HL Deb 28 June 1999 vol 603 cc8-10WA
Baroness Goudie

asked Her Majesty's Government:

Whether they will set out the criteria to exclude products from the NHS prescription which the Secretary of State for Health has notified to the European Commission to comply with Article 7 of Council Directive 89/105 EEC (the Transparency Directive). [HL3344]

The Parliamentary Under-Secretary of State, Department of Health (Baroness Hayman)

Since 1989, six criteria have been separately notified to the Commission. My right honourable friend the Secretary of State for Health has advised the Commission of the full set which currently apply, which are:

First, under the Selected List Scheme, medicinal products in 17 therapeutic categories which are excluded from prescription on the grounds that, on expert advice, they had no clinical or therapeutic advantage over other, cheaper, drugs in the following categories:

  • mild to moderate painkillers
  • indigestion remedies
  • laxatives
  • cough and cold remedies
  • vitamins
  • tonics
  • benzodiazepine sedatives and tranquillisers
  • antidiarrhoeal drugs
  • drugs for allergic disorders
  • hypnotics and anxiolytics
  • appetite suppressants
  • drugs for vaginal and vulval conditions
  • contraceptives
  • drugs used in anaemia
  • topical anti-rheumatics
  • drugs acting on the ear and nose
  • drugs acting on the skin

Second, products may be considered as "borderline substances" which are not truly medicinal products with clinical or therapeutic value and are excluded from National Health Service prescription on that ground.

Third, as well as being freely available on sale over the counter to the general public the cost to the NHS if the product(s) were to be supplied on prescription could not be justified at any price likely to be economic to the manufacturer and that the supply of the product is not considered a priority for the use of the limited resources available to the NHS.

Fourth, that products which nonetheless may meet a legitimate clinical or therapeutic need when properly prescribed are subject to misuse by drug misusers, and such misuse, or the manner in which the product is administered by drug misusers, gives rise to the risk of the physical or mental morbidity, and alternative products are available to meet all legitimate clinical or therapeutic needs.

Fifth, a medicinal product or a category of medicinal products may be excluded entirely from supply on NHS prescription. It may, alternatively, be excluded except in specified circumstances, or except in relation to specified conditions or categories of condition, or specified categories of patient. A medicinal product or a category of them may be so excluded where the forecast aggregate cost to the NHS of allowing the product (or category of products) to be supplied on NHS prescription, or to be supplied more widely than the permitted exceptions, could not be justified having regard to all the relevant circumstances including in particular: the Secretary of State for Health's duties pursuant to the NHS Act 1977 and the priorities for the expenditure of NHS resources.

Sixth, products which comprise an injection device prefilled with a drug may be excluded from supply on NHS prescription if the same drug is available and can be used more economically in a container which may be used in conjunction with a refillable injection device.