This Reed Smith client alert looks at the UK government’s response to the independent review of the regulation of cosmetic interventions in the UK.
The key issues In recent years, cosmetic procedures have become widely available on high streets across the UK. This fast paced growth has left the regulation of cosmetic procedures lagging behind. Cases such as silicone breast implants produced by the French company Poly Implant Prothese (PIP) which were made from unauthorised silicone filler and had double the rupture rate of other implants, have raised public concern. The industry in the UK is expected to reach an estimated value of £3.6 billion by 2015, and so the government has made it clear that more stringent regulation is required.
On 24 April 2013, an independent review of the regulation of cosmetic interventions, chaired by Sir Bruce Keogh, was published. The recent government response, dated 13 February 2014, formally sets out steps to be taken to address the current lack of effective regulation and legislation required to improve overall practice standards across the cosmetics industry. Some of these steps have already been put into practice. Changes include the introduction of a code of conduct, an ombudsman and accredited qualification of practitioners.
Changes proposed by the review Amongst its findings, the independent review proposed the following changes to improve the regulation of an industry which has the ability to change the way people look either temporarily or permanently:
Making all dermal fillers available by prescription only
Ensuring practitioners possess the required qualifications to conduct each procedure, from breast implants to offering botulinam toxin (Botox®)
The establishment of an ombudsman to assist patients who receive inadequate treatment
In summary, Sir Bruce Keogh stated that, when things go wrong, patients, “have been left high and dry,” under the current systems. Steps must be taken to ensure that this does not happen in the future.
The government response In essence, the UK government’s response sets out a number of proposals to ensure quality of care is improved, the public is adequately informed with regard to procedures and that necessary redress is available when complications arise post treatment. The response sets out its intentions under four headings:
Surgical Interventions. Firstly, the government unanimously recognised the need to develop training and practice standards for the industry. These are to be agreed by an established Cosmetic Surgery Inter-Specialty Committee in conjunction with the Royal College of Surgeons. A code of practice should mirror the requirements imposed on UK-based doctors. Gaining informed patient consent will be pinnacle to such a code.
Non-Surgical Interventions. All non-surgical practitioners must achieve the requisite accredited qualification to perform procedures, including Botox® and laser hair removal which, combined with dermal fillers, accounts for over 75% of the cosmetics industry. They must also be supervised by a qualified clinical professional. The government is considering legislating to address this issue. The training and skills needed to practice are due to be agreed by April 2014 in conjunction with Health Education England, including recommendations as to what will be the suitable body to accredit qualifications and hold a central register of practitioners.
Ensuring Safe Products. The government noted that a number of amendments may be introduced to EU legislation within the proceeding years, including amendments to the EU Medical Devises Directive and the EU General Product Safety Directive. This will bring certain implantable devices without a medical purpose into the scope of medical device governance legislation and it will increase regulation of products used in cosmetic interventions. The need for increased auditing and unannounced checks on cosmetic product manufacturers was recognised.
Responsible Information, Resolution & Redress. The need for socially responsible advertising of cosmetic products was noted and the General Medical Council (the regulatory body for medical practitioners in the UK) was nominated to develop a code to address, amongst other advertising techniques, the use of “before” and “after” photographs and sales promotions. The Advertising Standards Authority which regulates advertising in the UK has already taken a stance against irresponsible and inaccurate campaigns, banning Botox® advertisements by Dermaskin and HB Health as they failed to “stick to the facts”. In addition, continuity of care must be encouraged; practitioners must be accountable for their own practice and maintain adequate insurance which will cover the cost of treatment if complications arise. Perhaps most important of all is the government’s intention to further explore the establishment of a health service ombudsman to provide redress for patients who receive inadequate care.
Final thoughts The government’s overwhelming support for the independent review demonstrates the ever increasing pressure it is under to regulate an industry which can cause significant harm to the public should procedures go wrong. The review contains a warning to practitioners who are operating to poor standards of care, stating it will “legislate where necessary” and that “those who are not making the grade must raise their game or face the consequences”. However, the overall influence such changes will have is entirely dependent on the future enforcement of such regulations and sufficient publicity of the newly acquired rights for patients. This has not prevented criticism of the lack of direct action taken by the government’s response. Critics feel that the requirement for training fails to take into account other groups such as GPs and dentists who may be involved in cosmetic procedures. Instead, the response solely focuses on the role played by the Royal College of Surgeons. Furthermore, the response provides for no reclassification of procedures and treatments nor does it provide any incentive for practitioners to sign up to the proposed register. The success of the proposed regime is reliant on cosmetic practitioners conscious that their clients are aware of the required standards and have the rights to hold them to account.
A complete copy of the report produced by the independent review can be found here and a complete copy of the government response can be found here.