Recent news regarding the NHS has been largely negative. Examples of this include the inquiry into tainted blood donations and significantly longer waiting periods for patients as a result of a funding crisis within the NHS. Such news paints a dark picture for the contemporary NHS. However, a recent decision from the High Court has given the NHS the right to give its patients a cheaper and more effective treatment than was previously offered. The full name of the case: Bayer Plc v NHS Darlington Clinical Commissioning Group  EWHC 2465 (Admin) (the full judgment can be found here) was decided by Mrs Justice Whipple. This signifies the end of a 10 year fight to offer a cheaper treatment for Age-Related Macular Degeneration, although there had been previous calls to address the issue.
Two leading pharmaceutical companies, Novartis and Bayer, brought a case against the NHS in order to stop doctors prescribing a cheaper treatment for a serious eye condition. The serious, yet common, eye condition at the centre of this dispute is known as “Age-Related Macular Degeneration” (AMD). This is the most common form of blindness.
The case itself was brought against 12 NHS bodies, which were all situated in the northern regions of England. These particular NHS bodies offered a choice to their patients, which included either: Lucentis, Eylea (both of these drugs are licensed for eye treatment in the UK) or a drug called “Avastin". Lucentis and Eylea were and remain significantly more expensive than Avastin. Avastin (the marketed name of the drug Bevacizumab) is currently recommended by the World Health Organisation (WHO) for eye treatment, despite not being licensed for such treatment in the UK. Interestingly, Avastin is a popular medicine on a global scale, particularly in the United States. It is also important to know that the British Medical Journal found, through its investigations, that doctors had been deterred from prescribing Avastin in the past. This was due to a combination of: legal threats, misinformation, anti-competitive behaviour, and lobbying.
The central issue in this case was that the company which possessed the rights to Avastin had never obtained a licence to market the drug to address eye conditions. Avastin has, however, been marketed for cancer treatments. Novartis and Bayer also attempted to argue that it was contrary to the constitution of the General Medical Council (GMC) to prescribe “off-label” drugs and that this undermined the regulatory framework that was currently in place. It was also argued that "off-label" drugs do not undergo the same regulatory scrutiny as licensed medicines, therefore there were concerns regarding patient welfare.
It ought to be noted that a potential issue arises, depending on the view one takes. Namely, that the High Court may appear to be supporting the premise that patients are asked to accept an unlicensed treatment in order to save the NHS money. One point, as put forward by the President of the Royal College of Ophthalmologists, is that drug companies have a responsibility to apply for licences to distribute such drugs. It would be incorrect to request the NHS to apply for such licences. The role of licensing law is of course, to protect patients from poorly regulated drugs and/or drugs that have an unproven rate of effectiveness. However, this point is tackled quickly in this particular case. The National Institute for Health and Care Excellence (NICE) reached a conclusion in January 2018 to the effect that Avastin was as safe and effective as both Lucentis and Eylea. This information is likely to have been of crucial importance to the court owing to the expertise offered by the medical profession. It would appear that from a practical standpoint, Avastin was the correct drug to use; it would potentially free up significant funds which could be used elsewhere within the NHS.
The judgment has, however, been met with criticism from those within the medical profession. David Hambleton, of NHS South Tyneside Clinical Commissioning Group, has indicated that the decision would result in a reassessment of the current regulation by NICE and the Medicines and Healthcare products Regulatory Agency (MHRA), the UK's drug regulatory body. The reason for this is plain; the regulatory bodies have the option to allow off-label drugs. However, Mr Hambleton did go on to praise the judgment as it put “common sense over commercial interests.” Further criticism stems from one of the Deputy Chief Scientific Advisors to The Association of the British Pharmaceutical Industry. The suggestion here is that there is an adverse impact on the existing regulation in the field. Arguably there is less legal clarity now, which puts all parties within the field in a difficult position. This in turn will require the relevant government bodies to consider making the necessary amendments to provide sufficient protection to the existing legal regime.
Whilst the decision appears to be correct by allowing NHS bodies to select appropriate treatments, questions do arise. It is unclear what impact, if any, this decision will have on licensing laws within the UK or if there will be an upheaval of the current regulatory regime. It is also entirely possible that the judgment could lead to similar cases ending up before the courts in the future. Those cases, should they reach the courts, are likely to be decided by a different judge. Such a detail is important: judges can adjudicate differently. This could cause concern over whether the courts are the right arena in which to have such battles, or whether there should be a specialised system within the ambit of the MHRA to decide these issues, owing to the technical nature of the dispute.