The Human Fertilisation and Embryology Authority (HFEA) has informed us that it has been advised by the Medicines and Healthcare products Regulatory Agency (MHRA) that medical devices manufactured and used within the same healthcare institution without having been transferred to a different legal entity do not come within the scope of the Medical Devices Directives referred to, and do not therefore need to be CE marked.

I have nothing further to add to my previous answer of 20 February 2015, HL4711, regarding HFEA licencing conditions and guidance in relation to the use of CE marked and non-CE marked products.

As stated previously, European medicines legislation contains a provision which enables member states to put in place arrangements for the use of an unlicensed medicinal product which is provided for by way of an exemption from the requirement for a marketing authorisation. Under the exemption, clinicians may decide to use an unlicensed medicine in cases where there is not a licensed medicine available to meet the clinical needs of an individual patient. We do not anticipate this to affect the use of such unlicensed medicines within other European Union Member States, as it is up to Member States if they implement this provision and how they do so.

We do not consider that this affects levels of marketing authorisations and therefore harm the promotion of economic growth, as the provision is narrowly drawn and permitted only to meet the clinical needs of an individual patient under a prescriber’s responsibility. Medical devices without a CE marking could be used in the United Kingdom as part of a clinical investigation, following notification to the Medicines and Healthcare products Regulatory Agency (MHRA) and having gained ethical approval from the National Research Ethics Service and subsequent authorisation by both organisations. Medical professionals are able to use non-CE marked devices or CE marked devices for purposes for which they are not assigned by the manufacturer entirely on their own responsibility. The MHRA has no regulatory authority regarding the use of non CE marked Medical devices in other European Union countries.

In addition, we have recently launched an Accelerated Access Review which looks at how to promote the use of innovative medical products and devices within the National Health Service. The aim of this Review is to make the UK a world leader for the adoption of innovation in healthcare, so that we can become companies’ first choice within Europe.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published advice on how patients with pacemakers, implantable cardioverter defibrillators or neurostimulators can safely use airport security scanners. Full details of the current version of this advice are available at the following address on the gov.uk website:

https://www.gov.uk/government/publications/electromagnetic-interference-sources/electromagnetic-interference-sources

This advice states that we are not aware of any interference between body scanners and these devices, and gives some simple advice on how to avoid interference with screening wands and metal detectors.

This advice was published in 2010 following the introduction of body scanners to United Kingdom airports. A copy has been attached.

The advice was based upon a review of published literature.

Prior to 2010 the MHRA had not published airport security advice for these patients and therefore there has been no change to published policy.

Responsibility for advising airports in the United Kingdom rests with the Department for Transport (DfT). The MHRA advice has been reflected in the Code of Practice for Acceptable Use of Security Scanners in the Aviation Security Environment issued by DfT which can be found at:

https://www.gov.uk/government/publications/information-on-the-implementation-of-security-scanners.

A copy of the Code of Practice is attached.

DfT requires airports to follow this Code of Practice as part of the Directions served on the deployment of security scanners.

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.

There are no licensing requirements to open a private dispensing appliance contractor business. NHS England is responsible for determining whether a dispensing appliance contractor should be granted the right to provide National Health Service pharmaceutical services. Such determinations can generally be appealed to the Family Health Services Appeal Unit of the NHS Litigation Authority.

The Department keeps the operation of the relevant NHS regulations governing the right to provide NHS pharmaceutical services under regular review with NHS England, the NHS Litigation Authority and contractors’ representatives, as appropriate. We are not aware of any significant issues regarding the impact of these arrangements on small and medium-sized businesses offering continence products nor on the adoption of innovation in the NHS.

There are no licensing requirements to open a private dispensing appliance contractor business. NHS England is responsible for determining whether a dispensing appliance contractor should be granted the right to provide National Health Service pharmaceutical services. Such determinations can generally be appealed to the Family Health Services Appeal Unit of the NHS Litigation Authority.

The Department keeps the operation of the relevant NHS regulations governing the right to provide NHS pharmaceutical services under regular review with NHS England, the NHS Litigation Authority and contractors’ representatives, as appropriate. We are not aware of any significant issues regarding the impact of these arrangements on small and medium-sized businesses offering continence products nor on the adoption of innovation in the NHS.

The information requested is not collected.

Medicines for human use containing new active substances may not be developed without first being tested by an approved method. Unless a scientifically valid alternative is available, this will involve the use of animals. Such safety testing is a statutory requirement of European medicines law and is a necessary stage in the licensing of a new medicinal product for human use.

My Lords, the equipment and facilities to undertake cardiac ECMO support are available in all five NHS adult cardiothoracic transplant centres in England and in the five national respiratory ECMO centres, three of which share a location. Provision of cardiac ECMO support is a complex intervention with significant risks attached to it. A cardiac ECMO service requires a fully trained team to be available around the clock and does not consist of simply purchasing the medical equipment.

To ask Her Majesty’s Government whether extra-corporal membrane oxygenation (ECMO) machines that are capable of restoring heart functions some hours after an apparently fatal heart attack are in use in any NHS hospitals; and, if not, what consideration is being given to their installation.

That is very good news and I thank the Minister for it. It is desirable to have these facilities available. Does he agree that the group which would benefit most of all from this would be young people who die suddenly and unexpectedly, often in the sporting field? This is a much greater tragedy for families than the more usual cardiac attack at a later age. Should not more publicity be given so that people involved in those activities know that such facilities are available? You could get a young person by helicopter to one of those centres within the number of hours that your life would be prolonged for.

My Lords, as the noble Earl indicated in his opening remarks, a typical facility required in the provision of a service such as ECMO for adults who suffer acute myocardial infarction would include a perfusionist, intensive care facilities, an intervention cardiologist, a cardiologist expert in cardiac failure, a cardiac surgeon, together with specialist nurses. Preliminary results of studies suggest that the survival rate might be less than 30%. Does the noble Earl agree that more research is needed before such a treatment can be made available routinely?

My Lords, I refer noble Lords to my health interests. On the question raised by the noble Lord, Lord Patel, about evidence, would the noble Earl consider referring this to NICE for its expert advice?

My Lords, services that need ECMO machines would currently, in the new world, be commissioned by NHS England. Will my noble friend explain to the House what role, if any, the department now has in commissioning such services?

My Lords, is the Minister aware that Glenfield Hospital in Leicester, which has ECMO, saved many lives in the swine flu epidemic last year and does more than just hearts?

My Lords, can my noble friend clear up a point of confusion that may have arisen about his first Answer to this Question? It was reported in the Times newspaper by the science editor that people could be brought back from the dead up to seven hours after their hearts had stopped. Is that a report on which we can lay much credence?

My Lords, can we take it from the answer that the Minister gave two questions ago and the praise that he rightly gave to Glenfield Hospital in Leicester that that ECMO unit will not be closed down?

Specialist stoma nurses and other community nursing staff are trained to advise on the most appropriate products for individual patients. Clinical commissioning groups will be responsible for commissioning hospital and community services and will work with local clinicians to draw on their expertise when designing care for patients. For access to products in primary care, the existing Part IX of the drug tariff arrangements will continue and prescribers can prescribe any products listed in Part IX of the drug tariff as they consider appropriate.

We have made no such estimate. Based on its 2011-15 business plan, the National Institute for Health and Clinical Excellence (NICE) estimates the average cost for producing a piece of technology appraisal guidance to be £103,075. This is based on a budget allocation for its technology appraisals programme of £4,123,000 and the projected publication of 40 technology appraisals in 2011-12. NICE has not produced figures based on actual spend and outputs. In addition, academic support for the NICE appraisal programme is commissioned separately by the National Institute for Health Research.

Access to appropriate urology and stoma products is essential to enable people with urological conditions to avoid infection and to participate as fully as possible in the activities of daily life including employment. Specialist stoma nurses and other community nursing staff are trained to advise on the most appropriate products for individual patients, and prescribers can prescribe any products listed in Part IX of the Drug Tariff.

Oesophageal Doppler monitoring, along with other National Institute for Health and Clinical Excellence (NICE) approved fluid management monitoring technology, has been chosen as a high impact innovation for the National Health Service. It is for individual commissioners, working with their providers, to determine when and where they should be used in line with NICE guidance.

The NHS Technology Adoption Centre has produced a technology adoption pack, generically labelled “Intra-Operative Fluid Management”, which includes clarity on the competing technologies in the marketplace, together with the evidence that supports their use.