Medicines (Hansard, 27 February 2003)

§ Ms Blears

In April 2002, at the time of launch of Yasmin, a combined oral contraceptive authorised in the European Mutual Recognition procedure in June 2000, the Medicines Control Agency (MCA) identified advertising for the product through its routine monitoring of published advertising materials. The company—Schering Health Care Limited—was asked to provide the references quoted in the advertising material. At this stage, the evidence in the references was not examined as closely as it would have been, and subsequently was, in the event of a complaint from a health care professional from the perspective of the clinical usage of the product.

Following specific complaints from health professionals in August and September 2002, the MCA conducted an assessment of the claims made in advertising for Yasmin and concluded that the quality and extent of the evidence provided was not sufficiently robust to support the claims made and that the Yasmin advertising was in fact misleading. The MCA requested that the company, Schering Health Care Limited, withdraw the material and it did so in October 2002.

The company was subsequently required to submit all its advertising for Yasmin to the MCA for review prior to publication. The MCA has also required Schering Health Care Limited to issue a corrective statement concerning advertising for Yasmin. This will be sent to health professionals who received previous advertising material from 21 February 2003 and also published in all medical journals where previous advertisements had appeared.

The Agency makes an assessment of the safety, quality and efficacy of applications for a marketing authorisation. The data assessed in the Yasmin application included efficacy studies versus other licensed oral contraceptives as comparators. However, the comparative benefits of a particular product in relation to other products are not relevant to the Licensing Authority decision under the terms of the Medicines Act 1968, so long as there is acceptable evidence of efficacy.

702W

The control of medicines advertising in the United Kingdom is based on a long established system of self-regulation, underpinned by statutory powers administered by the MCA under the Medicines (Advertising) Regulations 1994 and the Medicines (Monitoring of Advertising) Regulations 1994. The MCA undertakes a range of duties, set out in a published guidance note, to ensure that claims for the benefits of medicines in advertising comply with the statutory requirements. These include preventing of advertising prior to publication in certain circumstances, monitoring of medicines advertising in medical and other journals and investigation of complaints about advertising from any source, including health professionals and the public.