Conflicts of Interest and Corruption at the European Medicines Agency
TRIBUNE – The health of the French deserves better than this criminal association.
Initially, the granting of a marketing authorization (MA) was the responsibility of each Member State. A 1993 regulation, replaced by a regularly amended 2004 regulation, established an evaluation agency: the European Medicines Agency (EMA).
The EMA consists of a Management Board of 36 members, most of whom represent the Member States (most often the director or president of their national agency). The Management Board appoints an Executive Director, who is supported by seven expert committees.
The agency is one of a vast category of more or less decentralized bodies, whose names themselves vary (agency, office, observatory, etc.), created to advise the European Commission on technical matters.
The Commission, as a political institution, remains free to follow this advice or not, and it is the Commission that grants the MA. But the EMA, with its expert competence, especially in the medical field, plays a crucial preparatory role.
It seems implausible, but 85.70% of the agency’s operating budget (346 million euros) comes from fees paid by the pharmaceutical industry and only 14.30% from public funding from the European Union…
As an agency of the European Commission, the EMA’s obligations in terms of transparency and access to documents derive from directives stipulating that any document held by the EMA in the course of its activities is in fact a public document.
However, the journal Prescrire has shown that the EMA refuses to communicate many documents, and that those that are transmitted are largely redacted.
Its lack of transparency was denounced when it refused to tell Members of Parliament the basis on which the laboratories that produced the vaccines were chosen and the amount of money paid for them.
The “predictability” of the EMA is so great that the American industry envies it, especially the neo-conservative “think tank” Pacific Research Institute, financed by the bio-technology industry, which militates for less and less government intervention. And for good reason! The day after his departure from the EMA in 2011, Executive Director Thomas Lönngren joined the board of directors of NDA Ltd, a lobbying company serving pharmaceutical companies, which recruited him as a “leading influencer”.
Pantouflage or “revolving doors” is a scourge. In a health sector that is both highly lucrative and highly regulated, companies have a great interest in placing their men in public agencies and implementing this entry strategy.
Italian Guido Rasi was then appointed director of the EMA in 2011, then forced to resign by the European Justice for undeclared conflict of interest, before being reappointed as director of the EMA again in 2015.
The current director, Emer Cooke, spent seven years at EFPIA, the main lobby of the pharmaceutical industry in the European Union, which organizes meetings in the European Parliament with representatives of GSK, Roche, Novartis, Pfizer…
A European audit by the Court of Auditors in 2012 confirms serious problems of conflict of interest within the EMA (and 3 other agencies: EASA (aviation safety) EFSA (food safety) and ECHA (safety of chemicals).
The report points out serious irregularities, with the EMA management favouring the presence, in the scientific committees, of experts in conflict of interest with the pharmaceutical companies whose products they evaluate.
Le Canard Enchaîné revealed that some of the EMA’s experts are employees or own shares in the pharmaceutical companies whose lucrative products they are supposed to evaluate.
Whistleblowers have denounced this problem: “For months, our company has been discreetly paying an expert to lobby for our product. The remuneration is exorbitant, but the most serious thing is that he is an expert at the EMA.”
In the Mediator (ER: which also goes by the name benfluorex, which caused up to 2,000 deaths in France) affair, the General Inspectorate of Social Affairs implicated several French experts, who sat at the European Medicines Agency, in the late banning of Mediator and the subsequent health drama.
The EMA itself offers pharmaceutical companies “scientific advice”, which is invoiced to help them submit their applications for marketing authorizations, particularly conditional ones, such as those for vaccines against cardiovascular disease (cMA).
However, drugs that are put on the market in an accelerated manner are often put on the market at the expense of the quality of the clinical evaluation. Worse, this evaluation is not sufficiently completed after marketing either.
A 2017 report notes “a general acceptance of corruption” within the EMA and:
– a general acceptance of corruption
– ineffective management structures
– inappropriate funding mechanisms
– unequal distribution of resources
“The pharmaceutical industry firmly holds the reins of a vast and richly endowed lobbying machine that has almost systematic access to decision-makers in the Commission […] and the Brussels institutions, including the EMA.”
In June 2020, the EMA made the decision to authorize Gilead’s remdesivir. (ER: Anecodotally, this drug is being used in American hospitals, for example, where erstwhile healthy patients end up on dialysis or have other kidney problems.)
The journal Prescrire commented, “Once again, the EMA has been less than rigorous in its relationship with the firms, at the expense of patients and caregivers, who are left in limbo.”
In October, following this seemingly senseless decision, the Commission signed a huge contract with Gilead, even though the company had just learned of the latest WHO study that invalidated the effectiveness of its treatment.
The health of the French people deserves better than a health dictatorship, it deserves a public drug centre, transparent and independent public expertise, a democratic decision-making process, and intelligent, benevolent and non-coercive health policies.
From a Twitter feed, courtesy of the author