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

Re: The “Saatchi bill” will allow responsible innovation in treatment

Saatchi law has been drafted with the noblest of intentions and if the letter of law is implemented in the spirit of the proposers, it would be particularly welcomed by terminally ill, mentally competent, consenting, adult cancer patients.

But I have my concerns; in particular, I am keen to see the legal minds reconcile the bill with the provisions of various EU directives on medicinal products. All new ‘medicines for human use’ in European Union are now subject to mandatory EU directives. (1).

As stated by MHRA on its website, the EU 'Directive 2001/83/EC relating to medicinal products for human use' takes precedence over Medicines Act in UK. (2).

I also cannot see the distinction between an ‘innovative treatment’ and a ‘research treatment’ and how this bill can side step the provisions of EU DIRECTIVE 2001/20/EC on clinical trials, notwithstanding the explicit support for clinical trials by the proposed law . (3).

Any medicinal product for human use, innovative or otherwise, needs authorisation from MHRA before it can be legally prescribed in UK. Perhaps the BMJ could invite MHRA to comment on the provisions of the proposed bill.

1. European Commission: Public health - Medicinal products for human use. URL: http://ec.europa.eu/health/human-use/index_en.htm (Accessed 26 April 2014).

2. MHRA (Medicines and Healthcare Products Regulatory Agency : An introduction to UK medicines regulation.URL : http://www.mhra.gov.uk/Howweregulate/Medicines/index.htm (Accessed 26 April 2014).

3. DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. URL: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:121:0034... (Accessed 26 April 2014).

Competing interests: As member of the NHS England-Cancer Drugs Fund (CDF) panel, on occasions, I have approved licensed cancer medicines for unlicensed conditions. http://www.england.nhs.uk/ourwork/pe/cdf/

26 April 2014
Santhanam SUNDAR
Consultant Oncologist
Dept of Oncology
Nottingham University Hospitals NHS trust