Serious Shortage Protocols in the Court of Appeal
Posted: Thursday, May 2nd, 2019
We reported recently that Mr Justice Supperstone had refused an application by The Good Law Project for permission to apply for judicial review of amendments to the Human Medicines Regulations that empower Ministers to introduce Serious Shortage Protocols.
Last week, Lord Justice Hickinbottom granted The Good Law Project permission to appeal against the refusal to the Court of Appeal. There is a single ground of appeal, namely that Ministers did not have power to make the Regulations. Lord Justice Hickinbottom said he found Mr Justice Supperstone's judgment "compelling", but was persuaded that The Good Law Project should have an opportunity to argue its case at a hearing.
Because the case partly depends on whether the UK has a no-deal Brexit, the judge directed an expedited hearing.
New GPhC guidance on online pharmacy and hub & spoke
Posted: Tuesday, April 16th, 2019
Last year, PLEA responded to a General Pharmaceutical Council consultation on the provision of online pharmacy services. The GPhC has just published new guidance on this and on hub & spoke dispensing. The guidance is detailed. Here are some of the key points:
The provision of pharmacy services at a distance, particularly online, carries particular risks by its nature. Risk assessments should be carried out.
If a pharmacy works with prescribers or prescribing services operating outside the UK, they should make sure that:
- they manage the extra risks that this may create
- they have sufficient indemnity insurance in place to cover
- the prescriber is registered in their home country where the prescription is issued and can lawfully issue prescriptions online to people in the UK
- the prescriber is working within national prescribing guidelines for the UK
Pharmacies should carry out a regular audit and keep records of
- decisions to make or refuse a sale
- any information about pharmacy services on the website
- how the pharmacy’s information security policy meets the Payment Card Industry Data Security Standard (PCI DSS) and data protection law
- feedback from people who use pharmacy services
- concerns or complaints received
- activities of third parties, agents or contractors
When parts of a pharmacy service take place at different locations (such as in a ‘hub and spoke’ or ‘click and collect’ service) pharmacies must be clear about which pharmacist is accountable and responsible for each part of the service, and which pharmacy technician and other staff are involved. When medicines are not given to the person or their representative in the registered pharmacy, but are delivered by a member of staff or an agent to the person’s home or workplace, there may be more risk of medicines being lost or delivered to the wrong person. Pharmacies must make sure there are clear lines of accountability and responsibility in these circumstances. If pharmacies contract out any part of your pharmacy service to a third party, pharmacies are still responsible for providing it safely and effectively. They should carry out ‘due diligence’ in selecting any contractors.
When there is no face-to-face contact, pharmacies should consider what information they and their staff record and keep to show that the pharmacy service provided is safe.
Pharmacy websites should be clear and not mislead pharmacy service users about the identity or location of the pharmacies involved in providing pharmacy services. This includes the identity and location of any online prescribing service.
Pharmacies should be able to show how they are assured that all prescribers, whether medical or non-medical, follow relevant guidance.
Websites should ensure that a person cannot choose a POM and its quantity before there has been an appropriate consultation with a prescriber.
Websites should display prominently:
- the name of the prescriber and the address of the prescribing service
- the prescriber’s registration number and the country where they are registered in
- whether the prescriber is a doctor or a non-medical independent prescriber
- check that the person receiving pharmacy services is who they claim to be, by carrying out an appropriate identity check (for example by keeping to the Identity Verification and Authentication Standard for Digital Health and Care Services, which provides a consistent approach to identity checking across online digital health and care services)
- make sure people receiving pharmacy services have the opportunity to ask questions about their medicines
- identify requests for medicines that are inappropriate, by being able to identify multiple orders to the same address or orders using the same payment details – this includes inappropriate combinations of medicines and requests that are too large or too frequent
- a prescriber, that the pharmacy chooses to work with is aware that some categories of medicines are not suitable to be supplied online unless further safeguards have been put in place
Finally, the guidance says that websites should look professional.
Bawa-Garba review decision
Posted: Wednesday, April 10th, 2019
Dr Haditha Bawa-Garba's review hearing at the Medical Practitioners Tribunal was taking place at the same time as our annual seminar, making our presentation on gross negligence manslaughter even more topical. During the presentation, we learned that Dr Bawa-Garba had been allowed to resume practice subject to conditions. The MPTS decision can be found here https://www.mpts-uk.org/hearings-and-decisions/medical-practitioners-tribunals/dr-hadiza-bawa-garba-apr-19
Brexit amendments to Human Medicines Regulations
Posted: Wednesday, April 10th, 2019
The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 were made last week. These Regulations will come into force on the day the UK exits the EU (whenever that is). The Regulations will amend the Human Medicines Regulations 2012 (HMR). The stated purposes are “to ensure [the Regulations] are fit for purpose in a no deal EU Exit scenario” and allows the MHRA to function as a standalone regulator, while continuing to recognise prescriptions from the EU/EEA.
The amendments are numerous. Here is a summary of some of them, based on an Explanatory Memorandum that accompanies the Regulations:
- Functions carried out at EU level will be transferred to the MHRA.
- EU Regulations that currently form part of domestic law will be revoked and will instead be restated in the HMR.
- The MHRA has advised pharmacists to continue to dispense EEA and Swiss prescriptions after Brexit. However, the wording in the new Regulations does not exactly replicate the advice. In the Regulations, the definition of “EEA health professional” will be replaced by ”approved country health professional”. Following Brexit, the MHRA will publish a list of approved countries and professions for the purpose of identifying who can write a prescription that can be lawfully dispensed in the UK.
- Since the UK will cease to be part of the EU licensing system, all medicines coming to the UK will be required to use the UK licensing system rather than EU procedures that have previously been available. Products that are already authorised through the European Medicines Agency will continue to be licensed in the UK in a no-deal scenario by being automatically converted to UK marketing authorisations. After exit day new licences granted under EU systems will not be recognised in the UK and a separate application will have to be made to the MHRA.
- The requirement for online suppliers of medicines to register with the MHRA and to display the EU common logo on their websites will be removed from the HMR.
- The requirements of the Falsified Medicines Directive that were introduced as recently as 9 February 2019 will be removed from the HMR because “UK stakeholders would no longer be able to comply with the requirement to verify and authenticate all relevant medicines. For example, the unique identifier in a 2D data matrix code for products coming from the EU will have been decommissioned (made inactive) on export from the EU and before entry to the UK as a third country. Furthermore… there will be no obligations on the UK supply chain to affix the safety features or to scan packs of medicines. Packs already affixed with FMD safety features will continue to be accepted in the UK, provided that they are in line with other UK packaging requirements”.
- The Explanatory Memorandum states that “In the interests of public safety, the Government will evaluate the options for a future UK falsified medicines framework, taking into account the investment already made by stakeholders.”
- Parallel importing can continue subject to the MHRA being satisfied that an imported medicine is essentially similar to the UK reference product. This is because the Government recognises parallel importing as “an important route of supply for medicinal products in the United Kingdom that provides cost savings to the NHS across the UK”.
EEA and Swiss prescriptions after Brexit
Posted: Sunday, April 7th, 2019
The Department of Health and Social Care has issued guidance for dealing with EEA and Swiss prescriptions in the event that the UK leaves the European Union on 12 April 2019 with no deal.
In short, pharmacists are advised to continute to dispense EEA and Swiss prescriptions in line with current guidance. The full DHSC guidance can be found here https://www.gov.uk/guidance/prescriptions-issued-in-the-eea-and-switzerland-guidance-for-pharmacists
High Court rejects legal challenge to serious shortage protocols
Posted: Monday, April 1st, 2019
As we reported on 17 March 2019, the Good Law Project (GLP) had applied for judicial review of the Human Medicines (Amendment) Regulations that had come into force on 9 February 2019. These Regulations had given ministers power to introduce serious shortage protocols (as well as implementing the Falsified Medicines Directive).
The case is The Queen (on the application of Good Law Project Limited) v Secretary of State for Health and Social Care  EWHC 800 (Admin). GLP argued that, amongst other things, the Secretary of State did not have power to make the Regulations, that serious shortage protocols would be inconsistent with section 64 of the Medicines Act 1068, and that there had not been proper consultation, and that he had failed to comply with his public sector equality duty.
In order to bring judicial review proceedings, GLP had to demonstrate an arguable case. Initially, after considering the papers, Mr Justice Swift had concluded that the case was not arguable. GLP renewed its application at an oral hearing before Mr Justice Supperstone. On 29 March 2019, Mr Justice Supperstone delivered a written judgment, finding that an arguable case has not been demonstrated.
In relation to section 64 of the Medicines Act, the judge described serious shortage protocols as "a parallel system to prescriptions". It is implicit in this observation that a pharmacist who made a supply in accordance with a serious shortage protocol could not be prosecuted under section 64 of the Medicines Act if a patient was harmed through receiving an alternative medicine to the one prescribed. Rulings on applications for permission to apply for judicial review usually follow short hearings without full argument, so the judgments that are handed down are not precedents that are binding on judges in future cases. Nevertheless, Mr Justice Supperstone's ruling may deter any prosecutions and may have some persuasive effect if any prosecution is brought.
GPhC enforcement policy for pharmacy premises
Posted: Wednesday, March 27th, 2019
The General Pharmaceutical Council has published an enforcement policy for registered premises https://www.pharmacyregulation.org/sites/default/files/document/registered_pharmacies_enforcement_policy.pdf
- sets out the GPhC’s approach and the principles it follows when using enforcement options
- summarises the range of enforcement options available to it
- outlines the criteria it takes into account when making decisions about which enforcement option, or combination of options, to use
The policy states that the GPhC is committed to using the minimum regulatory intervention required to achieve the desired result, known as “right-touch regulation”.
In addition to setting out its enforcement options and the criteria for taking enforcement action, the GPhC refers to its powers under the Regulation of Investigatory Powers Act 2000 (known as “RIPA”) to carry out covert surveillance if authorised by a Director.
The GPhC is expected to publish guidance on enforcement in the near future.
Claire Bryce-Smith, Director of Insights, Intelligence and Inspection at the GPhC, will address some of these issues in her presentation at our annual seminar on 9 April 2019 at the offices of Charles Russell Speechlys LLP, 5 Fleet Place, London EC4M 7RD. To book a free place, members should go to https://www.plea.org.uk/events.htm and log in. Anyone who has forgotten their log in details should email firstname.lastname@example.org
Judgment against GP set aside
Posted: Sunday, March 24th, 2019
In a News item on 11 December 2018, we reported on the case of Brayshaw v Partners in Apsley Surgery. It appears that the GP who was found to have been negligent had not been served with any of the court papers so the case against him proceeded in his absence. The GP only found out about the case when the judgment was drawn to his attention. In Brayshaw v Partners of Apsley Surgery  EWHC 3286 (QB), the judgment against the GP was set aside, though the judgment in respect of the allegations against the partners in the Apsley Surgery remains intact.
Legal challenge to serious shortage protocols
Posted: Sunday, March 17th, 2019
The Human Medicines Regulations (HMR) were amended with effect from 9 February 2019. The amendments implemented the Falsified Medicines Directive and gave ministers powers to introduce serious shortage protocols – see our News item of 20 January 2019.
The Good Law Project, a non-profit organisation that says it “fight[s] cases to defend, define or change the law” in the areas of Brexit, tax and workers’ rights, has applied for permission to bring judicial review proceedings to quash the serious shortage protocol powers.
The grounds of challenge (paraphrased) include:
- The Secretary of State for the Department of Health and Social Care (DHSC) did not have power to change the requirement to supply POMs otherwise than in accordance with a prescription.
- Even if the Secretary of State had power to amend the HMR, there was inadequate consultation.
- The Secretary of State failed to comply with his public sector equality duty.
- The Secretary of State acted inconsistently with the NHS Constitution.
Judicial review is a two-stage process. If a judge, usually considering the papers without a hearing, considers that the claimant has an arguable case, permission will be given for a full hearing. The Good Law Project has asked for the papers to be considered urgently and for any full hearing to be expedited.
The DHSC has filed a document at the High Court with its grounds for resisting the judicial review application, contending that the Good Law Project lacks sufficient status to even bring the case, and that its grounds are not properly arguable. It points out that if the judicial review case succeeded, the UK would be left without an important tool by which the Secretary of State can address any serious drug shortages arising, including post Brexit.
David Reissner has written a blog on the judicial review application which can be read here https://www.chemistanddruggist.co.uk/opinion/-legal-challenge-against-shortages-powers-surprise
Which country's professional standards apply?
Posted: Monday, March 11th, 2019
In Pantula Sastry v General Medical Council  EWHC 390 (Admin), Mr Justice May heard an appeal by a medical practitioner against a decision to remove his name from the medical register.
Dr Sastry had worked at a hospital in India in 2013 and 2014. He then worked in the UK for 4 years without incident. It was alleged that his treatment of a patient in India had led to the patient’s death. The treatment was the subject of an allegation that the doctor was unfit to practise by reason of misconduct. The Medical Practitioner Tribunal determined the case according to UK Good Medical Practice.
Dr Sastry argued that the Tribunal failed to have sufficient regard to the context that practices, laws and standards in India, where the treatment had taken place, were different to those in the UK. The court held that when considering whether a registrant undertaking professional duties outside the UK had fallen short of standards of professional conduct which the UK public was entitled to expect from its doctors, a tribunal had to take into account any particular limitations or local practices which applied in the foreign location. However, since the GMC’s remit was to protect the public in the UK and to promote proper professional standards in the UK, it was bound to assess conduct with UK professional standards in mind.
These news items are not exhaustive but are selected according to their relevance to pharmacy practice, NHS community pharmacy contracts and the regulation of the pharmacy profession. If you wish to add any items that you think we have missed, contact our news editor.