Guest blog by Reflector, Pharm Exec Europe‘s Brussels correspondent.
This column has frequently drawn attention to the complexities of getting anything done in Europe. A brilliant researcher can explore visionary horizons, an ambitious entrepreneur can offer a package of goods or services of inestimable value, but the degree of control and regulation becomes more intense every year — sometimes every month or week.
This is not an argument against controls, or against the democratic system that erects them. But just as new medicines or new services are subject to scrutiny before they are released, so too should a critical eye be passed over new developments in the controls that are introduced. And this week has seen a striking example meriting some review.
The European Ombudsman — a relatively new function in the European Union — has just opened an investigation into how the European Commission conducted a study into the use for research purposes of non-human primates, such as chimpanzees. The role of ombudsman is well recognised in Europe as a buffer against state or bureaucratic abuse. It gives the ordinary citizen a right of appeal. But like any valuable instrument, it requires some precision in use.
In this case, the ombudsman has launched an inquiry into what an animal rights lobby group has described as a ‘deeply flawed and biased’ Commission report about monkeys in research. The European Coalition to End Animal Experiments alleges that the Commission working group that drew up the report “lacked expertise in the area and that it failed to take certain evidence into account”.
The ombudsman has asked the Commission for its opinion. P. Nikiforous Diamandouros, who has just been re-appointed to the post by the European Parliament, is clearly determined to assert his renewed authority. “The Ombudsman has a vital role to play in promoting effective and transparent policy-making in the EU institutions,” he says in announcing his new inquiry. And he goes on: “I expect this role to become even more important in light of the Lisbon Treaty, which strengthens the right of citizens and associations to participate in the democratic life of the Union.”
Would it be inaccurate to discern the sound of someone scrambling onto a bandwagon in this declaration of self-importance? And would it be inappropriate to speculate that the ombudsman is now determined to seize on any grist might be brought to the mill of self-aggrandisement?
Many European pharmaceutical executives will be aware that the EU is currently in the process of updating its 20-year-old rules on the use of animal in experiments. The European Commission proposed a revision last year, and the European Parliament has already given its view, and the Council of Ministers is scheduled soon to adopt its position. It is, of course, a tangled debate, because of the inherent ethical problems posed by research using animals. It combines profound technical and scientific complexity with high emotion — heightened by the increased sensitivity to biodiversity and sustainability of recent decades.
But no-one in the industry is in any doubt as to the stakes in this debate: it affects the future of research and the future of medical science. It is too important to hijack for other motives. But the ombudsman seems heedless of the complexities. He takes at face value the complaint from the European Coalition to End Animal Experiments, and “noting that this issue is of great interest for the general public” — a questionable consideration in a matter supposedly of scientific and procedural exactitude — he ploughs on with his demand for a response by 30 April, and his undertaking to “ examine whether there has been any maladministration by the Commission.” The animal activists’ complaint is that the consultation process leading up to the legislative proposal was “unfair”, and that experts drafting the legislation did not take into account “a substantial amount of evidence” they supplied.
The sad truth is that if every complaint from every disappointed lobbyist is to be elevated to the level of a formal investigation, the democratic processes on which the EU is built are themselves jeopardised. And when the criterion for elevation to formal investigation status is the degree of public interest in a subject, effective democracy collapses completely.
The public have had ample opportunity to make their views heard on the subject. The parliament and the council are the appointed bodies to make decisions in light of all that input — and the process cannot be arrested simply because some people don’t like the way the discussion is going.