Activities of Andrey SLABAKOV related to 2021/2013(INI)
Shadow reports (1)
REPORT on a pharmaceutical strategy for Europe
Amendments (37)
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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;