Archive for August, 2010
The EU Ombudsman Nikiforos Diamandouros confirms the Lisbon treaty, the European Medicines Agency respects that: The right of access to information held by the authorities is a fundamental right in Europe. In the most recent case this has a concrete result: Patients now can request access to information about side-effects of their medicine.
Imagine your teenager being embarrassed about pimples. A certain pill is advised for help. But what if exactly the same pill causes your child to be depressive, even suicidal? Would you want to know? Should the public know?
This is the core of the question of a request for access to information held by the European Medicines Agency EMA. For year this has been kept secret in most EU countries, though it is patients’ only option to keep track on side-effects after a drug is on the market.
For years the EMA too refused access, but following a decision by the Ombudsman in April, it now decided to make accessible the so-called “adverse reaction reports” on the anti-pimple medicine Roaccutane, which for years has been under suspicion for its severe side-effects.
“I commend EMA’s constructive approach in this important case,” said Nikiforos Diamandouros, the EU-Ombudsman upon the EMA decision. “EMA’s work has a direct impact on the health of European citizens. It is, therefore, crucial to give the widest possible access to documents and to pursue a pro-active information policy for the benefit of citizens.”
The case was brought by an Irish man, whose son committed suicide after taking Roaccutane, is currently suing the pharmaceutical company Roche over the drug, which has been linked to behavioural problems and birth defects, according to the EUobserver.com.
For those, who want to use the EU rights of access to information the case is interesting not only because the Ombudsman confirms access as a fundamental right, but also for several other details. Read a practical analysis on Wobbing.eu.