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Novartis International AG

Novartis is a global medicines company focused on reimagining healthcare and medicine.

Lobbying Activity

Meeting with Olivér Várhelyi (Commissioner)

2 Dec 2025 · Pharma affairs

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

30 Oct 2025 · Pharmaceutical legislation

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

23 Oct 2025 · Pharmaceutical legislation + Critical Medicines Act

Meeting with Kris Van Dijck (Member of the European Parliament)

22 Oct 2025 · Radioligand Therapy (RLT)

Meeting with Olivér Várhelyi (Commissioner) and

2 Oct 2025 · All pressing portfolio topics

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

23 Sept 2025 · Critical Medicines Act

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

23 Sept 2025 · Health policy

Meeting with Vincenzo Matano (Cabinet of Executive Vice-President Raffaele Fitto) and PTC Therapeutics and Unknown Organization

17 Sept 2025 · Introductory Meeting on Coalizione VITA Activities

Novartis Urges EU-Wide Cardiovascular Health Checks for Adults

12 Sept 2025
Topic — EU plan to reduce cardiovascular disease burden through prevention and early detection.
Message — Novartis calls for implementing cardiovascular health checks in primary care across member states, including systematic screening for risk factors like LDL cholesterol and Lipoprotein a. They request dedicated EU funding to support implementation and training programs for healthcare professionals to enable earlier intervention.1234
Why — This would create markets for their cardiovascular diagnostics and treatments across EU member states.56
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Meeting with Vilija Sysaite (Cabinet of Executive Vice-President Stéphane Séjourné)

4 Sept 2025 · European competitiveness aspects

Meeting with Lukas Mandl (Member of the European Parliament)

9 Jul 2025 · Pharma Industry, Competitiveness

Meeting with Maya Matthews (Head of Unit Health and Food Safety)

3 Jun 2025 · The role of the Commission was here to facilitate the exchange between Novartis and the HTA Coordination Group Chairs about a medicinal product sent for joint clinical assessment

Meeting with Elena Nevado Del Campo (Member of the European Parliament)

28 May 2025 · Radioligandos

Meeting with Katarina Koszeghy (Cabinet of Commissioner Wopke Hoekstra) and ENEL SpA and

26 May 2025 · Exchange of views on the need and prospects for simplification in Pillar 2, in particular in light of the current situation with the US

Meeting with Bernardus Zuijdendorp (Head of Unit Taxation and Customs Union) and IBERDROLA and

26 May 2025 · Exchange of views on the need and prospects for simplification in Pillar 2, in particular in light of the current situation with the US

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

13 May 2025 · Bilateral meeting between Novartis and HERA on international coordination, legislation, innovation

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

11 Apr 2025 · Engagement regarding Novartis activities in Serbia and signature of an MoU with the Serbian Government

Meeting with Viktória Ferenc (Member of the European Parliament)

18 Mar 2025 · Introduction, exchange of views

Meeting with Jessika Roswall (Commissioner) and

15 Mar 2025 · Impact of EU environmental policies on the life science sector

Meeting with Olivier Chastel (Member of the European Parliament)

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

Meeting with Ana Rita Lopes Ramos (Head of Unit Energy) and RPP Group

11 Mar 2025 · Discussion on Supporting Therapeutic Radiopharmaceuticals Innovation

Meeting with Olivér Várhelyi (Commissioner) and

26 Feb 2025 · Healthcare, biotech and agri-food policies

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

18 Feb 2025 · Health

Meeting with Katri Teedumäe (Cabinet of Commissioner Olivér Várhelyi), Laszlo Andrejko (Cabinet of Commissioner Olivér Várhelyi)

18 Feb 2025 · EU health policy

Meeting with Raúl De La Hoz Quintano (Member of the European Parliament) and European Food Forum

18 Feb 2025 · Introduction

Meeting with András Tivadar Kulja (Member of the European Parliament) and F. Hoffmann-La Roche Ltd

18 Feb 2025 · Pharmaceutical Package

Meeting with Veronica Manfredi (Director Environment)

11 Feb 2025 · Exchange of views on the Urban Waste Water Treatment Directive and the Mercury Regulation

Meeting with Kerstin Jorna (Director-General Internal Market, Industry, Entrepreneurship and SMEs)

7 Jan 2025 · Exchange of views on biomanufacturing, environmental regulations in the EU, upcoming Biotech Act, Unitary patent and SPC.

Meeting with Irena Joveva (Member of the European Parliament)

22 Nov 2024 · Future of cancer care

Meeting with Wouter Beke (Member of the European Parliament)

21 Nov 2024 · EU Pharmaceutical Legislation

Meeting with Kristian Vigenin (Member of the European Parliament)

21 Nov 2024 · Implications of pharma legislation for Bulgaria

Meeting with Sakis Arnaoutoglou (Member of the European Parliament) and AstraZeneca PLC

21 Nov 2024 · Pharma industry, innovations and environmental impacts

Meeting with Elena Nevado Del Campo (Member of the European Parliament)

21 Nov 2024 · Prioridades medioambientales del sector

Meeting with Elsi Katainen (Member of the European Parliament)

21 Nov 2024 · Lääkemarkkinoiden sääntely

Meeting with Pietro Fiocchi (Member of the European Parliament)

21 Nov 2024 · Pharmaceutical legislation

Meeting with Jussi Saramo (Member of the European Parliament)

21 Nov 2024 · Lääkesääntely

Meeting with Niels Flemming Hansen (Member of the European Parliament)

21 Nov 2024 · A pharmaceutical strategy for Europe

Meeting with Ana Miguel Pedro (Member of the European Parliament)

20 Nov 2024 · Indústria Farmacêutica

Meeting with Bruno Tobback (Member of the European Parliament)

20 Nov 2024 · The European Pharmaceutical Industry: challenges and the need for steady supply chains for critical medicines

Meeting with Stine Bosse (Member of the European Parliament, Committee chair)

20 Nov 2024 · European health policy

Meeting with Veronika Cifrová Ostrihoňová (Member of the European Parliament)

20 Nov 2024 · EU's pharmaceutical legislation, Women's health

Meeting with Anna Stürgkh (Member of the European Parliament) and Bertelsmann SE & Co. KGaA

20 Nov 2024 · General exchange

Meeting with Tomislav Sokol (Member of the European Parliament) and MedTech Europe and

19 Nov 2024 · Health policy

Meeting with Francesco Torselli (Member of the European Parliament)

19 Nov 2024 · Incontro conoscitivo per discutere delle sfide e prospettive del settore sanitario italiano alla luce della normativa europea

Meeting with Andreas Glück (Member of the European Parliament) and Boehringer Ingelheim

4 Nov 2024 · Health

Meeting with Oliver Schenk (Member of the European Parliament) and Eli Lilly and Company and

4 Nov 2024 · Pharmastandort Deutschland

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

28 Oct 2024

Novartis welcomes the opportunity to comment on the draft Implementing Act on the joint scientific consultations (JSC) for medicinal products. Early dialogue between health technology developers (HTD), authorities, patient and clinical experts is a much-valued platform to inform the design of clinical development plans and the preparation of an evidence package relevant for both regulatory authorities and HTA bodies. However, there are key elements in this Implementing Act that could hinder the value of the JSC. More frequent request periods are needed as current proposals run contrary to the ambition of the HTAR to shape clinical development and evidence plans to inform future JCAs Limited JSC request periods greatly hinder the utility of the JSC procedure as it does not accommodate for the reality of medicines development. It makes it difficult for HTDs to predict, optimally plan the advice and gather timely input into clinical development (and regulatory decisions) at the right time in the product life cycle. In addition, having only two request periods in a year makes it almost impossible for a parallel EMA /JSC consultation request in the 2nd period to take place in the same year, given the timeframe for the advice procedure. Infrequent request periods and limited JSC slots may also have the unintended consequence of channeling companies to seek national advice from member states that have capacity to offer them. This would be a missed opportunity to advance the aims for the HTAR and shape clinical development plans to meet the evidence expectations of a broad number of European countries. Novartis advocates for: a) more frequent request periods, ideally with rolling monthly opportunities, as was the case during the JA3 pilot phase, b) publication of the calendar of JSC meeting dates (similar to the SAWP calendar) for both types of JSCs and c) earlier announcement, in 2Q/3Q, on the slots available for the following year to allow HTDs to optimally plan given dynamic development timelines. An agile and efficient JSC approach with clear and consolidated recommendations would make the advice procedure most impactful For the HTD, the JSC is of greatest value when it is truly joint and actionable. For this, a strong degree of consolidation amongst HTA agencies and a clear path forward should result from the consultation (discussion and recommendation), with joint feedback to inform clinical development and evidence plans to prepare for future JCAs. When it comes to the preparation of the outcome document, request for additional information should be consistent with the positions and discussions held at the advice meeting (which would be expected to reflect the joint advice). Follow-up requests should be for clarification only. Timely delivery of the recommendations is critical to facilitate swift follow-up and consideration in clinical development plan decisions. Protection of confidential information is critical; additionally, clarity around the engagement approach for external experts will benefit all parties involved in the JSC In a JSC, as competitive and confidential information is shared by the HTD on current development plans, strict protection and management of such information is critical. Consistent with the JA3 approach, the HTD should be first consulted before the BB is shared with any external experts. Additionally, it would be helpful for the HTD to be informed early in the procedure how external experts will be involved (as stakeholder or expert, through interviews or attendance at the meeting), and aspects they will be consulted on. This would allow the HTD to tailor the content of the briefing package to the target audience. In the case of parallel advice with the EMA, clarity is welcomed, both on the role of the experts invited by the EMA and those invited by the JSC subgroup, as well as how the feedback of all experts will be taken into consideration.
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Meeting with Sander Smit (Member of the European Parliament) and SUEZ Group

18 Oct 2024 · ENVI

Meeting with Ingeborg Ter Laak (Member of the European Parliament)

18 Oct 2024 · Radioligand Therapy

Meeting with Sophia Kircher (Member of the European Parliament)

3 Oct 2024 · Urban Waste Water Treatment Directive

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

24 Jul 2024

Novartis welcomes the opportunity to comment on the draft Implementing Act for the information exchange with the EMA. The information Health Technology Developers (HTDs) share with the EMA prior to marketing authorization applications (MAAs) is private, competitive and of strictly confidential nature. Novartis is open to share elements of information on upcoming MAAs with the HTA secretariat to inform capacity and resource planning for JCAs and JSCs, however, believes there should be key guiding principles and safeguards to ensure strong standards of confidentiality throughout this process in three areas: 1) mechanism, scope and timing of information sharing, 2) the governance and security of sharing through the IT platform and 3) protection of confidential information. High level of confidentiality should be applied to all information shared by the HTDs with the HTA secretariat for a product undergoing development or regulatory review and for which EMA has not yet published the full EPAR. Article 2. The timing of MAA is dependent on the timing of pivotal trials data readouts; it is subject to changes due to reasons out of control of the sponsor (e.g. the product in development does not actually achieve the intended efficacy and safety and as such will not proceed to registration) and importantly it is highly commercially confidential. Consequently, the information the HTDs share with EMA as pipeline update or to request for eligibility for the centralized procedure 7 to 21 months prior to actual application is volatile and highly sensitive. For the purposes of informing the annual work plan of the HTA Coordination Group, we believe that EMA could share with the HTA secretariat aggregate information, without compromising confidential information, on projected MAAs (for the current and the following year) to estimate JCA-eligible products by therapeutic area. Before eligibility decision has been granted by EMA, JCAs forecasts would remain at high level. Once the eligibility is confirmed by the EMA (~ 7 months prior to actual application) we would be supportive of the HTD confirming directly to the HTA secretariat the products becoming eligible for JCA procedures. This would allow the HTD to provide relevant level of detail on the indication as well as to ensure the appropriate level of protection of the information shared. Similarly, for JSCs, alternative approaches such as surveys with HTDs on projected number and timing of JSC requests in a given year may yield more useful insights for the HTA CG work plan. Articles 2(3) and 4. We are concerned that the commercially confidential information shared by HTDs might be used for different purposes (such as EHT reports) rather than solely the planning of JCAs and JSCs as per Article 8. In addition, we would welcome further clarity regarding the scope and confidentiality rules applying to the deliverables of the EHT subgroup to ensure trust and transparency for all stakeholders. EHT reports produced for the purposes of horizon scanning and assessment of the public health or financial burden for national systems based on publicly available information shall be kept distinct from reports intended for the planning of JCA and JSCs by the HTA CG and which are based on confidential information provided by HTDs. Article 8. We request that the protection of confidential information is upheld, and that information labeled as commercially confidential when shared in confidence with the EMA has the same level of protection across the whole process and by all parties involved at EU and member states levels. Article 9. We believe the current wording of this article is weak and neither fails to prevent nor disincentivize misconduct around information sharing. Thus, the Commission should consider amending the text to allow for the HTD to be informed in case of misuse of its information and the Commission to propose sanctions and corrective actions to prevent such situation to occur in the future
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Response to Health technology assessment – Procedural rules for the assessment and management of conflicts of interest in joint wo

26 Jun 2024

Novartis welcomes the opportunity to comment on the draft Implementing Act on the management of Conflict of Interest (COI). This is an important legislative act which will have a significant impact on the inclusivity of the evidence base and the quality of the output of the joint work. We believe concerns regarding the potential for bias due to COI are best handled by seeking a broad and representative range of views whilst being fully transparent about the interests of all contributing experts. In our view, guiding principles for the management of COI for the EU HTA joint work should 1) reflect a broad perspective, leveraging the best expertise in a transparent manner 2) support best clinical research practice to take place in Europe 3) be consistent with the EMA approach to management of COI. A COI policy supportive of the remit of the EU HTA work should be focused on driving a broad evidence base including expert experience and perspective. The Joint Clinical Assessment (JCA) report will provide an assessment of the evidence submitted with national agencies retaining the final decision-making on benefit rating. In this context, the JCA report should provide the most complete evidence base, with inclusivity of best available expertise (patients and clinicians) as a key principle for the COI policy. The selection of experts should be guided by the need for a range of views and experience to best inform EU HTA work. Firsthand experience of the medicine undergoing assessment is crucial. Exclusion of views because of conflicts risks leading to a process that is narrowly informed and biased especially with regard to rare diseases. Transparency: Declaration of conflicts, including the lack of them, is of vital importance for understanding the context in which views are expressed, but should not be used as a basis for exclusion of expert perspectives. Rather, a range of views from those best qualified to represent them is required. Guidance over Legislation: The soon to be established EU HTA system will evolve over time. Thus, the rules for managing COI (Annex II) would be best defined in a guidance document rather than in an implementing act to facilitate any future updates. A COI policy supportive of best clinical research, especially in areas of unmet medical need, to take place in Europe. In line with principles of patient focused medicine development Novartis works with patient and clinician communities to discover and develop innovative treatments. Patients and patient organizations should not be excluded from the opportunity to become an expert if they have consulted on patient relevant topics or contributed to medicines development. Equally, clinicians participating as investigators in a clinical trial should not be subject to a 3-year ban and be prohibited from providing their expert views. Such a long cooling-off period may not reflect rapid advances in science. It would exclude experts in rare diseases, precision medicine and highly specialized technologies (such as radioligand therapies), which often only have a small community of experts. Concerningly, this would be to the detriment of patient access. The involvement of patient and clinical experts should be guided by expertise whilst balancing conflicts through transparency. A tried and tested COI approach consistent with that of EMA. Over the years, the EMA Policy (Policy/0044)1 has proven to work in balancing independence with expertise with the flexibility required to involve external experts. Novartis would recommend the management of COI for the EU HTA to be consistent with that of EMA. Allowing a distinction between direct and indirect interests and a category of involvement only in discussions without voting rights could apply thus enabling the JCA to draw on a more representative range of expert views to keep the process lean and avoid additional administrative burden. 1 - EMA Policy 0044 - Handling of declarations of interests (europa.eu)
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Novartis urges greater industry involvement in EU clinical assessments

2 Apr 2024
Topic — Implementing rules for the joint clinical assessment of medicinal products in Europe.
Message — Novartis requests meaningful and systematic involvement of developers throughout the joint assessment process. They propose mandatory meetings to clarify assessment scopes and executable timelines for dossier preparation. The company also advocates for stronger protection of commercially confidential information.1234
Why — Rebalanced timelines would reduce the volume of analytical work performed at risk.56
Impact — Enhanced confidentiality protections may limit the transparency of information available to patients.78
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Meeting with Stelios Kympouropoulos (Member of the European Parliament)

20 Mar 2024 · rare diseases

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

25 Jan 2024 · Pharmaceutical review

Meeting with Pascal Arimont (Member of the European Parliament) and European Society of Cardiology

13 Dec 2023 · Prevention and non-communicable diseases - cardiovascular health checks

Meeting with Tomislav Sokol (Member of the European Parliament)

13 Dec 2023 · CVD

Meeting with Ondřej Knotek (Member of the European Parliament)

13 Dec 2023 · Pharmaceutical package and cardiovascular diseases

Meeting with Milan Brglez (Member of the European Parliament)

14 Nov 2023 · Pharmaceutical Legislation Package

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

7 Nov 2023 · Directive on Medicinal products for human use

Meeting with Maria da Graça Carvalho (Member of the European Parliament)

7 Nov 2023 · Reform of the EU pharmaceutical legislation

Meeting with Silvia Modig (Member of the European Parliament)

7 Nov 2023 · Topical Issues (staff level)

Meeting with Salvatore De Meo (Member of the European Parliament)

7 Nov 2023 · Pharmaceutical sector

Meeting with Franc Bogovič (Member of the European Parliament)

7 Nov 2023 · Discussion on the open issues in the EU pharmaceutical sector

Meeting with Ljudmila Novak (Member of the European Parliament)

7 Nov 2023 · Pharmaceutical Legislation Package

Meeting with Sirpa Pietikäinen (Member of the European Parliament)

7 Nov 2023 · Pharmaceutical Package

Meeting with Edina Tóth (Member of the European Parliament)

7 Nov 2023 · Upcoming topics in ENVI Committee

Meeting with Deirdre Clune (Member of the European Parliament) and MEDICINES FOR EUROPE

7 Nov 2023 · Pharmaceutical Package

Meeting with Klemen Grošelj (Member of the European Parliament)

7 Nov 2023 · A Pharmaceutical Strategy for Europe

Meeting with Dolors Montserrat (Member of the European Parliament) and MEDICINES FOR EUROPE

6 Nov 2023 · Revision of the pharmaceutical legislation

Meeting with Henna Virkkunen (Member of the European Parliament, Rapporteur for opinion) and European Federation of Pharmaceutical Industries and Associations and European Confederation of Pharmaceutical Entrepreneurs

20 Oct 2023 · Medicinal products for human use

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

13 Oct 2023 · Directive on Medicinal products for human use

Meeting with Catherine Amalric (Member of the European Parliament, Shadow rapporteur) and Bureau Européen des Unions de Consommateurs

21 Sept 2023 · Reform of the EU pharmaceutical legislation

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

13 Sept 2023 · Pharmaceutical legislation

Meeting with Tom Vandenkendelaere (Member of the European Parliament)

4 Sept 2023 · general introduction, pharmaceutical review

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and Novo Nordisk A/S and

18 Jul 2023 · Directive on Medicinal products for human use

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur) and European Social Insurance Platform AISBL

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

Meeting with István Ujhelyi (Member of the European Parliament) and Vaccines Europe

24 May 2023 · Health

Meeting with Miapetra Kumpula-Natri (Member of the European Parliament)

23 May 2023 · Meeting on EU's pharmaceutical legislation

Meeting with Sirpa Pietikäinen (Member of the European Parliament)

23 May 2023 · EU Medical Devices Legislation

Meeting with Nathalie Colin-Oesterlé (Member of the European Parliament) and Moderna, Inc.

3 May 2023 · Pharmaceutical review

Meeting with Pascal Arimont (Member of the European Parliament)

23 Mar 2023 · Cardiovascular diseases and diabetes

Meeting with Axel Voss (Member of the European Parliament, Shadow rapporteur) and BUSINESSEUROPE and

8 Mar 2023 · Corporate Sustainability Due Diligence

Meeting with Kevin Keary (Cabinet of Executive Vice-President Valdis Dombrovskis) and EuropaBio and Eli Lilly and Company

6 Mar 2023 · Pharma package

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

1 Mar 2023 · Medicines

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

1 Mar 2023 · NCDs

Meeting with István Ujhelyi (Member of the European Parliament) and Eli Lilly and Company

1 Mar 2023 · Cardiovascular Health

Meeting with Maria Luisa Llano Cardenal (Cabinet of Vice-President Margaritis Schinas)

13 Feb 2023 · EU strategic autonomy in the health sector

Meeting with Lucrezia Busa (Cabinet of Commissioner Didier Reynders), Ludovic Pierre (Cabinet of Commissioner Didier Reynders)

10 Jan 2023 · Commission Proposal for Directive on sustainability - Due Diligence (CSDDD)

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

30 Nov 2022 · Medicines

Meeting with Romana Jerković (Member of the European Parliament)

7 Nov 2022 · Pharmaceutical legislation

Meeting with Antonius Manders (Member of the European Parliament)

13 Oct 2022 · Pharmaceutical Strategy

Meeting with Milan Brglez (Member of the European Parliament)

12 Oct 2022 · Revision of the EU general pharmaceuticals legislation

Meeting with Matjaž Nemec (Member of the European Parliament)

12 Oct 2022 · Revision of the EU general pharmaceuticals legislation

Meeting with Eszter Batta (Cabinet of Commissioner Thierry Breton), Maurits-Jan Prinz (Cabinet of Commissioner Thierry Breton)

6 Oct 2022 · Energy prices’ impact on generic medicines manufacturing

Novartis seeks uniform health data rules and protected IP

27 Jul 2022
Topic — European Commission proposal to create a framework for sharing health data.
Message — Novartis calls for uniform implementation across the EU to avoid fragmentation. The company requests that regulators accept evidence from patient records and protect clinical trial data.123
Why — Standardized rules and protected data sharing would reduce research barriers and costs.45
Impact — EU patients might lose access to clinical trials if developers move research abroad.6
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Response to Unitary Supplementary Protection Certificates (SPC) – creation and granting procedure

5 Apr 2022

Bringing new therapies to patients is a long, complex and risky process that requires long-term and continuous investments. Patents are critical to that purpose and to the EU’s innovation and industrial ambitions. SPCs, by restoring some of the effective patent term lost when developing the medicine and applying for marketing authorization, are of fundamental importance to ensure sustainable investments into research and developing new medicines. The 2020 Evaluation of the SPC Regulation has confirmed the effectiveness of SPCs as incentives for pharmaceutical innovation while highlighting a few shortcomings, associated with the fragmentation of the system. Any changes should not risk jeopardizing a well-functioning SPC system and we call on the Commission to avoid that risk and rather make adjustments to overcome the fragmentation of the system. Novartis strongly supports the creation of a centralized system for SPC protection (option C1). The creation of a unitary SPC title is the logical next step to achieve a simpler and more effective system for SPCs based on European patents with unitary effect (“Unitary patents”). Without a unitary SPC title, the pharmaceutical industry will be unable to benefit from unitary patents. As “classical” European patents will also continue to be granted, if only for Member States which are not part of the UP system, a dual system should be established to achieve the desired harmonisation and transparency, combining: 1. a unitary SPC system for “Unitary patents” and 2. a single grant mechanism for national SPCs based on “classical” European patents. A single grant mechanism simplifies the administrative process, limiting duplication of work for applicants and national offices (NPOs), thereby allowing better use of resources and expertise. It allows any company holding a MA, centralized or not, to obtain national SPCs by filing a single SPC application through this mechanism. It improves consistency across NPOs’ practices as well as facilitates the transparency and availability of EU-wide SPC information through a common register. Novartis believes that the system delivering unitary SPCs and SPCs based on “classical” European patents should rely on a single centralized granting body to achieve the necessary harmonization. The body entrusted with granting SPCs should have the expertise to do so, that is both with patents, regulatory and administrative procedures but also with the specific question of granting SPCs in our industrial sector. To that purpose, Novartis recommends the creation of a virtual granting authority composed of SPC experts from NPOs. As a result, the majority of SPC filings going forward would be processed by this body. A single body for both pathways ensures a cost-efficient system. It is critical that decisions made by the virtual granting authority are challengeable before an instance which has the required SPC expertise. It must be possible for this body to refer points of law under the SPC Regulation to the CJEU to ensure a consistent interpretation. However, targeted amendments of the SPC Regulations (option C2) are unnecessary and unlikely to address the stated policy objectives. Many questions have been answered by the CJEU and it is unlikely that the substantive law could be clarified satisfactorily or comprehensively in an amended version. Any new provision or wording would inevitably raise new questions for interpretation by the CJEU, lead to further uncertainties for all parties and thus jeopardize the SPC system. Interpretative guidelines (option B) for the examination of SPC applications could provide illustrative guidance on how to apply the SPC Regulation in light of the CJEU case law and thereby facilitate decisions by the new centralized body (Option C1).
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Meeting with Cyrus Engerer (Member of the European Parliament) and Pfizer Inc.

3 Dec 2021 · Joint Procurement of Medicines

Response to Requirements for Artificial Intelligence

5 Aug 2021

Novartis welcomes the European Commission's first-of-its-kind legislative proposal on the use of Artificial intelligence (AI), which positions the EU as leader in trustworthy AI and digital. As healthcare company, we use this innovative science to discover and develop medicines. AI technologies are transforming how we innovate and operate and they offer high potential for improving healthcare quality. Novartis is using AI extensively in drug discovery and, more recently, applies AI to drug development. In development, we view the applicability of AI in two ways. One includes the horizontal capabilities and tools that increase our understanding of unstructured data from various sources, like images and texts for applications across our pipeline. The other way is the application of AI algorithms and methodologies for product-specific uses across the life-cycle: early discovery, development, manufacturing and deployment of products and services. We look forward to further engage to shape a system that is fit for future and fosters innovation. Novartis has published its commitment to ethical and responsible use of AI, provided in attachment. This includes a commitment to deploy AI systems in a transparent and responsible way and to ensure that the use of AI systems has a clear purpose that is respectful of human rights, is accurate, truthful, not misleading, and appropriate for their intended context. We are in agreement that a well-designed AI regulation is supportive of the protection of fundamental rights, ensuring safety and attributing liability. We want to comment on 3 key areas: 1) Definition of scope: the regulation would apply to the placing on the market, putting into service and use of AI systems: (i) software developed in line with the first Annex – covering AI based on machine-learning approaches, logic and knowledge-based approaches and statistical approaches and (ii) software that can, for a given set of human-defined objectives, generate outputs influencing the environments they interact with. Novartis believes that the scope should be more precise and narrow; focused on AI created through machine-learning approaches. Application of more general terms such as “rules-based” and “statistical” AI could cover applications which are not new, their underlying logic being transparent due to their explicit programming or curation. Our concern is that this regulation could place undue burden on long-utilized techniques/approaches, already agreed among regulators and industry today. 2) Risk assessment: the proposal introduces new oversight for “high-risk” AI systems which will require a case-by-case assessment from AI providers, based on the Annexes and a series of criteria. Among the identified high risks are harm to health and safety that could result from application to human beings, risk of negative impact on fundamental rights and potential for discrimination. We agree to cover these risks, but note that this proposal creates additional challenges for development of AI-driven software, if a different risk-level is applied vs the Medical Device and In-vitro Diagnostic Regulations. Clarification is needed on proposed criteria to specify “malfunctioning” of an AI algorithm. 3) Harmonization of approaches: the proposed AI Act will set forth obligations in addition those set forth in the Medical Device and In-vitro Diagnostic Regulation. We need harmonized regulatory definitions for AI & related terms, aligned risk classification and clarification on the responsibilities related to distributors who incorporate an algorithm vs. manufacturers of the algorithm. Clarification on the range of non-medical device uses of AI in development and their risk classification is needed; e.g. would AI used to categorize patients based on radiology scans or genetic profiles fall into this category? These data would be captured from medical devices, GDPR compliant, in clinical trials and would optimize data analytics.
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Meeting with Cyrus Engerer (Member of the European Parliament)

28 May 2021 · Newborn Screening

Novartis urges faster EU drug approvals through regulatory modernization

27 Apr 2021
Topic — Review of EU pharmaceutical legislation to improve medicine access and innovation.
Message — Novartis requests quicker regulatory approvals through more flexible regulations that embrace scientific advances like real-world data and artificial intelligence. They want simplified processes based on COVID-19 lessons and warn against lengthy legislative changes that could delay innovation.123
Why — This would maintain Europe's attractiveness for their R&D investments and speed market access.45
Impact — Patient safety advocates lose stricter approval processes that ensure thorough medicine evaluation.6
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Meeting with Carlo Fidanza (Member of the European Parliament)

17 Mar 2021 · Pharmaceutical Strategy

Meeting with Thierry Breton (Commissioner) and

18 Feb 2021 · COVID-19 vaccines production

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

5 Jan 2021

At Novartis, our mission is to reimagine medicine to improve and extend people’s lives, including transformative medicines for rare disease patients and children in Europe and around the world. Novartis appreciates the Commission (EC)’s recognition of the importance of orphan medicinal products (OMPs) and paediatric medicines in its IIA and we welcome the objectives of stimulating more development in areas of unmet need and improving access to new medicines for European patients. We are committed to working in partnership with the EC and Member States (MS) on constructive solutions to enable more patients in Europe have fast and equitable access to the medicines they need. OMPs are an important part of Novartis’ current and future product portfolio. We were the first pharmaceutical company to offer a CAR-T therapy, a truly transformative treatment for paediatric oncology patients. While science guides our research, the Orphan and Paediatric medicines regulations have given us predictability in our investment decisions; the EC Technopolis reports on OMP and paediatric incentives have highlighted this important benefit of the regulations. While we strongly support the objective of stimulating the development of paediatric medicines, we believe that revising the regulation as currently proposed in the IIA will not achieve this goal. The Paediatric Regulation introduced an obligation for companies developing products for adults to evaluate them for use in children. Reducing the rewards for completing obligations will not lead to more paediatric development. Implementing the 3-year action plan for Paediatric Regulation formulated by the EC and EMA in 2018 will address the shortcomings identified in the IIA. Accelerating the development of treatments specifically for paediatric-only diseases can be addressed within the Orphan Regulation (OR), as many of those are rare diseases. Given the long development timelines needed to develop paediatric medicines, the conclusion that a re-opening of the Paediatric Regulation is needed appears premature. Both the 2004 RAND report and Staff Working Documents were looking at a time horizon of 10-15 or nearer 20 years to see the full impact of the regulation. The 2016 Technopolis and EMA 10 year reports state that developments in treatments for neonates will take another 10-20 years to flow through to measurable impacts and that it is too early to draw any conclusions on the impact of the class waiver revision. Novartis shares the EC’s concerns for availability and access to medicines throughout Europe, which is not unique to OMPs. The root causes of uneven availability of medicines across MS are influenced by various factors and multiple stakeholders. Novartis works with payers and other stakeholders in every country to find sustainable access solutions for patients, such as managed access programs or novel payment models. However, these considerations are MS’ responsibilities and cannot be addressed through the OR. Novartis believes that a high-level platform at EU level to discuss patient access to innovative treatments is warranted. Novartis is a leader in Europe in innovative medicines as well as in generic and biosimilar medicines, expanding availability and reducing public spending. In our experience, the OR is rarely an impediment to generic entry; often the market for orphan medicines is simply not large enough to stimulate generic or biosimilar development. Novartis strongly believes it is important to maintain incentives for innovation. We are concerned by any initiatives that could undermine R&D investments and reduce predictability. Any legislative change needs to ensure that Europe remains competitive, supportive of innovation and attractive for R&D investments, in addition to providing fast access for as many patients as possible. We see opportunities to increase the effectiveness of the OR and are committed to engage with the EC and other stakeholders on concrete proposals.
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Meeting with Irena Joveva (Member of the European Parliament)

11 Dec 2020 · Pharmaceutical strategy and digitalization of the healthcare system

Meeting with Eszter Batta (Cabinet of Commissioner Thierry Breton)

3 Sept 2020 · Keeping existing pharmaceutical manufacturing capacity in the EU

Novartis urges EU to protect IP and harmonize health data

7 Jul 2020
Topic — The consultation addresses a strategy for affordable medicines and supply chain resilience.
Message — Novartis urges the EU to maintain strong intellectual property protections to support research. They advocate for a European Health Data Space to harmonize digital rules. They also believe tackling shortages requires shared liability among all actors.123
Why — This would protect their research investments and simplify digital operations across the EU.45
Impact — Supply chain partners would face higher liability while generic manufacturers face barriers.67
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Meeting with Stella Kyriakides (Commissioner)

7 Apr 2020 · Discussion on medicines (Production, clinical tests, supply and allocation)

Meeting with Stella Kyriakides (Commissioner) and

5 Feb 2020 · Discussion on Cancer and Europe's Beating Cancer Plan

Meeting with Giulia Del Brenna (Cabinet of Commissioner Carlos Moedas)

27 Nov 2018 · Health research in Horizon Europe

Meeting with Nils Behrndt (Cabinet of Vice-President Neven Mimica)

27 Nov 2018 · Access to health services, including pharmaceuticals, in developing countries

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis) and SANOFI

21 Feb 2018 · HTA; Supplementary Protection Certificates (SPC)

Meeting with Fabrice Comptour (Cabinet of Commissioner Elżbieta Bieńkowska), Kaius Kristian Hedberg (Cabinet of Commissioner Elżbieta Bieńkowska) and

15 Feb 2018 · pharmaceutical IP incentives

Meeting with Pierre Schellekens (Cabinet of Vice-President Miguel Arias Cañete)

1 Feb 2018 · Patent Issues

Meeting with Tom Tynan (Cabinet of Commissioner Phil Hogan)

25 Jan 2018 · Business discussion

Meeting with Lucie Mattera (Cabinet of Commissioner Pierre Moscovici) and SANOFI

25 Jan 2018 · European patent protection

Meeting with Günther Oettinger (Commissioner)

25 Jan 2018 · health policy

Meeting with Jyrki Katainen (Vice-President) and Bayer AG and Pfizer Inc.

21 Nov 2017 · Internal Market's industrial property legal framework relating to supplementary protection certificates (SPC) and patent research exemptions; innovation in the pharmaceutical industry

Meeting with Günther Oettinger (Commissioner)

21 Nov 2017 · research budget

Meeting with Michael Karnitschnig (Cabinet of Vice-President Johannes Hahn)

8 Nov 2017 · Economy and Investment in the EU Neighbourhood

Meeting with Manuel Mateo Goyet (Cabinet of Commissioner Mariya Gabriel)

8 Nov 2017 · E Health

Meeting with Miguel Ceballos Baron (Cabinet of Vice-President Cecilia Malmström)

7 Nov 2017 · Innovation and patents in trade policy

Meeting with Andrus Ansip (Vice-President) and

18 Jan 2017 · Data, e-health

Meeting with Bernardus Smulders (Cabinet of First Vice-President Frans Timmermans) and DIGITALEUROPE and

14 Jan 2016 · AECA Round-Table on “Dealing with Regulatory Burden

Meeting with Robert Madelin (Director-General Communications Networks, Content and Technology) and American Chamber of Commerce to the European Union and

3 Jun 2015 · New College and Better Regulation

Meeting with Daniel Calleja Crespo (Director-General Internal Market, Industry, Entrepreneurship and SMEs)

13 Mar 2015 · Industrial Policy for pharmaceuticals

Meeting with Robert Madelin (Director-General Communications Networks, Content and Technology) and BASF SE and

12 Feb 2015 · Digital Single Market, Innovation

Meeting with Carlos Moedas (Commissioner)

23 Jan 2015 · Bilateral meeting the CEO of Novartis & EFPIA President

Meeting with Věra Jourová (Commissioner) and Microsoft Corporation and

16 Jan 2015 · Round Table on Gender Diversity