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Drug companies enjoy impunity from EU authorities

Under European regulations, the European Commission can only impose a financial penalty on drug companies if their infringement has "substantial consequences for public health" and if they do not co-operate during the proceedings brought against them.

A routine inspection in 2012, carried out by the British Medicines and Healthcare Products Regulatory Agency (MHRA) on behalf of the European Medicines Agency (EMA), found that the company Roche had not analysed or reported more than 80 000 suspected adverse effects, involving 19 drugs, to drug regulatory agencies.

Five years later, the European Commission pronounced an extremely conciliatory verdict on the matter. The Commission absolved Roche on the pretext that the retention of information did not alter the harm-benefit balance of the 19 drugs concerned. The Commission endorsed the statements by the company that "accepted all the inspection findings. It took them extremely seriously and fully understands the EMA’s and Commission’s concerns. It has worked diligently to remediate the deficiencies as quickly as possible and also to enhance the company’s medical compliance and PV systems to prevent any recurrence". The proceedings were therefore stopped, and Roche will not have to pay the fine of nearly 700 million dollars that was at stake.

Given the financial stakes, it is understandable that Roche successfully sought leniency from the European authorities by adopting a humble and repentant attitude.

The leniency of the European authorities seems out of step with civil law as it applies to ordinary people. Pharmaceutical firms, however, are very well protected by the European Regulation governing penalties for infringement. The European Commission can only impose a financial penalty if the infringement has "substantial consequences for public health" and if the companies do not co-operate during the proceedings brought against them.

This was the first application of this Regulation; its shortcomings were all too evident, as was the deliberately weak stance taken by the regulatory authorities.

©Prescrire 1 January 2019

"Drug companies' impunity from EU authorities" Prescrire Int 2019; 28 (200): 27. (Pdf, free).

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