An increasing number of people in Britain are suffering from severe allergies, and doctors estimate that up to a dozen people a year die because they do not have adequate or early enough treatment for severe reactions to nuts, other foods, and bee and wasp stings.
An injection of adrenalin, if delivered in seconds, can reverse the condition known as anaphylactic shock, the symptoms of which include swelling of the mouth and larynx and a severe drop in blood pressure.
Sufferers have been awaiting supplies of a new portable 'pen' which can deliver a life-saving dose of adrenalin in seconds. But Boots, which applied three weeks ago for a licence to import the EpiPen direct from the United States, has had its application turned down by the Government-run Medicines Control Agency.
A spokesman for Allerayde, a company in Newark-on-Trent, Nottinghamshire, which was importing two or three EpiPens a month from the United States via Denmark but is out of stock at the moment, admitted its product was more expensive - pounds 35 each - than if imported direct from the US, as Boots intended.
The situation is further complicated because supplies of the only alternative to the EpiPen, an injector called Min-I-Jet which takes longer to set up, have also run out.
Parents of children affected by peanut allergy, who have formed the Anaphylaxis Campaign, described the situation as 'horrendous'. David Reading, whose daughter Sarah, aged 17, died from eating a tiny amount of peanut in the base of a lemon meringue pie, said: 'Adrenalin is a proven antidote. However much you try to label foodstuffs with correct information, there is always the risk that nuts could be contained in restaurant food or in packaged food because of anomalies in the labelling. In these circumstances, instant adrenalin is the only answer. Even a trip to hospital might take too long. It would be a tragedy if a child were to die because the EpiPen was not allowed into Britain.'
Sir Cranley Onslow, Conservative MP for Woking, plans to raise the matter in the House of Commons this week. 'I don't understand why the Medicines Control Agency has done this.'
Allergy specialists expressed concern last week that their patients were being denied a potentially life-saving invention. The new pen comes ready loaded with the correct dose. It can be delivered much faster than the alternative syringe, which has to be loaded - a time-consuming operation requiring a steady hand, not always available in a crisis.
Dr Richard Pumphrey, an immunologist at St Mary's Hospital, Manchester, said: 'I am disappointed that we are being denied a life-saving alternative for people who cannot cope with a normal syringe.
'For some people, the EpiPen is a much more satisfactory and safer way of giving adrenalin because there is no chance of their not giving the right dose, or not giving it at all because they cannot do it in the heat of the moment. I have prescribed the new pen for a number of people for whom the Min-I-Jet was unsuitable, but they have not been able to get hold of it.'
Dr Pumphrey said that although the EpiPen cost about pounds 21 if directly imported from the US compared with less than pounds 3 for the Min-I-Jet - distributed by International Medication Systems - it had a longer life. The 7,000 adults and children in Britain who needed such a gadget could keep an EpiPen for up to two years, against less than a year for the Min-I-Jet.
A spokesman for Boots said: 'We have been told that our application has been rejected. We understand that it is on the grounds that there is already a preferred licensed product on the market.'
Peter McGibbon, operation manager of IMS, which makes the Min-I-Jet, said demand for his product had increased dramatically in recent years.
A spokesman for the Department of Health said: 'As an equivalent is available already in the form of the Min-I-Jet, there is no point in having two items exactly the same. On top of that, the EpiPen is not licensed but is available on a named-patient basis. But the decision about Boots' import licence is still under review.'Reuse content