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Bundesverband der Pharmazeutischen Industrie e.V.

BPI e.V.

The BPI represents over 260 pharmaceutical companies in Germany, covering drug research, development, approval, manufacturing and marketing across traditional pharma, biotech, herbal medicines and homeopathy.

Lobbying Activity

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

13 Jan 2026 · Versorgungssicherheit für Arzneimittel

Meeting with Patricia Reilly (Cabinet of President Ursula von der Leyen)

23 Sept 2025 · to follow

Meeting with Patricia Reilly (Cabinet of President Ursula von der Leyen)

23 Sept 2025 · Exchange on Key EU Health and Industrial Policy Initiatives

German pharma group urges direct data access for heart research

16 Sept 2025
Topic — A European Union initiative to improve cardiovascular health, prevention, and medical innovation.
Message — BPI calls for EU-wide screening protocols and immediate access to health data for clinical trial sponsors. They also recommend establishing a pan-European registry for congenital heart defects to improve research outcomes.123
Why — Pharma companies would gain competitive advantages by bypassing intermediaries to access research-critical health data.4
Impact — Data intermediary bodies would lose their oversight role and the associated processing delays they manage.5
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Meeting with Marion Walsmann (Member of the European Parliament, Rapporteur for opinion)

4 Sept 2025 · Critical Medicines Act

Meeting with Oliver Schenk (Member of the European Parliament)

9 Jul 2025 · Frauengesundheit in der EU

Response to Critical Medicines Act

4 Jul 2025

The German Pharmaceutical Industry Association (BPI) welcomes the European Commissions initiative to reinforce Europes role as a pharmaceutical production hub. We support measures such as promoting strategic projects, streamlining administrative processes, and revising procurement criteria to improve the production and availability of critical medicines. Nevertheless, the Critical Medicines Act (CMA) should focus on EU-listed critical products to ensure targeted and effective measures. We call for tightening certain provisions to boost competitiveness, innovation, and the security of supply without adding bureaucratic burdens or distorting the market. The CMAs scope covers medicines on the Union List of Critical Medicines. The BPI stresses the need for objective and transparent criteria in identifying these products, and advocates stakeholder involvement in updates. Noting discrepancies between EU and national lists of critical medicines, we recommend including provisions that allow Member States to implement exceptional national measures to address specific supply issues not fully covered by the Union list. We also note the introduction of a new category, medicinal products of common interest, which currently lacks clear selection criteria. We therefore request greater transparency and clarity regarding its definition and scope. We endorse the CMAs declaration of critical medicines supply as a strategic EU objective, and value the Commissions coordination of Member State actions. We also call for formal recognition of the pharmaceutical industrys vital role in achieving this objective. The BPI supports the introduction of strategic projects for manufacturing, including investments in new and existing facilities. We recommend clear and uniform selection criteria for these projects across Member States, as well as pragmatic and flexible regulatory procedures to expedite implementation. Companies should be able to coordinate changes related to strategic projects directly with authorities, without prior approval from the Medicine Shortages Steering Group. We welcome measures for bureaucratic relief, streamlined environmental assessments, and exemptions from conflicting regulations for medicinal products granted privileged status. We also call for sufficient funding for strategic projects and urge the European Commission to conduct a thorough financial assessment for the next Multiannual Financial Framework. The BPI supports adapting procurement criteria to prioritise resilience and sustainability over the lowest price alone. We propose that tenders require a minimum number of market participants, mandate multiple awards, and reward European-based production. We advocate limiting tenders to specific product segments and ensuring sustainable business models for suppliers. Collaborative procurement mechanisms should remain voluntary for both Member States and marketing authorisation holders. We believe joint procurement should remain primarily a competence of the Member States, and therefore oppose extending the Commissions role, except in exceptional situations such as pandemics. The BPI highlights the importance of industry involvement in the Critical Medicines Coordination Group and values the existing Critical Medicines Alliance working groups. We find the CMAs approach to international cooperation too vague and call for clearer strategies and implementation plans. We urge limiting reporting obligations to existing formats to prevent duplication, minimise administrative burdens, and protect business secrets. The BPI supports the CMAs overarching goals but calls for targeted, transparent, and pragmatic measures that strengthen Europes pharmaceutical sector without adding undue complexity or bureaucracy. We emphasise the need for coherence with existing and future EU initiatives and continued dialogue with all stakeholders to ensure effective implementation. Please see annexed document for further elaborati
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German pharma group BPI calls for EU Biotech Agency

10 Jun 2025
Topic — Proposed EU legislation to accelerate biotech product transitions from laboratory to market.
Message — BPI recommends establishing a dedicated EU Biotech and Biomanufacturing Agency to manage infrastructure and funding. They also advocate for an Innovation Fund to support biotech companies from research through to manufacturing.12
Why — These measures would lower capital barriers and reduce administrative costs for pharmaceutical developers.34
Impact — International suppliers will see reduced demand as Europe prioritizes local raw material production.5
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Meeting with Andreas Glück (Member of the European Parliament, Shadow rapporteur for opinion)

22 May 2025 · Critical Medicines

German pharmaceutical industry demands clarity on EU deforestation compliance

13 May 2025
Topic — A consultation on amending Annex I of the EU regulation preventing deforestation.
Message — The group calls for clarifying that internal company products are exempt from rules. They also propose that written supplier declarations should satisfy due diligence requirements for downstream firms.12
Why — Pharmaceutical companies would avoid impossible-to-fulfill administrative burdens and costly verification processes.34
Impact — Regulators and environmental groups lose oversight if companies skip verifying supplier data.5
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Response to Communication on the EU Stockpiling Strategy

8 May 2025

The German Pharmaceutical Industry Association (BPI) welcomes the aim of the EU Stockpiling Strategy (EUSS) to develop a coordinated European approach to stockpiling critical medical countermeasures (MCMs). In light of increasing geopolitical uncertainty and emerging threats, strengthening the EUs crisis preparedness is vital. Establishing resilient supply chains and building strategic reserves of MCMs will enable authorities to maintain societal functioning and safeguard public health during emergencies. The EUSS must adopt a holistic approach, fostering collaboration among public authorities, health professionals, civil society, and industry. Maintaining an open dialogue with the pharmaceutical sectorespecially small and medium-sized enterprisesis essential to guide research and development efforts aligned with stockpiling needs. Effective cross-border coordination and alignment with Member States are crucial. Local and regional stockpiles should be developed to ensure rapid access to essential products, helping both to treat citizens and prevent disease spread during health emergencies. The EUSS should focus strictly on stockpiling MCMs for high-priority health threats, such as pathogens with pandemic potential and chemical, biological, radiological, and nuclear (CBRN) risksincluding vaccines. While these reserves are essential for rapid emergency response, stockpiling is not suitable for innovative medicines or as a solution to drug shortages. In fact, contingency stockpiling of low-demand productssuch as orphan or advanced therapy medicinal products (OMPs, ATMPs)can lead to unnecessary waste and operational burdens for manufacturers without addressing underlying supply issues. Instead, addressing medicine shortages requires stronger supply chain resilience and improved procurement criteria. To ensure the success of the EUSS, BPI recommends the following key principles: Focus on priority threats: Stockpiling should prioritize MCMs needed more quickly than they can be produced or imported during emergencies. This supports rapid response, protects first responders and healthcare workers, and helps to mitigate outbreaks at early stages. Selection criteria: The choice of MCMs should consider clinical effectiveness, safety across populations (including subgroups), as well as cost, availability, and time to access. Strategic storage locations: Warehouses should be safe, well-positioned, and geographically distributedparticularly relevant for CBRN incidents where regional response capacity is essential. Ownership and legal responsibility for these stocks must be clearly defined in advance, including obligations for authorisation, maintenance, and GxP compliance. The Commission should ensure that stockpile operations are efficient, low-bureaucracy, and cost-neutral. Adequate, sustainable funding: Long-term investment is necessary to build and maintain effective stockpiles. Stable financing not only enhances crisis preparedness but also creates a more predictable environment for R&D investment, supporting the EUs strategic autonomy and competitiveness in health security.
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German pharmaceutical association BPI urges stronger patents and doubled funding

17 Apr 2025
Topic — The EU is developing a strategy to boost global competitiveness in life sciences.
Message — BPI calls for a robust and predictable system of incentives and intellectual property rights. They request doubling funding for industry research in the next R&D programme.12
Why — Stronger patents and doubled funding would minimize financial risks for pharmaceutical developers.34
Impact — Non-EU suppliers would lose business as the strategy aims to reduce dependencies.5
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German pharmaceutical industry urges procurement reforms for supply security

7 Mar 2025
Topic — The European Commission is evaluating the effectiveness of current EU public procurement directives.
Message — The association calls for fostering European production and harmonizing procurement rules across the EU. They advocate for transparent tender criteria that reward sustainable practices and simplify processes for smaller companies.123
Why — These changes would protect European manufacturers from low-cost competition by prioritizing local and sustainable production.45
Impact — Non-European suppliers and low-cost manufacturers would lose their current competitive advantage in the market.6
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German pharma group BPI urges investment in medicine production

27 Feb 2025
Topic — The EU initiative aims to strengthen supply chains for critical medicines.
Message — The association recommends limiting the rules to the Union List of Critical Medicines. They advocate for state aid and tax credits to support European manufacturing. They also call for drug procurement to prioritize supply security over price.123
Why — The industry would benefit from increased subsidies and reduced competition from low-cost imports.45
Impact — Public health budgets may face higher costs if purchasing focuses on factors beyond price.6
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Response to Uniform rules on good manufacturing practice for veterinary medicinal products and active substances

19 Feb 2025

Sehr geehrte Damen und Herren, anbei finden Sie im Anhang die Stellungnahme zum GMP-Leitfaden für Tierarzneimittel. Wir möchten gern anmerken, dass die Konsultationsfrist von lediglich vier Wochen als unzureichend erachtet wird, um alle spezifischen Anforderungen und möglichen Änderungen gründlich zu prüfen. Zusätzlich bietet die vorgesehene Übergangsfrist von acht Monaten den Herstellern keine angemessene Möglichkeit zur Anpassung. Eine Verlängerung auf zwei Jahre wird daher als notwendig angesehen. Es bestehen keine nachweislichen Sicherheits- oder Qualitätsmängel, die eine separate Regulierung der GMP-Anforderungen für Human- und Veterinärmedizin rechtfertigen würden. Eine Trennung der Vorschriften könnte zu erheblichen Versorgungsengpässen führen, da Hersteller gezwungen wären, sich zwischen beiden Bereichen zu entscheiden. Darüber hinaus würde eine Abweichung von international anerkannten Standards wie VICH und ICH die Wettbewerbsfähigkeit europäischer Hersteller schwächen, den Zugang zu globalen Märkten erschweren und die regulatorische sowie bürokratische Belastung erhöhen. Die Notwendigkeit separater Produktionslinien würde zudem Investitionen in der EU unattraktiver machen und langfristig Forschung und Entwicklung im Bereich der Veterinärmedizin beeinträchtigen. Da kein erkennbarer Mehrwert für Sicherheit oder Qualität gegeben ist, sollte entweder die bewährte, bestehende GMP-Regelung beibehalten oder eine einheitliche Regulierung für Human- und Veterinärmedizin etabliert werden. Zusätzlich wird eine regelmäßige Überprüfung der Vorschriften im Dreijahresrhythmus empfohlen. Mit freundlichen Grüßen
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Response to Rules on good manufacturing practice for active substances used as starting materials in veterinary medicinal products

19 Feb 2025

Sehr geehrte Damen und Herren, anbei finden Sie im Anhang die Stellungnahme zum GMP-Leitfaden für Wirkstoffe (API). Wir möchten gern anmerken, dass die Konsultationsfrist von lediglich vier Wochen als unzureichend erachtet wird, um alle spezifischen Anforderungen und möglichen Änderungen gründlich zu prüfen. Zusätzlich bietet die vorgesehene Übergangsfrist von acht Monaten den Herstellern keine angemessene Möglichkeit zur Anpassung. Eine Verlängerung auf zwei Jahre wird daher als notwendig angesehen. Es bestehen keine nachweislichen Sicherheits- oder Qualitätsmängel, die eine separate Regulierung der GMP-Anforderungen für Human- und Veterinärmedizin rechtfertigen würden. Eine Trennung der Vorschriften könnte zu erheblichen Versorgungsengpässen führen, da Hersteller gezwungen wären, sich zwischen beiden Bereichen zu entscheiden. Darüber hinaus würde eine Abweichung von international anerkannten Standards wie VICH und ICH die Wettbewerbsfähigkeit europäischer Hersteller schwächen, den Zugang zu globalen Märkten erschweren und die regulatorische sowie bürokratische Belastung erhöhen. Die Notwendigkeit separater Produktionslinien würde zudem Investitionen in der EU unattraktiver machen und langfristig Forschung und Entwicklung im Bereich der Veterinärmedizin beeinträchtigen. Da kein erkennbarer Mehrwert für Sicherheit oder Qualität gegeben ist, sollte entweder die bewährte, bestehende GMP-Regelung beibehalten oder eine einheitliche Regulierung für Human- und Veterinärmedizin etabliert werden. Zusätzlich wird eine regelmäßige Überprüfung der Vorschriften im Dreijahresrhythmus empfohlen. Mit freundlichen Grüßen
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Meeting with Tiemo Wölken (Member of the European Parliament)

5 Feb 2025 · Women's Health

Response to Performance of pharmacovigilance activities for human medicines ( update of Implementing Regulation (EU) 520/2012)

15 Jan 2025

The German Pharmaceutical Industry Association (BPI) represents the common economic interests of its member companies, particularly in the areas of healthcare and location policy, security of supply and pharmaceutical legislation at state and federal level as well as in Europe. With successful companies, qualified employees, high productivity, innovative products and good working conditions, we help to secure Germany's long-term competitiveness as a pharmaceutical location. Our detailed comments on the implementing regulation can be found in the attached document.
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Response to Health technology assessment – Joint scientific consultations on medicinal products for human use

24 Oct 2024

BPI welcomes the EU HTA procedure and its goals to provide a transparent and inclusive framework for quality HTA, to reduce duplication for national HTA authorities and industry, to facilitate business predictability and ultimately, to accelerate access to medicines. Request windows for Joint Scientific Consultations (JSCs) should be announced twice yearly, with a 24-month planning horizon, allowing companies and the HTA Coordination Group (CG) to plan resources. The Implementing Act (IA) should account for in-person meetings, ensuring adequate time for thorough discussions and include an option for follow-up written advice to address later changes in development plans. To avoid the selection criteria becoming a pre-qualifier for JSC, it is important that they are used solely to prioritise between candidates when slots are limited. If selection criteria are to be applied, as listed in the draft JSC template shared with the HTA Stakeholder Network, these should be clarified in a separate guidance document, with definitions for each criterion and an explanation of how they will be used to choose between applicants. Furthermore, the goal must be to ensure that sufficient JSC capacities are available for all companies, since insufficient JSC capacities are unacceptable with regard to good and forward-looking study planning. The current draft lacks clarity on the timelines for the JSC process, making it difficult for companies to plan when they will receive advice or determine if it will allow for adjustments to the clinical trial design. The draft IA should outline specific timelines for key milestones, including ranges (e.g., between XX and YY days). This should cover when companies will receive a response to a JSC request after submission, the deadline for submitting the briefing book, the validation period for submissions, the time required for assessing the briefing book, the scheduling of the JSC meeting, and when the final outcome document will be provided following the meeting. Companies should be further involved in the organisation of the JSC meeting to ensure better alignment on the agenda and topics to be discussed. This should include inviting input from companies on the meeting scope and requiring alignment between companies and the assessors on the meeting scope to reflect the briefing book. Additionally, companies should be informed in advance about which experts/patients will be involved in the JSC. For rare diseases and ATMPs, it would often be necessary to have the same assessor and co-assessor for both the JSC and JCA due to the difficulty in finding someone with the right expertise for the role. The draft text specifies that the outcome documents of the CG and the CHMP should be exchanged. For parallel EMA SA/JSC processes, responses to questions common to both the EMA and HTA should be interlinked; that is, the outcome document and the final CHMP Scientific Advice should refer to each other for the common questions, allowing the company to obtain one aligned response. If the result is two independent outcome documents, the parallel advice process will be ineffective. A definition of appropriate information, which, according to Recital 7, will be exchanged by EMA and the HTA secretariat to ensure the synchronisation of the advice procedures should be added. The security and confidentiality of the IT platform must be ensured, and the necessity of a need-to-know principle when sharing commercially sensitive and hence confidential information will be critical for ensuring the confidentiality of data shared by companies and for building trust in the process.
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Response to Communication on the European Research Area Implementation

30 Sept 2024

The main health challenges in Europe that need to be addressed through research and innovation include fostering technological advancement, ensuring production sovereignty, and supporting European manufacturers of biopharmaceutical supplies. Many essential materials, such as active pharmaceutical ingredients (APIs), are currently sourced from countries like China and India. To secure Europes biotech supply chain, local production must be re-established, as many capabilities have been lost due to the growing focus on generic pharmaceuticals. A key issue is the need to support the entire value chainfrom idea to market-ready products. Funding mechanisms should offer better financing rates for small and medium-sized enterprises (SMEs) and Mid-caps, particularly when they collaborate with research organizations. Independent regulatory advisors could also assist SMEs and Mid-caps in advancing innovation. Moreover, greater support is needed for developing alternatives to animal testing, especially within the 3R framework, as SMEs often lack sufficient backing to validate new techniques. In the area of rare diseases, current regulations for orphan drugs and the narrow definition of unmet medical needs may restrict research funding. More support is necessary for developing new therapies, such as regenerative medicine and bioassays involving new modalities. Additionally, funding should focus on therapies for diseases and trauma in resource-limited countries or conflict zones. Incremental research, which builds on existing compounds, is underrepresented in current funding programs, despite its efficiency and faster development timelines. Moreover, the requirement to involve diverse disciplines and stakeholders in research projects can reduce the flexibility needed for effective exploration. AI holds significant potential in drug development, and a harmonized data infrastructure should be accessible to all stakeholders, including SMEs and research institutions. This infrastructure should be transnational and regularly updated. Incorporating AI and in silico tools into regulatory frameworks would help SMEs speed up the development process. Overarching regulations on AI use in healthcare, particularly concerning data protection, are also needed to foster innovation. Current funding mechanisms in the healthcare sector are often criticized for being too politically driven, which limits research efficiency. Funding should focus more on outcomes rather than political requirements, and greater flexibilitysimilar to what is seen in the cancer missionshould be applied to other medicinal R&D projects, which often require more time. Fragmentation in the funding landscape, as seen in programmes like the European Research Council (ERC) and the European Innovation Council (EIC), complicates participation for companies. Additionally, the suitability of the Horizon Europe programme for translating basic research into practical applications is questioned. Specifically, the lack of support for moving from preclinical research to patient-relevant clinical phases II-III is seen as a significant obstacle to advancing research to higher technology readiness levels. The recent opening of Horizon Europes EIC Accelerator to small Mid-caps is a positive step, but extending this to larger Mid-caps (up to 3,000 employees) is proposed, given the important role pharmaceutical Mid-caps play in many EU Member States. To streamline innovation, a one-stop-shop approach is suggested to reduce bureaucracy and fragmentation in funding structures. Additionally, project evaluations should measure success by the real-world impact of funded projects, focusing on how many result in products that benefit the European population. In conclusion, innovation should be viewed as a value chain stretching from idea to product. The focus should be on the healthcare impact of new products, whether they represent incremental or breakthrough innovations.
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Meeting with Andreas Glück (Member of the European Parliament)

23 Sept 2024 · Health

Response to Health technology assessment – Cooperation with the European Medicines Agency

23 Jul 2024

In principle, BPI supports the EU HTA procedure and its goals of creating a transparent and inclusive system for high-quality HTA, minimizing redundancy for national HTA authorities and industry, enhancing business predictability, and ultimately speeding up the availability of medicines for EU patients. We believe the scope of information sharing outlined in Article 2 (1) is relevant and focused on effectively planning JCAs and JSCs. However, product-level information from eligibility decisions for the centralized procedure is the only reliable data for planning JCAs. Information from earlier stages, such as 8-21 months before MAA or even 3-year pipeline data, is unsuitable for informing the annual work programme due to its unreliability at that stage. For early-stage information to be useful for planning JSCs, we suggest sharing it as aggregate data to estimate the volume of upcoming submissions. Forecasting the number of JSCs or MAAs depends on the maturity of drug development data, which is unlikely to be available a year in advance. For better planning, companies could share relevant information directly with the Coordination Group or via EMA on a quarterly or rolling basis. The specifics of this information sharing should be detailed in a separate guidance document developed in collaboration with industry stakeholders. While information exchange for planning and forecasting JCAs and JSCs between EMA and the Coordination Group is necessary, obtaining information directly from companies during the procedure is more efficient. If the Coordination Group needs information before starting a JCA for a specific product, we suggest utilizing existing pre-submission meetings between applicants and the EMA/(Co-) Rapporteur, involving the JCA Subgroup as needed. When exchanging data for conducting a JSC or JCA according to Article 8, companies must be informed about the information shared and its purpose to avoid misunderstandings or delays that could affect the quality of the procedures. It's crucial to maintain the separation between EMA MAA and JCA processes to meet their specific requirements effectively. Protecting confidential information is essential, and additional measures should be included in the draft text. These measures could involve different levels of protection, technical requirements, and obligations to inform about potential legal consequences. Information shared via the IT platform and further distributed within HTA bodies or with other stakeholders must have the same level of protection. Also, the exchange of general scientific or technical information described in Article 6 should not reference specific products or include confidential information. Lastly, the current wording of Article 9 is too vague, failing to specify how breaches of professional secrecy are determined or their consequences. It also lacks definitions of terms like individual expert, access based on need-to-know, and confirmation of signed CDAs. This article should create a strong disincentive for sharing protected information and outline the legal consequences of breaching confidentiality provisions.
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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

BPI supports the objective of the proposed draft rules for assessing and managing conflicts of interest to secure access to relevant expertise for Joint Scientific Consultations (JSC) and Joint Clinical Assessments (JCA). We agree that the measures applied in case of a conflict of interest should vary based on the declared interests and the roles and responsibilities of the individual expert. Ensuring the involvement of the most knowledgeable experts is crucial for high-quality JCAs. However, we believe that the draft rules outlined in Annex II fail to strike the right balance between ensuring high-quality assessments and managing potential conflicts of interest, as they are overly rigid. This would result in the automatic exclusion of experts whenever there is a potential conflict of interest, without considering the nature of the conflict or implementing measures to ensure the experts input can be impartially included. This approach could compromise the quality of assessments, as experts without conflicts of interest would be favoured irrespective of their expertise compared to those with a potential conflict. A more balanced approach could be achieved by removing Annex II from the Implementing Act and replacing it with a guidance document developed by the European Commission in consultation with the Coordination Group and the HTA Stakeholder Network. It would allow for timely adjustments based on experiences from the initial assessments. We agree that in case only experts with conflicts of interest are available, they should be involved appropriately while ensuring their selection and involvement is transparent. This is particularly crucial for specialised areas and technologies such as Orphan Medicinal Products (OMPs) and Advanced Therapy Medicinal Products (ATMPs), where the pool of experts is limited. Additionally, patient and clinician testimonies are especially significant in HTA for these specific disease areas. We welcome the proposed derogation in Article 7(3) as it addresses the need to involve the most knowledgeable experts in highly specialised areas. However, the current wording could still lead to situations where a JSC or JCA lacks input from individual experts, as the HTA secretariat would provide the relevant subgroup with a list of available experts and their conflicts of interest only "where considered appropriate by the Commission." To avoid the absence of expert input, particularly in crucial disease areas, we believe the relevant subgroups should always be informed of the list of potential experts by the HTA secretariat, and experts should be involved from that list in an appropriate manner. Furthermore, to prevent a lack of expert input in rare diseases, Annex I section 3 should include an exemption for strategic advisory roles related to orphan medicinal products.
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BPI urges early involvement in EU health technology assessments

2 Apr 2024
Topic — Implementing rules for joint clinical assessments of medicinal products across the European Union.
Message — The group requests systematic and early involvement for developers during the clinical assessment scoping phase. They demand longer timelines for data submission and stricter protections for confidential business information.123
Why — Extended timelines and earlier involvement would lower administrative pressure and business risks for manufacturers.4
Impact — Stricter confidentiality rules could limit public transparency regarding clinical data and assessment evidence.5
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Response to Revision of the variation framework for medicines

26 Feb 2024

The revision of the Commission Regulation (EC) No. 1234/2008 in the first step presents little evidence of reducing bureaucracy and deregulation. Some of the amendments seem a restriction to industry reducing flexibility. An opening clause to update regulatory information by using digital tools could already be introduced in the first step of amending the Regulation, e.g. for updating OMS data. Clear classification guidelines are necessary for operations and planning abilities for industry. Article 4: Industry needs for all amendments in an update of the Classification Guidelines an adequate timeline for implementation (at least six months). Article 5: The experience from our members is that timelines were not adhered to in the past, and we accept the 60 days if they are predictable. A more uncomplicated and fast system for unforeseen variation would beneficial. The option to file a change as a Type IBz should still be possible. Article 6a: For the additional regulatory tools, there should be an openness in the implementation of a risk-based approach for classifying and performing variations supporting the competitiveness of the EU in terms of lifecycle management. Article 7a: The cases of super-grouping of variations will be listed in the guidelines referred to Article 4 (1) (super-grouping). As the revised Classification Guideline is not available yet, the practical value of the super-grouping cannot be finally evaluated for the time being. The super-grouping as a flexible and resource-saving instrument should be reflected in the fee systems of the competent authorities as well as the procedure saves resources on side of the competent authorities. Furthermore, it would have a practical value to allow grouping of variations that are not directly consequential but suitable for one assessment supported by consolidated documentation. Article 8, 13a, 14: From industry point of view this is a restriction of flexibility as an immediate submissions of Type IA notifications are only possible in justified cases. BPI pleads for retaining the flexibility on submitting type IA notifications. For small and medium sized companies, it implicit additional bureaucratic and logistical effort to ensure regulatory compliance. Industry needs immediate submissions of type IA in order to update CPPs for filing these changes in countries outside the EU. It seems not possible to submit all Type IAs under one annual report in a super-grouping whilst at the same time comply with article 7a of the Regulation. To ensure continuity of supply we request pragmatical solutions for upclassified variations and for Type IA variations submitted beyond the 12 months period. Article 20: The introduction of Article 20 paragraph 11 is an efficient approach and streamlines the procedure. BPI pleads for retaining the flexibility on performing a worksharing procedure and for using may instead of shall in Article 20 first paragraph. The regulatory procedures should remain adaptable to the industry`s filing strategy. Annex II: BPI appreciates the risk-based approach in classifying quality changes related to biological medicinal products and that the classification of variations related to modification in the manufacturing process or sites of active substances for a medicinal product is deleted from the list of Type II variations. There are even more possibilities for downregulation. Herbal medicinal products: The draft of the Commission Regulation has not taken herbal medicinal products into consideration creating a more level playing field with other medicinal products resulting in downclassification of changes (B.I.a.2 a) and d), B.II.b.3a)). Medical Devices: From BPIs view handling variations to the medical device part in the amended Variation Regulation is a clear double regulation and should be avoided. Quality Changes: in cases where there is no risk for quality or safety lay these changes in the responsibility of the marketing authorisation holder.
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Meeting with Andreas Glück (Member of the European Parliament)

13 Feb 2024 · Event on Health Claims

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur)

20 Dec 2023 · Revision of Pharmaceutical Package (staff level)

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur)

20 Dec 2023 · Directive on Medicinal products for human use

German pharmaceutical industry urges cutting redundant EU reporting requirements

27 Nov 2023
Topic — The European Commission initiative aims to reduce administrative reporting burdens for EU companies.
Message — BPI recommends merging medical device plans and reports to eliminate duplicate documentation. They also suggest replacing manual administrative notifications with automated database updates.123
Why — These changes would reduce the full-time staff required to manage purely administrative filings.4
Impact — Human rights monitoring suffers if transparency requirements for raw material supply chains are weakened.5
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German pharmaceutical association BPI urges EU to protect drug data

1 Nov 2023
Topic — The European Commission is evaluating and revising the general pharmaceutical legislation and incentive framework.
Message — The organization calls for the current eight-year data protection period to be maintained and for five-year protection for repurposed medicines. They advocate for a flexible definition of medical needs and the rapid adoption of electronic product information.123
Why — Maintaining long-term data protection avoids the reduction of profitability and encourages future investment decisions.4
Impact — Generic producers and public health budgets lose from delayed entry of cheaper medicines.5
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German Drug Industry Urges Simplification of Medicine Variation Rules

22 Sept 2023
Topic — EU initiative to streamline administrative procedures for post-authorisation medicinal product changes.
Message — BPI calls to simplify the variation system and reflect regulatory needs using digital technology. The own responsibility of the marketing authorisation holder should be strengthened in the regulation.12
Why — This would lower high maintenance costs and restore essential production planning security.34
Impact — Regulatory authorities would lose their power to verify new safety information before implementation.5
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Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur) and Verband der Chemischen Industrie e.V.

13 Sept 2023 · SPC and Compulsory Licensing

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur) and European Federation of Pharmaceutical Industries and Associations and

7 Sept 2023 · Revision of the Pharmaceutical Legislation (staff level)

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and MEDICINES FOR EUROPE

6 Sept 2023 · Directive on Medicinal products for human use

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur) and AbbVie

28 Jun 2023 · Revision of Pharmaceutical Legislation (staff level)

Meeting with Andreas Glück (Member of the European Parliament)

13 Jun 2023 · Health Claims

Meeting with Norbert Lins (Member of the European Parliament, Committee chair)

31 May 2023 · "Health Claims" (gesundheitsbezogene Werbung)

German pharmaceutical industry seeks exemptions for medical packaging

6 Apr 2023
Topic — The Commission is reviewing requirements to reduce packaging waste and improve recycling design.
Message — BPI proposes differentiating packaging types while requesting longer transition phases for medical applicators. They also advocate for recognizing chemical recycling and using QR codes.123
Why — Exemptions would prevent significant cost increases and protect the viability of EU manufacturing.45
Impact — Patients could face higher prices for medicines if compliance costs are passed on.6
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German pharma industry urges unbureaucratic access to health data

28 Jul 2022
Topic — The creation of a European Health Data Space for medical research.
Message — The association demands framework conditions allowing industry access to health data without high bureaucratic effort. They call for harmonizing fragmented data protection interpretations across the EU. Furthermore, national bodies must have sufficient resources to meet deadlines for data requests.123
Why — Efficient data access would accelerate the development of market-ready pharmaceutical products.45
Impact — National regulators lose their ability to maintain stricter privacy interpretations.6
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German pharma group opposes EU-wide compulsory patent licensing

29 Apr 2022
Topic — EU initiative to harmonize compulsory patent licensing procedures for crisis response.
Message — The BPI argues that current international and national laws are sufficient and no additional EU action is needed. They suggest replacing state-led restrictions with voluntary cooperation between companies and authorities. Compulsory licensing must only be used as a last resort to avoid undermining innovation.123
Why — Rejecting EU harmonization preserves market exclusivity and protects high-risk investments in new therapies.45
Impact — Member States lose a coordinated mechanism to quickly secure critical goods during crises.67
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Meeting with Axel Voss (Member of the European Parliament, Shadow rapporteur)

7 Sept 2021 · Corporate Sustainability Due Diligence

Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

The BPI e.V. (BPI) representing more than 270 members, comprises the whole spectrum of the pharmaceutical industry, ranging from multinational corporations to SMEs, Mid-Caps as well as Startups. These companies ensure a timely and safe supply of medicinal products for all patients across the EU and globally. Concerning the evaluation and revision of the general pharmaceutical legislation, we welcome the Commission’s objective to simplify legislation and create regulatory attractiveness with the aim to reduce, where possible, regulatory approval times and regulatory costs while keeping the high standards of robust assessment of quality, safety, and efficacy. BPI believes that some measures, which have been applied during the ongoing Covid-19-pandemic, should be integrated into a future framework. This would also have a positive impact on the security of supply. We strongly encourage improving the security of the supply of medicinal products within the EU. However, a future framework should not impose more obligations on manufacturers and responsibilities should be equally distributed between all stakeholders along the supply chain. Further to this, we welcome the objective to strengthen the current system of incentives to foster innovation and international competitiveness of the sector. This approach should be in coherence with the recently published EU IP Action Plan, which rightly takes into account the role of a strong, coherent and predictable IP framework in fostering competitiveness and innovation. In addition, a strengthened incentive system also needs to include repurposed medicinal products as they deliver a great value for patients throughout the EU. A targeted approach in reducing environmental residues will prove to be more sustainable than general legislative regulations. When considering the policy options proposed in the Inception Impact Assessment, the European Commission should carefully examine the economic and regulatory burden they would impose on the pharmaceutical industry. It is of utmost importance to keep the broad spectrum of the sector in mind, especially with regards to SMEs and Mid-Caps. BPI fully supports the approach of the Commission to focus the revision of the pharmaceutical legislation on those provisions related to the objectives of the Pharmaceutical Strategy (i.e. “targeted approach”). The current structure of the basic pharmaceutical legislation, i.e. the coexistence of Directive 2001/83/EC and Regulation (EC) No 726/2004, should be kept. Amendments of provisions to be changed/improved should be done within the current structure. The current dual marketing authorisation system built on the Directive for decentralised/national procedures and the Regulation for the centralised procedure ensure a complete framework covering the whole lifecycle of medicinal products. This system that is in place since 2004 generally functions well. It secures the suitable allocation of tasks to the respective competent authorities and eliminates competition hurdles, especially for SMEs. The uncertainties, practical difficulties and increased efforts and costs, which would be associated with a transition from a Directive to a Regulation, should be avoided. A stable regulatory environment is not only needed for centrally authorised, innovative medicinal products, but also for established medicinal products approved by national competent authorities. These products are often non-prescription medicinal products for self-medication. They are an integral part of health care enabling citizens to take responsibility for their personal health and often support the routine patient care in Member States’ health systems. Please see attached document for further elaboration on some of the proposed policy options.
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Response to Revision of the EU legislation on medicines for children and rare diseases

22 Dec 2020

The German Pharmaceutical Industry Association (BPI e.V.), representing more than 270 members, comprises the whole spectrum of the pharmaceutical industry, ranging from multinational corporations to SMEs, Mid-Caps as well as Start-ups. This also includes companies with a special focus on the development of medicines for children and rare diseases. Our member companies ensure timely and safe drug supply for all patient populations across the EU and globally. Germany is home to numerous biotech companies in Europe and a large number of biopharmaceutical entrepreneurs and leaders in incremental innovation. These companies contribute to tomorrow’s healthcare solutions, including solutions for diseases in children and rare diseases. A conducive environment for innovation in Europe, including the support of a strong innovation ecosystem and IP framework would be contributing to foster national and European competitiveness, patient access to innovative therapies across Europe and the potential of attracting further investment in highly innovative biopharmaceutical regions and thus contributing to the broader scope of the Pharmaceutical Strategy for Europe. Ever since their adoption, both regulations have contributed significantly to the development of new medicinal products, improving the life of children and patients with rare diseases. This is due to the establishment of a solid incentives system, encouraging research in these areas. Regarding the proposed options of the Commission, we see four main points that we would like the Commission to consider: 1) All options suggested by the Commission require a clear definition of the term “unmet need” as it appears to have a different meaning to stakeholders depending on the context in which it is used. It would therefore be premature to include it in a revised legislation as there is no common understanding. However, we support the Commission’s approach to develop a better definition of unmet orphan and pediatric needs. A multi-stakeholder group, which also includes industry representatives, should work on defining the term. 2) Curtailing the established systems of available incentives will not solve the issue of access and availability of these particular medicines in Europe. This approach runs the risk of being counterproductive and hampers innovations in both pediatric and orphan medicinal products. Without incentives, companies are unlikely to take the necessary steps to develop and file for marketing authorisations for initial and/or additional indications. To avoid this and to foster research, we are convinced that it is necessary to strengthen the existing incentives ecosystem rather than limiting it. This is also underlined in the Commission’s IP Action Plan which deems a strong incentive environment necessary for innovation. 3) Rather than reviewing the existing legislation, we are of the opinion that there is room for improvement in the current system. This could be achieved for example by a broader acceptance of Real World Evidence, a closer European collaboration on HTA and establishing provisions to solve operational and timeline challenges in the development of pediatric medicines. 4) The reasons for access gaps across Europe are manifold. They stem from disparities in the Member States in the areas of certain policies, HTA processes, pricing & reimbursement policies, and so forth. To work on eliminating these gaps, we encourage the Commission to find solutions in collaboration with all stakeholders involved ranging from patients, Member States, the research community and industry. In further discussions, policymakers at EU level should resist the temptation to use the means of pharmaceutical law, patent law or intellectual property rights to try to solve problems whose causes should actually be tackled elsewhere and by the Member States individually.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

6 Jul 2020

The BPI e.V., representing more than 270 members, comprises the whole spectrum of the pharmaceutical industry, ranging from multinational corporations to SMEs, Mid-Caps as well as Start-ups. These companies ensure timely and safe drug supply for all patients across the EU and globally. We welcome the European Commission’s initiative to create a strategy that aims to support the industry’s competitiveness at the same time as ensuring high quality medicinal products for the European citizen. The European Commission’s roadmap and its Industrial Strategy both highlight the economic importance of the pharmaceutical sector for the EU. This sector comprises a huge variety of companies, from global corporations to SMEs and Mid-Caps. This must be taken into account by the Commission and should lead to a strategy feasible for all. The aim of the Pharmaceutical Strategy should be to create a balanced approach which creates an environment that allows the industry to grow and compete globally and sets a solid framework for it to function properly. Regarding prevalent shortages of certain medicinal products, especially off-patent medicinal products, we believe such a framework needs to acknowledge existing legal obstacles which need to be reviewed and adjusted accordingly. The focus of the strategy should not solely lie in the “re-shoring” of production. Instead, we need to focus on creating an environment that offers the means to strengthen already existing production sites along the whole chain of production throughout Europe as well as making it an attractive region for new production sites and new technologies. However, this also requires attractive regulatory conditions within the EU. A review or the mapping of existing procurement strategies in all member states as well as a possible extension of the state-aid exemptions in relation to the Covid-19-pandemic could offer solutions to the problem of shortages. The strategy should aim to foster and support all areas of research. Both innovative medicinal products as well as medicinal products which have been developed by means of incremental research should be included in funding programmes, as both are equally important to the well-being of patients all over the EU (as the medicinal products being tested in the SOLIDARITY study to fight the Covid-19 pandemic shows, they are all already known substances being repurposed). Regarding the innovation aspect, it is crucial to maintain and improve existing incentives in areas of a high medical need and market failure, e.g. medicinal products for rare, super rare diseases and for children as well as to fight antibiotic resistances. We welcome the European Commission’s approach to establish a harmonised HTA-process of pharmaceuticals, especially with regards to common standards and joint scientific consultations aiming to avoid duplication of work for national HTA bodies and industry which leads to a more sustainable system. During the ongoing pandemic EMA, HMA and CMDh enabled a Regulatory Flexibility for products for treatment of COVID-19 patients in order to avoid shortages. This flexibility should be kept and transferred into future regulations. Flexible measures should be applied to all products at risk of shortages to prevent stock-out and supply disruptions as well as for innovative products in areas of unmet medical need in general. As pharmaceutical research is closely connected with public and private research institutions, a common European data platform would ensure the necessary interoperability to exchange research data between these institutions and industry across Europe. BPI agrees that the environmental situation has to be improved. However, this cannot be seen as the sole responsibility of particular industrial sectors. The importance of protecting the environment is clearly noticed, but it has to be avoided that medicinal products do not reach a patient because their environmental profile may be questioned.
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Response to Initiative prohibiting and permitting under scrutiny certain hydroxyanthracene derivatives in food supplements

9 Apr 2020

It would be our utmost wish to take the chance and comment the intended changes concerning the use of botanical species containing hydroxyanthracene derivatives in food products. Even though we are a pharmaceutical industry association we suspect that herbal medicinal products may be affected by the classification of herbal substances and their preparations to be used in food products. Some of our member companies have already been working for a long time on numerous analysis and many more a planned to provide solid data to be used for an adequate classification of the botanical species under discussion. However, this still needs more time. Due to the current situation caused by the spreading of the novel Corona-virus and therefore the absorption of human resources, we would welcome an appropriate extension of time for submitting comments to the planned regulation of 3 to 6 months. During these difficult and unprecedented times , the Commission should aim to achieve facilitations for the industrial sector. We therefore believe that such an extension would be sensible and necessary as any changes should be based on reliable data.
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Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

10 Feb 2017 · Pharmaceuticals, Medicinal Products, HTA

Meeting with Vytenis Andriukaitis (Commissioner) and

12 Oct 2016 · EU regulatory framework for pharmaceuticals, access to medicines, HTA

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

4 Feb 2015 · Access to innovative medicine