§ Mr. Pavittasked the Secretary of State for Social Services if he will introduce amending legislation to the Medicines Act 1968 to make it necessary for the licensing authority to be satisfied that there is a medical or economic need for a new drug; what examination his Department has made of a similar provision in the legislation of Norway; and if he will make a statement.
Mr. EnnaisI am aware of the fact that the Norwegian legislation provides that approval for marketing is to be given only for
preparations which are medically justified and which are considered to be needed".
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Children's Regional Planning Area Local Authority Location Secure Places 1 Newcastle-upon-Tyne … … Axwell Park … 3 2 Bradford … … Springfield … 3 Rotherham … … Simmonite Road … 4 Wakefield … … Flanshaw Lane … 4 3 Stockport … … Baker Street … 2 5 Derbyshire … … Sinfin Avenue … 2 Derbyshire … … Clay Cross … 2 Northamptonshire … … Moulton … 3 6 Essex … … Boyles Court … 6 7 Buckinghamshire … … Netherfield … 3 Hertfordshire … … Six Mills Way … 2 Berkshire … … Brookside … 4 8 Hillingdon … … Middlesex Lodge … 8 Lambeth … … Cumberlow Lodge … 24* Waltham Forest … … Gordon Road, Chingford … 2 9 East Sussex … … Hailsham … 5 10 Hampshire … … Glen House … 2 12 Mid Glamorgan … … Church Village … 3 (Wales) West Glamorgan … … Cockett … 2 Clwyd … … Bersham Hall … 1 Total … 85 * Although sited at an observation and assessment centre these places will in fact be used for medium to long-term treatment and are not intended for girls on remand. I understand that in practice the Specialities Committee which is responsible for giving approval considers whether the new product has been proved to possess advantages over products already on the market and they take into account the volume of sales of existing products. Norway is atypical in that it has only a small indigenous pharmaceutical industry and depends upon products developed elsewhere. Until a product has been on the market for several years, it may not be possible to establish whether it has advantages in safety and efficacy over other products.
I have no proposals for amending the Medicines Act along these lines and there would be considerable difficulties about operating such a provision in this country.