Tom Brake (Carshalton and Wallington, Liberal Democrat)
To ask the Secretary of State for Health
(1) what steps his Department takes when notified of pharmaceutical companies contravening the rules contained in legislation on medical safety;
(2) what records he requires pharmaceutical manufacturers to keep of reported adverse reaction to their drugs.
Simon Burns (Minister of State (Health), Health; Chelmsford, Conservative)
Pharmaceutical companies have a statutory obligation to report adverse reactions and any information which may influence the evaluation of benefits and risks for medicinal products marketed in the United Kingdom, to the UK regulatory body, the Medicines and Healthcare products Regulatory Agency (MHRA). Criminal penalties (fines and incarceration) exist for breaches of these obligations in UK legislation.
MHRA conducts a programme of statutory pharmacovigilance inspections of UK marketing authorisation holders in order to examine compliance with the safety reporting requirements and in order to ensure that action is taken to address non-compliance.
MHRA evaluates all notifications of breaches of medicines legislation which are made to the agency and, where appropriate, investigations are conducted. When serious non-compliance with the safety reporting requirements for medicinal products is identified (through regular risk-based inspection or other means), MHRA can employ a range of options to address the findings. These include repeat inspections to assess whether appropriate corrective and preventative actions have been implemented; the issuing of warning letters; action through marketing authorisations and new marketing authorisation applications when considered appropriate (e.g. suspension of authorisations); referral for criminal prosecution in the UK (if offences have been committed); and referral to the European Medicines Agency for action to be taken under the European Union infringement regulation for medicinal products authorised via the central EU process, which may result in a marketing authorisation holder being fined.
UK Statutory Instrument 3144:1994 (as amended) states:
“The holder of a marketing authorization shall maintain a record of reports of which he is aware of suspected adverse reactions in accordance with the relevant Community provisions which shall be open to inspection by a person authorised by the licensing authority, who may take copies of the record and, if the licensing authority so directs, the authorization holder shall furnish the licensing authority with a copy of any such reports of which he has a record or of which he is or subsequently becomes aware.”
Current Community legislation (EU Directive 2001/83/EC) requires marketing, authorisation holders to maintain detailed records of all suspected adverse reactions of which the company becomes aware and to report suspected serious adverse reactions to relevant competent authorities (to MHRA in the UK).