The history of over-the-counter medicines has been a roller-coaster. The Rose case, which culminated in a decision from the House of Lords in 1704, established that apothecaries could prescribe and dispense medicines, breaking the monopoly of the College of Physicians [1]. After that, over-the-counter medicines continued to be generally available in Britain until 1860, when drugs of abuse were designated as prescription-only medicines. However, most other medicines remained generally available until the 1960s, when, in the hope of improving safety, most of them became prescription-only medicines, following a report of the Interdepartmental Committee on Drug Addiction, chaired by Sir Russell Brain [2]. The attempt may not have been successful. We don’t know what the risks of adverse effects were in those days, but they are currently quite high and the hoped-for improvement may not have transpired. Now the roller-coaster is tumbling down the slope again, and more and more medicines are becoming available over the counter. Take simvastatin. On 12 May 2004 the Secretary of State for Health for England and Wales, John Reid, announced that simvastatin, which is off patent, would become available from July 2004 for over-the counter sale in the UK in a 10 mg formulation. The announcement was welcomed by the Royal Pharmaceutical Society [3]. According to Gill Hawksworth, its President, ‘The Society believes that there is a clear public health benefit to be gained from making this important medicine available through pharmacies. The switch will give pharmacists more opportunities to use their skills’. However, the Consumers’ Association was not so impressed [3]: ‘The switch is tantamount to using the UK public as guinea pigs and smacks of a cost-cutting exercise’. A spokesman for the Royal College of General Practitioners said [4], ‘We understand that while a range of health tests will be offered before simvastatin is dispensed by a pharmacist the tests are not obligatory and we are concerned by this news… . Pharmacists currently do not have access to a patient's medical record which would help them judge whether simvastatin is necessary and help patients get appropriate and optimum treatment while protecting them against interactions and adverse effects’. And The Lancet gave the announcement the full benefit of a typical anonymous broadside entitled ‘OTC statins: a bad decision for public health’ [5]. Should simvastatin be available over the counter? Well, there are criteria. They have recently been reviewed in a US context [6], although surprisingly the author failed to distinguish between necessary criteria, such as efficacy and safety, and desirable criteria, such as making medicines more readily available. I shall mostly refer to medicines that are only available in pharmacies, rather than those on the General Sales List, which are available through supermarkets and other outlets without the supervision of a pharmacist. I shall also assume that pharmacists are alive to the problems of self-medication by patients and will take steps to advise them about seeking medical advice when appropriate. This is not true in all countries, and I shall therefore mostly restrict my comments to the UK, where it is.