Lobbying by F. Hoffmann-La Roche Ltd

F. Hoffmann-La Roche Ltd

Roche

Roche is a global biotechnology company and leader in diagnostics, developing medicines and diagnostics to improve lives worldwide.

Focus Areas

2024-2025

2020-2023

Links

Website Transparency Register Profile

ID: 18940431725-51

Lobbying Activity

Meeting with Victor Negrescu (Member of the European Parliament) and AstraZeneca PLC and

4 Nov 2025 · EUROPA CONNECT - Health EU Summit

Roche urges faster, synchronized EU medical device regulatory reforms

6 Oct 2025

Topic — This consultation evaluates the efficiency and proportionality of EU medical device safety rules.

Message — Roche requests synchronized decision-making to prevent 'ready' products from being held in regulatory patterns. They advocate for simplified clinical study pathways by removing redundant national requirements.1 2

Why — Roche would benefit from reduced complexity and faster timelines for new products.3

Impact — National governments lose the ability to maintain their own specific authorization requirements.4 5

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Meeting with Chiara Galiffa (Cabinet of Commissioner Maroš Šefčovič) and MedTech Europe and

25 Sept 2025 · EU – US relations

Roche urges EU to prioritize heart failure blood testing

16 Sept 2025

Topic — The consultation concerns the development of an EU plan for cardiovascular health.

Message — Roche calls for heart failure prioritization in the EU health plan. They want primary care blood testing to be reimbursed and standardized.1 2

Why — This policy would increase market demand for Roche's specific diagnostic products.3

Impact — Specialists and imaging centers would see a reduction in medical referrals.4

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Meeting with Chiara Galiffa (Cabinet of Commissioner Maroš Šefčovič)

8 Sept 2025 · state of play of the EU US trade relations

Response to Critical Medicines Act

4 Jul 2025

F. Hoffmann-La Roche Ltd (Roche) shares the objectives of the EC to bolster supply chain resilience and improve patient access across Europe. Roche's comments below are complementary to EFPIA's consultation response, which we endorse. To ensure that the goals to reinforce supply chain resilience and improve patient access are met effectively and without unintended negative consequences, Roche believes the Act's implementation should be targeted, risk-based, and innovation-supportive. Crucially, it must align with existing EU and national frameworks to avoid duplication and unnecessary regulatory complexity. Art. 3(7) must ensure that vulnerability evaluations are based on robust, product-specific criteria. These should include real-world shortage history, manufacturing complexity, and clinical relevance. It's vital to avoid misleading indicators like supplier concentration or geographic sourcing. The definition of 'medicinal products of common interest' (Art. 3(5)) should be narrowly applied and reserved for situations where persistent and verifiable access issues exist. Joint or collaborative procurement (Art. 21-23) should remain a last-resort measure, only used after national approaches have been fully explored. It is essential that such measures do not undermine national pricing or reimbursement frameworks. Public procurement (Art. 18) can be a valuable tool to support supply resilience if reoriented towards a value-based, multi-criteria approach. This approach should give due weight to supply chain robustness, sustainability, and clinical value. Art. 18 should recognise trusted international partners, such as Switzerland and other European countries members of the G7, as equivalent to EU-based suppliers. This will prevent undermining existing, secure supply networks. Art. 27 on international cooperation presents a vital opportunity to secure diversified and resilient global supply chains through strategic partnerships with like-minded countries, like Switzerland and other European countries members of the G7. We believe that resilience should be defined by the flexibility and strength of supply networks, not solely by location, thus avoiding protectionist measures that risk fragmenting the internal market. Strategic Projects (Art. 5-12) should explicitly encompass existing manufacturing capacity, investments in digital supply chain tools, and advanced production technologies that enhance flexibility and preparedness. Art. 20 on contingency stock obligations should be carefully calibrated, applying only to products confirmed as vulnerable and based on a coordinated, EU-level framework that replaces fragmented national approaches. Flexibility on stock formats and locations, developed in consultation with industry, is essential to avoid inefficiencies or disruptions. Data provisions under Art. 29 should prioritise leveraging existing platforms like EMVS and ESMP. Any new requirements must be proportionate, harmonised, and focused on closing genuine information gaps. The Critical Medicines Coordination Group (Art. 25 and 26) should function as a technical enabler of dialogue and implementation, rather than a centralised regulatory authority. The CMA's alignment with broader policy areas is critical. This includes ensuring coherence with environmental and chemical legislation to prevent unintended barriers to manufacturing within the EU. By embedding proportionality, coordination, and stakeholder dialogue throughout its implementation, the CMA can effectively support Europes dual ambition of enhancing medicine availability and maintaining global leadership in pharmaceutical innovation and manufacturing. Roche remains committed to engage in the upcoming discussions to ensure that the CMA effectively supports patient access to critical medicines in Europe.

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Roche Urges Unified EU Biotech Governance to Enhance Global Competitiveness

11 Jun 2025

Topic — The Commission is developing a Biotech Act to accelerate laboratory-to-market transitions for products.

Message — Roche proposes streamlining clinical research through a single orchestrating body for medical authorizations. They request predictable intellectual property protections and clarity on artificial intelligence rules for pharmaceuticals. The company advocates for risk-based approaches to reduce trade burdens like product re-testing.1 2 3

Why — Unified rules and faster assessments would lower administrative costs and speed up product launches.4

Impact — Environmental and chemical safety regulators may lose autonomy if pharmaceutical assessments become binding over theirs.5

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Response to EU Strategy on medical countermeasures

9 May 2025

F. Hoffmann-La Roche ltd (Roche) welcomes the recognition of the need for a coordinated, forward-looking EU approach to reinforce its preparedness and response against public health threats. As a science-driven company for pharmaceuticals and diagnostics, Roche is committed to working with EU institutions to shape pragmatic, data-informed policies that protect supply security without compromising innovation, quality, or patient outcomes. Given the increasing and varied threats from an uncertain geopolitical environment, it is essential for the EU to strengthen its preparedness and ability to respond to health threats, crises, and emergencies. The pandemic has exposed the limitations of national-level response measures and shown the complexity of the supply chains. To effectively address global health threats, the EU should coordinate its medical countermeasures (MCMs) strategy with reliable international partners to ensure aligned development, manufacturing, and equitable access. Switzerland and other European countries members of the G7 should be categorised as reliable international partners as they are not at the same level of supply risk as other regions of the world. This strategy should comprehensively address MCM availability and development, supporting the Preparedness Union Strategy's health objectives. Furthermore, it offers a chance to simplify and harmonize financial, regulatory, and political actions at both EU and Member State levels. This alignment would reduce administrative burdens, foster a strong industrial environment, and enhance health security competitiveness, thereby benefiting the broader economy. To effectively implement effective medical countermeasures, strong collaboration is needed between public authorities, public health experts, civil society, and the pharmaceutical and diagnostics industry. Maintaining open communication with industry is crucial for identifying practical countermeasures solutions and aligning R&D priorities with these demands. Pulling resources together and aligning objectives across Member States is essentialbut such efforts must reflect the unique complexities of medicinal and diagnostic products. Medicines are highly regulated, diverse, and technically complex, with production processes that are tightly controlled and often made to order. An adequate normative framework is required to support the launch of new MCMS, especially in case of public health emergencies. Digital infrastructure is essential to ensuring patients` access to healthcare solutions and effectively monitoring supply, demand, and current stock of MCM. Roche remains committed to engage in the upcoming discussions to ensure that the MCMs effectively supports patient access to critical medicines and diagnostics in Europe.

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Response to Communication on the EU Stockpiling Strategy

9 May 2025

F. Hoffmann-La Roche ltd (Roche) welcomes the recognition of the need for a coordinated, forward-looking EU approach to stockpiling. As a science-driven company for pharmaceuticals and diagnostics, Roche is committed to working with EU institutions to shape pragmatic, data-informed policies that protect supply security without compromising innovation, quality, or patient outcomes. Given the increasing and varied threats from an uncertain geopolitical environment, it is essential for the EU to strengthen its preparedness and ability to respond to health threats, crises, and emergencies. To effectively implement the EU Stockpiling Strategy (EUSS), strong collaboration is needed between public authorities, public health experts, civil society, and the pharmaceutical and diagnostics industry. Maintaining open communication with industry is crucial for identifying practical stockpiling solutions and aligning R&D priorities with these demands. Pulling resources together and aligning objectives across Member States is essentialbut such efforts must reflect the unique complexities of medicinal and diagnostic products. Medicines are highly regulated, diverse, and technically complex, with production processes that are tightly controlled and often made to order. For medicinal products like many ATMPs or biotechnologically derived products that are temperature sensitive or with a short shelf life stockpiling could be technically unfeasible. Stockpiling, while sometimes necessary, is not a one-size-fits-all solution and should be used only as part of a broader, risk-based resilience strategy. As the EMA has highlighted, inappropriate stockpiling, especially of innovative products, can disrupt supply chains, prolong shortages, and lead to inequitable access for patients. At Roche, we believe stockpiling must be targeted, meaning it should be reserved for critical medicines and diagnostics with known supply vulnerabilities and those required for crisis preparedness. It must also be proportionate, aligned with real-world risk and based on clear clinical need. Finally, stockpiling should be exceptional, a last resort when more sustainable measures are not viable. A resilient EU stockpiling policy must prioritize coordination over fragmentation. National-level mandates that operate in silos risk undermining supply continuity and harming equitable access. Roche supports EU-wide thresholds and guidelines for member states and centralized EU contingency stocks, covering product-specific ceilings and allowances for semi-finished goods based on a robust vulnerability assessment of critical medicinal products supply chains. Streamlining administrative requirements and avoiding duplication between national and EU systems is critical. Existing data already mandated by other authorities and stored in the European Medicines Verification System (EMVS) should be leveraged. This approach will enable companies and competent authorities to focus on ensuring the necessary supply of critical medicines. Roche also supports the use of multi-country packs and harmonized e-labelling to enable agile reallocation across borders, as well as centralized EU stockpiles that complementnot duplicatenational holdings. We support the idea of a European Solidarity Stock System to enable dynamic, needs-based rotation and redistribution in times of crisisensuring efficient resource use and continuity of patient care. Roche's comments above are complementary to EFPIA's and MedTech Europes consultation responses, which Roche endorses.

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Meeting with Hoa-Binh Adjemian (Head of Unit Enlargement and Eastern Neighbourhood)

25 Apr 2025 · Biotech in Serbia

Roche calls for streamlined rules to revive EU innovation

15 Apr 2025

Topic — A strategy to boost European competitiveness in the life sciences sector.

Message — Roche demands a streamlined regulatory system with a single body for clinical trials and integrated healthcare solutions. They advocate for stronger intellectual property protections and improved industry access to health data.1 2 3

Why — Simplified approval processes and robust patent protections would reduce administrative costs and safeguard R&D investments.4 5

Impact — National governments would lose regulatory autonomy, while environmental groups may see sustainability standards deprioritized.6 7

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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 EU rules on medical devices and in vitro diagnostics - targeted evaluation

20 Mar 2025

Our company welcomes the opportunity to give input on the IVDR/MDR targeted evaluation. The IVDR and the MDR are critically important Regulations to ensure access to safe and well performing products for the benefit of healthcare systems and patients in the EU and beyond. We fully support the goals of both Regulations and remain committed to full compliance with all its requirements. Our answers focus on our implementation experience and the application of the current framework. As the Regulations infrastructure is not yet fully implemented, only the parts of the Regulations that are implemented could be assessed. Areas of particular interest for our organisation are innovation and effciency in the development and commercialization of medical devices and IVDs, and the important role that IVDs play in clinical research. A summary of our feedback is attached.

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Meeting with Olivier Chastel (Member of the European Parliament)

18 Mar 2025 · Politique de santé de l'Union européenne

Roche Urges EU to Treat Swiss Production as Reliable

25 Feb 2025

Topic — New EU legislation to address supply chain vulnerabilities and reduce dependencies for critical medicines.

Message — Roche requests that the Critical Medicines Act focuses strictly on the Union List of Critical Medicines. They want Swiss production recognized as a reliable partner to avoid supply risk labels. They also call for streamlined administration using existing data to avoid duplication.1 2 3

Why — This ensures Roche's Swiss production remains competitive and minimizes regulatory compliance costs.4 5

Impact — Manufacturers in non-G7 regions may lose market share if procurement shifts away from lowest-price criteria.6 7

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Meeting with Mariateresa Vivaldini (Member of the European Parliament)

18 Feb 2025 · Meeting conoscitivo

Meeting with András Tivadar Kulja (Member of the European Parliament) and Novartis International AG

18 Feb 2025 · Pharmaceutical Package

Roche demands harmonized EU rules for healthcare innovation

31 Jan 2025

Topic — The European Commission is designing a strategy to strengthen the single market's global competitiveness.

Message — Roche requests consistent application of EU regulations across Member States to end market fragmentation. They advocate for harmonized clinical trial approvals and simplified health technology assessment criteria.1 2

Why — Harmonization would reduce administrative duplication and accelerate the delivery of new treatments to patients.3

Impact — National health authorities lose their autonomy to set unique local data and assessment requirements.4

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

27 Jan 2025 · Exploit interest in a scientific roundtable between the European Commission’s Joint Research Centre and the pharmaceutical industry on the topic of leveraging health data and data sciences for innovation

Meeting with Laurent Muschel (Acting Director-General Health Emergency Preparedness and Response Authority)

5 Nov 2024 · Pipeline presentation

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

28 Oct 2024

Roche, as a world leader in biomedical research and the in-vitro diagnostics sector, is committed to contributing to the future of healthcare in Europe. We support the implementation of the EU HTA Regulation (HTAR) to ensure timely and high-quality assessments for patient access across Europe and welcome the opportunity to provide feedback on the draft EU HTA Joint Scientific Consultation Implementing Act (JSC IA). Flexibility, capacity, and expertise at EU member state level for all molecules eligible for JSC Given the impact of JSCs on the success of future JCAs, Roche believes that it is essential to provide flexibility, capacity, and expertise to secure adequate and sustainable resources at the MS level for all eligible products (at multiple stages throughout development). This includes: - Establishing an approach for JSC request submissions on a rolling basis, which is synchronised with application timelines for EMA Scientific Advice instead of an open call system and ensuring all JSC-eligible products have an opportunity for early advice. - Though some flexibility is introduced by stating at least two request periods per year, the current open call system might lead to low submission and participation rates. - Roche recommends leaving timelines out of the implementing act and providing more specificity in the associated JSC Guidance Document. Roche recommends alignment with other articles which state "within the deadline set in the timetable referred to in Article 4." - Increased clarity on the selection criteria applied for the JSC assessor and co-assessor should be provided in the Guidance for the appointment of assessors and co-assessors. Closer alignment and clarity of process between EU HTA and EMA In the context of parallel JSC (pJSC), and acknowledging the different remits of each institution, we emphasise the importance of well synchronised activity between the HTA secretariat, JSC subgroup and EMA on the operational and procedural level. Specifically, we would appreciate more clarity on EMAs involvement in the JSC request process, decision making criteria and consequences for alternative options.. JSC outcome document reflecting EU-level consolidated advice Roche recommends that all Member States be involved in developing the JSC outcome document to enable harmonisation of evidence generation. Transparency as to which member state/HTA body was involved and any divergent views will aid Health Technology Developers (HTDs) in optimising the evidence package for national assessment procedures. Robust confidentiality frameworks and aligned conflict of interest standards between EMA and EU HTA - Ensuring transparency, secure data processing, and confidentiality is critical; as such the HTA IT platform for information exchange must protect critical documents' confidentiality. - Roche recommends aligning and applying the same standards between EU HTA, EMA, and EU-COM on management of conflict of interest. Utilising the Declaration of Interest (DOI) submitted to EMA rather than requiring a separate one for EU HTA purposes would streamline processes and avoid duplication. Roche's interest in ensuring the process is fit for purpose reflects our strong presence in Europe and technologies likely to go through this process as early as 2025. We remain ready to engage directly on these aspects and offer insights to ensure optimal outcomes for health care systems and patients in Europe. More detailed feedback on the draft implementing act, with concrete proposals, can be found in the enclosed PDF file.

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

22 Jul 2024

As a global leader in biomedical research and in-vitro diagnostics, Roche is committed to advancing healthcare in the EU by promoting scientific excellence and innovation. We back the EU HTA Regulation for high-quality clinical HTA and faster patient access, and we recognise the value of collaboration between EMA and the Coordination Group. However, there are some critical aspects that we wish to see re-emphasized, clarified or more explicitly specified in this implementing act (IA). Exchange between EMA and CG and its subgroups (facilitated by the HTA secretariat) shall be limited to information related to evidence generation planning and shall avoid matters related to evidence evaluation, in order to effectively respect the different remits. The IA lacks clarity on the specifics of information exchange between the CG, EMA, and the HTA Stakeholder Network regarding JCAs and JSCs. It's crucial to respect the differences in the remits of EMA and EU HTA joint work, and unclear proposals in the current draft could hinder this distinction. The purpose of one-way communication from EMA to the HTA secretariat is clear in the context of a JCA, as its timelines are aligned with the centralised procedure and heavily influenced by the therapeutic indication. However, the definition of "general issues of scientific and technical nature" is unclear, and it's uncertain why the CG should exchange such issues with the EMA and involve the HTA stakeholder network, in the context of product-specific JCAs and JSCs. Information exchange should focus on evidence generation and planning e.g. in the context of JSC and PLEG. Bilateral exchange of evidence evaluation information is deemed unnecessary in order to respect different remits. Roche values the opportunity for individual experts to participate in EMA procedures and EU HTA joint work, but recognizes that not all experts may be aware of their specific rights and responsibilities. Therefore, educating individual experts and setting clear expectations before their engagement will be essential. Any exchange of information shall be made transparent to the HTD in terms of purpose, content, timing and recipients (right of information); and any commercially sensitive information must be adequately protected with stronger penalties for those who breach the obligations. The IA lacks transparency and consultation with the HTD on information exchanges between EMA and the HTA secretariat, and subsequently the CG and its subgroups. It states that some requested information to be shared with the HTA secretariat is voluntarily disclosed by the HTD to EMA and may include commercially confidential data. While there's no legal obligation to provide this information, it is crucial for the HTD to know who will receive it to maintain confidence in voluntary disclosure. Any exchange of documents, data, or information from the EMA Marketing Authorisation Application dossier shall be made directly by the HTD to the HTA secretariat, in line with current provisions in the JCA IA. Any other exchange of information, i.e. between the EMA and HTA secretariat and subsequently with CG and its subgroups, shall be made fully transparent to the HTD, who should indicate the level of protection required in each instance. Therefore, clarity on levels of protection and implications is needed for appropriate information classification. Further clarification on technical and organisational measures, including IT platform technical measures, is also necessary. Moreover, appropriate confidentiality agreements shall be in place for all involved stakeholders and we recommend stronger and more clear consequences for breaches. Roche remains committed to engaging directly and offering insights and expertise to ensure the best outcome for healthcare systems and patients in the EU. More detailed feedback on the draft IA, with concrete proposals, can be found in the enclosed PDF file.

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Response to Health technology assessment – Procedural rules for the assessment and management of conflicts of interest in joint wo

21 Jun 2024

Roche, a leader in biomedical research and in-vitro diagnostics, supports the implementation of the EU HTA Regulation (HTAR) for timely and high-quality assessments across Europe. However, there are concerns regarding certain aspects of the current draft Implementing Act (IA) that could hinder successful implementation if not addressed. The IA requires balance between managing conflicts of interest and enabling selection of the right experts to ensure the overall quality and meaningfulness of the joint work outputs, and the ultimate benefit of patient access to innovative health technologies. Critical to achieving this is increased clarity within the IA and closer alignment with existing standards, including ensuring: - the transparency principle - crucial to enable the involvement of experts with the right expertise in all cases - is fully aligned not only with HTAR principles in the IA itself, but also within the proposals in the Annexes - alignment between EU HTA, EMA, and EU-COM on conflict of interest management; crucial due to possible involvement of the same experts. A staggered approach, similar to EMA's policy/0044, is reasonable to handle conflicts. Mitigation approaches are important to avoid delays, especially when replacements are needed - closer alignment on various aspects, such as criteria for assessing conflicts, flexibility for experts with family conflicts, distinct rules for representatives vs. experts, and distinctions for (co)assessors and principal investigators; and reimbursement of reasonable expenses should not be considered a financial interest. From our experience, Roche understands that impartiality and independence cannot always be fully guaranteed. In such situations transparency and mitigation measures should prevail, for all involved parties. Specifically: - Roche supports the publication of DoI but suggests disclosing only the existence of conflicts, not the specific details. Patient and healthcare professional organisations' input is highly valued, providing consensus-based input and community knowledge and should be prioritised over individual perspectives - clarity is needed for assessing and managing conflicts within the HTA secretariat itself. Furthermore, signed confidentiality agreements should be in place for all involved parties. Conflict of interest assessment should be objective and fact-based, with only clear conflicts leading to limitations or exclusions in joint work. Roche is committed to engaging directly and offering insights and expertise to ensure the best outcome for healthcare systems and patients in the EU. More detailed feedback on the draft implementing act, with concrete proposals, can be found in the enclosed PDF file.

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Meeting with Maroš Šefčovič (Executive Vice-President) and

15 Apr 2024 · Meeting WEF CEO Action Group for the European Green Deal

Roche Urges Deeper Inclusion in EU Drug Assessment Process

2 Apr 2024

Topic — New implementing rules for joint clinical assessments of medicinal products in Europe.

Message — Roche argues that developers must be meaningfully included throughout the procedure to ensure quality. They request access to draft documents and earlier assessor appointments to manage timelines. They also demand a framework to protect commercially sensitive information and trade secrets.1 2

Why — Extended preparation windows would help Roche avoid the risks of incomplete submissions.3

Impact — Public transparency is reduced if technical documentation is withheld from the public domain.4

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

6 Mar 2024 · Directive on Medicinal products for human use

Meeting with Laura Ballarín Cereza (Member of the European Parliament, Shadow rapporteur for opinion)

22 Feb 2024 · Pharmaceutical Package

Roche Warns EU Pharma Revision Threatens Innovation and Patient Access

8 Nov 2023

Topic — The European Commission is revising the general pharmaceutical legislation to ensure medicine affordability.

Message — Roche disagrees with linking data protection incentives to launching products in all Member States. They request the baseline duration for protection remain at eight years. They also require consultation for product label changes.1 2

Why — Maintaining current incentives protects Roche's revenue streams from earlier competition by generic manufacturers.3

Impact — National health budgets and patients could lose savings derived from faster generic market entry.4

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Roche warns EU pharma rules will stifle medical innovation

20 Oct 2023

Topic — The revision of the European Union's general pharmaceutical legal framework and supply security.

Message — Roche opposes linking data protection incentives to a mandatory two-year launch across all member states. They call for broad definitions of medical needs and caution against using environmental risks to deny drug approvals.1 2 3

Why — Longer exclusivity periods would protect the company's profit margins and investment predictability for new treatments.4 5

Impact — Future patients may lose access to breakthroughs if reduced incentives drive pharmaceutical investment away from Europe.6 7

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Response to Virtual worlds, such as metaverse

3 May 2023

Roche welcomes the opportunity to provide feedback to the European Commissions An EU initiative on virtual worlds: a head start towards the next technological transition, as a step towards setting a vision for how the EU will approach, regulate and leverage the virtual worlds in services of its citizens and overall economy. General considerations: This consultation demonstrates the European Unions effort to ensure citizens benefit from the full potential of the digital economy. An area that offers significant potential for improving the quality of life for Europeans is health. As a dedicated health ecosystem partner we see the potential in digital worlds to bring to life opportunities in digital health to provide high-quality healthcare, reduce inequities and increase access to innovation. Roche supports this effort to ensure that Europeans benefit from digital worlds in a way that balances right to privacy with societal benefits. We welcome the opportunity to work with the Commission to ensure digital worlds and the associated regulations are realised in a way that enables access to innovation and meaningful participation in digital worlds by all stakeholders. Context for Roche Feedback: Roches perspective is based on its role within the health sector, as a trusted data partner, uniquely positioned to represent the diagnostic, pharmaceutical and health information industry perspectives. Roche looks forward to any opportunity to provide more detailed feedback as the work to progress virtual worlds in the EU proceeds. Please see the attached document for a more comprehensive response and uses cases to illustrate progress already being made in this area within the health sector.

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Meeting with Mariya Gabriel (Commissioner)

18 Jan 2023 · EU Innovation Agenda

Roche demands intellectual property safeguards in European Health Data Space

27 Jul 2022

Topic — New EU legislation governing the sharing and secondary use of electronic health data.

Message — Roche advocates for strong private sector involvement and public-private partnerships in the framework. They emphasize the need to protect intellectual property and trade secrets during data sharing. Additionally, they urge the use of global standards over new EU-specific technical requirements.1 2 3

Why — This would protect their proprietary research while reducing the costs of technical compliance.4

Impact — Public health researchers might face restricted access to data deemed commercially sensitive by corporations.5

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Meeting with Caroline Boeshertz (Cabinet of Executive Vice-President Valdis Dombrovskis)

12 Jul 2022 · Pharmaceutical directive

Response to Cancer Screening Recommendation

22 Feb 2022

Roche supports the initiative to update to the 2003 Council recommendation on cancer screening, including an expansion to include prostate, lung and gastric cancers. We propose that the new cancer screening recommendation include the following 7 key considerations: 1) Update cervical cancer screening recommendation. With its robust and recent review of the evidence, we recommend the adoption of the 2021 WHO guidelines on cervical cancer screening: At minimum, starting regular cervical cancer screening at the age of 30 years among the general population of women using HPV DNA detection as the primary screening test, with regular screening interval of every 5 to 10 years when using HPV DNA, and stopping screening after the age of 50 years after two consecutive negative screening results consistent with the recommended regular screening intervals. 2) Update guidelines more frequently. As research, innovative diagnostic solutions and the evidence evolve rapidly, the Council recommendation on cancer screening should be updated on a periodic, more frequent basis (e.g. every 3-4 years). A clear governance and review process should be established in order to adapt the guidelines with the evolving evidence. 3) Set-up robust monitoring. The more frequent revisions should be supported by a robust and comprehensive EU-wide monitoring programme to ensure the achievement of performance indicators, quality improvement, the rapid adoption of innovation, and leveraging real world evidence. 4) Use of RWD. We strongly encourage the increased use of real-world data (RWD) and algorithms to proactively flag patients based on predefined characteristics and incorporate these into screening programmes. (https://pubmed.ncbi.nlm.nih.gov/34714986/) 5) Address barriers and inequities. Increased coordination and investment from EU Commission and MS is required to address the persistent barriers and inequities in cancer screening across and within MS. For example: - making cancer screening available independently of a primary care physician referral - awareness campaigns to educate/inform the general public on the benefit of early detection/ screening - continuous clinician education on usage and interpretation of new diagnostic technologies, relevant clinical/ referral pathways - increase use of digital technologies, e.g. Digital App for individuals and their Physicians to track, remind, and schedule all Cancer screening appointments and appropriate follow-up visits/procedures. 6) Reduce delay from screening to diagnosis and treatment. Concerted action to reduce delay from positive screening result to diagnosis & therapy plan. A clear EU-wide standard should be established, for example a maximum of 2 weeks for a differential diagnosis investigation and initiation of therapy after a positive screening result. 7) Follow the science. Technology advancements, such as next generation sequencing, are transforming our understanding of cancer’s origins and complexity. Instead of broad categorizations based on the location of tumours, genome sequencing is providing detailed characterizations of the combination of genetic mutations that trigger or aid cancer development in an individual. The treatment paradigm around molecular guided therapy strategies has been established in metastatic disease but there is growing evidence that genomic alteration can be detected in early stages as well. 8) Invest in research and pilots. We encourage The EU Commission to invest in cancer screening research and scalable pilots with clusters of Member States. It is essential that the EU and Member States finance randomized trials designed to produce the information necessary for policy-making, and investments are needed so that results become available in as early a phase as possible. This is particularly important in new promising areas such as genomic testing (multi-cancer screening) and the availability of personalised medicine

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Response to Requirements for Artificial Intelligence

30 Jul 2021

PLEASE SEE ATTACHMENT FOR FULL RESPONSE AND COMMENTS

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Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

Roche expects fast-paced developments in medicines, devices, data and digitalisation to converge into more personalised healthcare solutions, with increased benefit to society at a significantly reduced cost. While this evolution has started and will continue over the next decades, details are hard to predict. Preservation and development of a robust incentives system, real-time integration of advances into current regulatory frameworks will be key for Europe to lead in adapting to innovative approaches and making them available to patients. Fundamental adjustments are needed to EMA and the regulatory network, well beyond recent efforts, for patients to ultimately benefit from these developments and the learnings from the current pandemic (linked to proposed areas b, e, f, m): - The future regulatory system should cope flexibly with the dynamics of innovative science and technology, in particular as to new data sources (e.g. RWD/E), data interrogation and digitalisation (Example: DARWIN data network) - Regulators of medicines and devices, notified bodies, patients, healthcare professionals, academia, HTA bodies, industry should keep a continuous dialogue on the evolution of science and technology, its opportunities and challenges through flexible platforms - Pilots involving all relevant stakeholders will help understand how the system is to evolve and to pave the way for adaptations - Europe needs to mobilise its best experts for regulatory work and digitalisation - EMA and the Network should play a leading role in international collaboration and scientific reliance with other advanced agencies - To keep upcoming regulatory tasks financially sustainable, the future system needs to make optimal use of resources across EU and Member States (MS) - Consequently, the future foundation of the system should be a fully trust-based cooperation across EU scientific experts, MS regulators and decision makers, based on systematic joint capability building within EMA and the Regulatory Network - In line with this, full representation by all MS should be limited to final decision making - Future legislation must allow for fast adaptations whenever required, without resorting to lengthy revisions through ordinary legislative procedures - Mechanisms are needed to assess and agree, with relevant stakeholders, on appropriateness and prioritisation of activities and necessary adaptations in intervals of maximum 5 years, and to ensure budgeting (including industry’s contributions) of the agreed measures and activities In line with these principles, while building on EFPIA’s submission, Roche calls on the Commission to consider selected and non-exhaustive specific measures (details in annex): - Reinforcing collaboration in the system through its structure and a culture of reliance between MS in terms of expertise, ultimately reducing the number of committees with full MS representation in the assessment and decision process - A continuum of flexible scientific advice and interactions - An expertise-driven setup for advice and assessment through specific dynamic community-type networks for all relevant topics, e.g. therapeutic areas or new technologies, superseding the current model - Assessment of a new marketing authorisation application within maximum 150 days following submission - A decision making process of maximum 7 days, potentially combined with its transfer from the Commission to EMA, if the Treaty allows - A regulatory “sandbox” environment for the development and piloting of new regulatory tools - Translation of the outcome of EMA Regulatory Science and EMA/HMA Network Strategy into budget adaptations and capability building at EU and MS level

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Response to A European Health Data Space

3 Feb 2021

To whom it may concern, Roche welcomes the opportunity to provide feedback to the European Commission’s combined evaluation and roadmap/Inception Impact Assessment for A European Health Data Space (EHDS) as an important step towards informing the legislative proposal for the EHDS and realising the European Commission’s “A European strategy for data” released in 2020. We applaud this significant step towards establishing the European Health Data Space and look forward to working with the European Commission in progressing this work. Please see our specific comments attached including links to resources that may be of value in the forthcoming evaluations.

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Response to Legislative framework for the governance of common European data spaces

1 Feb 2021

Roche views the proposed DGA as a very positive development and is supportive of the Commission’s intent to enhance data flow and improve data sharing. Roche supports the aim of the DGA in line with its feedback to both the European Strategy for Data and the Legislative Framework for the Governance of Common European Data Spaces. The suggested elements of the DGA are largely aligned with this feedback, in particular to the extent these are addressing aspects of EU harmonisation (countering fragmentation), commitment to development of scalable data ecosystems and rapid, agile and flexible processes to enable data sharing. It is Roche’s understanding that the proposal is intended to support the use of data made available under existing rules without altering these rules or creating new sectoral obligations. On this basis, we find that the title of the DGA, referring to “data governance”, is slightly misleading, as it suggests an intention to establish a more comprehensive governance framework for “data” in general. We have seen in our review of the draft DGA that the title is creating confusion in particular with regard to enabling measures for data altruism and the legal grounds for processing of data in the context of re-use of data held by public bodies. It is perceived as if these enabling provisions are adding criteria for data sharing that would go beyond the legal grounds for processing in Regulation 2016/679 (“GDPR”). As the content of the proposed DGA is rather specific to enabling infrastructure for sharing of data, perhaps a title along the lines of “data sharing governance/processes/infrastructure act” would trigger less misconceptions. Further clarifications could also be included in the recitals (e.g. recitals 6, 11, 21). Roche would like to highlight the importance of clarifying that the data altruism provisions in the DGA are not intended to substitute existing mechanisms or add criteria for data sharing beyond what is contained under already existing rules, in particular in the GDPR. The provisions in the DGA are rather intended to facilitate consistent implementation of the GDPR. To enable data to flow easily through EU-wide and cross-sector value chains, a harmonised legislative environment is needed. It is Roche’s understanding that an additional prominent aim of the DGA, in particular considering the choice of instrument being a regulation, is to counter fragmentation through Member States’ legislative activities. Roche considers countering fragmentation (in particular fragmentation through differing interpretations of GDPR) a key element of the DGA and supports the suggested measures to ensure different national interpretations are reduced to the largest extent possible for the ultimate purpose of incentivizing and enabling data sharing and data flows within the EU. A related topic is the importance of an aligned understanding of key data protection concepts such as pseudonymization across Member States. Roche strongly encourages adoption of a set of common definitions to increase legal certainty for the purpose of further enabling data sharing and development of scalable data ecosystems within the EU. Other points discussed in the attached: - importance of nurturing a data sharing/ data altruism culture through visualizing, in a balanced manner, the benefits of data sharing and the value to individuals, health systems and societies at large of translating data into actionable information and thereby increase the willingness to participate in fit-for-purpose data ecosystems that encourage innovation. - creation of common data spaces as outlined in the European Commission Data Strategy should continue to be a priority. In particular in the field of healthcare, the COVID-19 crisis has shown the importance of a common, interoperable European Health Data Space, allowing for cross-border exchange of high-quality health data. - ongoing private and public sector engagement, generally

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

6 Jan 2021

Roche is committed to support the improvement of the regulatory environment in Europe and welcomes the opportunity to contribute to the revision of the pediatric and rare diseases legislation. We believe that the revision should not only address current bottlenecks but more importantly, and in line with the Pharma strategy, should make the legislation future-proof and consider also future treatment options and modalities. We support the development of an environment which ensures that innovation is rewarded and leads to more effective treatment options for patients with rare diseases and children, while reducing the overall societal and economic burden of rare conditions for patients, caregivers, health systems and wider society. Maintaining an appropriate incentive framework centered around IP protections, such as SPC and market exclusivity, complemented by specific additional incentives for areas of unmet need and ultra-rare diseases is key to ensure continuous and timely innovation in product development. Roche is committed to address the areas with highest unmet medical need, including very rare diseases as well as developing new treatment modalities, such as cell and gene therapies and integrated healthcare solutions. To support this, a framework for defining unmet needs, developed in a multi-stakeholder dialogue, as well as recognizing the importance of availability of multiple treatments are necessary. An option that recognizes the importance of additional incentives, while also supporting follow-on innovation (along the lines highlighted in Option 3) has the potential to foster the on-going dialogue in the right direction. We also welcome the acknowledgement of the potential that personalised medicine approaches and the use of biomarkers hold for improvements of patient outcomes. Adequately incentivizing the investment in technologies supporting personalised healthcare solutions is necessary to ensure continued scientific advance and would support Europe as a place for innovative research. The use of delegated acts to guide the definition of valid medical conditions will allow sufficient flexibility of the regulatory framework to future-proof the development of these medicines and alleviate concerns regarding the artificial multiplication of rare diseases. Improved efficiency of the regulatory framework for rare and paediatric diseases is welcome. This can be achieved by reducing the number of review cycles for orphan designated drugs and the granularity of initial PIP commitments, as well as early transatlantic dialogue and supporting streamlined communications between the scientific committees and Member States (MS). Given scarce expertise in some rare diseases, consideration can be given also to implementing an expertise- rather than a committee- based review system. Making rewards and incentives conditional on launch obligations fails to understand the economics behind biopharmaceutical research, the complexities of launching medicines across the EU, and the root causes of unequal availability and access across Member States. We support the Commission to work with MS and all stakeholders to identify the root causes and to find targeted solutions for improved availability and access across the EU. Roche is committed to pursue launching in all MS but root causes of unequal availability and patient access are multifactorial and cannot be solely attributed to unilateral company decisions. Targeted solutions will require a close collaboration of national healthcare systems (eg HTA and P&R bodies) on issues such as pan-European evidence generation for small and dispersed patient populations, meaningful joint clinical assessments, and novel pricing and payment models. Progress will require increased solidarity between MS, in particular a recognition of the unintended consequences that international reference pricing and parallel import requirements in wealthier MS have on availability and patient access in other MS.

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Response to Legislative framework for the governance of common European data spaces

31 Jul 2020

Roche welcomes the opportunity to provide feedback to the European Commission’s Inception Impact Assessment for the Legislative Framework for the Governance of Common European Data Spaces (the “IIA”), as an important step in enabling the future EU data spaces described in the European Commission’s “A European strategy for data” (the “Data Strategy”) released earlier this year.General considerations: At large, Roche supports the actions proposed in the IIA, including increased reuse of data held by the public sector, support for voluntary data sharing by individuals, interoperability and standardisation measures and establishment of infrastructure to facilitate data sharing. An overarching framework should address data control and expectations on transparency and privacy/security while allowing for necessary flexibility to accommodate multiple data access and sharing models (e.g. transactional, partnership, federated) and contexts of data use and consider: (i) use of common data language in the governance framework(s) itself (consistent use of common language will also help increase general understanding of the processes and tools used and builds trust among ecosystem partners) (ii) data ethics and the principle that use of data shall benefit patients (in the health data context)/the individual and society (iii) a baseline approach to data protection and privacy that considers practical aspects of compliance and enforcement (iv) recognition of data partners prerogative to protect commercially sensitive information (also considering competition laws) (v) value exchange within data ecosystems is agreed upon (vi) processes are sufficiently rapid, agile and flexible (vii) data standards for quality and interoperability (viii) whenever possible, a [cross-border] approach/commitment to development of scalable ecosystems The creation of common data spaces as outlined in the European Commission Data Strategy should be a priority. In particular in the field of healthcare, the current crisis shows the importance of a common, interoperable European health data space, allowing for cross-border exchange of high-quality health data. Please find attached a document outlining these considerations in further detail with citations

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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

6 Jul 2020

Healthcare industry solutions are becoming more personalized and integrated with increasing potential for cure. To ensure Europe benefits from this progress, we must recognise and respond to substantially intensified competition for life-science research, development and manufacturing investments, and the importance of ensuring access to innovation. Today the US and China set the pace with dedicated programmes to encourage innovative personalised and integrated healthcare solution pilots, attract investment and ensure preparedness for patient access. In addition, accelerated US regulatory pathways coupled with early coverage mechanisms have widened the gap between the US and EU in terms of patient access. While we welcome the Commission’s strong focus on health, we propose to address these growing issues through an ambitious shared vision: “Re-establish Europe as a global medical innovation power-house by the end of the decade, delivering more health benefits to EU patients, while reducing overall costs to society and strengthening the economy”. Realising this vision demands that we embrace the latest thinking and expand the current pharma strategy into a long-term healthcare innovation strategy, future proofing systems beyond crises, attracting continued research investment and rewarding medical innovation. KEY CHALLENGES 1. Fragmentation of responsibilities between EU and Member States - prevents institutions from driving a connected, holistic healthcare agenda; it also delays and complicates introduction of innovations 2. EU infrastructure and low risk tolerance - makes piloting for R&D more difficult vs. the US and China. 3. Inflexibility of EU regulatory systems - slows down innovations vs. other regions 4. Treatment of health expenditure as a cost rather than an investment - constrained patient access and shift of innovation to other regions 5. Delayed and restricted access to innovation and the lack of sustainable solutions for more equal access across EU - solution essential for maintaining innovation engine 6. Lack of preparedness and absence of reward systems for emerging personalized and integrated solutions/technologies - utilisation of the EU’s rich healthcare data is limited due to insufficient digitalisation and the absence of EU wide data governance and interoperability FIRST STEPS We support the EU in securing a strong mandate for an innovative healthcare agenda; establishing a new societal contract on health and healthcare with resulting benefits for patient outcomes, innovation and jobs, and healthcare system efficiencies: 1. Fostering a OneEUInnovation mindset - senior leaders should lead collaboration platforms such as EFPIA’s proposed High Level Forum on Better Access to Health Innovation 2. Introducing blend of measures at both EU and Member State level (see Annex) that will: a. Enable the introduction of new personalized and integrated solutions by supporting access to high quality data platforms (including on Real World Data), and smart risk approach for integrated development, regulatory, HTA and marketing b. Increase speed to innovation while preserving quality c. Foster regulatory/ HTA collaboration to ensure fit for purpose evidence generation that satisfies all parties (including patient groups) and enabling immediate patient access d. Introduce new pricing and payment models ensuring timely, equitable and affordable access while providing value based rewards for innovation e. Promote health system strengthening initiatives to fully leverage the benefits of innovative healthcare solutions f. Continue to support a European system that rewards and stimulates innovation TOGETHER We support the Commission’s objectives for health and the green deal. We call on the Commission, the Member States and Parliament, the industry and others, to work together to realise the vision and the opportunities laid out in this submission, which we consider complementary to EFPIA’s response.

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Response to Europe’s Beating Cancer Plan

3 Mar 2020

Roche strives to transform the lives of people with cancer and those who support them. With a large portfolio in diagnosing, treating and managing cancer, Roche can contribute to the design and implementation of Europe’s Beating Cancer Plan in two main areas: innovation in diagnostic procedures and personalized cancer treatment, and data and information management for better outcomes. Roche is committed to the EU´s mission to provide an innovative policy framework that facilitates public-private cooperation and supports Member States -MS in implementing EU Cancer Plan as well as National Cancer Plans -NCPs. Prevention: Cancer prevention programs must be included in NCPs to raise awareness and reduce exposure to risk factors. Lifestyle habits (eg tobacco, diet, alcohol, sun exposure, environmental pollutants, infections, obesity, physical inactivity) are a main reason for cancer-related deaths. Exploring and exploiting prevention methods should be prioritized and funded. The Plan should encourage MS to: promote healthy lifestyles, share best practice in prevention programs/educational activities, identify funding opportunities and allocate budgets that focus on prevention. Early detection and diagnosis: A cancer detected early is potentially curable, therefore efforts are needed to develop high performing diagnostics to ensure that most patients can benefit from broad genomic testing to qualify for innovative, targeted treatments. Screening program reimbursement remains a bottleneck in many MS.The Plan should encourage MS to: adopt early detection programs including awareness campaigns in NCPs and deliver public health strategies to improve screening uptake; explore evidence-based approaches to conduct screening for cervical, breast, skin, prostate, colon and lung cancer for high risk groups as appropriate; foster the development of high quality reimbursed diagnostics (IVD) in screening and early detection; make comprehensive genomic testing for patients with advanced cancer available across the EU by funding large scale testing programs. Treatment and care: MS regulatory frameworks are not ready for integrated, personalized solutions combining diagnostics and digital devices with innovative medicines tailored to individual patients’ needs. The Plan should encourage MS to: leverage existing efforts that speed up the uptake of novel integrated care plans (eg the DRUP protocol in the Netherlands); consider the use of RWD when appropriate and ensure regulatory frameworks are ready for ATMP, tumour-agnostic therapies and integrated, personalized solutions; fund initiatives that foster know-how transfer across countries by using innovative digital tools such as clinical decision support, digital treatment algorithms and therapy management programs; incentivize research and manufacturing of highly innovative drugs in the EU; incentivize the collection of patient-level data including electronic health records, advanced diagnostics platforms and digital tools eg wearables and apps. These insights are used by health systems to improve care and optimize resource allocation, by researchers and manufacturers to drive more targeted and efficient R&D, by healthcare providers to offer more personalized care and by patients to become empowered throughout their journey. Establishing a structure for cloud-based data sharing eg European Science Cloud, with access for all involved stakeholders is a key step. QoL for patients: The Plan should support MS to: build structures to deliver home based care to improve QoL and healthcare system sustainability; adopt digital tools that empower patients to systematically follow up for early detection of relapsing disease and management of early and late onset of treatment-related side effects; create programs focused on integrating cured patients into a normal life; take measures to improve workforce shortages eg schooling incentives, exchange programs and better payment conditions for healthcare workers

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Response to European Electronic Health Record (EHR) Exchange Format

20 Dec 2018

Roche’s response to the Commission Recommendation to establish a Format for a European Electronic Health Record (EHR) Exchange: As the world’s leading company in pharmaceuticals and diagnostics with a strong presence in the European Union, Roche is dedicated to making a sustained contribution to the future of healthcare in Europe and a policy and regulatory environment that encourages scientific excellence and innovation to the benefit of patients. At Roche, the development of innovative medicines and diagnostics with a focus on ‘Personalised Healthcare’ is at the core of our business. Roche welcomes the publication by the Commission of the Roadmap to establish a Format for a European Electronic Health Record (EHR) Exchange. We strongly support all efforts which lead to improved utilization of healthcare data for the purposes of improving the healthcare of patients, optimizing the use of healthcare resource and supporting the discovery and development of innovative healthcare technologies. We believe that increasing the adoption, standardization and harmonization of EHRs and enabling the interoperability of data derived from EHRs with other key sets of healthcare data are essential steps toward improved utilization of healthcare data and, ultimately, the creation of a "Learning Healthcare System" in Europe. Roche has been a leader in developing methods for the use of real world data (RWD) to support the development and evaluation of our products. Earlier this year, Roche acquired Flatiron Health, a privately held healthcare technology and services company headquartered in New York City, US, which is a market leader in oncology-specific EHR software, as well as the curation and development of real-world evidence for cancer research. With its large network of community oncology practices and academic medical centers across the US, Flatiron Health has created a technology platform designed to learn from the experience of every patient. Currently, Flatiron partners with over 265 community cancer clinics, six major academic research centers and 14 out of the top 15 therapeutic oncology companies. As a major European healthcare company, Roche is concerned that the limited uptake of EHRs, the lack of interoperability of healthcare data and the very limited cross-border exchange of healthcare data will critically hamper the attractiveness of Europe remains as a market for conducting clinical trials, engaging in healthcare research and attracting investment. Access to high quality data at scale is also, in our experience, a prerequisite for the development of artificial intelligence and advanced analytics capabilities. Roche would like to see the Commission put greater emphasis on their efforts to drive adoption and standardization of EHRs and ensure the flow of high-quality interoperable healthcare data across borders. We would welcome being included in a dialogue with the Commission to evaluate how our experience and capabilities can be used to support the Commission's efforts in this vital undertaking.

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Meeting with Günther Oettinger (Commissioner)

13 Oct 2017 · digital policy