ‘Equity and Health in All Policies: Solidarity in Health’,
Amendment 40 #
Motion for a resolution Recital A a (new) Aa. whereas the Treaties and the European Charter of Fundamental Right state that everyone shall have access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices; whereas this right should be enforced for all citizens, including those living in the smaller Member States and in the most peripheral areas of the Union;
Amendment 400 #
Motion for a resolution 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 introduce procurement procedures under which contracts may be awarded to a number of successful tenderers, in order to maintain market competition and reduce the risk of shortages, while guaranteeing high-quality and affordable treatment for patients;
Amendment 401 #
Motion for a resolution 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 introduce procurement procedures under which contracts may be awarded to a number of successful tenderers, in order to maintain market
Amendment 402 #
Motion for a resolution 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 consider introduc
Amendment 403 #
Motion for a resolution Paragraph 8 a (new) 8a. Notes that procurement practices focusing solely on prices have resulted in manufacturers pulling out from national markets leading to a lack of competition, market consolidation and an increased risk of medicines shortages; calls on the Commission and Member States to engage in a structured exchange to apply alternative criteria to the tendering process such as reliability of supply and the number of location and product sites;
Amendment 404 #
Motion for a resolution Paragraph 8 a (new) 8a. Notes that procurement practices focusing solely on the price have resulted in manufacturers pulling out of 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 other criteria than price in tendering procedures such as reliability of supply and the number and location of production sites;
Amendment 405 #
Motion for a resolution Paragraph 8 a (new) 8a. Stresses the urgent need to ensure that pharmaceutical patents do not impede supplies in the event of a shortage of medicines; stresses the need to secure necessary supplies at times of crisis or during any present and future epidemic outbreak by replacing pharmaceutical patents for medicines, vaccines and medical equipment with licences for public laboratories and manufacturers to supply generic copies of branded products without the need to negotiate with patent holders;
Amendment 406 #
Motion for a resolution Paragraph 8 a (new) 8a. Ask the Commission to examine if it is possible to create a legislative framework that encourage and enables healthcare systems to do tenders that award pharmaceutical companies that guarantee the supply of pharmaceuticals in difficult circumstances by focussing on production inside the EU and guarantee at least two different sources for the basic substance; ask the Commission to examine if legislative requirements to ensure more sustainable delivery of pharmaceuticals can be mandated under EU law;
Amendment 407 #
Motion for a resolution Paragraph 8 a (new) 8a. Calls on the Commission to expand its joint European response to include joint procurement actions and procedures for all developed vaccines, medication, medical equipment and medical technology; insists that this joint response be a priority post-pandemic, and be easily accessible for citizens in every Member State especially those that are particularly vulnerable from a public health and economic perspective due to their remote location or small size;
Amendment 408 #
Motion for a resolution Paragraph 8 a (new) 8a. Recalls the existing evidence highlighting the role of sustainable procurement practices in preventing medicines shortages; calls on the Commission to support Member States in the prevention of shortages by developing ad hoc EU Guidelines on procurement of medicines, under the current public procurement directive, aimed at ensuring long-term sustainability, competition, security of supply and stimulating investments in manufacturing;
Amendment 409 #
Motion for a resolution Paragraph 8 a (new) 8a. Highlights the role that public procurement procedures by Member States’ authorities could have in reducing the risk of shortage of medicines, namely with regard to the number of production sites requested in the call for Tenders and the kind of contractual sanctions envisaged for failure to supply;
Amendment 41 #
Motion for a resolution Recital A a (new) Aa. whereas the Charter of Fundamental Rights of the European Union recognises the fundamental right of citizens to health and medical treatment;
Amendment 410 #
Motion for a resolution Paragraph 8 a (new) 8a. Calls on the Commission and Member States to develop better procurement systems and guidance to ensure continued availability of old, generic and inexpensive medicines that are still needed in patient care;
Amendment 411 #
Motion for a resolution 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 412 #
Motion for a resolution Paragraph 8 b (new) 8b. Calls on the Commission to issue targeted and binding EU guidelines on the procurement of medicines, recommends that the public procurement Directive should recommend to Member States how to implement multi-winner framework agreements, applying Most Economically Advantageous Tender (MEAT) criteria and strengthen the security of medicines supply for Europe;
Amendment 413 #
Motion for a resolution Paragraph 8 b (new) 8b. Urges the Commission, in the context of the EU public procurement Directive 2014/24/EU, to promptly propose ad-hoc guidance for Member States to support sustainable tender practices for pharmaceuticals, where tender practices are used, notably on how to best implement the Most Economically Advantageous Tender (MEAT)criteria, looking beyond the lowest price criteria only and rewarding quality and security of supply investments;
Amendment 414 #
Motion for a resolution Paragraph 8 b (new) 8b. Calls on the Commission to publish targeted public procurement guidelines for the pharmaceutical sector including the contribution to the security of EU supply and sufficient manufacturing lead-time to guarantee the supply of medicines for patients; underlines that these guidelines should clarify recommendations for Member States on what to consider specifically for the pharmaceutical sector whilst awarding bids; whereas the guidelines should be based on the principle of the Most economically Advantageous Tender (‘MEAT’) criteria, which aims to ensure the best value for money rather than simply the cheapest product;
Amendment 415 #
Motion for a resolution Paragraph 9 Amendment 416 #
Motion for a resolution Paragraph 9 9.
Amendment 417 #
Motion for a resolution 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
Amendment 418 #
Motion for a resolution Paragraph 9 9.
Amendment 419 #
Motion for a resolution Paragraph 9 9.
Amendment 42 #
Motion for a resolution Recital A a (new) Aa. whereas access to medicines is a growing problem within EU, usually associated with the high price of medicines and hindering European citizens` right to access to healthcare; whereas it is expected for the socio- economic situation to decline as a consequence of coronavirus pandemic and to worsen the living conditions for vulnerable citizens;
Amendment 420 #
Motion for a resolution Paragraph 9 9.
Amendment 421 #
Motion for a resolution Paragraph 9 9.
Amendment 422 #
Motion for a resolution 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
Amendment 423 #
Motion for a resolution Paragraph 9 9. Calls on the Commission
Amendment 424 #
Motion for a resolution Paragraph 9 9. Calls on the Commission and the Member States to
Amendment 425 #
Motion for a resolution Paragraph 9 9. Calls on the
Amendment 426 #
Motion for a resolution Paragraph 9 9. Calls on the Commission and the Member States to create
Amendment 427 #
Motion for a resolution Paragraph 9 9. Calls on the
Amendment 428 #
Motion for a resolution 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, on the model of army or hospital pharmacies, to manufacture priority medicines of strategic importance for health care in the absence of an existing industrial production facility and ensuring security of supply; 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; calls on the Commission to make proposals on the establishment within the Union of public-private partnerships along the lines of the US Biomedical Advanced Research and Development Authority;
Amendment 429 #
Motion for a resolution Paragraph 9 9. Calls on the Commission and the Member States to c
Amendment 43 #
Motion for a resolution Recital A a (new) A a. whereas there are no definitions harmonised between Member States of ‘shortages’, ‘tensions’, ‘supply disruptions’ and ‘overstocking’; whereas a distinction should be made between ‘medicinal products of major therapeutic interest’ (MITMs) and ‘medicines of health and strategic interest’(MISS);
Amendment 430 #
Motion for a resolution 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 in all Union countries irrespective of economic or spatial differences; stresses the key contribution that can be made by new technologies and artificial intelligence with proper data protection safeguards in enabling European laboratory researchers to form networks and share their objectives and findings;
Amendment 431 #
Motion for a resolution 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 to complement the supply, in order to avoid possible shortages of medicines in case of emergency; 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;
Amendment 432 #
Motion for a resolution 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 findings, whilst fully respecting the General Data Protection Regulation;
Amendment 433 #
Motion for a resolution Paragraph 9 9. Calls on the Commission and the Member States to examine the possibility of creat
Amendment 434 #
Motion for a resolution 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
Amendment 435 #
Motion for a resolution 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
Amendment 436 #
Motion for a resolution 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
Amendment 437 #
Motion for a resolution Paragraph 9 a (new) 9a. Calls for full transparency at EU and Member State level through a Europe-wide medicines shortages database and an early warning system involving the main supply-chain stakeholders, including manufacturers, healthcare distributors, pharmaceutical wholesalers, pharmacists to prescribers and the competent national authorities, about existing and anticipated shortages, providing their root causes in a harmonised, comparable format;
Amendment 438 #
Motion for a resolution Paragraph 9 a (new) 9a. Underlines the growing success of public/private partnerships, in particular the European Innovative Medicines Initiative (IMI) within the framework of the research programme, whose aim is precisely to meet the challenge of ensuring safe and effective medicines, and believes that the scope of the IMI could be broadened, from pure research to the production of medicines;
Amendment 439 #
Motion for a resolution 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 44 #
Motion for a resolution 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 440 #
Motion for a resolution Paragraph 9 a (new) 9a. Calls on the Commission to take action against the spread of falsified medicines from unauthorised websites and vendors that are raising concerns nowadays; this practice can cause serious harm and can lead to severe health problems or worsen the health condition of citizens; EU coordination in mapping and combatting of counterfeit of medicines is essential;
Amendment 441 #
Motion for a resolution Paragraph 9 a (new) 9a. 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 442 #
Motion for a resolution Paragraph 10 Amendment 443 #
Motion for a resolution Paragraph 10 10. Calls for
Amendment 444 #
Motion for a resolution Paragraph 10 10. Calls for links to be e
Amendment 445 #
Motion for a resolution Paragraph 10 10. Calls for links to be established between the pharmaceutical industry and other production sectors, such as farming, in a bid to develop the production of active ingredients in the EU; calls for efforts to counter over-specialisation in certain sectors and for substantial investment in research, the bioeconomy and biotechnology, for the purposes of resource diversification; considers that the industrial recovery of Europe needs to prioritize twin digital and ecological transformation of our societies and building of resilience to external shocks;
Amendment 446 #
Motion for a resolution Paragraph 11 11. Stresses the importance of research and innovation, and calls for the establishment of a genuine European network
Amendment 447 #
Motion for a resolution Paragraph 11 11. Stresses the importance of research and innovation, and calls for the establishment of a genuine European network
Amendment 448 #
Motion for a resolution Paragraph 11 11. Stresses the importance of research and innovation
Amendment 449 #
Motion for a resolution Paragraph 11 11. Stresses the importance of research and innovation,
Amendment 45 #
Motion for a resolution Recital A a (new) Aa. whereas medicine shortages are a growing public health threat with a serious impact on health care systems and public health;
Amendment 450 #
Motion for a resolution Paragraph 11 11. Stresses the importance of research and innovation, and calls for the establishment of a genuine European
Amendment 451 #
Motion for a resolution Paragraph 11 11. Stresses the importance of research and innovation, and calls for the establishment of a genuine European network
Amendment 452 #
Motion for a resolution 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 quality of medical research; calls on the Commission to provide increased financial resources under Horizon Europe and other EU programmes to strengthen support for rare diseases through increased research, clinical trials, best practices sharing, and medication development; insists that best practices, clinical trials, and medication pertaining to rare diseases be available to all citizens regardless of their Member State;
Amendment 453 #
Motion for a resolution 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 quality of medical research, and emphasises that a stable research and development system can have a positive impact on production capacities and stability of supply; supports such an ecosystem based on stable intellectual property, targeted incentives for unmet medical needs, qualified scientific staff and robust public research institutes;
Amendment 454 #
Motion for a resolution 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 quality of medical research; stresses that when research is wholly or partially funded by EU funding and other public funds, the results need to stay within the public domain and have clear affordability and accessibility conditions attached to them;
Amendment 455 #
Motion for a resolution 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 quality of medical research; highlights the role of European projects and SMEs in improving access to medicines in the Union; underlines the crucial role of the Horizon Europe program in this respect;
Amendment 456 #
Motion for a resolution 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 quality of medical research;
Amendment 457 #
Motion for a resolution Paragraph 11 11. Stresses the importance of research and innovation, including the off-patent segment, and calls for the establishment of a genuine European network, given that the price of relocation must not be a deterioration in the quality of medical research;
Amendment 458 #
Motion for a resolution Paragraph 11 11. Stresses the importance of research and innovation, also in the off patent segment, and calls for the establishment of a genuine European network, given that the price of relocation must not be a deterioration in the quality of medical research;
Amendment 459 #
Motion for a resolution Paragraph 11 11. Stresses the importance of research and innovation, including the off-patent segment, and calls for the establishment of a genuine European network, given that the price of relocation must not be a deterioration in the quality of medical research;
Amendment 46 #
Motion for a resolution Recital A a (new) Aa. whereas medicine shortages are a growing public health threat with a serious impact on health care systems and public health;
Amendment 460 #
Motion for a resolution Paragraph 11 11. Stresses the importance of high quality medical 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 quality of medical research;
Amendment 461 #
Motion for a resolution Paragraph 11 a (new) 11a. Calls on the Commission to take the first steps to enhance transparency of research and development costs of medicines;
Amendment 462 #
Motion for a resolution Paragraph 11 a (new) 11a. Calls on the Commission and the Member States to screen foreign direct investments in medicines manufacturing plants as part of Europe's critical health infrastructure.
Amendment 463 #
Motion for a resolution 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 464 #
Motion for a resolution Paragraph 11 a (new) 11a. Calls on the Commission to ensure that, when EU public money is spent on research, the results of that research are not protected by intellectual property rights and price accessibility to patients is guaranteed for the products developed; stresses the importance of public research and development activities and institutions and of cooperation at international level, while expressing concerns over the dominant role of multinationals in the pharmaceutical sector; urges all pharmaceutical companies to pool their data and knowledge in a collective effort to identify, test, develop and manufacture vaccines and treatments to curb COVID-19;
Amendment 465 #
Motion for a resolution Paragraph 11 a (new) 11a. Stresses the need to ensure that health professionals and the general public have access to safe, effective and good quality medicines and health products by monitoring and regulating continued compliance with good clinical practice regarding the authorisation of clinical trials and the conduct thereof, in line with the highest health protection standards;
Amendment 466 #
Motion for a resolution Paragraph 11 a (new) 11a. Contends that, especially during global health emergencies, publicly- funded scientific research should not be constrained by patent protection since it may constitute an undue and disproportionate obstacle to a quicker achievement of results and be in contradiction with the purpose of public financial support, in particular tackling the urgent medicine needs of EU citizens;
Amendment 467 #
Motion for a resolution Paragraph 11 a (new) 11a. Calls for reform of the TRIPS agreement so poor countries can have equitable and affordable access to the technologies and medicines they need; calls for public health medicines to be exempt from the patent system to ensure that poor countries have the legal right to produce and import generic versions of life-saving medicines;
Amendment 468 #
Motion for a resolution Paragraph 11 a (new) 11a. Notes the impact on the supply of medicines of the UK's withdrawal from the EU, particularly for Ireland, and calls for targeted actions to ensure continued and rapid access to safe medicines and medical devices for patients, including a secure and consistent supply of radioisotopes;
Amendment 469 #
Motion for a resolution Paragraph 11 a (new) 11a. Calls on the Commission and the Member States to consider implementing an EU wide formulary (list) of approved medicines, indicating which products are interchangeable and key information on the composition, description, prescribing and timely administration of medicines;
Amendment 47 #
Motion for a resolution Recital A a (new) Aa. whereas medicine shortages are a growing public health threat with a serious impact on health care systems and public health;
Amendment 470 #
Motion for a resolution Paragraph 11 a (new) 11a. Calls for strengthening of the European Medicines Market to speed up patients’ access to medicines, make care more affordable, maximise savings in national health budgets and avoid administrative burdens for pharmaceutical companies;
Amendment 471 #
Motion for a resolution Paragraph 11 a (new) 11a. Calls for strengthening of the European Medicines Market to speed up patient access to medicines, make care more affordable, maximise savings in national health budgets and avoid administrative burdens for generic and biosimilar companies ;
Amendment 472 #
Motion for a resolution Paragraph 11 a (new) 11a. Stresses the responsibility of the pharmaceutical industry regarding shortages of medicines in order to ensure the continuity in delivering; urges the industry to make a back-up plan in case of a shortage of any medicine;
Amendment 473 #
Motion for a resolution Paragraph 11 a (new) 11a. Stresses the importance of promoting independent, peer-reviewed scientific research on the medical use of cannabis, including through the study of the effects of standardised and magistral preparations;
Amendment 474 #
Motion for a resolution Paragraph 11 b (new) 11b. Stresses the need to ensure adequate provisions for medicine supply chains across the EU-UK borders are included in the future relationship agreement with the United Kingdom, as well as ensuring contingency plans are in place in case of a ‘no deal’;
Amendment 475 #
Motion for a resolution Paragraph 11 b (new) 11b. Points out that generic and biosimilar medicines enable increased competition, reduced prices and savings for healthcare systems, thus helping to improve access to medicines for patients
Amendment 476 #
Motion for a resolution Paragraph 11 b (new) 11b. Calls on the Commission to increase its involvement in supporting critical health infrastructure protection in Member States and to start applying the European Programme for Critical Infrastructure Protection (EPCIP) to the health infrastructure sector;
Amendment 477 #
Motion for a resolution Paragraph 11 b (new) 11b. Stresses the importance of encouraging clinical trials for medicines used off-label to ensure their safe and optimal use;
Amendment 478 #
Motion for a resolution Paragraph 11 b (new) 11b. Calls for European wide tracking of public financial resources used for R&D for each medicinal product as well as final net price charged;
Amendment 479 #
Motion for a resolution Paragraph 11 c (new) 11c. Deplores the litigation cases aiming to delay generic entry; calls on the Commission to ensure that the end of the innovator's period of commercial exclusivity is respected;
Amendment 48 #
Motion for a resolution Recital A a (new) Aa. whereas drug shortages are sometimes artificially created by pharmaceutical companies that choose to produce more profitable drugs while neglecting less profitable ones;
Amendment 480 #
Motion for a resolution Paragraph 11 c (new) 11c. Calls for EU legislative action to ensure that reinvestment of profits, affordability and accessibility become standard requirements on contracts related to public funding for R&D of medicinal products between public institutions and pharmaceutical companies;
Amendment 481 #
Motion for a resolution Paragraph 11 d (new) 11d. Stresses that the added value and economic impact of biosimilar medicines on the sustainability of healthcare systems should be analysed, their market entry should not be delayed, and, where necessary, measures to support their introduction to the market should be examined;
Amendment 482 #
Motion for a resolution Paragraph 11 d (new) 11d. Calls for additional funding into Horizon 2020 to be specifically dedicated to clinical trials and new medicinal products that have a clear societal value with public sharing of research results;
Amendment 483 #
Motion for a resolution Paragraph 11 e (new) 11e. Calls for a revision of EU Regulation (EC) No 141/2000 on orphan medicinal products to reverse the ‘burden of proof’ for the ten-year market exclusivity clause in order that the holder of the market authorisation has to prove that the product is not sufficiently profitable to cover R&D costs;
Amendment 484 #
Motion for a resolution Paragraph 11 e (new) 11e. Calls on the Member States to adopt a common position and start negotiations on the proposal for a Regulation of the Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU;
Amendment 485 #
Motion for a resolution Paragraph 11 f (new) 11f. Calls on the Commission to present a revision of Directive 89/105 /EEC on the transparency of measures regulating the prices of medicinal products in order to ensure effective controls and full transparency of the procedures used to determine the prices and reimbursement of medicines in the Member States;
Amendment 486 #
Motion for a resolution Subheading 2 More vigorous action at European level to better co
Amendment 487 #
Motion for a resolution Paragraph 12 Amendment 488 #
Motion for a resolution Paragraph 12 12. Recommends the introduction of
Amendment 489 #
Motion for a resolution Paragraph 12 12. Recommends th
Amendment 49 #
Motion for a resolution Recital A b (new) Ab. whereas uncoordinated initiatives at national level, such as stockpiling and penalties, are not the right solution and could lead to an increased risk of medicines shortage;
Amendment 490 #
Motion for a resolution Paragraph 12 12. Recommends the introduction of
Amendment 491 #
Motion for a resolution Paragraph 12 12. Recommends
Amendment 492 #
Motion for a resolution Paragraph 12 12. Recommends the
Amendment 493 #
Motion for a resolution Paragraph 12 12. Recommends the introduction of
Amendment 494 #
Motion for a resolution Paragraph 12 12. Recommends the introduction of centralised management under the leadership of the European Medicines Agency (EMA) to bring about greater transparency in the production and distribution chains of medicines and the creation of a European supply management unit tasked with developing a European strategy to prevent and resolve
Amendment 495 #
Motion for a resolution Paragraph 12 12. Recommends the introduction of centralised management of information to bring about greater transparency in the distribution chain and the
Amendment 496 #
Motion for a resolution Paragraph 12 12. Recommends
Amendment 497 #
Motion for a resolution Paragraph 12 12. Recommends the introduction of centralised management to bring about greater transparency in the distribution chain and the creation of a European supply management unit tasked with
Amendment 498 #
Motion for a resolution Paragraph 12 12. Recommends the introduction of centralised management
Amendment 499 #
Motion for a resolution Paragraph 12 12.
Amendment 5 #
Motion for a resolution Citation 8 a (new) - having regard to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC,
Amendment 50 #
Motion for a resolution Recital A b (new) Ab. whereas medicine shortages impose significant costs on both public and private health stakeholders;
Amendment 500 #
Motion for a resolution Paragraph 12 12. Recommends the introduction of centralised management 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; underlines that full transparency must be ensured about the causes of shortages including the market withdrawal of a medicine due to economic reasons:
Amendment 501 #
Motion for a resolution Paragraph 12 12. Recommends the introduction of centralised management to bring about greater transparency and more interaction between competent authorities and industry about potential disruption or interruption of supply 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 502 #
Motion for a resolution Paragraph 12 12. 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 503 #
Motion for a resolution Paragraph 12 12. Recommends the introduction of centralised management, under the auspices 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 504 #
Motion for a resolution Paragraph 12 12. Recommends the introduction of centralised management coordinated by the European Medicine Agency to bring about
Amendment 505 #
Motion for a resolution Paragraph 12 12. Recommends the introduction of
Amendment 506 #
Motion for a resolution Paragraph 12 12. Recommends the introduction of centralised management under the 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 507 #
Motion for a resolution Paragraph 12 12. Recommends the introduction of centralised management 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
Amendment 508 #
Motion for a resolution Paragraph 12 12. Recommends the introduction of centralised management 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
Amendment 509 #
Motion for a resolution Paragraph 12 12. Recommends the introduction of centralised management 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
Amendment 51 #
Motion for a resolution Recital A b (new) Ab. whereas ensuring patient access to essential medicines is one of the core objectives of the EU and the WHO, and of Sustainable Development Goal 3; whereas universal access to medicines depends on their timely availability and their affordability for everyone, without any geographical discrimination;
Amendment 510 #
Motion for a resolution Paragraph 12 12. Recommends the introduction of
Amendment 511 #
Motion for a resolution Paragraph 12 a (new) 12a. Recalls that the EMA and the 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 the Commission, the EMA and the National Medicines Agencies, the Member States and the pharmaceutical supply chain actors to come up with a common definition of a shortage to better take into account patients' needs while avoiding different national definitions and approaches;
Amendment 512 #
Motion for a resolution Paragraph 12 a (new) 12a. Calls on the Commission and the Member States to reflect on the establishment of harmonised shortage management plans obliging producers to identify medicines of major therapeutic interest requiring the introduction of preventive and corrective measures in order to avoid or alleviate any disruption in supplies;
Amendment 513 #
Motion for a resolution Paragraph 12 a (new) 12a. Stresses the need to maintain open borders via green lanes, facilitating crossing borders to those pharmaceutical or medical companies distributing and supplying medicines and/or personal protection equipment (PPE), to avoid possible shortages of medicines;
Amendment 514 #
Motion for a resolution Paragraph 12 a (new) 12a. Welcomes the recent creation green lanes, set up to facilitate the transport of all goods, in order to allow the smooth running of the transport not only of medicines but also of raw materials, intermediate products and related materials, including packaging;
Amendment 515 #
Motion for a resolution Paragraph 12 a (new) 12a. Recommends the creation of a permanent system for monitoring of medicine shortages in the EU, coordinated by the EMA, with additional resources;
Amendment 516 #
Motion for a resolution Paragraph 12 a (new) 12a. Calls on the Commission and Member States to introduce mandatory shortage preventions plans for pharmaceutical companies;
Amendment 517 #
Motion for a resolution Paragraph 12 b (new) 12b. Calls for the establishment of European lists of 'medicinal products of major therapeutic interest' along the lines of the 'WHO model list of essential medicines'; suggests that the EMA shortage risk indicators (manufacturing and quality) be used to identify high risk products,
Amendment 518 #
Motion for a resolution Paragraph 12 c (new) 12c. Calls for the introduction of a specific statute for certain mature medicines which would be accompanied by incentives for manufacturers to maintain their marketing on the European market and ensure diversification of European production;
Amendment 519 #
Motion for a resolution Paragraph 12 d (new) 12d. Encourages the development of shortage prevention and management plans across all Member States; believes that these plans could result from an analysis of manufacturing and distribution risks and include measures on building up stocks, diversifying sources of supply for raw materials and creating other manufacturing sites to ensure resilience from production;
Amendment 52 #
Motion for a resolution Recital A b (new) Ab. whereas shortages may concern essential medicines for which an interruption of treatment can be life- threatening; whereas the increase in demand for medicines to treat COVID-19 could also threaten their availability for patients who use them to manage their chronic and/or rare diseases;
Amendment 520 #
Motion for a resolution Paragraph 12 e (new) 12e. Underlines that several Member States have already established alert systems which facilitate the anticipation and prevention of shortages; calls for the establishment of alert systems to anticipate shortage of medicines at national and European levels;
Amendment 521 #
Motion for a resolution Paragraph 13 Amendment 522 #
Motion for a resolution Paragraph 13 Amendment 523 #
Motion for a resolution Paragraph 13 13.
Amendment 524 #
Motion for a resolution Paragraph 13 13. Calls on the Commission to develop European health strategies
Amendment 525 #
Motion for a resolution Paragraph 13 13. Calls on the Commission to develop European health strategies on the basis of a common basket of drugs for the treatment of cancer and infections
Amendment 526 #
Motion for a resolution Paragraph 13 13. Calls on the Commission to develop European health strategies on the basis of a common basket of drugs for the treatment of cancer and infections
Amendment 527 #
Motion for a resolution Paragraph 13 13. Calls on the Commission to develop European health strategies on the basis of a common basket of drugs for the treatment of cancer and infections
Amendment 528 #
Motion for a resolution Paragraph 13 13. Calls on the Commission to develop European health strategies on the basis of a common basket of drugs for the treatment of cancer and infections
Amendment 529 #
Motion for a resolution Paragraph 13 13. Calls on the Commission to develop European health strategies on the basis of a common basket of drugs
Amendment 53 #
Motion for a resolution Recital A b (new) Ab. whereas the reason of medicine shortages is multifactorial, patient consumption does not always follow a trend and could change rapidly in a crisis;
Amendment 530 #
Motion for a resolution Paragraph 13 13. Calls on the Commission to develop European health strategies on the basis of a common basket of drugs for the treatment of cancer and infections whose prices are
Amendment 531 #
Motion for a resolution Paragraph 13 13. Calls on the Commission to develop European health strategies on the
Amendment 532 #
Motion for a resolution Paragraph 13 13. Calls on the Commission to develop European health strategies on the basis of a common basket of drugs for the treatment of cancer and infections
Amendment 533 #
Motion for a resolution Paragraph 13 13. Calls on the Commission to develop European health strategies on the basis of a common basket of drugs for the treatment of cancer and infections
Amendment 534 #
Motion for a resolution Paragraph 13 13. Calls on the Commission to develop European health strategies on the basis of a common basket of drugs for the treatment of cancer
Amendment 535 #
Motion for a resolution Paragraph 13 13. Calls on the Commission to develop European health strategies on the basis of a common basket of drugs for the treatment of cancer and infections whose prices are harmonised, taking account of differences in clinical approach across the Member States, in a bid to counter recurrent shortages and ensure that patients have access to treatment;
Amendment 536 #
Motion for a resolution Paragraph 13 13. Calls on the Commission to develop European health strategies on the basis of a common basket of drugs for the treatment of cancer and infections whose prices to consumers are harmonised across the Union, in a bid to counter recurrent shortages and ensure that patients have equal access to treatment;
Amendment 537 #
Motion for a resolution Paragraph 13 13. Calls on the Commission to develop European health strategies
Amendment 538 #
Motion for a resolution Paragraph 13 a (new) 13a. Calls on the Commission to elaborate an European harmonised framework for a transparent pharmaceutical pricing policy taking in account the public money contribution for both research and subsidizing activities; moreover calls on the Commission to propose an European harmonized framework for a mechanism for national pricing and reimbursement systems in order to achieve a fair and sustainable pricing and procurement;
Amendment 539 #
Motion for a resolution Paragraph 13 a (new) 13a. Calls on the Commission to further extend the joint procurement procedures on behalf of the Member States for medicines and medical equipment; particularly to establish joint procurement for medicines to treat rare diseases in order to ensure that these medicines are available in all Member States and at an equal price;
Amendment 54 #
Motion for a resolution Recital A c (new) Ac. whereas medicine shortages could pose a risk to the success of Union and Member State health initiatives, such as Europe's Beating Cancer Plan;
Amendment 540 #
Motion for a resolution Paragraph 13 a (new) 13a. Calls on the Commission to develop a European system for monitoring the need for medicines to prevent cancer and infections, accompanied by an early warning system in case of malfunctions at European level;
Amendment 541 #
Motion for a resolution Paragraph 14 Amendment 542 #
Motion for a resolution Paragraph 14 14. Calls on the Commission to create a European contingency reserve of medicines
Amendment 543 #
Motion for a resolution 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
Amendment 544 #
Motion for a resolution Paragraph 14 14. Calls on the Commission to create, as part of the ‘RescEU’ mechanism, a European
Amendment 545 #
Motion for a resolution Paragraph 14 14. Calls on the Commission to
Amendment 546 #
Motion for a resolution 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,
Amendment 547 #
Motion for a resolution Paragraph 14 14. Calls on the Commission to create a European contingency reserve of medicines of strategic importance for health care, such as the ones included in the World Health Organisation Model List of Essential Medicines for adults and for paediatric populations, supplies of which are critical, along the lines of the ‘RescEU’ mechanism, in order to alleviate shortages outside crisis periods;
Amendment 548 #
Motion for a resolution Paragraph 14 14. Calls on the Commission to assess the option 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; stresses the importance of ensuring adequate consultation of patients and consumer groups in this process;
Amendment 549 #
Motion for a resolution 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; insists that the use of such a reserve be transparent, accountable, and fair for all Member States;
Amendment 55 #
Motion for a resolution Recital A c (new) Ac. whereas patients should have access to the healthcare and treatment options of their choice and preference;
Amendment 550 #
Motion for a resolution Paragraph 14 14. Calls on the Commission to create a European contingency reserve of medicines of strategic importance for health care, taking account of differences in clinical approach across the Member States, supplies of which are critical, along the lines of the ‘RescEU’ mechanism, in order to alleviate shortages outside crisis periods;
Amendment 551 #
Motion for a resolution 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; acknowledges that such reserves must be proportionate to their objective;
Amendment 552 #
Motion for a resolution 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 and unjustified price hikes in such cases and outside crisis periods;
Amendment 553 #
Motion for a resolution 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 and to make it an emergency European pharmacy;
Amendment 554 #
Motion for a resolution 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 555 #
Motion for a resolution Paragraph 14 a (new) 14a. Calls on the Commission to ensure transparency around the functioning of RescEU 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 and do not create unintended consequences in other Member States;
Amendment 556 #
Motion for a resolution Paragraph 14 a (new) 14a. Calls on the Commission to reinforce the harmonised definition of medicine shortage, proposed by the EMA and HMA joint task force in 2019;
Amendment 557 #
Motion for a resolution Paragraph 14 a (new) 14a. Calls on the Commission and Member States to adopt a common definition of medicines shortages in the EU, and a common minimum set of data requirements for reporting and cataloguing shortages;
Amendment 558 #
Motion for a resolution 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 559 #
Motion for a resolution Paragraph 14 b (new) 14b. Calls on the Commission to revise the European rules on data and market exclusivity and include an exception clause to ensure that Member States can make use of compulsory licensing for medicinal products for rare diseases and to accelerate the generic production and supply of lifesaving medicines in times of shortages;
Amendment 56 #
Motion for a resolution Recital A d (new) Ad. whereas it is imperative to prevent medicine shortages, and mitigate their effects in case they occur;
Amendment 560 #
Motion for a resolution Paragraph 15 Amendment 561 #
Motion for a resolution Paragraph 15 Amendment 562 #
Motion for a resolution Paragraph 15 15. Calls on the Commission and the Member States to
Amendment 563 #
Motion for a resolution Paragraph 15 15. Calls on the Commission and the Member States to adopt a joint definition of ‘medicines of strategic importance for health care’ and of ‘criticality’, emphasising the value of these medicines for public health, the lack of alternatives and the vulnerability of the production
Amendment 564 #
Motion for a resolution Paragraph 15 15. Calls on the Commission and the Member States to adopt a joint definition of ‘medicines of strategic importance for health care’ and of ‘criticality’, emphasising the value of these medicines for public health, the lack of alternatives and the vulnerability of the production chain;
Amendment 565 #
Motion for a resolution Paragraph 15 15. Calls on the Commission and the Member States to adopt a joint definition of ‘medicines of strategic importance for
Amendment 566 #
Motion for a resolution Paragraph 15 15. Calls on the Commission and the Member States to adopt a joint definition of ‘medicines of
Amendment 567 #
Motion for a resolution Paragraph 15 15. Calls on the Commission and the
Amendment 568 #
Motion for a resolution Paragraph 15 15. Calls on the Commission and the Member States to adopt a joint definition of ‘medicines of strategic importance for health care’ and of ‘criticality’, emphasising the value of these medicines for public health, the lack of alternatives and the vulnerability of the production chain;
Amendment 569 #
Motion for a resolution Paragraph 15 15. Calls on the Commission and the Member States to adopt a joint definition of ‘medicines of strategic importance for health care’ and of ‘criticality’, emphasising the value of these medicines for public health, the lack of alternatives and the vulnerability of the production chain; calls for
Amendment 57 #
Motion for a resolution Recital A d (new) Ad. whereas pharmaceuticals are one of the pillars of healthcare, and whereas insufficient access to essential medicinal products and high prices of innovative medicines pose a serious threat to population health and to the sustainability of national health care systems;
Amendment 570 #
Motion for a resolution Paragraph 15 15. Calls on the Commission and the Member States to adopt a joint definition of ‘medicines of strategic importance for health care’ and of ‘criticality’, emphasising the value of these medicines for public health, the lack of alternatives and the vulnerability of the production chain; calls for
Amendment 571 #
Motion for a resolution Paragraph 15 15. Calls on the Commission and the Member States to adopt a joint definition of ‘medicines of strategic importance for health care’ and of ‘criticality’, emphasising the value of these medicines for public health, the lack of alternatives and the vulnerability of the production chain; calls for a European
Amendment 572 #
Motion for a resolution Paragraph 15 15. Calls on the Commission and the Member States to adopt a joint definition of ‘medicines of strategic importance for health care’ and of ‘criticality’, 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
Amendment 573 #
Motion for a resolution Paragraph 15 15. Calls on the Commission and the Member States to adopt a joint definition of ‘medicines of strategic importance for health care’ and of ‘criticality’, 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; calls for scheduled, independent and transparent reviews from the European regulatory authority so as to make sure designated medicinal quotas are quantifiable and puts all Member States on a level playing field and not give any advantage to one Member State over another;
Amendment 574 #
Motion for a resolution Paragraph 15 15. Calls on the Commission and the Member States to adopt a joint definition of ‘medicines of strategic importance for health care’ and of ‘criticality’, 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
Amendment 575 #
Motion for a resolution Paragraph 15 15. Calls on the Commission and the Member States to
Amendment 576 #
Motion for a resolution 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
Amendment 577 #
Motion for a resolution Paragraph 15 15. Calls on the Commission and the Member States to adopt a joint definition of ‘medicine shortages’ relevant for all stakeholders and ‘medicines of strategic importance for health care’ and of ‘criticality’, 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 578 #
Motion for a resolution Paragraph 15 15. Calls on the Commission and the Member States to adopt a joint definition of 'medicines shortages' relevant for all stakeholders, ‘medicines of strategic importance for health care’ and of ‘criticality’, 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 579 #
Motion for a resolution Paragraph 15 a (new) 15a. Calls for the adoption of common definitions of 'supply disruption' and 'stock-out' of medicines as well as a grid of criteria for assessing the risk associated with each of these situations;
Amendment 58 #
Motion for a resolution Recital A e (new) Ae. whereas, in many cases, the prices of new medicines, notably cancer treatments, have increased during the past few decades to the point of being unaffordable to many EU citizens
Amendment 580 #
Motion for a resolution Paragraph 15 a (new) 15a. Calls on the Commission and the Member States to adopt the following common definition of ‘medicines of major therapeutic interest’ (MMTI): medicines or classes of medicines for which an interruption of treatment is likely to jeopardise the vital prognosis of patients in the short or medium term, or represents a significant change in patient outcomes with regard to the severity or potential evolution of the disease;
Amendment 581 #
Motion for a resolution Paragraph 15 b (new) 15b. Calls for the adoption of a common definition of 'medicinal products of major therapeutic interest' with reference to their usefulness in public health, the absence of an alternative and the fragility of the production chain;
Amendment 582 #
Motion for a resolution 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;
Amendment 583 #
Motion for a resolution Paragraph 16 16. Calls on the Commission and Member States to develop innovative and coordinated strategies and to step up exchanges of good practice
Amendment 584 #
Motion for a resolution Paragraph 16 16. Calls on the Commission and Member States to develop innovative and coordinated strategies and to step up exchanges of good practice
Amendment 585 #
Motion for a resolution Paragraph 16 16. Calls on the Commission and Member States to develop innovative and coordinated strategies and to step up exchanges of good practice
Amendment 586 #
Motion for a resolution 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
Amendment 587 #
Motion for a resolution 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)
Amendment 588 #
Motion for a resolution 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)
Amendment 589 #
Motion for a resolution 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)
Amendment 59 #
Motion for a resolution Recital A f (new) Af. whereas the entry of generics and biosimilars into the market is an important mechanism for increasing competition, reducing prices and ensuring the sustainability of healthcare systems; whereas their market entry should not be delayed;
Amendment 590 #
Motion for a resolution 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 be designated as the regulatory authority tasked with preventing shortages of essential medicines,
Amendment 591 #
Motion for a resolution 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 be designated as the regulatory authority tasked with preventing shortages of essential medicines
Amendment 592 #
Motion for a resolution Paragraph 16 16. Calls on the Commission and Member States to ensure the setting up of common, European medical stocks; calls on the Commission and the Member States to develop innovative and coordinated joint strategies and to step up exchanges of good practice in the area of stock management; stresses that ensuring all Member States have fair and transparent access to these stocks through joint European coordination is crucial to managing vulnerabilities and risks to the supply chain; considers that the European Medicines Agency (EMA) could be designated as the regulatory authority tasked with preventing shortages of essential medicines, with a correspondingly wider remit and more staff;
Amendment 593 #
Motion for a resolution 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 preventi
Amendment 594 #
Motion for a resolution 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 be designated as the regulatory authority tasked with preventing shortages of
Amendment 595 #
Motion for a resolution 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 be designated as the regulatory authority tasked with preventing shortages of essential medicines, with a correspondingly wider remit and more staff; calls on the Commission to amend existing legislation in order to strengthen the Agency's capacities;
Amendment 596 #
Motion for a resolution 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 with a view to preventing both insufficient stock and stockpiling; considers that the
Amendment 597 #
Motion for a resolution 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 Centre for Disease Prevention and Control (ECDC) or the European Medicines Agency (EMA) could be designated as the regulatory authority tasked with preventing shortages of essential medicines, with a correspondingly wider remit and more staff;
Amendment 598 #
Motion for a resolution 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
Amendment 599 #
Motion for a resolution 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
Amendment 6 #
Motion for a resolution Citation 11 a (new) - having regard to the Regulation 2020/561 amending Regulation 2017/745 on medical devices, as regards the dates of application of certain of its provisions,
Amendment 60 #
Motion for a resolution Recital A g (new) Ag. whereas the COVID-19 crisis has exacerbated the EU’s long-existing structural problems related to the supply of medicines, and the dependency on third-country import for medicines and medical materials;
Amendment 600 #
Motion for a resolution 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)
Amendment 601 #
Motion for a resolution 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 be designated as the
Amendment 602 #
Motion for a resolution Paragraph 16 a (new) 16a. Calls on the Commission and Member States to seek closer collaboration and exchanges of best practice in efforts to mitigate the impact of medicine shortages, for example by giving pharmacists greater latitude to better manage patient care and ensure continuity of treatment;
Amendment 603 #
Motion for a resolution Paragraph 16 a (new) 16a. Following good practices of the Commission, of EMA and CMDh guidance to support availability of medicines used in the COVID-19 pandemic, calls on the Commission and relevant authorities to optimise the regulatory system and to simplify regulatory processes to ensure a reduction of the administrative burden of maintaining medicinal products on the market, to react quickly to patients’ needs and ensure prompt supply and access to high quality treatments; simplification can be achieved by amending the existing Regulation (EC) No 1234/2008 (Variations Regulation) and the Variations Classification Guidelines and making the most of the telematics tools at pan-European level;
Amendment 604 #
Motion for a resolution Paragraph 16 a (new) 16a. Points out that the EU has no equivalent of the US Biomedical Advanced Research and Development Authority (BARDA), which is responsible for procurement and development of countermeasures against bioterrorism, chemical, nuclear and radiological threats as well as pandemic influenza and emerging diseases; believes that the creation of an EU equivalent to BARDA should be considered;
Amendment 605 #
Motion for a resolution Paragraph 16 a (new) 16a. Calls on the Commission to study and establish a fund for orphan medicines that would be financed by the Member States, to procure collectively on behalf of the Member States the orphan medicines for all the EU;
Amendment 606 #
Motion for a resolution Paragraph 16 b (new) 16b. Calls on the Commission and the Member States to develop innovative and coordinated strategies and to step up exchanges of good practice in the area of stock management; recognises the European Medicines Agency (EMA) the body best suited to take the responsibility of the European response to medicines shortages; considers that the European Medicines Agency (EMA) should be designated as the regulatory authority coordinating and monitoring medicines shortages at EU level during emergencies and beyond with a correspondingly stronger mandate and better infrastructure; notes that EMA should be entirely publicly funded as a prerequisite to its independence;
Amendment 607 #
Motion for a resolution Paragraph 16 b (new) 16b. Calls on the Commission and relevant authorities to provide regulatory flexibility to mitigate medicines shortages when they occur, by allowing targeted measures such as more flexibility for multi-language packs, different pack size and e-leaflet, to ensure that patients are able to access high-quality and safe medicines faster;
Amendment 608 #
Motion for a resolution Paragraph 17 Amendment 609 #
Motion for a resolution Paragraph 17 17. Calls for further
Amendment 61 #
Motion for a resolution Recital B B. whereas medicine shortages can lead to possible delays in treatment or the need to switch to alternative therapies that could be less effective and increase risk of adverse side effect and a danger to life when concerning essential medicines; whereas medicines to treat cancer, infections and disorders of the nervous system account for more than half of those in short supply;
Amendment 610 #
Motion for a resolution Paragraph 17 17.
Amendment 611 #
Motion for a resolution Paragraph 17 17. Calls for further invitations to tender to be issued at European level, following a reasoned opinion and under the control of the Commission, in an effort to counter shortages, as
Amendment 612 #
Motion for a resolution Paragraph 17 17.
Amendment 613 #
Motion for a resolution Paragraph 17 17. Calls for further
Amendment 614 #
Motion for a resolution Paragraph 17 17. Calls for further invitations to tender 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; notes the potential for Member States, in particular smaller Member States, to use joint procurement to address affordability as a cause of shortages;
Amendment 615 #
Motion for a resolution Paragraph 17 17. Calls for further invitations to tender to be issued at European level in an effort to counter shortages during a time of crisis, as has been done following the onset of the COVID-19 virus, with simplified procedures in the interests of improved response times;
Amendment 616 #
Motion for a resolution Paragraph 17 17. Calls for further invitations to tender to be issued at European level in an effort to counter shortages during a time of crisis, as has been done following the onset of the COVID-19 virus, with simplified procedures in the interests of improved response times;
Amendment 617 #
Motion for a resolution Paragraph 17 17. Calls for further invitations to tender to be issued at European level in an effort to counter shortages during time of crisis, as has been done following the onset of the COVID-19
Amendment 618 #
Motion for a resolution Paragraph 17 17. Calls for further invitations to tender to be issued at European level in an effort to counter shortages, as has been done following the onset of the COVID-19 virus, simplifying procedures in the interests of better preparations and improved response times;
Amendment 619 #
Motion for a resolution Paragraph 17 a (new) 17a. Calls on the Commission to consider measures such as expedient compulsory licensing of essential medicinal products on legitimate grounds of public health needs and fundamental rights as a way to allow Member States to more easily respond to shortage of medicines, including when it results from or is caused by public health crisis; recalls that this is one of the public health flexibilities in the field of patent protection already included in the World Trade Organisation’s TRIPS Agreement, further reaffirmed by the 2001 Doha Declaration; similarly, calls on the Commission to reflect on how increasing the level of transparency of voluntary licensing agreements could improve this response strategy;
Amendment 62 #
Motion for a resolution Recital B B. whereas medicines to treat cancer, infections and disorders of the nervous system account for more than half of those in short supply and the postponement or any interruption of the treatment could lead to worse health outcomes, increasing the burden of the disease and the healthcare expenditure;
Amendment 620 #
Motion for a resolution 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 621 #
Motion for a resolution Paragraph 17 a (new) 17a. Calls for the full and rapid application of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials for medicinal products for human use; considers that this Regulation would facilitate the launch of large clinical trials carried out in a harmonised and coordinated manner at EU level;
Amendment 622 #
Motion for a resolution Paragraph 17 a (new) 17a. Calls on the Commission to encourage producers, on a voluntary basis, to introduce a labelling system - visible to and identifiable by patients / consumers - concerning the place of origin and production of medical products and active ingredients, in order to avoid the risks of falsified medicines and to meet consumers' expectations;
Amendment 623 #
Motion for a resolution Paragraph 17 a (new) 17a Calls on the Commission to speed up the implementation of the European Telematics Strategy with the aim to fully digitalize the entire regulatory system (both at EMA and national regulatory authorities level); considers that the key is to allow better coordination between authorities and industry in order to have a more robust and prompt reaction in times of crises;
Amendment 624 #
Motion for a resolution Paragraph 17 a (new) 17a. Calls on the Commission and Member States to revisit the idea of transparency of net pricing and reimbursement of different treatments, to allow Member States equal footing when negotiating with pharmaceutical companies for treatments that are not jointly procured;
Amendment 625 #
Motion for a resolution Paragraph 17 a (new) 17a. Calls on the Commission and the EMA to work with industry to ensure that medicines made available in one Member State are available in all other Member States, in particular smaller Member States;
Amendment 626 #
Motion for a resolution Paragraph 17 a (new) 17a. Notes the need to assess and to promote effective stock management of medicines shortages in cases of “parallel exports” and the potential beneficial effect of generic substitution by pharmacies proved to be deficient in some member states during the spread of the COVID-19 virus;
Amendment 627 #
Motion for a resolution Paragraph 17 a (new) 17a. Considers it essential that more focus is given to the possible illegality of supply quota systems and to whether they are used as means of pressure to introduce legislation to ban parallel exports; calls on the Commission to introduce minimum requirements for Market Authorisation Holders (MAHs) to initiate investigations to identify the true root causes of the shortages and to impose sanctions upon those manufacturers who cause shortages by failing to manufacture enough without justified reason;
Amendment 628 #
Motion for a resolution Paragraph 17 a (new) 17a. Calls on the Commission and the Council to assess the impact of intra-EU parallel trade and supply quotas on medicines unavailability and consumer access, in particular by addressing the issue of essential medicines disappearing from a Member States and then re- appearing at higher prices;
Amendment 629 #
Motion for a resolution Paragraph 17 a (new) 17a. Calls on the Commission to undertake a comprehensive study on the causes of supply shortages, taking particular account of the role of parallel trade in creating supply shortages which allows wholesalers to purchase medical products in one Member State and sell them in another;
Amendment 63 #
Motion for a resolution Recital B B. whereas medicines to treat cancer, infections and disorders of the nervous system account for more than half of those in short supply; whereas injectable specialties appear to be the most vulnerable to the risk of shortage due to the complexity of their manufacturing process;
Amendment 630 #
Motion for a resolution Paragraph 17 a (new) 17a. Calls on the Commission to do a careful assessment about the impact of parallel trade on patients’ and consumers’ access to medicines in the different Member States; calls for such a study to inform the need for better guidance to Member States on parallel trade; in this regard calls on the Commission to assess the possibility of withdrawal of the movement of medicine from the restrictions applied under Articles 34 and 35 TFEU;
Amendment 631 #
Motion for a resolution 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 632 #
Motion for a resolution Paragraph 17 a (new) 17a. Calls on the Commission to take appropriate action on parallel trade in favour to prevent and address medicine shortages;
Amendment 633 #
Motion for a resolution Paragraph 17 b (new) 17b. Notes that the differences in the price of a medicine from one Member State to another have led to the development of parallel exports, which can increase the risk of supply stress and cause of shortages; recalls that the free movement of goods within the Union allows certain wholesaler-distributors called "short-liners" to buy medicines in one Member State and to resell them more expensive in neighbouring countries; calls for the adoption of preventive measures to limit the parallel trade of medicines within the Union;
Amendment 634 #
Motion for a resolution 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 635 #
Motion for a resolution Paragraph 17 b (new) 17b. Calls on the Commission to assess whether, for the specific purpose of safeguarding public health against the risk of essential medicines shortage, reducing the time of patent protection, as well as secondary patents, or conditioning the granting of such protection in view of the amount of production that takes place with the Union could help achieve that objective;
Amendment 636 #
Motion for a resolution Paragraph 18 18. Calls on the Commission to
Amendment 637 #
Motion for a resolution Paragraph 18 18. Calls on the Commission to set up
Amendment 638 #
Motion for a resolution Paragraph 18 18. Calls on the Commission to set up a
Amendment 639 #
Motion for a resolution Paragraph 18 18. Calls on the Commission to set up an innovative centralised digital platform for sharing more standardised information provided by national agencies and all stakeholders regarding
Amendment 64 #
Motion for a resolution Recital B B. whereas medicines to treat cancer, infections and disorders of the nervous system account for more than half of those in short supply; whereas shortages are more and more frequent for widely used essential products that have been on the market for years;
Amendment 640 #
Motion for a resolution Paragraph 18 18. Calls on the Commission to set up an innovative centralised digital monitoring platform
Amendment 641 #
Motion for a resolution 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 including manufacturers, wholesalers and pharmacists, regarding shortages of medicines and medical equipment; such a platform should be efficient, easy to work with and transparent; 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
Amendment 642 #
Motion for a resolution 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 intensify market surveillance and to provide a clear overview of problems, shortages and requirements in each Member State, with a view to
Amendment 643 #
Motion for a resolution Paragraph 18 18. Calls on the Commission to set up an innovative centralised digital platform for
Amendment 644 #
Motion for a resolution Paragraph 18 18. Calls on the Commission to set up an innovative centralised digital platform for reporting, notifying and sharing information provided by national agencies and all stakeholders regarding shortages of medicines and medical equipment; stresses that this platform should be effective, easy to use, secure and transparent; 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 difficulties, shortages and requirements in each Member State, with a view to preventing stockpiling; calls on the Commission and the Member States to establish a standardised early-warning system at national and EU level, strengthening the obligations of pharmaceutical companies to immediately report any interruption in the supply of medicines;
Amendment 645 #
Motion for a resolution 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 difficulties, shortages and requirements in each Member State, with a view to preventing stockpiling; calls on the Commission and the Member States to set up an early warning system both at national and European level in order to reinforce the obligation to notify pharmaceutical companies of any interruption or tension in the supply of medicines;
Amendment 646 #
Motion for a resolution 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
Amendment 647 #
Motion for a resolution Paragraph 18 18. Calls on the Commission to set up an innovative centralised digital platform for reporting and notifying information in a harmonised way, as well as sharing information provided by national agencies and all stakeholders regarding shortages of medicines and medical equipment; points out that such a platform should be efficient, easy to work with, transparent and avoid duplications; welcomes the introduction by the EMA of the SPOC and i-SPOC systems; calls for existing information systems to be evaluated and if needed improved so as to provide a clear overview of problems, shortages and requirements in each Member State, with a view to preventing stockpiling;
Amendment 648 #
Motion for a resolution Paragraph 18 18. Calls on
Amendment 649 #
Motion for a resolution Paragraph 18 18. Calls on the Commission to set up an innovative centralised digital platform
Amendment 65 #
Motion for a resolution Recital B B. whereas medicines to treat cancer, infections, diabetes and disorders of the nervous system account for more than half of those in short supply;
Amendment 650 #
Motion for a resolution 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 demand for and shortages of medicines and medical equipment; welcomes the work of the joint EMA- HMA taskforce on the availability of medicines and 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 demand, problems, shortages and requirements in each Member State, with a view to preventing stockpiling and anticipating shortages before they occur;
Amendment 651 #
Motion for a resolution Paragraph 18 18. Calls on the Commission to set up an innovative centralised digital platform for sharing information provided by
Amendment 652 #
Motion for a resolution 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
Amendment 653 #
Motion for a resolution 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 difficulties, shortages and requirements in each Member State, with a view to preventing stockpiling and unjustified price hikes in times of crisis;
Amendment 654 #
Motion for a resolution 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 including manufacturers, wholesalers and pharmacists 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;
Amendment 655 #
Motion for a resolution Paragraph 18 18. Calls on the Commission to set up an innovative centralised digital platform, which can be consulted by the public, 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 difficulties, shortages and requirements in each Member State, with a view to preventing stockpiling;
Amendment 656 #
Motion for a resolution Paragraph 18 18. Calls on the Commission to set up an innovative centralised and publicly accessible 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;
Amendment 657 #
Motion for a resolution 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 available stocks and 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;
Amendment 658 #
Motion for a resolution Paragraph 18 18. Calls on the Commission to set up an innovative centralised digital monitoring 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
Amendment 659 #
Motion for a resolution Paragraph 18 a (new) 18a. Recommends the development of a catalogue of shortages in all the Member States which would allow the EMA to easily update its public catalogue of shortages assessed by its Committee for Medicinal Products for Human Use (CHMP) and / or its Committee for the pharmacovigilance risk assessment (PRAC);
Amendment 66 #
Motion for a resolution Recital B a (new) Ba. whereas medicine shortages can lead to possible delays in patients’ treatment, to the need to switch to alternative therapies that could be less effective, to adverse effects and adherence problems or even life threat when a shortage concerns essential medicines;
Amendment 660 #
Motion for a resolution Paragraph 18 a (new) 18a. Calls for structural cooperation in the field of pharmaceutical policy between EU Member States, respecting the competences between the national and EU-level, through transparent, and where possible joint, price negotiations for medicines, especially for orphan medicines;
Amendment 661 #
Motion for a resolution Paragraph 18 a (new) 18a. Calls on the Commission to coordinate a Pan-European response on medicines shortages to ensure equitable and sustainable access to medicines; considers that a coordinated EU response is of utmost importance to avoid spillover effects of individual and uncoordinated national measures to address medicines shortages and ensure the right of patients to universal, equitable, affordable, effective, safe and timely access to essential medicines, as well as to guarantee the sustainability of the EU public healthcare systems; stresses that this Pan-European approach must focus on coordinating Member State policy measures to address the root causes of medicines shortages;
Amendment 662 #
Motion for a resolution Paragraph 18 a (new) 18a. Calls on the Member States to develop effective governance systems to improve collaboration between all supply chain operators and the national authorities in order to increase the efficiency and effectiveness of joint notification and evaluation procedures; calls on the Member States and the European Medicines Agency (EMA) to further step up their collaboration to improve notification, monitoring and reporting procedures regarding medicine shortages;
Amendment 663 #
Motion for a resolution Paragraph 18 a (new) 18a. Calls on the Commission to launch a multi-stakeholder consultation platform to identify root causes, including but not limited to supply chain issues, that increase the risk of medicine shortages; considers that such a platform should include all stakeholders, including patients, health professionals and other relevant civil society organisations and focus particularly on assessing in detail the experience of patients and the impact of shortages on their health, treatment and care across the EU and across diseases;
Amendment 664 #
Motion for a resolution Paragraph 18 a (new) 18a. Calls on the Commission and the Member States to guarantee through the new "EU4Health" programme that equal access to treatment is available to all patients across the Union, particularly in case of severe illness, and that price of treatment does not play a role in access to quality care; urges Member States to show solidarity by increasing access to cross-border treatment;
Amendment 665 #
Motion for a resolution 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 666 #
Motion for a resolution Paragraph 18 a (new) 18a. Calls on the Commission and Member States to re-balance stocks based on patients’ and hospitals’ needs instead of stockpiling; notes that to ensure a fair allocation at EU level, it is necessary to have an equitable distribution of medicines based on shared protocols on the use of medicines to give priority to those who urgently require it;
Amendment 667 #
Motion for a resolution Paragraph 18 a (new) 18a. Calls on the Commission and the Member States to adopt a joint position regarding the potential beneficial effect of common policy for medicines shortages action and promotion of generic substitution policy combined with respective limitations in cases where the substitution is not feasible;
Amendment 668 #
Motion for a resolution 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 669 #
Motion for a resolution Paragraph 18 a (new) 18a. Considers it essential to abandon the public-private partnership model for the development of medicines and to sufficiently fund public research in medicines for the public good;
Amendment 67 #
Motion for a resolution Recital B a (new) Ba. whereas medicine shortages can lead to possible delays in patients’ treatment, to the need to switch to alternative therapies that could be less effective, to adverse effects and adherence problems or even life threat when a shortage concerns essential medicines;
Amendment 670 #
Motion for a resolution Paragraph 18 a (new) 18a. Calls on the Commission to place an obligation on all MAHs to make a formal notification of expected and potential shortages to be enshrined in EU law as well as an obligation to maintain safety stock surplus of 2-3 months for medicines of significant therapeutic interest;
Amendment 671 #
Motion for a resolution Paragraph 18 a (new) 18a. Calls on the Commission and the Council to establish and update together with the Member States, EMA and relevant stakeholders an evolving list of essential medicines which are short of supply;
Amendment 672 #
Motion for a resolution Paragraph 18 b (new) 18b. Stresses the need to establish proper pandemic preparedness plans under medical supervision for critical medicines at EU level based on solidarity between Member States, and ensuring that non-pandemic related medicines continue to reach the patients in need;
Amendment 673 #
Motion for a resolution Paragraph 18 b (new) 18b. Calls for the abandonment of the Stability and Growth Pact, which has impeded Member States from properly funding their health services, has driven the privatisation agenda, and contributed to the disastrous response of the EU to the COVID-19 pandemic;
Amendment 674 #
Motion for a resolution Paragraph 18 c (new) 18c. Considers that the European Centre for Disease Control (ECDC) should release modelling data about the likely progression of the pandemic in each Member State in order to anticipate demand to adjust the manufacturing capacity and distribution channels accordingly to supply those medicines needed to the right regions at the right time;
Amendment 675 #
Motion for a resolution Paragraph 19 19. Considers it essential to improve
Amendment 676 #
Motion for a resolution Paragraph 19 19. Considers it essential to improve early communication with
Amendment 677 #
Motion for a resolution Paragraph 19 19.
Amendment 678 #
Motion for a resolution 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 679 #
Motion for a resolution Paragraph 19 19.
Amendment 68 #
Motion for a resolution Recital B a (new) Ba. whereas medicine shortages can lead to possible delays in patients’ treatment, to the need to switch to alternative therapies that could be less effective, to adverse effects and adherence problems or even life threat when a shortage concerns essential medicines
Amendment 680 #
Motion for a resolution Paragraph 19 19. Considers it essential to improve an early 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 681 #
Motion for a resolution Paragraph 19 19. Considers it essential to improve an early 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 682 #
Motion for a resolution Paragraph 19 19. Considers it essential to improve an early 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 683 #
Motion for a resolution Paragraph 19 19. Considers it essential to improve early 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 alternative;
Amendment 684 #
Motion for a resolution 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 685 #
Motion for a resolution Paragraph 19 a (new) 19a. Observes that doctors must have access to up-to-date information to be able to adequately respond to arising and existing shortages; early awareness of a supply problem and early identification of potential therapeutic alternatives may mitigate the possibility for adverse reactions endangering patient safety;
Amendment 686 #
Motion for a resolution Paragraph 19 a (new) 19a. Calls on the Commission and Member States to ensure effective use of the Joint Procurement Agreement (JPA) for medical countermeasures; calls on expanding the scope of the JPA so it can be used beyond situations of cross-border health threat;
Amendment 687 #
Motion for a resolution Paragraph 19 a (new) 19a. Considers it essential to examine the nature of medicine shortages and recommend alternative treatments to patients and health professionals;
Amendment 688 #
Motion for a resolution Paragraph 19 a (new) 19a. Recalls that misinformation can lead to inappropriate use of medicines and the creation of unnecessary stockpiling;
Amendment 689 #
Motion for a resolution Paragraph 19 b (new) 19b. Calls for compliance with European rules on the labelling, composition and dosage of medicines, particularly on a specialty subject to supply tensions;
Amendment 69 #
Motion for a resolution 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 690 #
Motion for a resolution Paragraph 19 b (new) 19b. Underlines the importance of patient empowerment and a patient- centred approach, urges the Commission and Member States to improve patients representation and input into the decision-making process around addressing potential supply issues affecting their medicines;
Amendment 691 #
Motion for a resolution Paragraph 20 20. Calls
Amendment 692 #
Motion for a resolution Paragraph 20 20. Calls
Amendment 693 #
Motion for a resolution Paragraph 20 20. Calls
Amendment 694 #
Motion for a resolution Paragraph 20 20. Calls for an electronic product information
Amendment 695 #
Motion for a resolution Paragraph 20 20. Calls for
Amendment 696 #
Motion for a resolution Paragraph 20 20. Calls for the paper information notice to be supplemented by an electronic information notice to be drawn up in all the official Union languages for every medicine
Amendment 697 #
Motion for a resolution Paragraph 20 20. Calls for an electronic product information
Amendment 698 #
Motion for a resolution 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;
Amendment 699 #
Motion for a resolution Paragraph 20 20. Calls for an electronic information notice to be drawn up in all
Amendment 7 #
Motion for a resolution Citation 13 — having regard to the proposal for a regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU (COM(2018) 0051), and to the European Parliament legislative resolution of 14 February 2019 on said proposal;
Amendment 70 #
Motion for a resolution Recital B a (new) Ba. whereas medicine shortages may lead to delays in the treatment of patients, the need to use alternative therapies that could be less effective and, accordingly, to adverse effects and even a danger to life where a shortage concerns vital medicines;
Amendment 700 #
Motion for a resolution Paragraph 20 20. Calls for an electronic information notice to be drawn up in all the Union languages and in a barrier-free way for every medicine on the EU market, in order to facilitate and fast-track sales of medicines between Member States in order to ensure faster patients' accessibility to high-quality and safe medicines; recommends the provision of more comprehensive information on the origin of medicines;
Amendment 701 #
Motion for a resolution 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 via bar or matrix codes, in order to facilitate sales of medicines between Member States and to fight against parallel trade; recommends the provision of more comprehensive information on the origin of medicines;
Amendment 702 #
Motion for a resolution 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 703 #
Motion for a resolution Paragraph 20 20. Calls for an electronic information notice to be drawn up in all the Union languages for every medicine on the EU
Amendment 704 #
Motion for a resolution Paragraph 20 20. Calls for an electronic information notice to be drawn up in a
Amendment 705 #
Motion for a resolution Paragraph 20 a (new) 20a. Stresses the importance of ensuring the smooth functioning of the Single Market in order to eliminate barriers to the access of medicines, medical devices and protective equipment to all citizens, especially those living in Member States that, due to their small size or to their remote position, heavily rely on imports and do not have easy access to the supply chain;
Amendment 706 #
Motion for a resolution Paragraph 20 a (new) 20a. Calls on the Commission and Member States to improve channels of reporting and communication between all supply chain operators and the national authorities, developing policies and strategies for the notification of medicine shortages in line with the following principles: (a) ensuring greater transparency and availability of data regarding medicine shortages; (b) encouraging the early detection and central appraisal of possible shortages by means of reliable notification systems linking all medicine supply chain operators and the national authorities; (c) increasing access to information available along the entire supply chain.
Amendment 707 #
Motion for a resolution Paragraph 20 a (new) 20a. Considers regulatory flexibility should be given to parallel traders, not least in relation to language requirements; in that regard recommend that the packaging of medicines should be harmonised at EU level; calls on Commission and regulatory authorities to enable and promote the use of electronic package information leaflets (ePIs); highlights the need to ensure that ePIs should complement but not replace paper leaflets;
Amendment 708 #
Motion for a resolution Paragraph 20 a (new) 20a. Condemns the exploitation of shortages for criminal purposes; recalls that counterfeiting or falsification of medicines and medical products worsens supply tensions; calls for the strengthening of measures to combat these practices: the control of online platforms offering drugs, the strengthening of cooperation between relevant EU and national agencies and the respect of the victims’ rights;
Amendment 709 #
Motion for a resolution Paragraph 20 a (new) 20a. Stresses the need to use state-of- the-art track-and-trace systems and technologies for medicines, from when the active ingredients are produced, in order to improve the reliability of the entire production, packaging and distribution chain and ensure a high quality of medicines;
Amendment 71 #
Motion for a resolution Recital B a (new) Ba. whereas drug shortages may lead to possible delays in the treatment of patients, the need to switch to alternative treatments that may be less effective, and may have side effects and even put patients’ lives at risk;
Amendment 710 #
Motion for a resolution Subheading 3 a (new) Preventing and responding to shortages in the event of health crises
Amendment 711 #
Motion for a resolution Paragraph 20 b (new) Amendment 713 #
Motion for a resolution Paragraph 21 21.
Amendment 714 #
Motion for a resolution Paragraph 21 21. Welcomes, following the onset of the COVID-19 crisis, the introduction of more flexible rules in a bid to mitigate shortages and facilitate the circulation of medicines between Member States: acceptance of different packaging formats, reuse procedure to enable marketing authorisation holders to obtain approval in another Member State, longer expiry periods,
Amendment 715 #
Motion for a resolution Paragraph 21 21. Welcomes, following the onset of the COVID-19 crisis, the introduction of more flexible rules in a bid to mitigate shortages and facilitate the circulation of medicines between Member States: acceptance of different packaging formats, reuse procedure to enable marketing authorisation holders to obtain approval in another Member State, extension of validity of Good Manufacturing Practices certificates, longer expiry periods, use of veterinary medicinal products, etc.; calls on the Commission, the EMA and national regulatory authorities to monitor strictly the use of these arrangements, ensure that patient safety is not compromised and to keep them available in the event of problems or shortages; welcomes in this regard also the extension of the date of application of the Medical Devices Regulation.
Amendment 716 #
Motion for a resolution Paragraph 21 21. Welcomes, following the onset of the COVID-19 crisis, the introduction of more flexible rules in a bid to mitigate shortages and facilitate the circulation of medicines between Member States: acceptance of different packaging formats, reuse procedure to enable marketing authorisation holders to obtain approval in another Member State, longer expiry periods, use of veterinary medicinal products, etc.; calls on the Commission to monitor strictly the use of these arrangements and to keep them available in the event of problems or shortages; further calls on the Commission and the Member States to avoid as much as possible short- term requirements and to focus on finding a long-term solution to shortages;
Amendment 717 #
Motion for a resolution Paragraph 21 21. Welcomes, following the onset of the COVID-19 crisis, the introduction of
Amendment 718 #
Motion for a resolution Paragraph 21 21. Welcomes, following the onset of the COVID-19 crisis, the introduction of more flexible rules in a bid to mitigate shortages and facilitate the circulation of medicines between Member States: acceptance of different packaging formats, reuse procedure to enable marketing authorisation holders to obtain approval in another Member State, longer expiry periods, use of veterinary medicinal products
Amendment 719 #
Motion for a resolution Paragraph 21 a (new) 21a. Welcomes the Commission’s Guidelines on the optimal and rational supply of medicines to avoid shortages during the COVID-19 outbreak, and suggests building on its concepts; calls on actors in the supply chain to monitor their stocks and production capacity, share information with authorities, report shortages and monitor any potential disruptions in the supply of medicines, including early notification for predictable shortages; calls on the EMA to coordinate joint industry efforts to find effective measures and resources to reduce shortages and meet the demand for medicines;
Amendment 72 #
Motion for a resolution Recital B a (new) Ba. whereas in the Member States with small markets, the medicines to treat rare diseases are often not available or available at substantially higher costs than in larger markets;
Amendment 720 #
Motion for a resolution Paragraph 21 a (new) 21a. Calls on the Commission, EMA and national regulatory authorities, capitalizing on all pragmatic efforts made during the COVID-19 crisis, to continue to allow regulatory flexibilities for Marketing Authorisations Holders, for example covering procedures for changes in suppliers of APIs, the designation of new manufacturing sites, faster import authorisations, leading to better mitigation of medicines shortage ;
Amendment 721 #
Motion for a resolution 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 722 #
Motion for a resolution Paragraph 21 a (new) 21a. Calls on the Commission to create a European strategic reserve of medicinal products of major interest, along the lines of the ‘RescEU’ mechanism, in order to alleviate shortages outside crisis periods; believes that the EMA could be the European regulatory authority responsible of this strategic reserve in order to prevent shortages of these medicines;
Amendment 723 #
Motion for a resolution Paragraph 21 a (new) 21a. Asks the Commission to make an evaluation of the effects of free movement of goods on the shortages of medicines; calls on the Commission to consider the possibility of reviewing the free movement of certain medicines when strictly necessary to guarantee its supply; asks in this regard especially a particular approach for orphan medicinal products;
Amendment 724 #
Motion for a resolution Paragraph 21 a (new) 21a. Calls on the Commission, EMA and relevant regulatory authorities to ensure that regulatory flexibilities continue to be applied in the efforts to mitigate medicines shortage from occurring;
Amendment 725 #
Motion for a resolution Paragraph 21 a (new) 21a. Calls on the Commission, in the context of the upcoming Pharmaceutical Strategy, to propose and implement an ambitious agenda to optimise the current regulatory framework, in order to contribute to the prevention of medicines shortage by reducing the administrative burden both for the regulators and the industry, reflecting the evolution in technology, as well as fostering greater economic resilience and therefore access to and availability of affordable medicines for patients; in this context, encourages the Commission to make use and implement the digital and telematics tools at pan-European level, as well as to consider amending Regulation (EC) No 1234/2008 (Variations Regulation) and the Variations Classification Guidelines;
Amendment 726 #
Motion for a resolution Paragraph 21 b (new) 21b. Stresses that its resolution of 17 April 2020 calls for the creation of a European Health Reaction Mechanism (EHRM) to respond to all types of health crises, to ensure operational coordination at European level, to restore European sovereignty over products health and to strengthen European cooperation in research and innovation; considers that this mechanism could monitor the constitution and the triggering of the strategic reserve of medicines and ensure its proper functioning within the Union;
Amendment 727 #
Motion for a resolution Paragraph 21 b (new) 21b. Calls on the Commission and EMA to optimise the regulatory framework by implementing its telematics strategy and amending Regulation (EC) No 1234/2008 (Variations Regulation) and the Variations Classification Guidelines; this will contribute to the prevention of medicines shortage and align with the progress in technology;
Amendment 728 #
Motion for a resolution Paragraph 21 c (new) 21c. Recalls that its resolution also calls for the competences, budget and staffing of EMA to be substantially increased in order to allow it to coordinate medical responses in times of crisis; considers it essential that EMA has solid governance to meet future challenges such as monitoring and responding to shortages in coordination with the Member States; underlines that, in the long term, EMA should be able to make conditional marketing authorizations upon guarantees of supply and accessibility from manufacturers; hopes that the reinforcement of the staff of EMA will enable it to carry out inspections of production sites established in third countries;
Amendment 729 #
Motion for a resolution Paragraph 21 d (new) 21d. Recalls that a company that markets a medicine can enjoy data exclusivity for a period of eight years as of the first marketing authorization according to Article 14(11) of the Commission Regulation No. 726/2004; calls on the Commission to propose a revision of this regulation to temporarily authorize the granting of compulsory licenses in the event of a health crisis in order to allow a producer to market a generic medicine;
Amendment 73 #
Motion for a resolution Recital B a (new) Ba. whereas shortage of medicines destabilizes the organization of care and generates high human and financial costs;
Amendment 730 #
Motion for a resolution Paragraph 21 e (new) 21e. Considers that in the event of a health crisis the closure of borders and customs controls cannot constitute an obstacle to cross-border movement of medicinal products of major interest within the Union; calls on the Commission and the Member States to set up secure and rapid procedures for checking products at the border during a health crisis in compliance with EU law;
Amendment 731 #
Motion for a resolution Paragraph 22 22.
Amendment 732 #
Motion for a resolution Paragraph 22 22. Takes the view that the introduction of stress tests to assess the resilience of health systems in emergencies
Amendment 733 #
Motion for a resolution Paragraph 22 22. Takes the view that the introduction of stress tests to assess the resilience of health systems in emergencies would provide an effective means of countering shortages in the event of pandemics and
Amendment 734 #
Motion for a resolution Paragraph 22 22. Takes the view that the introduction of stress tests by the Member States to assess the resilience of respective health systems in emergencies would provide an effective means of countering shortages in the event of pandemics and of identifying structural risk factors which go to create shortages;
Amendment 735 #
Motion for a resolution Paragraph 22 a (new) 22a. Emphasises that the health systems of the Member States differ in nature depending on (i) the relationship between the public and private systems; (ii) the centralised/decentralised management and administration systems; (iii) whether there is co-payment or fully public funding; or (iv) health coverage; calls, therefore, on the Commission and the Member States to agree on the criteria based on which these stress tests should be carried out; calls on the Commission and the Council, on the basis of the results of these tests, to draw up recommendations addressed to the Member States (and, in certain cases, to their regions), in order to strengthen their health systems and to cover any essential needs that could arise in the event of a health emergency;
Amendment 736 #
Motion for a resolution Paragraph 22 a (new) 22a. Welcomes, following the onset of the COVID-19 crisis, the introduction of more flexible rules in a bid to mitigate shortages and facilitate the circulation of medicines between Member States: acceptance of different packaging formats, reuse procedure to enable marketing authorisation holders to obtain approval in another Member State, longer expiry periods, use of veterinary medicinal products, etc.; calls on the Commission to monitor strictly the use of these arrangements and to keep them available in the event of problems or shortages;
Amendment 737 #
Motion for a resolution 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;
Amendment 738 #
Motion for a resolution Paragraph 22 a (new) 22a. Calls for transparency regarding European medicine stock levels; points out that the introduction of a European medicine stocktaking system could facilitate transparency in the supply chain by updating manufacturers regarding market reserves, making it possible to improve supply management;
Amendment 739 #
Motion for a resolution 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 74 #
Motion for a resolution Recital B a (new) Ba. whereas two billion people worldwide do not have access to basic medicines;
Amendment 740 #
Motion for a resolution Paragraph 22 a (new) 22a. Recalls the words of the United Nations Secretary-General, who recently stated that future COVID-19 treatment is ‘a public good’ that should be made available to all; warns that public health protection is incompatible with the desire for profit, which can only be satisfied through the suffering of the many;
Amendment 741 #
Motion for a resolution Paragraph 22 a (new) 22a. Calls on the Commission to address shortages in the context of the evaluation of orphan and paediatrics legislation, with the objective of ensuring access and affordability while also dealing with unmet medical needs;
Amendment 742 #
Motion for a resolution 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 743 #
Motion for a resolution Paragraph 22 b (new) 22b. Calls on the Commission to put the issue of the shortages of oncology medicines at the centre of the treatment part of the forthcoming Europe's Beating Cancer Plan;
Amendment 744 #
Motion for a resolution 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 745 #
Motion for a resolution Paragraph 22 c (new) 22c. Calls on the Commission to use the EU4Health Programme to address the root causes of medicines shortages in the EU;
Amendment 746 #
Motion for a resolution 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;
Amendment 75 #
Motion for a resolution Recital B a (new) Ba. whereas the COVID-19 pandemic has highlighted the importance of a well- functioning internal market and robust supply chains for medicines and medical equipment; whereas a European dialogue on how to ensure this is needed;
Amendment 76 #
Motion for a resolution Recital B b (new) Bb. whereas access to suitable and affordable diagnostic tests and vaccines is as vital as access to safe, effective and affordable medicines;
Amendment 77 #
Motion for a resolution Recital C C. whereas
Amendment 78 #
Motion for a resolution Recital C C. whereas the loss of E
Amendment 79 #
Motion for a resolution 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
Amendment 8 #
Motion for a resolution Citation 13 a (new) - having regard to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and to the Doha Declaration on the TRIPS Agreement and Public Health,
Amendment 80 #
Motion for a resolution 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
Amendment 81 #
Motion for a resolution Recital C C. whereas
Amendment 82 #
Motion for a resolution Recital C C. whereas the loss of European sovereignty and independence in the health
Amendment 83 #
Motion for a resolution 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
Amendment 84 #
Motion for a resolution 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
Amendment 85 #
Motion for a resolution Recital C C. whereas the
Amendment 86 #
Motion for a resolution 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
Amendment 87 #
Motion for a resolution 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
Amendment 88 #
Motion for a resolution Recital C C. whereas the loss of European sovereignty and independence in the health sector is linked to the relocation of production, with 40 % the volume of medicinal end products marketed in the EU now originating in third countries; whereas
Amendment 89 #
Motion for a resolution 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
Amendment 9 #
Motion for a resolution Citation 14 a (new) - having regard to Commission communication of 27 May 2020 on "Europe's moment: Repair and Prepare for the Next Generation",
Amendment 90 #
Motion for a resolution 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
Amendment 91 #
Motion for a resolution 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
Amendment 92 #
Motion for a resolution Recital C C. whereas the loss of European
Amendment 93 #
Motion for a resolution 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 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; whereas India has itself become very dependent on China, despite its status as the largest producer of generic medicines in the world;
Amendment 94 #
Motion for a resolution Recital C a (new) Ca. whereas this European dependence in the production chain for active pharmaceutical ingredients (APIs) is not irreversible - it is above all a question of the industrial and political choices to be made in order to approach the situation of 30 years ago, when only 20% of the raw materials for medicines came from third countries, and whereas it is satisfied to note that the complex active ingredients forming part of the composition of the most innovative medicines are still overwhelmingly manufactured in the EU;
Amendment 95 #
Motion for a resolution Recital C a (new) Ca. whereas the EU continues to have a strong pharmaceutical manufacturing sector, particularly in the innovative sector, and is the world's largest exporter of pharmaceutical products, part of a global trade in pharmaceuticals; whereas the supply of generic medicines at a lower cost involving manufacturing outside the EU enables the affordability of medicines, impacting Member State healthcare budgets and patients' access;
Amendment 96 #
Motion for a resolution Recital C a (new) Ca. whereas, as the consequence of the COVID19 health crisis, the EU will be facing an economic crisis that will have impact on the shortages of medicines and the competitiveness of the EU pharmaceutical industry;
Amendment 97 #
Motion for a resolution 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 98 #
Motion for a resolution Recital C a (new) Ca. whereas, an economic crisis will likely result from the COVID-19 pandemic in Europe, and this will challenge even further the competitiveness of the European pharmaceutical industry and sustainable access to medicines for patients;
Amendment 99 #
Motion for a resolution 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;
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2020-09-12Show (4) Changes | Timetravel
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2020-09-04Show (3) Changes | Timetravel
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2020-09-03Show (2) Changes | Timetravel
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2020-08-31Show (3) Changes | Timetravel
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2020-08-18Show (3) Changes | Timetravel
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2020-08-14Show (2) Changes | Timetravel
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2020-08-04Show (3) Changes | Timetravel
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| docs/9/docs/0/url |
https://www.europarl.europa.eu/doceo/document/A-9-2020-0142_EN.html
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| events/3/docs/0/url |
https://www.europarl.europa.eu/doceo/document/A-9-2020-0142_EN.html
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2020-08-03Show (3) Changes | Timetravel
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2020-07-23Show (4) Changes | Timetravel
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2020-07-17Show (3) Changes | Timetravel
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2020-07-15Show (3) Changes | Timetravel
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| events/2 |
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| procedure/Modified legal basis |
Rules of Procedure EP 159
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2020-07-10Show (2) Changes | Timetravel
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| forecasts |
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2020-07-09Show (2) Changes | Timetravel
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2020-07-08Show (2) Changes | Timetravel
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2020-07-07Show (3) Changes | Timetravel
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2020-07-06Show (3) Changes | Timetravel
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2020-07-04Show (2) Changes | Timetravel
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2020-07-02Show (1) Changes | Timetravel
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2020-07-01Show (2) Changes | Timetravel
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2020-06-27Show (3) Changes | Timetravel
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2020-06-26Show (1) Changes | Timetravel
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2020-06-23Show (2) Changes | Timetravel
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2020-06-19Show (4) Changes | Timetravel
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2020-06-18Show (2) Changes | Timetravel
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2020-06-17Show (4) Changes | Timetravel
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2020-06-16Show (8) Changes
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