The consultation was launched to discover if the current law – The Medicines For Human Use Regulations 1994 – needed to be changed, following the MHRA's report earlier this year of its investigation into whether Glaxo failed to inform it in a timely manner about info which it had on the safety of its Paxil antidepressant, knowna as Seroxat in the UK, when used in patients aged under 18.
The government decided there was little chance of gaining a conviction and so the case did not proceed to criminal prosecution. But the legislation in force at that time was not sufficiently clear or comprehensive as to require companies to inform the regulator of safety info when the drug was being used for, or tested outside, its licensed indications, says the government, in its response to the consultation, PharmaTimes writes (see back story).
There have been several European Union developments since that case, including a new clinical trials directive and legislative changes to clarify the obligation to report "promptly" any relevant safety info arising from clinical trials using products outside their normal conditions of use, PharmaTimes notes.
The European Commission is also proposing to strengthen the EU system for monitoring the safety of medicines but, given the length of time that this may take, the MHRA has committed to changing UK legislation in the interim to clarify the requirements.
The proposed changes to the 1994 Regulations will state explicitly, to ensure there remains "no room for doubt in industry's and regulators' minds," that Marketing Authorisation holders should report information from both clinical trials outside the licensed indication and arising from third countries and to provide a timescale for reporting, says the government, according to PharmaTimes.
The MHRA's review of the consultation says that a number of respondents - including the Faculty of Pharmaceutical Medicine, Wyeth, the British Association of Research Quality Assurance, the Association of the British Pharmaceutical Industry, the BioIndustry Association and the mental health charity Mind – expressed concern over the use of the word "promptly." As a result, it says, the proposed new legislation will use the term "as soon as reasonably practical" instead.