BioNTech and Moderna lobby the EU, Swiss and UK regulatory agencies to stop mRNA injections being classified as gene therapy

BioNTech and Moderna are frantically lobbying the European Parliament to stop a reclassification of mRNA injections as “gene therapy” in the upcoming revision to the European Union’s (“EU’s”) pharmaceutical legislation.

Moderna is also lobbying the European Medicines Agency (“EMA”), the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) and the Swiss Agency for Therapeutic Products (“Swissmedic”) to urgently “rethink their gene therapy definition.” 

According to an article published last year in the International Journal of Molecular Sciences, the mode of action of covid-19 mRNA injections should classify them as gene therapy products but they have been excluded by regulatory agencies. The wide and persistent biodistribution of mRNAs and their protein products, incompletely studied due to their classification as vaccines, raises safety issues.

Moderna and BioNTech expected to have their products regulated as gene therapies. Moderna, Inc. acknowledged in its Q2 2020 Securities and Exchange Commission (SEC) filing that “currently, mRNA is considered a gene therapy product by the FDA.” Furthermore, BioNTech founder, Ugur Sahin, in a 2014 article, stated “One would expect the classification of an mRNA drug to be a biologic, gene therapy, or somatic cell therapy.”

mRNA: Vaccine or Gene Therapy? The Safety Regulatory Issues, International Journal of Molecular Sciences, 22 June 2023

That Big Pharma is now lobbying the European Parliament to not classify mRNA as gene therapy was raised by a Member of the European Parliament (“MEP”), Virginie Joron, who submitted a written question to the European Commission on 2 February:

On 17 January 2024, BioNTech and Moderna lobbyists hosted a lunch in the European Parliament with Members to discuss the forthcoming revision of the pharmaceutical legislation.

Their main objective was to change the legislation’s definition of ‘gene therapy’. At present, mRNA vaccines (like the COVID-19 vaccine) are to be classified as gene therapy. However, they felt that only products that modified the genome should be classified as gene therapy. [Emphasis added]

1. Do EMA and the Commission classify Comirnaty and Spikevax mRNA vaccines as gene therapy? If so, what are the corresponding regulatory consequences?

2. Has EMA carried out DNA integration assessments or is it going to request them from independent laboratories?

3. What is the Commission’s position on this opaque lobbying without debate?

Lobbies calling for mRNA vaccines not to be classified as gene therapy, Question for written answer, European Parliament, 2 February 2024

The lunch hosted by BioNTech and Moderna on 17 January was held under the auspices of the “Kangaroo Group,” a MEP-industry group providing extracurricular contact between corporate industry lobbyists and MEPs.

The invitation to BioNTech-Moderna’s Kangaroo Group lunch stated:

BioNTech and Moderna are leading pharmaceutical and biotechnology companies in mRNA Platform Technology. Both companies recognise the importance of the overall objectives of the European Commission’s proposal for a reform of the EU General Pharmaceutical Legislation (GPL), creating an innovative and competitive EU healthcare ecosystem at a global level, investing in R&D, increasing equal access to and availability of innovative medicines to patients across the EU.

As demonstrated during the covid-19 pandemic, mRNA is an agile and flexible platform technology, enabling faster provision of vaccines and treatments to patients. mRNA-based products for disease prevention or treatment are under development for cancer, rare diseases, HIV, malaria, mpox and priority pathogens as well as other life threating [sic] conditions.

 In this context, it is important that the GPL provides a clear and broad scope for the definition of Platform Technologies, as well as a clear demarcation between Gene Therapies Medicinal Products that alter human genomes, and those that do not (e.g. mRNA).

The establishment of a legal basis for a “Platform Technology Master File” and the development of accompanying scientific guidance by the European Medicines Agency is needed to ensure global regulatory alignment, enable and strengthen the development of platform technologies in Europe and to realise their public health potential. [Emphasis added]

1st  Strasbourg Lunch Debate 2024, Wednesday, 17 January 2024 at 13.00 hrs, Kangaroo Group

It’s not the first time that more than one Big Pharma company has joined forces to lobby European officials.  In 2021, the research and campaign group Corporate Europe Observatory highlighted a worrying “high level of unity among Big Pharma.”  The subject of the article was lobbyists defending Big Pharma’s monopoly on intellectual property (patent) rights on vaccines.

EFPIA (The European Federation of Pharmaceutical Industries and Associations) … is Big Pharma’s main lobby group in Europe

The internal documents released to Corporate Europe Observatory show that several branches of the [European] Commission have stayed in close contact with EFPIA since the outbreak of the pandemic.

In connection with the meeting [in early December 2020], EFPIA left the Commission with a document outlining the position of the pharmaceutical lobby. The document was authored by the pharmaceutical sectors’ global association, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), which shows a high level of unity among Big Pharma. All the more worrying. [Emphasis our own]

Big pharma lobby’s self-serving claims block global access to vaccines, Corporate Europe, 19 April 2021

Lobbying members of the Kangaroo Group to not classify mRNA injections as gene therapy were Moderna’s Dr. Maren von Fritschen, who used to work for lobbying company Kalms Consulting, and BioNTech’s Head of Regulatory Affairs Dr. Constanze Blume.  They were listed as giving an introduction at the event.

Further reading: BioNTech, Moderna Lobby To Stop EU ‘Gene Therapy’ Classification, The Daily Beagle, 13 February 2024

In a post on LinkedIn, von Fritschen declared her pleasure about the opportunity to lobby the Kangaroo Group about a definition of gene therapy medicinal products that excluded mRNA products.

Within weeks of the Kangaroo Group lunch, von Fritschen chaired a “crucial regulatory session” at the 3^rd mRNA Hanson Wade Health Summit to lobby regulatory bodies about the “urgent need” to “rethink their gene therapy definition.”  In this case, those being targeted were members of  EMA, MHRA and Swissmedic.

“Strengthen public trust” – there is no trust to strengthen. It is not possible to strengthen something that does not exist.  Someone may have to inform EMA, MHRA, Swissmedic and von Fritschen that by their actions they are not, if they ever could, “strengthening trust” in mRNA products.

What is the Kangaroo Group?

There are three decision-making bodies in the EU: the European Parliament, which is the only one whose members are directly elected by citizens; the European Commission, which proposes legislation and manages the day-to-day business of the bloc; and the European Council, which is made up of member states.

In 2015, Corporate Europe Observatory highlighted the “murky channels for corporate influence in the European Parliament” and warned that “unofficial cross-party groups of MEPs and industry are a stark illustration of continued lobbying under the radar.”

What differentiates MEP-industry forums – as unofficial cross-party groups – from official intergroups is that they are not subject to the same transparency rules and safeguards. “In fact, [MEP-industry forums] are not subject to any rules at all, and can keep their members, funding and even existence hidden from public view,” Corporate Europe Observatory wrote.

“All 15 MEP-industry forums we looked at in 2011 still appear to be active (or have been active in the last year or so), with at least four more identified, and who knows how many more we are unaware of,” they said.

One of the 15 MEP-industry forums was the Kangaroo Group.  In 2015, the corporate backers of the Group included Volvo, Phillip Morris, BAT, Deutsche Bank, BP, ACEA, CEFIC, Unilever and Roche.

The group is incorporated under Belgian law as a non-profit organisation and has been entered into the EU Transparency Register as a think tank. Its president is MEP Michael Gahler and its board members include the vice-president of the European Parliament, Rainer Wieland. 

In 2023, the members of the group consisted of 16 MEPs; 28 people from institutions, academia and experts; 38 people from industry, services and trade; and, 38 corporations of which 8 are pharmaceutical companies.

In the past, the Kangaroo Group has been criticised for being a back-door entry point for lobbyists from the arms industry. IP Integrity wrote in 2011 that in particular, the Working Group on Space, Defence and Security had been accused of being a channel for arms industry lobbyists to shape EU defence policy.

At the time, Corporate Europe Observatory wrote to the European Parliament’s College of Quaestors asking why the Kangaroo Group had an office in the Parliament building.

“The Kangaroo Group is not a registered Intergroup, nor does it appear to have any other official status vis-a-vis the European Parliament. But members of the group, which include some 50 big companies, including Goldman Sachs, BP and Volkswagen, benefit from the privileged access to the Parliament and to MEPs,” Corporate Europe Observatory said.

In 2012, due to the pressure exerted by Corporate Europe Observatory, the Kangaroo Group moved its official office from the premises of the European Parliament into a new office – in the immediate vicinity of Parliament.

In 2021, Corporate Europe Observatory published a study which revealed that Big Pharma spends at least €36 million a year to lobby the EU. The industry employs 290 lobbyists to push for its interests in Brussels, not including so-called hired gun lobbyists at lobby consultancies.

“It is crystal clear that Big Pharma continues to dramatically outnumber and outspend civil society actors working on public health or medicines issues,” Corporate Europe Observatory wrote.

Consultant lobbyists and lobby groups may not be the only lobbyists Europeans should be concerned about.  There may also be lobbyists from within.

Heiko von der Leyen, born into a family that belonged to the German nobility, is married to the President of the European Commission and works for the global biotech company Orgenesis. A 2022 written question to the European Commission explains why that’s a problem:

The husband of current Commission President Ursula von der Leyen is the medical director of Orgenesis Inc., a company that collaborates with Pfizer-BioNTech and is directly involved in the development of gene therapies, in particular messenger ribonucleic acid (mRNA) vaccines. It also has dealings with consortia that have participated in and won tenders for recovery funds for research and development in at least two Member States.

The Commission President has a prominent role in managing relations with pharmaceutical companies and in managing European funds for researching and developing gene therapies. Her husband derives appreciable economic benefit from the way in which her top position in the EU influences his business.

Given the foregoing, how does the Commission intend to resolve this serious conflict of interest? [Emphasis added]

Potential conflict of interest of the Commission President, Question for written answer to the Commission, European Parliament, 17 November 2022

It was subsequently claimed by the Transparency Commissioner, Věra Jourová, that Heiko von der Leyen did not break any conflict of interest rules by working in a company that was awarded EU money.

With BioNTech and Moderna’s most recent lobbying activity, perhaps it is time for the Transparency Commissioner to take another look.

Featured image: Maren von Fritschen at the Kangaroo Group lunch debate at the European Parliament on 17 January 2024.