New rules and guidelines on how companies should monitor potential side effects of drugs.

January 10, 2014 - News story

The first of July, 2012, a new law came into force concerning new rules and guidelines on how companies should monitor potential side effects of drugs. The aim is to improve and protect public health. Ariane Kyller has looked closer on how 15 different companies - large as well as small companies and both Swedish- and foreign companies - implemented the new law.

”Many companies has been working hard to adjust to the new law, and many needed to change their existing system. However, my study is done in an early stage and it is difficult to assess the impact on business costs and work effort already. But overall I think that it is really good that the authorities are aiming high to get closer to the goal of reducing patients suffering and optimize the use of medicines”, says Ariane Kyller.


All pharmacovigilance matters should now be handed centrally at the European Medicine Agency, EMA, and all adverse event reports collected into a single database. All decisions are taken centrally and it will now be equal for all countries. This aim to give a more efficient process in the long run. However, Ariane says, same rules for all companies, regardless the size of the company, might be tougher for small companies because of increased costs. All processes must be adapted to meet the new requirements and this means increased corporate administration and new working areas and increased costs, at least in the beginning.


”But however, and surprisingly, it's not that much of a difference in how the company collects side effects, because the companies were ahead of the law and collected information even outside approvals”, says Ariane Kyller.


Ariane sees many benefits from the new legislation, which she thinks will be good for patients and patient safety.

”But overall, Sweden has been pretty good at this even before, compared to many other countries. Another good thing is also that the new legislation requires all companies to selfmonitor and guard their products - it is not enough to only launch a product”,

Ariane Kyller concludes and says that even for Sweden there can be improvements, especially concerning adverse drug events for older people.


Everything should be finished during 2015 and in five years from now the system will be evaluated again to see the outcome of the new law.

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