In the wake of a high pro le court case, what laws can prevent unquali ed people from giving botulinum toxin injections? We investigate a surprisingly complex area.
The case of Jamie Winter, the beauty therapist who bought botulinum toxin on the Internet for £70 then injected it into clients in their homes, has just ended with her being convicted of fraud. Her offence in the eyes of the law? Telling her customers that she had completed a training course, which she’d actually ducked out of for being too expensive. Now, many in the industry are asking why Winter was prosecuted for fraud: not for injecting someone else with a prescription only medicine. Initially she was charged with assault, because one of her clients suffered swollen eyes after the injections, but because they consented to the treatment, those charges were dropped. Had Winter admitted that she was untrained, and her clients were willing to go ahead with the injections, she would not have been guilty of fraud either. So how does the law apply to rogue operators? Despite the Keogh report, it is still legal for anyone – qualified or not – to inject botulinum toxin. In that respect, Winter was in the clear. Also, it is not illegal to buy a licensed medicine over the Internet, or to administer it in people’s homes. The only way Winter broke the law was in acting alone. The Medicines and Healthcare Regulations Agency (MHRA) say that botulinum toxin injections should be done ‘under supervision or under the directions’ of a medical practitioner. Botox® is a prescription only medicine (POM), and The Human Medicines Regulations 2012 makes it illegal to sell, administer or possess a POM with intent to supply. The offences carry a maximum penalty of two years imprisonment or an unlimited fine. Sally Taber, director of the Independent Healthcare Advisory Services says, “Botox® has to be prescribed by a doctor, dentist or nurse prescriber. If they feel that an unqualified injector is competent to do it, currently they can authorise this. But it is certainly not good practice.” Janet Kettels, director of corporate a airs and public relations at Allergan agrees, “These treatments are medical procedures and should only be given in the right clinical environment by a qualified healthcare professional trained in clinical assessment and patient care,” but this is not a legal obligation. However, Jeanette Aspinall, department head of medical negligence and litigation at Fletchers Solicitors, says, “The European Committee for Standardisation published a draft guideline on who can provide cosmetic procedures and where these should be carried out, which could be introduced by autumn next year. Anyone who outs it could face prosecution, fines and possibly imprisonment.” Given the side effects reported, it seems unlikely that the product Winter bought for £70 over the internet was a genuine botulinum toxin injectable, and almost certainly not Botox®. However, if clients believed it to be the real thing - the law should still hold, as the Medicines Act states: “No person shall, to the prejudice of the purchaser, sell any medicinal product which is not of the nature or quality demanded by the purchaser.” And if Winter was passing o one product as another she might have been sued for damages from her own clients. If she claimed to be providing Botox®, she might be subject to an infringement claim from Allergan. So why was she charged with fraud? The MHRA has special powers to investigate, arrest and prosecute for medical crimes, however, a MHRA spokesperson explains, “In legal terms, fraud is a more serious offence than medical offences and this explains why the police brought the prosecution. If we discover evidence of more serious crimes, such as fraud, then we will refer our investigation to the police.” Also, Botox® is a very complex area. For example, an unqualified person who bought a drug claiming to be Botox® via the Internet could claim they were being paid to supply their services, not the drug. They would still need to be acting under the supervision of a doctor, dentist or nurse prescriber. It comes down to the specific details of each case and regulatory action can lie between professional bodies, the Care Quality Commission (who are responsible for the regulation of private clinics) and the MHRA which can make punitive action complex, and outcomes less certain. Is Jamie Winter a lone bad apple, or are there others in the barrel? “There is no data on this, but it is likely to be far more common than we would like to believe,” says Emma Davies, chair of The British Association of Cosmetic Nurses. While regulation is necessary, no amount will stop those determined to operate outside the law. However, exemplary prosecutions with appropriate sentencing by the MHRA for medical crimes that are reported in newspapers may do more to dissuade cosmetic cowboys and educate patients to their danger, than any amount of regulation.
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