Written Question · S4W-07576 · Session 4
What steps it (a) has taken or (b) will take to ensure that the public is provided with information about the (a) risks, (b) limitations an…
The question
To ask the Scottish Executive what steps it (a) has taken or (b) will take to ensure that the public is provided with information about the (a) risks, (b) limitations and (c) possible benefits of screening for medical conditions involving (i) the use of genetic testing and (ii) exposure to radiation offered by commercial companies.
The answer
The Scottish Government does not provide the public with information about risks, limitations and possible benefits of screening provided by commercial companies.
The Scottish Government provides the public with information about the risks, limitations and possible benefits for population-based screening, in line with the advice from the UK National Screening Committee. This information is included in the NHS Health Scotland leaflets and these leaflets are available to download from the NHS Health Scotland website at: http://www.healthscotland.com/topics/health-topics/screening/breast.aspx.
In addition, information on the risks of radiation is also published on the NHS Inform website at: http://www.nhsinform.co.uk/Health-Library/Articles/R/radiation/risks-of-radiation.
We are supportive of the Human Genetics Commission’s (HGC) Common Framework of Principles for direct-to-consumer genetic testing services which was published in 2010 and which aims to tackle informed consent, marketing, risk communication, availability of counselling and data protection for direct to consumer genetic testing. It is important that when people choose to undergo this kind of genetic testing that they have the appropriate information available to them and if necessary access to appropriate counselling and support.
If HGC makes any recommendations on devolved matters for Scotland, the secretariat will ensure that these are presented in reports so that they are clearly distinguished as matters for the relevant territories. Devolved administrations will then be able to respond to them as appropriate.
Genetic tests with a medical purpose are covered by the In Vitro Diagnostic Medical Devices Directive (98/79/EC) and, as such, the test kits used should be CE-marked. This directive is intended to ensure that IVDs do not compromise the health and safety of patients, users and third parties and attain the performance levels attributed to them by their manufacturer.
The Scottish Government provides the public with information about the risks, limitations and possible benefits for population-based screening, in line with the advice from the UK National Screening Committee. This information is included in the NHS Health Scotland leaflets and these leaflets are available to download from the NHS Health Scotland website at: http://www.healthscotland.com/topics/health-topics/screening/breast.aspx.
In addition, information on the risks of radiation is also published on the NHS Inform website at: http://www.nhsinform.co.uk/Health-Library/Articles/R/radiation/risks-of-radiation.
We are supportive of the Human Genetics Commission’s (HGC) Common Framework of Principles for direct-to-consumer genetic testing services which was published in 2010 and which aims to tackle informed consent, marketing, risk communication, availability of counselling and data protection for direct to consumer genetic testing. It is important that when people choose to undergo this kind of genetic testing that they have the appropriate information available to them and if necessary access to appropriate counselling and support.
If HGC makes any recommendations on devolved matters for Scotland, the secretariat will ensure that these are presented in reports so that they are clearly distinguished as matters for the relevant territories. Devolved administrations will then be able to respond to them as appropriate.
Genetic tests with a medical purpose are covered by the In Vitro Diagnostic Medical Devices Directive (98/79/EC) and, as such, the test kits used should be CE-marked. This directive is intended to ensure that IVDs do not compromise the health and safety of patients, users and third parties and attain the performance levels attributed to them by their manufacturer.
In the Official Report
No contribution in the Official Report cites S4W-07576 by reference.