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Johnson Johnson

JJ

Johnson & Johnson is the world's largest healthcare company, working to improve health access and outcomes across pharmaceuticals, medical devices, and consumer health products.

Lobbying Activity

Meeting with Ioana Diaconescu (Head of Unit Taxation and Customs Union)

16 Jan 2026 · Johnson & Johnson requested this meeting to engage with DG TAXUD regarding the simplification agenda in the field of direct taxation.

Johnson & Johnson urges EU to scrap quantum ownership rules

10 Dec 2025
Topic — The EU initiative aims to accelerate quantum technology research and industrial deployment.
Message — The company calls for a quantum sandbox to test healthcare applications and wants healthcare recognized as a priority domain. They also request the removal of ownership declarations that currently exclude global companies.12
Why — Lifting ownership restrictions allows the firm to access strategic EU research funding.3
Impact — Domestic European firms would lose their exclusive access to strategic quantum research grants.4
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Meeting with Andreas Glück (Member of the European Parliament)

4 Dec 2025 · Health policy

Meeting with Ulla Schwager (Head of Unit Competition) and AstraZeneca PLC and

3 Dec 2025 · Exchange of views on developments in the pharmaceutical industry and aspects of competition law and policy enforcement in this industry sector

Meeting with Olivér Várhelyi (Commissioner) and

1 Dec 2025 · Digital and AI as an enabler in healthcare

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

1 Dec 2025 · Competitiveness and sustainable healthcare

Meeting with Andi Cristea (Member of the European Parliament) and American Chamber of Commerce to the European Union and

25 Nov 2025 · Recent developments in EU-US trade policy

Meeting with Maroš Šefčovič (Commissioner) and

28 Oct 2025 · Priorities of the EU’s trade agenda

Meeting with Liesbet Sommen (Member of the European Parliament) and Bayer AG and

23 Oct 2025 · Pharmaceutical legislation + Critical Medicines Act

Meeting with Bernd Biervert (Cabinet of Commissioner Maroš Šefčovič), Chiara Galiffa (Cabinet of Commissioner Maroš Šefčovič)

17 Oct 2025 · EU – US relations

Johnson & Johnson urges streamlined data rules and AI clarity

14 Oct 2025
Topic — EU digital simplification agenda covering data regulation, cybersecurity, and AI rules.
Message — The company requests harmonized data policies across EU laws, clearer guidance on cross-border data transfers, and streamlined cybersecurity reporting. They seek proportional AI regulation with clear guidance on research exemptions and alignment with medical device rules.1234
Why — This would reduce compliance costs and complexity for their cross-border healthcare operations.567
Impact — Reduced reporting requirements could limit visibility into cybersecurity incidents affecting patients and consumers.8
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Meeting with Hildegard Bentele (Member of the European Parliament) and American Chamber of Commerce to the European Union and

8 Oct 2025 · Biotech

Meeting with Victor Negrescu (Member of the European Parliament) and American Chamber of Commerce to the European Union and

8 Oct 2025 · AmCham EU Healthcare Committee Meeting

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

25 Sept 2025 · EU – US relations

Johnson & Johnson urges sustained funding for cardiovascular disease prevention

15 Sept 2025
Topic — EU cardiovascular health plan addressing the leading cause of death in Europe.
Message — The company requests sustained political prioritization of cardiovascular disease with focus on access and equity. They call for challenging short-term funding approaches and reforming end-to-end care pathways. They emphasize enabling data-driven tailored care through better use of real-world evidence.12345
Why — This would protect their market for innovative cardiovascular treatments and medical devices from cost containment measures.67
Impact — Healthcare systems face pressure to fund expensive innovations despite budget constraints and cost containment goals.89
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Meeting with Victor Negrescu (Member of the European Parliament)

5 Sept 2025 · Presentation of Position on the Critical Medicines Act

Meeting with Dan-Ştefan Motreanu (Member of the European Parliament)

3 Sept 2025 · Critical Medicines Act / address the root causes of medicine shortages while strengthening Europe’s life sciences ecosystem and competitiveness

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

17 Jul 2025 · Critical Medicines Act

Meeting with Letizia Moratti (Member of the European Parliament) and Dow Europe GmbH

16 Jul 2025 · Industrial Policy

Meeting with Pietro Fiocchi (Member of the European Parliament)

15 Jul 2025 · tematiche sanitarie

Meeting with Vytenis Povilas Andriukaitis (Member of the European Parliament)

15 Jul 2025 · Critical Medicines Act

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

1 Jul 2025 · CMA

Meeting with Manuela Ripa (Member of the European Parliament) and Dow Europe GmbH and

26 Jun 2025 · REACH Reform

Response to Health technology assessment - Joint clinical assessments of medical devices and in vitro diagnostic medical devices

25 Jun 2025

Johnson & Johnson welcomes the opportunity to provide feedback on the draft Implementing Act (IA) for JCAs of medical devices. Our feedback is based on experiences with EU HTA collaboration over a decade, including both pharmaceutical and medical device REAs in Joint Actions 2 & 3, and engagements as the Regulation evolved. We are deeply concerned that our contributions appear to have been ignored, resulting in an IA that is unfit for medical devices. We are aligned with our trade association MedTech Europe, and provide our additional perspective on three specific issues: 1) Selection, 2) Timing, and 3) Duration of JCA. Selection: There is confusion on who selects topics for JCA. Recital 4 states it is the recommendation of the Coordination Group (CG). Rec. 5 however suggests the Commission can select devices NOT recommended by the CG. Yet Rec. 6 states the Secretariat will inform HTDs of devices NOT recommended by the CG for JCA to provide legal certainty. There is therefore contradiction, which continues in Art 2.1(a) related to Rec. 4 & 6, and Art 2.2 to Rec. 5. In practice, this means a HTD could receive a no JCA from the CG, but yes JCA from the EC. We suspect Rec. 5 is erroneous. If however this is not an error, please advise where in Regulation 2021/2282 the criteria for EC selecting devices for JCA not selected by the CG can be found. Timing & Duration: The draft IA projects a degree of urgency for JCA to be conducted soon after certification, which we do not recognise with device related HTA, and ignores the issues identified in Rec. 37 of Regulation 2021/2282, specifically around timing of appropriate evidence. As a result, it proposes a process that we consider will not deliver robust and informative JCA reports, and is more demanding on the HTD than the equivalent process for medicines. Art 2 indicates that a HTD will be informed of selection for JCA upon adoption of the CG recommendation, after the certification process has been completed (Rec. 3). HTDs cannot therefore predict selection, so preparing a JCA will only start after certification. The HTD will therefore only have the duration of scoping (60) and dossier development (100), approx. 160 days to compile a dossier. Indeed, this scheduled time is less than the equivalent total for medicines, where medicines can even prepare ahead of time. This is in an environment where most EU member states do not use HTA to inform initial access decisions. Therefore, this urgency and limited time for HTDs appears unjustified and not fit for purpose. More concerning is most companies are small to medium sized, so this will impose resource and timing constraints to an extent that the JCA process may be difficult if not impossible to meet. We reiterate our position, consistent with the Impact Assessment (2016), reinforced by experience from JA2 & JA3, that JCAs of devices need to clarify the questions within MSs they will inform. A cut and paste of HTA for pharmaceuticals will not address questions or decision points for the introduction of innovative medical devices. We believe this situation can be remedied with a few simple adjustments. We propose: 1-The scoping phase proposed in Art 11 to be expanded, with more HTD engagement, not necessarily limited to 60 days, to define what an appropriate evidence base could be to inform a meaningful JCA for the innovative medical device. 2-The final scope would identify post-launch evidence collection options, in an efficient, coordinated manner to address the requested evidence needs. 3-A timescale to be agreed to initiate the JCA once the evidence is available. This would fit with most HTA timescales on innovative medical devices, allow resource planning by smaller HTDs, and facilitate the inclusion of additional products within the same class, if such devices launched soon, avoiding unintended product/class challenges previously well documented. We remain available to discuss solutions to enable a workable Regulation.
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Meeting with Mohammed Chahim (Member of the European Parliament, Shadow rapporteur for opinion) and European Federation of Pharmaceutical Industries and Associations and

25 Jun 2025 · Roundtable Critical Medicines Act

Meeting with Michalis Hadjipantela (Member of the European Parliament)

10 Jun 2025 · Meeting regarding Critical Medicines Act

Meeting with Ondřej Knotek (Member of the European Parliament, Shadow rapporteur)

5 Jun 2025 · Critical Medicines Act

Meeting with Jessica Polfjärd (Member of the European Parliament) and Pandemic Action Network

5 Jun 2025 · Health Policy

Meeting with Kilian Gross (Head of Unit Communications Networks, Content and Technology)

3 Jun 2025 · Exchange of views on application of the AI Act to the healthcare sector.

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

Meeting with Jeannette Baljeu (Member of the European Parliament)

26 Mar 2025 · EU pharmaceutical package

Meeting with Roberto Viola (Director-General Communications Networks, Content and Technology) and

25 Mar 2025 · Discussion on Artificial Intelligence (AI), MedTech technologies and digital health

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

20 Mar 2025 · J&J requested the meeting to address issues related to the recent adoption of the Commission proposal for a Critical Medicines Act (CMA) and other activities envisaged by the Commission which are deemed relevant to the pharmaceutical industry.

Johnson & Johnson calls for harmonized EU medicine supply rules

27 Feb 2025
Topic — This initiative addresses supply chain vulnerabilities to strengthen Europe's critical medicine supply.
Message — J&J urges the EU to harmonize national measures and avoid additional complexity. They request a risk-based approach that differentiates between critical and vulnerable medicines. Finally, stockpiling should be coordinated at the EU level to ensure solidarity.123
Why — These changes would lower compliance costs and protect their international manufacturing networks.45
Impact — Member States lose individual control over national stockpiling and local procurement criteria.6
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Meeting with Oliver Schenk (Member of the European Parliament)

14 Jan 2025 · Priorities for the new legislative term 2024-2029

Meeting with Eszter Lakos (Member of the European Parliament)

9 Dec 2024 · Pharmaceutical industry - site visit

Meeting with Vytenis Povilas Andriukaitis (Member of the European Parliament)

9 Dec 2024 · EU Health Policy

Meeting with Michalis Hadjipantela (Member of the European Parliament)

13 Nov 2024 · Introductory Meeting

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

5 Nov 2024 · European Health policy

Meeting with Stine Bosse (Member of the European Parliament)

23 Oct 2024 · European health and environmental policy

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

24 Jul 2024

Johnson & Johnson welcomes the opportunity to provide feedback on the draft Implementing Act (IA). Our feedback relates to the relevance of this Implementing Act across medicinal products, medical devices, and in vitro diagnostics. We are aligned with our trade associations, EFPIA and MedTech Europe, and provide an additional perspective on the key issue of ensuring confidentiality below. The introduction to the IA identifies that information provided voluntarily by the Health Technology Developer (HTD) for the purposes of EMA planning is to be shared more widely with the HTA secretariat, the HTACG, and its subgroups. Recital 6 recognises that measures need to be included in the Implementing Act to protect such information. We consider the draft IA should be enhanced specifically on how confidentiality will be ensured, and what sanctions will apply should a breech in confidentiality occur. Specifically: Articles 2.1 & 2.2 The information outlined is proprietary to the HTD. Given this information is confidential, we would propose that HTDs be responsible for sharing with the HTA Secretariat on an annual cycle, rather than the EMA. This will ensure the commercially sensitive information is adequately identified to the HTA Secretariat, and the HTD is aware of what sensitive information is shared under the HTA Regulation (HTAR). Article 2.1.iii Without prejudice for the bullet above, the therapeutic indication summary is unlikely to be available 18 months or more from submission what is available is the disease area, (eg treatment of breast cancer, or management of diabetes). This should be edited for clarity of expectation. Articles 2.3 & 4 These Articles describe how information provided to the EMA, in confidence and voluntarily, for the purposes of informing the EMA work plan, could now find its way via the HTA Secretariat to the EHT (Emerging Health Technologies) subgroup for the purpose of fulfilling their obligation under Article 22 of HTAR, of providing reports on emerging health technologies. There is no clarification on the nature of these reports, whether they will be confidential, or how wide the circulation would be. The uncertainty of the use of this data has the potential to undermine its original reason for capture. The Commission should instigate a Need to Know principle, so that scope of access to confidential information is defined by the purpose and not shared beyond those with a legitimate need. We consider that the information supplied by the EMA should only be used for, and not go beyond those involved in JCA and JSC planning activities. Article 8.1 supports this. Specifically, no commercially sensitive data should be disclosed in reports by the EHT under Art 22 HTAR. Information for the EHT subgroup should be obtained from other, non-confidential sources, or from the International Horizon Scanning Initiative (IHSI). Article 8 This Article implies that the EMA determines the degree of confidentiality attributed to information passed to the HTA Secretariat. We believe the HTD, as owner of the data, should determine what is confidential. Article 9 Whilst this Article describes how failure to respect the obligations of professional secrecy will be established, it fails to provide: a) description of procedures to manage potential breaches (such as notifying the data originator); b) details of sanctions or disciplinary measures, damages as well as remedial actions on the EC side, for example as stipulated in Art 8 of the EC Commission decision 2015/444 and Art 9 EC decision 2015/443. This Article should therefore be further developed. Recital 12 Will access requests to commercial confidential information be exempted from disclosure? If not, will HTDs have a right to comment based on either existing EMA policy or (EC) No 1049/2001? Thank you for the opportunity to respond to the draft Implementation act. We remain available to discuss solutions to enable a workable Regulation.
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Meeting with Lukas Sieper (Member of the European Parliament) and European Federation of Pharmaceutical Industries and Associations and

16 Jul 2024 · Introductory meeting at networking event

Meeting with Werner Stengg (Cabinet of Executive Vice-President Margrethe Vestager)

20 Jun 2024 · AI technology and their implications for the health sector

Meeting with Stella Kyriakides (Commissioner) and

20 Jun 2024 · Digitalisation of healthcare.

Meeting with Daniel Freund (Member of the European Parliament)

27 May 2024 · Podiumsdiskussion zur Europawahl

Meeting with Svenja Hahn (Member of the European Parliament)

14 May 2024 · Exchange on current affairs

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

8 May 2024 · Directive on Medicinal products for human use

Johnson & Johnson warns EU clinical assessment rules are unworkable

2 Apr 2024
Topic — The European Commission is setting rules for joint clinical assessments of medicines.
Message — J&J requests involvement in defining the assessment scope and more preparation time. They propose a 4.5-month window to develop robust and informed evidence dossiers.12
Why — This avoids penalizing companies that have fast regulatory approval timelines for medicines.34
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Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur)

4 Jan 2024 · Directive on Medicinal products for human use

Meeting with Henna Virkkunen (Member of the European Parliament, Rapporteur for opinion)

27 Nov 2023 · Medicinal products for human use

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

22 Nov 2023 · Revision of the Pharmaceutical Legislation

Meeting with Javier Zarzalejos (Member of the European Parliament, Shadow rapporteur)

7 Nov 2023 · Meeting with Johnson & Johnson to discuss the Supplementary protection certificates (SPCs) package

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

30 Oct 2023 · Pharmaceutical Package (Regulation)

Meeting with Alin Mituța (Member of the European Parliament)

17 Oct 2023 · Pharma Package directive

Meeting with Michal Wiezik (Member of the European Parliament)

17 Oct 2023 · Pharmaceutical Package

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

17 Oct 2023 · Pharmaceutical Package (Directive)

Meeting with Catherine Amalric (Member of the European Parliament, Shadow rapporteur)

26 Sept 2023 · Reform of the EU pharmaceutical legislation

Meeting with Annalisa Tardino (Member of the European Parliament, Rapporteur)

18 Sept 2023 · Incontro con Janssen e Meridian

Meeting with Sirpa Pietikäinen (Member of the European Parliament)

31 Aug 2023 · Pharmaceutical Package

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

29 Aug 2023 · Directive on Medicinal products for human use

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur) and Deutsche Krankenhausgesellschaft e.V.

29 Aug 2023 · Revision of the Pharmaceutical Legislation (staff level)

Meeting with Katherine Power (Cabinet of Commissioner Mairead Mcguinness) and MedTech Europe

13 Jul 2023 · Medical devices legislation and EU sanctions

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and American Chamber of Commerce to the European Union and

11 Jul 2023 · Directive on Medicinal products for human use

Meeting with István Ujhelyi (Member of the European Parliament)

5 Jun 2023 · European Health Union

Meeting with Mohammed Chahim (Member of the European Parliament)

22 May 2023 · Pharmaceutical Strategy

Meeting with István Ujhelyi (Member of the European Parliament)

4 May 2023 · Health

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

27 Apr 2023 · Medicines

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

14 Mar 2023 · European Health Data Space - EHDS

Meeting with Nils Torvalds (Member of the European Parliament, Rapporteur)

13 Mar 2023 · Urban wastewater treatment

Meeting with Stelios Kympouropoulos (Member of the European Parliament)

27 Feb 2023 · general discussion on the Pharmaceutical Strategy revision

Meeting with Nathalie Colin-Oesterlé (Member of the European Parliament)

20 Feb 2023 · Pharmaceutical review

Meeting with Susana Solís Pérez (Member of the European Parliament, Shadow rapporteur)

26 Jan 2023 · EHDS

Meeting with Sara Cerdas (Member of the European Parliament, Shadow rapporteur)

25 Jan 2023 · European Health Data Space

Meeting with Sara Cerdas (Member of the European Parliament) and Vodafone Belgium SA and All Policies for a Healthy Europe

20 Jan 2023 · Air Quality Directive

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

30 Nov 2022 · Lessons learned on impact of COVID-19 pandemic

Meeting with Susana Solís Pérez (Member of the European Parliament)

28 Nov 2022 · MDR

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

29 Sept 2022 · cancer

Johnson & Johnson urges IP safeguards and industry board representation

28 Jul 2022
Topic — This consultation concerns the creation of a unified European framework for sharing health data.
Message — J&J requests healthcare industry representation on the EHDS Board. They advocate for federated networks and clearer protection for trade secrets and intellectual property. The company also seeks clarity on international data transfers and GDPR alignment.123
Why — This would protect proprietary assets while enabling more effective investment in innovative medical solutions.4
Impact — European researchers and patients lose out on global innovation if data transfer rules are restrictive.5
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Johnson & Johnson Urges EU Smoke-Free Rules for E-Cigarettes

18 Jul 2022
Topic — The European Commission is updating smoke-free recommendations to cover electronic cigarettes and outdoor areas.
Message — The company supports extending smoke-free legislation to heated tobacco products and electronic cigarettes. They also propose banning smoking in playgrounds, schools, and private cars when children are present.12
Why — Restricting tobacco and e-cigarette usage encourages smokers to switch to their nicotine replacement products.34
Impact — Heated tobacco and e-cigarette manufacturers lose market appeal and face stricter usage limitations.56
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Meeting with Werner Stengg (Cabinet of Executive Vice-President Margrethe Vestager)

12 Jul 2022 · AI Act, European Health Data Space, Data Act.

Meeting with Alin Mituța (Member of the European Parliament)

6 Jul 2022 · European Cancer Beating Plan

Meeting with Sara Cerdas (Member of the European Parliament)

23 Jun 2022 · Lung cancer screening programs

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

21 Jun 2022 · Medicines

Johnson & Johnson warns EU patent licensing plans are misguided

29 Apr 2022
Topic — The EU is consulting on harmonizing compulsory patent licensing procedures for crisis situations.
Message — The company believes enhancing compulsory licensing at the EU level is a misguided approach. They argue that voluntary technology transfers are the most effective way to expand production. This framework protects the IP necessary to facilitate medical innovation.12
Why — Avoiding mandatory licensing allows the company to protect its long-term research investments.3
Impact — Generic manufacturers lose the opportunity to produce and scale up affordable treatments.4
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Response to Requirements for Artificial Intelligence

6 Aug 2021

Johnson & Johnson welcomes the opportunity to build a trustworthy and innovative ecosystem for artificial intelligence (AI), where the AI Act (AIA) plays a critical role in combination with the existing regulatory framework. The AIA should have a clear scope and framework, facilitating its implementation and avoiding complexity, in order to build trust between citizens, developers, deployers and users and create a favourable environment which fosters innovation. The international implications of this regulation and cross-border regulatory cooperation are important to ensure EU citizens and businesses have access to beneficial AI solutions. The AIA includes in its objectives addressing health-related AI systems, and aims to support parties in effectively managing risks and unlocking the potential benefits of using AI in healthcare. We support the current approach of focusing on healthcare applications that are covered under the Medical Devices Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR), such as Software as Medical Device (SaMD). This proposal is joining a very robust regulatory framework which already addresses potential risks emerging from the development and use of AI in medical technologies. The interplay of the new regulation with regulations such as the General Data Protection Regulation (GDPR), MDR and IVDR needs to be further clarified. Medical devices, including many aspects related to medical software, are comprehensively and clearly regulated under the EU MDR/IVDR, which pursue similar objectives as the AIA, i.e., ensuring a high level of protection of human health and avoiding a harmful impact on the health and safety of persons, and they already take into account the use of AI systems operating as “components of products”. In order to achieve legal certainty, we believe that those requirements (e.g., conformity assessment, database registration, Notified Bodies, etc.) already specified under the sectoral legislation, i.e., MDR/IVDR, should supersede AIA provisions. Nevertheless, the AIA may help fill any potential gaps by giving a framework upon which the Medical Devices Coordination Group (MDCG) could develop further guidance for AI in medical technologies. The scope of the regulation needs a clear definition of AI. As written, it could cover any software or statistical approach, leading to a lack of certainty regarding which products are within the scope of which obligations. Taking into account the GDPR experience will be fundamental for a successful development of this regulation, as we observed how important objectives and well-intended architecture led to fragmented interpretation and inconsistent implementation across Member States. The role and flexibility given to Member States should not lead to divergence but rather to ensuring a more cohesive and harmonized interpretation, implementation and enforcement of the legislation.
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Meeting with Maurits-Jan Prinz (Cabinet of Commissioner Thierry Breton)

28 May 2021 · Vaccine delivery schedule for June/July and expansion of production capacity

Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

The EU’s general pharmaceutical legislation has provided strong foundations for pharmaceutical innovation and medicines development, helping to tackle some of the leading causes of disease and life-threatening illnesses. We welcome the opportunity to discuss improvements to ensure the framework is more patient-centred, future-proof and crisis-resistant, offering a world-class regulatory environment to ensure medical innovation continues to take place in Europe. Unmet medical needs (UMN) and incentives To effectively respond to future health threats, address ongoing healthcare challenges, while enhancing its attractiveness as an R&D hub, Europe must strengthen its world-class research, IP and incentives framework. The current system should be reinforced, not undermined to create a robust ecosystem that provides access to essential medicines, transformational therapies and sustained innovation. A key success factor will be converging around a common, multi-stakeholder understanding of UMN. This should include broad perspectives and a flexible mechanism with clear criteria, encompassing areas without optimal treatments. We welcome novel incentives for UMN (e.g. new antimicrobials) to supplement the current framework. Future-proofing the regulatory environment We need a modernised regulatory system to be more competitive globally and bring innovative/transformative products to patients faster. We welcome policy options that: •Enable a more agile centralised authorisation framework and streamlined procedures incl. accelerated pathways, continuous & less formalised scientific dialogue throughout development, more acceptability of RWE in regulatory/HTA decision-making, better use of digital technology and further expanding the use of electronic product information (incl. labelling). •Build flexibility so the framework can adapt to scientific & technological developments e.g. optimal regulatory pathways for medicine/device combination products and personalised medicines. Beyond the general pharmaceutical legislation, the EU could seek more effective regulations for medicines containing GMOs, centralize assessment and harmonize dossiers; make the variation framework less cumbersome; implement the Clinical Trials Regulation to facilitate innovative clinical trials; and reduce the regulatory burden for OTC products. Access & availability We recognise access concerns and encourage a separate discussion with all stakeholders to address their multifactorial root causes. Beyond the pharmaceutical regulation, we suggest improving access through local HTA reforms, value-based healthcare, innovative payment methods, ensuring P&R deadlines are respected, optimising the use of RWE and encouraging greater self-care. We hope that the future HTA Regulation will enable faster access and better evidence-based decision-making. Policy options proposed in the roadmap such as tying incentives to placing products on all EU markets would be disproportionate as it puts the onus solely on the industry (some country access hurdles are outside of our control). It would also be ineffective as it would not address these local access hurdles and disincentivise medical innovation in Europe. Tying incentives to transparency on R&D costs would have a similar effect as it would likely undervalue the complexity, high risks and total costs of the pharmaceutical innovation model and would create perverse incentives rewarding less effective medicines with higher development costs. Security of supply and oversight of supply chains Policy measures need to support strong, resilient global supply chains that ensure patient access to medical goods, including during major public health threats. They should ensure open global trade, the free flow of medical goods and encourage geographical diversity so that supply chains can adjust to ensure stability and avoid potential shortages and disruptions. We welcome discussions in the EU Commission’s supply chain structured dialogue
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Meeting with Thierry Breton (Commissioner)

10 Apr 2021 · Vaccine production and deliveries

Response to European Health Emergency Response Authority

24 Feb 2021

The COVID-19 pandemic has shown that the EU needs to strengthen its preparedness and response to serious cross-border health threats. Johnson & Johnson (J&J) welcomes the Commission’s proposal of creating HERA to prepare for future pandemics by enabling stronger surveillance, risk assessment and supporting the discovery, development, manufacturing, and deployment of new medical countermeasures. It is essential that the global system prepares for an effective response to the next global outbreak by creating the following capabilities: • Rapid detection and analysis of newly emerging pathogens • Large-scale investments into research and development for new health technologies (vaccines, therapeutics, diagnostics and medical devices) • Development, maintenance and manufacturing of platform technologies that can be used for rapid and crisis-relevant vaccine, drug, diagnostic and medical devices deployment • Joint EU Procurement/Contracting of key medical countermeasures through a centralized mechanism in sufficient volumes to ensure development of new technologies and warm-base manufacturing infrastructure As a company that has been extensively involved in developing medical countermeasures in global health crises (Ebola, Covid-19), J&J believes that HERA will be particularly effective in strengthening the global pandemic preparedness and response systems if it has the following features: HERA should be equipped to collaborate throughout the entire process for the discovery, development, production, and deployment of effective countermeasures for future health crises, including pre-clinical and clinical development, manufacturing scale-up and validation, regulatory interactions and submissions, procurement and potential stockpiling. HERA should be adequately resourced. Predictable long-term funding, ideally for a 7-year period to align with the EU’s multi-annual financial framework will be important. HERA should be flexible and be able to be the sole funder of projects for new health technologies with limited commercial opportunity and to co-fund projects with greater market potential. HERA should be able to rapidly supplement projects in response to changing needs and have a clear mandate to operate in time of crisis on behalf of the EU Member States to enable rapid responses. A collaboration platform for cooperation among industrial partners / businesses is needed. Respecting EU statutes, requirements, and legal frameworks, pragmatic and flexible decision-making must be a cornerstone of the agency. Unbureaucratic, speedy processes – for example ease of contracting and simplicity of joint project oversight – are fundamental. Awards should be made to one lead contracting entity, accountable to manage and deliver the project. Such lead contracting entity should have the freedom to involve third party subcontractors for performing the projects, driven by science, excellence and independently of global geographical location. The new agency should be staffed with experts with industry knowledge and experience in drug, vaccine, diagnostics and medical devices development to be able to effectively select, rapidly negotiate, and monitor its projects and to drive product development and licensure. HERA’s legal set-up should incorporate a framework to provide adequate indemnification and liability protection to manufacturers who are willing to supply vaccines, drugs, diagnostics and medical devices for use in emergency settings. A global countermeasure sharing mechanism, to allow for resell and donation to third countries should be incorporated. J&J applauds the EU’s ambition to improve EU’s pandemic preparedness and response system through the creation of HERA. Options 2B and 3 described in the IIA involve very promising elements. Creating HERA is both timely and prescient to achieve the goal of contributing to global & European biosecurity and bio-preparedness. Finally, we welcome the HERA incubator program.
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Meeting with Eszter Batta (Cabinet of Commissioner Thierry Breton), Fabrice Comptour (Cabinet of Commissioner Thierry Breton), Valère Moutarlier (Cabinet of Commissioner Thierry Breton)

23 Feb 2021 · Vaccine Manufacturing

Response to Proposal for a Regulation on a Union framework addressing public health emergencies (EMA)

2 Feb 2021

The COVID-19 pandemic has clearly shown that there are opportunities to further strengthen and improve the EU health security framework to be ready for all health threats. Therefore, Johnson & Johnson (J&J) welcomes and supports the EU’s goal to equip the EMA with a stronger mandate. Collaboration throughout the pandemic has proven to be valuable; we are committed to collaborate and to be part of this shaping dialogue, as we believe this is just a first step in future-proofing the capacity and mandate of the Agency. We encourage coordination with the private sector and (potential) Marketing Authorization holder (MAH) (= ”Developer” cfr. Art 2) to help ensure that strategic stockpiles of critical healthcare supplies comprise products (appropriate to circumstances) at the right volume, along with proper monitoring and logistics plans, as well as establishing anti-hoarding measures. Current definitions included in Art 2, such as “major event”, “shortage”, “developer” should be further clarified. Similarly, we ask for a clearer scope and binding nature of the Medicines Steering Group (MSG)’s recommendations in case of a major event / identifying critical medicines (Art 8.3, 10.6, 16.3) that is based on regulatory solutions to address shortages (e.g. labelling flexibility). We welcome the option for the MSG Chair to invite MAHs to attend meetings. We support the proposal of the permanent iSPOC system to complement today’s reporting obligations, without duplicating MAH efforts and including strong confidentiality provisions (Art 10). We support the Emergency Task Force scientific advice process and the new process to facilitate clinical trial advice (Art 14, 15). This is a welcome step towards harmonized clinical trial advice at a European level and subsequent national application. Examples of a streamlined and expedited regulatory and approval process under this framework for medicines for public health emergencies that could reduce timelines and speed up patient access should be used as case studies to call for efficiency gains in the authorization process for medicines used outside of public health emergencies. Such accelerated processes should be enabled by a flexible and integrated product support infrastructure (Art 16.2). The timeline for CHMP endorsement of the Emergency Task Force accelerated scientific advice should be clarified if not completed within the 20 days following the submission of the request to EMA (Art 15.2). We support the intention to establish and manage IT infrastructures to support the regulation allowing EMA to coordinate vaccines safety and effectiveness studies (including jointly establishing a vaccine monitoring platform). We note that development of electronic tools can take time and hope that these IT initiatives can be developed to the same ambitious timelines as the legal proposals. We support the proposal for additional budget to be made available to support this work. The proposal to commit more focus and resources to medical devices at EU level is welcome. EMA processes and working modes are based on medicine lifecycles and approval timelines. Medical device lifecycles and approval timelines are shorter and the EMA will need to reflect this (Art 28) ensuring innovative devices within the scope of product coverage are not hindered from reaching the patient. We note and support that the intention is not for a wholesale new regulatory role for EMA in the regulation of devices, and trust that medical devices expertise and experience will be installed in the agency for its coordinating role. We support the actions summarized in Art 21 and 22 while pointing out that coordination of the different groups in urgent timelines may be challenging.
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Response to Proposal for a Regulation establishing a European Centre for Disease Prevention and Control (ECDC)

2 Feb 2021

The COVID-19 pandemic has clearly shown that there are opportunities to further strengthen and improve the EU health security framework to be ready for all health threats. Therefore, Johnson & Johnson (J&J) welcomes and supports the EU’s goal to equip ECDC with a stronger mandate in epidemiological surveillance, preparedness and response planning, reporting and auditing. We also encourage continued international collaboration. On a same note, J&J is engaged in a number of forums and co-founded the Pandemic Action Network alongside the Bill & Melinda Gates Foundation to help ensure that countries are better prepared to prevent, detect and respond to pandemic threats. We welcome the plans to provide a swift preparedness response to crises, which could lead to a faster development of understanding of the illness (Art 3). The content of the individual recommendations of the Agency will be key to avoid that its non-binding nature could prevent stakeholders being tied to certain measures. It will be important to ensure collaboration with industry to deliver the right outcomes and priorities on the crisis issues. It is equally important that the Agency can share relevant data with manufacturers of medical countermeasures, so that they can react early and adapt their shortage prevention strategies to cover demand at patient level. J&J very much supports the accelerated digitalization of platforms and applications for the epidemiological surveillance, which could lead to more, interoperable, and higher-quality data. This must be undertaken in compliance with GDPR provisions. Better platforms may reduce administrative and regulatory burdens for the Agency and its stakeholders (Art 5). We support the creation of a monitoring platform for vaccines safety and effectiveness and the conduct of related post marketing studies, jointly with EMA (Art 5a). We encourage those conducting studies to consult marketing authorization holders on studies. The elements proposed in the Regulation under Art 5 to 8 will contribute to a faster, higher quality, information sharing between Member States, to better informed policy decisions and a generally better prepared policy environment for pandemics and help ensure a timely and pro-active input and support from ECDC for all Member States and the European Commission for responses to health crises. We note that health data will be made available for regulatory purposes and assume that, in respect to medicines, this relates to decision making made by the relevant medicines regulatory authorities. The role of the Advisory Forum should be consistent with Art 18 of the ECDC Regulation and shall not overlap with the role of the ECDC management team nor the Management Board. We strongly support ECDC’s engagement with industry experts (Art 18, c). Finally, the amendment of this regulation is an excellent opportunity to further optimize and re-design ECDC’s governance and decision-making process, following the principles of efficiency, transparency and accountability, including the avoidance of future overlaps between mandates and competencies of ECDC, EMA and the upcoming HERA. The Regulation is an opportunity to provide the framework for an institutionalised dialogue between ECDC and the industry, delimited by stringent standards regulating stakeholder engagement with public institutions, and this to avoid any conflicts of interest. Successful examples can be found with WHO (https://www.who.int/about/partnerships/non-state-actors) and the US Centers for Disease Control and Prevention (https://www.cdc.gov/partners/partnering.html). Throughout our more than 130-year history, J&J has had a legacy of responding during crisis, from natural disasters to health outbreaks. We believe we have a responsibility to step in and invest in solutions for global public health crises and are proud to be contributing to the global response to COVID-19.J&J would be very willing to engage in the dialogue on the proposed Regulation.
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Response to Proposal for a Regulation on serious cross-border threats to health

2 Feb 2021

The COVID-19 pandemic has clearly shown opportunities for a strengthened and improved EU health security framework, ready for all health threats. Therefore, Johnson & Johnson (J&J) welcomes and supports the Commission’s proposal for a Regulation on serious cross-border health threats, providing a stronger and more comprehensive legal framework allowing the Union to react rapidly and trigger the implementation of preparedness and response measures. In order to foster ongoing dialogue, the Health Security Committee (Art 4) and the Advisory Committee on public health emergencies (Art 24) should be allowed to consult stakeholders, including industry, on topics relevant to their activities and decisions, through a newly created dedicated stakeholder group. On an exceptional basis in cases of serious cross-border threats to health (e.g. pandemics), where supply is challenging, we would agree to joint procurement as defined and subject to the conditions provided under Decision 1082/2013/EU (Art 12). The COVID-19 pandemic has increased attention on medical product supply chains. Global interdependence within supply chains can enhance resiliency and flexibility, and therefore cannot be underestimated in responding to health emergencies. As governments take protective measures to stem the current pandemic and to prepare for future public health emergencies, some measures may inadvertently impact the flow of critical medical goods across territories by closing trade lanes. In addition, political debates related to reshoring all medical product production within individual countries have emerged. Yet given the complexities and potential disruptions of undermining carefully established and functioning supply chains, limiting product flow across borders and reshoring efforts would pose significant risk that could lead to shortages, cost fluctuations, and disruption of patient care. Measured approaches can help ensure more resilient global medical supply chains. Regarding the overall coordination of Union and Member State response to serious cross-border threats to health, it would be important to ensure a system where the free movement of medicinal products and essential workers is protected, and where unilateral decisions by Member States do not threaten the supply of essential medicinal products to the patients that need them most. J&J supports a greater epidemiological surveillance role for ECDC strengthening EU’s overall pandemic preparedness planning and response (Art 13) yet would prefer more clarity on how surveillance standards will be defined and amended, and whether there is any opportunity for stakeholder input. Moreover, Art 13, 7 could include the update frequency of the communicable diseases list, timeliness of the update process, whether stakeholders will be consulted and expectations towards Member States on handling the list (Art 13, 9). We support greater use of data to inform policy making; yet we miss a mechanism (e.g. digital platform for surveillance, Art 14) that notifies manufacturers of epidemiological data in a timely manner, modelling and response scenarios developed by EU bodies, so they can help to ensure right allocation of supply (Art 19). The use of data from electronic health records (Art 14) can be facilitated by adopting a European Health Data Space, in compliance with GDPR (per the European Data Strategy). Supply chains must be designed to weather a myriad of disruptive forces that occur worldwide. Built-in multiregional redundancies help support the resiliency of the medical supply chain (Art 25). We are pleased to see that AMR is specifically called out in the Regulation, as it poses a serious cross-border threat. We suggest that cross-sectoral cooperation mentioned in the Regulation also consider the need for incentives to support innovation in the broken antibiotics market, promotion of appropriate use and access for antibiotics, and streamlined regulatory approvals for antibiotics.
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Meeting with Ursula von der Leyen (President) and SANOFI and

31 Jan 2021 · Meeting with CEOs of the pharmaceutical companies with which the Commission has signed Advance Purchase Agreements

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

6 Jan 2021

The Orphan and Paediatric Regulations have spearheaded a wave of innovations in underserved areas. They have undeniably delivered on their objectives considering the marginal economic case for developing most of these medicines; but more must be done. We welcome the opportunity to discuss how to improve them so they better address unmet needs, unintended effects and are more future proof. To build a resilient EU Health Union and ensure medical innovation takes place in Europe, the current framework should be reinforced, not undermined. Any revision should be based on clear and predictable regulatory criteria and facilitate, not curb, continued R&D investments into orphan and paediatric medicines. Unmet medical need A key success factor will be converging around a better definition of unmet need that can stand the test of time and evolution of science. This will require multi-stakeholder alignment (incl. patients/carers) and a flexible mechanism with clear criteria. Lowering the prevalence criterion to channel incentives towards the 95% of rare diseases without treatment would not necessarily address the highest unmet needs. Indeed, most rare disease patients (98%) are affected by only a few (11%) of the more prevalent rare diseases (Wakap et al. 2019). It will be also important to ensure continued R&D into areas with existing treatments as multiple treatment options help to address affordability concerns and improve patient outcomes. Incentives and exclusivity Orphan medicine ‘overcompensation’ concerns should not justify the significant changes proposed because the cases are limited (14%) and should be looked at more holistically, taking into account failures / under-compensation. Without the Regulation, 74 medicines would not have been developed (Dolon, Oct 2020). Modulating, capping and setting conditions on orphan exclusivity will weaken the overall rewards for investing in high-risk R&D, possibly making it less attractive than the general regime. This will not promote innovation in highly complex and still underserved areas. For paediatrics, undermining rewards could impact investment, advancement of science and will not redirect investment into unmet need. These proposed changes also risk discouraging the development of follow-on indications and undermine the full potential of rare and paediatric medicines. Complementary exclusivity/novel incentives (incl. at EU Member State level) should supplement the current framework to prioritize highest unmet need, stimulate R&D and improve the broader pan-European infrastructure for paediatric and rare disease development. We support dedicated research funding for academia and SMEs and investments across the whole ecosystem to incentivize fundamental research and foster collaboration to address urgent unmet needs. Access and availability We recognise access concerns and encourage a separate discussion with all stakeholders to address their multifactorial root causes. Changes to these regulations will not address them because incentives are but one of multiple access drivers and reducing them will deprive of a powerful regulatory tool to drive investments and innovation. Although we aim for broad patient access across the EU, we witness significant local market access hurdles in some countries. Tying incentives to placing products on all/most EU markets could heavily penalise us despite our efforts to ensure equal access and will not address country variances. It will disincentivize the use of the orphan/paediatric regime and curtail the EU industry’s ability to develop such medicines. Suggestions to improve access include abiding by strict P&R deadlines, implementing specific and more harmonized orphan & paediatric HTA pathways/criteria and P&R processes, ensuring the optimal use of RWE and innovative payment methods; or considering a differential pricing regulatory framework (incl. non-extra territoriality and prohibiting International Reference Pricing).
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Response to Intellectual Property Action Plan

13 Aug 2020

Johnson & Johnson (J&J) appreciates the EC’s recognition of innovation. We believe that Intellectual Property Rights (IPRs) are a critical pillar of pharmaceutical innovation, medical progress and our economy. Without IPRs, companies would not have the certainty they need to invest in the long, complex and costly process of delivering new medicines to patients, healthcare systems and society. J&J is supportive of enabling the Unitary Patent Package to offer a “one-stop-shop” for patent protection and enforcement. J&J welcomes a less fragmented SPC system, keeping in mind that a single EU wide SPC cannot exist without the Unitary Patent Package. In the future, R&D and clinical development may increasingly rely on AI generated data. J&J is supportive of a clear IP framework that will afford IP protections for AI assisted innovation. Any AI focused policies must consider and contemplate IPR’s, the latter being essential to enabling and supporting AI assisted innovation. Our business model heavily relies on and promotes partnerships with small and medium sized biotech companies and J&J is therefore supportive of improved processes that enhance SMEs, researchers, etc. access to an affordable IP system. Regarding the IPR Enforcement Directive, the absence of an early dispute resolution mechanism for pharmaceutical patent disputes in the EU continues to present challenges to innovative pharmaceutical companies. A carefully constructed early dispute resolution mechanism would provide greater certainty and serve the interests of all stakeholders. J&J also welcomes the willingness to step up the fight against counterfeiting. The intent of the European Falsified Medicines Directive 2011/62/EU is to ensure that no falsified medicines penetrate the supply chain by imposing additional requirements on manufacturers and supply chain operators including pharmacies. Now is the time to increase efforts to ensure its proper implementation. J&J supports the EU’s efforts to establish a robust global level playing field for IP protection and enforcement, consistent with its trade strategy. This is critical to ensuring the success of Europe’s IP-intensive industries on a global scale, and, that our industry remains a world leader in innovation. We equally support the EU’s role as potential global trend-setter for access to health. In that respect, we regretfully take notice of the fact that IPRs – in the context of the relevant analysis by the European Commission (EC) – are often linked to affordability and access challenges. While we acknowledge that demands on EU healthcare systems are now greater than ever and remain committed to collaborate with governments and payers to co-create access solutions across the lifecycle of our medicines, it is our view that the two discussions ought to remain separate.
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Response to Legislative framework for the governance of common European data spaces

31 Jul 2020

Insights derived from data have the potential to make healthcare systems more sustainable, supporting the daily life of patients as well as decision-makers faced with the challenge of assessing different technologies and treatments in the context of fixed budgets. In this context we submit the following considerations: Data sharing & altruism • A robust and secure opt-out model for the sharing of patient data, combined with a compelling and easily understandable offer for patients to share their data, would unlock a wealth of data for the development of crucial health innovations. Control over data generated by patients should remain with the patients and they should be empowered to access and influence the use of this data. While J&J welcomes efforts to inspire data altruism, a clear and compelling value proposition where “would-be data altruists” understand how their data will be used and reused and the benefits that this would bring is needed. This should be coupled with an open discussion about the benefits of opt-in vs. opt-out data collection models. For health data, there is currently a concerning lack of mechanisms through which data can be donated. • J&J is an interested partner when it comes to B2B data sharing. The vast majority of issues with B2B data sharing can be solved through contractual negotiations; however, some problems remain. A lack of standardization and interoperability can make it difficult to share data of a necessary quality and richness. The Commission could consider incentives for data sharing. • J&J believes that responsible sharing of clinical trial data can advance science and improve public health. In this spirit, we have been partnering since 2014 with the Yale Open Data Access (YODA) Project to provide researchers with increased access to pharmaceutical & medical device clinical trial data as well as trials of consumer products. European Health Data Space, Data standardization and interoperability J&J understands a European Health Data Space (EHDS) as the biggest opportunity laid out in the Data Strategy to improve the way healthcare systems are managed and health research is conducted. The Commission could consider the following: • The EHDS should be a federated data network. Federated models have the potential to unlock the barriers to accessing healthcare data and, in turn, facilitate learning healthcare systems, while at the same time ensuring the highest level of protection of personal data and commercial intellectual property. Through a federated model, the different sources of healthcare data act as nodes in a network. Importantly the data remain on site, unaltered and uncompromised. It is only the final output of the data analysis that is shared within the framework under secure conditions which ensure legal compliance. A successful example of a federated data network model is IMI EHDEN project, and the prior project EHR4CR and current spin-offs on EHR2ED and HVD4CR. • The EHDS should be built on F.A.I.R. data principles. Data should be findable, accessible, interoperable and reusable in order to ensure maximum value from any data collected. The data space governance model should be an enabler of safe, secure data sharing, which would empower citizens, health authorities and companies to level up their ability to share critical insights under the highest ethical and technical standards within an agreed code of conduct. • Data standardisation efforts must be approached regionally with global alignment as a target. As healthcare systems become more digitalized, it will become increasingly difficult to regulate and standardise data at all levels including at a regional, national and local level (e.g. EHRs), particularly with the growing use of vital technologies like AI. • Data quality improvement programs which include public procurement measures as well as long-term incentives for improving both data quality and data harmonization such as those currently available in the U.S.
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Meeting with Didier Reynders (Commissioner) and

9 Jul 2020 · Liability issues in the context of research for a vaccine against COVID-19

Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

7 Jul 2020

We hope the EU Commission’s Pharmaceutical Strategy will support Europe’s medical research and innovation ecosystem, enhance resilience to global health threats and drive economic recovery. We support EFPIA’s response to the consultation and emphasise the following: Reform European Health Systems COVID-19 has pointed out the devastating effects of the lack of investment in health systems. The Pharmaceutical Strategy should thus be reframed into the broader context of European Health Systems reforms. The ambitious EU4Health programme should steer Europe away from an austerity-driven recovery, towards reforms which increase cross-sectoral investment in health & wellbeing, support innovation, improve health outcomes and prepare for future health threats. Ensure regulations facilitate innovation and support value-based access solutions The EU has been open to new regulatory approaches in the crisis and should leverage them going forward to facilitate innovation and access: accelerate regulatory approvals for high unmet needs; use RWD optimally in decision-making; accept innovative clinical trials; enable dynamic regulatory assessments; secure pathways to personalised medicines and biomarker validation; greater harmonisation (eg. paediatrics, clinical trials approval centralisation, early access mechanisms), reliance on other health authority assessments (eg. inspections) and simplification (eg. e-labelling). The current IP and R&D ecosystem have played a key role in the quick development of COVID-19 treatments/vaccines. To respond to future threats and ongoing health challenges, it is crucial that the EU pharmaceutical industry remains a world leader and that medical innovation is carried out in Europe. The Strategy should therefore reinforce the current framework and propose specific incentives to further facilitate research for unmet medical needs. It should clearly differentiate affordability, shortages or access from IP incentives discussions. Shifting to value-based healthcare will help drive sustainability of health systems by making better use of resources. In many EU countries HTA processes and methodologies are not adapted to innovative therapies, creating access delays. EU HTA cooperation could assist by driving reforms in HTA methods to better reflect the value of these technologies. Accelerate digitalization of healthcare The COVID-19 crisis showed that telemedicine solutions and digital technology eg. AI in clinical trials, can yield more insightful data, enhanced patient experience and operational efficiency. It showed that health data collection is key for real-time disease diagnosis and tracking, epidemiological research or treatment discovery. The Strategy should focus on standardising health data as findable, accessible, interoperable and reusable, and more than ever, create a European Health Data Space based on a federated network, with a clear governance framework for data access including practical GDPR guidance for secondary use for research and a robust EU cybersecurity framework for digital health to build trust across healthcare systems. Build EU resilience to global threats Closer EU cooperation in pandemic preparedness, a stronger ECDC and accelerated EMA assessments of treatments/vaccines will help build Europe’s resilience to public health threats. The EU Vaccine strategy is a further step in the right direction and should enable structured discussions on an end-to-end strategy addressing critical issues eg. liability exposure for those involved in the deployment of vaccines as well as a fair compensation mechanism for those suffering damages from this during the pandemic; joint procurement; and an EU BARDA mechanism to help fund R&D and production. We support the EU aim to secure strategic access to essential medicines. We source a large portion of our APIs in Europe but we also advocate for measures to ensure a strong and resilient global supply chain while strengthening its diversity and resilience.
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Meeting with Geneviève Tuts (Cabinet of Commissioner Didier Reynders)

26 Jun 2020 · Covid-19 vaccine - research and liability issues

Response to Europe’s Beating Cancer Plan

3 Mar 2020

Johnson & Johnson, with its 3 segments – pharmaceuticals, medical devices, and consumer goods – is the largest broadly-based healthcare company in the world. We are committed to transforming cancer care in the EU by working with stakeholders on prevention, diagnosis, treatment and quality of life of those affected by the disease. We believe the EU can have a significant impact on improving cancer patients’ pathway through the following actions and instruments: Creating a data culture and fostering evidence-based approaches for better patients’ outcomes: Data can improve patients’ outcomes, from diagnosis to treatment, and reduce inefficiencies. Data collected in real life settings can also help drive new understandings of value and support healthcare decision-makers in the context of fixed healthcare budgets. Europe should create an accessible, connected and interoperable European Health Data Space (EHDS) which benefits from individual, private sector and public healthcare data. To achieve this, the EHDS should: - Be based on ethical principles, helping e.g. with further guidance on the protection of health data to facilitate better access of data while protecting individual privacy. - Rely on federated data models, as inspired by successful IMI projects (e.g. EHDEN). - Leverage EU tools, such as research programmes, public private partnerships (e.g. IMI PIONEER) and structural funds to better inform patient pathways, research and reward innovative solutions. EU could support financially national initiatives already at the disposal of Member States (MS), e.g. national cancer registries, data infrastructure and AI tools. - Promote data culture where EU and MS encourage training and retraining of healthcare stakeholders. The EU should also prioritise digital literacy for citizens and patients to better understand the use of digital technologies and build further trust and uptake. Facilitating early screening and diagnosis: Early detection of cancer greatly increases the chances for successful treatment and better patient outcomes, improving efficiency in dealing with the disease. Increased investment in cancer prevention, early screening and diagnosis should reflect the growing burden and ensure best possible treatment options. We believe EU should tackle barriers associated with social, economic and system-related factors, including screening capacity, availability of specialists, speed and adequacy of referral, fast access to imaging, pathology capacity, patient’s engagement programmes and others. In this respect, EU should revisit its screening guidelines (including expansion to other cancer areas with the highest burden, consider more research and starting to use liquid biopsy to look for cancer cells from a tumor that are circulating in the blood to help find cancer at an early stage) to increase screening rates for the target population as well as provide guidelines and structural support to achieve high quality and effectiveness throughout Europe. Benchmarking national cancer plans: The EU should support MS through benchmarking of national cancer plans and their effectiveness. In this aspect, EU could set up a dashboard to track patient outcomes (incidence, mortality, 5-year survival and quality of life) as well as benchmark national policies and action plans against those. EU should also encourage best practice sharing among the MS and facilitate cooperation among centres of excellence building on the concept of European Reference Networks. Supporting scientific dialogue between the stakeholders: The Roadmap states that ‘more patient-centred approaches need to be adopted within health care systems’. We believe that European patients should be more empowered in terms of decision-making regarding their treatment. We would encourage the support for a transparent, scientific dialogue between the stakeholders: patients, doctors and healthcare companies to allow for a better understanding between the treatment options.
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Meeting with Christos Stylianides (Commissioner) and

16 Feb 2019 · Discussion on Ebola

Meeting with Eduard Hulicius (Cabinet of Commissioner Věra Jourová)

2 May 2018 · New deal for consumers – Representative actions proposal

Response to EU cooperation on Health Technology Assessment

29 Mar 2018

Johnson & Johnson (JnJ) welcomes the opportunity to comment on the proposed HTA Regulation. Our companies provide innovative technologies across the Pharmaceutical, Medical Device and Diagnostic sectors, advancing the health and well-being of people around the world. A significant proportion of our technologies are therefore in scope of the Regulation. We have supported early collaborative efforts, such as the EUnetHTA Joint Actions, and have contributed to both pharmaceutical and medical device pilots of Relative Effectiveness Assessments. JnJ supports the concepts outlined in the European Commission’s proposal, provided they: have a positive impact on access for patients; ensure efficient use of resources, reduce unnecessary duplication; and ensure quality outputs supporting better & faster decision making, ensuring a level playing field for all parties involved. Specifically, JnJ supports the acknowledgement that access pathways for pharmaceuticals and medical devices are fundamentally different in EU Member States, and that therefore the timing and application of HTA varies as a result, which impacts the relevance of various parts of the proposed Regulation to the different Sectors. We also support the European Commission’s recognition that Joint Clinical Assessments only provide information, and do not constitute a decision for Member States who retain responsibly for the organization and delivery of healthcare on their respective territory. We therefore share the concerns of the Regulatory Scrutiny Board; that the case for mandatory uptake of Joint Clinical Assessments does not address the current access shortcomings, and that Member State support appears lacking. We believe that without Member State support, the mandatory stipulation becomes redundant, as national work-arounds will be found to support local decision-making. If that happens, the Joint EU work simply becomes an additional step. Therefore, as Member States have yet to demonstrate they are willing to accept jointly defined and assessed clinical assessments to inform, in a mandatory way, their local decision-making, JnJ considers that participation in and use of Joint Clinical Assessments should remain voluntary, at least until all stakeholders are confident that their development and use will realise the benefits intended through the Regulation. The draft legislation has some useful and constructive proposals that could improve efficiencies for stakeholders, and access for patients, but Member State willingness to use the outputs is critical. Furthermore, methodological issues within HTA are constantly evolving, and addressing these should be the priority focus of the collaboration, thus improving consistency in methodology and predictability of outcomes across Member States. As such, JnJ believes that the methods and processes should be an output of the collaboration, and not governing rules set in tertiary legislation. A key issue with current HTA processes is the variability in methodologies between Member States. Examples include variability in acceptance of Real World Evidence; the acceptability of indirect comparisons; and willingness to accept oncology studies with immature data, often complicated by cross-over between treatment arms. Agreement on best practices on these issues should be a priority of any Regulation, and ensuring the best practices are adhered to. JnJ would support the proposal for Parallel Scientific Consultations with multiple HTA agencies if the guidance is on behalf of the Member State agencies, (i.e. parallel advice) and not an EU majority vote (joint advice) (with and w/o EMA) to enable discussions supporting development requirements. JnJ also supports the identification of Emerging Health Technologies (horizon scanning) with significant anticipated impacts on patient outcomes or health care systems, to inform national work plans and future health services, provided it is conducted efficiently.
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Meeting with Piet van Nuffel (Cabinet of Commissioner Marianne Thyssen)

22 Feb 2018 · EU Intellectual Property Rights framework

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis), Paula Duarte Gaspar (Cabinet of Commissioner Vytenis Andriukaitis) and G & H Associates (Europe) Ltd

28 Jun 2016 · Alzheimer's disease: research to prevent Alzheimer

Meeting with Eveline Lecoq (Cabinet of Commissioner Carlos Moedas)

4 Feb 2015 · European research policy

Meeting with Carlos Moedas (Commissioner)

23 Jan 2015 · Meeting on Ebola research