Asked by: Bob Blackman (Conservative - Harrow East)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what guidance exists for Integrated Care Boards on supporting individuals with complex, medicine-induced disabilities arising from sodium valproate.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Independent Medicines and Medical Devices Safety Review, First Do No Harm, identified significant shortcomings in National Health Service care pathways for people harmed by sodium valproate, including fragmented services, limited diagnostic expertise, delays in diagnosis, and inequitable access to multidisciplinary care. NHS England has acknowledged variation in the availability and adequacy of care pathways, the impact of delayed diagnosis and misdiagnosis on long-term outcomes, and the need for improved care coordination for those requiring lifelong support.
In response, NHS England has commissioned a Fetal Exposure to Medicines Services Pilot, being delivered by the Newcastle upon Tyne Hospitals NHS Foundation Trust and the Manchester University NHS Foundation Trust. The pilot provides multidisciplinary diagnostic assessment and is informing the development of improved care pathways, including consideration of specialist multidisciplinary services to support earlier diagnosis, better coordination of care, and reduced reliance on emergency care. Initial learning was shared with NHS England in September 2025, with final recommendations expected this summer to inform decisions on any national commissioning, subject to funding.
Finally, whilst integrated care boards (ICBs) are the responsible commissioners of the majority of health services, including services related to medically induced disabilities, no specific guidance has been issued to ICBs in relation to supporting individuals with complex, medicine-induced disabilities arising from sodium valproate.
Asked by: Al Pinkerton (Liberal Democrat - Surrey Heath)
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 raise awareness of the health risks associated with (a) unlicensed or (b) illicit medicines among patients in (i) Surrey and (ii) Surrey Heath constituency.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA), acting on behalf of my Rt Hon. Friend, the Secretary of State for Health and Social Care, is responsible for the regulation of medicines intended for human use in the United Kingdom. This includes applying the legal controls on the retail sale, supply, and advertising of medicines, which are set out in the Human Medicines Regulations 2012.
Sourcing weight loss medicines from unregulated suppliers significantly increases the risk of receiving a product which is either falsified or not authorised for human use. Products purchased in this way will not meet the MHRA’s strict standards for quality, safety, and efficacy and can therefore expose patients to incorrect dosages or dangerous ingredients.
Public safety is the number one priority for the MHRA, and its Criminal Enforcement Unit works hard to prevent, detect, and investigate illegal activity involving medicines and medical devices and takes robust enforcement action where necessary. It works closely with other health regulators, customs authorities, law enforcement agencies, and private sector partners, including e-commerce and the internet industry to identify, remove and block online content promoting the illegal sale of medicines and medical devices.
The MHRA seeks to identify and, where appropriate, prosecute online sellers responsible for putting public health at risk. Between 1 April 2024 and 31 March 2025, the MHRA and its partners seized approximately 17 million doses of illegally traded medicines with a street value of more than £37 million.
During the same period, it disrupted approximately 190,000 website and social media links responsible for advertising medicinal products illegally. Additionally, collaboration with one well-known online marketplace led to the successful identification and blocking of more than 1.5 million unregulated prescription medicines, over-the-counter medicines, and medical devices before they could be offered for sale to the public.
The MHRA is continually developing new and innovative ways to combat the illegal trade in medicines and to raise public awareness. These measures include:
publication of a #Fakemeds campaign which explains how to access medicines through safe and legitimate online sources, with further information available at the following link:
https://fakemeds.campaign.gov.uk/;
public guidance on how to safely access and use GLP-1 medications, available at the following link:
https://www.gov.uk/government/publications/glp-1-medicines-for-weight-loss-and-diabetes-what-you-need-to-know/glp-1-medicines-for-weight-loss-and-diabetes-what-you-need-to-know;
development of an online service which allows the public to check if a website has been deemed ‘Not Recommended’ by the MHRA;
development of a web-based reporting scheme allowing the public to report suspicious online sellers to the MHRA; and
extensive work with media outlets to raise awareness of the dangers of illegal medicines.
The MHRA’s continued efforts have led to more medicines being seized than ever before, significant custodial sentences for offenders, the forfeiture of criminal profits and considerable success in disrupting the illegal supply of medicines.
Asked by: Al Pinkerton (Liberal Democrat - Surrey Heath)
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 tackle the sale and distribution of illicit or unlicensed medicines in (a) Surrey and (b) Surrey Heath constituency.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA), acting on behalf of my Rt Hon. Friend, the Secretary of State for Health and Social Care, is responsible for the regulation of medicines intended for human use in the United Kingdom. This includes applying the legal controls on the retail sale, supply, and advertising of medicines, which are set out in the Human Medicines Regulations 2012.
Sourcing weight loss medicines from unregulated suppliers significantly increases the risk of receiving a product which is either falsified or not authorised for human use. Products purchased in this way will not meet the MHRA’s strict standards for quality, safety, and efficacy and can therefore expose patients to incorrect dosages or dangerous ingredients.
Public safety is the number one priority for the MHRA, and its Criminal Enforcement Unit works hard to prevent, detect, and investigate illegal activity involving medicines and medical devices and takes robust enforcement action where necessary. It works closely with other health regulators, customs authorities, law enforcement agencies, and private sector partners, including e-commerce and the internet industry to identify, remove and block online content promoting the illegal sale of medicines and medical devices.
The MHRA seeks to identify and, where appropriate, prosecute online sellers responsible for putting public health at risk. Between 1 April 2024 and 31 March 2025, the MHRA and its partners seized approximately 17 million doses of illegally traded medicines with a street value of more than £37 million.
During the same period, it disrupted approximately 190,000 website and social media links responsible for advertising medicinal products illegally. Additionally, collaboration with one well-known online marketplace led to the successful identification and blocking of more than 1.5 million unregulated prescription medicines, over-the-counter medicines, and medical devices before they could be offered for sale to the public.
The MHRA is continually developing new and innovative ways to combat the illegal trade in medicines and to raise public awareness. These measures include:
publication of a #Fakemeds campaign which explains how to access medicines through safe and legitimate online sources, with further information available at the following link:
https://fakemeds.campaign.gov.uk/;
public guidance on how to safely access and use GLP-1 medications, available at the following link:
https://www.gov.uk/government/publications/glp-1-medicines-for-weight-loss-and-diabetes-what-you-need-to-know/glp-1-medicines-for-weight-loss-and-diabetes-what-you-need-to-know;
development of an online service which allows the public to check if a website has been deemed ‘Not Recommended’ by the MHRA;
development of a web-based reporting scheme allowing the public to report suspicious online sellers to the MHRA; and
extensive work with media outlets to raise awareness of the dangers of illegal medicines.
The MHRA’s continued efforts have led to more medicines being seized than ever before, significant custodial sentences for offenders, the forfeiture of criminal profits and considerable success in disrupting the illegal supply of medicines.
Asked by: Olivia Blake (Labour - Sheffield Hallam)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether the Cancer Plan will specifically address the availability of products containing Melanotan II.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government is taking steps to prevent, diagnose, and treat cancers more quickly, including skin cancers. The forthcoming National Cancer Plan will cover the entirety of the cancer pathway from referral and diagnosis to treatment and ongoing care. It will set out how we will improve outcomes for cancer patients, including by speeding up diagnosis and treatment, ensuring patients have access to the latest treatments and technology, and ultimately driving up this country’s cancer survival rates. We will publish the National Cancer Plan in the new year to reduce the number of lives lost to cancer over the next 10 years.
We received over 11,000 responses to our call for evidence from individuals, professionals, and organisations, and we are reviewing the submissions from skin cancer partners. While no formal assessment has been made of the availability and levels of the use of tan-enhancing products containing Melanotan II, respondents shared concerns about tanning products and their potential links to cancer, particularly melanoma. Our expansive engagement will allow the National Cancer Plan to have patients at its heart.
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the regulation of medicinal products and medical devices in the United Kingdom.
Although tanning is not considered to be a medical purpose, injectable products containing Melanotan I or Melanotan II have been determined as medicinal products due to their similarity to the authorised medicine Scenesse.
In relation to nasal sprays containing Melanotan I or Melanotan II, there are no equivalent authorised medicines, and in the absence of medicinal claims, they are not regarded as medicinal products.
Medicinal products must hold a relevant Marketing Authorisation to be legally sold and supplied in the United Kingdom. This also guarantees that the medicines have been tested for conformity with strict standards of quality, safety, and efficacy. The MHRA takes action when a medicinal product without appropriate authorisations is identified.
Asked by: Al Pinkerton (Liberal Democrat - Surrey Heath)
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 review how information on potentially hazardous medicinal products is shared across the NHS.
Answered by Karin Smyth - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring the safety of medicines and medical devices, and it continually reviews product safety.
When a safety issue is identified, the MHRA communicates with healthcare professionals and stakeholders through various channels, such as the GOV.UK website, direct emails, and safety alerts, and may use different methods depending on the urgency and impact of the issue.
The MHRA’s three-year Strategy for Improving Communications aims to deliver more coordinated, targeted, and effective safety communications to healthcare professionals and patients using the best available channels.
NHS England has stipulated that all large providers of National Health Services must designate a Medication Safety Officer. They are mandated to implement medication safety within their organisations and are updated regularly on current issues and learning.
NHS England is also reducing risk to staff by increasing the availability of ready to administer products through its Transforming Aseptic Services Programme, with further information available at the following link:
The Care Quality Commission’s (CQC) Medicines Optimisation Quality Statement, a copy of which is attached, is focused on ensuring that patients are able to access their medicines safely. The CQC would therefore expect providers to be following their organisations processes and national guidance, where relevant, to ensure that this happens. Organisations providing care need to ensure that staff have the relevant information available to them to keep patients safe through appropriate medicines use, as well as supporting them to undertake their roles safely.
Asked by: Sharon Hodgson (Labour - Washington and Gateshead South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether the (a) availability and (b) levels of use of tan-enhancing products containing Melanotan II is being considered in the development of the forthcoming cancer plan.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government is taking steps to prevent, diagnose, and treat cancers more quickly, including skin cancers. The forthcoming National Cancer Plan will cover the entirety of the cancer pathway from referral and diagnosis to treatment and ongoing care. It will set out how we will improve outcomes for cancer patients, including by speeding up diagnosis and treatment, ensuring patients have access to the latest treatments and technology, and ultimately driving up this country’s cancer survival rates. We will publish the National Cancer Plan in the new year to reduce the number of lives lost to cancer over the next 10 years.
We received over 11,000 responses to our call for evidence from individuals, professionals, and organisations, and we are reviewing the submissions from skin cancer partners. While no formal assessment has been made of the availability and levels of use of tan-enhancing products containing Melanotan II, respondents shared concerns about tanning products and their potential links to cancer, particularly melanoma. Our expansive engagement will allow the National Cancer Plan to have patients at its heart.
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the regulation of medicinal products and medical devices in the United Kingdom. Although tanning is not considered to be a medical purpose, injectable products containing Melanotan I or Melanotan II have been determined as medicinal products due to their similarity to the authorised medicine Scenesse.
In relation to nasal sprays containing Melanotan I or Melanotan II, there are no equivalent authorised medicines and in the absence of medicinal claims, they are not regarded as medicinal products.
Medicinal products must hold a relevant Marketing Authorisation to be legally sold and supplied in the UK. This also guarantees that the medicines have been tested for conformity with strict standards of quality, safety, and efficacy.
The MHRA takes action when a medicinal product without appropriate authorisations is identified.
Asked by: Helen Morgan (Liberal Democrat - North Shropshire)
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 leverage emerging technologies to combat falsified medicines and improve patient safety.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
No assessment of the impact of the disapplication of the EU Falsified Medicines Directive (EU FMD) on the United Kingdom’s medicine supply chain has been made by the Department. However, the Medicines and Healthcare products Regulatory Agency (MHRA) is not aware of any falsified medicines reaching patients through the legal supply chain in at least the last five years.
The MHRA leads work to combat falsified medicines and protect patient safety, including through the application of the Human Medicines Regulations 2012 to online and retail sales. The MHRA uses several different approaches to support its work to combat falsified medicines entering the UK supply chain, including by leveraging emerging technology, for instance:
Any additional initiatives to use emerging technologies, such as smartphone verification scanning, would require careful consideration of the evidence of the reduction of the risk to patients, as well as investment needed for infrastructure, and further regulatory changes for manufacturers and wholesalers. There are provisions in the Medicines and Medical Devices Act 2021 providing powers to enable the introduction of a similar system to the EU FMD with ‘safety features’ and verification in the UK. However, the powers allow us to go beyond the EU FMD and use derived data from any system for other health related purposes. For example, to support the recall of medicines, to support patient care, research, policy development, medicine supply, preventing diversion, supporting patient access to medicines, and countering fraud in primary care. However, regulations would be needed to set out the detail of any scheme, which would require consultation. Consideration is being given as to whether to consult on options for a potential UK system.
Asked by: Helen Morgan (Liberal Democrat - North Shropshire)
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 impact of the disapplication of the EU Falsified Medicines Directive on the UK’s medicine supply chain.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
No assessment of the impact of the disapplication of the EU Falsified Medicines Directive (EU FMD) on the United Kingdom’s medicine supply chain has been made by the Department. However, the Medicines and Healthcare products Regulatory Agency (MHRA) is not aware of any falsified medicines reaching patients through the legal supply chain in at least the last five years.
The MHRA leads work to combat falsified medicines and protect patient safety, including through the application of the Human Medicines Regulations 2012 to online and retail sales. The MHRA uses several different approaches to support its work to combat falsified medicines entering the UK supply chain, including by leveraging emerging technology, for instance:
Any additional initiatives to use emerging technologies, such as smartphone verification scanning, would require careful consideration of the evidence of the reduction of the risk to patients, as well as investment needed for infrastructure, and further regulatory changes for manufacturers and wholesalers. There are provisions in the Medicines and Medical Devices Act 2021 providing powers to enable the introduction of a similar system to the EU FMD with ‘safety features’ and verification in the UK. However, the powers allow us to go beyond the EU FMD and use derived data from any system for other health related purposes. For example, to support the recall of medicines, to support patient care, research, policy development, medicine supply, preventing diversion, supporting patient access to medicines, and countering fraud in primary care. However, regulations would be needed to set out the detail of any scheme, which would require consultation. Consideration is being given as to whether to consult on options for a potential UK system.
Asked by: Helen Morgan (Liberal Democrat - North Shropshire)
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 efficacy of smartphone-enabled barcode scanning in the verification of medicines.
Answered by Zubir Ahmed - Parliamentary Under-Secretary (Department of Health and Social Care)
No assessment of the impact of the disapplication of the EU Falsified Medicines Directive (EU FMD) on the United Kingdom’s medicine supply chain has been made by the Department. However, the Medicines and Healthcare products Regulatory Agency (MHRA) is not aware of any falsified medicines reaching patients through the legal supply chain in at least the last five years.
The MHRA leads work to combat falsified medicines and protect patient safety, including through the application of the Human Medicines Regulations 2012 to online and retail sales. The MHRA uses several different approaches to support its work to combat falsified medicines entering the UK supply chain, including by leveraging emerging technology, for instance:
Any additional initiatives to use emerging technologies, such as smartphone verification scanning, would require careful consideration of the evidence of the reduction of the risk to patients, as well as investment needed for infrastructure, and further regulatory changes for manufacturers and wholesalers. There are provisions in the Medicines and Medical Devices Act 2021 providing powers to enable the introduction of a similar system to the EU FMD with ‘safety features’ and verification in the UK. However, the powers allow us to go beyond the EU FMD and use derived data from any system for other health related purposes. For example, to support the recall of medicines, to support patient care, research, policy development, medicine supply, preventing diversion, supporting patient access to medicines, and countering fraud in primary care. However, regulations would be needed to set out the detail of any scheme, which would require consultation. Consideration is being given as to whether to consult on options for a potential UK system.
Asked by: Baroness Morris of Yardley (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what plans they are developing to create a barcoded stock management system for medicines, akin to the EU's falsified medicines directive.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The European Union’s Falsified Medicines Directive’s (FMD) primary purpose was to help prevent falsified medicines from entering the legal supply chain through the introduction of safety features on the packaging and verification at certain points of the supply chain to confirm authenticity. The monitoring and management of shortages was not part of its original legal framework.
There are provisions in the Medicines and Medical Devices Act 2021 providing powers to enable the introduction of a similar system to the EU’s FMD’s ‘safety features’ and verification in the United Kingdom. However, the powers allow us to go beyond the FMD and use derived data from any system for other health related purposes. For example, to support the recall of medicines, to support patient care, research, policy development, and medicine supply, to prevent diversion and support patient access to medicines, and to counter fraud in primary care. Regulations would be needed to set out the details of any scheme, which would require consultation. Consideration is being given as to whether to consult on options for a potential UK system. Any consultation would be published in the usual way on the GOV.UK website.