“Saatchi bill”: legal hurdles and clinical irrelevanceBMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g3146 (Published 14 May 2014) Cite this as: BMJ 2014;348:g3146
- Santhanam Sundar, consultant oncologist1
The “Saatchi law” was drafted with the noblest of intentions but it faces serious hurdles in achieving the aim of promoting innovative treatments.1
Firstly, the bill needs to be reconciled with various mandatory EU directives on medicinal products.2 As the Medicines and Healthcare Products Regulatory Agency states, the EU “Directive 2001/83/EC relating to medicinal products for human use” takes precedence over the UK Medicines Act.3 Because “innovative treatments” and “research treatments” are virtually identical, this bill also needs to be reconciled with the EU directive on clinical trials.4
Secondly, the development of novel, innovative treatments has a high failure rate. Only one in 1000 new compounds that enter preclinical testing are estimated to make it to human testing and only a fifth of these receive Food and Drug Administration approval.5 This is not due to any legal or financial hurdles—most novel drugs are just not good enough for clinical use. So the proposed law is unlikely to promote innovative treatments. Worse, it could harm patients by promoting the use of ineffective new drugs. Hence, unlicensed drugs, however innovative, should be tested in peer reviewed, ethically approved, clinical trials to obtain scientifically credible information on safety and efficacy.
Thirdly, there is an important distinction between licensed and unlicensed drugs. Licensed drugs are likely to have good safety data so their use for unlicensed conditions is less risky. The legal safeguards proposed in the Saatchi law could end up curtailing the current widespread use of licensed drugs for unlicensed conditions.
Cite this as: BMJ 2014;348:g3146
Competing interests: As a member of the NHS England-Cancer Drugs Fund (CDF) panel, on occasions, I have approved licensed cancer medicines for unlicensed conditions www.england.nhs.uk/ourwork/pe/cdf/.