HC Deb 23 January 1984 vol 52 cc437-8W
Dr. Roger Thomas

asked the Secretary of State for Social Services is he will ensure that when drugs and medications are exported, particularly to countries of the Third world, that the data sheets that are mandatory to accompany those drugs when distributed in the United Kingdom are made available with the exported drugs and brought directly to the attention of the health authorities of the countries importing British pharmaceutical manufactures.

Mr. Kenneth Clarke

Data sheets are not distributed with drugs in the United Kingdom. They are circulated separately to doctors to give them information which they may take into account before prescribing the medicinal product concerned. The information they contain may well be inappropriate in Third world countries where the uses and availability of the product may be different. It is for the appropriate authority in each country in the Third world to decide what information should accompany imported products.

However, should those authorities wish to refer to the United Kingdom data sheets these are available in the data sheet compendium which is published by the Association of the British Pharmaceutical Industry. Our Department circulates a copy of each edition of the compendium and the British National Formulary to those regulatory authorities named in the list of regulatory authorities produced by the World Health Organisation. The compendium is also provided on request free of charge to the regulatory authorities of Third world countries by that associations or the International Federation of Pharmaceutical Manufacturers Association in Geneva. We therefore endeavour to make the information available in company data sheets to the authorities in Third world and other countries which may assist them to take their own informed decisions about the basis upon which drugs are prescribed, dispensed and sold to their patients.