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Drugs: Licensing

Question for Department of Health

UIN HL5504, tabled on 9 March 2015

To ask Her Majesty’s Government, further to the remarks by Lord Wallace of Saltaire on 11 February (HL Deb, col 1243) and the Written Answer by Earl Howe on 5 March (HL5130), how the prior use in clinical practice within the United Kingdom of either medicinal products or medical devices that lack CE marking might affect the use of such materials in clinical practice within other European Union member states; and how the anticipated duty to promote economic growth would affect marketing authorisation.

Answered on

23 March 2015

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.