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Verband Forschender Arzneimittelhersteller e.V.

vfa

Der vfa ist der Wirtschaftsverband der forschenden Pharma-Unternehmen in Deutschland.

Lobbying Activity

Response to Circular Economy Act

3 Nov 2025

The Circular Economy Act (CEA) aims to advance the EUs transition to a circular economy by fostering a single market for circular products, secondary raw materials, and waste. It supports the goals of the Clean Industrial Deal, Competitiveness Compass, and Draghi report by strengthening economic resilience, decarbonisation, and reducing dependency on non-EU raw materials. The vfa (German Association of Research-Based Pharmaceutical Companies) endorses these goals recognizing circularitys potential to lower Europes carbon footprint. However, the pharmaceutical sectors strict safety and quality standards require particular attention when integrating circular practices. Key Challenges for pharmaceutical sector Strict pharmaceutical Regulations: Pharmaceutical manufacturing must comply with stringent EU and global GxP-rules. These restrict recycled content due to risks of contamination, instability, or reduced product safety. Hazardous Waste Classification: Most unused or expired medicines are treated as hazardous waste, preventing reuse or recycling within or beyond the sector. Cross-Border Restrictions: EU rules currently impede transport of medical waste between member states, blocking efficient use of specialized recycling plants. Divergent Legislations: Conflicting or overlapping requirements (e.g., between CEA and PPWR) impede harmonization. Economic Viability: Recycling complex products such as devices, batteries, or injection pens is commercially unattractive without incentives or R&D support. Policy Recommendations Circular measures must align with pharmaceutical standards to avoid misuse, contamination, or counterfeiting. Harmonized EU rules to scale circularity and maintain competitiveness. Enable cross-border waste flow to permit centralized, specialized recycling of medicinal waste under strict safety controls. Avoid mandatory recycled content in manufacturing and packaging of pharmaceutical products unless product stability and patient safety are fully ensured. Establish an EU-wide framework for safe collection, transport, and reuse of pharmaceutical waste, removing redundant national barriers. Promote R&D in new recycling technologies and pharmaceutical-grade materials (e.g., multi-layer blisters combining virgin and recycled content). Encourage take-back and reuse schemes for packaging and medical devices (e.g., cooling boxes, electronic pens) through targeted incentives. Harmonize standards and certification for recycling processes to ensure quality, compliance, and traceability across the EU. Limit Digital Product Passports (DPPs) to non-pharmaceutical products to avoid patient confusion and additional regulatory burdens. Preserve public trust. Medicines not suitable for circularity must remain accepted for treatment to ensure access and confidence. Conclusion Research-based pharmaceutical companies are committed to supporting the EUs circular economy objectives while safeguarding patient safety. The sector calls for a balanced pan-European circular economy framework that harmonizes rules, drives innovation, and ensures compliance with sector specific legislations without compromising product quality. With proper legal and economic conditions, pilot projects can be scaled EU-wide, creating both, environmental and economic benefits. Innovation opportunities include e.g. recovery of valuable active ingredients from unused medicines or science-based expiry date revisions to avoid waste. The vfa and the pharmaceutical industry stands ready to work with EU policymakers on practical, harmonized standards that enable circular value chains while maintaining Europes competitiveness and public health integrity.
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Response to EU cardiovascular health plan

15 Sept 2025

The German Association for Research-Based Pharmaceutical Companies (vfa) strongly welcomes the European Commission's initiative to introduce an EU cardiovascular health plan that includes primary, secondary, and tertiary prevention, care, and rehabilitation. vfa also supports the definition of clear objectives and measurable targets to enable proper evaluation. Cardiovascular diseases (CVDs) remain the leading cause of death in EU member states and place an increasing burden on patients, healthcare systems, and societies. The EU cardiovascular health plan should take into account the frequent co-occurrence and mutual influence of metabolic risk factors, such as obesity and diabetes, on the development of CVDs. Accordingly, primary prevention measures should begin in early childhood, with a focus on fostering active and healthy lifestyles in kindergartens and schools to improve children's health and reduce the growing burden of obesity across the EU. In addition, adherence to recommended vaccination schedules, particularly for elderly people, should be further supported to minimize potential negative impacts on the pathogenesis of CVDs. Secondary prevention measures should include early and regular check-ups. The timely initiation of coordinated disease management could further improve health outcomes and should be supported by digital tools that empower patients to participate in their own treatment, raise awareness of the disease, and improve its management. The EU cardiovascular health plan should also promote research and innovation to improve health outcomes across CVDs and address unmet medical needs. In doing so, the plan can strengthen the European research ecosystem, foster innovation, and boost competitiveness.
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Response to Critical Medicines Act

6 Jun 2025

The German association of research-based pharmaceutical companies (vfa) welcomes the political goal of increasing the resilience of pharmaceutical supply chains, reducing unilateral dependencies, and ensuring long-term security of supply in Europe. The vfa notes that different product categories, i.e. Union List of Critical Medicines (ULCM) and medicinal products of common interest (MPCI) should enable targeted political control. The vfa calls on the European Commission to design the measures carefully and to implement them in a practical, innovation-friendly and proportionate manner so that innovation, competitiveness, attractiveness of the location and access to innovative medicinal products are not unintentionally jeopardized. The following points are particularly important: Strengthen technological sovereignty by building strategic production capacities Utilize existing data more efficiently to reduce bureaucratic burden Significantly limit the collaborative procurement of innovative medicinal products To strengthen Europes technological sovereignty, the CMA must promote strategically relevant production and innovation capacities across the entire value chain regardless of company size. In line with Articles 5, 15 and 16, public funding for strategic projects should follow clear, transparent and practicable criteria, including defined indicators of supply vulnerability. Funding instruments must remain innovation-friendly and aligned with existing EU initiatives. According to Articles 7 to 14, strategic projects should benefit from accelerated, coordinated administrative procedures without creating additional burdens. Article 12 rightly calls for coherence with environmental and chemical legislation to prevent unintended regulatory obstacles. Intellectual property and business confidentiality must be protected throughout. In addition, Article 29 introduces new data obligations for MAHs regarding supply and logistics chains. Despite promises of confidentiality and no duplication, the potential bureaucratic burden and risk of trade secret disclosure remain high. These obligations must be strictly limited to existing formats (ESMP or EMVS) and to a single authority. EMVS data should be leveraged to create an EU-wide early warning system, enabling real-time supply transparency and reducing the need for costly central warehousing without any new reporting duties. The definitions of MPCI in Article 2 in combination with collaborative procurement instruments of Article 21, 22 and 23 pose considerable risks for research-based pharmaceutical companies in terms of pricing, competition conditions, and market incentives in the EU, which could unintentionally hamper innovation and impede access to innovative medicines in countries such as Germany. These provisions entail significant risks to the attractiveness of the German market (including through an increase in parallel trade) and major risks of misuse of procurement as cost-containment instruments, which would further weaken the competitiveness of the EU. Therefore, collaborative procurement of MPCI must be limited to very few specific situations of high urgency and impact for EU patients and include a voluntary mechanism for the manufacturer's consent to list the product as MPCI. At the same time, it must be ensured that the procurement of MPCI does not extend beyond the Member States that are facing access problems. Thus, collaborative procurement must be limited to Member States with comparable access problems and health systems, where procurement offers real added value compared to national mechanisms that have already been exhausted. To this end, clear criteria for market failure and fully exhausted national processes must be established. Finally, safeguards are needed to ensure the confidentiality of procurement prices while limiting parallel trade to avoid unintended consequences for the German market.
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Response to EU Life sciences strategy

17 Apr 2025

As the German association representing research-based pharmaceutical companies, vfa (Verband Forschender Arzneimittelhersteller e.V.) strongly advocates for a bold and forward-looking European Life Sciences Strategy. The life sciences sector, which includes the research-based pharmaceutical industry, is not only a cornerstone of Europes economic strength but also essential to public health and societal resilience. To ensure long-term leadership, the EU must anchor its strategy in four core priorities. 1. Achieving a competitive EU market that attracts, values, and rewards innovation in line with other economies at the forefront of patient care: Europe must shape an environment that encourages and rewards innovation, comparable to global leaders. Despite its strong scientific foundation, barriers such as limited risk capital, regulatory uncertainty, and fragmented national policies deter investment. To build a truly competitive market, the EU must deploy targeted financial instruments and offer strategic support, particularly for start-ups and small to mid-sized enterprises. Europe must invest in attracting and retaining a highly skilled workforce by expanding education and training programs that address broader demographic challenges, including an ageing population and the increasing prevalence of chronic disease. Health expenditure should be viewed not as a cost but a strategic investment. The return should be measured in improved productivity, reduced social care costs, and increased revenue from health-related industries. 2. Strengthening rather than weakening Europes intellectual property provisions: A stable, strong intellectual property framework is essential to attracting life sciences investment. Recent proposals to shorten regulatory data protection and reduce market exclusivity risk eroding investor confidence. Europe must preserve its current 8+2-year model and ensure legal certainty, which is critical for enabling high-risk pharmaceutical innovation and ensuring timely patient access to new therapies. 3. Adopting a world-leading regulatory framework conducive to innovation: Europes regulatory system must ensure safety and efficacy while also enabling innovation. This requires transparent and efficient processes that reflect rapid advancements in science and technology. Procedures should be streamlined, digital tools expanded, and cross-border fragmentation reduced. While the Clinical Trials Regulation holds promise, targeted amendments and full implementation across Member States are needed. Sufficient resources and agile decision-making are essential at all regulatory levels. Moreover, Europe must act as a unified region to stay globally competitive. The swift implementation of the European Health Data Space is especially critical to harnessing digital health, AI, and novel therapies. Legal clarity around digital tools and secondary health data use is vital for innovation. 4. Providing strategic leadership, regulatory alignment, and policy coherence across the life sciences ecosystem: Long-term competitiveness demands aligned leadership, consistent regulation, and a strong industrial base. Europe must harmonize industrial, environmental, health, and innovation policies. Current inconsistenciesespecially in environmental and chemical legislationthreaten pharmaceutical production and supply chains. A coordinated strategy is essential to securing Europes resilience and manufacturing capacity. Establishing an EU Office for Life Sciences would improve oversight and policy alignment. Regular competitiveness checks, cross-sector coordination, and reduced administrative burden would strengthen the innovation landscape. The EU should adopt a dedicated Action Plan targeting areas of high unmet medical need, including orphan drugs, advanced therapy medicinal products, biopharmaceuticals, and antibiotics, driving investment, research collaboration, and accelerated patient access to transformative treatments.
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Meeting with Oliver Schenk (Member of the European Parliament)

19 Mar 2025 · Pharmaceutical Industry in Germany

Response to Health technology assessment – Joint scientific consultations on medicinal products for human use

29 Oct 2024

As stipulated by the Regulation (EU) 2021/2282 on health technology assessment (HTA), the European Commission (EC) is seeking feedback on the draft Implementing Regulation regarding the procedures for joint scientific consultations (JSC) on medicinal products for human use at the European Union (EU) level. The draft provides rules for the submission of requests for JSC, the selection and consultation of stakeholder organizations and patients, clinical experts and other relevant experts (individ-ual experts). It further details the cooperation, by exchange of information, with the European Medicines Agency (EMA) where a health tech-nology developer (HTD) requests the consulta-tion to be carried out in parallel with the scientific advice by EMA. The JSC is a crucial tool for HTDs. It offers the promise to increase the predictability of Euro-pean HTA, by creating the opportunity for HTDs to align the evidence generation of clinical development programs for new medicines to European Joint Clinical Assessment (JCA) requirements. This, in turn, should facilitate the national HTA, support pricing & reimbursement processes and ultimately improve access to new medicines in the EU. To achieve these objectives, JSCs must be offered to all HTDs that seek advice and must be provided in a timely manner to enable informed clinical development. Neither premise is achieved with this draft implementing regulation. The number of JSC is not aligned to demand, while the provision of timely advice is complicated by lack of a prac-tical rolling timetable with sufficient request periods and necessary lead time. Further, important specifications are still missing. Firstly, to ensure a timely and predictable process for HTDs, a clear timetable with deadlines for JSC without scientific advice by EMA needs to be specified. Secondly, information is missing about the process of integrating the Member States inputs into JSC, raising concerns about the applicability of JSC in all the EU Member States. Here, transparency about Member States contributions to the JSC should be ensured. The draft regulation also sets new rules for establishing a new template of the briefing package to be used where the JSC is carried out in parallel with scientific advice by EMA. It is important that the process includes the perspective of HTDs as users of the tool, to make it fit-for-purpose. This should be ensured by engaging the industry associations of the stakeholder network. The draft regulation shows the commitment to protect confidential business information. However, given the highly competitive nature of information shared by HTDs during JSC, these rules should be strengthened. This should include ensuring an equivalent level of protection as EMA, limiting shared information with individual experts to HTA-relevant contents, adding sanctions for non-compliance with professional secrecy and inserting a reference to imple-mented regulations based on the Directive (EU) 2016/943 that relates to national criminal prosecution for individuals who disclose confidential business information.
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Response to Health technology assessment – Cooperation with the European Medicines Agency

24 Jul 2024

As stipulated by the Regulation (EU) 2021/2282 on health technology assessment (HTA), the European Commission (EC) is seeking feedback on the draft Implementing Regulation (IR) that lays down detailed procedural rules concerning cooperation, in the form of exchange of information, of the Member State Coordination Group on Health Technology Assessment (CGHTA), with the facilitation of the secretariat of the Coordination Group (HTA secretariat), with the European Medicines Agency (EMA) on the joint clinical assessment (JCA) and joint scientific consultation (JSC). The draft IR provides rules concerning cooperation, in the form of exchange of information regarding the planning and forecast of the JCA and JSC, identification of patients, clinical experts and other relevant experts to be involved in JCA and JSC, regarding general scientific and technical matters related to JCA and JSC and security of sharing and protection of confidential information exchanged between the EMA and the HTA secretariat and CGHTA or its subgroups and their members within the context of JCA and JSC. Cooperation and exchange of information between EMA and CGHTA with meaningful involvement of the HTD are a prerequisite for a successful European HTA. Thus, the vfa supports a policy that aims for good cooperation and exchange of information between the EMA and CGHTA that includes the HTD in the information exchange, while preserving the separation of the respective remits of the EMA and CGHTA. To ensure that trade and business secrets are not disclosed, strict rules on the protection of confidential business information must be implemented. To ensure high-quality, transparent and efficient JCA and JSC, the HTD should be included in the information exchange between EMA and CGHTA on aspects of the individual product of the HTD. The vfa welcomes the ECs clear intention to protect confidential business information. However, the proposed rules do not go far enough to ensure effective protection. The EC should ensure that the CGHTA provides an equivalent level of protection as EMA by specifying necessary technical and organizational measures the CGHTA must implement to ensure protection. For instance, a mechanism for CGHTA should be implemented to restrict access to protected information based on the individual's role, thus increasing the level of protection. Further, EMA should only share aggregate product formation related to the planning and forecast of JCA and JSC with the HTA secretariat, while HTD should be responsible to share individual product information directly with the HTA secretariat. The EC must also ensure that exchanges on general scientific or technical issues related to JCA and JSC do not contain references to individual product information or share confidential information with the stakeholder network. Importantly, the sanctions in case of failure to respect the obligations of professional secrecy appear not strong enough to deter the misconduct regarding the disclosure of confidential business information, by orienting the punishment on the case of a failure to declare a conflict of interest. Here, a stronger sanction is needed. Importantly, a duty for the CGHTA to inform about legal consequences of disclosing confidential information should be implemented, including a reference to implemented regulations based on the Directive (EU) 2016/943 that relates to national criminal prosecution for individuals who disclose confidential business information. The disclosure of trade secrets can have serious consequences under data protection and criminal law. Germany imposes heavy fines and even prison sentences of up to 5 years for offences. The exclusion of the HTD from the information exchange of EMA and CGHTA is a major risk for European HTA process, as it makes the prepa-ration and participation of the HTD in the process more difficult. Thus, the EC must ensure the inclusion of the HTD in information exchange of EMA, HTA.
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Response to Health technology assessment – Procedural rules for the assessment and management of conflicts of interest in joint wo

25 Jun 2024

The Regulation (EU) 2021/2282 on health technology assessment (HTA) stipulates that the joint work should aim to achieve the highest level of quality, transparency and independence. To preserve the scientific integrity of the joint clinical assessments and joint scientific consultations, rules should be developed to ensure the independence and impartiality of patients, clinical experts and other relevant experts involved, and avoid conflicts of interest. The European Commission is seeking feedback on the draft Implementing Regulation laying down rules for the application of the EU Regulation on Health Technology Assessment (Regulation 2021/2282), regarding conflict of interest. The Implementing Regulation contains definitions and procedural aspects relating to the declaration and identification of conflicts of interest and their management. The rules apply to individuals, both representatives of the HTA Coordination Group (HTACG) and their subgroups and individual external experts in the health technology developers industrial sector (i.e. patients, clinical experts and other relevant experts) who participate in the joint work of the Coordination Group and its subgroups. The rules should ensure that these individuals have no financial or other interest, which could affect their independence and impartiality. The vfa supports a policy that aims for a high level of quality, transparency and independence in joint work. However, the European Commission's proposal to guarantee independence is not balanced in terms of ensuring quality. The vfa is concerned that the proposed strict rules for dealing with conflicts of interest will exclude the right people with relevant, in-depth expertise and will ultimately reduce the scientific quality of the joint work. The vfa recommends a pragmatic approach to involving the best available expertise, including individuals representing organizations, with transparent documentation of the declared interests.
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Response to Health technology assessment - Joint clinical assessments of medicinal products

28 Mar 2024

The introduction of the Joint Clinical Assessment is intended to improve the availability of innovative therapies in the EU, reduce the bureaucratic burden for HTA authorities and health technology developers and should aim to achieve the highest level of quality of the assessment. Germanys Association of Research-Based Pharmaceutical Companies (vfa) has clear expectations regarding the implementation of the EU HTA Regulation. These revolve around establishing a predictable, workable, and efficient process, characterized by reduced bureaucracy. Such measures are aimed at fostering competitiveness within the sector. The European Commission has presented the draft of the implementing regulation that lays down procedural rules for the joint clinical assessments of medicinal products for human use at the Union level for public consultation. Vfa is concerned that the industry's expectations are not met. The implementation carries considerable risks due to a process that is little predictable, hardly workable, and not very efficient. This process restricts the fundamental rights of health technology developers to be heard, receive good administration, or protect commercially confidential information. The heightened bureaucracy will inevitably impact competitiveness, while lax regulations regarding the protection of trade secrets will undermine trust in the European process. Thereby, potentially jeopardizing Germany's, as well as the EU's attractiveness as a location for the pharmaceutical industry. To achieve a predictable, workable, and efficient process safeguarding procedural rights of health technology developers with strong protection of trade secrets the following key recommendations must be considered: The HTA secretariat should always invite the health technology developer to provide further information relevant for the development of the assessment scope, including their view on the assessment scope (Article 2(3)). The HTA secretariat should share the input of Member States to the assessment scope proposal with the health technology developer (Article 9(3)). The HTA secretariat should share the consolidated assessment scope proposal with the health technology developer and give it the opportunity to provide input (Article 9(3)). The JCA Subgroup, should invite the health technology developer to provide their input during the assessment scope consolidation meeting (Article 10(1)). The HTA secretariat should always invite the health technology developer to an assessment scope explanation meeting no later than 10 days from the day on which the JCA Subgroup finalises the assessment scope (Article 11). The deadline to submit the dossier should be extended to 135 days (4.5 months) from the date of the notification of the first request to the health technology developer (Article 12(2)). A joint dossier advice should be implemented, to provide the health technology developer with the possibility to receive advice on the scope ahead of application for a marketing authorisation, thereby increasing predictability of the dossier submission process. The deadline to which the health technology developer should signal technical or factual inaccuracies and confidential information should be extended to 14 days from the date on which it received the revised draft joint clinical assessment and summary reports (Article 14(4)). To overcome the hurdles related to changes to therapeutic indications, the interaction between assessors and health technology developers should be strengthened and the deadline for submitting an updated dossier made more flexible (Article 16(1), 16(4)). The Commission should not publish the underlying documentation of the dossier of the health technology developer that contains confidential information (Article 20). The Commission should consider the views of the health technology developer on commercially confidential information and provide a conflict resolution mechanism (Article 20).
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Meeting with Matthias Ecke (Member of the European Parliament)

22 Aug 2023 · Industrie- und Pharmagesetzgebung

Response to Periodic evaluation of the implementation of Regulation (EU) 2017/1001 on the European Union trade mark

5 Dec 2022

Auf die Sondierung zu einer Bewertung der Durchführung der Unionsmarkenverordnung (EU) 2017/1001 möchte der vfa folgende Einschätzung zum Thema Gebührenfestsetzung abgeben: Die EU-Kommission merkt zu Recht in Abschnitt 39 ihrer Stellungnahme an, dass eine ausgewogene und harmonische Koexistenz der Markensysteme in der EU zu gewährleisten ist und in diesem Zusammenhang die entsprechende Höhe der Gebühren die wirtschaftliche Bedeutung der betreffenden Rechte des geistigen Eigentums widerspiegeln soll. Ferner soll verhindert werden, dass Verbraucher Rechte an Marken über ihre Interessen hinaus erlangen, d.h. ohne die Absicht und Möglichkeit, diese in der gesamten EU wahrzunehmen. Die EU-Marke gewährt seinen Inhabern ein Markenrecht in allen 27 Mitgliedsstaaten der EU. Die Gebühren für die Erteilung eines solchen Rechts durch das EUIPO sind keinesfalls zu hoch und stehen in einem angemessenen Verhältnis zu denen, die für die Erteilung eines Markenrechts in nur einem EU-Mitgliedstaat und nur mit Wirkung für diesen anfallen. Ferner stellen die Gebühren für die Erteilung für EU-Marken eine noch wahrnehmbare Schwelle gegen zu viele Anmeldungen von Marken dar, die wirtschaftlich nicht sinnvoll sind. Dies kann zu einer Überflutung des EU-Markenregisters mit unnützen Rechten führen , was dessen derzeit hohe Akzeptanz und damit Relevanz für den Schutz Geistigen Eigentums in der EU nachhaltig beeinträchtigen könnte. Ferner dürften die Gebühren in der bestehenden Höhe geeignet sein, bösgläubige Markenanmelder abzuhalten.
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Meeting with Karsten Lucke (Member of the European Parliament)

27 Apr 2022 · Forschung und Entwicklung

Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

A vital innovation ecosystem accompanied by an agile regulatory framework are prerequisites for a modern pharmaceutical system. Therefore, the German Association of Research-Based Pharmaceutical Companies (vfa), representing 47 of the world’s leading research-based pharmaceutical companies, welcomes the initiative by the Eu-ropean Commission to review the long-standing general pharmaceuti-cal legislation. In order to deliver on the objectives, set out in the EU Pharmaceutical Strategy, it is indispensable to preserve those ele-ments which have proven their value and to engage with all relevant stakeholders on those aspects which require further development to keep pace with the developments in science and technology - for the benefit of patients, the availability of innovative products, to foster a sustainable environment and to support the competitiveness of a globally operating pharmaceutical industry. However, a thorough analysis of the current framework remains imperative. The vfa would like to highlight the following: • Technological changes, scientific developments and conse-quently new `cutting edge products` require a revision in or-der to adapt accordingly to be open for future developments. Simultaneously questioning incentives in the OMP and Paediat-ric legislation is creating a situation where Europe weakens it-self in the international competition between the different re-gions in the world and as a consequence confidence in invest-ment will decrease. • The unequal access across Europe has been acknowledged. However, it is highly doubtful that changes to the legal frame-work by reducing incentives and rewards or even linking them to market launch obligations or transparency requirements will solve the multifaceted access and availability issue. Instead, it is precisely in these areas of high medical need (incl. OMPs and Paediatrics) that research and development activities in Europe become less attractive. • Expanding the role of the European Medicines Agency in as-sessing drug devices/ diagnostic combination products will be crucial to further foster the agility and competitiveness of Eu-rope’s regulatory framework. • The simplification and streamlining of approval procedures and documentation are of enormous importance: They can con-tribute to make products available faster (as demonstrated for Covid-19 vaccines) and reduce shortages. • A replacement of paper patient information through electronic versions should be enhanced as much as possible. Preparatory work for a well-functioning system has been done in Germany with Gebrauchsinformation 4.0 [Package Leaflet (GI 4.0)]. • The establishment of a secure shared access to a European Health Data Space as well as a cross-border pool of 10 million genomes for the purposes of research, innovation and clinical application, including personalised medicine, should be further explored. Such data are of great importance for the industry. • Enhanced transparency and oversight of the supply chain is crucial to identify bottle necks and provide safe and steady supply of medicines to the patient. The European interopera-bility network formed according to regulations of the Falsified Medicines Directive already links together national repositories and can serve as basis for identifying and overcoming short-ages. Generally, as well as importantly, any revision of the pharma-ceutical legislation must offer balanced solutions where Eu-rope can strengthen its competitiveness without threatening highly valued patient access to pharmaceuticals from day 1 as it is the case in Germany, and should be the result of a broad and thorough discussion. vfa and its membership stand ready to work with the European Commission, the European Parliament and the national stakeholders, e.g. the Federal Ministry for Health, to come to the best solution for a better healthcare in Europe and consequently in Germany.
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Response to Revision of the EU legislation on medicines for children and rare diseases

5 Jan 2021

The German Association of research-based pharmaceutical companies (vfa) welcomes that the European Commission (EC) is focusing on unmet medical needs (UMN). The current range of therapies for the treatment of patients with rare diseases (RD) and of children is encouraging and has been boosted by different EU initiatives over the past. At the same time, it is obvious that developing those therapies is challenging and that more research and development (R&D) needs to be done to find further ways to improve the therapeutic care for patients with RD and for children. To contribute holistically to the IIA vfa would like to highlight some aspects. The Orphan Drug Regulation is a great success. Over the past two decades it stimulated R&D in the field of RD. Since its implementation around 180 orphan medicinal products (OMPs) have been approved to treat more than 140 RD. But it is also true: most of the 8000 RD still have no therapeutic option; the majority of UMN cannot yet be targeted because relevant knowledge is still missing. Generated sales for the majority of OMPs are rather limited. Approximately two thirds of OMPs on the German market have annual revenues below EUR 10 million, more than half thereof are below EUR 1 million. Generic and biosimilar competition is depending on economic reasons and is therefore limited for OMPs. Since 2007, the Paediatric Regulation has resulted in over 400 new treatment options for children (new marketing authorisations and new indications); thereof 159 were authorised since 2017 alone – a number which is not reflected in the EC evaluation (cut-off date 2016). This shows that the Paediatric Regulation delivers. vfa likes to encourage the EC to take the following concerns into consideration for the best regulatory and incentives framework to improve the availability of therapies for RD patients and children: • The term UMN is defined differently by various stakeholders. Joint clarification via a multi-stakeholder dialogue incl. industry is needed. • Incentives have made a decisive contribution to R&D activities in the area of UMN. Reducing incentives in general or restricting them to certain UMN areas will ultimately lead to fewer R&D activities, resulting in fewer OMPs. It is also questionable that there will be a steering effect to R&D in most difficult scientific areas. • Having one OMP available to treat a certain RD does not mean that there is no longer an UMN in this area. Incentives remain essential in this context as RD patients should benefit from therapeutic choices. New rewards, e.g. additional transferable vouchers for priority review or regulatory rewards vouchers, could address UMN. • Incentives for off-patent products specifically developed and authorised for children and an improved broader pan-European infrastructure for paediatric-focussed development in the Member States are needed. • Questioning incentive instruments is gambling away confidence in investing in Europe and results in losing ground compared to other competing regions in the world. • vfa acknowledges the unequal access to pharmaceuticals across some EU Member States which is in contrast to the highly valued patient access in Germany from day one after approval (e.g. about 94% of OMPs are available to German patients). Consequently, the EU should encourage a proper analysis of the current situation and root causes. In summary, reducing incentives and rewards or even linking them with obligations to launch in a specific number of markets will not solve the access issue but will, in parallel, reduce R&D activities in the relevant fields of paediatric and RD. Instead, EC should consider all options including non-legislative ones. vfa and its membership stand ready to work with the EC, the European Parliament and the national decision makers and stakeholders to come to the best solution for a European regulatory framework which delivers on the promise of better treatments for patients.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

7 Jul 2020

vfa response on EU Commission’s Roadmap The Covid-19 pandemic revealed how essential a vital innovation ecosystem is to overcome global health threats, to maintain people’s health and to fos-ter European economies. The EU Pharmaceutical Strategy has the potential to strengthen the solid basis we have in Europe and to enhance a policy envi-ronment where Europe will catch up to close the gap to other regions regard-ing medical innovation while recognizing the importance of the pharmaceuti-cal industry. The German Association of Research-Based Pharmaceutical Companies (vfa) represents the interest of 44 of the world’s leading research-based pharma-ceutical companies. Its membership employs approx. 80,000 people, 18,000 of them in R&D. In Germany alone, these companies invest more than EUR 7 billion annually in drug research which corresponds to EUR 30 million per working day. Having a resilient health care system even in pandemic crisis requires a clear commitment to the pharmaceutical industry as a vital building block and a strong collaboration of all relevant stakeholders within the health care sys-tem. Hence, the German research-based pharmaceutical industry and the German healthcare system have ensured that all innovative, patented phar-maceuticals have been available in the required quantities through supply chains which withstood stress during the pandemic. The roadmap currently misses the opportunity to address the necessary driv-ers of innovation thus, helping to pave the way for Germany and all other European member states to become jointly a world leader in this area. There-fore, the EU Pharmaceutical Strategy must take up the missing elements in order to put Europe on a future-oriented footing. For more pharmaceutical research and development and production in collaboration with reliable in-ternational partners, certain factors have a key role: • A European research infrastructure, the digitization in the health care systems, the availability and the use of health data are needed to generate medical knowledge to develop advanced treatments and vaccines. The structural support for public and public-private research cooperation and close integration with the EU research programme "Horizon Europe" will elevate Europe’s potential to speed up patient access. But foremost a European Health Data Space will be an im-portant step for a European exchange of health data. • A sustainable industrial policy gives companies an incentives frame-work which is indispensable for progress. Questioning the necessity of intellectual property protection and incentive instruments alike is gambling away confidence in investing in Europe. As a consequence, Europe and especially Germany are increasingly losing ground com-pared to other countries, specifically the United States and some Asian countries. A strong and reliable IP and incentives framework is key to be an attractive and dynamic location for medical research to meet further unmet medical need i.a. for pediatric patients and pa-tients with rare diseases. • In contrast to the highly valued patient access to pharmaceuticals in Germany from day 1 of approval, vfa acknowledges that unequal ac-cess and lack of availability of medicines in European Member States is seen as an urgent matter that requires solutions. One element to overcome access and availability problems across Europe is the finali-sation of the regulation on a sustainable European Health Technology Assessment process, which presents a unique opportunity to ensure harmonisation regarding clinical evidence needs by regulators, HTA and industry. The EU Pharmaceutical Strategy should incorporate this potential and should drive the process between the European legisla-tive institutions. vfa and its membership stand ready to work with the European Commission, the European Parliament and the national stakeholders, e.g. the Federal Ministry for Health, to come to the best solution for a better healthcare in Europe and consequentl
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Response to Evaluation of the legislation on medicines for children and rare diseases (medicines for special populations)

21 Dec 2017

The legislation on medicines for children and rare diseases has been a success story for the patients since meanwhile many medicines have been successfully developed in these fields - and many more are in development. Therefore there is no need to change theses regulations. Yet this does not mean that everything is fine. A more pragmatic implementation of the regulation, including phased agreement on PIP components would be welcome. The problem for the companies is that they have to detail paediatric Investigation plans very early in the development of a new medicine. This means that ressources are unnecessarily spent in case that the development has to be suspended or that many variations to the detailed PIP have to be made later on. Therefore a slim PIP should be sufficient in the early stage which could be more detailed in later phases. Another problem is a growing gap between the approval and the use of pediatric medicines due to the HTA processes in individual member states, which in most cases are not taking into account the special conditions for pediatric development. What we see is that the paediatric studies which have been agreed upon in the PIP are not accepted by HTA agencies so that paediatric medicines are not or not fairly reimbursed. This problem will grow in the future since for ethical reasons the PDCO is meanwhile accepting - under certain conditions - simulation and extrapolation instead of clinical studies whereas HTA agencies are insisting on randomised clinical studies. Regarding orphans: Up to now we have specific medicines for more than hundred orphan diseases. Since up to 8 000 orphan diseases are now known we will need the incentives provided in the Orphan Regulation for many more years.
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Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

10 Nov 2017 · Health technology assessment, eHealth

Response to Revision of the European Union trade mark Regulation (2nd part)

1 Nov 2016

The Sub-Committee Trademarks of the Association of Research-Based Pharmaceutical Companies (vfa-Verband Forschender Arzneimittelhersteller e.V.) would like to give the following comments on the Draft Commission Implementing Regulation: (1) As to Recitals: Art. (11) should be read as follows: “Maximum rates for representation costs incurred by the successful party to proceedings before the Office should be specified taking into account the need to ensure that the obligation to bear the cost may not be misused, for instance, for tactical reasons by the other party.” (2) As to Title II, Application Procedure: The second sentence of Art. 9 should read as follows: “Where the mark can only be provided in the form of an electronic file, the entry concerning the representation of the mark may be substituted by an electronic link to that file.” Comment: As before, it should remain a key principle of EU trademark law that a trademark should be graphically represented where ever this is possible. Such graphical representations of trademarks facilitate legal searches which are the only way for trademark owners to assess the legal availability of their new trademark candidates and therewith necessary to limit the risk of future trademark conflicts. Furthermore, European trademark owners engaged in international business have to deal with national trademark offices of countries where high burdens for accepting foreign documents still exist. In order to secure their trademarks also in such jurisdictions, certified copies of EU Trademark registration certificates are necessary where the respective trademarks are graphically represented. The access to such certificates of registration on the EUIPO’s website should be even more easy and self-explaining than it is currently the case. This website should also contain information on the competent authority for granting an Apostille (if required) and on the competent consulate of the relevant country where legalizations of certified copies of the certificate of the registration is required ( i.e. the consulate of which EU-Member State ? or is it the representation, if any, of that country before the European Commission ?). (3) As to Title IV, Transfer Art. 13 (1.)(a) should read as follows: “the application number or the registration number of the EU trade mark;” Comment: The purpose of this proposed change is to clarify that also pending trademark applications should be subject of a transfer of a trademark. (4) As to Title VII, Costs Comment to Art. 18(1)(a)(i): Given the fact that the EU is a big territory, the successful party itself or its representative should plan their trips in their discretion but in a reasonable manner as far as time and cost are concerned. Fixed parameters such as a train has to be used for distances up to 800km should be avoided since they may not be feasible for all cases. In any event, the losing party should reimburse the successful party all reasonable cost relating to proceedings before the EUIPO as evidenced by necessary documentation. Referring to other norms (see Art. 18(1.)(a)(ii) makes only sense if the costs would then be calculated by EUIPO staff. Otherwise, it cannot be the responsibility of a trademark owner and/or its representative, to have deep knowledge of EU-internal re-imbursement policies for travel- and other feels. (5) As to Title XIII, Procedures concerning the International registration of Marks Art. 35 (1.) first sentence should read as follows: “A request for conversion of an international registration […] shall, without prejudice to the requirements laid down in Article 159 (4), (5), (6) and (7) of that Regulation , contain […]”
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