Leaving without a deal will put lives at risk - we're not prepared

by Jo Maugham QC

Leaving without a deal will put lives at risk - we're not prepared

by Jo Maugham QC
Jo Maugham QC
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Director and founder of Good Law Project
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Director and founder of Good Law Project
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Latest: March 19, 2019

An update on our judicial review of serious shortage protocols

Yesterday we learned that the High Court had refused permission to appeal. You can read the refusal here.

We are not in the habit of criticising decisions of the Court but we think the reasoning is ...

Read more

What happens to your medicines if we leave without a deal?

Absence of legal framework for imports/exports drastically affects supply chains. Likely shortages as stockpiling plans cannot cope for more than a few weeks.

That is not our view. It is the view of the two Specialist Advisers to the House of Commons Health and Social Care Committee, Professor Tamara Hervey and Dr Nick Fahy.

And the consequences could be widespread. This is an extract from written evidence given by the Medical Schools Council to the Health and Social Care Committee (HSCC):

To take just one example, 3.7 million people in the UK have been diagnosed with diabetes. Diabetes UK estimates that by 2025 the number will have risen to 5 million – yet less than 3% of insulin is manufactured in the UK. Any disruption to the supply chain could have catastrophic consequences for nearly 10% of the UK’s population, as was the case when another major trading bloc broke up without agreement, in 1991, when deaths from diabetes in post-Soviet states rose 10-20 times.

More, frightening, detail can be seen in this transcript of oral evidence given to the HSCC.

The Government has refused to say what medicines are at risk. But it does recognise the possibility of shortages in new regulations: 

"enabling Ministers to issue Serious Shortage Protocols (SSPs) that, where appropriate, enable community pharmacies to dispense against an SSP instead of a prescription without going back to the prescriber first."

In other words, if your drugs run out, it will be your pharmacist (not the Doctor who knows your medical history) who prescribes something different - or gives you reduced amounts. This is both alarming - the pharmacist will know little or nothing of your medical history - and contrary to public promises that if "we do experience temporary shortages of specific medicines... your doctor will prescribe the best alternative to your usual medicine."

But you don't need to take it from me. Here's what the regulations state:

"SSP is a written protocol that... where the United Kingdom... is... experiencing... a serious shortage of... prescription only medicines... provides for the... supply by... a pharmacist... of a different strength, quantity or pharmaceutical form of the prescription only medicine."

We believe the regulations are unlawful. Before implementing changes like these, the law requires proper consultation - rather than the hurried and secretive process we had - so Government can be sure it understands and manages the risks to patients' lives. 

Here is what the Academy of Royal Colleges has said:

Whilst we recognise the necessity for a short consultation period we were concerned at what appears to have been a very limited initial consultation with no general notification and no information on the DHSC consultations website. It does seem inexplicable and unacceptable that an issue of this importance is not the subject of wide consultation and that medical royal colleges as doctors’ professional bodies were not specifically engaged in the process.

And it goes on to express serious concerns about the use of SSPs.

Government, after introducing the regulations, and facing pressure from groups representing those suffering from epilepsy and other neurological disorders, accepted that SSPs were unsuitable for epilepsy patients. But we are aware that other groups of patients also have serious concerns about the use of SSPs. 

Good Law Project has today written to the Government threatening to issue judicial review proceedings on Monday 26 February if it does not agree to withdraw the use of SSPs pending proper consultation and compliance with the Government's legal duties.

Lives are at risk. This is no time to place fast and loose with the law. 





Good Law Project has instructed Adam Hundt of Deighton Pierce Glynn and Stephen Knafler QC and Yaaser Vanderman of Landmark Chambers.

We are raising funds for the costs of paying their legal fees, gathering evidence from experts and affected groups of patients, and meeting any adverse costs liability if the legal action fails. We have added 20% to cover the running costs of the Good Law Project. We are looking to raise £30,000 to cover the stage up to the grant of permission. The stretch target is for a further £40,000 to cover the costs up to a substantive hearing. 

Jolyon Maugham QC, Director of the Good Law Project, continues to work unpaid. 






Update 1

Jo Maugham QC

March 19, 2019

An update on our judicial review of serious shortage protocols

Yesterday we learned that the High Court had refused permission to appeal. You can read the refusal here.

We are not in the habit of criticising decisions of the Court but we think the reasoning is very poor and we have asked the Court for an urgent oral permission hearing. We will, of course, keep you updated.

Meanwhile the Government debated serious shortage protocols in the House of Commons yesterday

We continue to believe it is critically important to establish whether what Government describes as a “thoroughly important measure... to address serious drug shortages... in the event of a no deal Brexit” is lawful.

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