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Merck

Merck is a science and technology company operating in Healthcare, Electronics and Life Science, generating €22.2 billion in revenues with 64,000 employees across 66 countries.

Lobbying Activity

Meeting with Tomas Baert (Cabinet of President Ursula von der Leyen) and NEC Corporation

4 Dec 2025 · Presentation of the three work streams of the EU-Japan Business Round Table

Meeting with Tomislav Sokol (Member of the European Parliament, Rapporteur)

20 Nov 2025 · Health Policy

Meeting with Gabriela Firea (Member of the European Parliament) and European Students' Union

13 Nov 2025 · Shaping Europe Together:Youth Priorities for 2025-2029

Meeting with Nina Carberry (Member of the European Parliament)

28 Oct 2025 · Equine Health Technologies

Meeting with Gabriela Firea (Member of the European Parliament) and European Students' Union

27 Oct 2025 · Preparation of Shaping Europe Together:Youth Priorities for 2025-2029

Meeting with Eva Schultz (Cabinet of Executive Vice-President Roxana Mînzatu)

20 Oct 2025 · Meeting on the fertility matters in relation to EU Gender Equality and Demography Strategies

Meeting with Alexandr Hobza (Cabinet of Executive Vice-President Stéphane Séjourné) and FIPRA International SRL and Global Life Sciences Solutions Operations UK Ltd (doing business as Cytiva)

15 Oct 2025 · Exchange of views on regulatory environment for Life Sciences Manufacturing sector

Meeting with Sonia Vila Nunez (Cabinet of Executive Vice-President Roxana Mînzatu) and Unknown Organization and

1 Oct 2025 · To formally present and discuss the Movement +Fertility, and the Portuguese Manifesto for reproductive equality and a sustainable future.

Merck urges EU cardiovascular plan prioritizing expanded screening

12 Sept 2025
Topic — The consultation addresses a proposed EU initiative to improve cardiovascular health and prevention.
Message — Merck recommends EU-wide guidelines for screening, specifically targeting pre-diabetes and thyroid disorders. They advocate using digital tools and AI to improve patient engagement and remote monitoring. The company proposes creating a European network of integrated centers for coordinated patient care.123
Why — Standardizing screening for pre-diabetes and thyroid issues would increase demand for Merck's medicinal portfolio.45
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Meeting with Boriša Falatar (Cabinet of Commissioner Hadja Lahbib)

9 Sept 2025 · gender equality and strengthening health preparedness

Response to Gender Equality Strategy 2026-2030

23 Jul 2025

The demand for long-term care (LTC) in the EU is expected to grow significantly in the coming decade, placing increased pressure on care systems and infrastructure. Without adequate investment and reform, much of this burden will fall on women, who already shoulder a disproportionate share of informal caregiving. This entrenched gender imbalance risks deepening inequalities and undermining both labour market participation and the EUs broader economic resilience. Merck KGaA, Darmstadt, Germany (Merck) is firmly committed to advancing gender equality by supporting informal carers through policy, advocacy, and workplace innovation. As the European Commission defines its post-2025 Gender Equality Strategy for 2026-2030, Merck stands ready to contribute proven solutions that recognize, empower, and support carers who are at the heart of healthcare and economic resilience. Against this background, we recommend that the Commission consider the following when designing the Strategy: 1. Invest in Long-Term Care (LTC) Services & Infrastructure: Support and incentivise Member States to expand access to affordable LTC and childcare to reduce dependency on informal care and enable womens full labour force participation. 2. Enforce and Expand the EUs Work-Life Balance Directive: Ensure equitable carer leave, flexible work arrangements and financial support to informal carers across Member States. 3. Tackle Gender Norms in Caregiving: Support awareness campaigns and male caregiver engagement through national and EU-level programmes and initiatives. Support Member States in scaling family-friendly workplace reforms. 4. Harmonize National Caregiving Policies: Provide consistent, EU-wide standards such as income support, respite care, and caregiver recognition, allowing to elevate the role of informal care as a shared public responsibility, not a private burden disproportionately borne by women. 5. Support Womens Health and Fertility: Recognize and address how informal caregiving intersects with access to fertility care and reproductive autonomy.
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Meeting with Gabriela Tschirkova (Cabinet of Commissioner Valdis Dombrovskis), Zaneta Vegnere (Cabinet of Commissioner Valdis Dombrovskis)

10 Jul 2025 · competitiveness

Meeting with Olivér Várhelyi (Commissioner)

10 Jul 2025 · Exchange of views on the EU pharma and health policy matters

Meeting with Jana Dabbelt (Cabinet of Commissioner Olivér Várhelyi)

3 Jul 2025 · • Intro to company • pharma legislation and CMA • UWWTP and health-specific policies (mental health, fertility, cancer and cardiovascular health)

Meeting with Giulia Del Brenna (Head of Unit Internal Market, Industry, Entrepreneurship and SMEs) and FIPRA International SRL and

1 Jul 2025 · The specifics of life science-related upcoming initiatives, including the new Bioeconomy Strategy, the Biotech Act, and Life Science Strategy.

Meeting with Michael McGrath (Commissioner) and

27 Jun 2025 · Exchange of views on issues relating to competitiveness and corporate sustainability

Merck urges "Biotech Omnibus" to boost European innovation and competitiveness

11 Jun 2025
Topic — The EU is consulting on measures to accelerate the biotechnology sector's market transition.
Message — Merck requests a "Biotech Omnibus" to simplify regulatory processes and accelerate market access. They want the EU budget to prioritize biotech and provide guarantee funds to lower investment risks. They also advocate for harmonizing clinical trial regulations to attract research.12
Why — This strategy would reduce Merck's financial risks while accelerating its product approvals.3
Impact — Taxpayers would bear the financial burden if high-risk private projects fail.4
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Meeting with Sven Simon (Member of the European Parliament)

10 Jun 2025 · Innovation und nachhaltiges Wachstum: Ein Realitätscheck für Europas strategische Ambitionen

Merck urges legal certainty and less bureaucracy for AI science

4 Jun 2025
Topic — This initiative seeks a strategic policy approach for AI adoption within European scientific research.
Message — Merck requests legal certainty for AI adoption and the minimization of bureaucratic obstacles to empower researchers. They also suggest incentivizing collaborations between industry and academia to scale innovation.123
Why — This would reduce compliance costs and speed up their AI-driven drug and semiconductor discovery processes.45
Impact — Regulatory bodies may lose oversight if standards are lowered to minimize perceived bureaucratic obstacles.6
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Merck urges regulatory clarity to boost industrial AI innovation

4 Jun 2025
Topic — The EU is developing a strategy to accelerate industrial AI adoption.
Message — Merck requests a framework providing legal certainty and greater freedom for AI adoption. They advocate for a risk-based approach and protected intellectual property rights.123
Why — This would reduce legal risks and protect the company's long-term research investments.45
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Meeting with Dolors Montserrat (Member of the European Parliament, Rapporteur)

26 May 2025 · New EU Pharmaceutical Legislation

Meeting with Olivier Girard (Head of Unit Health Emergency Preparedness and Response Authority)

21 May 2025 · Discussion on availability and access to medical countermeasures manufactured by Merck

Meeting with Alisa Tiganj (Cabinet of Commissioner Christophe Hansen), Antonella Rossetti (Cabinet of Commissioner Christophe Hansen) and

29 Apr 2025 · Role of animal health sector in contributing to a sustainable livestock sector in the EU; Trade and animal health and agricultural policies; Upcoming livestock strategy: content and timeline; Digitalisation in support of farmers

Merck urges smart regulation to boost EU life sciences

16 Apr 2025
Topic — The EU is developing a strategy to improve life sciences competitiveness.
Message — Merck calls for life sciences to be recognized as strategic. They seek predictable rules and exemptions to avoid double regulation.12
Why — Simplified rules would lower the rising costs associated with chemical evaluations.3
Impact — Health and environmental groups may face risks from relaxed chemical standards.4
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Meeting with Tomislav Sokol (Member of the European Parliament)

8 Apr 2025 · Health policy

Meeting with Peter Agius (Member of the European Parliament)

8 Apr 2025 · Introduction

Meeting with Daniel Caspary (Member of the European Parliament)

7 Apr 2025 · Austausch

Meeting with Maurice Whelan (Head of Unit Joint Research Centre), Tobias Wiesenthal (Head of Unit Joint Research Centre) and

4 Apr 2025 · Scientific roundtable discussion between the European Commission’s Joint Research Centre and the pharmaceutical industry on the topic of leveraging health data and data sciences for innovation

Response to Commission Delegated Regulation amending certain annexes of the ‘Anti-Torture’ Regulation'

1 Apr 2025

As a global economic operator and supplier of chemicals used for research and analytical purposes, we are concerned about the unclear formulated amendment of Annex III of the EU Anti-Torture Regulation, which, if it will remain as it is, will highly impact us. So far, it is stated in 3.7 that "malodorant chemical mixtures formulated to produce a foul and deeply unpleasant smell for riot control purposes" will be added to the list of regulated products. This very general product description with no clear list of products or substances with CAS number and HS codes is leaving room for interpretation of national customs and control authorities, and hence could lead to an unharmonized application of the EU legal regulation across the EU Member States. Unclear is furthermore, how far the 10 listed substances under "notes" have to be considered as the binding 10 newly regulated substances. Moreover, the HS codes mentioned as examples in 3.7. are somehow misleading as they are referring to pure substances as well as mixtures at the same time.
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Meeting with David Ciliberti (Cabinet of Commissioner Glenn Micallef)

28 Mar 2025 · Introductory meeting

Merck urges voluntary taxonomy reporting to reduce administrative burdens

25 Mar 2025
Topic — The initiative aims to simplify EU taxonomy reporting and reduce compliance costs.
Message — Merck wants reporting thresholds applied per activity rather than cumulatively across the company. They suggest making OpEx disclosures voluntary and allowing at least one year for implementation. Finally, the company argues that all taxonomy reporting should be made voluntary for businesses.123
Why — These changes would significantly lower administrative costs and reduce technical complexity for reporting teams.4
Impact — Investors lose standardized data needed to compare the sustainability of different corporate activities.5
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Meeting with András Tivadar Kulja (Member of the European Parliament)

20 Feb 2025 · European Healthcare

Meeting with Eva Maydell (Member of the European Parliament)

15 Feb 2025 · EU Competitiveness Agenda

Meeting with Henna Virkkunen (Executive Vice-President) and

15 Feb 2025 · Private roundtable on transatlantic and global cooperation on tech organised on the margins of the Munich Security Conference

Meeting with Svenja Hahn (Member of the European Parliament) and Microsoft Corporation and

14 Feb 2025 · Exchange on upcoming digital EU legislation

Merck urges EU to unify healthcare rules and capital markets

31 Jan 2025
Topic — The EU is updating its single market strategy to boost global competitiveness.
Message — Merck supports creating a unified regulatory framework for healthcare to replace fragmented national standards. They also demand a Capital Markets Union and digitalized administrative procedures to streamline operations.12
Why — Unified standards and digitalized procedures would lower compliance costs and accelerate market entry.34
Impact — National governments may lose autonomy as Member States are pressured to relinquish unique standards.5
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Response to Digital Product Passport (DPP) service providers

9 Dec 2024

Merck Life Science response to EU public consultation on Digital Product Passports rules for service providers public consultation: Merck Life Science would like to provide feedback on several key requirements that are essential for the successful implementation of Digital Product Passports (DPP). We supply scientists with the tools to carry out their work. We provide both materials and chemical products for research and development and analysis, as well as for production of chemical products for a wide variety of uses (healthcare, diagnostic, biotechnology, etc). Our vast portfolio of hundreds of thousands of chemical products alone means we are in a unique position to test whether initiatives like Digital Product Passports are scalable. 1. Data Processing, Data Exchange Protocols, and Data Formats: It is crucial that the DPP framework establishes clear standards for data processing and exchange protocols. Consistent data formats will facilitate interoperability between stakeholders, including manufacturers, regulators, and other stakeholders. We recommend adopting widely recognized standards to ensure seamless integration with existing systems and to promote data sharing across the supply chain. 2. Data Storage, Archiving, and Data Persistence: The DPP system must incorporate robust data storage solutions that ensure long-term data persistence. This is particularly important in the life sciences, where product information may need to be retained and accessed for decades after the product's initial release. We advocate for the use of cloud-based solutions with redundancy and backup capabilities to prevent data loss, along with clear guidelines on data retention periods to comply with regulatory requirements. 3. Data Authentication, Reliability, and Integrity: Ensuring data authenticity and integrity is paramount, especially in the life sciences where product safety is critical. We recommend implementing advanced encryption methods, digital signatures, and blockchain technology to enhance data reliability. Regular audits and validation processes should be established to maintain data integrity and to provide stakeholders with confidence in the accuracy of the information contained within the DPP. 4. Application Programming Interfaces (APIs) for DPP Life-Cycle Management and Searchability: Application programming interfaces are essential for enabling efficient life-cycle management of DPPs. Manufacturers, distributors, and regulators are all likely to use different systems; without standardized APIs, integration across systems would be near impossible.. This will enhance the searchability of product information and facilitate real-time updates. Additionally, APIs must support secure access controls to protect sensitive information while allowing authorized users to retrieve necessary data. In conclusion, the implementation of digital product passports holds great promise for improving transparency and safety in the life sciences sector. By addressing the aforementioned areas, we can ensure that the DPP framework is robust, secure, and effective in meeting the needs of all stakeholders involved. For more information, contact Liesbet Dendas, Director Government Affairs and Policy EMEA, Merck Life Science: liesbet.dendas(*at*)merckgroup.com. EU Transparency Register: 49654992078-52
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Meeting with Peter Liese (Member of the European Parliament) and BASF SE and

4 Dec 2024 · Austausch

Meeting with András Tivadar Kulja (Member of the European Parliament)

12 Nov 2024 · Brain health

Meeting with Tomislav Sokol (Member of the European Parliament)

15 Oct 2024 · Health policy

Meeting with Nicolás González Casares (Member of the European Parliament)

15 Oct 2024 · Non-communicable diseases

Response to Commission Roadmap to phase out animal testing

14 Oct 2024

Merck develops, manufactures, and markets high-quality medicines, innovative products for the biotech and pharmaceutical industries and for academic research as well as specialty chemicals for high-tech applications, e.g. in the semiconductor industry. We appreciate the opportunity to provide feedback on this matter to further reduce animal testing and ultimately transition to an animal-free regulatory system under relevant pieces of chemical legislation. We invite the European Commission to seize the opportunity for REACH and other regulations to embrace New Approach Methodologies (NAMs) and Integrated Approach to Testing and Assessment (IATA) and work towards accelerating their validation and acceptance globally. In this contribution, we focus in the attached document on the extension of the use of computational (in silico) models and molecular based in vitro high-throughput screening (HTS) assays to prioritize, screen and characterize chemical activity and toxicity, along with a thorough examination of existing data, with a view to providing the best protection of human and ecological health, as promised under the European Green Deal. Where currently for regulatory purposes or in case of pharmaceutical development and production animal testing cannot be avoided, we at Merck focus on reducing animal testing, e.g. by driving forward the phasing out of animal testing where it is scientifically feasible using the 3-basket approach and actively engage with contract institutes to improve animal husbandry in line with our internal standards. Thank you in advance for considering our comments, detailed in the attached document.
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Merck warns against losing agency expertise in chemical streamlining

21 Mar 2024
Topic — A proposal to centralize and streamline chemical safety assessments across various EU agencies.
Message — Merck insists on retaining the ability of each Agency to evaluate product safety within their specific mandates. They argue that risk assessments must differ by product area because the relevance of hazards varies.12
Why — Protecting specialized assessments would prevent regulatory decisions that might otherwise disrupt Merck's diverse innovation projects.3
Impact — The EU's innovation landscape and sectors like Healthcare could suffer if non-expert agencies dictate decisions.4
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Merck warns chemical data proposal creates excessive administrative burden

21 Mar 2024
Topic — EU initiative to centralize chemical data sharing for better safety assessments
Message — Merck requests a precise definition of which studies require notification to authorities. They suggest limiting the scope to studies that have clear regulatory relevance. They also emphasize protecting confidential business information from accidental disclosure.12
Why — Limiting the scope would reduce the significant administrative costs and resource requirements.34
Impact — Authorities might make incorrect safety assessments if they lack specific chemical context.5
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Meeting with Henrike Hahn (Member of the European Parliament, Shadow rapporteur) and Verband der Automobilindustrie and

21 Mar 2024 · Critical Raw Materials

Meeting with Frédérique Ries (Member of the European Parliament, Shadow rapporteur)

25 Jan 2024 · Revision of the Pharmaceutical Legislation

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

11 Jan 2024 · Cardiovascular health

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

11 Oct 2023 · Directive on Medicinal products for human use

Merck warns pharma reform threatens European innovation and investment

9 Oct 2023
Topic — The EU is revising pharmaceutical laws to improve access to affordable medicines.
Message — Merck opposes reducing data protection periods and narrowing definitions of medical needs. They argue these changes create unpredictability and risk for research investments.12
Why — Longer exclusivity periods protect Merck’s profit margins and future market position.34
Impact — Generic manufacturers and public health budgets lose from delayed market competition.5
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Merck warns EU pharma reforms will discourage medical innovation

9 Oct 2023
Topic — The European Commission is revising the general pharmaceutical legal framework.
Message — Merck urges the EU to maintain stable and predictable regulatory data protection to support research investments. They caution against narrowing the definition of unmet medical needs, which could discourage incremental innovation.12
Why — Maintaining current protection periods ensures the company can finance future drug development and stay competitive.3
Impact — Patients may suffer from fewer innovative medicines being available if research investments move outside Europe.45
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Meeting with Martin Hojsík (Member of the European Parliament, Rapporteur)

5 Oct 2023 · REACH, Soil

Meeting with Johan Nissinen (Member of the European Parliament)

21 Sept 2023 · läkemedel

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 Karsten Lucke (Member of the European Parliament)

29 Jun 2023 · COVI Report / R&D

Meeting with César Luena (Member of the European Parliament)

7 Jun 2023 · EU Pharmacuetical Strategy

Meeting with Elina Melngaile (Cabinet of Executive Vice-President Valdis Dombrovskis), Zaneta Vegnere (Cabinet of Executive Vice-President Valdis Dombrovskis) and

5 Jun 2023 · Trade & Technology Council, Global Steel and Aluminum Arrangement, Critical Minerals Agreement

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

18 Apr 2023 · Medicines

Response to Revision of EU legislation on hazard classification, labelling and packaging of chemicals

30 Mar 2023

Merck Life Science thanks the Commission for the opportunity to comment. We believe the proposed revision of CLP may constitute something of a missed opportunity to improve on labelling and communication and currently works counter to some of the stated aims of the revision. For this reason, we kindly suggest to consider amending the proposal to: Facilitate the availability of the latest chemical safety information by allowing digital labels for the purpose of updating the supply chain of changes expected to impact products in stock; Improve the clarity of labels by not constraining design, using minimal font sizes and lines spacing and allowing the removal of non-critical label elements from physical labels for professional users and small packages (e.g. 125 mL) when used with digital labels; Align the timetable for implementation of the revised Regulation to those typically used by CLP ATP in order to reduce burden on industry. Merck Life Science KGaA is a key supplier of the Life Science industry in Europe and around the world, working with our customers to ensure chemicals are available for companies providing innovative products and solutions as well as being a key supplier in the manufacturing of pharmaceuticals, medical devices, and diagnostic devices. We are committed to contributing to meet the ambitions of the EU Chemicals Strategy for Sustainability and welcome the opportunity that the revision of CLP brings to improve clarity in hazard communication through digitalisation of this information. Unfortunately, the current proposal misses opportunities to do so and expects changes in an unrealistic implementation timeframe. We produce more than 100,000 different chemical substance and mixtures, in packaging of all sizes. Most users of our products are highly trained scientists, professionals and technicians. These require around 100 million labels per year across hazardous chemicals in small containers. Merck Life Science is well established in providing tailored digital safety information to our users. This proposal limits the ability of doing this in the future so works counter to its stated aims. We offer three areas where the proposal could be amended to reach its stated objectives: supporting safe use of chemicals by improving communication on chemical hazards; and strengthening and simplifying the legal framework to improve compliance. The current proposal increases administrative burden for all stakeholders and does not improve clarity. The attachment provides some details and examples on where each of these areas could be improved. Please see attached document for further details.
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Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur) and Stryker

23 Mar 2023 · Medicines

Meeting with Ibán García Del Blanco (Member of the European Parliament)

2 Mar 2023 · Exchange of views on the Intellectual Property, Data Act and AI

Meeting with Valdis Dombrovskis (Executive Vice-President)

18 Feb 2023 · Review of pharmaceutical legislation. TRIPS waiver.

Meeting with Dolors Montserrat (Member of the European Parliament, Rapporteur)

1 Feb 2023 · Lessons learned on impact of COVID-19 pandemic

Meeting with Mariya Gabriel (Commissioner)

18 Jan 2023 · Deep tech innovation for life sciences & biological components EU Innovation Agenda EU Mission on cancer R&I for health EU Research on semi-conductors

Meeting with Dan Nica (Member of the European Parliament, Rapporteur)

12 Dec 2022 · Dinner debate on Chips Act

Meeting with Lesia Radelicki (Cabinet of Commissioner Helena Dalli)

8 Nov 2022 · Share initiatives and explore ways of collaboration and synergy

Meeting with Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)

7 Sept 2022 · Revision of the pharmaceutical legislation.

Merck urges liability protections and security safeguards in Data Act

13 May 2022
Topic — New EU legislation aimed at facilitating data access and ensuring fair value distribution.
Message — Merck requests incentives for data sharing instead of broad distribution of rights. They want data holders shielded from liability for third-party errors or cybersecurity failures. Additionally, they call for clearer rules on data retention and public sector access.12
Why — Limiting liability for third-party actions protects the company from unforeseen legal and financial costs.3
Impact — Increased infrastructure and technical requirements could lead to higher prices for individual consumers.4
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Meeting with Aliénor Margerit (Cabinet of Commissioner Paolo Gentiloni)

4 Apr 2022 · Current issues such as the transformation of the European economy, and how the Chemical and Pharmaceutical industry

Meeting with Tom Berendsen (Member of the European Parliament, Rapporteur)

16 Feb 2022 · Industry Strategy - Pharmaceutical ecosystem

Meeting with Margaritis Schinas (Vice-President) and

30 Nov 2021 · Pharma Strategy

Meeting with Caroline Boeshertz (Cabinet of Executive Vice-President Valdis Dombrovskis), Elina Melngaile (Cabinet of Executive Vice-President Valdis Dombrovskis), Kevin Keary (Cabinet of Executive Vice-President Valdis Dombrovskis) and

26 Oct 2021 · Pharmaceutical sector – trade related issues

Meeting with Mauro Raffaele Petriccione (Director-General Climate Action)

3 Sept 2021 · FF55 and the pharmaceutical industry

Response to Requirements for Artificial Intelligence

5 Aug 2021

Please see attached document.
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Meeting with Romana Jerković (Member of the European Parliament)

1 Jun 2021 · Pharmaceutical strategy

Response to Evaluation and revision of the general pharmaceutical legislation

26 Apr 2021

The future EU frameworks for regulatory approval, access and incentives to innovation must be articulated around strong industrial policies, attractiveness and predictability, as key enablers to innovation and speeding up access to patients. The legislative review should support European developers and manufacturers in leading science progress and remaining competitive globally. We fully endorse the EFPIA position on the key foundations of a modernized EU regulatory framework, to capture new science, provide agility and fit for purpose methods and processes. It is crucial that the EU provides an effective expedited regulatory pathway. Other priorities include: revised clinical trial approaches and optimized use of real world data and evidence; dynamic regulatory end-to-end assessment processes across the full product life cycle; clear regulatory pathway and processes for drug/device combinations and companion diagnostics; enabled planning and convergence of data generation requirements and data assessment amongst industry, regulatory and HTA authorities; modernized framework for variations. We must ensure that any future review of incentives not only maintains but further reinforces and builds upon the many strong foundations of the EU system. We support the political goal to focus on unmet needs. The definition of unmet needs must entail due flexibility, consider evolving patient and clinical needs, scientific progress, as well as include therapeutic areas where unmet needs remain despite the availability of treatments. Novel incentives must be set up for areas where further efforts are needed. The concept of transferable incentives (vouchers), with adequate flexibilities and guardrails, provide a very attractive reward and effective tool to push innovation. The review provides an opportunity to support our efforts in securing supply and preventing shortages, by enabling flexibilities and contingencies (as opposed to mandatory approaches) to be rolled out by manufacturers. Policies that can support increased resilience must be evidence-based, and include facilitated multi-sourcing or flexible, scalable manufacturing processes and sites, improved transparency of patient demand and stock levels all along the supply chain, and ensuring open trade and adequate level playing field in quality and environmental standards globally. We welcome the political goal to address access inequalities now. Our primary objective remains bringing new treatment options to as many patients as possible as quickly as possible. Ensuring access and availability is an essential imperative which must be addressed with fit for purpose solutions, addressing the primary root causes of the challenges. The underlying root causes are complex, multifactorial, and many are linked to national policies. They must therefore be addressed by working with governments, with potential support from EU policy and financial instruments, shaped to help countries overcome health, social and economic inequalities. Such efforts should also tackle counterproductive national healthcare system practices, such as duplicative evidence requirements, inconsistent value assessment, restrictive pricing and reimbursement policies, as well as budget containment measures. These practices delay access to patients, as do the unintended negative effects of international reference pricing. Incentives ensure that pharmaceutical companies can continue to bring new treatments to patients. These should not be tied to other, unrelated considerations, such as pricing decisions or marketing requirements. We call on national governments to take measures to unlock outstanding access hurdles; we call on the European Commission and national governments to set up a High-Level Forum on Better Access to Health Innovation to advance joint win-win solutions with industry partners. We are convinced this is a necessary step and we remain fully committed to contribute to this process.
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Meeting with Maurits-Jan Prinz (Cabinet of Commissioner Thierry Breton)

12 Apr 2021 · Global supply chains for disposables

Meeting with Thierry Breton (Commissioner)

2 Mar 2021 · Vaccine production

Response to Revision of the EU legislation on medicines for children and rare diseases

5 Jan 2021

Merck, a leading science and technology company with headquarters in Germany, is strongly committed to developing innovative medicines in areas of unmet needs, improving patients clinical outcomes and quality of life. We share the European Commission’s (EC) goal to continue supporting medical innovation in areas of unmet needs and the European pharmaceutical industry as global leader in health innovation. To achieve these goals, some essential considerations and principles must be at the core of the intended review of the Orphan and Paediatric Regulations. We urge the EC to appropriately integrate them into its ongoing impact assessment and welcome the opportunity to provide more detailed insights. The current incentives have proven to be effective in accelerating Research & Development (R&D) and discovery of medicines in the field of Rare Diseases (RD). The core mechanisms should be kept. By nature, R&D in RD entails very high level of investment, time consuming, and has a high uncertainty. The OMP Regulation meant a significant step in increasing R&D across Europe, leading to outstanding scientific and technological advances in different therapeutic areas. The speed of innovation doubled in 2000-2017 vs the previous 20 years, with 142 medicines launched on 107 orphan indications. Without the current Regulation, 52% of those medicines would not have been developed, 2 million European patients would not have benefitted from them, and 6 b€ in European R&D investments(1) would not have occurred. These numbers demonstrate the close interconnection between the OMP Regulation and both private investments and clinical outcomes. The R&D ecosystem for OMPs is on a very fragile equilibrium. Any changes would put at risk the effectiveness of the incentive system and our capability to bring health innovation in the future. We share the EC’s belief that more can be done to further accelerate innovation, improve and speed up access to innovation. However, we are strongly concerned that most of the options being explored would disincentivize innovation in areas of unmet needs where significant R&D efforts are still needed. Limiting orphan designation to “ultra-rare” diseases only, and/or reducing incentives to subsequent indications, could be an immediate show-stopper in the development of new medicines in unmet medical needs (UMN) areas. The definition of UMN should not exclude areas where treatments are available, but where nevertheless unmet needs remain. Access and pricing considerations are variable, multifactorial and never fully depend on the industry. Corresponding challenges cannot be tackled by changing regulations. Reducing incentives and setting additional hurdles, will unquestionably lower the attractiveness, predictability and feasibility of R&D investments, and thus, critically hinder future innovation in these UMN areas. The review must focus on: - identifying areas of critical unmet needs - creating ADDITIONAL mechanisms to foster innovation where needed - implementing the necessary infrastructure to leverage the European data space to support these goals. Merck acknowledges remaining access challenges and we are strongly committed to make our innovations available to each patient in need. Merck calls on the EC to establish a structured dialogue with industry stakeholders and national governments, to identify and facilitate structural, long term solutions to the access hurdles which lead to unequal availability across member states. This must be done in addition to and not necessarily by revising the incentives framework. These are interconnected but different goals, which need consistent but targeted and differentiated policies at EU and, importantly, national level. Keeping and strengthening the current incentive model is key to avoid getting a competitive disadvantage compared to other regions of the world. (1)Dolon report 2020, Estimated impact of EU Orphan Regulation on incentives for innovation, www.dolon.com
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

6 Jul 2020

Merck KGaA welcomes the European Commission’s goal to support EU Member States in addressing outstanding health care challenges and preparing the grounds for the health care systems of the future. The EU Pharmaceutical Strategy has the potential to deliver a stronger medical research and an effective innovation eco-system in Europe, designed to effectively meet future patients, citizens and health care systems’ needs, as well as to enhance our preparedness and resilience to future global health threats. Improving the sustainability of health care systems is a critical element to this. We remain, however, concerned that the Roadmap does not holistically address all the necessary challenges and drivers in order to realize its own ambition of supporting the industry in Europe to be a world leader in innovation and to strengthen the security of strategic supply chains. A holistic and balanced approach involving all stakeholders is essential to reinforce our future ability, companies and society’s as a whole, to timely deliver innovative medicines and value for patients and health care systems. This is a crucial and joint responsibility, with decision-makers at all levels and the research, medical and patient community, which we, at Merck, have at the very core of our values. This touches upon our goals and efforts throughout the entire medicine life-cycle, starting with the R&D ecosystem until the varied factors which impact the actual availability of medicines to patients locally. Specifically, Europe needs a research infrastructure that delivers the next generation of vaccines and treatments; a regulatory framework that is stable, fast, effective and globally competitive, and a strong innovation ecosystem, with adequate intellectual property and incentives framework, all of which must be coupled with consistent, targeted measures to address outstanding access and availability challenges at local level. The Strategy must seize the digital transformation as an opportunity for health care innovation in the EU, by aligning regulatory science, research, and policy framework, whilst preserving the highest ethical standards. This includes also revised clinical trial approaches and optimized use of real-world data and evidence; dynamic regulatory assessment process end-to-end across the full product life cycle; clear assessment pathway for drug/device combinations; enabled planning and convergence of data generation requirements and data assessment amongst industry, regulatory and HTA authorities; modernized framework for variations. We also call upon the Commission and European governments to lead a global pandemic response and preparedness strategy, through greater international collaboration. The COVID19 crisis has not only pointed to critical areas for action, it has also been a testimony of the strategic role that pharmaceutical companies like Merck play by delivering innovative treatments of today and the innovative treatments of the future, and of our true commitment to join efforts with governments, the research and medical community in addressing crucial challenges. We welcome the Commission’s commitment to establish a constructive stakeholder dialogue. As genuinely European, science and technology company, with global operations, Merck is committed to actively contribute to this process by bringing our scientific, technical expertise and vision to reach these goals. To ensure an informed, targeted policy making process, stakeholder dialogue and consultations, we encourage the Commission to drive this process based on a constructive approach and evidence-based analysis of the outstanding pain points, their root causes and thorough policy impact assessment. The factors involved are complex and must be carefully discussed with all actors. It is essential to avoid unfounded assumptions throughout process and stakeholder consultations, which would undermine the ultimate purpose and effectiveness of the future Strategy.
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Response to Commission Regulation amending the CLP Regulation (EC) 1272/2008 and correcting Commission Regulation (EU) 2018/669

7 Feb 2019

Merck is deeply convinced that from a scientific point of view there is no comprehensible reasoning for the proposed classification as a CMR substance, hence Merck’s position is “no classification of titanium dioxide”. Merck fully agrees to and supports the TDMA as well as the VCI and VdMi position “no classification of titanium dioxide” – these industry associations provide in their comments comprehensive reasoning why the proposed classification of titanium dioxide is not adequate and moreover adds confusion for the consumer. Merck is deeply concerned about the proposal for classifying titanium dioxide as carc. cat. 2. In addition to the below described importance of titanium dioxide for Merck’s product portfolio the economic impact is significant not only for the manufacturer itself but also for actors further down the supply chain. Merck is a manufacturer and downstream user of titanium dioxide. Titanium dioxide is used by Merck in a broad range of different products. Main product categories are pearl effect pigments, functional fillers, functional materials and inorganic UV-filters. Merck’s overall production volume of titanium dioxide is significantly above 1000 t/year with titanium dioxide being used in roughly 800 different products. Our products are used in various applications as but not limited to automotive coatings, technical coatings, plastic master batches, cosmetic and pharmaceutical formulations and food. These are highly specialized application areas where a substitution is hardly possible – due to the excellent properties of titanium dioxide. Titanium dioxide is a key component of our products – in case of a classification as carc. cat 2 most of these products would be at risk as in some areas such a classification is directly related to a ban of these products, (e.g. cosmetic products). In other areas it is very likely that the downstream users/the market will not accept using CMR classified products in their applications. Within the respective Merck business unit overall ~ 1000 employees are currently employed – 500 of these in the production plants. Based on an experience of over 60 years of handling titanium dioxide in powder form, we are not aware of any relation to the development of cancer in this group. Neither downstream users indicated any carcinogenic effects due to handling of our titanium dioxide containing products nor did end consumers when using products containing titanium dioxide. While titanium dioxide has been used for decades, there is yet no epidemiological study known to us which unambiguously demonstrates a relationship between titanium dioxide exposure and cancer. It is well known and scientifically well accepted, that carcinogenic effects observed in animal studies can be addressed to particle effects and lung overload phenomena rather than to substance intrinsic properties of titanium dioxide. Having this information in mind, allows for the conclusion that observed (particle) effects are out of scope of CLP. More importantly, such particle related effects are sufficiently addressed and covered by OSHA Regulation, which specifically addresses exposure to dusts – which might occur when powdery forms of titanium dioxide are handled in a workplace environment. Considering the beforementioned, any classification of titanium dioxide would not lead to an increased level of protection for the exposed personnel compared to existing precautionary measures. Furthermore, even products where titanium dioxide is fixed in a multilayer cluster (e.g. pearlescent pigments) and where titanium dioxide does not exist in a free form would be affected by a classification. For these products dust limits under OSHA have proven to be adequate over the last decades. It is further worthwhile to point out that titanium dioxide is the most frequently used pigment worldwide and has been safely used in consumer products for decades.
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Meeting with Giulia Del Brenna (Cabinet of Commissioner Carlos Moedas)

29 May 2018 · Preparation of the IMI 10th Anniversary

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23 Nov 2016 · EPFIA's Priorities

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

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