"Patient safety is the prime consideration in the decision to make a medicine available over the counter. The safety of carrying out this switch has been debated thoroughly and the case made convincingly that the balance of potential health benefits and any possible risks is overwhelmingly positive".

Outcome of the consultation exercise (ARM 18)

Consultation letter ARM 18 was issued on 17 November 2003 with a deadline for comments of 16 January 2004. It was circulated within the health services, to interested organisations and officials in the Scottish Executive, Welsh Assembly and Northern Ireland (devolved administrations). One hundred responses were received expressing a wide variety of views on the proposed reclassification. Key pharmaceutical bodies, such as the Royal Pharmaceutical Society of Great Britain were in favour of the reclassification with only minor comments. Other pharmacy professional bodies, some of the Royal Colleges, some clinicians and patient groups such as Heart UK were supportive in principle of simvastatin being available as a pharmacy medicine, but raised issues over the proposals as presented. About two thirds of respondents were in favour of the proposal.