New rules restrict medical testing in EU
High costs could push drug companies out
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By Pauliina Grönholm
Finland has a fairly high per capita rate of human drug testing.
The amount of clinical research has decreased during the last ten years, however.
In 2005, 238 new studies were reported to the National Agency for Medicines.
The number for the previous year was 293. In 1996 there had been 310.
Drug manufacturers fund most of the studies. About one fifth of drug tests involve of independent studies that do not receive external funding.
The decline in independent research is of special concern to doctors.
According to Coronaria Media, which hosts an information forum for doctors, doctors are interested in doing medical research, but a shortage of and a lack of suitable patients make research difficult.
"Research is getting to be so expensive that only large drug manufacturers have the resources for it", says Akseli Hemminki, docent of the University of Helsinki.
Hemminki attributes the situation to an EU directive concerning clinical research on patients which was enacted in 2004. The purpose of the directive was to increase patient security and improve research. According to him, however, the new rules have made research more difficult, especially for independent researchers.
The rising cost of research has also alarmed the pharmaceutical industry. It is feared that an increasing amount of drug companies will conduct their research in countries where it is cheaper.
"It can already be seen that the cost of research is rising faster in Finland than in other EU countries", says Mia Bergström of Pharma Industry Finland.
"The EU directive has increased the amount of red tape, but it concerns the entire EU area, and will also reflect on the price of medicine before long", says Seppo Pakkala, head of The Clinical Research Institute Helsinki University Central Hospital.
There are two sides to bureaucracy, however, says Ali Bardy of the National Agency for Medicines. Some studies done outside the EU have been cheaper, but have resulted in the cancellation of sales permits.
"Medical research has become more expensive in Finland, but the quality of research has improved", says Bardy. The research requirements have not changed noticeably, but reporting has become more complicated.
Helsingin Sanomat / First published in print 7.8.2006
More on this subject:
 Volunteering to test experimental drugs
BACKGROUND: Failed British medical test sparked safety concerns
FACTFILE: About one in five medical tests involve treatment of cancer
Helsingin Sanomat
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