Asked by: Lord Beamish (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 15 April 2019 to Question 242742 on Plastic Surgery: Insurance, what steps he is taking to ensure that (a) redress and (b) safeguarding systems are accessible by members of the public who experience unacceptable treatment standards from non-regulated healthcare professionals providing aesthetic procedures.
Answered by Jackie Doyle-Price
The Government is committed to improving the safety of cosmetic procedures through better training for practitioners, and clear information so that people can make informed decisions about their care.
The Department is working with stakeholders, including professional associations, to review industry standards of practise as part of the manifesto commitment to ensure there is “effective registration and regulation of those performing cosmetic interventions”.
We urge anyone seeking a cosmetic procedure to take the time to find a reputable, safe, and competent practitioner who is subject to statutory regulation, or on an accredited voluntary register overseen by the Professional Standards Authority. Using a registered practitioner provides assurance that they are appropriately qualified, registered and insured.
Asked by: Lord Beamish (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will reclassify dermal fillers as prescription-only medicines.
Answered by Jackie Doyle-Price
Currently, the Medicines and Healthcare products Regulatory Agency only regulates dermal fillers that are placed on the United Kingdom market as medical devices, as defined in the Medical Devices Regulations 2002. The majority of these products are intended to be used in reconstructive surgery, and thus they are considered to be medical devices, although some manufacturers also indicate their products for aesthetic use as well.
Cosmetic dermal fillers placed on the market without any medical purpose being attributed to them by the manufacturer fall outside the scope of the Medical Devices Regulations, although in practice the majority of the products on the UK market are CE marked as medical devices.
From May 2020 all dermal fillers, irrespective of their composition and intended use, will be regulated as medical devices under Annex XVI of the Medical Device Regulations (EU 2017/745). The Regulations will significantly strengthen the quality assurance and safety of dermal fillers and ensure a consistent legal status of these products on the UK market. This will lead to a stronger market surveillance of these products.
Medical devices cannot be designated as ‘prescription only’, as this term only applies to medicinal products. The Government currently has no plans to introduce such a category for medical devices.
The Government is committed to the safe and effective regulation of medical devices in the UK; we continue to strengthen safety while ensuring patients and the public have fast access to new, innovative devices.
Through the ‘no deal’ statutory instrument, which will amend the Medical Devices Regulations 2002, the UK will have a regulatory system in place, which will mirror all the key elements contained in Medical Device Regulations (EU 2017/745) and which will be brought into force in line with the transitional timetable being followed by the European Union for the full application of this Regulation.
Asked by: Lord Beamish (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether he has plans to introduce regulations on dermal fillers.
Answered by Jackie Doyle-Price
The Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the United Kingdom.
Currently, a dermal filler may be regulated either as a general product, a medicine or a medical device, depending on its composition and intended use. From May 2020 all dermal fillers, irrespective of their composition and intended use, will be regulated as medical devices under Annex XVI of the Medical Device Regulations (EU 2017/745). The Regulations will significantly strengthen the quality assurance and safety of dermal fillers and ensure a consistent legal status of these products on the UK market. This will lead to a stronger market surveillance of these products.
The Government is committed to improving the safety of cosmetic procedures through better training for practitioners, and clear information so that people can make informed decisions about their care. The growth in non-surgical treatments increases the need for consumer protection and we are currently working with stakeholders to strengthen the regulation of cosmetic procedures.
We urge anyone seeking a cosmetic procedure to take the time to find a reputable, insured and appropriately qualified practitioner who is either subject to statutory regulation or on a voluntary register accredited by the Professional Standards Authority.
Asked by: Alex Sobel (Labour (Co-op) - Leeds Central and Headingley)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether he plans to bring forward regulations on who is permitted to administer (a) botox injections and (b) dermal fillers.
Answered by Jackie Doyle-Price
The Government is committed to improving the safety of cosmetic procedures through better training for practitioners, and clear information so that people can make informed decisions about their care. The growth in non-surgical treatments increases the need for consumer protection and we are currently working with stakeholders to strengthen the regulation of cosmetic procedures.
The Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the United Kingdom.
Botulinum injections (commonly known under the brand name ‘Botox’) are prescription-only medicines. A prescriber may delegate responsibility for the administration of the medicine, but they retain responsibility for ensuring that the secondary practitioner provides the treatment safely.
Currently, a dermal filler may be regulated either as a general product, a medicine or a medical device, depending on its composition and intended use. From May 2020 all dermal fillers, irrespective of their composition and intended use, will be regulated as medical devices under Annex XVI of the Medical Device Regulations (EU 2017/745). Whilst it is outside of the remit of the Regulations to make provisions for who can administer or use medical devices on another person, the Regulations will significantly strengthen the quality assurance and safety of dermal fillers.
We urge anyone seeking a cosmetic procedure to take the time to find a reputable, insured and appropriately qualified practitioner who is either subject to statutory regulation or on a voluntary register accredited by the Professional Standards Authority.
Asked by: Matthew Offord (Conservative - Hendon)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will make an assessment of the potential merits of introducing a requirement for practitioners of cosmetic interventions to receive proper training and an assessment before undertaking procedures.
Answered by Jackie Doyle-Price
The Government is committed to improving the safety of cosmetic procedures through better training for practitioners, and better information so that people can make informed decisions about their care.
Cosmetic surgery, where the surgical procedure involves the use of instruments or equipment which are inserted into the body, is a regulated activity and can only be performed by surgeons who are registered with the General Medical Council. Providers are required to register with the Care Quality Commission and meet the fundamental standards of safety and quality.
The Joint Council of Cosmetic Practitioners was established in 2018 to accredit and assess practitioners and education and training providers within the non-surgical sector with the overarching aim of ensuring patient safety.
We urge anyone seeking a cosmetic procedure to take the time to find a reputable, safe, and qualified practitioner who is subject to statutory regulation, or on a voluntary register accredited by the Professional Standards Authority.
Asked by: Jim Shannon (Democratic Unionist Party - Strangford)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what safeguards are in place to ensure that robotic surgery for operations is adequately monitored.
Answered by Caroline Dinenage
Safeguards apply to all forms of surgery: it is the responsibility of the professionals involved to ensure that they operate to the right level of competence and of the organisations they work for to ensure that they have in place effective forms of supervision, learning and support.
All robotic surgical systems are classed as medical devices and fall under the regulation of the Medical Device Directive.
In addition, although the Care Quality Commission does not ordinarily enquire about different types of surgical technique during its inspections, it does look at arrangements, systems and processes and governance that a provider has in place to ensure care and treatment is safe, effective, responsive, caring and well-led.
Asked by: Ranil Jayawardena (Conservative - North East Hampshire)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure that there are means of recourse against private sector providers for patients experiencing long-term side effects as a result of laser eye surgery performed by private providers.
Answered by Caroline Dinenage
Public and private sector providers of laser eye surgery are required by law to register with the Care Quality Commission (CQC) for regulation and doctors in the United Kingdom are required to register with the General Medical Council (GMC). The CQC and the GMC have a range of powers for addressing failures in care.
Providers are also expected to follow the National Institute for Health and Care Excellence (NICE) guidelines on photorefractive (laser) surgery. The CQC, NICE and the Royal College of Ophthalmologists are all clear that the risks and complications of such procedures should be discussed with patients beforehand.
No estimate has been made of the number of people experiencing long-term side effects as a result of laser eye surgery because this data is not held centrally.
Asked by: Ranil Jayawardena (Conservative - North East Hampshire)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure that providers of laser eye surgery clearly outline the risks of that procedure to patients prior to such surgery taking place.
Answered by Caroline Dinenage
Public and private sector providers of laser eye surgery are required by law to register with the Care Quality Commission (CQC) for regulation and doctors in the United Kingdom are required to register with the General Medical Council (GMC). The CQC and the GMC have a range of powers for addressing failures in care.
Providers are also expected to follow the National Institute for Health and Care Excellence (NICE) guidelines on photorefractive (laser) surgery. The CQC, NICE and the Royal College of Ophthalmologists are all clear that the risks and complications of such procedures should be discussed with patients beforehand.
No estimate has been made of the number of people experiencing long-term side effects as a result of laser eye surgery because this data is not held centrally.
Asked by: Ranil Jayawardena (Conservative - North East Hampshire)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what estimate his Department has made of the number of people experiencing long-term side effects as a result of laser eye surgery.
Answered by Caroline Dinenage
Public and private sector providers of laser eye surgery are required by law to register with the Care Quality Commission (CQC) for regulation and doctors in the United Kingdom are required to register with the General Medical Council (GMC). The CQC and the GMC have a range of powers for addressing failures in care.
Providers are also expected to follow the National Institute for Health and Care Excellence (NICE) guidelines on photorefractive (laser) surgery. The CQC, NICE and the Royal College of Ophthalmologists are all clear that the risks and complications of such procedures should be discussed with patients beforehand.
No estimate has been made of the number of people experiencing long-term side effects as a result of laser eye surgery because this data is not held centrally.
Asked by: Bambos Charalambous (Labour - Southgate and Wood Green)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what steps his Department is taking to ensure that all surgeons offering cosmetic procedures in the private sector are certified by the Royal College of Surgeons.
Answered by Philip Dunne
The Government is committed to the effective regulation of those performing cosmetic procedures. Following Sir Bruce Keogh’s review of the regulation of cosmetic interventions, the Royal College of Surgeons has published a set of professional standards for cosmetic surgery and has launched a new certification scheme. This allows patients to search for a surgeon, including those in the private sector, who has appropriate training, qualifications and experience to perform the procedure they are considering.