The Pharmaceutical Journal reports that the Good Law Project threaten DHSC with legal challenge over “failure to consult properly”
From The Pharmaceutical Journal 21 FEB 2019
The Good Law Project has warned the Department of Health and Social Care that it will start judicial review proceedings if serious shortage protocol powers are not revoked on the grounds that the consultation was “insufficient and unlawful”.
A non-profit group has threatened the government with legal action unless it revokes new powers designed to allow pharmacists to switch patients’ medicines if there is a shortage.
The Good Law Project has said it will start judicial review proceedings over newly implemented “serious shortage protocol” powers if the Department of Health and Social Care (DHSC) fails to remove the amendments in legislation by 25 February 2019.
Amendments to the Human Medicines Regulation 2012, which came into force on 9 February 2019, mean the government can now issue protocols asking pharmacists to respond to a medicines shortage in one of four ways: to dispense a reduced quantity, a therapeutic equivalent, a generic equivalent or an alternative dosage form of the drug.
Under the protocol, the pharmacist would not have to consult the patient’s GP before making the switch.
The Good Law Project is now seeking to launch a judicial review of the amendments, partially on the grounds that the government’s initial consultation – which lasted one week on 5–12 December 2018 – was “insufficient and unlawful”.
In a legal document sent on 19 February 2019 from the group’s lawyers to the DHSC to inform them of their intent to start the review proceedings, the Good Law Project said it was “unclear exactly who the Secretary of State consulted with and how/on what basis”.
It added: “The failure to consult properly with organisations representing specific patient interests was unlawful.”
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 [Serious Shortage Protocols] 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, Chief Executive of SUDEP Action, who is supporting the judicial review said “Patients, doctors and pharmacists are used to prescriptions and 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.
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 Pre Action Protocol Letter can be seen here