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Access to Medical Treatments (Innovation) Act 2016

Contents

Commentary on provisions of Act

Section 1: Access to innovative medical treatments

  1. Section 1 provides that the purpose of the Act is to promote access to innovative medical treatments (including the off-label use of medicines or the use of unlicensed medicines) by making provision for a database of innovative medical treatments, and for access to information contained in that database.

Section 2: Database of innovative treatments

  1. Subsection (1) gives the Secretary of State a power to make regulations conferring functions on the HSCIC in connection with the establishment, maintenance and operation of a database. The database will contain information about innovative medical treatments carried out by doctors in England, and the results of those treatments. Before making regulations the Secretary of State must consult the HSCIC (subsection (6)).

  1. Subsection (2) provides that "innovative medical treatment" means medical treatment for a condition that involves a departure from the existing range of accepted medical treatments for the condition. This will include the use of medicines and medical devices in innovative ways, and would include treatments where only part of the treatment is innovative.

  1. Subsection (3)(a) provides that the regulations can confer on the HSCIC the power to make provision about the information to be recorded in the database and procedures relating to how it is recorded.

  1. Subsections (3)(b) and (4) provide that the regulations can make provision about access to information recorded in the database, including provision requiring or authorising the HSCIC to disclose information, and to impose conditions on those to whom information is disclosed. It is intended that the regulations will make provision for other doctors to access information recorded in the database for the purpose of sharing knowledge about innovative medical treatments and encouraging learning.

  1. Subsection (8) provides that the regulations are subject to the negative resolution procedure.

  1. Information about treatments will only be able to be disclosed where this is in accordance with the law, in particular the common law duty of confidentiality and the Data Protection Act 1998.

Section 3: Section 2: supplementary

  1. Subsections (1) and (6) are self-explanatory.

  1. Subsection (2) provides that the use of certain types of medicinal products may be "innovative medical treatment" (and therefore covered by the database to be established pursuant to section 2), namely the use of medicinal products outside of their licensed indications (off label use) and the use of unlicensed medicines (e.g. UK manufactured "specials"). Whilst the description of innovative medical treatment in section 2(2) would in any event have been broad enough to include these types of treatment, this subsection makes it explicit that these uses may be innovative. These kinds of treatments are not necessarily always innovative, however, and off label use of medicines in particular may be part of standard care for some conditions.

  1. Clinicians are currently free to prescribe off-label and unlicensed medicinal products where this is in the best interests of a patient, and in accordance with relevant legislation and guidance. The Medicines and Healthcare Products Regulatory Agency (MHRA) and the General Medical Council have published guidance on the "hierarchy" for the use of licensed medicinal products, off-label use and use of unlicensed medicines. The guidance states that prescribers should first consider using a licensed medicine within its licensed indications, where possible; if that is not possible, then a licensed medicine off-label should be used, and only if neither of these is available should an unlicensed medicine be considered. The guidance explains that licensed products have been assessed by the MHRA and evidence has been provided to demonstrate that the quality, safety and efficacy of the product are acceptable for the therapeutic, diagnostic or preventative use for which the product is licensed. If licensed products are used ‘off-label’, some of this assessment may not apply, but some will still be valid. This is lower risk than using an unlicensed product for which no evidence of safety, quality and efficacy have been submitted to regulatory authorities for review. Lower cost cannot justify off label use or the use of an unlicensed medicine when an alternative licensed product exists. The provisions of the Act have no impact on this hierarchy.

  1. Subsection (3) includes further explanation about what is understood by the off label use of medicines. It may involve the use of an authorised product (that is, a product in relation to which a marketing authorisation is in force) for a purpose, or condition, other than the one which is specified in the product’s marketing authorisation. It might also involve other departures from the product’s marketing authorisation, such as different target patient populations (e.g. use in children of a product authorised only for use in adults) and different doses or formulations. Subsection (4) cross-refers to certain definitions in the Human Medicines Regulations 2012/1916, which provide the legal framework in the UK for the regulation of medicinal products.

  1. Subsection (5) ensures that the database established by section 2 may contain information about treatments carried out for the purposes of medical research (including, for example, in the context of a clinical trial). Such inclusion does not affect the regulation of medical research.

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