In recent years, we have seen a sharp rise in the number of applications whereby doctors request permission to cooperate with a pharmaceutical company.
The increase follows the Danish Medicines Agency's persistent efforts through awareness-raising campaigns and new legislation. Over a 10-year period, the number of applications has thus increased from as little as 32 applications in total in the years 2002-2006 to approx. 2250 applications in 2011.
Increase follows after several campaigns
These markedly improved results are, among other things, an outcome of legislative changes in 2009 through which the companies became obliged to report which doctors, dentists and proprietary pharmacists they cooperate with.
This information allows us to double-check whether or not, doctors, dentists and proprietary pharmacists comply with their obligation to obtain permission before they start collaborating with the pharmaceutical companies.
In cases where the obligation has not been observed, we generally issue a reprimand. The method has contributed to making 2010 a record-breaking year with approx. 2400 applications.
The decade's tremendous increase is also the benefit of earlier campaigns in 2006 and 2007, where all doctors affected received a personal letter reminding them of the obligation to apply. In 2007, the number of applications increased to 650 from the preceding extremely low level.
Research projects account for the majority
The largest group of applications concern permissions to collaborate with the industry in research projects in the form of clinical trials or non-interventional trials. Other typical applications concern permissions to give lectures or to sit on advisory boards.
Only very few refusals are given
The Danish Medicines Agency refuses very little applications. The reason is that the vast majority of applications are within the limits of what we can authorise.
The Danish Medicines Agency refuses an application if there is an obvious risk that the doctor or dentist may pay inappropriate regard to the choice of medicine when having to prescribe or recommend medicine. For example, if a doctor or dentist has a financial motivation or a particularly close personal relationship with a pharmaceutical company.
When the Danish Medicines Agency issues reprimands, it is often because the doctor has never applied for permission, or because the doctor has already started cooperating with the company before being permitted to do so.
Almost all applications are reviewed within three to five weeks.