Activities of Pernille WEISS related to 2021/2013(INI)
Plenary speeches (1)
A pharmaceutical strategy for Europe (debate)
Shadow opinions (1)
OPINION on a pharmaceutical strategy for Europe
Amendments (75)
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 33 #
Draft opinion
Recital B a (new)
Recital B a (new)
Amendment 35 #
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; whereas safe, affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies, alongside investment and research, and in every aspect of the medicine regulatory lifecycle;
Amendment 36 #
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; whereas safe, affordable and innovative medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies, alongside investment and research;
Amendment 45 #
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 of our national health systems to cross-border threats, more European integration is necessary; whereas a European Health Union, which contributes to an increasingly social Union, is key in this processdevelopment, production and delivery of accessible, affordable, and available medicines can be supported by applying a predictable EU policy framework that fosters public and private investments benefitting both patients and society as a whole;
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 51 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
B a. whereas the disruption of the global supply chain ensuing from the COVID-19 pandemic has highlighted the EU’s dependency on third countries in the health sector; whereas the EU's open strategic autonomy and security of supply should be ensured by diversification of supply chains for essential medicines and medicinal products, including European manufacturing sites, as well as by applying public procurement rules that should not consider price as the sole criterion;
Amendment 52 #
Draft opinion
Recital B c (new)
Recital B c (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 91 #
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 99 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
C a. Whereas a growing portion of Europeans are living with co-morbidities; whereas these must be addressed in European health policies;
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 149 #
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Stresses the importance of improving patients and healthcare professionals’ education on medicines by setting up a dedicated Europe-wide online resource centre;
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 169 #
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, obesity and neurodegenerative diseases or to deal with antimicrobial resistance (AMR);
Amendment 175 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Considers the serious and constantly increasing risks of AMR to public health, environment, food production, and economic growth; recognises the value of public health campaigns aimed at the prevention of infections using vaccines;
Amendment 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 177 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Calls on the Commission to support research into the treatment of major noncommunicable diseases, including obesity as a primary morbidity as well as where it exists as a gateway chronic disease to other noncommunicable diseases;
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 188 #
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
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 207 #
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 (especially to incentivise First-in-Child development of paediatric anticancer medicines), 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 to guide and regularly evaluate the implementation of national plans to fight these diseases;
Amendment 209 #
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
Amendment 209 #
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 diseases, obesity and the interlinkages with other noncommunicable 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 to guide and regularly evaluate the implementation of national plans to fight these diseases;
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 247 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to promote dialogue with the Member States and stakeholders to assess new criteria for national pricing, such as whether a product is ‘Made in Europe’, whether the EU invested in the product to support research, or whether prices should be adapted to the value of the therapeutic benefit of the medicine, or whether it is a generic or biosimilar medicine, and the primary and broader needs of the population;
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 256 #
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Calls on the Commission to apply public procurement rules that should not consider price as the sole and main selection criterion;
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;
Amendment 310 #
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Stresses that cost savings generated from the use of biosimilars should be reinvested in a transparent and tangible way; calls on the European Commission to encourage Member States to support the transparent practices of biosimilar-related cost savings; calls on the European Commission to facilitate arrangements such as gainsharing programmes;
Amendment 319 #
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7 b. Calls on the Commission to ensure that EU funding for biomedical research and development includes clauses that contribute to the availability and affordability of final products;
Amendment 339 #
Motion for a resolution
Paragraph 9
Paragraph 9
9. Highlights the benefits of public- private partnership tenders for national health systems in funding research into and the production of innovative medicines, only if driven by public interest considerations;
Amendment 356 #
Motion for a resolution
Paragraph 10
Paragraph 10
10. StreCalls on the Commission to assess the importanceact of new joint EU public procurement contracts by the Commission and the Member States, especially for emergency medicines and unmet therapeutic needs; stresses that joint public procurement should not hinder patient access, medical innovation or competition;
Amendment 383 #
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 equitable access to innovative medicines are expensiveis a challenge across Member States; welcomes the Commission’s intention to review pharmaceutical legislation to promote robust competition and to stabilise and balance national drug pricing system; highlights that decisions on the pricing and reimbursement of medicines are the purview of Member States;
Amendment 398 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11 a. Calls on the Commission to create a High-Level Forum on Better Access to Medicines to identify multi-stakeholder solutions to introducing new health technologies that can broaden access, reduce delays and mitigate the impact of shortages;
Amendment 422 #
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; 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, which will integrate data from real-world evidence;
Amendment 434 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Calls on the Commission to expand the role of EMA in the assessment of drug-device/diagnostic combination products to simplify the fragmented supervisory framework; believes that greater regulatory agility and efficiency can be achieved by adopting a more expertise-driven scientific assessment on marketing authorisations within the European Medicines Agency(EMA);
Amendment 445 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
Amendment 455 #
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12 b. 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 459 #
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 463 #
Motion for a resolution
Paragraph 12 c (new)
Paragraph 12 c (new)
12 c. Calls on the Commission to facilitate assessment processes that allow for early and iterative dialogue on data and evidence as they are generated; calls on the EMA and national medicine agencies to prioritise the submission of data from randomised controlled clinical trials that compare an investigational medicine against the standard treatment;
Amendment 471 #
Motion for a resolution
Paragraph 12 d (new)
Paragraph 12 d (new)
12 d. Requests 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 476 #
Motion for a resolution
Paragraph 12 e (new)
Paragraph 12 e (new)
12 e. Notes that decisions taken regarding the EU's pharmaceutical regulatory environment will have implications beyond Europe's borders, given that several third countries recognize and rely on EU requirements, particularly when it comes to the facilitation of exports and the waiving of requirements to test these in third countries when they come from the EU; therefore emphasizes the importance of maintaining such mutual recognition agreements with third countries and ensuring that these remain up to date;
Amendment 519 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Highlights the fact that gene and cell therapies, personalised medicine, nanomedicines and nanotechnology, next- generation vaccines, including the m-RNA derivatives, e-health and the ‘Million plus genomes’ initiative can bring enormous benefits in relation to the prevention, diagnosis, treatment and post-treatment of all diseases; urges the Commission to develop appropriate regulatory frameworks, to guide new business models, and to run information campaigns to raise awareness and encourage the use of these innovations;
Amendment 524 #
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15 a. Recognises that ATMPs are fundamentally different from traditional pharmaceuticals as they address the root causes of disease and that their fundamental durability and potential curative nature can allow them to be the future of medicine; acknowledges that regulatory bodies such as the EMA are set to review and approve dozens of ATMPs over the coming years, underlining the need for the Commission to establish in addition to its ATMP Action Plan a robust regulatory landscape that facilitates access for all the eligible European patients, and to continue to build on Europe’s position as a major player in ATMPs in order for Europe to remain globally competitive in ATMP development;
Amendment 618 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. Supports the Commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain, public authorities, non-governmental patient and health organisations and the research community to address the root causes of shortages of medicines and the weaknesses in the global medicines manufacturing and supply chain;
Amendment 659 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Stresses the need for the pharmaceutical industry to be environmentally friendly and climate- neutral throughout the life cycles of medicinal products; calls on the Commission to strengthen inspection and auditing throughout the production chain, particularly outside the EU; urges the Commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-EU countries; calls on the Commission to address the problem of domestic pharmaceutical waste, with measures to reduce packaging and the size of containers to ensure they are no larger than necessary, and to bring medical prescriptions into line with real therapeutic needs; notes that the creation of electronic systems of information and identification of packaging would be an effective way to reduce it; acknowledges steps taken already by the pharmaceutical industry like, for example, the Eco-Pharmaco- Stewardship initiative;
Amendment 665 #
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 chainespecially the part of the production chain located outside the EU; urges the Commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-EU countries; calls on the Commission to address the problem of domestic pharmaceutical waste, with measures to reduce packaging and the size of containers to ensure they are no larger than necessary, and to bring medical prescriptions into line with real therapeutic needs;
Amendment 674 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22 a. Points out that residue of production, use and disposal of medicines can negatively affect ecosystems and water quality; calls on the Commission to assess the sufficiency of current requirements for environmental risk assessment and conditions of uses of medicines; urges the Commission to explore innovative digital solutions for monitoring and improving the efficiency of medicines consumption and quality;
Amendment 685 #
Motion for a resolution
Paragraph 22 b (new)
Paragraph 22 b (new)
22 b. Insists that the pharmaceutical strategy for Europe should consider the objectives of the Zero Pollution Action Plan for water, air and soil;
Amendment 712 #
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23 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; urges the Commission to maintain a comprehensive and predictable regulatory framework that fosters the investment and innovation of especially European pharmaceutical SMEs and mid-caps;