Products used in direct-to-consumer testing services providing health-related information are regulated as in vitro 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.
Manufacturers of in vitro 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.
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.
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.
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.
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.
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.
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.
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.