§ Mr. Deakinsasked the Secretary of State for Social Services (1) whether he has made any inspection of the manufacture of foreign-made blood administration sets and dialysis solutions which are imported for use in the National Health Service;
(2) if he will take steps to prevent the import of unapproved devices for blood administration and sterile solutions for use in the National Health Service;
(3) how standards in the European Economic Community manufacturing practice for blood administration and sterile solutions compare with those in the United Kingdom; and if he proposes to take any initiative to secure harmonisation of such standards;
(4) what action his Department takes to ensure follow-up inspections of foreign units making blood administration sets and sterile solutions for use in the National Health Service after a product licence has been granted; and if he will consider granting such licences on the basis that they end after a fixed period.
§ Dr. VaughanWe have no powers to prevent the importation of blood administration sets where the foreign manufacturing facilities and standards have not been inspected by officers of the Department. However, National Health Service authorities are advised by the Department to purchase their standard blood sets from approved suppliers only.
Before any firm, home or foreign, can be included in the Department's approved list of suppliers, officials of the Department inspect the firm's manufacturing facilities to see that they comply with the Department's "Guide to 215W Good Manufacturing Practice", published through Her Majesty's Stationery Office. Any firms approved are then liable to follow-up inspections at any time.
Blood administration sets are regarded as devices and as such do not require a product licence.
Overseas manufacturers of dialysis solutions for which product licences are held are inspected before and after the granting of such a licence. Product licences are granted or renewed for a maximum period of five years.
Sterile solutions which are medicinal products under the terms of the Medicines Act and which are not covered by a product licence may be imported to the order of a doctor for a particular patient of his. The Act provides exemptions from importation controls for practitioners in these circumstances.
Harmonisation of standards, both for European Community countries and others, is a responsibility of the International Standards Organisation, in which this country participates. I believe that we are amongst the leaders in the development of arrangements for improving manufacturing standards.
§ Mr. Deakinsasked the Secretary of State for Social Services if there are National Health Service standards for the manufacture of blood products; and what steps he is taking to ensure that blood products used in the National Health Service comply with any such standards.
§ Dr. VaughanStandards for the manufacture of blood products for use in the United Kingdom are set out in the Department's "Guide to Good Pharmaceutical Manufacturing Practice", published by Her Majesty's Stationery Office. Manufacture of these products is subject to inspection to ensure that they are of the requisite standard.