Asked by: Baroness Hayter of Kentish Town (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what discussions they have had with the General Medical Council (GMC) about whether doctors are included on GMC registers by gender or biological sex.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The General Medical Council (GMC) is the regulator of all medical doctors, physician assistants and physician assistants in anaesthesia, still legally known as anaesthesia associates and physician associates, practising in the United Kingdom. The GMC is independent of Government, directly accountable to Parliament and is responsible for operational matters concerning the discharge of its statutory duties.
The GMC maintains the official register of registered medical practitioners. Under the Form and Content of the Register Regulations, the GMC records a doctor's gender rather than sex.
The Government has had some discussions with the GMC about this topic. In light of the Supreme Court ruling in the case of For Women Scotland v. The Scottish Ministers regarding the meaning of “sex” in the Equality Act 2010, the GMC is in the process of reviewing its policy position regarding the recording of a doctor’s gender or biological sex on its registers.
Asked by: Baroness Hayter of Kentish Town (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what discussions they have had with the General Medical Council about whether patients who ask for a doctor of a preferred sex will be told the biological sex or declared gender of that medical professional.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The General Medical Council (GMC) is the regulator of all medical doctors, physician assistants and physician assistants in anaesthesia, still legally known as anaesthesia associates and physician associates, practising in the United Kingdom. The GMC is independent of Government, directly accountable to Parliament and is responsible for operational matters concerning the discharge of its statutory duties.
The Government has had discussions with the GMC on this issue. The GMC’s Good Medical Practice states that professionals must act with honesty and integrity and ensure their conduct justifies patient’s trust in them and the public’s trust in the profession. They must also recognise a patient’s right to choose whether to accept their advice. It is up to individual healthcare providers, rather than the GMC, to consider patient requests for care based on sex.
Asked by: Baroness Hayter of Kentish Town (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the public health risks posed by illegal online sales of optical appliances, particularly for children and other vulnerable groups.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the regulation of medicines for human use, medical devices, and blood products for transfusion 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 medicines from unregulated suppliers significantly increases the risk of getting a product which is either falsified or not authorised for use. Products purchased in this way will not meet the MHRA’s strict quality and safety standards and could 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. Last year, the MHRA and its partners seized more than 17 million doses of illegally traded medicines, including those usually issued on prescription. Additionally, the MHRA has also disrupted thousands of links to websites and social media pages selling medical products to the public illegally.
The MHRA’s FakeMeds campaign provides advice to people in the UK who are considering buying medication online, outlining how products can be accessed from safe and legitimate source.
Anyone who believes they’ve had a side effect from a medicine, or who believes they’ve received falsified stock, can report it to the MHRA’s Yellow Card scheme.
Asked by: Baroness Hayter of Kentish Town (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what steps they are taking to ensure a level playing field for UK-based optometry practices and regulated optical business that provide compliant contact lens sales, in the light of unregulated overseas websites selling lenses in the UK.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) ensures that medical devices placed on the market and put into service in the United Kingdom meet these regulatory requirements by:
- assessing all allegations of non-compliance brought to us, using a risk-based system;
- monitoring the activity of the UK approved bodies we designated to assess the compliance of manufacturers; and
- investigating medical devices as a result of adverse incident reports or intelligence indicating a potential problem.
If the MHRA considers a product to be breaching the medical devices regulations, typically, the MHRA’s Devices Compliance Unit will contact the manufacturer or, if the manufacturer is based outside of the UK, The UK Responsible Person, outlining our concerns and requesting further information with a view to bringing them into compliance.
If a manufacturer fails to co-operate with our requests and continues to place a non-compliant product on the market, or there is a serious risk to public health, the MHRA may consider using our enforcement powers. Guidance on how we enforce medical device regulations can be accessed on the GOV.UK website, in an online only format.
In addition to our investigatory and enforcement activities, the MHRA maintains ongoing relationships with external stakeholders, including other Government enforcement agencies and major online selling platforms to address non-compliant listings of medical devices available on the UK market, including those listed on overseas websites. This collaboration typically involves reporting mechanisms and proactive engagement with external online platforms to identify, address, and prevent non-compliant listings.
Asked by: Baroness Hayter of Kentish Town (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what plans they have to (1) extend regulatory powers, (2) improve reporting mechanisms, and (3) work with (a) online platforms, (b) manufacturers, (c) professional bodies, and (d) enforcement agencies, to address the illegal online sale of optical appliances.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that medicines, medical devices, and blood components for transfusions on the market in the United Kingdom are safe, effective, and manufactured to the highest standards of quality. The Medical Devices Regulations 2002 (MDR 2002) establish the statutory framework that medical devices must meet in order to comply with these standards.
Optical appliances as medical devices must comply with the MDR 2002, which include bearing the UKCA or CE marking on the packaging or labelling of the device. Manufacturers or their UK representatives must also monitor the use of these devices when used in the UK and report serious incidents to the MHRA. Allegations of deficiencies and incidents that do not meet these standards must be reported to the MHRA through the Yellow card scheme or informed though published guidance around enforcement and compliance.
Asked by: Baroness Hayter of Kentish Town (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what steps they are taking to strengthen enforcement against the illegal online sale of optical appliances, including by overseas suppliers operating in the UK market.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that medicines, medical devices, and blood components for transfusions on the market in the United Kingdom are safe, effective, and manufactured to the highest standards of quality. The Medical Devices Regulations 2002 establish the statutory framework that medical devices must meet in order to comply with these standards.
Optical appliances as medical devices must comply with requirements set out in the regulatuons, which include bearing the UKCA or CE marking on the packaging or labelling of the device. Manufacturers based outside of the United Kingdom must have a UK responsible person, and all devices must be registered with the MHRA prior to being placed on the market. Manufacturers or their UK representatives must also monitor use of these devices when used in the UK and report serious incidents to the MHRA.
The MHRA ensure that medical devices placed on the market and put into service in the UK meet these regulatory requirements by: assessing all allegations of non-compliance brought to us, using a risk-based system; monitoring the activity of UK approved bodies we designate to assess the compliance of manufacturers; and investigating medical devices as a result of adverse incident reports or intelligence indicating a potential problem.
If the MHRA considers that a product is breaching the medical devices regulations, typically, the MHRA Devices Compliance Unit will contact the manufacturer or, if the manufacturer is based outside of the UK, the UK Responsible Person, outlining the agency’s concerns and requesting further information with a view to bringing them into compliance.
If a manufacturer fails to co-operate with our requests and continues to place a non-compliant product on the market, or there is a serious risk to public health, the MHRA may consider using our enforcement powers. Guidance on how we enforce medical device regulations is available at the following link:
In addition to our investigatory and enforcement activities, the MHRA maintain ongoing relationships with external stakeholders including major online selling platforms to address non-compliant listings of medical devices available on the UK market, including those listed on overseas websites. This collaboration typically involves reporting mechanisms and proactive engagement with external online platforms to identify, address and prevent non-compliant listings.
Asked by: Baroness Hayter of Kentish Town (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government whether they plan to update medical device regulations to bring UK-based online contact lens retailers under a clear regulatory framework; and whether they plan to introduce measures including (1) a recognised compliance mark, (2) stronger border controls, and (3) oversight to ensure customers identify lawful suppliers and reduce the risk of eye infections.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that medicines, medical devices, and blood components for transfusions on the market in the United Kingdom are safe, effective, and manufactured to the highest standards of quality. The Medical Devices Regulations 2002 (MDR 2002) establish the statutory framework that medical devices must meet in order to comply with these standards.
Opthalmic medical devices must comply with the MDR 2002, which include bearing the UKCA or CE marking on the packaging or labelling of the device. Manufacturers or their UK representatives must also monitor use of these devices when used in the UK. Allegations of deficiencies that do not meet these standards must be reported to the MHRA through the Yellow card scheme or informed though published guidance, with further information available on the GOV.UK website.
The MHRA is not responsible for the movement of medical devices across borders.
Asked by: Baroness Hayter of Kentish Town (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of extending fracture liaison services to all integrated care boards; and what lessons they have drawn from the impact of fracture liaison services in other jurisdictions, including the devolved authorities.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
Fracture liaison services (FLS) are a globally recognised care model for secondary fracture prevention and can reduce the risk of refracture by up to 40%.
FLS are commissioned by integrated care boards, which make decisions according to local need. Officials continue to work closely with NHS England to explore a range of options to provide better quality and access to these important preventative services. This includes how best to support systems, who are responsible for commissioning.
We are considering evidence and examples from a wide range of sources, including existing services and the devolved administrations.
Asked by: Baroness Hayter of Kentish Town (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what meetings the Secretary of State for Health and Social Care has had with (1) the General Medical Council, (2) the Academy of Medical Royal Colleges, (3) other health regulators, since 5 July.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The Central Government Corporate Transparency Commitments require Government departments to publish details of ministers’ and senior officials’ meetings with external individuals or organisations on a quarterly basis. We will be publishing the meetings that my Rt. Hon. Friend, the Secretary of State for Health and Social Care attended, in accordance with the transparency guidelines.
Asked by: Baroness Hayter of Kentish Town (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to Written answer by Baroness Merron on 28 November (HL1675), why on page 9 of the Child Death Reporting Form, under the heading "Domain B", there is a column to be completed asking for the gender of the mother, if this does not need to be specified.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The Child Death Notification Form and the Child Death Reporting Form are part of the National Child Mortality Database. These continue to capture the sex of the child for under 18-year-olds, in line with sex being a protected characteristic under the 2010 Equality Act.
The Child Death Overview Panel (CDOP) has a statutory obligation to notify the National Child Mortality Database within 48 hours of a child’s death, and they do so through A Child Death Notification Form. There is no reference to the mother’s gender in this form.
Following this, the Child Death Reporting Form and relevant supplementary reporting forms are sent out by the CDOP to every professional who has had contact with the child during life, or who has been involved in the investigation after death, to gather information when a child dies. In the Child Death Reporting Form, there is space for the professional to provide information on the gender of the mother. This is not a mandatory requirement to supply this information. This question has existed on the reporting form since at least 2010, and pre-dates the National Child Mortality Database.