§ Sir Cranley OnslowTo ask the Secretary of State for Health what steps she is taking to ensure that adequate supplies of adrenalin injections suitable for the immediate treatment of anaphylactic reaction are generally available; and what discussions her Department has had with the Medicines Control Agency on this subject.
§ Mr. SackvilleResponsibility for this matter has been delegated to the Medicines Control Agency under its chief executive, Dr. K. H. Jones. I have asked him to arrange for a reply to be given.
Letter from Dr. K. H. Jones to Sir Cranley Onslow, dated 17 June 1994:
Adrenaline Injections for the treatment of Anaphylactic ReactionsThe Secretary of State has asked me to reply to your question concerning supplies of Adrenaline injections suitable for the immediate treatment of anaphylactic reactions and their availability.The Medicines Control Agency is an Executive Agency of the Department of Health responsible for safeguarding public health by licensing medicines, monitoring adverse drug reactions, surveillance of marketed drugs and publication of standards. The Agency carries out the day to day activities of the Licensing Authority which comprises Ministers. The Chief Executive reports to the Secretary of State for Health, and the Agency remains in frequent and regular contact with the Department.Adrenaline Injection in a preloaded syringe (Min-I-Jet) was granted a product licence for the treatment of anaphylactic reactions after assessment for safety, quality and efficacy. The manufacturer however recently experienced production difficulties resulting in shortages of supply during April and May 1994. Further and adequate supplies of the Min-I-Jet became available during the week commencing 6 June 1994.It is a principle of UK Medicines Control that doctors have clinical freedom to prescribe unlicensed medicinal products and Section 13(1) of the Medicines Act grants an exemption allowing very limited quantities of imports of such products. This is allowed without reference to MCA and it is on this basis that an unlicensed Adrenaline Injection in a self-injecting syringe (Epipen) has been imported from the United States of America by or to the order of doctors in the UK for the treatment of their particular patients. This product has not been assessed by this Agency and prescribers assume full responsibility for its use.The shortage of licensed Min-I-Jets resulted in an increased demand for unlicensed Epipen and the Boots Company applied to the MCA for an exemption to import a significant quantity in anticipation of orders from doctors in accordance with Statutory Instrument SI (1984) 673. Normally exemption under this Regulation is refused if there is an equivalent licensed product on the market. In accordance with this practice, exemption was initially refused because of the restored availability of Min-I-Jets. However, it became apparent that although adequate supplies of Min-I-Jets had been resumed, those supplies might not have reached community pharmacists in all areas. The decision to refuse Epipen exemption status was therefore reviewed and subsequently reversed.The demand for Adrenaline Injection is currently being met by the licensed Min-I-Jets supplemented by the unlicensed Epipen. This Agency understands that an application for a UK product licence may be submitted for Epipen. In such circumstances the application would be assessed by the MCA and if granted the licence would enable Epipen to be marketed in the UK.