§ Mr. BurstowTo ask the Secretary of State for Health what progress has been made since the Drugs and Therapeutics Bulletin report of 2001 to ensure that all new drugs are labelled with a black triangle warning. [174476]
§ Ms Rosie WintertonThe black triangle scheme is intended to facilitate the intensive monitoring of new medicines for which there is relatively limited safety data available. A black triangle symbol is used in the product information to identify the medicines for which the Committee on Safety of Medicines (CSM) and the Medicines and Healthcare products Regulatory Agency (MHRA) request health professionals to report all suspected adverse reactions rather than serious reactions alone. This is a voluntary scheme and, while1834W use of the symbol is not a legal requirement, it is expected that marketing authorisation holders (MAHs) will use the black triangle symbol where requested to do so by the MHRA.
Following the publication of a survey in Drugs and Therapeutics Bulletin in 2001 entitled, "Failings in treatment advice, SPCs and black triangles", the MHRA formally reviewed the use of the black triangle symbol on product information. Companies were requested to submit summaries of product characteristics (SPCs) and promotional material for their products under intensive monitoring and it was subsequently found that approximately 9 per cent. did not display the symbol on their material. Importantly, the review found that all black triangle products had the symbol routinely displayed in the British National Formulary (BNF) and the monthly index of medical specialities (MIMS). These publications are widely used by health professionals when prescribing medicines. This was due to active liaison between the MHRA and MIMS and the BNF. During the review, the Association of the British Pharmaceutical Industry was also contacted and undertook to inform new companies of the scheme.
As a routine measure, the advertising unit at the MHRA reviews advertisements for new products in a selection of key published journals, and the assessment includes checking to see if the black triangle symbol is displayed. In accordance with published criteria, the unit may also ask a company to submit all promotional material to the MHRA for pre-vetting. Any omission of the black triangle symbol is brought to the immediate attention of the company, who would be asked to resubmit an amended advertisement. In general, companies are found to comply with the scheme for incorporating the black triangle symbol on their promotional material.