The resignation of the former EU Commissioner for Health and Consumer Protection, John Dalli, shed light on the various industrial interests that surround the European Commission and that arouse suspicions of conflicts of interest on a regular basis.
Be it on the tobacco directive, the dangers of aspartame or bisphenol (BPA), faced with huge economic stakes, European health regulations are frequently slowed down by industry pressure. European citizens, taken hostage by these interests, are the first victims.
At the European Parliament, we have not resigned to lobbying overruling democratic decisions, particularly when it comes to health. On a regular basis, we demand a stricter implementation of transparency rules and declarations of interests from experts.
Let us take an example: a current and apparently very technical affair sheds some light on the complexity of the European machinery and how this complexity can be used by private interests to hijack Europe. The case concerns ORPHACOL, a medicine for the treatment of two extremely rare and serious types of orphan liver disease which can be life-threatening, often very soon after birth, if not treated. This medicine is a product of academic clinical research of a hospital in Paris. A marketing authorization was requested to make it available not only in France but all over Europe.
Despite more than 20 years of use in France, despite the unanimously positive opinion of the European Medicine Agency's (EMA), despite a qualification of the medicine as having a "notable public health interest," despite the repeated expression of a favorable opinion from Member States, the marketing authorization was refused by the European Commission.
The European Commission has no scientific expertise whatsoever. It systematically follows the opinions of European Agencies and expert committees of the Member States. In the history of centralized marketing authorization of medicines, it is the first time that a series of scientific opinions are not followed suit by the European Commission.
This unprecedented case must lead to the question: Why? What are the motives of the European Commission and who stands to benefit from these protracted procedures and refusals?
As I have raised at the European Parliament during several committee meetings, everything leads to the conclusion that the aim is to favor an (American) pharmaceutical company that has belatedly requested a marketing authorization for a similar medicine.
When an institution in charge of health and consumer protection overturns a scientific decision, faces the indignation of Member States concerning its tactics and does not meet the demands for transparency from the European Parliament, such suspicions are legitimate.
This case sheds a new light on the arbitrariness that can overtake an institutional machinery when it ignores democratic alerts, in particular coming from the European Parliament. Confident in its rights, its legal and technical know-how, the European Commission has shown its arbitrariness, thinking that an injustice committed to a small pharmaceutical company would go unnoticed.
More than a year before the next European elections and while European citizens are expressing a growing defiance toward Europe, the European Commission shares her fair share of responsibility. On this case, the image of Europe as a whole is tarnished. The European Commission has to acknowledge its error and approve this medicine which is supported by everyone. Most importantly, in order not to have other cases that may raise legitimate or imaginary suspicion, more than ever we have to implement mechanisms that enable the European Parliament to make itself heard and respected. The interest, the credibility and the legitimacy of Europe are at stake.