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.

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:

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:

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.

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.

Maren von Fritschen on LinkedInretrieved 14 February 2024

Within weeks of the Kangaroo Group lunch, von Fritschen chaired a “crucial regulatory session” at the 3rd 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.

Maren von Fritschen on LinkedInretrieved 14 February 2024

“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:

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.





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