In a not too distant future the pharmaceutical industry will be far less dependent on rats and pigs for studies. The new technology QSAR – or Quantitative Structure-Activity Relationship – which is essentially a computer-modeling of toxicity in pharmaceuticals has the potential to replace animal testing.
“The various regulatory authorities are starting to notice it. There are some differences in regulations, and there is some tardiness in getting it approved, but the clinical legislation in the EU concerning chemicals (REACH) dictates that up-front you have to use QSAR as the initial method for testing your substance,” explains Anders Permin, who is head of Human Health and Safety at the not-for-profit organization DHI.
The technology has been under development for many years, but very few people in this country can use it.
Legislation to make up ground
“We can use it DHI, and then it is being worked on at DTU. DTU works on it from a research-angle, while we put it to use.”
Within pharmaceuticals they haven’t gone so far as to say that QSAR can replace animal tests altogether, but it can be used exploratory in the beginning phases. And DHI recommends that.
“Legally it is not possible to replace animal testing at the moment. But it probably will be in time. As the models improve, the regulatory authorities will have to accept the use of QSAR,” Anders Permin explains.
But it could take 5, 10 or 15 years. Authorities stipulate the use of animal tests within pharma-biotech. But professionally it is to a large extent possible to pin-point any problems that might arise through QSAR.
He also believes that authorities are open to the use of QSAR rather than animal tests in the future.
“In regards to animal tests, you speak of the three R’s – reduction, refinement and replacement – and QSAR hits all three. And they are very important to the legislators. It’s a bull’s eye.”
- translated by Martin Petersen