How serious is the European Medicines Agency about handling conflicts of interest? One employee of the agency, which has been caught up in two embarrassing conflicts scandals of its own over the past two years, claims the regulator is now going overboard by attempting to force her to sell Bayer stock, even though the requirement had not gone into effect at the time the EMA made the demand.
And so, the employee recently filed a complaint with the European Ombudsman in hopes of convincing EMA officials to back off. In her view, the EMA is out of line to make what she contends is a retroactive demand and, she argues, may subject her to insider trading charges, since she has access to non-public information about the pharmaceutical industry. She also contends that, as a scientific administrator, she does not play a role in scientific assessments. Separately, she laments that a sale would cause a big loss due to changes in German tax law, but EMA officials dismissed her arguments.
"I object to the practice of EMA management to apply rules without being able to identify the corresponding provisions in the new rules that should support their requests, i.e., specifically, their request to employees to sell shares/patents they have owned and declared since the beginning of their employment, as well as the timeframe for disposition within six months, which seems not to be covered in the new rules, and therefore, arbitrary," she wrote European Ombudsman Nikiforos Diamandouros last March. Her name has not been disclosed.
In response, the Ombudsman opened a case (see this) and asked the EMA to explain its actions and reasoning. He noted that draft rules, which the EMA cited last year in making its demand of its employee and went into effect this past February, prohibits the acquisition of 'non-allowed direct interests' during the employment period and requires people accepting employment with the EMA to sell non-allowed direct interests. So he asked the EMA to explain how the wording can be interpreted as applying to existing employees that obtained shares before the new rules went into force (you can read the e-mails, letters and rules, which we requested from the Ombudsman, here and here).
The squabble raises some interesting questions. For instance, if such stock holdings among its employees can be considered a conflict now, why did the EMA not adopt a similar position in years past? The answer is that the EMA did not have such policies in place until recently, which suggests that conflicts of interest of various sorts may have been tolerated. And here is another question: are EMA officials attempting to compensate for their own recent transgressions? The unnamed employee argues the EMA is discriminating, in fact, against her.
Last year, the European Anti-Fraud Office began probing the EMA in connection with the scandal involving Servier Laboratories and its Mediator diabetes drug, which has been blamed for at least 500 deaths in France. A member of the European Parliament had complained that 80 percent of the EMA budget comes from drugmakers (read here). Later, the chair of the EMA's Committee for Medicinal Products for Human Use, which approves new drugs, resigned over his role as a scientific advisor to the French healthcare regulator.
The EMA was also embarrassed when former EMA head Thomas Lonngren opened his consulting business to advise the pharmaceutical industry two months before leaving the agency in late 2010. Compounding matters, the EMA approved his consulting arrangements and found there was no misuse of confidential or privileged info gained while he headed the EMA, there was no activity that risked improper influence on EMA decisions and none of his activities posted a conflict (look here).
What will happen, of course, remains to be seen. In the past, the Ombudsman did not hesitate from being tough on the EMA when it came to releasing clinical trial data (see this), but conflicts of interest are an equally explosive hot button that his office is only now being asked to review. The EMA employee does raise an interesting point about what appears to be a retroactive demand. On the other hand, she owned stock in a drugmaker while working for a regulatory agency that oversees drug approvals. What do you think?
Should the EMA employee sell her stock?
- No (56%, 34 Votes)
- Yes (44%, 26 Votes)
Total Voters: 61