Unlicensed drugs - BBC Radio 4 Interview

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Prescription DrugsLes Halpin was interviewed by John Humphrys on BBC Radio 4’s Today Programme on 15 February 2013 about giving people with rare, life threatening conditions the right to try unlicensed drugs.

Mr Les Halpin himself was diagnosed with Motor neurones disease in 2011 and now unable to move his arms or legs and has limited breathing. Motor neurone disease is a rare condition that progressively damages the nervous system, causing the muscles to waste away.

When Mr Halpin was diagnosed 2 years ago he realised that there had been no new drugs licenced for use in motor neurone disease for a considerable amount of time. Therefore, Mr Halpin wants to change the law so that he, and other people who are suffering can take experimental, non licensed drugs that may help his condition, or at the very least will allow important data to be collected in the hope that (if he can’t be helped) eventually drugs may be developed for other people.

Essentially, Mr Halpin wants the law to change so that he (and others) can become human guinea pigs if they want to. Talking on BBC Radio 4, Mr Halpin stated that he is fully aware that there would be risks involved in taking unapproved drugs and he is prepared to take experimental drugs so long as he has been provided with full disclosure of those risks involved.

Sir Michael Rawlins, President of the Royal Society of Medicine and head of National Institute for Clinical Excellence (NICE), sympathised with Mr Halpin but felt that it was not necessary to change the law. Sir Rawlins felt that the problem lay with individual NHS institutions rather than the law.

Sir Rawlins explained that before experimental drugs can be given it is necessary to have some indication that the drug may work, that the drug was not likely to cause any adverse side effects that would worsen the condition and that there must be some idea as to the dose of the drug to be administered.

In his opinion the main problem was getting permissions from the NHS to do the research. Following recommendation he says that the government established a new body in ‘The Health Research Authority’ which has now been running for a year and which he hopes will cut through the bureaucracy.

On the other hand, Professor Sir Peter Lachmann, former president of the Academy of Medical Sciences, disagrees and believes that a change in the law is needed.

In his opinion no one is developing new drugs for serious diseases such as motor neurone disease because under the present regulations it is very difficult for small companies to take drugs to market because of the huge cost of phase 3 testing and the fact that these trials take years to complete.

Professor Lachmann blames the change in the law in the wake of the thalidomide compensation claims, after which liability for the drug companies was no longer dealt with under the tort of negligence but became strict liability. He states that as a result of this change it became impossible to indemnify the manufacturer of new drugs and so it became impossible for small companies to continue to produce/trial new drugs.

Professor Lachmann was of the view that there are no innovative new drugs in the pipeline for motor neurone disease because there are not enough companies working on it and until the law is changed so that there is no longer strict liability then there will be no change.

Professor Lachmann, did however, point out that Mr Halpin could use unlicensed drugs on a named patient basis without breaking any laws although this would only apply to him and not to all other sufferers.

Essentially, The Medicines (Exemption from Licences) (Importation) Order 1984 allows that the clinician may feel that no drug licensed by the MCA, and therefore freely available on prescription from a pharmacist, would be suitable for the particular patient. In this case, if he or she knows of a drug not currently licensed, which would be more appropriate for such a patient, he or she may prescribe it on a Named Patient basis. And so this may be an answer for Mr Halpin in the short term.

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