Government response to Cumberlege Review and the Medicines & Medical Devices Bill
Posted: Tuesday, January 12th, 2021
Last July, we reported on the Cumberlege Review which followed the PIP breast implant scandal. The Government has just published its response to the review https://www.gov.uk/government/speeches/update-on-the-governments-response-to-the-independent-medicines-and-medical-devices-safety-review . Points of note include:
- The Government has tabled an amendment to the Medicines and Medical Devices Bill to establish the role of an independent Patient Safety Commissioner, in line with Baroness Cumberlege’s second recommendation. The Bill reached its Report Stage in the House of Lords on 12 January 2021.
- The Commissioner will act as an independent advocate for patients, and strengthen the ability of our health services to listen to the voice of patients. The Commissioner will be established as a statutory office holder, appointed by the Secretary of State for Health and Social Care, and will act independently on behalf of patients.
- The Commissioner’s core duties will be to promote the safety of patients and the importance of the views of patients in relation to medicines and medical devices. To help in carrying out these duties, the commissioner will have a number of powers and functions, including the ability to make reports and recommendations to the NHS and independent sector, and to request and share information with these bodies.
- The Government did not accept the proposal to establish a redress agency as recommended by Baroness Cumberlege. Baroness Cumberlege had concluded that the MHRA needs substantial revision particularly in relation to adverse event reporting and medical device regulation, and it needs to ensure that it engages more with patients and their outcomes. The Government’s position is that the MHRAhas already begun a substantial programme of work to improve how it involves patients in all aspects of its work, to reform systems for reporting adverse incidents with medicines and medical devices, and to strengthen the evidence base for its regulatory decisions.
- The Medicines and Medical Devices Bill will give Ministers power to establish a UK-wide medical device information system. This system will mean that the MHRA can routinely collect medical device, procedure and outcome data from all NHS and private provider organisations across the UK.
Separately from the Government’s response to the Cumberlege report, the Government has responded to criticisms of the very wide powers in Medicines and Medical Devices Bill. The Government has introduced an amendment to the Bill, stipulating that an overarching objective of making regulations must be to safeguard public health for human medicines and medical devices. In the case of veterinary medicines, the overarching objective must be to promote the health and welfare of animals; the health and safety of the public; or the protection of the environment.
Recent articles by our members - COVID-19 vaccination, Inquest, MURs, professional conduct
Posted: Monday, January 11th, 2021
Members have written a number of articles of interest recently -
Andrea James’ blog on a Coroner’s report into a death after a pharmacy error that followed a prescription change aimed at reducing pharmacy visits http://insights.brabners.com/post/102go2u/prevention-of-future-deaths-report-issued-following-community-pharmacy-error
Noel Wardle’s Chemist & Druggist blog How pharmacists can avoid supplying the COVID-19 vaccine unlawfully https://www.chemistanddruggist.co.uk/opinion/lawyer-reveals-pharmacists-supply-COVID-19-vaccine
Noel Wardle’s Chemist & Druggist blog Pharmacists should be aware of the downsides to new MUR legislation https://www.chemistanddruggist.co.uk/opinion/pharmacists-should-be-aware-downsides-new-mur-legislation
Charles Russell Speechlys’ Pharmacy Brief https://communications.crsblaw.com/17/2268/uploads/pharmacy-brief---december-2020.pdf
Susan Hunneyball’s Chemist & Druggist blog Pharmacists delivering COVID vaccines have some legal protection https://www.chemistanddruggist.co.uk/opinion/pharmacists-delivering-covid-vaccines-have-some-legal-protection-
Susan Hunneyball’s Chemist & Druggist blog Pharmacist expertise is crucial for COVID-19 vaccination programme https://www.chemistanddruggist.co.uk/opinion/pharmacist-expertise-crucial-covid-19-vaccination-programme
Rachel Warren’s blog on professional conduct and the case of Beckwith v Solicitors Disciplinary Tribunal https://blog.charlesrussellspeechlys.com/post/102glbm/beckwith-v-sdt-private-v-professional
Defamation in reporting fitness to practise cases
Posted: Thursday, January 7th, 2021
The tort of defamation (usually involving libel) does not often impinge on pharmacy law. It is covered in the current edition of Dale & Appelbe’s Pharmacy and Medicines Law, but the forthcoming 12th edition will feature other torts instead. The recent case of Onwude v Dyer, Godlee and BMJ Publishing Limited  EWHC 3577 (QB) may be of some interest to members as well as providing comfort to journalists who report fitness to practise cases in the pharmacy press.
Mr Onwude is a gynaecologist. He treated two patients with whom he had had an unrelated busines arrangement. Allegations were made about the treatment and his invoicing. The Medical Practitioner Tribunal (MTP) found allegations of misconduct, including an allegation of dishonesty, were proved. It directed that Mr Onwude’s name be erased from the medical register.
The decision was reported in the British Medical Journal (BMJ) under the headline “Gynaecologist is struck off for dishonesty and intention to cause distress”. The report that followed did not mention that the decision would not take effect until the expiry of a 28-day appeal period. The MPT directed an immediate suspension pending any appeal.
In the event, Mr Onwude appealed to the High Court and his appeal was upheld. The BMJ reported the successful appeal. Mr Onwude sued the BMJ and two journalists for libel, based no the report of the original hearing which had not mentioned that the decision and findings were subject to appeal.
The major issues related to the defences of statutory qualified privilege under section 15 of the Defamation Act 1996 and a public interest defence in section 4 of the Defamation Act 2013.
Mr Onwude told the His Honour Judge Richard Parkes QC (sitting as a High Court judge) that the essence of his complaint was that he had never been struck off: he had been suspended pending appeal, but his name had not been erased.
The judge found that the journalist’s decision not to mention in the first article the existence of a right of appeal was reasonable because this was generally known and understood by the readership. He said that “the reasonable reader is not naïve, nor unduly suspicious”.
Although Mr Onwude complained that the BMJ had declined to publish a corrective piece he had submitted, the BMJ’s refusal to do this was reasonable because it had already published a report of his successful appeal.
To rely on the public interest defence, the journalist had to show that she reasonably believed that publishing the statement complained of was in the public interest. She gave evidence that she reported MPT decisions which related to professional practice because they raised issues from which other doctors could learn, and thus avoid getting themselves into situations where their fitness to practise might be brought into question. The judge said that the decision to erase a doctor from the medical register was “of the highest public interest”. He accepted the journalist’s evidence and decided that the public interest defence was made out.
Revised Caldicott Principles - pharmacies to need Caldicott Guardians in 2021?
Posted: Wednesday, December 23rd, 2020
Every NHS organisation has had to have a Caldicott Guardian since 1998, and each local authority with adult social care responsibilities has been required to do so since 2002.
Caldicott Guardians act as “the conscience of the organisation” as a “senior person within a health or social care organisation who makes sure that the personal information about those who use its services is used legally, ethically and appropriately, and that confidentiality is maintained.”
After a consultation and review of the Caldicott Principles, the National Data Guardian (NDG) has finalised revised Principles including a new eighth principle designed to increase transparency and avoid patients having any surprises about how the data is used https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/941865/NDG_CP_and_CG_consultation_response_FINAL_08.12.20.pdf
In addition, the NDG intends to use her statutory power to give guidance which will specify that all public bodies within the health and adult social care sector should appoint a Caldicott Guardian. The list of such bodies may include pharmacies and GP practices.
The guidance will cover the role and responsibilities of Caldicott Guardians, with particular attention given their role in helping to uphold the Caldicott Principles.
Where it may not be proportionate for small organisations to have their own Caldicott Guardian, the guidance may make it clear that the role might be part of a separate role, perhaps that of Data Protection Officer, and one Guardian may serve several organisations or businesses.
The guidance will specify that Caldicott Guardians should have the freedom to act; cover issues around accountability – distinguishing between accountability for advice and decision making; and emphasise the importance of appropriate relationships to boards’ or executive decision-making in relevant organisations.
There will be a consultation early in 2021 with a view to final guidance being published by the end of 2021.
Human Medicines Regulations amended to allow pharmacists to vaccinate against COVID-19
Posted: Monday, December 21st, 2020
The Human Medicines Regulations have been amended for a period expiring on 1 April 2021. The amendments in the Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 make the following changes amongst others:
1. Certain providers of NHS and public health services, for example NHS trusts and foundation trusts, may issue Patient Group Directions (PGDs) in relation to parenterally administered medicinal products under powers that previously could only be used to issue PGDs in relation to medicinal products that are not parenterally administered.
2. The PGDs that allow retail pharmacy businesses to administer COVID-19 or influenza vaccines may be used at a location other than a registered pharmacy.
3. Thirdly, doctors, nurses and pharmacists are allowed to prepare or assemble COVID-19 vaccinations, or supervise their preparation or assembly, in circumstances in which they were not previously permitted to do so without the appropriate licences.
4. Authorised medicinal products which are to be used for the reformulation of COVID-19 vaccines, most commonly diluents, may be “assembled” into new products (for example by packing them down into different quantities and relabelling them), without those new products needing to be covered by new marketing authorisations.
The requirement to behave professionally at all times v Article 8 EHCR
Posted: Tuesday, December 1st, 2020
Article 8 of the European Convention on Human Rights concerns the right to respect for private life. There is a tension between Article 8 and the obligation in standard 6 of the GPhC’s Standards for pharmacy professionals which requires pharmacy professionals to behave in a professional manner at all times, not only during working hours. This tension was considered by Mr Justice Singh when the Pharmacists Defence Association challenged the introduction of the Standards in R (on the application of Pitt) v General Pharmaceutical Council  EWHC 809 (Admin); the challenge was unsuccessful because the applicant could not show that regulating behaviour in a registrant’s private life would necessarily infringe the registrant’s Convention right to private life.
In Beckwith v Solicitor’s Regulation Authority  EWHC 3231 (Admin), the High Court allowed the appeal of a senior solicitor whom the Solicitors Disciplinary Tribunal found had acted “inappropriately” by having a consensual “sexual encounter” with a junior colleague after an event at which they had both had too much to drink.
The High Court held that professional rules:
“may reach into private life only when conduct that is part of a person's private life realistically touches on her practise of the profession ... or the standing of the profession ... Any such conduct must be qualitatively relevant. It must, in a way that is demonstrably relevant, engage one or more of the standards of behaviour which are set out in or necessarily implicit from the [professional standards]. In this way, the required fair balance is properly struck between the right to respect for private life and the public interest in the regulation of the ... profession. Regulators will do well to recognise that it is all too easy to be dogmatic without knowing it: popular outcry is not proof that a particular set of events gives rise to any matter falling within a regulator’s remit.”
GPhC fails PSA standards and launches consultation on Fitness to Practise
Posted: Wednesday, November 4th, 2020
The Professional Standards Authority (PSA) has just published its annual review of the GPhC’s performance. The report can be accessed here https://www.professionalstandards.org.uk/docs/default-source/publications/performance-reviews/performance-review-gphc-2019-20.pdf?sfvrsn=1acd7620_8
The GPhC failed to meet three out of five standards and in relation to one of the two standards that were met, the PSA had “significant queries about the robustness of the GPhC’s triage process for fitness to practise referrals” and the PSA’s decision “finely balanced”.
The timeliness of processing fitness to practise cases seems to have been a concern that the PSA has commented on every year. The PSA said:
“… improvements we were expecting to see in the overall end to end timeframe for concluding…cases had not materialised…and our audit found avoidable or unexplained delays in a high proportion of the cases we reviewed.”
All timeframes were heading in the wrong direction. In numbers, it took:
- over 60 weeks from receipt of a referral to a final Investigating Committee decision;
- 40 weeks from final Investigating Committee decision to final Fitness to Practise Committee decision;
- early 100 weeks from referral to a final Fitness to Practise Committee decision
The GPhC had more than twice as many open cases older than 156 weeks than it did in 2015/16.
We reported a few months ago that the GPhC had presented a new Fitness to Practise strategy to its Council. The GPhC has just launched a consultation on the strategy. A link to the consultation is here https://www.pharmacyregulation.org/news/gphc-launches-consultation-fitness-practise-strategy . PLEA plans to respond to the consultation. If you have any particular views you want us to reflect, please email our Chair, David Reissner, at firstname.lastname@example.org by 30 November 2020.
GPhC responds to Times investigation by serving improvement notice
Posted: Thursday, October 29th, 2020
The GPhC continues to make use of its newish powers under the Pharmacy Premises Regulations. Responding to a story about a pharmacy "sell[ing] hormones for trans children online", the GPhC has carried out an inspection and served an improvement notice on the owner of the pharmacy. The improvement notice can be accessed here https://inspections.pharmacyregulation.org/pharmacy/enforcement/1123405-2020-10-21-156.pdf
DHSC consultation on amending Human Medicines Regulations
Posted: Friday, September 18th, 2020
The Department of Health and Social Care has just completed a consultation (conducted over only three weeks) on amending the Human Medicines Regulations (HMR). The aim of the proposed amendments is to enable COVID-19 vaccines (when available) to be used before there has been time to grant a marketing authorisation “if there is a compelling case, on public health grounds, for using a vaccine before it is given a product licence”.
Currently, regulation 345 of the HMR gives immunity from liability for loss and damage where the MHRA recommends or requires the use of a product without a marketing authorisation. Regulation 345 currently extends immunity to manufacturers, marketing authorisation holders, their employees and health care professionals. The amendments proposed to the HMR include extending immunity from liability for loss and damage to pharmaceutical companies that place unlicensed products on the market; and also to extend immunity to other health care workers.
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.