115 Amendments of Pietro FIOCCHI related to 2021/2013(INI)
Amendment 3 #
Motion for a resolution
Citation 5 a (new)
Citation 5 a (new)
— having regard to the Commission’s Strategic Agenda for Medical Ionising Applications(SAMIRA) Action Plan of 5 February 2021 in support of the European Beating Cancer Plan;
Amendment 28 #
Draft opinion
Recital B
Recital B
B. whereas universal access to medicines is a fundamental right, the full realiszation of which is incompatible with a pharmaceutical model based primarily on the pursuit of profitcan be achieved through policy ecosystem that fosters medical innovation, to the benefit of patients and society as a whole;
Amendment 33 #
Motion for a resolution
Recital A
Recital A
A. whereas health is fundamental to the well-being of Europeans and equitable access to healthcare is a pillar of the EU Member States’ national health policies; whereas safe, effective and affordable medicines are needed to combat all diseases; whereas patientsublic interest and patient safety and well-being should be at the centre of all health policies, alongside investment and research;
Amendment 39 #
Draft opinion
Recital B a (new)
Recital B a (new)
B a. whereas a competitive and resilient European research-based pharmaceutical industry is more responsive to patients’ needs, and of strategic interest for public health, economic growth, jobs, trade, and scientific and technological progress;
Amendment 49 #
Motion for a resolution
Recital B
Recital B
B. whereas COVID-19 has had an impact on people’s health and on the economy; whereas it has highlighted both the EU’s strengths and weaknesses; whereas in order to strengthen the resilience and integrity of our national health systems to cross-border health threats, more European integcooperation is necessary; whereas a European Health Union, which contributes to an increasingly social Union, is key plays an important role in this process;
Amendment 73 #
Motion for a resolution
Recital C
Recital C
C. whereas the pharmaceutical strategy covers the full cycle of medicines, including research, testing, authorisation, consumption and disposal, and contributes to meeting the objectives of the European Green Deal, the digital transformation and climate neutrality;
Amendment 74 #
Draft opinion
Paragraph 1
Paragraph 1
1. Calls on the Commission to work towards a European public biomedical infrastructure covering the entire medicines value chain of medicines, and to develop the prospective European Health Emergency Response Authority (HERA) along those lines; recognises the importance of involving all stakeholders in the development and activities of HERA, building on the positive experiences of public-private partnerships throughout the COVID-19 pandemic;
Amendment 96 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
C a. whereas a molecule can be repurposed, reformulated and combined with new digital technologies (complex combination) to address unmet patient needs and contribute to healthcare system sustainability;
Amendment 104 #
Motion for a resolution
Recital C b (new)
Recital C b (new)
C b. whereas the strategy recognises the key role that generic and biosimilar medicines play in hugely increasing equitable access for patients and for the sustainability of healthcare systems and that their entry into the market after exclusivity expiry should not be delayed;
Amendment 110 #
Draft opinion
Paragraph 2
Paragraph 2
2. CallPoints onut the Commission to keep the results of Union-funded R&D in the public domain; points out that the protectionat a strong EU intellectual property regime is essential for the continued innovation of medicines and vaccines, and exist in the interest of patients must not runand society at large, including by ensuring that Europe counter to the right to healthinues to be an attractive location for R&;D investment and industrial development;
Amendment 113 #
Motion for a resolution
Recital C c (new)
Recital C c (new)
C c. whereas the Bolar exemption allows the development of generic and biosimilar medicinal products for regulatory approvals during the IP protection of the reference product in order to ensure market entry as soon as possible after the IP expiry, based on the basic rationale that free competition should be allowed as soon as protection expires;
Amendment 118 #
Motion for a resolution
Recital C d (new)
Recital C d (new)
Amendment 121 #
Motion for a resolution
Recital C e (new)
Recital C e (new)
C e. whereas biosimilar medicines create opportunities beyond access to medicines, such as benefit sharing across healthcare and thus providing better health and services to patients;
Amendment 122 #
Motion for a resolution
Recital C f (new)
Recital C f (new)
C f. whereas generic medicines are the majority of prescription medicines dispensed to European patients and have doubled the access to medicines without impacting the healthcare budgets;
Amendment 123 #
Motion for a resolution
Recital C g (new)
Recital C g (new)
C g. whereas patents have a significant impact on access to medicines and on sustainability of healthcare budgets; whereas the European Patent Office (EPO) plays a key role in the registration of European patents and it is fundamental to ensure the highest quality and efficiency of the patent granting process in the interest of patent applicants, consumers and the public;
Amendment 135 #
Draft opinion
Paragraph 3
Paragraph 3
3. Calls on the Commission to develop a new incentive model, look into decoupling mechanisms as an alternative to exclusive protections, and attach strict conditions to public funds in accordance with the principle of fair return on investmenttargeted incentives, in areas where the development of products would otherwise not be sustainable for companies, such as transferable market exclusivities to stimulate the development of new antimicrobials, based on decoupling mechanisms;
Amendment 140 #
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Emphasises the value of the existing intellectual property (IP) framework as the key driver of medical innovation; calls on the Commission to leverage the Pharmaceutical, Industrial, Digital Strategies and the renewed EU’s trade policy to promote European competitiveness, by ensuring a sound EU IP framework that protects investment in medical research and allows industry to remain an innovator and world leader in R&D and advanced manufacturing, integrating cutting edge technology and sustainable processes, and thus making the EU capable to compete with challenger regions such as the US and China;
Amendment 144 #
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Stresses the importance of optimisation and efficient use of existing therapeutic options, including off-patent generic and biosimilar medicines use wherever they are available, in all policies in support of sustainable and equitable access and care, equity and affordability;
Amendment 152 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Considers that investment in research has not been sufficient to meet the therapeutic needs of patients with rare diseases,research and scientific progress have so far not resulted in developing successful therapies for patients with rare diseases, chronic diseases including cancer and paediatric cancers, and neurodegenerative diseases, or in means to deal with the growing threat of antimicrobial resistance (AMR), concerning all AMR pathogens, or to prevent infectious diseases outbreaks; calls for the introduction of new targeted measures to effectively address these areas;
Amendment 155 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Considers that investment in researchresearch and scientific progress hasve not yet been sufficient to meet the therapeutic needs of patients withfor the underserved areas of rare diseases, paediatric cancers and neurodegenerative diseases or, to deal with antimicrobial resistance (AMR) concerning all AMR pathogens, or to prevent infectious diseases outbreaks; calls for the introduction of new targeted incentives to effectively address these areas;
Amendment 157 #
Draft opinion
Paragraph 4
Paragraph 4
4. Calls onWelcomes the Commission to develop a mandatory European licence in order’s initiatives to strengthen European capacities to be able to respond rapidact quickly to health crises;
Amendment 172 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Welcomes the intention of the European Commission to assess and review the existing incentives framework; calls on the Commission to stimulate competition by adapting a regulatory framework and stimulating investments in off-patent orphan and paediatric medicines, including for oncology, paediatric cancers, and neurological diseases;
Amendment 180 #
Motion for a resolution
Paragraph 2 b (new)
Paragraph 2 b (new)
2 b. Considers the serious and constantly increasing risks of AMR to public health, environment, food production, and economic growth; recognises the value of public health campaigns aimed at the prevention of infections using vaccines;
Amendment 184 #
Draft opinion
Paragraph 6
Paragraph 6
6. Calls on the Commission to support novel pricing models based on real production costsvalue to patients and wider society;
Amendment 184 #
Motion for a resolution
Paragraph 3
Paragraph 3
3. Considers it imperative that a common EU therapeutic guide for antimicrobials be drafted in close cooperation with all relevant authorities; recommends that this guidance document be introduced and that communication campaigns on AMR be coordinated through a single calendarmore closely at EU level;
Amendment 188 #
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
Amendment 191 #
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Highlights the importance of existing antibiotics in the fight against AMR and the need to continue to make these available for patients by developing targeted measures aimed at ensuring that economic conditions do not lead to market withdrawals;
Amendment 196 #
Draft opinion
Paragraph 6 b (new)
Paragraph 6 b (new)
6 b. Recognises that an increased pressure on vaccine pricing could discourage investment in the development of innovative technologies and production capacity in EU; stresses that vaccine prices should be reflective of the comprehensive value of vaccination to the European citizens;
Amendment 197 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission to incorporate new criteria into the system of incentives for research into and the development of newbuild on the existing incentives regime, and improve it with additional incentives, such as transferable exclusivity extensions, for medicines for unmetderserved therapeutic needs, prioritisingand prophylactic areas, where the development of projeducts promoted by the pharmaceutical industrywould otherwise not be sustainable for companies, prioritising projects combating rare diseases, paediatric cancers, neurodegenerative diseases and AMR, with the aim of finding more therapeutic and prophylactic options and meeting the needs of patients and health systems; calls on the Commission to target its framework programme funding into projects where there is insufficient basic science to develop treatments, such as neurodegenerative disease; calls on the Commission to promote the creation of an EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;
Amendment 200 #
Draft opinion
Paragraph 7
Paragraph 7
7. Calls on the Commission to promote joint procurementexplore joint procurement only in exceptional circumstances and for extraordinary public cross-border health threats, such as the COVID-19 pandemic, if purchase of products cannot be ensured as efficiently by other means, and apply the most economically advantageous tender (MEAT) criteria more stringently; highlights that joint public procurement should have a clearly defined scope and be limited in time, and should not hinder patient access, medical innovation and fair competition; highlights that joint procurement shall not risk impacting supply flows negatively by increasing the risk of shortages in the EU or third countries, and should not jeopardise product choice, or create market distortion or any concentration of demand;
Amendment 201 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission, together with the Member States, to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs, prioritising public interests and patient safety when assessing projects promoted by the pharmaceutical industry to combating rare diseases, cancer, including paediatric cancers, neurodegenerative diseases and AMR, with the aim of finding more therapeutic options and meeting the needs of patients and health systems; calls on the Commission to promote the creation of an EU framework toactively promote awareness and provide for guidance and regularly evaluatesupport with the implementation of national plans to fight these diseases;
Amendment 216 #
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Stresses the importance of continuous innovation, including in the off-patent segment, to address patients’ unmet needs; calls on the Commission to design a fit-for purpose regulatory framework that will enable the development of the so-called value added medicines as well as recognise this category of affordable innovation with appropriate incentives and its value for healthcare systems;
Amendment 219 #
Draft opinion
Paragraph 8
Paragraph 8
Amendment 228 #
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. Recognises that the pharmaceutical industry plays a crucial role in addressing underserved areas, during health crisis and beyond, and drives patient access to quality innovative medicines; recognises that the pharmaceutical industry is a strategic sector in Europe, which must be supported with adequate, strong industrial policies to ensure that Europe stays a globally leading hub for healthcare innovation; recognises the value of adequately involving the industry in the roll out of the Pharmaceutical Strategy for Europe, for it to successfully achieve its goals;
Amendment 229 #
Motion for a resolution
Paragraph 4 b (new)
Paragraph 4 b (new)
4 b. Welcomes the very positive impact that the Regulation on orphan medicinal products (EC/141/2000) and the Regulation on medicinal products for paediatric use (EC/1901/2006) have had on developing medicines; invites the Commission to maintain the philosophy of these Regulations, namely incentives and rewards, and appropriate disease thresholds to allow for investment in rare disease; recognises that more work is needed to enhance the lives of more patients and calls on the Commission to allow for measures targeting important underserved areas, such as transferable exclusivities, and streamlining and simplifying regulatory procedures;
Amendment 238 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to promote a high-level dialogue with the Member States and stakeholders to assess new criteria for national pricing, such as whether a product is ‘Made in Europe’, whether the EU invested in the product to support research, or whether prices should be adapted to, including patient and industry representatives, to assess how national pricing can incentivise R&D investment in the EU, including considerations such as high environmental manufacturing standards, capacity of supply and investment in innovation, and to promote novel pricing and payment models to foster sustainability in European health systems, strong patient outcomes, and rewards for innovation, and drive a harmonised transformation to an outcomes-focused approach considering the value of the therapeutic and prophylactic benefit of the medicine, and the primary and broader needs of the population;
Amendment 239 #
Draft opinion
Paragraph 8 b (new)
Paragraph 8 b (new)
8 b. Calls on expanding the role of EMA in the assessment of drug- device/diagnostic combination products to simplify the fragmented supervisory framework; believes that greater regulatory agility and efficiency can be achieved by adopting a more expertise- driven scientific assessment on marketing authorisations within the European Medicines Agency (EMA); believes that the final decision making should occur within maximum 7days of the final scientific opinion;
Amendment 242 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to promote the dialogue with the Member States and stakeholders to assess newinclude procurement criteria forin national pricingtenders, such as whether a product is ‘Made in Europe’, whether the EU invested in the product'Resilient and robust supply chain management,’ investments in manufacturing, investments made by the EU to support research, or whether prices should bealso adaptedation to the value of the therapeutic benefit of the medicine, and the primary and broader needs of the population;
Amendment 245 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to actively promote dialogue with the Member States and stakeholders to assessprovide for more guidance with existing and potentially new criteria for national pricinges, such as whether a product is ‘Made in Europe’ represents a more effective and affordable treatment alternative, whether the EU has invested in the product to support research, or whether prices should be adapted to the costs as well as to the value of the therapeutic benefit of the medicine, and the primary and broader needs of the population;
Amendment 249 #
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Calls on the Commission to build on the work of the Europe’s Beating Cancer Plan and ensure that Europe becomes the worldwide centre of excellence for R&D in emerging, innovative fields of medicine; underlines that State-of-the art technologies and treatment classes, such as nanomedicines, stand to provide solutions to current treatment challenges in areas such as cancer and cardiovascular diseases; Highlights that these innovative fields of medicine should be supported by fit-for- purpose regulatory frameworks, such as a centralised approval procedure for nanomedicines;
Amendment 250 #
Draft opinion
Paragraph 8 c (new)
Paragraph 8 c (new)
8 c. Encourages European federated data networks that contribute to optimal research, development and healthcare delivery; highlights the need for a clearer definition of Secondary data use vs. Primary data collection;
Amendment 257 #
Draft opinion
Paragraph 8 d (new)
Paragraph 8 d (new)
8 d. Supports the adaptation of existing frameworks for the acceptability in decision making and adoption of artificial intelligence (AI) technologies to provide a pathway through which AI can be developed, adopted and implemented in healthcare systems through inclusivity, capacity and trust;
Amendment 257 #
Motion for a resolution
Paragraph 5 b (new)
Paragraph 5 b (new)
5 b. Calls on the Commission and Member States to develop new pricing models for generic medicines aimed at ensuring healthy competition from day one whilst encouraging the continued marketing of mature products still therapeutically valuable;
Amendment 259 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Calls on the Commission to review the incentive system, increase price transparency, highlight the causes limiting affordability and patient access to medicinal products, and propose sustainable solutions that also promote competitionwork with Member States and medicine marketing authorization holders to identify and address the root-causes of unavailability of medicines, and find adequate solutions to address the outstanding barriers to timely and effective patient access; calls on the Commission to enhance affordability, based on the fundamental pricing principle of solidarity across Member States, adequately rewarding the value of medicines across EU Member States and supporting the research-based industry as EU strategic, competitive and globally leading sector;
Amendment 272 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Calls on the Commission to work with Member States to review the incentive system, increase price transparency when it comes to the costs calculated in the prices, highlight the causes for limiting affordability and patient access to medicinal products, and propose sustainable solutions that also promote competition;
Amendment 275 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Stresses the importance of generic, biosimilar and value added medicines for consistently increasing equitable access for patients and making the healthcare systems sustainable in a European Union where access is still uneven; calls urgently on the Commission to ensure healthy competition at the expiry of intellectual property exclusivities by removing all barriers to access competition, such as patent linkage and banning IP evergreening practices that unduly delay access to medicines and allowing single global development;
Amendment 286 #
Motion for a resolution
Paragraph 6 b (new)
Paragraph 6 b (new)
6 b. Recommends that political accountability of the European Patent Office (EPO) to the European Parliament be established in the interest of patent applicants, consumers and the public; calls on the Commission to address any abuses of EPO patent granting processes considered anticompetitive in its Pharmaceutical Sector Inquiry Report of 2009;
Amendment 291 #
Motion for a resolution
Paragraph 7
Paragraph 7
7. Stresses that generic and biosimilar medicines are accessible and affordable treatmentscompetition after loss of patent and exclusivity leads to price decreases, greater affordability and contributes greatly to the budgetary sustainability of healthcare systems; calls on the Commission to introduce measures to support a greater market presence of these medicines and to harmonise at EU level the interpretation of the so-called Bolar provision concerning possible exemptions from the legal framework for the Unitary Patent system for generic drug manufacturerharmonise at EU level the interpretation of the so-called Bolar provision with the broader scope of the Bolar exemption in force in the patent laws of most member states; further calls on the Commission to design rules for the industry that promote research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines, in respect of individual patient needs and clinicians’ freedom to prescribe the best treatment choice for each patient;
Amendment 292 #
Motion for a resolution
Paragraph 7
Paragraph 7
7. Stresses that generic and biosimilar medicines are accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systembroadly increasing patient access to treatments as well as to the budgetary sustainability of healthcare systems by generating cost savings while maintaining equal quality of care, as well as freeing up resources for the development of new treatments; calls on the Commission to introduce the necessary and appropriate measures to support a greater market presence of these medicines and to harmonise and enlarge at EU level the interpretation of the so-called Bolar provision concerning possible exemptions from the legal framework for the Unitary Patent system for generic drug manufacturers; further calls on the Commission to design rules for the industry that promote research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the intercommon European guidelines for the implementation of physician-led switchaingeability of biosimilar medicine of biologic medicine, including biosimilar medicines as defined by EMA; underlines that for the purposes of these guidelines, “physician” must signify exclusively medical doctors authorised to prescribe medical products;
Amendment 294 #
Motion for a resolution
Paragraph 7
Paragraph 7
7. Stresses that generic and biosimilar medicines areoffer accessible and affordable treatments and contribute greatly to the budgetary sustainability of healthcare systems; calls on the Commission to introducprovide measures to support a greater market presence of these medicines and, to harmonise at EUnd enlarge at European level the interpretation of the so-called "Bolar provision," concerning possible exemptions from the legal framework for the Unitary Patent systemon patent regulatory framework for generic drug manufacturers; further calls on the Commission to design rules for the industry that promote research, development and the production of generic and biosimilar medicines in the EUEurope and to propomote harmonised EU protocols for the interuropean Member State guidelines for the implementation of physician-led switchaingeability of biosimilar medicines of biological medicines, including biosimilar medicines as defined by the European Medicines Agency;
Amendment 306 #
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Welcomes the Commission’s recognition of the importance of full clarification of the provision for the conduct of trials on patented products to support generic and biosimilar medicines marketing authorisation applications (so called Bolar provision); calls for urgent European harmonisation and enlargement of the Bolar exemption, including all the processes needed to launch off-patent medicine at the expiry of patents including administrative actions to enable generic and biosimilar medicines to be on the market on day-1. Urges a clear ban on all forms of patent linkage in the EU legislation, which are anti-competitive and delay generic and biosimilar market entry, frustrating the objectives of the Bolar exemption;
Amendment 309 #
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Stresses that cost savings generated from the use of generics and biosimilars should be reinvested in a transparent and tangible way; calls on the European Commission to facilitate arrangements such as gainsharing programmes that allow savings from generic and biosimilar competition to stream back to hospitals and be used to improve patient care in a given healthcare setting; calls on the European Commission to launch and actively promote the awareness of a ‘Best Practice Network’ where Member States as well as hospitals can share best practices on reinvestment of the freed-up budget;
Amendment 316 #
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7 b. Highlights that the take-up of new and innovative treatments, as well as their successful delivery to patients, depends on the knowledge, preparedness of and technical base at the disposal of medical personnel; calls on the Commission and on Member States to further cooperate through sharing knowledge and best practices regarding emerging innovative medicines and treatments, to better prepare their medical professionals;
Amendment 317 #
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7 b. Calls on the Commission to leverage the Pharmaceutical, Industrial, Digital Strategies and the renewed EU trade policy to promote European competitiveness by ensuring sound intellectual property frameworks that protect investment in medical research and allow industry to remain an innovator and world leader, making the EU capable to compete with challenger regions such as the US and China;
Amendment 320 #
Motion for a resolution
Paragraph 8
Paragraph 8
Amendment 341 #
Motion for a resolution
Paragraph 9
Paragraph 9
9. Highlights the benefits of public- private partnership tenders for national health systems in order to funding research into and theand production of innovative medicines and medicine repurposing;
Amendment 347 #
Motion for a resolution
Paragraph 10
Paragraph 10
10. Stresses the importance of new joint EU public procurement contracts by the Commission and the Member States, especially for emergency medicines and unmet therapeutic needs; stresses that EU joint procurement should be used only in exceptional circumstances and for extraordinary public cross-border health threats, such as the COVID-19 pandemic, if purchase of products cannot be ensured as efficiently by other means, to ensure patient access to emergency medicines; highlights that joint public procurement should have a clearly defined scope and be limited in time, and should not hinder patient access, medical innovation and fair competition; highlights that joint procurement shall not risk impacting supply flows negatively by increasing the risk of shortages in the EU or third countries, and should not jeopardise product choice, or create market distortion or any concentration of demand;
Amendment 349 #
Motion for a resolution
Paragraph 10
Paragraph 10
10. Stresses the importance of new joint EU public procurement contracts by the Commission and the Member States, especially for emergency medicines and unmet therapeutic needsmedicines during health crises, as well as unmet therapeutic needs, while taking into account the need for a better balance between public and private interests, including clear rules on liability for manufacturers, as well as the need for sufficient flexibility for Member States, as well as respect for the principle of subsidiarity, due to national specificities or divergent financial capacities across the EU;
Amendment 361 #
10 a. Calls on the Commission to make an assessment of the ICU joint procurement initiative and take the lesson learned to improve this tool by limiting it to serious cross-border threats to health; considers that it should not impact pre- existing contractual agreements with suppliers of medical countermeasures and should be carried out in accordance with the Directive 2014/24/EU in a transparent manner, while respecting the following conditions: the procurement process, criteria, timelines, specifications, and formalities must be transparent and workable; a preliminary consultation phase involving potential participating manufacturers must take place; clear volume commitments irrespective of the selected supply modality must be ensured;
Amendment 373 #
Motion for a resolution
Paragraph 10 b (new)
Paragraph 10 b (new)
10 b. Recognises the low healthcare budget allocations to immunisation programmes, including immunisation implementation and monitoring, across Member States, compared to the far- reaching health and economic benefits that vaccinations provide;
Amendment 386 #
Motion for a resolution
Paragraph 11
Paragraph 11
11. Is concerned that the affordability of medicines remains a challenge for national health systems, and that innovative medicines are expensive; welcomes the Commission’'s intention to review pharmaceutical legislation to promote robust and timely competition ands a key enabler for resilience and efficiency, as well as to stabilisze and balance the national drugs pricing systems;
Amendment 387 #
Motion for a resolution
Paragraph 11
Paragraph 11
11. Is concerned that the affordability of medicines remains a challenge for national health systems, and that innovative medicines are expensive; welcomes the Commission’s intention to review pharmaceutical legislation to promote robust competition and toin order to support Member States in stabiliseing and balanceing national drug pricing systems;
Amendment 394 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11 a. Calls on the Commission to support and promote wide implementation of novel pricing and payment models to improve patient access to innovative medicines, by facilitating best-practice sharing between Member States, ensuring an appropriate data infrastructure, and addressing legal barriers;
Amendment 403 #
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
11 b. Calls on the Commission to create a High-Level Forum on Better Access to Health Innovation to identify multi- stakeholder solutions to introducing new health technologies that can broaden access, reduce delays and mitigate the impact of shortages;
Amendment 416 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Insists that a competitive EU pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable, flexible and agile regulatory environment, which at the same time sustains a robust and responsible framework of requirements, safeguarding the principle of prevention and the availably of safe, effective and quality medicines on the EU market; believes that it can thrive globally with a clear, robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space;
Amendment 421 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Insists that a competitive EU research-based pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable, flexible and agile regulatory environment; believes that it canthe European research-based pharmaceutical industry can only thrive globally with a clear, robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space;
Amendment 428 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Recalls that priority should be given to the continuous optimisation of regulatory processes while maintaining high scientific standards, in order to keep up with scientific and technological progress, ensure fit-for-purpose requirements, enable simplified administrative tasks associated with maintaining medicinal products on the market by amending the existing Variations Regulation, ensure continuous access to information for patients and healthcare professionals, and simplified flow of medicines from one Member State to another in case of a shortage. Encourages the Commission to make the best use of information technology for regulatory processes, including digital and telematics tools, in order to improve regulatory efficiency;
Amendment 439 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Recalls the importance of close collaboration between the Commission and Member States to reduce fragmentation in the application of the General Data Protection Regulation, which substantially increases the complexity and burden of conducting clinical research in Europe;
Amendment 452 #
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12 b. Supports the adaptation of existing frameworks for the acceptability in decision making and adoption of AI technologies to provide a pathway through which AI can be developed, adopted and implemented in healthcare systems through inclusivity, capacity and trust, while adhering to the high EU standards for personal data protection; reiterates that with all AI-based technologies, human oversight must at all times be guaranteed;
Amendment 453 #
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12 b. 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 462 #
Motion for a resolution
Paragraph 12 c (new)
Paragraph 12 c (new)
12 c. Calls on expanding the role of EMA in the assessment of drug- device/diagnostic combination products to simplify the fragmented supervisory framework; believes that greater regulatory agility and efficiency can be achieved by adopting amore expertise- driven scientific assessment on marketing authorisations with in the European Medicines Agency (EMA); believes that the final decision making should occur within maximum 7 days of the final scientific opinion;
Amendment 473 #
Motion for a resolution
Paragraph 12 d (new)
Paragraph 12 d (new)
12 d. Calls on the Commission to legitimise EMA’s PRIME scheme and include a PRIME designation in the legislative framework;
Amendment 477 #
Motion for a resolution
Paragraph 12 e (new)
Paragraph 12 e (new)
12 e. Calls on the Commission to ensure that the regulatory system is adequately resourced to share advice given across the system, and to rapidly embrace new technologies via regulatory alignment;
Amendment 480 #
Motion for a resolution
Paragraph 12 f (new)
Paragraph 12 f (new)
Amendment 483 #
Motion for a resolution
Paragraph 12 g (new)
Paragraph 12 g (new)
12 g. Urges the Commission to work with Member States to reduce fragmentation in the application of the General Data Protection Regulation, which substantially increases the complexity and burden of conducting clinical research in Europe;
Amendment 484 #
Motion for a resolution
Paragraph 12 h (new)
Paragraph 12 h (new)
12 h. Notes that decisions taken regarding the EU's pharmaceutical regulatory environment will have implications beyond Europe's borders, given that several third countries recognise and rely on EU requirements, particularly when it comes to the facilitation of exports and the waiving of requirements to test these in third countries when they come from the EU; therefore emphasises the importance of maintaining such mutual recognition agreements with third countries and ensuring that these remain up to date;
Amendment 487 #
Motion for a resolution
Paragraph 12 i (new)
Paragraph 12 i (new)
12 i. Encourages European federated data networks that contribute to optimal research, development and healthcare delivery; highlights the need for a clearer definition of Secondary data use vs. Primary data collection;
Amendment 489 #
Motion for a resolution
Paragraph 12 j (new)
Paragraph 12 j (new)
12 j. Supports the adaptation of existing frameworks for the acceptability in decision making and adoption of AI technologies to provide a pathway through which AI can be developed, adopted and implemented in healthcare systems through inclusivity, capacity and trust;
Amendment 492 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls on the Commission to revise the useaddress the fragmented implementation of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the EU(SPCs) across Member States by introducing a unified SPC grant mechanism and/or create a unitary SPC title;
Amendment 499 #
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13 a. Urges the Commission to take full account of, and assess the effective implementation of, the SPC manufacturing waiver in light of the several conditions and limitations posed to it;
Amendment 501 #
Motion for a resolution
Paragraph 13 b (new)
Paragraph 13 b (new)
13 b. Stresses the importance of timely and healthy competition to deliver equitable access to medicines; calls on the Commission to carefully evaluate the actual impact that any proposal for a unitary or unified SPC would have on generic and biosimilar medicines, and on equitable patients’ access to treatments;
Amendment 504 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Stresses the importance of creating quality jobs in the EU along the entire pharmaceutical value chain, with the support of the NextGenerationEU instrument; calls on the Commission to propose measures to promote employment in the pharmaceutical sector, facilitating talent retention and mobility at EU level in all EU Member States, facilitating geographical balance, talent retention and employment opportunities across the whole EU;
Amendment 511 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Highlights the fact that gene and cell therapies, personalised medicine, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ initiative can bring enormous benefits in relation to the prevention, diagnosis, treatment and post-treatment of all diseases; urges the Commission to develop appropriate regulatory frameworks, to guide new business modelsstresses the transformative potential of these novel therapies and technologies for patients as well as societies at large, for example by enabling a shift from expensive chronic management and care to one-time treatment, thereby reducing costs for health systems, and strengthening their efficacy, sustainability and resilience; urges the Commission to ensure sufficient regulatory expertise to support intensive dialogue with developers, and to develop appropriate regulatory frameworks, including for new vaccines and therapeutics for use in emergencies and those addressing other unmet medical needs, to guide new business models without compromising/lower standards for safe and efficacious products of consistently high-quality, and to run information campaigns to raise awareness and encourage the use of these innovations;
Amendment 512 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Highlights the fact that gene and cell therapies, personalised medicine, radionuclide therapy, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ initiative can bring enormoussignificant benefits in relation to the prevention, diagnosis, treatment and post- treatment of all diseases; urges the Commission to develop appropriate regulatory frameworks, to guide new business modelstresses the transformative potential of these novel therapies and technologies for patients as well as societies at large, for example by enabling a shift from expensive chronic management and care to one-time treatment, thereby reducing costs for health systems, and strengthening their efficacy, sustainability and resilience; urges the Commission, in close cooperation with Member States, to develop appropriate regulatory frameworks, to guide new business models without compromising the high level of safety, quality and effectiveness of medicines, and to run information campaigns to raise awareness and encourage the use of these innovations;
Amendment 522 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Highlights the fact that gene and cell therapies, personalised medicine, nanotechnology, next- generation vaccines, e-health, medicines repurposing and the ‘'Million plus genomes’' initiative can bring enormous benefits in relation to the prevention, diagnosis, treatment and post-treatment of all diseases; urges the Commission to develop appropriate regulatory frameworks, to guide new business models, and to runpromote information campaigns to raise awareness and encourage the useapplication of these innovations;
Amendment 526 #
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15 a. Urges the European Commission and EMA to consider the full life-cycle of all innovative medicines and therapies including gene and cell therapies, personalised medicine, nanotechnology, next generation vaccines, and ensure a fit-for-purpose framework for off-patent competition at the time of loss of exclusivity;
Amendment 533 #
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls on the Commission to fully implement the Clinical Trials Regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products, scientific advances and technological transformation; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off- patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety, supported by an EU- wide clinical trials network; _________________ 9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1.calls on the Commission to establish mechanisms for continuous dialogue between the ECDC, EMA and vaccines developers on the establishment and functioning of the vaccine platform to monitor vaccine efficacy and safety;
Amendment 534 #
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls on the Commission to fully implement the Clinical Trials Regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products, scientific advances and technological transformation and re- examine the need for exemptions in light of these advances, while safeguarding the interest of public health and of patients for safe, effective and quality medicines on the EU market; supports a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off- patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety, supported by an EU- wide clinical trials network; _________________ 9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1.
Amendment 546 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Urges the Commission, based on the experience with the authorisation of COVID-19 vaccines, to work with the EMA to consider extending the application of rolling reviews to other emergency medicines; further calls on the Commission to work with the EMAFurther calls on the Commission to work with EMA and the EU regulatory network to develop the use of electronic product information for all medicines in the EU;
Amendment 553 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Urges the Commission, based on the experience with the authorisation of COVID-19 vaccines, to work with the EMA to consider extending the application of rolling reviews to other emergency medicineand further regulatory flexibilities to other emergency medicines and innovative medicinal products for underserved areas; further calls on the Commission to work with the EMA to develop the use of electronic product information for all medicines in the EU and allow electronic patients information instead of paper insert;
Amendment 555 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Urges the Commission, based on the experience with the authorisation of COVID-19 vaccines, to work in close cooperation with the EMA to consider extending the application of rolling reviews to other emergency medicines, while safeguarding high level of safety, quality and effectiveness; further calls on the Commission to work with the EMA to developfurther accelerate the use of electronic product information for all medicines in the EU;
Amendment 560 #
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17 a. Welcomes the Commission’s acknowledgement of the difficulties faced by SMEs during the regulatory approval, licensing and product launch processes; highlights that the heavy administrative burden may hinder SMEs’ ability to develop and bring to patients innovative medical products, including for unmet medical needs and rare diseases; reiterates that the administrative burden often forces SMEs into buyouts by larger pharmaceutical companies or into leaving the EU altogether; calls on the Commission and Member States to take SMEs under special consideration when ensuring a level playing field in the process for simplifying and streamlining procedures, due to the fact that, unlike large pharmaceutical companies, SMEs cannot easily absorb administrative costs; calls on the Commission to bring up to date the capabilities of EMA for providing information and assistance to SMEs during the authorisation process; calls on the Member States to establish One-Stop- Shop contact points for SMEs, providing all necessary information, as well as expert help and assistance, to facilitate compliance with national standards and procedures;
Amendment 561 #
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17 a. Welcomes the fact that the strategy recognises that the better use of electronic product information (ePI) will support the better delivery of information to patients and support a wider availability of medicines, especially in critical situations; calls on the Commission to urgently implement the ePI with a targeted dialogue - between regulators, the industry and all relevant stakeholders – to design a EU Roadmap that will define timelines and harmonised EU standards as well as educational campaigns for patients and healthcare stakeholders;
Amendment 566 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to assess how the conditional marketing authorisation approach has been used by regulators and industry to speed up the availability of innovative medicines to patients, with a view to making better use of conditional marketing authorisation in the future; reassess the system which leads from conditional marketing authorisation to standard marketing authorisation or to the exceptional renewal of the authorisation; calls on the EMA to thoroughly carry out the final evaluation and ensure the strict compliance by producers with all of the requirements for each medicine under conditional marketing authorisation in order to ensure the efficacy and safety of such medicine; asks for the time before the final evaluation to be reduced from five to three years;
Amendment 567 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to reassess the system which leads from conditional marketing authorisation to standard marketing authorisation or to the exceptional renewal of the authorisation, based on robust clinical data; calls on the EMA to thoroughly carry out the final evaluation and ensure the strict compliance by producers with all of the requirements for each medicine under conditional marketing authorisation in order to ensure the efficacy and safety of such medicine; asks for the time before the final evaluation to be reduced from five to three years, where sufficient data are available;
Amendment 570 #
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18 a. Welcomes the Commission’s SAMIRA Action Plan and calls on the Commission to evaluate whether the current pharmaceutical legislation remains appropriately aligned with scientific progress in the development of therapeutic applications of nuclear medicine, recognising that the current legislative framework is largely tailored to diagnostic applications of radiopharmaceuticals;
Amendment 574 #
Motion for a resolution
Paragraph 18 b (new)
Paragraph 18 b (new)
18 b. Calls on the Commission to reinforce the role and capacities of EMA with regards to novel medicines; recalls that new treatment modalities, such as radionuclide therapies and nanotechnologies, may require the development of specific clinical development guidelines to support manufacturers with the development of new medicines in innovative fields; reiterates that ensuring sufficient experience and capacity in relation to new treatment modalities is fundamental for the EMA to efficiently guide companies and assess new medicines;
Amendment 578 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; calls on the Commission to develop an earlyrecognises the multiple drivers of shortages and therefore the importance of ensuring the involvement of manufacturers and other supply chain stakeholders to prevent and manage medicines’ shortages; calls on the Commission to build on existing systems such as the European Medicines Verification System (EMVS), to develop a warning system for drug shortages, based on a European information network on supply problems, to increase public-private collaboration and to monitor the obligation on the part of industry and all supply chain stakeholders to provide early and transparent information on the availability of medicinesdemand of medicines, parallel trade activities, export bans and unexpected manufacturing or quality problems, while ensuring that reporting burdens do not increase, become ineffective or unjustified; stresses that confidentiality should be safeguarded; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies; calls for systematic regulatory measures of flexibility to mitigate shortages when they occur;
Amendment 585 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Recalls that the EU’'s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; calls on the Commission to develop an early warning system for drug shortages, based on a European information network on supply problems, to increasethe improved collection of digital information linked to telematics and digital shortages reporting, and greater public-private collaboration and, to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;
Amendment 621 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Supports the Commission in its efforts to conduct a structured dialogue with playerelevant actors in the pharmaceutical value chain, public authorities, non- governmental patient and health organisations and the research community to address weaknesses in the global medicines manufacturing and supply chain;
Amendment 622 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20 a. Call on the Commission, in the context of the medicines manufacturing structured dialogue, to propose reforms and incentives to stimulate investments in medicines manufacturing and resilience of the pharmaceutical supply chain by introducing market reforms that make markets sustainable via smart procurement to reduce industrial consolidation pressure and create a level playing field, including digital transformation of the regulatory system that would maintain high EU scientific standards while dramatically reducing administrative burdens and vastly improving the EU crisis response to shortages as well as to stimulate investments in manufacturing technology (greening, digital, process technology, automation) that are needed to enable EU manufacturers to upgrade their technology to compete and to meet societal expectations for security, value added innovation and the environment;
Amendment 634 #
Motion for a resolution
Paragraph 20 b (new)
Paragraph 20 b (new)
20 b. Recalls the role of sustainable procurement practices in preventing medicines shortages and that, as recognised in the EU industrial strategy, public procurement can lead to market consolidation and increases the risk of shortages; calls on the Commission to support Member States in the prevention of shortages by developing EU rules on procurement of medicines, under the current public procurement directive, aimed at ensuring long-term sustainability, competition, security of supply and stimulating investments in manufacturing; considers that these targeted guidelines should cover clarifications and recommendations to Member States on how to implement multi-winner framework agreements, apply Most Economically Advantageous Tender (MEAT) criteria, recognise investments in security of supply for Europe, ensure timely procurement processes to ensure the plurality of manufacturers and competition of multi- source medicines as soon as they are available;
Amendment 642 #
Motion for a resolution
Paragraph 21
Paragraph 21
21. Calls on the Commission to facilitate agreements between the EMA and non-EU regulatory agencies on preventing emergencies and coordinating responses to them, while adhering to the high EU standards for personal data protection; encourages the Commission to work with World Trade Organization members to facilitate trade in health products, increase resilience in global supply chains through stable access to raw materials, and to ensure the creation of minimum necessary stocks for both raw materials and medical equipment, and contribute to an effective response in the event of a health emergency;
Amendment 649 #
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21 a. Insists that the quality of raw material imports for the pharmaceutical industry from outside the EU must be ensured at all times; calls on the Commission and on Member States to improve quality control and introduce penalties for repeat offenders;
Amendment 654 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Stresses the need for the pharmaceutical industry to bean environmentally -friendly and climate- neutral pharmaceutical industry throughout the life cycles of the medicinal products; calls on the Commission to strengthen inspection and auditing throughout the and to ensure that no action taken jeopardises access to safe and effective pharmaceutical treatments for human patients; calls on the Commission to develop, with industry, global manufacturing frameworks for environmental produtection chain medicines manufacturing; urges the Commission to ensure a quality and environmental sustainability standardsle framework for active pharmaceutical ingredients imported from non-EUthird countries; calls on the Commission to address the problem of domestic pharmaceutical waste, with measures to reducincentives to optimise packaging, and the size of contalso to facilitate mediciners to ensure they are no larger than necessary, and to bring medical prescriptions into line with real therapeutic needsmovement to mitigate shortages if they occur; calls on the Commission to take into account existing and self- regulated initiatives as models in future EU initiatives on pharmaceuticals in the environment, as well as to be based on scientific evidence;
Amendment 661 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Stresses the need for the pharmaceutical industry to be environmentally friendly and climate- neutral throughout the life cycles of medicinal products; calls on the Commission to strengthen inspection and auditing throughout the production chain, particularly outside the EU; urges the Commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-EU countries; calls on the Commission to address the problem of domestic pharmaceutical waste, with measures to reduce packaging and the size of containers to ensure they are no larger than necessary, and to bring medical prescriptions into line with real therapeutic needs; notes that the creation of e-leaflets would be an effective way to reduce packaging; acknowledges steps taken already by the pharmaceutical industry to adopt and strengthen green practices, including for example the Eco-Pharmaco- Stewardship initiative;
Amendment 664 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Stresses the need for the pharmaceutical industry to be environmentally friendly and climate- neutral throughout the life cycles of medicinal products; calls on the Commission to strengthen inspection and auditing throughout the production chain, including outside the EU; urges the Commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-EU countries; calls on the Commission to address the problem of domestic pharmaceutical waste, with measures specifically aimed ato reduceing packaging and the size of containers to ensure they are not larger than necessaryor more intricately layered than necessary, thus helping to reduce price and waste, and to bring medical prescriptions into line with real therapeutic needs;
Amendment 668 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22 a. Welcomes the fact that the strategy recognises that better use of the electronic product information (ePI) will support the better delivery of the information for patients and support a wider availability of medicines; calls on the Commission to release an EU Implementation Roadmap for ePI with a defined timeline and suggested measures at EU and Member State level; urges the Commission to review the requirement of the pharmaceutical legislation(Article 58 of Directive 2001/83/EC1) to include a package leaflet (PL) in the packaging of all medicines or directly convey all information required (by Articles 59 and 62 of the Directive) on the outer or immediate packaging with a goal to completely replace PL with ePI;
Amendment 683 #
Motion for a resolution
Paragraph 22 b (new)
Paragraph 22 b (new)
22 b. Highlights the fact that currently 40% of medicines marketed in the EU originate in non-EU countries, while 60 - 80% of active pharmaceutical ingredients are produced in China and India; stresses the urgent need to bring the pharmaceutical industry back to Europe and to stimulate new job growth inside the EU by establishing a minimal required percentage of the value chain to remain within the EU;
Amendment 700 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to seek a better enabling environment for innovation through stronger protection of intellectual property in the EU and in foreign markets; encourages the Commission to further facilitate access to global markets for the EU pharmaceutical industry, including small and medium- sized enterprises, through a level playing field and a regulatory framework promoting the highest standards on quality and safety at international level, facilitating trade agreements that prizvalue innovation-based competitiveness, in order to make the pharmaceutical sector a strategic pillar of the EU; highlights the importance of removing trade barriers and red tape in third countries, and ensuring fair access to international markets for companies operating in the EU;
Amendment 701 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to further facilitate access to global markets for the EUuropean pharmaceutical industry, including small and medium-sized enterprises, througSMEs, with a level playing field and a regulatory framework, facilitating trade agreements that prize innovation-basedmanufacturing and technological know-how competitiveness, in order to make the pharmaceutical sector a strategic pillar of the EU;
Amendment 707 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to further facilitate access to global markets for the EU pharmaceutical industry, including small and medium-sized enterprises, through a level playing field and a robust and clear regulatory framework facilitating trade agreements that prize innovation- based competitiveness, in order to make the pharmaceutical sector a strategic pillar of the EU;
Amendment 709 #
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23 a. Emphasises that the implementation of an open, free, fair, transparent and enforceable rules-based multilateral trading system is fundamental to ensure global availability of medical products and limiting vulnerabilities in the future; calls on the Commission to develop a medicines trade agenda that ensures that EU Free Trade Agreements should not focus exclusively on enforcing Intellectual Property standards in third countries, but they should take into account the impact on generic and biosimilar medicines in the EU and in third countries, as well as include coordination on regulatory standards; calls on the Commission to implement the single development programmes with third parties on generic medicines, complex generic medicines and biosimilar medicines to avoid unnecessary and unethical studies;
Amendment 719 #
Motion for a resolution
Paragraph 24
Paragraph 24
24. Reiterates its commitment to continue working with the Commission and the World Health Organization and the International Council for Harmonisation to standardise effective, safe and sustainable regulatory frameworks for medicinal products;
Amendment 720 #
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24 a. Highlights that according to the WHO, an increasing number of counterfeit drugs are also being sold in developing countries in connection with COVID-19, and continue to be distributed in Europe as well; calls on the Commission and on Member States to improve control of medical products and equipment entering the EU; calls further for the introduction of more stringent penalties for producers and distributors of counterfeit medicines;