60 Amendments of Angelika NIEBLER related to 2021/2013(INI)
Amendment 3 #
Draft opinion
Paragraph 1
Paragraph 1
1. Stresses the importance of developing a newat the EU pharmaceutical strategy which is consistent with the Union’s competences under the Treaties and with the principles of proportionality and subsidiarity, as a means of stimulating the development of European enterprises and making them competitive at global level and of guaranteeing better prevention and preparedness and more effective responses to future health emergenciess to build a stronger European Health Union in particular by supporting closer EU cooperation in research and development and by sharing health data;
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 11 #
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Stresses that R&D is key for the development of innovative medicines, therapies and diagnosis;
Amendment 17 #
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Highlights that supporting the competitiveness and innovative capacity of the EU’s pharmaceutical industry is crucial;
Amendment 19 #
Draft opinion
Paragraph 1 c (new)
Paragraph 1 c (new)
1c. Underlines that the EU has to foster patients access to medicines, support the competitiveness of the EU’s pharmaceutical industry, develop the EU’s open strategic autonomy and ensure both robust supply chains and a strong EU voice on the global stage;
Amendment 20 #
Draft opinion
Paragraph 1 d (new)
Paragraph 1 d (new)
1d. Welcomes the Commission’s Action Plan on Intellectual Property which shall help companies, especially small and medium-sized companies (SMEs), to make the most of their inventions and creations and ensure they can benefit our economy and society and which aims at enabling the European innovative industry to remain a global leader;
Amendment 22 #
Draft opinion
Paragraph 1 e (new)
Paragraph 1 e (new)
1e. Fully supports the IP Action Plan proposal to upgrade a series of existing IP tools and make them fit for the digital age, including improving the supplementary protection certificates (SPC) for patented medicinal products among other;
Amendment 23 #
Draft opinion
Paragraph 1 f (new)
Paragraph 1 f (new)
1f. Recalls the Council conclusions ‘An EU Industrial Policy Strategy: a Vision for 2030’ of May 2019 recognising that a well-functioning and effective intellectual property rights regime is key to continued development and growth and recalling that it is essential to continue developing, improving and updating the European intellectual property frameworks, so as to ensure that ideas and inventions can be effectively developed and brought to the market, in particular by and for SMEs, to the benefit of the European economy and society at large;
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 24 #
Draft opinion
Paragraph 1 g (new)
Paragraph 1 g (new)
1g. Recalls the European Commission’s ‘Updating the 2020 New Industrial Strategy: Building a stronger Single Market for Europe’s recovery’ of May 2021 which states that the EU is strategically dependent on third countries regarding pharmaceutical ingredients and other health related products, which could lead to vulnerabilities for the EU and affect the EU’s core interests, and refers to the pharmaceutical strategy to address these issues;
Amendment 27 #
Draft opinion
Paragraph 2
Paragraph 2
2. Emphasises the key importance of intellectual property protection in the EU, which is essential if the EU is not to be dependent on third countries and is to enhance its strategic autonomy in the field of medicines; calls for a joint review process involving European, national and regional institutions, along with health professionals, industry representatives and stakeholders, with a view to identifying shared approaches, in particular to the challenges posed by the COVID-19 pandemic;
Amendment 33 #
Draft opinion
Recital B a (new)
Recital B a (new)
Amendment 36 #
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Calls for the European Commission to carefully analyse which lessons have to be learned from the challenges posed by the Covid-19 pandemic for the pharmaceutical strategy;
Amendment 38 #
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Underlines the need to ensure a smart use of IP, and to better fight IP theft, as smart IP policies are essential to help companies to grow, to create jobs and to protect and develop what makes them unique and competitive;
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 48 #
Draft opinion
Paragraph 3
Paragraph 3
3. Stresses the importance of facilitating and supporting research in the EU, not least in orderin order to be world market leader in improving existing and developing new medicines which could then lead to an increase of the number of patents filed in the Member States in this area; stresses that one of the priorities should be to develop medicines in areas where needs have been met only insufficiently or not at all or where commercial interest is low; draws attention, in that connection, to the key role played by AI and its potential as a driver of research and development in the health and pharmaceutical sector;
Amendment 52 #
Draft opinion
Recital B c (new)
Recital B c (new)
Amendment 54 #
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Stresses that a revision of the system of legal incentives and obligations to support innovation, access and affordability of medicines across the EU has recognised the relationship with intellectual property rights;
Amendment 64 #
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Urges to make the IP system more effective for SMEs, through actions to simplify IP registration procedures (e.g. reforming EU legislation on industrial designs), to improve access to strategic IP advice (e.g. by making such advice available in all EU-level R&D funding), and to facilitate the use of IP as a lever to gain access to finance;
Amendment 67 #
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Stresses that investing in research and development is a costly, high-risk endeavour; underlines that patents are intended to offer some guarantee of a return on investment, but the patent system is also designed to balance the interests of inventors with those of the public; repeats therefore that pharmaceutical companies need intellectual property (IP) rights and thus patents to achieve profits and keep innovating also in the interest of the consumers and patients;
Amendment 70 #
Draft opinion
Paragraph 4 c (new)
Paragraph 4 c (new)
4c. Stresses that R&D in drugs are very often not successfully completing clinical trials and thus are not resulting in final drug approval;
Amendment 71 #
Draft opinion
Paragraph 4 d (new)
Paragraph 4 d (new)
4d. Underlines that the patent systems all over the world are drafted in a way that for a specific period of time, only for the duration of the patent, the inventor is allowed to commercially exploit its patent. Thereafter, the invention can be freely exploited by anyone;
Amendment 72 #
Draft opinion
Paragraph 4 e (new)
Paragraph 4 e (new)
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 83 #
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Notes that most of the time, radical innovation in the pharmaceutical sector is driven by SMEs (“biotechs”);
Amendment 85 #
Draft opinion
Paragraph 6 b (new)
Paragraph 6 b (new)
6b. Regrets that the EU is less attractive then other countries, such as the USA, in terms of pharmaceutical research and development which is mainly due to a financial environment which encourages more risk-taking by venture capital;
Amendment 86 #
Draft opinion
Paragraph 6 c (new)
Paragraph 6 c (new)
6c. Underlines the importance of a strong, efficient, transparent and balanced system of IP and trade secrets protection and the need for a coherent overall strategy to ensure both protection of – and fair access to – innovation to ensure that all companies established in the EU, including small and medium- sized ones, can effectively capitalise on their IP and make use of new technologies;
Amendment 89 #
Draft opinion
Paragraph 6 d (new)
Paragraph 6 d (new)
6d. Finally highlights that it is of outmost importance to speak with “a strong EU voice” on the global stage;
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 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 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 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 180 #
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Stresses that R&D in drugs are very often not successfully completing clinical trials and thus are not resulting in final drug approval;
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 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 209 #
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
Amendment 220 #
Draft opinion
Paragraph 8
Paragraph 8
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 280 #
Draft opinion
Paragraph 8 i (new)
Paragraph 8 i (new)
8 i. Whereas the Horizon Europe programme provides essential support for research and innovation; whereas the programme is a key driver of job creation, industrial competitiveness, research and innovation also in the health and pharmaceutical sector;
Amendment 283 #
Draft opinion
Paragraph 8 j (new)
Paragraph 8 j (new)
Amendment 286 #
Draft opinion
Paragraph 8 k (new)
Paragraph 8 k (new)
8 k. Stresses that the EU has to build a stronger European Health Union in particular by supporting closer EU cooperation in research and development and by sharing health data;
Amendment 287 #
Draft opinion
Paragraph 8 l (new)
Paragraph 8 l (new)
8 l. Stresses that R&D is key for the development of innovative medicines, therapies and diagnosis;
Amendment 288 #
Draft opinion
Paragraph 8 m (new)
Paragraph 8 m (new)
8 m. Highlights that supporting the competitiveness and innovative capacity of the EU’s pharmaceutical industry is crucial;
Amendment 289 #
Draft opinion
Paragraph 8 n (new)
Paragraph 8 n (new)
8 n. Welcomes the Commission’s Action Plan on Intellectual Property which shall help companies, especially small and medium-sized companies (SMEs), to make the most of their inventions and creations and ensure they can benefit our economy and society and which aims at enabling the European innovative industry to remain a global leader;
Amendment 290 #
Draft opinion
Paragraph 8 o (new)
Paragraph 8 o (new)
8 o. Fully supports the IP Action Plans proposal to upgrade a series of existing IP tools and make them fit for the digital age, including improving the supplementary protection certificates (SPC) for patented medicinal products among other;
Amendment 291 #
Draft opinion
Paragraph 8 p (new)
Paragraph 8 p (new)
8 p. Recalls the Council conclusions ‘An EU Industrial Policy Strategy: a Vision for 2030’ of May 2019 recognising that a well-functioning and effective intellectual property rights regime is key to continued development and growth and recalling that it is essential to continue developing, improving and updating the European intellectual property frameworks, so as to ensure that ideas and inventions can be effectively developed and brought to the market, in particular by and for SMEs, to the benefit of the European economy and society at large;
Amendment 292 #
Draft opinion
Paragraph 8 q (new)
Paragraph 8 q (new)
8 q. Recalls the Commission’s ‘Updating the 2020 New Industrial Strategy: Building a stronger Single Market for Europe’s recovery’ of May 2021 which states that the EU is strategically dependent on third countries regarding pharmaceutical ingredients and other health related products, which could lead to vulnerabilities for the EU and affect the EU’s core interests, and refers to the pharmaceutical strategy to address these issues;
Amendment 293 #
Draft opinion
Paragraph 8 r (new)
Paragraph 8 r (new)
8 r. Underlines the need to ensure a smart use of IP, and to better fight IP theft, as smart IP policies are essential to help companies to grow, to create jobs and to protect and develop what makes them unique and competitive;
Amendment 294 #
Draft opinion
Paragraph 8 s (new)
Paragraph 8 s (new)
8 s. Urges to make the IP systemmore effective for SMEs, through actions to simplify IP registration procedures(e.g. reforming EU legislation on industrial designs), to improve access to strategic IP advice (e.g. by making such advice available in all EU-level R&D funding), and to facilitate the use of IP as a lever to gain access to finance;
Amendment 295 #
Draft opinion
Paragraph 8 t (new)
Paragraph 8 t (new)
8 t. Stresses that investing in research and development is a costly, high-risk endeavour; underlines that patents are intended to offer some guarantee of a return on investment, but the patent system is also designed to balance the interests of inventors with those of the public; repeats therefore that pharmaceutical companies need intellectual property (IP) rights and thus patents to achieve profits and keep innovating also in the interest of the consumers and patients;
Amendment 296 #
Draft opinion
Paragraph 8 u (new)
Paragraph 8 u (new)
8 u. Underlines that the patent systems all over the world are drafted in a way that for a specific period of time, only for the duration of the patent, the inventor is allowed to commercially exploit its patent. Thereafter, the invention can be freely exploited by anyone;