95 Amendments of Margarita DE LA PISA CARRIÓN 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 4 #
Motion for a resolution
Citation 5 a (new)
Citation 5 a (new)
— having regard to the Commission communication of 10 March 2020 entitled ‘A New Industrial Strategy for Europe’ COM (2020) 102 final
Amendment 5 #
Draft opinion
Recital A
Recital A
A. whereas the pandemic has revealed a number of problems that already existed in the EU, such as shortages of essential medicines and the limitations of the current set-up for managing value chains and accessibility to medicines and vaccines;
Amendment 10 #
Draft opinion
Recital A a (new)
Recital A a (new)
A a. whereas over the last decades numerous peoples lives have been saved thanks to research; whereas this research can only be conducted in a innovation- friendly ecosystem, which has investor certainty and IP-right protection at the core;
Amendment 14 #
Draft opinion
Recital A a (new)
Recital A a (new)
Aa. whereas intellectual property rights contribute to the accessibility, innovation and competitiveness of the sector;
Amendment 17 #
Draft opinion
Recital A b (new)
Recital A b (new)
A b. whereas IP-rights are property rights; whereas property rights are fundamental rights and protected by Article 1 of protocol no 1. to the European Convention on Human Rights and article 17 of the EU Charter on fundamental rights;
Amendment 20 #
Draft opinion
Recital A c (new)
Recital A c (new)
A c. whereas research on pharmaceuticals is often co-financed with public money; whereas public money shall serve the public interest;
Amendment 25 #
Draft opinion
Recital B
Recital B
B. whereas universal, equitable access to medicines is a fundamental right the full realisation of which is incompatible with a pharmaceutical model based primarily on the pursuit of profit;
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 36 #
Draft opinion
Recital B a (new)
Recital B a (new)
Ba. whereas the COVID-19 crisis has shown that innovation in the development of medicines is a key factor in health, and therefore calls on the Commission to focus the pharmaceutical strategy on boosting efforts to promote medical research and innovation in the EU;
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 50 #
Bb. whereas there is a need to seek industry solutions for the development of medicines that are not covered or are for rare diseases, improvements in treatment and the production of reserve antibiotics;
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 90 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas the new pharmaceutical strategy must be implemented taking into account the lessons learned from the COVID-19 crisis, especially the need to reduce the EU's dependence in sectors of a strategic nature.
Amendment 105 #
Motion for a resolution
Recital C b (new)
Recital C b (new)
Cb. whereas the pandemic has brought to the fore a number of pre-existing problems, such as limited capacity to produce vaccines, lack of essential medicines and an unevenly functioning supply chain.
Amendment 112 #
Draft opinion
Paragraph 2
Paragraph 2
2. Calls on the Commission to keep the results of Union-funded R&D in the public domain; points out that the protection of patents must not runmaintain simple public access to patenting and licensing conditions, information on clinical and pre-clinical trials and public and private counter to the right to healthributions;
Amendment 114 #
Draft opinion
Paragraph 2
Paragraph 2
2. Calls on the Commission to keepensure that the results of Union-public funded R&D in the public domain; points out that the protection of patents must not run counter to the right to(either on Union or Member State- level) shall benefit the public health;
Amendment 116 #
Motion for a resolution
Recital C c (new)
Recital C c (new)
Cc. whereas there is a need to seek new synergies between the updated European industrial strategy, the pharmaceutical strategy, the EU4 health programme and the European recovery plan.
Amendment 119 #
Motion for a resolution
Recital C d (new)
Recital C d (new)
Cd. whereas the European Green Deal must encourage rather than hinder the development of a vibrant and dynamic pharmaceutical industry within the EU.
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 #
Draft opinion
Paragraph 4
Paragraph 4
4. Calls on the Commission to develop a mandatory European licence in order to be able to respond rapidly to health crises; Takes the view that, in health emergencies involving shortages of medicines or vaccines, suspending patents is not a short-term solution to the problem; calls on the Commission to look into the development of exceptional mechanisms to make it possible to respond rapidly to health crises based on an impact analysis; takes the view that, in such crises, the Commission should work within a long-term framework and draw up a plan for the production of medicines or vaccines and, alternatively, identify solutions such as voluntary licensing by pharmaceutical companies to companies with production capacity, ensuring at all times that safety requirements are met;
Amendment 161 #
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, paediatric cancers and neurodegenerative diseases or to deal with antimicrobial resistance (AMR); calls for unmet needs and the concept of additional therapeutic value too be more closely defined.
Amendment 178 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Considers it essential to establish a new dialogue with patients and to place their needs at the heart of R&D strategy and policy;
Amendment 179 #
Motion for a resolution
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Highlights the valuable role of community pharmacies and recognises also their valuable contribution during the pandemic by continuously providing an essential and quality service; Stresses that pharmacists are an independent, reliable and trustworthy source of information; Suggests that pharmacists play a more active role in pharmacovigilance activities to assess and monitor the effectiveness of medicines and invites Member States to include them in their health, care and research programmes; Calls for greater recognition of pharmacies in rural areas, which enable such areas to retain their populations and ensure the well-being of citizens.
Amendment 181 #
Draft opinion
Paragraph 6
Paragraph 6
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 186 #
3a. Takes note of the increase in antimicrobial resistance and the threat it poses to public health and food safety; Notes that despite the lack of development of new antibiotics in Europe, it is essential to boost their production within the EU and reduce disparities in access across the Member States.
Amendment 189 #
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Notes that greater transparency in the Member States’ pricing negotiations could provide inspiration for best practices; calls on the Member States to share their best practices on a voluntary basis with a view to achieving greater agility in the process; emphasises that pricing is a national power that takes account of the free market and is based on free competition;
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 214 #
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Points out the need for better communication among the interested parties: industry, research groups, government bodies and health professionals;
Amendment 214 #
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Notes that there is a lack of instruments to combat antibiotic resistance and that there are no short- term solutions. Calls on the Commission to encourage R&D in the field of antimicrobial resistance; supports new legislative initiatives to ensure more effective R&D, with better planning as regards European research funding, making it possible to tackle the rise of antimicrobial resistance.
Amendment 216 #
Draft opinion
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Calls on the Member States to bear in mind, when pricing, the balance between the risks and the benefits of developing a medicine;
Amendment 217 #
Draft opinion
Paragraph 8
Paragraph 8
Amendment 231 #
Motion for a resolution
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Calls on the Commission to faciliate the Member States' ability to set their own priorities for innovation in the manufacturing process of new antibiotics; Notes the need to facilitate access to new antibiotics while maintaining access to old ones;
Amendment 232 #
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Welcomes the new European pharmaceutical strategy that is being presented as a fresh opportunity for the EU to enhance its competitiveness and consolidate the role of European industry, avoiding the relocation of companies; stresses that this is a unique opportunity for the EU to play a more prominent role at global level;
Amendment 233 #
Motion for a resolution
Paragraph 4 c (new)
Paragraph 4 c (new)
4c. Supports the continuation of the Innovative Medicines Initiative and invites the European Investment Bank to play a more active role in financing innovative initiatives in the field of antimicrobial resistance; Stresses the importance of implementing the joint action plan on antimicrobial resistance and health infections.
Amendment 234 #
Motion for a resolution
Paragraph 4 d (new)
Paragraph 4 d (new)
4d. Points out that the concept of unmet medical needs cannot exclude those areas where treatment is available but patients need better results; Stresses that in order to encourage this type of research, solutions are needed to encourage the achievement of these objectives; stresses that a system based solely on research incentives will not achieve the objectives in the fight against rare diseases; Proposes extending the EMA's PRIME scheme to orphan drugs.
Amendment 235 #
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. Calls on the Commission to develop a digital platform or contact points between Member States to provide information, communication and advice to participate in innovation projects at European level;
Amendment 235 #
Motion for a resolution
Paragraph 4 e (new)
Paragraph 4 e (new)
4e. Stresses the relevance of developing a new funding model for antimicrobial medicines that provides a return on R&D investment without relying on the sale of medicines.
Amendment 240 #
Draft opinion
Paragraph 8 b (new)
Paragraph 8 b (new)
8b. Emphasises that in order for the EU to be globally competitive it must overcome a series of challenges and create a long-term strategy that includes the simplification of the process of bringing new products to market; emphasises that changes need to be made to European legislation to provide an incentive for internal production – both of the finished product and of European active pharmaceutical ingredients – and to prevent industrial relocation;
Amendment 243 #
Draft opinion
Paragraph 8 b (new)
Paragraph 8 b (new)
8 b. Stresses the importance of timely and healthy competition to deliver equitable access to medicines; calls for initiatives to be proposed to develop mechanisms to ensure the competition and as a consequence, the equitable access to medicines;
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 251 #
Draft opinion
Paragraph 8 c (new)
Paragraph 8 c (new)
Amendment 252 #
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls for greater price transparency and invites Member States to continue to share their best-pricing practices on a voluntary basis; Stresses that pricing should remain a national competence, taking account of diversity across the EU.
Amendment 256 #
Draft opinion
Paragraph 8 d (new)
Paragraph 8 d (new)
8d. Calls on the Commission to develop a digital platform on which solutions are developed to create contact points between Member States to provide channels of information, communication and advice for the purposes of participating in innovation projects at European level;
Amendment 262 #
Draft opinion
Paragraph 8 e (new)
Paragraph 8 e (new)
8e. Calls on the Commission to simplify bureaucracy and registration procedures so that they do not impede the marketing of medicines and so that medicines can be accessible to patients as early as possible;
Amendment 265 #
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 competition; Calls for maximum transparency in the use of public research and development funding and for easy public access to information regarding patenting/licensing conditions, the findings of clinical trials and public/private contributions.
Amendment 268 #
Draft opinion
Paragraph 8 f (new)
Paragraph 8 f (new)
8f. Calls for environmental objectives to be realistic and not to get in the way when it comes to consolidating a lively and dynamic pharmaceutical strategy;
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 273 #
Draft opinion
Paragraph 8 g (new)
Paragraph 8 g (new)
8g. Calls on the Commission to design specific instruments to promote products produced in Europe over those produced in third countries;
Amendment 274 #
Draft opinion
Paragraph 8 h (new)
Paragraph 8 h (new)
8h. Calls on the Commission to develop mechanisms to provide channels of information, communication and appropriate advice so as to make participation in innovation projects more accessible at European level, above all for SMEs and research centres;
Amendment 281 #
Draft opinion
Paragraph 8 i (new)
Paragraph 8 i (new)
8i. Calls for there to be cooperation and communication among experts, scientists, industry and all interested parties with a view to exchanging views and information in order to achieve the objectives laid down in the pharmaceutical strategy;
Amendment 283 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Recalls that the administration must be proactive in reaching agreements to improve access to medicines for which public funds have been granted in their conception and development phase.
Amendment 284 #
Draft opinion
Paragraph 8 j (new)
Paragraph 8 j (new)
8j. Emphasises that research into and the production and use of medicines should follow ethical principles that guarantee the right to life, dignity and the integrity of the person;
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 297 #
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 systems; calls on the Commission to introduce measchanges to the legislation and a simplified approval procedures to support a greater market presence of these medicines andin specific cases; calls 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 manufacturers; further calls on the Commission to design rules for the industrycalls for the revision of the Bolar provision to bring legal certainty to the sector and encourage investment in key areas; calls, furthermore, on the Commission and the Member States to design rules that are conducive to thate promoteion of research, development and the production of generic and biosimilar medicines in the EU and to propose EU protocols for the interchangeability of biosimilar medicines;
Amendment 325 #
Motion for a resolution
Paragraph 8
Paragraph 8
8. Welcomes the fact that the Commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; further welcomes the fact that the Commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the need to reducedevote more resources at European level to combat unfair and abusive market practices with regard to medicines; stresses the need to reduce and speed up medicine approval times at national level and align them with European Medicines Agency (EMA) times, in order to ensure rapid and equal access to medicines for everyone in the EU;
Amendment 345 #
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Underlines the need for new funding lines to support the work of new start-ups and SMEs in the field of medical biotechnology, while respecting criteria relating to safety and ethics.
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 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 436 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Stresses that EU legislation frequently acts as a bottleneck, stifling many of the innovations that SMEs are seeking to market; calls on the EU to review its pharmaceutical policies and become a hub for global medical innovation;
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 456 #
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12b. Stresses that innovation is far outstripping legislation; calls on the Commission to introduce a degree of regulatory flexibility in order to be able to respond more rapidly and effectively to new requirements and products, while respecting safety and ethical criteria.
Amendment 461 #
Motion for a resolution
Paragraph 12 c (new)
Paragraph 12 c (new)
12c. Stresses that innovation must focus on those areas of greatest need in order to create a true health and innovation strategy that does not currently exist; calls on the Commission to create an innovation ecosystem that facilitates the exchange of experience and access for SMEs; suggests giving greater weight to scientific research so that it can identify medical priorities independently of commercial interests.
Amendment 470 #
Motion for a resolution
Paragraph 12 d (new)
Paragraph 12 d (new)
12d. Points out that the Pharmaceutical Strategy should contribute to improved interaction with regulators, the development of non-legislative initiatives, flexibility in labelling and the adaptation of clinical trials to new needs.
Amendment 474 #
Motion for a resolution
Paragraph 12 e (new)
Paragraph 12 e (new)
12e. Invites the Commission and Member States to provide information, communication and advice to enable SMEs to participate more effectively and in a coordinated manner in innovation projects; Notes that the Commission should seek new advisory strategies to facilitate access to innovation funds for smaller companies; Points out that bureaucratic hurdles and complexity make it difficult for SMEs or public research centres to take full advantage of European innovation programmes.
Amendment 479 #
Motion for a resolution
Paragraph 12 f (new)
Paragraph 12 f (new)
12f. Underlines that the current intellectual property model has proven its effectiveness but needs to develop further to respond to new challenges in the pharmaceutical sector;
Amendment 482 #
Motion for a resolution
Paragraph 12 g (new)
Paragraph 12 g (new)
12g. Invites the Commission and the Member States to consider the possibility of introducing exceptional and temporary mechanisms to be able to react rapidly to crises and shortages.
Amendment 485 #
Motion for a resolution
Paragraph 12 h (new)
Paragraph 12 h (new)
12h. Points out that the EU should focus on developing adequate capacity for the sustainable production of active substances, raw materials and medicines which reduce dependence on external sources; Advocates providing greater legal certainty for drug developers.
Amendment 488 #
Motion for a resolution
Paragraph 12 i (new)
Paragraph 12 i (new)
12i. Suggests promoting clinical data registries to improve the ability to assess the outcome of a given medicine.
Amendment 494 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls on the Commission to revise the use 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; Stresses that this revision should be accompanied by an impact assessment and take account of horizontal regulation in the area of intellectual property.
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 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 541 #
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Calls for an in-depth review of the rules governing clinical trials in order to consolidate a clear and proportionate set of rules to ensure legal certainty for operators; Notes that many European companies conduct their clinical trials outside the EU because of the many bureaucratic hurdles imposed by EU law in areas such as data protection.
Amendment 542 #
Motion for a resolution
Paragraph 16 b (new)
Paragraph 16 b (new)
16b. Calls on the Commission to improve the participation of public researchers in clinical trials, to provide new guidelines on clinical trials, to encourage European networking for better use of public funds, to facilitate cooperation with the UK, to relax regulations to allow clinical trials in several countries simultaneously, and to develop specific provisions in relation to cancer or personalised medicines where long-term research is essential.
Amendment 548 #
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 EMA to develop the use of electronic product information for all medicines in the EU; Points to the urgent need to move forward with the creation of a European health data space to improve the scope and added value of clinical studies and research, thereby facilitating the digital transformation of our health systems.
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 563 #
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Emphasises that research into and the production and use of medicines should follow ethical principles that guarantee the right to life, dignity and the integrity of the person.
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 598 #
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Calls on the Commission to draw up a new definition of 'supply shortages' and to implement an early warning system; invites the Commission to take into consideration the information exchange systems in place in some Member States, based on communication between distribution and pharmacies, which have so far been effective in detecting supply shortages and which may inspire future initiatives without creating new structures, building rather on the experience gained in the Member States and the capacity of national medicines agencies.
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 631 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Stresses that flexibility in pharmaceutical regulations to meet the challenges of COVID-19 should be extended to unmet needs through more streamlined and less bureaucratic procedures, while maintaining all guarantees of safety and quality.
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 648 #
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21 a. Supports the broadened mandate of the EMA and its new responsibilities; calls for the centralisation of scientific advice procedures, thereby strengthening the EMA's capacity in the field of medical technologies; reiterates that the approval process must respond in an appropriate and timely manner to the needs of patients and the pharmaceutical industry.
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 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 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 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;
Amendment 721 #
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24 a. Stresses the need to ensure that Brexit does not adversely affect our capacity for innovation in the medical field.
Amendment 722 #
Motion for a resolution
Paragraph 24 b (new)
Paragraph 24 b (new)
24 b. Recalls that, in situations of crisis or health emergencies, changes to intellectual property rules are not useful to meet short-term needs; invites the Commission to seek solutions, for example in the area of licensing, to address new needs for the production of vaccines or medicines.