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Written Question
Non-surgical Cosmetic Procedures: Licensing
Friday 14th July 2023

Asked by: Carolyn Harris (Labour - Swansea East)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will hold discussions with relevant stakeholders in the beauty and aesthetics sector on developing a licensing scheme for non-surgical cosmetic procedures.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

The Government intends to publish a public consultation on proposals for the scope of the treatments to be included within the licensing scheme for non-surgical cosmetic procedures later this summer. The Department continues to meet regularly with stakeholders to discuss the scope and development of the licensing scheme. As part of this work, I held a roundtable discussion with a broad range of stakeholders on 14 June. The Department will also work with stakeholders to determine the education and training requirements that practitioners will have to meet, alongside hygiene, cleanliness and indemnity requirements, to demonstrate that they can practise safely.


Written Question
Non-surgical Cosmetic Procedures: Licensing
Friday 14th July 2023

Asked by: Carolyn Harris (Labour - Swansea East)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, when he plans to publish a consultation on a licensing scheme for non-surgical cosmetic procedures.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

The Government intends to publish a public consultation on proposals for the scope of the treatments to be included within the licensing scheme for non-surgical cosmetic procedures later this summer. The Department continues to meet regularly with stakeholders to discuss the scope and development of the licensing scheme. As part of this work, I held a roundtable discussion with a broad range of stakeholders on 14 June. The Department will also work with stakeholders to determine the education and training requirements that practitioners will have to meet, alongside hygiene, cleanliness and indemnity requirements, to demonstrate that they can practise safely.


Written Question
Non-surgical Cosmetic Procedures: Licensing
Friday 14th July 2023

Asked by: Carolyn Harris (Labour - Swansea East)

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 developing an aesthetics licensing scheme to provide (a) education, (b) training and (c) progression routes into the sector for (i) medical and (ii) non-medical practitioners.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

The Government intends to publish a public consultation on proposals for the scope of the treatments to be included within the licensing scheme for non-surgical cosmetic procedures later this summer. The Department continues to meet regularly with stakeholders to discuss the scope and development of the licensing scheme. As part of this work, I held a roundtable discussion with a broad range of stakeholders on 14 June. The Department will also work with stakeholders to determine the education and training requirements that practitioners will have to meet, alongside hygiene, cleanliness and indemnity requirements, to demonstrate that they can practise safely.


Written Question
Drugs: Licensing
Wednesday 21st June 2023

Asked by: Carolyn Harris (Labour - Swansea East)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what estimate he has made of the number of D150 applications for women's health products that have taken more than 150 days to be assessed by the Medicines and Healthcare products Regulatory Agency in the latest period for which data is available.

Answered by Will Quince

The Medicines and Healthcare products Regulatory Agency (MHRA) offers a 150-day assessment timeline for all high-quality marketing authorisation applications.

A total of 1,016 medicinal products have been waiting for MHRA marketing authorisation approval for more than 150 days. Of these, 36 are for women’s health.


Written Question
Drugs: Licensing
Wednesday 21st June 2023

Asked by: Carolyn Harris (Labour - Swansea East)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what estimate he has made of the number of D150 applications that have taken more than 150 days to be assessed by the Medicines and Healthcare products Regulatory Agency in the latest period for which data is available.

Answered by Will Quince

The Medicines and Healthcare products Regulatory Agency (MHRA) offers a 150-day assessment timeline for all high-quality marketing authorisation applications.

A total of 1,016 medicinal products have been waiting for MHRA marketing authorisation approval for more than 150 days. Of these, 36 are for women’s health.


Written Question
Drugs: Licensing
Wednesday 21st June 2023

Asked by: Carolyn Harris (Labour - Swansea East)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of the causes of the time taken by the Medicines and Healthcare products Regulatory Agency to process D150 applications.

Answered by Will Quince

Delays to the processing of marketing authorisation applications have resulted from a combination of factors, including implementation of new licensing pathways and the need to divert resource to deal with urgent and unforeseen public health issues like the COVID-19 pandemic. The Medicines and Healthcare products Regulatory Agency (MHRA) is changing its assessment processes to speed up the processing of submitted applications. Resource issues are being addressed as a matter of priority with targeted recruitment. The MHRA is also implementing a new IT system to manage licensing applications and improve processing times.


Written Question
Drugs: Licensing
Wednesday 21st June 2023

Asked by: Carolyn Harris (Labour - Swansea East)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of the adequacy of the criteria used by the Medicines and Healthcare products Regulatory Agency in granting licences for medicines.

Answered by Will Quince

The Medicines and Healthcare products Regulatory Agency (MHRA) together with the Commission on Human Medicines (CHM) and its expert advisory groups (EAGs) operates procedures to support the development, evaluation and granting of licences of medicinal products. In the United Kingdom, all medicinal products for human use are subject to a system of licensing laid down by the UK Human Medicines Regulations (HMRs). Medicines licensing procedures protect public health by ensuring that harmful products do not get licensed and that products are licensed with appropriate indications, dosage, precautions and warnings. For a marketing authorisation to be granted, medicinal products have to meet pre-defined and stringent criteria on efficacy, safety and quality. A marketing authorisation can only be granted when the benefit-risk in relation to quality, safety and efficacy is found to be positive.

The MHRA has a number of licensing pathways available, with the aim of ensuring the products can be made available for patients in the UK in the shortest time possible and to support and protect public health. Common for all these procedures, is the focus on the quality, safety and efficacy of the product. The review is conducted by a multidisciplinary team of assessors, to ensure a thorough and broad assessment of the product. Independent advice from the CHM and its EAGs is sought for any complex issues or those that may pose a risk to patients or public health by the identification of Major Objections. Pharmaceutical companies are required to provide a risk management plan outlining known safety concerns, pharmacovigilance activities and risk minimisation measures. In addition, for novel products, additional safety monitoring is put in place for the early stages of the lifecycle.


Written Question
Drugs: Licensing
Tuesday 20th June 2023

Asked by: Carolyn Harris (Labour - Swansea East)

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether the Medicines and Healthcare products Regulatory Agency prioritises certain health conditions in assessing the potential merits of granting licences for medicines.

Answered by Will Quince

The Medicines and Healthcare products Regulatory Agency (MHRA) does not have a specific list of conditions to which it gives priority when reviewing applications for new medicine licenses. However, it does prioritise applications where there is a public health need, for instance a new medicine which offers a treatment which is not yet available or a generic medicine where there might otherwise be a risk to supply. When deciding whether to prioritise a medicine, the MHRA collaborates with the Department and National Health Service to make sure its decisions align with their priorities.


Written Question
CPR and Defibrillators: Education
Wednesday 14th June 2023

Asked by: Carolyn Harris (Labour - Swansea East)

Question to the Department for Education:

To ask the Secretary of State for Education, what recent estimate she has made of the levels of Cardiopulmonary Resuscitation and Automated External Defibrillator training being taught in (a) privately funded schools and (b) higher and further education settings.

Answered by Nick Gibb

All state funded schools in England are required to teach first aid as part of statutory Health Education, which includes basic first aid. Pupils in secondary schools are taught further first aid, including how to administer CPR and the purpose of defibrillators. Schools may also incorporate further defibrillator awareness and training materials to support this as part of the wider curriculum.

In 2022, the Department announced it would provide automated external defibrillators (AEDs) to schools in England to plug local gaps and provide more schools and local communities access to first aid equipment. Since the start of the programme, over 9,300 devices have been delivered to state funded schools in England.

The Department has not made an assessment of the effectiveness of CPR and AED training in schools and is undertaking an evaluation of Relationships, Sex and Health Education (RSHE) generally. The Department has contracted IFF Research to undertake quantitative and qualitative research into the quality of the implementation of RSHE, including teacher confidence in teaching the statutory requirements. The Department anticipates that the final report from IFF Research will be published in early 2024. Details of the IFF Research contract are available at: https://www.contractsfinder.service.gov.uk/Notice/0cc4d6b1-d266-459e-aaee-f5e22e4ad4c6.

As part of the Ofsted assessment of a school’s support for pupils’ personal development, inspectors make a professional judgement on whether the school is providing appropriate and effective teaching in the range of curriculum subjects, including RSHE. Schools are accountable for what they teach and should ensure that all RSHE content is factual, age appropriate, and suitable for their pupils. As part of their personal development judgement, inspectors would consider whether schools are teaching content in line with the RSHE statutory guidance.

Independent or fee paying schools are regulated by the Independent School Standards. Schools not meeting the Standards face regulatory action up to and including de-registration, or effective closure. Independent schools are not required by the Standards to provide CPR and AED training, so no such assessment has been made of the degree to which they do so. Independent schools are required to teach Health Education as part of Personal, Social, Health and Economic education and it is good practice to follow the statutory Health Education curriculum.

Further education colleges and Higher Education Institutions are autonomous organisations and as such are responsible for matters of health and safety training in their organisations.


Written Question
CPR and Defibrillators: Education
Wednesday 14th June 2023

Asked by: Carolyn Harris (Labour - Swansea East)

Question to the Department for Education:

To ask the Secretary of State for Education, what estimate she has made of the implementation and effectiveness of Cardiopulmonary Resuscitation and Automated External Defibrillator training in state-funded schools since its inclusion in the national curriculum in 2020.

Answered by Nick Gibb

All state funded schools in England are required to teach first aid as part of statutory Health Education, which includes basic first aid. Pupils in secondary schools are taught further first aid, including how to administer CPR and the purpose of defibrillators. Schools may also incorporate further defibrillator awareness and training materials to support this as part of the wider curriculum.

In 2022, the Department announced it would provide automated external defibrillators (AEDs) to schools in England to plug local gaps and provide more schools and local communities access to first aid equipment. Since the start of the programme, over 9,300 devices have been delivered to state funded schools in England.

The Department has not made an assessment of the effectiveness of CPR and AED training in schools and is undertaking an evaluation of Relationships, Sex and Health Education (RSHE) generally. The Department has contracted IFF Research to undertake quantitative and qualitative research into the quality of the implementation of RSHE, including teacher confidence in teaching the statutory requirements. The Department anticipates that the final report from IFF Research will be published in early 2024. Details of the IFF Research contract are available at: https://www.contractsfinder.service.gov.uk/Notice/0cc4d6b1-d266-459e-aaee-f5e22e4ad4c6.

As part of the Ofsted assessment of a school’s support for pupils’ personal development, inspectors make a professional judgement on whether the school is providing appropriate and effective teaching in the range of curriculum subjects, including RSHE. Schools are accountable for what they teach and should ensure that all RSHE content is factual, age appropriate, and suitable for their pupils. As part of their personal development judgement, inspectors would consider whether schools are teaching content in line with the RSHE statutory guidance.

Independent or fee paying schools are regulated by the Independent School Standards. Schools not meeting the Standards face regulatory action up to and including de-registration, or effective closure. Independent schools are not required by the Standards to provide CPR and AED training, so no such assessment has been made of the degree to which they do so. Independent schools are required to teach Health Education as part of Personal, Social, Health and Economic education and it is good practice to follow the statutory Health Education curriculum.

Further education colleges and Higher Education Institutions are autonomous organisations and as such are responsible for matters of health and safety training in their organisations.