The European Medicines Agency (EMA) said today that it is taking action to investigate safety deficiencies that may be present in Roche’s reporting system.

The EMA said that it will be working with local and national medicines authorities in the EU to assess possible impacts on patients, as well as looking at whether the deficiencies have had an impact on the overall risk-benefit profile of any products involved in the investigation.

They did clarify that, at the present time, they do not consider there to be any immediate negative impact for patients and there is no need for patients or healthcare professionals to take action. The investigation appears to be more of a routine check and in the interest of the EMA being thorough, rather than because of any specific oversight on the part of Roche.

Nonetheless, the announcement has been prompted by a report from the UK medicines regulatory authority (MHRA) after a routine inspection of safety reporting systems at Roche uncovered deficiencies.

The MHRA said that at the time of inspection it identified around 80,000 patient reports for medicines marketed by Roche in the USA, that had not been examined, to find out whether the reports represented adverse reactions to the medicines. The reports include more than 15,000 deaths, but it is unknown at present whether these were due to natural causes, the progression of a disease or linked to the medicines the patients were taking.

Roche has said in more recent information that it is a far smaller number of reports than the number given by the MHRA, and obviously any medical company is likely to meet scrutiny and complaints about its products, for reasons that can range from hypochondria to emotional distress at a loved one’s death through to very real and dangerous side effects for new drugs.

Nonetheless, authorities need to verify the extent of Roche’s oversight. The term ‘deficiencies’ keeps cropping up and seems universally designed to protect both the company and the agencies, as it could range from a minor clerical oversight that doesn’t affect patients, right through to full blown mismanagement or deliberate failure to disclose information. At this moment, it seems unfair to either the company or the Agencies to speculate.

The scandal does look set to widen somewhat. Although it is unclear whether the patient reports were submitted directly to EU authorities through other channels, such as medical professionals, the ‘deficiencies’ are said to include 23,000 adverse reactions to medicines and 600 reactions to clinical trials. Obviously, a patient that is willing to take experimental medicine does so at their own risk to some extent, but any complaints or side effects they report should go into the system.

The Committee for Medicinal Products for Human Use (CHMP), CHMP Pharmacovigilance Working Party and the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) have stated that they discussed the issues arising from the Roche inspection at their meetings in May and June 2012.

So far, all we know is that Roche has been asked and has indicated that it will:

  • Roche to ensure that all known reportable events are immediately reported to the appropriate EU authorities in accordance with their existing legal obligations. The company must confirm to the Agency that this has been done, both for products in clinical trials and for marketed products.
  • Roche to submit a revised comprehensive action plan by 27 June 2012 for the evaluation and reporting of all outstanding cases and plans or corrective measures to ensure the correct processing of reports on suspected adverse drug reactions in the future. This includes evaluation of each of the 80,000-plus reports received by the patient support program in the USA and appropriate follow-up.

The EMA has said it will work closely with the FDA to evaluate and assess the impact the findings might have on public health, including any changes to the balance of the risk-benefit of the medicines involved.

Roche has clarified, unequivocally, that the oversights were not deliberate with a spokesman telling Reuters that:

“Roche acknowledges it did not fully comply with regulations and appreciates the concerns that can be caused by this issue for people using its products … Roche is committed to actively pursuing corrective and preventative actions to address this matter expeditiously. The non-reporting of these potentially missed adverse events was not intentional.”

Swiss based Roche is the world’s largest manufacturer of cancer medicines, it also produces drugs for viral infections, the central nervous system and inflammatory diseases.

Written by Rupert Shepherd