Observations Medical Legislation

The “Saatchi bill” will allow responsible innovation in treatment

BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g2771 (Published 15 April 2014) Cite this as: BMJ 2014;348:g2771
  1. Michael D Rawlins, president
  1. 1Royal Society of Medicine, London W1G 0AE, UK
  1. m.d.rawlins{at}ncl.ac.uk

The Medical Innovation Bill currently under consultation aims to make it easier for doctors to try untested interventions

Many doctors, myself included, will have occasionally tried, when all other treatment options have failed, to treat patients with novel interventions. They may do so when there is no recognised form of effective treatment; or when existing ones have not produced the desired effect. The legal basis for such recourse, at least for pharmaceuticals, has been the so called “named patient” provisions of Section 9 of the Medicines Act 1968,1 which permits any doctor to be able “to sell, procure or supply a medicinal product to a patient under his or her care.”

Although my own experience of novel interventions has been disappointing, some such interventions have led to important advances. Indeed, these observations are arguably a form of “n of 1” trial.

However, confidence in using the Medicines Act’s named patient provisions has become eroded. Several legal authorities have pointed out that departing from what is regarded as “established practice” or “the standard of care” leaves a doctor open to …

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