57 Amendments of Aldo PATRICIELLO related to 2021/2013(INI)
Amendment 6 #
Draft opinion
Recital A
Recital A
A. whereas the pandemic has revealed the strengths and limitations of the current set-up for managing value chains and accessibility to medicines and vaccines;
Amendment 23 #
Draft opinion
Recital B
Recital B
B. whereas universequal access toibility, affordability, and availability of medicines is a fuanda mental right the full realisation of which is incompatible with a pharmaceutical model based primarily on the pursuit of profitdicinal products is essential; whereas the EU can support this by applying a predictable policy framework that fosters public and private investments ensuring affordable patient access to medicines and benefit to society as a whole;
Amendment 32 #
Draft opinion
Recital B a (new)
Recital B a (new)
B a. whereas the covid19 experience also demonstrated how the European pharmaceutical industry and manufacturers have been resilient and had contingency plans in place avoiding any major disruption for critical products, notably on ICU medicines. This was also possible thanks to the bilateral dialogue and two-way communication established, demand visibility and close cooperation between governments/regulators and actors, a practice which should be maintained and continued on a regular basis;
Amendment 33 #
Draft opinion
Recital B a (new)
Recital B a (new)
Amendment 46 #
Draft opinion
Recital B b (new)
Recital B b (new)
B b. whereas during the covid19 pandemic, uncoordinated actions at national level, such as national hoarding and extreme stockpiling undermined industry’s ability to deliver equitable supply in all markets. This represents a lesson learned to avoid in any future crisis situations;
Amendment 47 #
Draft opinion
Recital B b (new)
Recital B b (new)
B b. whereas Europe’s pharmaceutical sector is a major contributor to the EU economy in terms of creation of highly skilled jobs and investment in innovation; whereas the pharmaceutical sector is a significant driver of trade and economic growth in the EU;
Amendment 52 #
Draft opinion
Recital B c (new)
Recital B c (new)
Amendment 53 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
B a. Whereas the combination of cost containment measures, lack of market predictability, combined with an onerous and rigid regulatory framework are challenging sustainable and equitable access to medicines, especially for very old inexpensive essential drugs, as well as the competitiveness of the European pharmaceutical industry;
Amendment 56 #
Motion for a resolution
Recital B b (new)
Recital B b (new)
Amendment 59 #
Motion for a resolution
Recital B c (new)
Recital B c (new)
B c. Whereas during the COVID-19 pandemic, uncoordinated actions at national level, such as hoarding and extreme stockpiling undermined the industry’s ability to deliver equitable supply in all markets; whereas this represents a lesson learnt to avoid in any future crisis situation;
Amendment 73 #
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 and to develop the prospective European Health Emergency Response Authority (HERA) along those lines; considers that HERA should closely collaborate with public and private entities to plan, coordinate and build an ecosystem of private and public capabilities which can provide suitable emergency frameworks for EU access to key raw materials in case of global supply chocks;
Amendment 92 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
C a. whereas a competitive and resilient European research-based pharmaceutical industry is more responsive to patients’ needs and to strategic interest for public health, economic growth, jobs, trade, and scientific and technological progress;
Amendment 103 #
Motion for a resolution
Recital C b (new)
Recital C b (new)
C b. whereas medicine producers made the biggest contribution to research investment in 2019, with over €37 billion; whereas the sector provides 800 000 direct jobs and a €109.4billion trade surplus; whereas the sector generates about three times more employment indirectly – upstream and downstream – than it does directly;
Amendment 108 #
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 run counter to the right to healthPoints out that the protection of the social contract between European pharmaceutical companies, patients and society as a whole rests on the EU intellectual property framework; points out that the intellectual property framework acts as a driver of investments in research and development, which is essential to innovation;
Amendment 137 #
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 to ensure equitable access to medicines also in areas where the development of products would otherwise not be sustainable;
Amendment 139 #
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Welcomes the impact of the Regulation on orphan medicinal products (EC/141/2000) and the Regulation on medicinal products for paediatric use (EC/1901/2006); notes however that scientific progress and investment in research have not been sufficient for the unmet needs of patients with rare diseases, paediatric cancers and neurodegenerative diseases, to deal with antimicrobial resistance (AMR) or to prevent infectious diseases outbreaks; Calls on the Commission to support a regulatory framework which strengthens incentives for orphan medicines research and development in the EU to effectively address these shortcomings;
Amendment 144 #
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Stresses the importance of continuous innovation, including 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 these category of affordable innovation with appropriate incentives and its value for healthcare systems;
Amendment 151 #
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3 b. Calls on the Commission to incentivise child specific and first-in-child innovation and to facilitate the repositioning of medicines failing in adults when there is scientific and preclinical rationale;
Amendment 153 #
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 concerning all AMR pathogens, or to prevent infectious diseases outbreaks; calls for the introduction of new targeted incentives to effectively address these areas;
Amendment 156 #
Draft opinion
Paragraph 4
Paragraph 4
4. Calls onWelcomes the Commission to develop a mandatory European licence in order to be able to respond rapidly to health's proposal to foster production and investment in Europe as well as to simplify and streamline relevant procedures in order to be able to respond rapidly to health crises; points out that a regulatory framework which supports the open strategic autonomy of the EU will benefit patients also outside times of crises;
Amendment 176 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Considers the serious and constantly increasing risks of AMR topublic health, environment, food production, and economic growth; recognises the value of public health campaigns aimed at the prevention of infections using vaccines;
Amendment 177 #
Draft opinion
Paragraph 5
Paragraph 5
5. Calls for public investment in R&D to be made transparent and for it to be reflected in product availability and pricingaffordability;
Amendment 182 #
Draft opinion
Paragraph 6
Paragraph 6
6. Calls on the Commission to support pricing models based on real production costs, innovation and value to patients; calls also on the Commission to investigate novel pricing and payment models and their possible impact on patient access to innovative medicines;
Amendment 198 #
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 new medicines for unmet therapeutic needs, prioritising projects promoted by the pharmaceutical industry combating rare diseases, paediatric cancers, neurodegenerative diseasebuild on the existing incentives regime, and improve it with additional incentives, such as transferable exclusivity extensions, for underserved therapeutic and prophylactic areas where the development of products would otherwise not be sustainable for companies, prioritising projects 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 203 #
Draft opinion
Paragraph 7
Paragraph 7
7. Calls ononsiders that the Commission to promoteand Member States could consider launching joint public procurement and apply most economically advantageous tender (MEAT) criteria more stringently- procedures in times of health crises, as has been done during the COVID-19 crisis, with simplified and transparent procedures in the interest of improved response times; highlights that joint public procurement should not hinder patient access, medical innovation or competition;
Amendment 208 #
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Welcomes the setting up of a structured dialogue on manufacturing and supply chain with and between the actors in the pharmaceuticals manufacturing value chain and public authorities to identify vulnerabilities in the global supply chain of critical medicines, raw pharmaceutical materials, intermediates and active pharmaceutical substances; in this context, urges the Commission, member states and parties involved to define as soon as possible a clear and ambitious policy roadmap through economic, regulatory and industrial reforms to secure and modernize existing manufacturing capabilities of medicines, technology and APIs in Europe, for example by rewarding investments in security of supply and manufacturing improvements;
Amendment 209 #
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
Amendment 213 #
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. 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 220 #
Draft opinion
Paragraph 8
Paragraph 8
Amendment 227 #
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. Calls on the Commission, on top of the structured dialogue on manufacturing and supply chain, to set up a focused, action oriented High Level Pharmaceutical Forum involving Ministers of Health and policy makers, regulators, payers, industry and other concerned stakeholders of the Healthcare supply chain. The key objective would be to share the learnings from the COVID19 situation and draw the conclusions to establish a pan European and effective policy framework to prevent shortages in the long term and ensuring a well- functioning, sustainable industry that continues to act as a catalyst to enable sustainable access to medicines for patients and innovation;
Amendment 231 #
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. Points out that small and medium sized enterprises (SMEs) and mid-caps play a crucial role in the pharmaceutical value chain, often as first-movers and drivers of innovation; calls on the Commission to maintain a comprehensive and predictable regulatory framework that fosters the investment and innovation of especially European pharmaceutical SMEs and mid-caps;
Amendment 244 #
Draft opinion
Paragraph 8 b (new)
Paragraph 8 b (new)
8 b. Calls on the Commission to address unjustified trade restrictions; points out that trade barriers can harm the accessibility and affordability of medicinal products;
Amendment 246 #
Draft opinion
Paragraph 8 c (new)
Paragraph 8 c (new)
8 c. Calls on the Commission and Member States to fully implement the Clinical Trials Regulation; supports a new framework for the design of innovative trials, the simplification of the requirements for the conduct of clinical trials and additional support for the conduct of so-called pragmatic 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;
Amendment 255 #
Draft opinion
Paragraph 8 d (new)
Paragraph 8 d (new)
8 d. Calls for the prudent implementation of the General Data Protection Regulation (GDPR) with regard to data minimisation, purpose limitation, the secondary use of data as well as on data transfer to third countries to avoid unnecessary restriction for health research and cross-border data sharing;
Amendment 260 #
Draft opinion
Paragraph 8 e (new)
Paragraph 8 e (new)
8 e. 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;
Amendment 265 #
Draft opinion
Paragraph 8 f (new)
Paragraph 8 f (new)
8 f. Calls on the Commission to develop new- and extend the scope of existing Mutual Recognition Agreements on Good manufacturing practice (GMP) certificates (most importantly on inspections and batch testing) with more countries who have high manufacturing standards; points out that this could make it easier to include sites in third countries in a production supply chain, without giving up European standards to allow for broadening the production capacity in times of crisis.
Amendment 272 #
Draft opinion
Paragraph 8 g (new)
Paragraph 8 g (new)
8 g. Calls on the Commission and the Member States to screen foreign direct investment in pharmaceutical manufacturing plants, which are part of Europe’s critical health infrastructure;
Amendment 276 #
Draft opinion
Paragraph 8 h (new)
Paragraph 8 h (new)
8 h. Calls on the Commission to increase its involvement in supporting critical health infrastructure protection in Member States and to start applying the European Programme for Critical Infrastructure Protection to the health infrastructure sector;
Amendment 293 #
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 patents 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 propose EU protocols for the intermote harmonized European and Member States guidelines for the implementation of physician-led switchaingeability of biosimilar medicines of biologic medicines, including biosimilar medicines as defined by the European Medicines Agency;
Amendment 313 #
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. 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 367 #
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
Amendment 372 #
Motion for a resolution
Paragraph 10 b (new)
Paragraph 10 b (new)
Amendment 374 #
Motion for a resolution
Paragraph 10 c (new)
Paragraph 10 c (new)
10 c. Recalls that the primary purpose of joint procurement should be to guarantee stability in an unpredictable environment in the context of a cross- border health crisis only, ensuring equitable access for patients and increased visibility and predictability for the actors involved; believes that for multi-source markets, joint procurement is not the right solution to achieve its objective; however, if it is used, it shall be in the context of cross border threats to health only and shall be carried in a transparent, timely and effective way to prevent market disruption and to ensure that all parties involved, both relevant authorities and manufacturers, can fulfil their contractual responsibilities,
Amendment 395 #
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 404 #
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
Amendment 432 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. 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 within the European Medicines Agency (EMA); believes that the final decision-making should occur within maximum 7 days of the final scientific opinion;
Amendment 458 #
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12 b. Calls on the Commission to legitimise EMA’s PRIME scheme and include a PRIME designation in the legislative framework;
Amendment 466 #
Motion for a resolution
Paragraph 12 c (new)
Paragraph 12 c (new)
12 c. 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 472 #
Motion for a resolution
Paragraph 12 d (new)
Paragraph 12 d (new)
12 d. Calls on the Commission to facilitate assessment processes that allow for early and iterative dialogue on data and evidence as they are generated;
Amendment 475 #
Motion for a resolution
Paragraph 12 e (new)
Paragraph 12 e (new)
Amendment 478 #
Motion for a resolution
Paragraph 12 f (new)
Paragraph 12 f (new)
12 f. 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 481 #
Motion for a resolution
Paragraph 12 g (new)
Paragraph 12 g (new)
12 g. Supports the adaptation of existing frame works 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 486 #
Motion for a resolution
Paragraph 12 h (new)
Paragraph 12 h (new)
12 h. 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 600 #
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19 a. Recalls that the root causes of medicines shortage should be assessed and tackled and systemic sustainable reforms put in place, before imposing any disproportionate, quick-fix and punitive measures, such as penalties and uncoordinated and extreme stockpiling requirements; underlines that root causes include economic causes, increasing regulatory burdens, unforeseen surges in demand, supply chain interdependencies and manufacturing challenges;
Amendment 624 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20 a. Welcomes the reference in the strategy to the fact that actions in the area of public procurement can foster competition and improve access. In this context, urges the Commission to consider the importance of diversified supplies and sustainable procurement practices for pharmaceuticals, notably with multi- winners tender, and, in the context of the EU public procurement Directive 2014/24/EU, to promptly propose ad-hoc guidance for Member States to support sustainable tenders practices for pharmaceuticals, where tender practices are used, notably on how to best implement the MEAT (Most Economic Advantageous Criteria) criteria, looking beyond the lowest price criteria only and rewarding quality and security of supply, as well as environmental and social investments in manufacturing;
Amendment 653 #
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 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 quality and environmental sustainability standardsframework 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 containers to ensure they are no larger than necessary, and to bring medical prescriptions into line with real therapeutic needs; s well as to facilitate medicines movement to mitigate shortages if they occur; Call on the Commission to take into account existing and self- regulated initiatives as models in future EU initiatives on pharmaceuticals in the environment, which shall be proportionate and based on scientific evidence;
Amendment 671 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22 a. Believes that in addition to the structured dialogue on manufacturing and supply chain, a wider political high level pharmaceutical forum is also needed, bringing together policymakers, regulators, payers, patient organizations, industry representatives and other relevant stakeholders in the healthcare supply chain in order to tackle other policy areas, such as prevent shortages, address pharmaceutical sustainability issues and ensure the competitiveness of the European pharmaceutical industry overall;