Safety, Quality, Efficacy: Regulating Medicines in the UK

More documents

Recommendations

Info

SAFETY, QUALITY, EFFICACY: REGULATING MEDICINES IN THE UK 2.46 Purchasing prescription-only medicines without a prescription carries potentially serious risks: ! self-diagnosis may be incorrect; ! the medicine purchased may not be appropriate to treat the condition; ! side-effects from the medicine may be serious, including exacerbating other existing conditions, and there may be adverse interactions with other medicines being taken; and ! the quality and safety of the medicine is not assured. 2.47 The problem of illegal internet selling requires international co-operation. None of the EU regulators we visited had yet made substantial headway in tackling it, and all recognised that it would be very difficult to achieve full compliance with medicines legislation. The Medicines Control Agency has been monitoring the problem for two years, and has made this area of enforcement activity a priority in 2002-03. Work will focus on commonly purchased prescription-only medicines from UK-based websites, whilst sites based overseas will be referred to the appropriate national regulatory authorities. In the meantime, the Agency is taking enforcement action on illegal internet sales of prescription-only medicines through the closure of web sites and prosecution. Reviewing medicines advertising and promotional material A combination of statutory and self-regulation covers advertisements for medicines 2.48 Direct advertising of prescription-only medicines to the public is illegal in the UK and the rest of the European Union. Advertising of medicines available over the counter is, however, allowed. And advertising of prescription medicines to doctors or others qualified to prescribe or supply them is also legal. The control of medicines advertising in the UK is based on a longestablished system of self-regulation underpinned by statutory powers administered by the Agency. The three main bodies involved in the self-regulatory system are the Prescription Medicines Code of Practice Authority, the Proprietary Association of Great Britain and the Advertising Standards Authority, of which the first two administer Codes of Practice. 2.49 The Proprietary Association of Great Britain, the trade association of companies selling non-prescription medicines, examines all advertisements submitted by its members and consults with the Agency. When advertising prescription-only medicines to health professionals, companies are required to comply with the Association of the British Pharmaceutical Industry Code of Practice. The Prescription Medicines Code of Practice Authority, run at arm's length by the Association of the British Pharmaceutical Industry, handles complaints against the Code, publishing its rulings, and may require advertisements to be withdrawn. 2.50 While the Agency has the power to require sight of advertisements in advance, it usually exercises this power only where: ! the product is a newly licensed and intensively monitored medicine; ! the product has been reclassified to make it available without prescription for the first time; or ! the product's previous advertising has breached the regulations. 2.51 The Agency's Advertising Unit carries out monitoring of prescription-only medicine advertising in medical journals, concentrating particularly on newly launched products. It also investigates complaints about advertising from any source, including health professionals and the public. In 2001-02, 50 advertisements were amended or withdrawn after scrutiny by the Agency, and a further 81 potential breaches were identified through complaints, following which action was taken. Examination at any stage by the Agency does not preclude it from taking later action if it subsequently decides there has been a breach of regulations, and this was the case in October 2002 when it requested the withdrawal of an advertisement for an oral contraceptive, which had also been examined by the Prescription Medicines Code of Practice Authority. part two 27
SAFETY, QUALITY, EFFICACY: REGULATING MEDICINES IN THE UK part three 28
Page 1 and 2: Safety, quality, efficacy: regulati
Page 3 and 4: Safety, quality, efficacy: regulati
Page 5 and 6: SAFETY, QUALITY, EFFICACY: REGULATI
Page 13 and 14: 8part one SAFETY, QUALITY, EFFICACY
Page 31: SAFETY, QUALITY, EFFICACY: REGULATI
Page 55 and 56: 50 appendix nine Country Medicines

Safety, Quality, Efficacy: Regulating Medicines in the UK

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?