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753958
star this property registered interest false more like this
star this property date less than 2017-07-19more like thismore than 2017-07-19
star this property answering body
Department of Health more like this
star this property answering dept id 17 more like this
star this property answering dept short name Health more like this
star this property answering dept sort name Health remove filter
star this property hansard heading Radioisotopes: Imports more like this
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property question text Her Majesty's Government (1) what assessment they have made of the potential impact of not reaching agreement with the EU by April 2019 on the supply of the radioisotope molybdenum-99 used to produce technetium-99m which is required for over 80 per cent of diagnostic medicine procedures in the UK; (2) what assessment they have made of the potential impact of delays or disruption to the supply of diagnostic medicine procedures that may result; and (3) what contingency plans they have put in place to mitigate such delays or disruption to that supply after Brexit. more like this
star this property tabling member printed
Lord Mendelsohn more like this
star this property uin HL1104 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
star this property date of answer less than 2017-07-31more like thismore than 2017-07-31
unstar this property answer text <p>The Government is fully aware of the importance of molybdenum-99 and the reliance on this medical radioisotope for diagnostic procedures in the National Health Service. The United Kingdom’s ability to import medical isotopes from Europe and the rest of the world will not be affected by withdrawal from Euratom. It is in everyone’s interest to not disrupt the timely access of treatment to patients and to ensure that cross-border trade with the European Union and Euratom is as frictionless as possible.</p> more like this
star this property answering member printed Lord O'Shaughnessy more like this
star this property question first answered
less than 2017-07-31T13:38:56.527Zmore like thismore than 2017-07-31T13:38:56.527Z
star this property answering member
4545
star this property label Biography information for Lord O'Shaughnessy more like this
unstar this property tabling member
4286
unstar this property label Biography information for Lord Mendelsohn remove filter
50255
star this property registered interest false more like this
star this property date less than 2014-05-07more like thismore than 2014-05-07
star this property answering body
Department of Health more like this
star this property answering dept id 17 more like this
star this property answering dept short name Health more like this
star this property answering dept sort name Health remove filter
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property question text To ask Her Majesty's Government which official, with what job title, is responsible and accountable for departmental management information in the Department of Health. more like this
star this property tabling member printed
Lord Mendelsohn more like this
star this property uin HL6973 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
star this property date of answer less than 2014-05-13more like thismore than 2014-05-13
unstar this property answer text <p>Within the Department of Health the official who holds responsibility for Departmental management information is Richard Douglas, Director-General for Finance and the National Health Service.</p><p> </p><p> </p> more like this
star this property answering member printed Earl Howe more like this
star this property question first answered
less than 2014-05-13T12:00:00.00Zmore like thismore than 2014-05-13T12:00:00.00Z
star this property answering member
2000
star this property label Biography information for Earl Howe more like this
unstar this property tabling member
4286
unstar this property label Biography information for Lord Mendelsohn remove filter
167244
star this property registered interest false more like this
star this property date less than 2014-12-02more like thismore than 2014-12-02
star this property answering body
Department of Health more like this
star this property answering dept id 17 more like this
star this property answering dept short name Health more like this
star this property answering dept sort name Health remove filter
star this property hansard heading 23andMe more like this
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property 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. more like this
star this property tabling member printed
Lord Mendelsohn more like this
star this property uin HL3345 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
star this property date of answer less than 2014-12-16more like thismore than 2014-12-16
unstar this property 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>
star this property answering member printed Earl Howe more like this
star this property grouped question UIN
HL3343 more like this
HL3344 more like this
HL3346 more like this
HL3347 more like this
HL3348 more like this
star this property question first answered
less than 2014-12-16T14:44:44.277Zmore like thismore than 2014-12-16T14:44:44.277Z
star this property answering member
2000
star this property label Biography information for Earl Howe more like this
unstar this property tabling member
4286
unstar this property label Biography information for Lord Mendelsohn remove filter
167245
star this property registered interest false more like this
star this property date less than 2014-12-02more like thismore than 2014-12-02
star this property answering body
Department of Health more like this
star this property answering dept id 17 more like this
star this property answering dept short name Health more like this
star this property answering dept sort name Health remove filter
star this property hansard heading DNA: Screening more like this
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property 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. more like this
star this property tabling member printed
Lord Mendelsohn more like this
star this property uin HL3346 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
star this property date of answer less than 2014-12-16more like thismore than 2014-12-16
unstar this property 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>
star this property answering member printed Earl Howe more like this
star this property grouped question UIN
HL3343 more like this
HL3344 more like this
HL3345 more like this
HL3347 more like this
HL3348 more like this
star this property question first answered
less than 2014-12-16T14:44:44.437Zmore like thismore than 2014-12-16T14:44:44.437Z
star this property answering member
2000
star this property label Biography information for Earl Howe more like this
unstar this property tabling member
4286
unstar this property label Biography information for Lord Mendelsohn remove filter
167247
star this property registered interest false more like this
star this property date less than 2014-12-02more like thismore than 2014-12-02
star this property answering body
Department of Health more like this
star this property answering dept id 17 more like this
star this property answering dept short name Health more like this
star this property answering dept sort name Health remove filter
star this property hansard heading 23andMe more like this
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property 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. more like this
star this property tabling member printed
Lord Mendelsohn more like this
star this property uin HL3348 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
star this property date of answer less than 2014-12-16more like thismore than 2014-12-16
unstar this property 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>
star this property answering member printed Earl Howe more like this
star this property grouped question UIN
HL3343 more like this
HL3344 more like this
HL3345 more like this
HL3346 more like this
HL3347 more like this
star this property question first answered
less than 2014-12-16T14:44:43.767Zmore like thismore than 2014-12-16T14:44:43.767Z
star this property answering member
2000
star this property label Biography information for Earl Howe more like this
unstar this property tabling member
4286
unstar this property label Biography information for Lord Mendelsohn remove filter
167242
star this property registered interest false more like this
star this property date less than 2014-12-02more like thismore than 2014-12-02
star this property answering body
Department of Health more like this
star this property answering dept id 17 more like this
star this property answering dept short name Health more like this
star this property answering dept sort name Health remove filter
star this property hansard heading 23andMe more like this
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property 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. more like this
star this property tabling member printed
Lord Mendelsohn more like this
star this property uin HL3343 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
star this property date of answer less than 2014-12-16more like thismore than 2014-12-16
unstar this property 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>
star this property answering member printed Earl Howe more like this
star this property grouped question UIN
HL3344 more like this
HL3345 more like this
HL3346 more like this
HL3347 more like this
HL3348 more like this
star this property question first answered
less than 2014-12-16T14:44:43.937Zmore like thismore than 2014-12-16T14:44:43.937Z
star this property answering member
2000
star this property label Biography information for Earl Howe more like this
unstar this property tabling member
4286
unstar this property label Biography information for Lord Mendelsohn remove filter
167246
star this property registered interest false more like this
star this property date less than 2014-12-02more like thismore than 2014-12-02
star this property answering body
Department of Health more like this
star this property answering dept id 17 more like this
star this property answering dept short name Health more like this
star this property answering dept sort name Health remove filter
star this property hansard heading Medicines and Healthcare products Regulatory Agency more like this
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property 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. more like this
star this property tabling member printed
Lord Mendelsohn more like this
star this property uin HL3347 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
star this property date of answer less than 2014-12-16more like thismore than 2014-12-16
unstar this property 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>
star this property answering member printed Earl Howe more like this
star this property grouped question UIN
HL3343 more like this
HL3344 more like this
HL3345 more like this
HL3346 more like this
HL3348 more like this
star this property question first answered
less than 2014-12-16T14:44:44.603Zmore like thismore than 2014-12-16T14:44:44.603Z
star this property answering member
2000
star this property label Biography information for Earl Howe more like this
unstar this property tabling member
4286
unstar this property label Biography information for Lord Mendelsohn remove filter
167243
star this property registered interest false more like this
star this property date less than 2014-12-02more like thismore than 2014-12-02
star this property answering body
Department of Health more like this
star this property answering dept id 17 more like this
star this property answering dept short name Health more like this
star this property answering dept sort name Health remove filter
star this property hansard heading 23andMe more like this
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property 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. more like this
star this property tabling member printed
Lord Mendelsohn more like this
star this property uin HL3344 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
star this property date of answer less than 2014-12-16more like thismore than 2014-12-16
unstar this property 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>
star this property answering member printed Earl Howe more like this
star this property grouped question UIN
HL3343 more like this
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star this property question first answered
less than 2014-12-16T14:44:44.103Zmore like thismore than 2014-12-16T14:44:44.103Z
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2000
star this property label Biography information for Earl Howe more like this
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4286
unstar this property label Biography information for Lord Mendelsohn remove filter