Czech SUKL claims to have effective clinical studies monitoring system

2010-02-09

The Czech Drug Control Agency (SUKL) has issued assurances about the effectiveness of its clinical studies monitoring system, following media reports about the alleged use of post-authorisation clinical studies by pharmaceutical companies to encourage doctors to prescribe their products. The Lidove Noviny daily speculated – quoting the Czech branch of Transparency International – that some of post-authorisation studies carried out in the country may be used by pharmaceutical companies as a cover-up to pay doctors for prescribing their medicines. The SUKL claims, however, that it has been monitoring pharmaceutical companies’ activities in this area for over two years and that all offenders have been fined. The last fine issued by the SUKL for this type of illegal activity amounted to CZK 550,000 (€20,986).
Pharmaceutical companies operating in the Czech Republic are obliged by the law to register every study – both pre- and post-authorisation – with the SUKL, with a CZK 1m (€0.04m) fine for those who fail to do so. Last year, companies registered about 117 clinical studies with the SUKL.