Serious Shortage Protocols

The Good Law Project threatens Judicial Review of Serious Shortage Protocols

 

The Good Law Project has today threatened [1] to issue judicial review proceedings on Tuesday 26 February unless Government cancels powers to allow pharmacists to alter prescriptions for people with serious medical conditions in the event of medicines shortages.

The powers – called “Serious Shortage Protocols” (SSPs) – give pharmacists the right to supply a different quantity or pharmaceutical quality of medicine in the event of the country experiencing a serious shortage of prescription-only medicines after 29 March 2019 [2].  These new powers took force on 9 February, and have been criticised for being rushed out without proper consultation with patient and clinical groups.

The Academy of Royal Colleges has stated it is “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.”

After facing pressure from groups representing those suffering from epilepsy and other neurological disorders, the Government accepted that replacement drugs were unsuitable for epilepsy patients, but left it open to pharmacists to reduce the strength or dosage of epilepsy medication. Epilepsy-focussed charities say this will leave patients at risk. A wide range of groups, including diabetics and those living with HIV, also have serious concerns about the use of SSPs.

Jolyon Maugham QC, Director of the Good Law Project, said:

“Both doctors and patients have proper concerns about their safety in the event of medicine shortages. We want the Government to withdraw the prospect of SSPs until it has complied with its legal duties and consulted properly on their use. If the Government does not take this step, the Good Law Project will launch judicial review proceedings in the High Court.”

Professor Tamara Hervey, Specialist Adviser to Parliament’s Health and Social Care Committee, said:

“In the event of a no-deal Brexit, there would be likely to be shortages of medicines. The absence of a legal framework for imports and exports drastically affects supply chains. Stockpiling plans cannot cope for more than a few weeks. This is a serious issue for people needing a regular supply of a particular type, strength and quality of medicine.”

Jane Hanna OBE, Chief Executive of SUDEP Action, who is supporting the judicial review said

“Patients, doctors and pharmacists are used to prescriptions & the processes surrounding them. For people with long-term conditions, like epilepsy, what is on the prescription may represent months and years of trying out the best medication schedule. Changes made to this delicate balance can for some, undo this in an instant. For epilepsy this could lead to less seizure control,, impacting on quality of life (ie: losing a driving licence, affecting home and work) and significantly for some this can prove fatal.  At present if a supply of medication is made in error, lessons can be learnt because of the clarity of who signed and who supplied the prescription. We are leading a coalition of epilepsy charities who are extremely concerned however, that this new law has been rushed in with such speed and no one knows how patient safety will be properly protected. Whilst pharmacists are skilled professionals, they are not specialists in long-term conditions and their associated risks, and they do not have the full patient history. If under this law the clinical prescriber who knows the patient is to be by-passed by a group of centralised clinicians and individual pharmacists, we need the Government to take the time to make sure this is safe. Lives cannot be risked because of short deadlines.”

Deborah Gold, Chief Executive of NAT (National AIDS Trust) said:

“We are deeply concerned that these changes were made without proper consultation. Prescribing HIV medication is a complex process which must take account of a multitude of factors. The only person qualified to safely alter the medication prescribed to a person living with HIV is that person’s HIV consultant.”

The Good Law Project has instructed Adam Hundt of Deighton Pierce Glynn, and Stephen Knafler QC and Yaaser Vanderman of Landmark Chambers. It has launched a crowdfunder [3] to raise 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. It has added 20% to cover the running costs of the Good Law Project. The Good Law Project is 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.

For further information please contact [email protected]goodlawproject.org.

NOTES:

[1] The Pre Action Protocol Letter can be seen here https://jolyonmaugham.files.wordpress.com/2019/02/finalassent.pdf

[2] The Human Medicines (Amendment) Regulations 2019 can be seen here https://www.legislation.gov.uk/uksi/2019/62/regulation/9/made

[3] Preview at https://www.crowdjustice.com/draft/3641/r/VEzvdHXVT7mlLqHGZp1Phw/ URL from 10pm 19 February 2019 at https://www.crowdjustice.com/case/not-ready-for-no-deal


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