Basis for regulation

Neither patients nor doctors are in a position to decide for themselves across the range of medicines that they use, which ones are pure and stable, and effective and safe.

They need assurance that the medicines they are offered fulfil these requirements and are supported by information that permits optimal use. The information about and the usage of medicines gets out of date, and there is an obligation on licence holders continually to review their licence with particular regard to safety. Marketing Authorisation Holders (MAH), i.e. pharmaceutical companies, can also change the efficacy claims to their licence, e.g. new indications, extension of age groups, or change the safety information e.g. add new warnings, or contraindications. The quality aspects may also need to be revised as manufacturing practices change. MAH's have strong profit motives for making claims about their drugs. Only governments can provide the assurance about all those aspects in the life of a medicine, (in so far as it can be provided).

The principles of official (statutory) medicines regulation are that

• No medicines shall be marketed without prior licensing by the government.

• A licence shall be granted on the basis of scientific evaluation1 of:

— safety, in relation to its use: evaluation at the point of marketing is provisional in the sense that it is followed in the community by a pharmacovigilance programme

— efficacy (now often including quality of life)

1 Except in the case of traditional herbal medicines (which can be ineffective and/or hazardous), as well as other substances used in the 'legitimate practice' of complementary medicine, for which this requirement cannot be met. Official regulators, finding themselves between 'the rock' of maintaining scientific principles and 'the hard place' of banning complementary medicines that are popular with the public (a political impossibility), have reacted in accordance with the highest traditions of their calling as civil servants. They have produced a compromise mix of reinterpreted regulations with circumspect labelling that will allow these products to continue to be sold without, it is hoped, misleading the public.

— supply: i.e. whether the drug is suitable to be unrestrictedly available to the public or whether it should be confined to sales through pharmacies or on doctors' prescriptions; and what printed information should accompany its sale (labelling, leaflets).

• A licence shall specify the clinical indications that may be promoted and shall be for a limited period (5 years), which is renewable on application.

• A regulatory authority may order a drug to be taken off the market at any time for good cause

• A licence may be varied by an application from the MAH to update efficacy, safety and quality sections.

Plainly manufacturers and developers are entitled to be told what substances are regulated and what are not2 and what kinds and amounts of data are likely to persuade a regulatory authority to grant a marketing application (licence) and for what medical purpose. In summary, medicines regulation aims to provide an objective, rigorous and transparent assessment of efficacy, safety and quality in order to protect and promote public health but not to impede the pharmaceutical industry. It may be appreciated that an interesting tension exists between regulator and regulated.3

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