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Moderna, Inc.

Moderna’s mRNA technology quickly enabled Moderna to pivot when the COVID-19 crisis emerged and to manufacture and deliver a safe, effective vaccine against COVID-19.

Lobbying Activity

Meeting with Tilly Metz (Member of the European Parliament, Shadow rapporteur) and Vaccines Europe

10 Sept 2025 · Critical Medicines Act

Meeting with Florika Fink-Hooijer (Director-General Health Emergency Preparedness and Response Authority)

2 Jun 2025 · Pandemic preparedness

Meeting with Stelios Kympouropoulos (Member of the European Parliament) and BioNTech SE

17 Jan 2024 · Kangaroo Lunch debate on Platform Technologies and the pharmaceutical legislation review

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

16 Jan 2024 · Pharmaceutical legislation

Response to Evaluation and revision of the general pharmaceutical legislation

8 Nov 2023

Moderna, with its mission to deliver the greatest possible impact to people through mRNA medicines, welcomes the overall objectives of the revision of the General Pharma Legislation (GPL) as proposed by the Commission to create an innovative and competitive EU healthcare ecosystem, to invest in R&D, and to provide early innovative medicines to patients. It is essential that the new system provides a suitable framework both current and future innovations, such as platform technology approaches, to keep the EU attractive for innovative companies. Being generally aligned with the positions of the EU trade associations representing innovative medicines companies and their proposed amendments, Moderna complementary aims to further strengthen the EC proposal by the following: 1. Appropriate legal basis for platform technology approaches to enable faster development and authorisation of innovative medicines in Europe based on platform technologies for the benefit of patients. Moderna acknowledges the EC proposal of the legal basis for the well-established active substance master file (ASMF) concept and to broaden it for biologicals in an additional quality master file (AQMF). Complementary, we propose the Platform Technology Master File (PTMF) and the development of accompanying scientific guidance by the EMA. This would meet the proposed re-use of data as part of the regulatory fitness and simplification of the EU regulatory framework. 2. Maintenance of the current flexibility of naming active substances: We recognise the contribution that WHOs International Non-Proprietary Name (INN) system provides naming active substances in a consistent way, globally. Situations may arise in which at the time of submission an INN does for whatever reason not (yet) exist. To avoid any potential delay in approval and patient access, it is important to maintain the flexibility of naming as regulated currently. 3. Limitation of the term gene therapy medicinal product (GTMP) to products editing or altering the human/patient genome: From a scientific perspective as well as from public health perception, a GTMP is only a product which ultimately edits or alters the human/patient genome. The focus lies on the patients genome and whether it is or is not affected. There is a high risk that the proposed broad definition also including non-gene-altering/-editing products as GTMPs creates a misperception or even confusion, resulting to a semantic ambiguity in the field of gene therapy. As an example, COVID-19 pandemic and vaccine misinformation led to inaccurate reports that mRNA vaccines for prevention of an infectious disease would alter the host genome. The potential for this to be repeated with negative consequences for public health care is high if the legislation does not limit the definition of GTMP to gene-altering/-editing products. This classification would not alter scientific standards for benefit/risk assessment nor have any influence on regulatory procedures but rather clarify demarcation, reduce the risk of misinformation, recognise scientific and common understanding as well as focus limited regulators` resources to assess innovative therapies according to their specific requirements. 4. Mandatory implementation of electronic product information (ePI) for products administered by Health Care Professionals, such as vaccines: We recommend that ePI is fully transitioned across the EU, replacing the paper information leaflet entirely without delay.
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Response to Evaluation and revision of the general pharmaceutical legislation

8 Nov 2023

Moderna, with its mission to deliver the greatest possible impact to people through mRNA medicines, welcomes the overall objectives of the revision of the General Pharma Legislation (GPL) as proposed by the Commission to create an innovative and competitive EU healthcare ecosystem, to invest in R&D, and to provide early innovative medicines to patients. It is essential that the new system provides a suitable framework both current and future innovations, such as platform technology approaches, to keep the EU attractive for innovative companies. Being generally aligned with the positions of the EU trade associations representing innovative medicines companies and their proposed amendments, Moderna complementary aims to further strengthen the EC proposal by the following: 1. Appropriate legal basis for platform technology approaches to enable faster development and authorisation of innovative medicines in Europe based on platform technologies for the benefit of patients. Moderna acknowledges the EC proposal of the legal basis for the well-established active substance master file (ASMF) concept and to broaden it for biologicals in an additional quality master file (AQMF). Complementary, we propose the Platform Technology Master File (PTMF) and the development of accompanying scientific guidance by the EMA. This would meet the proposed re-use of data as part of the regulatory fitness and simplification of the EU regulatory framework. 2. Maintenance of the current flexibility of naming active substances: We recognise the contribution that WHOs International Non-Proprietary Name (INN) system provides naming active substances in a consistent way, globally. Situations may arise in which at the time of submission an INN does for whatever reason not (yet) exist. To avoid any potential delay in approval and patient access, it is important to maintain the flexibility of naming as regulated currently. 3. Limitation of the term gene therapy medicinal product (GTMP) to products editing or altering the human/patient genome: From a scientific perspective as well as from public health perception, a GTMP is only a product which ultimately edits or alters the human/patient genome. The focus lies on the patients genome and whether it is or is not affected. There is a high risk that the proposed broad definition also including non-gene-altering/-editing products as GTMPs creates a misperception or even confusion, resulting to a semantic ambiguity in the field of gene therapy. As an example, COVID-19 pandemic and vaccine misinformation led to inaccurate reports that mRNA vaccines for prevention of an infectious disease would alter the host genome. The potential for this to be repeated with negative consequences for public health care is high if the legislation does not limit the definition of GTMP to gene-altering/-editing products. This classification would not alter scientific standards for benefit/risk assessment nor have any influence on regulatory procedures but rather clarify demarcation, reduce the risk of misinformation, recognise scientific and common understanding as well as focus limited regulators` resources to assess innovative therapies according to their specific requirements. 4. Mandatory implementation of electronic product information (ePI) for products administered by Health Care Professionals, such as vaccines: We recommend that ePI is fully transitioned across the EU, replacing the paper information leaflet entirely without delay.
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Meeting with Laura Ballarín Cereza (Member of the European Parliament, Shadow rapporteur for opinion) and BioNTech SE

30 Oct 2023 · Pharmaceutical Package (Directive)

Meeting with Tiemo Wölken (Member of the European Parliament) and MEDICINES FOR EUROPE and BioNTech SE

18 Oct 2023 · Pharma Revision - Directive (staff level)

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 István Ujhelyi (Member of the European Parliament)

3 May 2023 · Health

Meeting with Nathalie Colin-Oesterlé (Member of the European Parliament) and Novartis International AG

3 May 2023 · Pharmaceutical review

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

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

Meeting with Stella Kyriakides (Commissioner) and

3 Nov 2022 · Videoconference with Moderna CEO on future of mRNA platform; ongoing cooperation on the management of the pandemic

Meeting with Stelios Kympouropoulos (Member of the European Parliament)

11 Oct 2022 · Lessons-learnt from COVID-19

Meeting with Karsten Lucke (Member of the European Parliament)

22 Jul 2022 · Corona Impfstoffe

Meeting with Kathleen Van Brempt (Member of the European Parliament, Committee chair)

31 May 2022 · The current situation of the pandemic and the mRNA technology

Meeting with Ursula von der Leyen (President)

26 Nov 2021 · Meeting with CEO of Moderna

Meeting with Thierry Breton (Commissioner)

10 Apr 2021 · Vaccine production and deliveries

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