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Roche Faces Fines for Not Reporting Side Effects of Drugs

Roche could receive a fine of as high as 5% of its entire European Union sales

October 24, 2012 – EMA, the European Medicines Agency started an infringement action against drug maker Roche for not reporting properly thousands of side effects of medications, which EMA described as a failure to comply with its obligations.

Roche could receive a fine of as high as 5% of its entire European Union sales that amount to more than $13 billion. That means the company could be facing a fine of over $685 million.

The action is against the arm of Roche called Roche Registration Ltd. The European Commission was requested to investigate a number of allegations that details were not provided by the company on the different side effects for 19 medications that had been authorized, including Tamiflu and Herceptin.

EMA is based in London and it is the first time it has initiated proceedings of this nature since new regulatory laws started in 2007.

The European Commission will receive a report from the Agency with its final outcome of the investigation. The EC can impose penalty payments or fines under the new regulations if it determines that Roche did not live up to its obligations.

The issue started with an inspection by Medicines and Healthcare Regulatory Agency of the United Kingdom in 2012. The MHRA said it found many shortcoming of pharmacovigilance on the part of Roche. Allegedly, Roche did not completely assess more than 80,000 cases of side effects from potential drugs.

Roche stressed that not any of its safety profiles for its medications were affected. The company said it was fully cooperating with authorities. Roche stressed that the reports over possible safety issues had no come from any clinical trials, but had come from a support scheme for its patient’s in the U.S. who were not able to afford medications.

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