Access to Medical Treatments (Innovation) Bill

Explanatory Notes

Policy background

3 The Bill is intended to build upon provisions in Lord Saatchi’s Medical Innovation Bill ("the MIB"), which was first introduced into the House of Lords in the 2013-14 parliamentary session. In a statement to the House of Commons in November 2013, the Secretary of State for Health, Jeremy Hunt, undertook to carry out a full consultation on the issues raised by the MIB. 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.

4 A public consultation ran from February to April 2014 and the Government’s response was published in July 2014. The MIB successfully passed through the House of Lords, but ran out of parliamentary time after reaching the Commons.

5 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.

6 The Access to Medical Treatments (Innovation) Bill takes on board this history and seeks to promote access to innovative medical treatments by making provision about negligence, along the lines of the MIB, and by providing for the establishment of a database of innovative medical treatments.

7 The Bill therefore 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.

8 The Bill also makes provision to encourage responsible innovation by doctors. Under the current law a doctor will not be negligent when departing from the existing range of medical treatments if he can show that his decision is supported by a responsible body of medical opinion. This is called the "Bolam" 1 test and has been developed by the courts.

9 The Bill gives a doctor the option of following a series of steps to show that he has acted responsibly. The steps are intended to reflect the steps under the current law which a responsible doctor could be expected to take when innovating. The Bill therefore seeks to offer clarity for doctors in advance of offering innovative treatment about the steps that they need to take to demonstrate that the decision to innovate was taken responsibly, rather than requiring doctors to wait for this to be determined by a court at a later date if their actions are challenged.

10 The provisions relating to negligence apply only to doctors (and not to other healthcare professionals) because they respond to concerns specifically raised by doctors.

1 Bolam v Friern Hospital Management Committee [1957] 1 WLR 582

Prepared 12th October 2015