§ 24. Mr. Greenwayasked the Secretary of State for Social Services if he has yet made the order to implement the conclusions of his consultations on the subject of controlling parallel importing of medicinal products; and if he will make a statement.
§ Mr. Kenneth ClarkeI have approved the draft of the new Medicines (Exemption from Licences) (Importation) Order in its final form. It is now being printed and will be laid before Parliament as soon as possible. The proposed licensing scheme for parallel imports will come into operation at the same time as the order is laid.
§ 46. Dr. Mawhinneyasked the Secretary of State for Social Services how many cases have been reported to him in the past 12 months in which National Health Service patients have suffered damage to their health arising from deficiencies in parallel imported drugs; and if he will make a statement.
§ Mr. Kenneth ClarkeWe have not received any authenticated evidence of damage to a patient's health as a result of using a parallel imported medicine.
However, we recognise the potential risk and are taking steps to eliminate it. This is the reason for the licensing scheme to control parallel imported medicines, plans for which were announced recently. The scheme provides that parallel imports must be licensed in an EC member state and must have no different therapeutic effect from the product already licensed in the United Kingdom. Also the same conditions on storage, distribution, packaging, labelling and inspection will apply as to medicines which have been manufactured in this country.