Progress: Procedure completed
Role | Committee | Rapporteur | Shadows |
---|---|---|---|
Lead | ENVI | COLIN-OESTERLÉ Nathalie ( EPP) | MORETTI Alessandra ( S&D), TRILLET-LENOIR Véronique ( Renew), RIVASI Michèle ( Verts/ALE), REGIMENTI Luisa ( ID), KOPCIŃSKA Joanna ( ECR), KONEČNÁ Kateřina ( GUE/NGL) |
Committee Opinion | DEVE | KEMPA Beata ( ECR) | Michèle RIVASI ( Verts/ALE), Marlene MORTLER ( PPE) |
Committee Opinion | EMPL | ||
Committee Opinion | TRAN | CAMPOMENOSI Marco ( ID) | Clare DALY ( GUE/NGL), José Ramón BAUZÁ DÍAZ ( RE), Sara CERDAS ( S&D) |
Committee Opinion | JURI | LEBRETON Gilles ( ID) | Emmanuel MAUREL ( GUE/NGL), Viktor USPASKICH ( RE) |
Committee Opinion | INTA | KOVATCHEV Andrey ( EPP) | Agnes JONGERIUS ( S&D), Emmanuel MAUREL ( GUE/NGL) |
Committee Opinion | ITRE | MÉLIN Joëlle ( ID) | Katalin CSEH ( RE), Sara SKYTTEDAL ( PPE), Elżbieta KRUK ( ECR), Romana JERKOVIĆ ( S&D) |
Lead committee dossier:
Legal Basis:
RoP 54
Legal Basis:
RoP 54Events
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.
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
- 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
Votes
A9-0142/2020 - Nathalie Colin-Oesterlé - § 60 #
A9-0142/2020 - Nathalie Colin-Oesterlé - § 93/1 #
A9-0142/2020 - Nathalie Colin-Oesterlé - § 93/2 #
A9-0142/2020 - Nathalie Colin-Oesterlé - Résolution #
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 #
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