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2020 seminar programme announced - 5 May - Save the date!

Posted: Wednesday, February 5th, 2020

We are delighted to announce that our 2020 annual seminar will take place on 5 May 2020 at Aston University School of Pharmacy. Save the date!

The programme will be:

Booking will be essential. We will send out further details soon.

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,

In deciding on the penalty, the ICO noted amongst other things:

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 [2019] 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:

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:

 

 

 

 

 

 

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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.