The last time I wrote about the serious shortage protocol (SSP), Mr Justice Supperstone had just refused to give not-for-profit organisation the Good Law Project permission to challenge their lawfulness. The Good Law Project is nothing if not persistent: they then asked an appeal judge, Lord Justice Hickinbottom, to give them permission to appeal to the Court of Appeal.
Lord Justice Hickinbottom said he found Mr Justice Supperstone’s judgment “quite compelling”, but was persuaded that the Good Law Project should have the opportunity at a hearing to argue that the secretary of state had no power to make the SSP regulations.
Because the Good Law Project claims a SSP is more likely to be issued while a no-deal Brexit is possible, Lord Justice Hickinbottom directed an early hearing and this will take place on May 10.
Under the NHS Act, the secretary of state has a legal duty to make regulations to ensure that patients receive adequate prescribed medicines. The Good Law Project is an anti-Brexit organisation, but whatever your views on Brexit, surely medicines should be about patients, not politics?
The politicisation of potential future shortages was exacerbated by significant and ill-informed opposition in parliament to the SSP regulations. SSPs were introduced to save GPs having to spend time dealing with patients who were sent back to ask for a new prescription because the item originally prescribed was not available. SSPs weren’t introduced to give pharmacists the freedom to choose an alternative drug.
The Department of Health and Social Care has made it clear that SSPs will be drawn up with input from clinicians and that they will specify what alternatives pharmacists may supply. What’s more, SSPs will not be used for products unsuitable for substitution, such as epilepsy treatments.
Adding further controversy, Conservative MP Ann Marie Morris told C+D recently that the government should clarify what constitutes a “serious” shortage before it grants pharmacists the power to dispense an alternative without a prescription. This would not be sensible.
A decision on whether there is a shortage of a product will depend on things like what quantities are available, where they are and what the demand is. Whether a shortage is serious will depend not only on comparing the demand with the quantities available, but a range of factors, including what the medication in question is used to treat. Obviously, a shortage of a cancer treatment will be viewed differently to a shortage of paracetamol.
Putting ministers’ powers into the straitjacket of a definition will not help patients receive the medicines they need.
David Reissner is chair of the Pharmacy Law and Ethics Association