Policy background
The Access to Medical Treatments (Innovation) Act 2016 provides for the establishment of a database of innovative medical treatments including the off-label use of medicines and the use of unlicensed medicines.
	The Act follows Lord Saatchi’s Medical Innovation Bill ("the MIB"), which was first introduced into the House of Lords in the 2013-14 parliamentary session. The objective of the MIB was to clarify the legal position for doctors wishing to carry out innovative treatments by providing that it is not negligent for a doctor to depart from standard treatments, so long as the decision to do so is made responsibly. The intended effect was to reduce doctors’ concerns about claims in clinical negligence, meaning that they would be more confident to innovate.
	During its passage through the Lords, 22 amendments were made to the MIB. One of these – successfully tabled by Lord Hunt of Kings Heath – was to provide for a data registry as a means of recording innovations carried out in reliance on the Bill and to enable this information to be made accessible to medical practitioners. Whilst the Government agreed with the spirit of this amendment, it resisted it on the basis that it raised a number of complex issues in relation to the establishment and enforcement of a data registry which would need to be resolved through further dialogue with the medical community. Nonetheless, the amendment was accepted by the House.
	The Access to Medical Treatments (Innovation) Bill as introduced by Chris Heaton-Harris sought to build on the MIB by making provision to encourage responsible innovation by doctors, and to establish a database of innovative medical treatments. The majority of lawyers, clinicians and patient representatives were united in their opposition to the provisions relating to clinical negligence, citing concerns that the provisions would undermine the existing common law "Bolam" test and that they would remove patient safeguards. Chris Heaton-Harris, and the Government, remained convinced that these provisions were a safe and appropriate way to give greater certainty to innovating doctors, but acknowledged (following extensive consultation with lawyers and clinicians) that this view was not universal. Consequently, Chris Heaton-Harris tabled amendments at Report stage to remove these provisions, which were accepted by the House.
	The Act provides a regulation-making power for the establishment of a database of innovative medical treatments by the Health and Social Care Information Centre ("the HSCIC"). It is intended that information relating to innovative medical treatments, and the outcomes of those treatments, carried out by doctors in England will be passed to the HSCIC through the use of coding in patient notes. The detailed design of the database would be consulted upon with professional bodies and organisations. It is envisaged that the patient’s right to privacy would be respected and the data securely managed. The database would be searchable by other doctors to use as a knowledge base of innovation. Again it is intended that the exact detail of how the access to the database would be granted would be consulted upon with professional bodies and organisations. The database would support the Government’s emphasis on increased transparency and sharing of innovation and learning.
	The Act also provides that the database can cover innovative medical treatments carried out for the purpose of research (including, for example, in the context of a clinical trial) but makes it clear that this will have no impact on the regulation of medical research.
	The Act makes it clear that it may include medicines being used off-label and the use of unlicensed medicines. The Act defines off-label as meaning the use of a drug for a purpose for which its use is not specified (i.e. a different condition), for a person for whom its use is not specified (e.g. giving children a product licensed only for adults), or use in a way which it is not specified (e.g. a different dose or route of administration). It defines the term "marketing authorisation" (MA) with reference to the Human Medicines Regulations 2012, and defines "authorised medicinal product" as one for which a MA is in force.