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168449

registered interest
date	08/12/2014
answering body	Department for Communities and Local Government
answering dept id	7
answering dept short name	Communities and Local Government
answering dept sort name	Communities and Local Government
hansard heading	Local Government: Pensions
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government what is their estimate of the current level of the Local Government Pension Scheme deficit.
tabling member printed	Lord Mendelsohn
uin	HL3479
answer	answer is ministerial correction date of answer 16/12/2014 answer text <p>The Scheme conducts an actuarial valuation every three years. The 2013 valuation estimated that the Local Government Pension Scheme in England and Wales had a funding level of 79% and a deficit of £47 billion.</p><p> </p><p>The shadow Scheme Advisory Board has also brought together the funds’ triennial valuation reports to provide a view of the Scheme’s overall position (<a href="http://www.lgpsboard.org/index.php/schemedata/scheme-valuation" target="_blank">http://www.lgpsboard.org/index.php/schemedata/scheme-valuation</a>). The Government has asked the shadow Board to identify and assess alternative ways to address the deficit and looks forward to receiving their proposals.</p><p> </p><p>In addition, the Government introduced a reformed Local Government Pension Scheme from 1 April 2014, which will help the funds to reduce this deficit and ensure the scheme remains affordable in the long term and fair to both scheme members and taxpayers. Furthermore, the Government’s consultation <em>Opportunities for collaboration, cost savings and efficiencies</em> set out how the funds could reduce their investment costs by a further £660 million each year by working together and investing more efficiently.</p><p> </p><p>The consultation is available at: <a href="https://www.gov.uk/government/consultations/local-government-pension-scheme-opportunities-for-collaboration-cost-savings-and-efficiencies" target="_blank">https://www.gov.uk/government/consultations/local-government-pension-scheme-opportunities-for-collaboration-cost-savings-and-efficiencies</a></p> answering member printed Lord Ahmad of Wimbledon question first answered 16/12/2014 13:21:43 answering member 4210 label Biography information for Lord Ahmad of Wimbledon
tabling member	4286 label Biography information for Lord Mendelsohn

168450

registered interest
date	08/12/2014
answering body	Department for Communities and Local Government
answering dept id	7
answering dept short name	Communities and Local Government
answering dept sort name	Communities and Local Government
hansard heading	Local Government: Pensions
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government whether they estimate that savings could be made to the administration of the Local Government Pension Scheme and the operation of its sub-funds if the management of the funds were moved from active managers to tracker funds; and if so, to what extent.
tabling member printed	Lord Mendelsohn
uin	HL3480
answer	answer is ministerial correction date of answer 16/12/2014 answer text <p>The consultation <em>Opportunities for collaboration, cost savings and efficiencies </em>set out how the Local Government Pension Scheme could deliver annual savings of £660 million by reforming the way the funds make their investments. Advice commissioned by the Minister for the Cabinet Office and the Minister for Local Government using the Contestable Policy Fund was used to inform the consultation. Of the £660 million savings identified, the analysis showed that £420 million could be found by using passive, rather than active management of listed assets such as bonds and equities. Over 200 consultation responses were received and a Government response will be published early in 2015.</p><p> </p><p>Both the consultation and supporting analysis are available at: <a href="https://www.gov.uk/government/consultations/local-government-pension-scheme-opportunities-for-collaboration-cost-savings-and-efficiencies" target="_blank">https://www.gov.uk/government/consultations/local-government-pension-scheme-opportunities-for-collaboration-cost-savings-and-efficiencies</a></p> answering member printed Lord Ahmad of Wimbledon question first answered 16/12/2014 13:20:28 answering member 4210 label Biography information for Lord Ahmad of Wimbledon
tabling member	4286 label Biography information for Lord Mendelsohn

168451

registered interest
date	08/12/2014
answering body	Department for Communities and Local Government
answering dept id	7
answering dept short name	Communities and Local Government
answering dept sort name	Communities and Local Government
hansard heading	Local Government: Pensions
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government what the performance of active fund managers has been over the last six years in the 89 sub-funds of the Local Government Pension Scheme.
tabling member printed	Lord Mendelsohn
uin	HL3481
answer	answer is ministerial correction date of answer 16/12/2014 answer text <p>The Department does not hold data on the performance of active fund managers working Local Government Pension Scheme funds.</p><p> </p><p>The consultation <em>Opportunities for collaboration, cost savings and efficiencies </em>was developed using analysis provided to the Minister for the Cabinet Office and the Minister for Local Government using the Contestable Policy Fund. The analysis examined the investment returns of the Scheme as a whole in each of the major equity markets as well as for bonds and gilts. The evidence demonstrated that over the ten years to 31 March 2013, regardless of whether active or passive fund managers were used, the aggregate performance of the Scheme had been in line with each market index.</p><p> </p><p>Both the consultation and supporting analysis are available at: <a href="https://www.gov.uk/government/consultations/local-government-pension-scheme-opportunities-for-collaboration-cost-savings-and-efficiencies" target="_blank">https://www.gov.uk/government/consultations/local-government-pension-scheme-opportunities-for-collaboration-cost-savings-and-efficiencies</a></p> answering member printed Lord Ahmad of Wimbledon question first answered 16/12/2014 14:33:40 answering member 4210 label Biography information for Lord Ahmad of Wimbledon
tabling member	4286 label Biography information for Lord Mendelsohn

168452

registered interest
date	08/12/2014
answering body	Department for Communities and Local Government
answering dept id	7
answering dept short name	Communities and Local Government
answering dept sort name	Communities and Local Government
hansard heading	Local Government: Pensions
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government what fees have been paid (including management, performance and trading costs) by all the managers of funds in the Local Government Pension scheme.
tabling member printed	Lord Mendelsohn
uin	HL3482
answer	answer is ministerial correction date of answer 15/12/2014 answer text <p>The Department for Communities and Local Government publishes statistics about the Local Government Pension Scheme each year, using data provided by each of the 89 administering authorities in England and Wales. In the financial year 2013-14, the authorities reported fund management costs to be £494 million and administration costs to be £133 million.</p><p> </p> answering member printed Lord Ahmad of Wimbledon question first answered 15/12/2014 17:43:57 answering member 4210 label Biography information for Lord Ahmad of Wimbledon
tabling member	4286 label Biography information for Lord Mendelsohn

167242

registered interest
date	02/12/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	23andMe
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government what contact the Medicines and Healthcare Products Regulatory Agency had with the US Food and Drug Administration prior to its approval of 23andMe.
tabling member printed	Lord Mendelsohn
uin	HL3343
answer	answer is ministerial correction date of answer 16/12/2014 answer text <p>Products used in direct-to-consumer testing services providing health-related information are regulated as <em>in vitro</em> diagnostic medical devices and are subject to European Union legislation that sets out minimum standards of safety and quality. The testing service itself is not subject to this legislation, only the products.</p><p> </p><p> </p><p> </p><p>Manufacturers of <em>in vitro</em> diagnostic medical devices are required to register with the competent authority in the country where they are placing the device on the market. In the United Kingdom this is the Medicines and Healthcare products Regulatory Agency (MHRA). In this registration a manufacturer declares that their devices are safe and meet all of the relevant requirements of the legislation including having evidence to support their performance claims. For some higher risk devices a manufacturer has to have its product checked before it is placed on the market. Such checks are undertaken by third-party conformity assessment bodies called notified bodies.</p><p> </p><p> </p><p> </p><p>The role of the MHRA is to ensure that all medical devices placed on the UK market are compliant with the relevant legislation and to enforce this legislation on behalf of the Secretary of State. The MHRA fulfils this role by monitoring notified bodies (for higher risk devices) and operating the UK medical device vigilance system, which involves assessing and responding to safety concerns involving devices.</p><p> </p><p> </p><p> </p><p>The MHRA does not have a role in assessing the additional costs or benefits of devices to the National Health Service and so has not done so in the case of the service offered by 23andMe.</p><p> </p><p> </p><p> </p><p>Furthermore, under existing EU legislation, testing services are regulated in the country where the test is being performed. The tests offered by 23andMe are performed in laboratories that are based in the United States of America and as such are covered by US legislation.</p><p> </p><p> </p><p> </p><p>The Government has advised that no test will be 100% reliable, that 23andMe should be used with caution and that the information provided by 23andMe should not lead consumers to make any changes of medical significance, such as changes to medication, without first consulting their healthcare professional. If consumers need more information about the conditions listed in their results then they can visit the NHS Choices website for more information.</p><p> </p><p> </p><p> </p><p>The MHRA discussed the 23andMe Personal Genome Service with the US Food and Drug Administration (FDA) and shared information under the confidentiality commitment that is in place between the two agencies.</p><p> </p><p> </p><p> </p><p>The MHRA also held discussions with 23andMe prior to them launching their product in the UK. In those discussions, 23andMe explained that the product being offered in the UK is different to their US product in that many of the drug responses, inherited conditions and genetic health risks that were of concern to the FDA have been removed. 23andMe also presented results of surveys with UK-based consumers of their existing service that demonstrated that 4% of people had a specific conversation with their general practitioner (GP) as a result of their test results but it is not known how many GP visits led to National Health Service treatment.</p><p> </p><p> </p><p> </p><p>In the context of those discussions, the MHRA also agreed with 23andMe that they would take part in an enhanced surveillance program. Such a program involves regular sharing of safety information that might not otherwise meet the threshold for reporting to the competent authority. This will allow the MHRA to have a more in depth look at the performance of the test in use and if this highlights any regulatory or safety issues then they will consider further action.</p><p> </p> answering member printed Earl Howe grouped question UIN HL3344 HL3345 HL3346 HL3347 HL3348 question first answered 16/12/2014 14:44:43 answering member 2000 label Biography information for Earl Howe
tabling member	4286 label Biography information for Lord Mendelsohn

167243

registered interest
date	02/12/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	23andMe
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government whether the US Food and Drug Administration provided the Medicines and Healthcare Products Regulatory Agency with information about the status of its ban on 23andMe; and whether it was likely to change its position.
tabling member printed	Lord Mendelsohn
uin	HL3344
answer	answer is ministerial correction date of answer 16/12/2014 answer text <p>Products used in direct-to-consumer testing services providing health-related information are regulated as <em>in vitro</em> diagnostic medical devices and are subject to European Union legislation that sets out minimum standards of safety and quality. The testing service itself is not subject to this legislation, only the products.</p><p> </p><p> </p><p> </p><p>Manufacturers of <em>in vitro</em> diagnostic medical devices are required to register with the competent authority in the country where they are placing the device on the market. In the United Kingdom this is the Medicines and Healthcare products Regulatory Agency (MHRA). In this registration a manufacturer declares that their devices are safe and meet all of the relevant requirements of the legislation including having evidence to support their performance claims. For some higher risk devices a manufacturer has to have its product checked before it is placed on the market. Such checks are undertaken by third-party conformity assessment bodies called notified bodies.</p><p> </p><p> </p><p> </p><p>The role of the MHRA is to ensure that all medical devices placed on the UK market are compliant with the relevant legislation and to enforce this legislation on behalf of the Secretary of State. The MHRA fulfils this role by monitoring notified bodies (for higher risk devices) and operating the UK medical device vigilance system, which involves assessing and responding to safety concerns involving devices.</p><p> </p><p> </p><p> </p><p>The MHRA does not have a role in assessing the additional costs or benefits of devices to the National Health Service and so has not done so in the case of the service offered by 23andMe.</p><p> </p><p> </p><p> </p><p>Furthermore, under existing EU legislation, testing services are regulated in the country where the test is being performed. The tests offered by 23andMe are performed in laboratories that are based in the United States of America and as such are covered by US legislation.</p><p> </p><p> </p><p> </p><p>The Government has advised that no test will be 100% reliable, that 23andMe should be used with caution and that the information provided by 23andMe should not lead consumers to make any changes of medical significance, such as changes to medication, without first consulting their healthcare professional. If consumers need more information about the conditions listed in their results then they can visit the NHS Choices website for more information.</p><p> </p><p> </p><p> </p><p>The MHRA discussed the 23andMe Personal Genome Service with the US Food and Drug Administration (FDA) and shared information under the confidentiality commitment that is in place between the two agencies.</p><p> </p><p> </p><p> </p><p>The MHRA also held discussions with 23andMe prior to them launching their product in the UK. In those discussions, 23andMe explained that the product being offered in the UK is different to their US product in that many of the drug responses, inherited conditions and genetic health risks that were of concern to the FDA have been removed. 23andMe also presented results of surveys with UK-based consumers of their existing service that demonstrated that 4% of people had a specific conversation with their general practitioner (GP) as a result of their test results but it is not known how many GP visits led to National Health Service treatment.</p><p> </p><p> </p><p> </p><p>In the context of those discussions, the MHRA also agreed with 23andMe that they would take part in an enhanced surveillance program. Such a program involves regular sharing of safety information that might not otherwise meet the threshold for reporting to the competent authority. This will allow the MHRA to have a more in depth look at the performance of the test in use and if this highlights any regulatory or safety issues then they will consider further action.</p><p> </p> answering member printed Earl Howe grouped question UIN HL3343 HL3345 HL3346 HL3347 HL3348 question first answered 16/12/2014 14:44:44 answering member 2000 label Biography information for Earl Howe
tabling member	4286 label Biography information for Lord Mendelsohn

167244

registered interest
date	02/12/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	23andMe
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government what advice they will give to patients about the reliability of information received from tests by 23andMe; and whether any indication of a health condition should lead patients to seek National Health Service treatment.
tabling member printed	Lord Mendelsohn
uin	HL3345
answer	answer is ministerial correction date of answer 16/12/2014 answer text <p>Products used in direct-to-consumer testing services providing health-related information are regulated as <em>in vitro</em> diagnostic medical devices and are subject to European Union legislation that sets out minimum standards of safety and quality. The testing service itself is not subject to this legislation, only the products.</p><p> </p><p> </p><p> </p><p>Manufacturers of <em>in vitro</em> diagnostic medical devices are required to register with the competent authority in the country where they are placing the device on the market. In the United Kingdom this is the Medicines and Healthcare products Regulatory Agency (MHRA). In this registration a manufacturer declares that their devices are safe and meet all of the relevant requirements of the legislation including having evidence to support their performance claims. For some higher risk devices a manufacturer has to have its product checked before it is placed on the market. Such checks are undertaken by third-party conformity assessment bodies called notified bodies.</p><p> </p><p> </p><p> </p><p>The role of the MHRA is to ensure that all medical devices placed on the UK market are compliant with the relevant legislation and to enforce this legislation on behalf of the Secretary of State. The MHRA fulfils this role by monitoring notified bodies (for higher risk devices) and operating the UK medical device vigilance system, which involves assessing and responding to safety concerns involving devices.</p><p> </p><p> </p><p> </p><p>The MHRA does not have a role in assessing the additional costs or benefits of devices to the National Health Service and so has not done so in the case of the service offered by 23andMe.</p><p> </p><p> </p><p> </p><p>Furthermore, under existing EU legislation, testing services are regulated in the country where the test is being performed. The tests offered by 23andMe are performed in laboratories that are based in the United States of America and as such are covered by US legislation.</p><p> </p><p> </p><p> </p><p>The Government has advised that no test will be 100% reliable, that 23andMe should be used with caution and that the information provided by 23andMe should not lead consumers to make any changes of medical significance, such as changes to medication, without first consulting their healthcare professional. If consumers need more information about the conditions listed in their results then they can visit the NHS Choices website for more information.</p><p> </p><p> </p><p> </p><p>The MHRA discussed the 23andMe Personal Genome Service with the US Food and Drug Administration (FDA) and shared information under the confidentiality commitment that is in place between the two agencies.</p><p> </p><p> </p><p> </p><p>The MHRA also held discussions with 23andMe prior to them launching their product in the UK. In those discussions, 23andMe explained that the product being offered in the UK is different to their US product in that many of the drug responses, inherited conditions and genetic health risks that were of concern to the FDA have been removed. 23andMe also presented results of surveys with UK-based consumers of their existing service that demonstrated that 4% of people had a specific conversation with their general practitioner (GP) as a result of their test results but it is not known how many GP visits led to National Health Service treatment.</p><p> </p><p> </p><p> </p><p>In the context of those discussions, the MHRA also agreed with 23andMe that they would take part in an enhanced surveillance program. Such a program involves regular sharing of safety information that might not otherwise meet the threshold for reporting to the competent authority. This will allow the MHRA to have a more in depth look at the performance of the test in use and if this highlights any regulatory or safety issues then they will consider further action.</p><p> </p> answering member printed Earl Howe grouped question UIN HL3343 HL3344 HL3346 HL3347 HL3348 question first answered 16/12/2014 14:44:44 answering member 2000 label Biography information for Earl Howe
tabling member	4286 label Biography information for Lord Mendelsohn

167245

registered interest
date	02/12/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	DNA: Screening
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government what are the minimum standards required for a personal genome service to be approved by the Medicines and Healthcare Products Regulatory Agency.
tabling member printed	Lord Mendelsohn
uin	HL3346
answer	answer is ministerial correction date of answer 16/12/2014 answer text <p>Products used in direct-to-consumer testing services providing health-related information are regulated as <em>in vitro</em> diagnostic medical devices and are subject to European Union legislation that sets out minimum standards of safety and quality. The testing service itself is not subject to this legislation, only the products.</p><p> </p><p> </p><p> </p><p>Manufacturers of <em>in vitro</em> diagnostic medical devices are required to register with the competent authority in the country where they are placing the device on the market. In the United Kingdom this is the Medicines and Healthcare products Regulatory Agency (MHRA). In this registration a manufacturer declares that their devices are safe and meet all of the relevant requirements of the legislation including having evidence to support their performance claims. For some higher risk devices a manufacturer has to have its product checked before it is placed on the market. Such checks are undertaken by third-party conformity assessment bodies called notified bodies.</p><p> </p><p> </p><p> </p><p>The role of the MHRA is to ensure that all medical devices placed on the UK market are compliant with the relevant legislation and to enforce this legislation on behalf of the Secretary of State. The MHRA fulfils this role by monitoring notified bodies (for higher risk devices) and operating the UK medical device vigilance system, which involves assessing and responding to safety concerns involving devices.</p><p> </p><p> </p><p> </p><p>The MHRA does not have a role in assessing the additional costs or benefits of devices to the National Health Service and so has not done so in the case of the service offered by 23andMe.</p><p> </p><p> </p><p> </p><p>Furthermore, under existing EU legislation, testing services are regulated in the country where the test is being performed. The tests offered by 23andMe are performed in laboratories that are based in the United States of America and as such are covered by US legislation.</p><p> </p><p> </p><p> </p><p>The Government has advised that no test will be 100% reliable, that 23andMe should be used with caution and that the information provided by 23andMe should not lead consumers to make any changes of medical significance, such as changes to medication, without first consulting their healthcare professional. If consumers need more information about the conditions listed in their results then they can visit the NHS Choices website for more information.</p><p> </p><p> </p><p> </p><p>The MHRA discussed the 23andMe Personal Genome Service with the US Food and Drug Administration (FDA) and shared information under the confidentiality commitment that is in place between the two agencies.</p><p> </p><p> </p><p> </p><p>The MHRA also held discussions with 23andMe prior to them launching their product in the UK. In those discussions, 23andMe explained that the product being offered in the UK is different to their US product in that many of the drug responses, inherited conditions and genetic health risks that were of concern to the FDA have been removed. 23andMe also presented results of surveys with UK-based consumers of their existing service that demonstrated that 4% of people had a specific conversation with their general practitioner (GP) as a result of their test results but it is not known how many GP visits led to National Health Service treatment.</p><p> </p><p> </p><p> </p><p>In the context of those discussions, the MHRA also agreed with 23andMe that they would take part in an enhanced surveillance program. Such a program involves regular sharing of safety information that might not otherwise meet the threshold for reporting to the competent authority. This will allow the MHRA to have a more in depth look at the performance of the test in use and if this highlights any regulatory or safety issues then they will consider further action.</p><p> </p> answering member printed Earl Howe grouped question UIN HL3343 HL3344 HL3345 HL3347 HL3348 question first answered 16/12/2014 14:44:44 answering member 2000 label Biography information for Earl Howe
tabling member	4286 label Biography information for Lord Mendelsohn

167246

registered interest
date	02/12/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Medicines and Healthcare products Regulatory Agency
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government what is the difference in the reliance that individuals can place on what they learn from a medical product regulated by the Medicines and Healthcare Products Regulatory Agency compared to an information product.
tabling member printed	Lord Mendelsohn
uin	HL3347
answer	answer is ministerial correction date of answer 16/12/2014 answer text <p>Products used in direct-to-consumer testing services providing health-related information are regulated as <em>in vitro</em> diagnostic medical devices and are subject to European Union legislation that sets out minimum standards of safety and quality. The testing service itself is not subject to this legislation, only the products.</p><p> </p><p> </p><p> </p><p>Manufacturers of <em>in vitro</em> diagnostic medical devices are required to register with the competent authority in the country where they are placing the device on the market. In the United Kingdom this is the Medicines and Healthcare products Regulatory Agency (MHRA). In this registration a manufacturer declares that their devices are safe and meet all of the relevant requirements of the legislation including having evidence to support their performance claims. For some higher risk devices a manufacturer has to have its product checked before it is placed on the market. Such checks are undertaken by third-party conformity assessment bodies called notified bodies.</p><p> </p><p> </p><p> </p><p>The role of the MHRA is to ensure that all medical devices placed on the UK market are compliant with the relevant legislation and to enforce this legislation on behalf of the Secretary of State. The MHRA fulfils this role by monitoring notified bodies (for higher risk devices) and operating the UK medical device vigilance system, which involves assessing and responding to safety concerns involving devices.</p><p> </p><p> </p><p> </p><p>The MHRA does not have a role in assessing the additional costs or benefits of devices to the National Health Service and so has not done so in the case of the service offered by 23andMe.</p><p> </p><p> </p><p> </p><p>Furthermore, under existing EU legislation, testing services are regulated in the country where the test is being performed. The tests offered by 23andMe are performed in laboratories that are based in the United States of America and as such are covered by US legislation.</p><p> </p><p> </p><p> </p><p>The Government has advised that no test will be 100% reliable, that 23andMe should be used with caution and that the information provided by 23andMe should not lead consumers to make any changes of medical significance, such as changes to medication, without first consulting their healthcare professional. If consumers need more information about the conditions listed in their results then they can visit the NHS Choices website for more information.</p><p> </p><p> </p><p> </p><p>The MHRA discussed the 23andMe Personal Genome Service with the US Food and Drug Administration (FDA) and shared information under the confidentiality commitment that is in place between the two agencies.</p><p> </p><p> </p><p> </p><p>The MHRA also held discussions with 23andMe prior to them launching their product in the UK. In those discussions, 23andMe explained that the product being offered in the UK is different to their US product in that many of the drug responses, inherited conditions and genetic health risks that were of concern to the FDA have been removed. 23andMe also presented results of surveys with UK-based consumers of their existing service that demonstrated that 4% of people had a specific conversation with their general practitioner (GP) as a result of their test results but it is not known how many GP visits led to National Health Service treatment.</p><p> </p><p> </p><p> </p><p>In the context of those discussions, the MHRA also agreed with 23andMe that they would take part in an enhanced surveillance program. Such a program involves regular sharing of safety information that might not otherwise meet the threshold for reporting to the competent authority. This will allow the MHRA to have a more in depth look at the performance of the test in use and if this highlights any regulatory or safety issues then they will consider further action.</p><p> </p> answering member printed Earl Howe grouped question UIN HL3343 HL3344 HL3345 HL3346 HL3348 question first answered 16/12/2014 14:44:44 answering member 2000 label Biography information for Earl Howe
tabling member	4286 label Biography information for Lord Mendelsohn

167247

registered interest
date	02/12/2014
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	23andMe
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty’s Government what assessment the Medicines and Healthcare Products Regulatory Agency has made of the additional costs or benefits to the National Health Service of the use of 23andMe.
tabling member printed	Lord Mendelsohn
uin	HL3348
answer	answer is ministerial correction date of answer 16/12/2014 answer text <p>Products used in direct-to-consumer testing services providing health-related information are regulated as <em>in vitro</em> diagnostic medical devices and are subject to European Union legislation that sets out minimum standards of safety and quality. The testing service itself is not subject to this legislation, only the products.</p><p> </p><p> </p><p> </p><p>Manufacturers of <em>in vitro</em> diagnostic medical devices are required to register with the competent authority in the country where they are placing the device on the market. In the United Kingdom this is the Medicines and Healthcare products Regulatory Agency (MHRA). In this registration a manufacturer declares that their devices are safe and meet all of the relevant requirements of the legislation including having evidence to support their performance claims. For some higher risk devices a manufacturer has to have its product checked before it is placed on the market. Such checks are undertaken by third-party conformity assessment bodies called notified bodies.</p><p> </p><p> </p><p> </p><p>The role of the MHRA is to ensure that all medical devices placed on the UK market are compliant with the relevant legislation and to enforce this legislation on behalf of the Secretary of State. The MHRA fulfils this role by monitoring notified bodies (for higher risk devices) and operating the UK medical device vigilance system, which involves assessing and responding to safety concerns involving devices.</p><p> </p><p> </p><p> </p><p>The MHRA does not have a role in assessing the additional costs or benefits of devices to the National Health Service and so has not done so in the case of the service offered by 23andMe.</p><p> </p><p> </p><p> </p><p>Furthermore, under existing EU legislation, testing services are regulated in the country where the test is being performed. The tests offered by 23andMe are performed in laboratories that are based in the United States of America and as such are covered by US legislation.</p><p> </p><p> </p><p> </p><p>The Government has advised that no test will be 100% reliable, that 23andMe should be used with caution and that the information provided by 23andMe should not lead consumers to make any changes of medical significance, such as changes to medication, without first consulting their healthcare professional. If consumers need more information about the conditions listed in their results then they can visit the NHS Choices website for more information.</p><p> </p><p> </p><p> </p><p>The MHRA discussed the 23andMe Personal Genome Service with the US Food and Drug Administration (FDA) and shared information under the confidentiality commitment that is in place between the two agencies.</p><p> </p><p> </p><p> </p><p>The MHRA also held discussions with 23andMe prior to them launching their product in the UK. In those discussions, 23andMe explained that the product being offered in the UK is different to their US product in that many of the drug responses, inherited conditions and genetic health risks that were of concern to the FDA have been removed. 23andMe also presented results of surveys with UK-based consumers of their existing service that demonstrated that 4% of people had a specific conversation with their general practitioner (GP) as a result of their test results but it is not known how many GP visits led to National Health Service treatment.</p><p> </p><p> </p><p> </p><p>In the context of those discussions, the MHRA also agreed with 23andMe that they would take part in an enhanced surveillance program. Such a program involves regular sharing of safety information that might not otherwise meet the threshold for reporting to the competent authority. This will allow the MHRA to have a more in depth look at the performance of the test in use and if this highlights any regulatory or safety issues then they will consider further action.</p><p> </p> answering member printed Earl Howe grouped question UIN HL3343 HL3344 HL3345 HL3346 HL3347 question first answered 16/12/2014 14:44:43 answering member 2000 label Biography information for Earl Howe
tabling member	4286 label Biography information for Lord Mendelsohn