First penalty for GDPR breach imposed on a pharmacy
Posted: Tuesday, December 31st, 2019
On 20 December 2019, the Information Commissioner’s Office ICO published its first financial penalty - £275,000 - for a breach of the General Data Protection Regulation (GDPR) that came into force across Europe on 25 May 2018. The penalty was imposed on a pharmacy, Doorstep Dispensaree Ltd (DDL).
The ICO had been informed by the MHRA that during an investigation the MHRA had found in a rear courtyard of DDL’s Edgware premises 47 unlocked crates, two disposal bags and a cardboard box full of documents – perhaps 500,000 - containing recent personal data that included names, addresses, dates of birth, NHS numbers, medical information and prescriptions. The data subjects were mainly patients in 78 care homes. The documents were not secure or marked “confidential”.
The ICO considered that personal data had been processed insecurely in a manner that breached GDPR. The ICO sent written questions to DDL, both informally and formally, but DDL did not co-operate with the ICO’s enquiries. Amongst other things,
- When DDL eventually supplied its written procedures to the ICO, they were mainly documents that pre-dated GDPR and did not reflect current requirements
- DDL had contracted with licensed waste disposal company, and argued that the waste disposal company was to blame
- DDL argued that the data were stored securely because the containers were in a locked yard, but admitted that there was access to the yard down a fire escape from residential flats.
In deciding on the penalty, the ICO noted amongst other things:
- GDPR requires protection not just against unauthorised or unlawful processing by third parties, but also against accidental loss and requires the use of appropriate technical or organisational measures.
- DDL’s written procedures called for shredding of patient identifiable information, but this had not been done.
- Several of DDL’s data protection policies were out of date and/or inadequate and/or generic templates (prepared by the NPA).
- DDL had no retention policy that would have ensured data were not retained longer than necessary for the purpose for which the data had been obtained
- The volume and sensitivity of the data.
- Changes made by DDL to prevent repetition of GDPR breaches were not relevant to the seriousness of what had happened although they were a mitigating factor.
- Special category data should have been treated with the utmost care, but DDL had been negligent and the breaches had been repeated.
- The data subjects whose data had not been protected were likely to be elderly or otherwise vulnerable.
- Data subjects were not told how data relating to their health would be handled.
- The breaches were not deliberate, but the evidence of poor data protection practice amounted to “significantly negligent conduct”.
- The absence of measures to ensure data protection by design and default was a “major failing for a controller that routinely processes large quantities of highly sensitive health data”. It was a “cavalier attitude to data protection”.
- DDL’s level of co-operation was poor.
DDL has a right of appeal to the First Tier Tribunal.
Legal challenge to accreditation of homeopathic practitioners
Posted: Wednesday, October 30th, 2019
Yesterday's newspapers carried the story that Sir Simon Stevens, the Chief Executive of NHS England, had written to the Professional Standards Authority about its decision to re-accredit the Society of Homeopaths.
Under a scheme set up by the then Department of Health in 2014, the Professional Standards Authority for Health and Social Care (PSA) accredited a voluntary register maintained by the Society of Homeopaths. Homeopathic practitioners on the register can display a quality mark to signify that they meet the PSA’s standards. The accreditation is subject to annual review.
In April 2019, the PSA published its annual review for the year 2018/19. It renewed the accreditation and made a number of recommendations. As part of the review, audits of registrants’ websites were carried out. The audits focussed on registrants who practised CEASE (Complete Elimination of Autistic Spectrum Expression) therapy and/or vaccination-related therapy. CEASE therapy suggests that there is a direct link from vaccination and other conventional medicine to the causes of autism and other serious health conditions, and the CEASE website made claims that conflicted with the advice of the NHS and had the potential to cause harm if followed.
The re-accreditation of the Society of Homeopaths by the PSA is currently the subject of a pending application for judicial review by the Good Thinking Society because the Society of Homeopaths’ register includes practitioners that offer and promote CEASE therapy. The Good Thinking Society argues that the PSA failed in its legal duty to consider the potential effects of its decision on disabled people, such as the autistic children at whom CEASE therapy is aimed. It also argues that the decision to re-accredit, given what the PSA knew about CEASE therapy, was irrational.
Passing off medicines and trade mark infringement - the colour purple
Posted: Thursday, October 17th, 2019
In Glaxo Wellcome UK Ltd v Sandoz Ltd  EWHC 2545 (Ch), Mr Justice Arnold had to rule on a claim by Glaxo that Sandoz were passing off a generic Accuhaler as Glaxo’s Seretide. Seretide has purple colouring and the claim was largely based on the adoption by Sandoz of a similar colour scheme. Glaxo alleged that patients were likely think that the Sandoz inhaler was from the manufacturers of Seretide and that the use of the colour purple misrepresented to healthcare professionals and patients that the generic inhaler was equivalent to the Accuhaler even though its mechanism, strength and licenced use were different.
Mr Justice Arnold dismissed Glaxo’s claims. He found there was no evidence that patients would assume that any purple inhaler came from the manufacturers of Seretide and there was no evidence that patients had been confused. There was no evidence of confusion on the part of healthcare professionals.
When describing the regulatory regime relating to the supply of medicinal products, the judge noted (paragraph 43) the requirement in regulation 214 of the Human Medicines Regulations 2012 to supply a Prescription Only Medicine in accordance with a prescription, and observed that if a pharmacist supplied a generic medicine when a branded product had been prescribed, this would not only be an offence, but also a trade mark infringement and/or the tort of passing off.
Veterinary medicines after Brexit
Posted: Thursday, October 17th, 2019
The Government has announced that all veterinary medicines authorised for use in the UK will continue to be authorised after Brexit and can remain on the market for sale and supply in their existing packaging https://www.gov.uk/government/news/veterinary-medicines-will-continue-to-be-available-after-brexit-joint-statement-from-vmd-and-noah?utm_source=a036be0e-fdc4-47e9-9e43-abebfeaf6481&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
Government Brexit Guidance on medicines and medical devices
Posted: Thursday, October 10th, 2019
The Government has published a raft of Brexit guidance relating to medicines. The guidance specifically relates to a no-deal Brexit. There is too much to summarise here. A list of the guidance and the links is as follows:
- Exporting active substances for medicines https://www.gov.uk/government/publications/exporting-active-substance-manufacturer-in-the-uk-if-we-leave-the-eu-without-a-deal?utm_source=9ed76ae9-5dd4-41d9-8f28-9d9aade1ba0e&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Importation of investigational medicinal products https://www.gov.uk/government/publications/guidance-on-importation-of-investigational-medicinal-products-from-approval-countries?utm_source=38b3d355-6cc5-44a7-b399-c30c0b520d51&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- How orphan medicinal products will be managed https://www.gov.uk/government/publications/guidance-on-importation-of-investigational-medicinal-products-from-approval-countries?utm_source=38b3d355-6cc5-44a7-b399-c30c0b520d51&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Provision for traditional herbal medicinal products and homeopthic medicinal products https://www.gov.uk/guidance/guidance-on-new-provisions-for-traditional-herbal-medicinal-products-and-homoeopathic-medicinal-products-in-a-no-deal-scenario?utm_source=5e0f7db6-852f-47b1-8971-136b554702c1&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Importing medicines from the EEA https://www.gov.uk/government/publications/importing-medicines-from-an-eea-state-which-is-on-an-approved-country-for-import-list?utm_source=e54665db-d807-4057-ad89-1719ac089b38&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Applying for a certificate of pharmaceutical product https://www.gov.uk/guidance/applying-for-a-certificate-of-pharmaceutical-product-in-a-no-deal-scenario?utm_source=2b068dd1-5fb7-47c4-aa3b-7b1d58f14b92&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Guidance on air freight of medicines https://www.gov.uk/government/publications/guidance-on-distribution-and-importation-of-medicines-and-active-substance-from-approved-countries?utm_source=e2cdee10-0fed-4e60-9dc1-47b1b908f674&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Converting Centrally Authorised Products to UK marketing authorisations https://www.gov.uk/government/publications/guidance-on-distribution-and-importation-of-medicines-and-active-substance-from-approved-countries?utm_source=e2cdee10-0fed-4e60-9dc1-47b1b908f674&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Regulating medical devices https://www.gov.uk/guidance/regulating-medical-devices-in-the-event-of-a-no-deal-scenario?utm_source=de04e7b7-9ef3-4d20-b1ca-0fac2e5944e1&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Webinars on submissions to the MHRA and use of new systems https://www.gov.uk/government/publications/how-to-make-regulatory-medicines-submissions-to-the-mhra-if-the-uk-leaves-the-eu-with-no-deal?utm_source=02db27e5-756f-4d67-9627-126158661eab&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Qualified persons responsible for pharmacovigilance (QPPV) https://www.gov.uk/guidance/guidance-on-qualified-person-responsible-for-pharmacovigilance-qppv-including-pharmacovigilance-system-master-files-psmf-if-the-uk-leaves-the-eu-w?utm_source=b231df6e-1f53-4d79-884e-e3efb8348454&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Contingency legislation covering regulation of medicinal products and medical devices https://www.gov.uk/government/news/contingency-legislation-covering-regulation-of-medicines-and-medical-devices-in-a-no-deal-scenario?utm_source=21ea0f1d-efbd-4eac-8fb7-5462c5b57310&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- MHRA consutation on legislative proposals https://www.gov.uk/government/consultations/mhra-consultation-on-eu-exit-no-deal-legislative-proposals?utm_source=20f0f36e-3a63-45fc-bdc1-8215eee0e6ac&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Exceptions and modifications to EU good pharmacovigilance practice https://www.gov.uk/government/publications/exceptions-and-modifications-to-the-eu-guidance-on-good-pharmacovigilance-practices-that-will-apply-in-a-no-deal-brexit?utm_source=89f0758d-3704-451e-adac-ab9f5eed1cb9&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Converting Parallel Distribution Notices to UK Parallel Import Licences https://www.gov.uk/guidance/guidance-on-converting-parallel-distribution-notices-pdns-to-uk-parallel-import-licences-pils-in-a-no-deal-scenario?utm_source=7effa142-3340-4d41-af0a-046606d979ef&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Reference medicinal products https://www.gov.uk/guidance/guidance-on-reference-medicinal-products-rmps-if-the-uk-leaves-the-eu-without-a-deal?utm_source=6d1b131d-68d2-4bcc-895b-abffdd6ad84d&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Registration of clinical trials for investigational medicinal products https://www.gov.uk/guidance/guidance-on-registration-of-clinical-trials-for-investigational-medicinal-products-and-publication-of-summary-results?utm_source=5558eb31-fd10-4eff-a8dd-9bf63b786796&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Handling of Decentralised and Mutual Recognition procedures https://www.gov.uk/guidance/guidance-on-handling-of-decentralised-and-mutual-recognition-procedures-in-a-no-deal-scenario?utm_source=88e334ff-23f6-4e5a-a54b-f69c8c4f7cbf&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Variations to marketing authorisations https://www.gov.uk/guidance/guidance-on-how-variations-to-marketing-authorisations-mas-will-be-handled-after-exit-day-if-the-is-no-deal?utm_source=510d59ba-a73f-4bf2-be9d-db9973333142&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Conversion of Community Marketing Authorisations to UK Marketing Authorisations https://www.gov.uk/government/publications/conversion-of-community-marketing-authorisations-to-uk-marketing-authorisations-letter-to-industry?utm_source=8b25bfbb-7e24-4b98-bc4e-bd73684e581b&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- List of approved countries for authorised human medicines https://www.gov.uk/government/publications/list-of-approved-countries-for-authorised-human-medicines-in-a-no-deal-scenario?utm_source=32ed8ebb-0bbc-421d-ae2f-9ca869d4a481&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Registering new packaging information for medicines https://www.gov.uk/guidance/updates-to-packaging-components-and-instructions-on-submissions-if-the-uk-leaves-the-eu-without-a-deal-for-those-marketing-authorisations-ma-issued?utm_source=d52522de-8d63-479f-9926-656d7f9e758e&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Marketing Authorisation applications when Member States had not been in agreement https://www.gov.uk/guidance/guidance-on-marketing-authorisation-applications-submitted-to-the-uk-that-have-been-referred-under-article-29-in-a-no-deal-scenario?utm_source=a60d8070-4656-41f8-a774-6a3425d5a750&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- Pharmacovigilance procedures https://www.gov.uk/government/publications/guidance-on-pharmacovigilance-procedures-in-the-event-the-uk-leaves-the-eu-without-a-deal?utm_source=119cf6dd-0db3-46c2-be3c-82bba3401b1b&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
- MHRA guidance and publications https://www.gov.uk/government/collections/mhra-guidance-and-publications-on-a-possible-no-deal-scenario?utm_source=b34c7d01-0615-49d1-9560-811ec5907a3c&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate
GPhC whistleblowing report
Posted: Wednesday, September 18th, 2019
The 9 healthcare regulators have just published an annual report on the way whistleblowing disclosures have been dealt with. The aim of the report is to increase transparency in the way that whistleblowing disclosures are dealt with and to raise confidence among whistleblowers that their disclosures are taken seriously.
The GPhC’s section of the report records the following responses to whistleblowing disclosures received between 1 April 2018 and 31 March 2019:
Under review 7
Closed with no action taken 3
Onward referral to alternative body 1
Regulatory action taken 5
In addition, one disclosure received during the previous reporting period was concluded with guidance.
Equality Act and withdrawing pharmacy services
Posted: Friday, August 30th, 2019
In an article just published in Chemist & Druggist, David Reissner looks at the Equality Act implications of withdrawing pharmacy services. The article can be accessed here: https://www.chemistanddruggist.co.uk/opinion/legal-view-what-consider-stopping-free-deliveries-or-mds
GPhC Publication and disclosure policy in FtP cases
Posted: Sunday, August 25th, 2019
Last Summer, we responded to a GPhC consultation on its Publication and disclosure policy. The new policy has now been published https://www.pharmacyregulation.org/sites/default/files/document/gphc-publication-and-disclosure-policy-gphc0034-august-2019.pdf.
As well as setting out the GPhC’s new policy for publishing the reports of pharmacy inspections, the policy includes:
- Registrants will usually be told if a concern about their fitness to practise has been received unless the GPhC thinks telling the registrant would adversely affect an investigation.
- The identity of an informant will not be disclosed without the informant’s agreement.
- A registrant’s employer may be informed that a concern has been received if the GPhC thinks this is in the public interest.
- An informant will not routinely be informed of the registrant’s response to any request for information, but it may be disclosed on a case-by-case basis. An informant will be informed of the outcome of an investigation.
- Fitness to Practise Committee decisions will be searchable on the GPhC website for 12 months if a registrant’s fitness to practise has been found to be impaired. (This does not include health cases or cases where an interim order has been made, because these cases are heard in private.)
- Varying lengths of time a Fitness to Practise determination appears on the online register. In the case of removal, the period will be 5 years and (the person’s entry on the register showing that they have been removed will remain for 10 years). In the case of suspensions, the determination will appear on the online register for the period of suspension plus 2 years.
Court rules on whether there is a right to silence in Fitness to Practise proceedings
Posted: Thursday, August 15th, 2019
In The Queen (on the application of Evgeniy Kuzmin) v GMC  EWHC 2129 the High Court addressed the question of whether a medical practitioner had a right to silence when appearing before the Medical Practitioner Tribunal and whether adverse inferences could be drawn from silence. As explained below, the significance of the case is not limited to proceedings involving medical practitioners.
Dr Kuzmin was working for an out-of-hours service. He was accused, amongst other things, of poor record keeping. Pending a final hearing, conditions were placed on his registration. These conditions included a requirement to notify any out-of-hours service of the conditions. Dr Kuzmin did not notify an employer of the conditions. No misconduct was found in relation to the original allegations, but it was alleged that the failure to notify the out-of-hours service of the conditions on his registration was misconduct.
In fitness to practise proceedings before the Medical Practitioner Tribunal, Dr Kuzmin filed a written statement, strenuously denying dishonesty and said that any failure was a “complete oversight”. At the conclusion of the GMC’s presentation of its case, Dr Kuzmin’s barrister submitted that there was no case to answer. That submission was unsuccessful. Dr Kuzmin then withdrew his statement and declined to give evidence.
The GMC argued that the Tribunal could draw an adverse inference from the refusal to give evidence and that there was no innocent explanation for the doctor’s failure to inform the out-of-hours service of the conditions imposed on his registration. The Tribunal decided it could draw inferences from silence. The case was then adjourned so that Dr Kuzmin could apply to the High Court for judicial review.
The High Court (Lord Justice Hickinbottom and Mr Justice Butcher) held:
- Disciplinary proceedings are civil, not criminal proceedings (in which a defendant has different rights and protections);
- Ordinarily the public would expect a professional man to give an account of his actions – there is no right to silence in disciplinary/fitness to practise cases;
- It would not be unfair if the possibility that an adverse inference might be drawn makes a healthcare professional feel obliged to give evidence;
- Whether an adverse inference is drawn in any particular case will be “highly dependent upon the facts of the particular case”;
- No inference will be drawn unless:
- a prima facie case to answer has been established;
- the individual has been given appropriate warning that if he does not give evidence than an inference may be drawn; and an opportunity to explain why it would not be reasonable for him to give evidence, and, if it is found that he has no reasonable explanation, an opportunity to give evidence;
- There is no reasonable explanation for his not giving evidence;
- There are no other circumstances in the particular case which would make it unfair to draw such an inference.
The significance for pharmacists and other healthcare professionals
The significance of this decision is not limited to cases against medical practitioners. The Court cited an earlier judgment concerning a pharmacist - R (Panjawani) v Royal Pharmaceutical Society of Great Britain  EWHC 1127 (Admin) as authority for its decision (1) that there is no right to silence in professional disciplinary proceedings; and (2) that adverse inferences can be drawn from silence in proper circumstances. That was a case in which a pharmacist was accused of failing to account for a quantity of Viagra, but had failed to explain what had become of it. In fact, the pharmacist successfully argued that an adverse inference should not have been drawn because the regulator had never given him a proper opportunity to explain what had happened to the Viagra.
The recent Kuzmin case is also of importance to all healthcare professionals because Lord Justice Higginbottom suggested it might be useful for all healthcare regulators to give guidance on the existence of the power to draw adverse inferences and how it might be used in fitness to practise cases.
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.