Dr Anthony Barton and I , along with the authors of this particular section, Charles Gibson QC, Geraint Webb QC, and James Purnell, were delighted to read Mr Justice Hickinbottom's judgment in Wilkes v Depuy, on the 6th December.
'Risk-benefit in this context is explained in the commendable consideration of the issues surrounding “Product liability for medicinal products” in the chapter of that name by Charles Gibson QC, Geraint Webb QC and James Purnell in “Clinical Negligence” (Michael Powers QC and Anthony Barton eds, 5th Edition (2015), Chapter 13) (“Powers & Barton”), at paragraph 13.29, as follows:
“Underpinning the continuous process of review of medicinal products throughout their lifecycle, is the recognition that all medicines carry risks as well as provide benefits to the patients. No medicine is 100 per cent safe, and all medicines have side effects. A licence will only be granted or renewed if there is deemed to be a positive balance of risks and benefits (in other words, the benefits of the product outweigh the risks) or the product is, in the [MHRA’s] own words, ‘acceptably safe’. Determining the safety of a product is a holistic approach that calls for an integrated assessment of the clinical and laboratory adverse effects associated with the product in terms of their frequency, seriousness, severity, reversibility and outcome, and determining whether the risk can be mitigated by warnings on any risk factors. That assessment is complex and takes into account a range of factors including the nature of the disease or condition to be treated, the type of patient and the duration of treatment. It is important to appreciate that regulators approve or disapprove a drug on the basis of risk/benefit at a population level and not at an individual patient level….”'