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Pharma Deutschland e.V

Pharma Deutschland

Pharma Deutschland is a major German pharmaceutical association representing prescription and over-the-counter medicine manufacturers.

Lobbying Activity

Meeting with Gabriela Tschirkova (Cabinet of Commissioner Valdis Dombrovskis)

3 Nov 2025 · Simplification: Urban Wastewater Treatment Directive (UWTD)

Pharma Deutschland urges EU to protect access to ethanol disinfectants

13 Oct 2025
Topic — The consultation seeks to simplify EU food and feed safety and biocidal product regulations.
Message — The association requests extending socio-economic exemptions to allow consumer use of hazardous biocidal substances. They also propose aligning approval periods for certain active substances to seven years.12
Why — This would prevent market bans on essential substances, maintaining profitability for disinfectant and hygiene manufacturers.34
Impact — Health and environmental organizations lose protections as hazardous substances remain on the consumer market.5
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Meeting with Florika Fink-Hooijer (Director-General Health Emergency Preparedness and Response Authority)

18 Sept 2025 · Exchange on DG HERA’s work, in particular focus on the EU’s health resilience and the recently adopted MCM strategy

Meeting with Olivér Várhelyi (Commissioner) and

18 Sept 2025 · Current relevant legislative files and geopolitical health trends

Meeting with Ekaterina Zaharieva (Commissioner) and

18 Sept 2025 · Exchange on the pharma industry and the hurdles they face.

Pharma Deutschland backs EU-wide cardiovascular health and innovation plan

17 Sept 2025
Topic — This consultation focuses on establishing a strategic framework for European cardiovascular health.
Message — Pharma Deutschland calls for a strategic framework strengthening prevention and expanding access to therapeutic interventions. They advocate for integrating digital solutions and prioritizing the European Health Data Space. The organization also requests lower innovation barriers through accelerated procedures and harmonised regulation.123
Why — Faster regulatory procedures and easier data access would reduce costs and research delays.45
Impact — Data management intermediaries may lose their role as industry bypasses existing structures.6
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Meeting with Jutta Paulus (Member of the European Parliament)

2 Sept 2025 · Pharmaindustrie und kommunale Abwasserrichtlinie

Meeting with Marion Walsmann (Member of the European Parliament, Rapporteur for opinion)

24 Jul 2025 · CMA

Meeting with Oliver Schenk (Member of the European Parliament, Rapporteur for opinion)

1 Jul 2025 · Critical Medicines Act

Pharma Deutschland seeks specific healthcare measures in EU Biotech Act

11 Jun 2025
Topic — The Commission aims to create an enabling environment to accelerate biotechnology market access.
Message — The association urges a differentiated approach to biotechnology in healthcare under the wider Act. They want to streamline clinical trial authorisations and move beyond price-driven procurement logic. This targeted approach would ensure rules are adapted to the needs of biotech innovators.1234
Why — This would lower development costs and protect valuable trade secrets from disclosure to competitors.56
Impact — Health systems may face increased spending if drug procurement ignores lowest price criteria.7
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Meeting with Hildegard Bentele (Member of the European Parliament, Shadow rapporteur)

11 Jun 2025 · Surface water and groundwater pollutants

Meeting with Jens Gieseke (Member of the European Parliament)

10 Jun 2025 · Austausch zu EU Politik

Response to Communication on the EU Stockpiling Strategy

9 May 2025

Pharma Deutschland welcomes the European Commissions initiative to establish a coherent EU strategy for strategic stockpiling. In light of increasing geopolitical uncertainties, frequent supply disruptions, and global supply chain dependencies, coordinated European action is essential. However, stockpiling for is not a universal solution it must be targeted, risk-based, balanced and realistic, especially considering the specific characteristics of pharmaceuticals. The necessary financial and human resource commitments by companies must be fairly compensated. Key recommendations: 1. Prevent Fragmentation Promote EU Coordination: National stockpiling measures often create supply imbalances and market distortions across borders. A harmonized EU framework with minimum standards, clear definitions, and coordination duties is needed. A central EU solidarity stockpile and transparent crisis-vs-routine rules should help avoid redundancies. 2. Targeted, Risk-Based Stockpiling: Stockpiling should focus only on clearly defined, vulnerable medicines based on supply risks and seasonal needs. Unsuitable products (e.g. ATMPs, radionuclides) must be excluded. Planning must be product-specific and based on actual demand, with EU-level thresholds and bulk-level storage to improve flexibility. 3. Involve the Private Sector Including SMEs and Midcaps: Successful implementation requires early and structured collaboration with the pharmaceutical industry. This includes fair inclusion of SMEs and mid-sized companies in regulatory and financial frameworks, realistic logistics, and shared risk assessments. 4. Ensure Sustainable Financing Models: Strategic stockpiling requires significant investment. Mixed-financing models (e.g. cost-sharing, tax incentives), mechanisms to offset expiration risks, and integration with national reimbursement systems are essential to ensure industry participation. 5. Enable Digital Coordination and Efficient Governance: A tiered governance model, real-time digital stock monitoring, and integration of existing systems (e.g. EMVS, securPharm) can streamline coordination. Avoiding duplication through TRIS notifications and harmonized labeling/packaging is key. 6. Foster International Cooperation: Supply chains are global. The EU should pursue international agreements on manufacturing, storage, and logistics of critical medicines, and align with platforms like WHO, G7, and OECD. Conclusion: Pharma Deutschland supports a resilient EU-wide stockpiling strategy one that is harmonized, risk-based, and inclusive. Stockpiling must not replace preventive health policy, and national solo efforts must be avoided to ensure reliable access to essential medicines across Europe, especially during crises. The full statement is attached.
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Meeting with Angelika Niebler (Member of the European Parliament) and Merck Sharp Dohme Europe Belgium SRL

15 Apr 2025 · European health policies

Meeting with Oliver Schenk (Member of the European Parliament)

2 Apr 2025 · Pharmaindustrie in Europa

Meeting with Manuela Ripa (Member of the European Parliament)

20 Mar 2025 · Health topics

Meeting with Jan Ceyssens (Cabinet of Commissioner Jessika Roswall)

20 Mar 2025 · Presentation of the industry’s views on the potential costs and impact of the extended producer responsibility (EPR) scheme introduced in the urban wastewater directive (in force)

Pharma Deutschland urges EU to prioritize supply security over price

7 Mar 2025
Topic — The European Commission is evaluating the effectiveness and relevance of current public procurement directives.
Message — Pharma Deutschland advocates moving beyond the lowest price to include quality and sustainability criteria. They call for a 'Buy European' rule to prioritize domestic production of critical medicines. They also seek simplified digital procurement to help smaller companies participate in tenders.123
Why — European pharmaceutical manufacturers would gain a competitive edge over cheaper, non-EU production sites.4
Impact — Non-EU manufacturers lose guaranteed equal treatment in high-value pharmaceutical tender processes.5
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Pharma Deutschland urges long-term incentives for European medicine production

27 Feb 2025
Topic — A consultation on reducing supply chain dependencies and vulnerabilities for critical medicines in Europe.
Message — Pharma Deutschland requests a review of environmental laws to protect supply security. They seek streamlined reporting and digital-only information to ease cross-border distribution.12
Why — This would lower compliance costs and improve profitability for mid-sized pharmaceutical manufacturers.3
Impact — Environmental groups lose if wastewater standards are lowered to reduce industry financial pressure.4
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Meeting with Peter Liese (Member of the European Parliament) and Eurogroup for Animals and

29 Jan 2025 · Austausch

Meeting with Svenja Hahn (Member of the European Parliament) and Verband der Automobilindustrie and

24 Jan 2025 · Exchange on Green Claims

Meeting with Michel Sponar (Acting Head of Unit Environment)

15 Jan 2025 · Discussion on the implementation of the recast UWWTD, with a focus on Extended Producer Responsibility (Article 9)

Meeting with Hildegard Bentele (Member of the European Parliament, Shadow rapporteur)

17 Dec 2024 · Surface water and groundwater pollutants

Meeting with Peter Liese (Member of the European Parliament) and Bayer AG

12 Dec 2024 · Austausch

Meeting with Andrea Wechsler (Member of the European Parliament) and Zimmer Biomet Holdings

3 Dec 2024 · EU Environmental Policy

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

29 Oct 2024

Pharma Deutschland e.V. would like to thank you for the opportunity to comment on the draft implementing act - Ref. Ares(2024)6931211 - 01/10/2024. In view of the crucial importance of the JSC process for the overall success of the EU HTA, Pharma Deutschland considers the regulations proposed in the above-mentioned draft for pharmaceutical manufacturers and health technology developers (HTD) as not yet sufficiently concrete to ensure sufficient coordination between the joint scientific advice and the future assessment of health technologies and to give HTD sufficient planning certainty with regard to clinical development programs. Our main concerns relate to the following aspects: - The provision of necessary resources for a sufficient number of consultations. - An unrestricted choice of consultation content that is not limited to clinical trials in the planning stage. - Making the application phases for consultancy applications more flexible and providing guidance on interpreting the selection criteria for products receiving consultations. - Involving experts timely and providing them with relevant information. - Publication of the key findings from the consultations, particularly in the event of a lack of consulting capacity. - Maintaining confidentiality. Please see the attached statement for further details.
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Response to Health technology assessment – Procedural rules for the assessment and management of conflicts of interest in joint wo

26 Jun 2024

Pharma Deutschland does not consider the proposed regulations for medicines manufacturers to be sufficient to develop drugs for patients successfully and introduce them into the European market. The Commission´s proposal does not adequately include specificities of new health technologies concerning the involvement of clinical experts. For a successful start of the Joint Clinical Assessment in less than seven months, a constructive dialogue between all actors, including the medicines manufacturers, is urgently required. Pharma Deutschland is ready for this dialogue. Please see the attached statement for further details.
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Pharma Deutschland urges mandatory industry involvement in drug assessments

28 Mar 2024
Topic — Implementing rules for joint clinical assessments of medicinal products under EU health technology regulations.
Message — Pharma Deutschland demands mandatory bilateral meetings and the right to provide input during the scoping phase. They also seek longer submission deadlines and better protection for commercially sensitive data.12
Why — Mandatory involvement and longer deadlines would help companies protect trade secrets and improve submission quality.34
Impact — Health authorities may face slower assessment timelines due to mandatory manufacturer consultations and longer deadlines.56
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Response to Revision of the variation framework for medicines

28 Feb 2024

Der BAH unterstützt den vorgelegten Entwurf einer delegierten Verordnung zur Änderung der Verordnung (EG) Nr. 1234/2008 (Variation-Verordnung), sieht aber weiteren Raum für Optimierungen, um dem ursprünglichen Ziel, den Prozess der Änderungen von Zulassungen zu rationalisieren und zu vereinfachen, noch besser gerecht zu werden. Insbesondere möchten wir die aus unserer Sicht notwendige Ergänzung der Definition von Typ IA Variations betonen. Dieser Variation-Typ wird häufig von Behörden zur Einreichung sicherheitsrelevanter Textänderungen z.B. nach PSUSA Verfahren empfohlen, da hier keine inhaltliche Beurteilung mehr erforderlich ist, was bei Typ IA Variations Verfahrensimmanent ist. Allerdings haben diese Änderungen unbestritten eine Auswirkung auf Wirksamkeit und/oder Sicherheit des Produktes Daher schlägt der BAH vor, die Definition von Typ IA Änderungen in Artikel 2 zu ergänzen. Zudem sollte Artikel 24 die Implementierung betreffend ergänzt werden, um den Unterschieden dieser Variations im Vergleich zu eigen-geplanten Änderungen Rechnung zu tragen. Hierdurch kann eine rechtssichere Basis für nationale Empfehlungen und Regelungen zur Umsetzung in die gedruckten Packmaterialien geschaffen werden, welche berücksichtigen, dass die Umsetzung von Änderungen der informierenden Texte einer gewissen Vorlaufzeit bedarf. Im Falle dieser Typ IA Änderungen werden die Einreichefristen i.d.R. von CMDh bzw. NCA fest vorgegeben, daher ist eine vorherige Umsetzung in den gedrucken Materialien vor der Einreichung in der Regel nicht möglich. Unser Vorschlag berücksichtigt die Besonderheit dieser Variations sowie die Empfehlungen und Interpretationen der CMDh. Im Hinblick auf die Einstufung von Änderungen schlagen wir die Möglichkeit eines Downgradings von Variations vor, welche keine Auswirkungen auf die Qualität, Wirksamkeit oder Sicherheit des Arzneimittels haben. Zudem spricht sich der BAH für eine Ausweitung des risikobasierten Ansatzes für die Klassifizierung von Änderungen aus, so dass alle Produkttypen (einschließlich der pflanzlichen Arzneimittel) von diesem Ansatz profitieren können. Für Änderungen, die noch nicht klassifiziert sind und für die eine Artikel 5 Empfehlung eingeholt wird, sollte das Prüfverfahren beschleunigt werden. Das Grouping von Variations ist aktuell sehr strikt geregelt. Dadurch sind viele Änderungen nur in mehreren Anzeigen abzuarbeiten. Eine Verbesserung wäre die Möglichkeit, zusammenhängende Qualitätsänderungen grundsätzlich in einem Grouping zusammenzufassen und gemeinsam umzusetzen. In Bezug auf das Verfahren zur Arbeitsteilung (Worksharing) sind Änderungen von Typ IB oder Typ II aktuell eine Voraussetzung zur Anwendbarkeit. Vor dem Hintergrund der neu vorgeschlagenen Regelungen zum Super-Grouping, die sehr begrüßt werden, sollten auch Typ IA Änderungen in das Worksharing-Verfahren integriert werden können. Letzteres sollte aus Sicht der Industrie zudem fakultativ für Antragsteller bleiben. Weiterhin schlagen wir vor, bereits jetzt die gesetzlichen Grundlagen für die Digitalisierung zu implementieren, auch wenn das Thema Digitalisierung erst im 2. Schritt des Prozesses zur Überarbeitung der Variation-Regulation grundsätzlich angegangen werden soll. Dadurch können Änderungen in diesem Rahmen zukünftig umgesetzt werden, sobald die technischen Voraussetzungen dafür gegeben sind. Infrage kommende, geringfügige Änderungen des Typs IA/IA(IN) könnten dann in vielen Fällen einfach in PMS abgebildet werden, so dass keine separate Einreichung mehr nötig wäre. Derartige digitale Lösungen bestehen schon jetzt (z.B. über die Datenbank nach Artikel 57) und sollten daher analog ausgeweitet und ready-for-future gemacht werden. Die vollständige, detaillierte Stellungnahme des BAH ist dem Anhang zu entnehmen.
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Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and AbbVie and Haleon

14 Feb 2024 · Directive on Medicinal products for human use

Meeting with Peter Liese (Member of the European Parliament) and Verein Deutscher Zementwerke e.V.

12 Jan 2024 · Austausch

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and ReAct - Action on Antibiotic Resistance

8 Dec 2023 · Directive on Medicinal products for human use

Pharma Deutschland slams bureaucratic EU pharmaceutical reform plans.

3 Nov 2023
Topic — The European Commission is evaluating and revising the general pharmaceutical legislative framework.
Message — The group requests limiting shortage prevention plans only to critical medicines. They advocate for clear incentives for pediatric drug research to prevent off-label use. They demand that authorization holders be consulted before updating product information using health data.123
Why — Limiting regulatory requirements reduces compliance costs and preserves competitiveness for medical manufacturers.45
Impact — Medium-sized companies face reduced market competitiveness due to more difficult access to approval procedures.6
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Pharma Deutschland Warns EU Drug Reform Threatens Industry Competitiveness

3 Nov 2023
Topic — Evaluation and revision of the general European Union pharmaceutical legal framework and public health legislation.
Message — The association opposes mandatory prescriptions for antivirals and requests longer data protection for over-the-counter medicines. They also request removing new bureaucratic burdens like stricter environmental assessments and shortage obligations.12
Why — These changes would preserve market access and reduce compliance costs for mid-sized pharmaceutical manufacturers.3
Impact — Patients and health systems face higher costs and delayed care if common medicines require prescriptions.4
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Pharma Deutschland Urges More Flexible Medicine Lifecycle Management Rules

26 Sept 2023
Topic — The initiative reviews procedures for post-authorisation changes to human medicine marketing authorisations.
Message — Pharma Deutschland requests a more flexible framework to make the lifecycle management of medicines more efficient. They propose extending the risk-based approach to all medicines and simplifying grouping and worksharing procedures. They also advocate for digital solutions to report minor changes through existing databases.1234
Why — Streamlined rules would significantly lower administrative costs and resource burdens for pharmaceutical manufacturers.5
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Pharma Deutschland Urges Leaner EU Green Claim Regulations

20 Jul 2023
Topic — EU initiative requiring companies to substantiate environmental claims through footprint methods.
Message — The association calls for a more streamlined regulation accessible to small and medium-sized enterprises. They argue existing national laws and unfair practice directives already effectively prevent misleading green claims.12
Why — Maintaining the current system would prevent pharmaceutical companies from facing excessive certification costs.34
Impact — Consumers risk higher prices and limited information if smaller firms are priced out.56
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Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur) and AstraZeneca PLC and Affordable Medicines Europe

6 Jul 2023 · Revision of Pharmaceutical Legislation (staff level)

Response to Revision of the Urban Wastewater Treatment Directive

14 Mar 2023

Der BAH, BPI, ProGenerika und vfa vertreten die Interessen der deutschen Arzneimittel- und Medizinprodukteindustrie gegenüber der Politik, Behörden und Institutionen im Gesundheitswesen. Die politische Interessenvertretung und die Betreuung der Mitglieder erstrecken sich auf die Gebiete der verschreibungspflichtigen und nicht verschreibungspflichtigen Arzneimittel sowie auf Medizinprodukte, wie z.B. Medical Apps und digitale Gesundheitsanwendungen. In der Summe sprechen die vier pharmazeutischen Verbände für über 500 Mitgliedsunternehmen. Grundsätzlich unterstützen die beteiligten Verbände die Initiative der EU-Kommission, Maßnahmen zur Verringerung der Verschmutzung des kommunalen Abwassers zu ergreifen und den ökologischen Zustand der Gewässer zu verbessern. Allerdings erscheint der nun vorliegende Entwurf der Kommission zur Reform der EU-Kommunalabwasserrichtlinie nicht ausgereift. Ohne eine im Detail nachvollziehbare Begründung werden weitreichende Maßnahmen vorgeschlagen, die zu einer substanziellen und dauerhaften ökonomischen Belastung vieler Arzneimittel-Hersteller mit negativen Auswirkungen auf die Arzneimittelversorgung führen würden. Die ausführliche Stellungnahme zusammen mit der Zusammenfassung eines durchgeführten wissenschaftlichen Gutachtens finden Sie im Anhang.
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Pharma Deutschland Demands Equal Access to European Health Data

28 Jul 2022
Topic — The European Health Data Space proposal facilitates health data sharing for research and care.
Message — The association demands that industrial research be explicitly recognized as a legitimate user of secondary health data. They request strict protections for trade secrets and a harmonized implementation across all member states to avoid regulatory fragmentation.123
Why — Explicit data access and IP protections will reduce development risks and costs.4
Impact — Public health bodies may face increased costs due to market-rate data fees.5
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Pharma Deutschland seeks limits on EU supply chain liability

23 May 2022
Topic — The EU is consulting on new sustainability due diligence rules for large companies.
Message — The association requests limiting due diligence to the first downstream level and replacing civil liability with fines. They also propose extending the reporting cycle for small and medium enterprises from one to three years.123
Why — The industry avoids expensive litigation and reduces administrative burdens for its member companies.45
Impact — Impacted individuals lose the right to seek financial compensation through European civil courts.67
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Pharma Deutschland Urges Strong Patent Protection and Simpler Regulation

27 Apr 2021
Topic — The EU is revising pharmaceutical laws to improve innovation and medicine supply.
Message — The organization insists that intellectual property protection must not be restricted. They propose extending data exclusivity for non-prescription switches to three years. They also suggest making pandemic-era regulatory flexibilities, such as remote assessments, permanent.123
Why — Extended exclusivity periods would safeguard their research investments from generic competition.45
Impact — Generic drug manufacturers would face significant delays entering the European market.6
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Response to European Health Emergency Response Authority

24 Feb 2021

The BAH welcomes the European Commission's efforts to address the weaknesses in European health preparedness and crisis response to severe cross-border health threats revealed by the COVID-19 pandemic. We understand the intention to facilitate coordinating activities along the entire value chain and the monitoring of production capacities, raw material needs and availability through a European Health Emergency Response Authority (HERA). However, it is of utmost importance to shed light on the multifactorial causes of development, production, procurement and distribution problems in order to take appropriately targeted measures. In setting up a new authority, it is crucial for medicines manufacturers that the roles between the different European authorities are clearly defined – also against the background of the concrete proposals to extend the mandates of the European Medicines Agency (EMA) as well as the European Centre for Disease Prevention and Control (ECDC) – and that no duplicate or even multiple structures are established. In this context, coordination and cooperation with national authorities must ultimately also be clarified. The aim should be to simplify the administrative and regulatory framework in order to establish efficient decision-making structures. In this context, the other strategic initiatives of the European Commission, such as the Pharmaceutical Strategy for Europe, as well as the ongoing efforts to create the necessary infrastructure for the success of the existing regulatory framework, such as the Regulation on Medical Devices, should also be considered. The principle must be to avoid unnecessary duplication of work, ensure a proportionate and appropriate division of responsibilities, and create the necessary synergies with other policies and stakeholders. Among other things, the new EU authority should increase the production capacity and adaptability of medicines manufacturers. However, this does not necessarily require a new authority. Already a higher level of regulatory flexibility for medicines manufacturers might achieve the desired results to a certain extent. The administrative burden regarding approval and market access must be reduced to a reasonable level. For example, it should be easier for a medicines manufacturer to switch to another active ingredient manufacturer as part of the production process, thus facilitating substitution, especially in the case of supply shortages. Particular attention should generally be paid to the too far-reaching regulatory requirements for medicines with known substances for which regulatory relief would increase the availability of products. To generate real added value from HERA, it would be appropriate to first carefully evaluate existing decision-making structures and verify which (additional) roles might be taken over by the new authority. This includes urgent responses to health threats but also long-term planning for example in the context of the EU research programs. The new EU authority would have to complement and create synergies with the work of existing EU agencies, in particular the ECDC and EMA. Furthermore, the causes of the weaknesses in European health preparedness and crisis response to severe cross-border health threats revealed by the COVID-19 pandemic are multifactorial. In order to support the response capacity of Member States and the availability of and access to countermeasures, evaluation and promotion of various short-, medium-, and long-term solutions are needed.
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Response to A European Health Data Space

3 Feb 2021

Der BAH begrüßt die Initiative der Europäischen Kommission zum European Health Dataspace (EHDS) und hat folgende Erwartungen und Anforderungen: 1. Die EU KOM sollte den Status quo erheben, um einen konkreten Überblick über die einzelnen Länder und darüber zu erlangen, welche wesentlichen Hemmnisse für einen gemeinsamen Datenraum bestehen, um den Rechtsrahmen möglichst zielgenau und effizient auszurichten. (Siehe u.a. unterschiedlichen Umsetzungen europäischer Vorgaben in nationales Recht.) 2. Komplexität ist zu verhindern. Es sollte ein sparsamer Umgang mit Regelungen erfolgen. Inflationäre Beteiligung von Behörden/Institutionen ist zu vermeiden. 3. Es sollten verbindliche rechtliche Regelungen zur Haftung, aber auch zum Schutz des geistigen Eigentums entwickelt werden. 4. Der dynamischen Entwicklung in der Digitalisierung des Gesundheitswesens ist mit einer agilen Regulatorik in Europa Rechnung zu tragen. Die bestehenden Entscheidungsstrukturen in der EU sind schnellstmöglich zu reformieren, um im Wettbewerb mit z.B. China und den USA bestehen zu können. 5. Vorhandenen Daten zu Substanzen und Therapien aus der klinischen Entwicklung, aber auch aus dem Versorgungsalltag sollten für in Forschung und Entwicklung engagierte Institutionen und Unternehmen zur Verfügung stehen und für die angestrebten Zulassungen und die notwendige Evidenzgenerierung genutzt werden können. 6. Für eine möglichst schnelle und effiziente Nutzung der vorhandenen Daten unterschiedlicher Quellen in den Mitgliedssaaten, sollten diese so vorgehalten und aufbereitet werden, dass sie anlassbezogen in paneuropäisch konsentierten Strukturen und Formaten sowie anonymisiert an einen zentralen europäischen Hub, aufgehängt bei der EMA, gemeldet werden können. Der Hub sollte eine koordinierende Funktion haben, selbst aber keine Daten speichern. 7. Solidarische Incentivierungsmodelle, weniger monetärer als vielmehr wissensbasierter Art, sollten die verschiedenen Stakeholder motivieren, Daten einerseits zu geben und andererseits zu nutzen. Es ist zu vermeiden, dass Daten zu einem Verkaufsprodukt werden. 8. Das EHDS sollte sukzessive, aber von Beginn an spürbare Teilprojekte umsetzen (z.B. Schaffung eines Datenraums in Bezug auf Krebsregisterdaten.) 9. Mit den Daten aus der realen Versorgung sind Mehrwerte für Patienten zu generieren, in dem die Chancen für eine zielgerichtete und direkte Information über gesundheitliche Leistungen sowie für die Entwicklung von neuen Therapiemöglichkeiten wahrgenommen werden. Das setzt voraus, dass auch die Anbieter von Gesundheit, wie Arzneimittel-Hersteller, die Möglichkeit haben, Daten als Forschungs- und Informationsgrundlage zu erhalten, um genau diese Therapiemöglichkeiten für Patienten zu entwickeln. 10. Mit dem EHDS sind Kommunikations-, Bewegungs- und Wahlfreiheit der Europäer in Bezug Gesundheits-Coaching und -Monitoring sowie Datensouveränität zu gewährleisten. 11. Interoperabilität ist ganzheitlich zu fördern. Alle Datenstrukturen, Schlüsselsysteme und Nomenklaturen sollten an den international anerkannten Standards ausgerichtet sein. Es ist zu prüfen, inwieweit es in Europa einer ordnenden Einrichtung bedarf, die einen konkreten Umsetzungsrahmen und Werkzeuge für die Digitalisierung des Gesundheitswesens schafft. 12. Der EHDS muss den höchsten Anforderungen an IT-Sicherheit und Datenschutz Rechnung tragen und sollte daher von vorneherein so angelegt sein, dass er mit dem fortlaufenden technischen Fortschritt mithalten kann, aber auch den stetig dazulernenden kriminellen Gefährdern ein Schritt voraus ist. 13. Die bisher gültigen Regelungen zu KI wurden für vergleichsweise starre Bereiche geschaffen und passen in vielen Fällen nicht zu der sich permanent weiterentwickelnden KI. Zur Verbesserung der Versorgung mit Hilfe von KI ist es daher bedeutsam, mit dem EHDS einen Rechtsrahmen zu schaffen, der dieser Technologie Rechnung trägt und innerhalb dessen Unternehmen robuste, genaue und sichere KI-Lösungen entwickeln können.
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Response to Proposal for a Regulation on a Union framework addressing public health emergencies (EMA)

2 Feb 2021

In general, BAH welcomes the transfer of coordinating, advisory and supporting tasks to the EU or the EMA respectively in certain defined (crisis) situations, particularly in connection with combating shortages. In order to secure production and supply, unilateral national measures such as restrictions on the free movement of goods, export bans or similar measures must be avoided. Across Europe, borders always have to remain open, at least for the movement of goods and merchandise and for commuters. In crisis situations, a coordinated approach makes sense and is necessary. In the current pandemic situation, the coordinating measures at European level via the list of critical medicines and the SPOC or I-SPOC communication procedure have proven to be useful. It is also beneficial to organise procurement measures on a European scale in such a situation. The EU has a better negotiating position on the world market compared to a single member state. In addition, the interests of all member states can be better considered on an equal footing. However, the experience with the current procurement of COVID-19 vaccines must be taken into account here so that rapid and targeted action is possible in future. In summary, it can be stated that first and foremost, existing structures should be used before a significant number of others are created. The envisaged tasks of the Emergency Task Force could be taken over by the ECDC. It has the appropriate experts and is to have its range of tasks expanded in a further regulation anyway. In addition, the network of national regulatory authorities, which is also very well established and has proven good collaboration in the context of the current pandemic, should be used primarily in connection with dealing with and combating shortages. These are also more likely to consider regional specificities. Due to the various regulatory projects with partial expansion of existing structures and expansion through new structures, the interfaces, the tasks and responsibilities must be precisely defined so that the regulations are practicable. For further details please see the attached file.
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Meeting with Margaritis Schinas (Vice-President) and

30 Nov 2020 · Future of Medicines

Response to Intellectual Property Action Plan

14 Aug 2020

Bundesverband der Arzneimittel-Hersteller e.V. (BAH) – the German Medicines Manufacturer Association - entirely agrees with the onset of the IP-Roadmap stating under A.: Nevertheless the IP-Roadmap falls short of its objective in so far as it does not seem to include ´Know How` as the elementary asset of the EU-economy but specifies only a limited scope of IP rights in referring to “IP rights (IPRs) such as patents, trade marks, designs, geographical indications and copyright…”. Small and medium sized enterprises throughout the EU nevertheless tend to be more Know How based than anything and not relying on the more elaborate IPRs like patents, designs and geographical indications that require involvement of manpower, expertise, costs, professional specialists and correspondence with state agencies to obtain. Even today Know How is a more fruitful driving force of development at a small but constant scale rather than patents or designs that require a distinctive and significant leap in innovation to be granted at all. Thereby protection may not solely be obtainable under the regime of IPRs named under the IP-Roadmap so far for the vast majority of innovations held by small and medium sized enterprises whereby they may hold valuable intellectual property protected under law as Know How. BAH hereby request the IP-Roadmap to be extended to encompass Know How. Know How will be valuable as an asset of commercial interests only if dealt with as a trade secret. The EU has already embarked to improve the protection of undisclosed Know How and business information (trade secrets) against their unlawful acquisition, use and disclosure by way of DIRECTIVE (EU) 2016/943 of 8 June 2016. Nevertheless this Directive does not apply to EU or national administrative agencies where trade secret holders are required to disclose information, including trade secrets (Art.1 section 2. lit. (b) (EU) 2016/943). This Directive does also not apply to “Union or national rules requiring or allowing Union institutions and bodies or national public authorities to disclose information submitted by businesses (Art.1 section 2. lit. (c) (EU) 2016/943). Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents under its Art. 4 section 2. defines exceptions to access to a document where disclosure would undermine the protection of “commercial interests of a natural or legal person, including intellectual property”. “Intellectual property” within this clause also refers to Know How. It is desirable to define data, documents and information containing Know How more generally as trade secrets also to be protected by Union institutions and bodies or national public authorities. Under it´s ´Pharmaceutical strategy for Europe` the EU aims to take legislative and non-legislative action to “help European pharmaceutical companies’ compete on the global level on an equal footing.”. This immediately relates to the more comprehensive objective to “reduce direct dependence on raw materials sourced from non-EU countries”: https://ec.europa.eu/health/human-use/strategy_de It is obvious that legal impediments to obtain legal protection for Know How held by Union institutions and bodies or national public authorities as trade secrets is detrimental to accomplish one or more of these aims. The aims defined under the ´Pharmaceutical strategy for Europe` as such qualify as a ´public interest` as well as an ´economic policy of the Community or a Member State` as referred to in Art. 4 section 1 (a) Regulation (EC) No 1049/2001. It is desirable that both under the IP Action Plan as well as the Pharmaceutical strategy for Europe the EU may give rise to reconsiderations with regard to the obligations and prerogatives set out in Union or national law on the public or individual disclose of information submitted by businesses as well as to the access to documents containing Know How.
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Response to EU cooperation on Health Technology Assessment

26 Mar 2018

Arzneimittel-Hersteller können von einem einheitlichen europäischen HTA-Prozess profitieren, da die unterschiedlichen nationalen und regionalen Anforderungen die Unternehmen vor große Herausforderungen stellen. So variieren der Startzeitpunkt und die Dauer des HTA-Prozesses sowie die klinischen Anforderungen innerhalb der EU-Mitgliedstaaten. Diese teilweise sehr unterschiedlichen nationalen Herangehensweisen bewirken unterschiedliche Resultate im HTA-Prozess sowie eine Vervielfachung der Arbeits- und Kostenbelastung für Unternehmen. Zusätzlich werden die Patienten in Europa von einem europäischen HTA-Prozess profitieren, da sie innovative Arzneimittel schneller nutzen können und die Mitgliedstaaten, die für ihre nationalen Gesundheitssysteme und die Preis- und Erstattungsregeln zuständig sind, die Ergebnisse der gemeinsamen klinischen Bewertung berücksichtigen müssen. Maßgebende Regelungen werden im Laufe der Gesetzgebung durch delegierte Rechtsakte getroffen, so dass der HTA-Verordnungsentwurf momentan noch zahlreiche Fragen offen lässt, z.B. bzgl. der Vergleichstherapie/Komparator oder der Auswahl des Assessors/Co-Assessors. Ebenso ist die Bestimmung der Methoden, die einem ‚joint clinical assessment‘ zugrunde liegen, im Entwurf nicht enthalten. Die Abwesenheit einer Definition der Methodik ist ein Hauptkritikpunkt an dem vorliegenden Verordnungsentwurf. Entscheidend für den Nutzen einer EU-HTA für Hersteller ist die konkrete Ausgestaltung der Methodik und der prozeduralen Regeln. Diese werden jedoch weitgehend in delegierten Rechtsakten und Durchführungsrechtsakten ausgelagert und nicht im Verordnungsentwurf selbst geregelt. Die Kontroll- und Beteiligungsrechte dieser Rechtsakte von EU-Parlament oder EU-Rat und natürlich auch der Verkehrsbeteiligten sind sehr eingeschränkt. Dies schafft eine erhebliche Unsicherheit über den Nutzen und Erfolg einer HTA-Verordnung. Der aktuelle Verordnungsentwurf sieht eine geringe Beteiligung der Hersteller (pU) vor. Diese Beteiligungsrechte müssen ausgebaut werden – primär beim Erstellen der Berichte nach Artikel 6, aber auch z.B. im Hinblick auf die Möglichkeit, neue oder erweiterte Daten vorzulegen. Zusätzlich scheinen die Verfahren rein schriftlich durchgeführt zu werden, was abzulehnen ist. Zum möglichen Rechtsschutz werden keine Aussagen getroffen. Es ist zu begrüßen, dass die Bewertung nicht-klinischer Aspekte (Kosten, soziale Auswirkungen etc.) in dem Verordnungsentwurf ausgenommen sind. Nur nationale Entscheidungen können hierbei zielführend sein, um lokale Versorgungsrealitäten zu berücksichtigen. Entscheidungen über Erstattung oder Preise müssen also weiterhin national geregelt werden, so wie es Artikel 168 (7) AEUV vorsieht. National zugelassene Arzneimittel wie z.B. die überwiegende Zahl der OTC-Arzneimittel fallen nicht in den Anwendungsbereich der Verordnung. Grundsätzlich sollten alle OTC-Arzneimittel sowie stoffliche Medizinprodukte zur Selbstbehandlung zukünftig von der Verordnung ausgenommen werden.
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