Excessive drug prices - Court of Appeal rules on Flynn and Pfizer
Posted: Sunday, March 15th, 2020
In December 2016, the Competition and Markets Authority (CMA) found that Pfizer and Flynn Pharma Limited had breached competition law by charging unfairly high prices for phenytoin sodium capsules. Pfizer and Flynn had imposed, overnight, a very large increase in the price of the capsules in September 2012 despite there being no material change in the underlying costs. NHS expenditure on phenytoin sodium capsules rose from about £2 million a year in 2012 to about £50 million in 2013 with, for example, the price of 100mg packs of the drug rising from £2.83 to £67.50. The prices charged in the UK were also many times higher than Pfizer’s prices for the same drug in every other European country it sold capsules in, and several Clinical Commissioning Groups complained about the impact on the services they would be able to offer patients.
The CMA said it was intervening to protect patients, the NHS, and the taxpayers who fund it. The CMA found Pfizer and Flynn’s conduct to be a particularly serious abuse of a dominant position in the market and imposed fines totalling £90m.
Flynn and Pfizer appealed to the Competition Appeals Tribunal (CAT) which overturned the financial penalties because of errors of fact and law made by the CMA. The CMA appealed against the CAT decision, and the Court of Appeal has now partly upheld the appeal.
In Competition and Markets Authority v Flynn Pharma Limited and Pfizer Inc ( EWCA Civ 339), the Court of Appeal has held that in deciding whether there had been an abuse of a dominant position, a range of methodologies could be used, but the basic test was whether a price was "unfair". In broad terms, a price would be unfair when the dominant undertaking had reaped trading benefits it could not have obtained in conditions of "normal and sufficiently effective competition", namely "workable" competition. A price which was excessive because it bore no reasonable relation to the economic value of the good or service was an example of such an unfair price.
In the light of this ruling, the CMA must now reconsider whether there was an abuse of a dominant position and, if so, what action to take.
New GP contract - fax machines and electronic prescriptions
Posted: Thursday, March 12th, 2020
The Secretary of State has made the National Health Service (General Medical Services Contracts and Personal Medical Services Agreements) (Amendment) Regulations 2020. These Regulations will bring new NHS contracts for GPs into force in England on 1 April 2020.
Of interest to the community pharmacy sector, if GPs have an alternative secure electronic means of communication, such as NHS Mail, they must not use fax machines.
In addition, even if a patient has not nominated a pharmacy for the purpose of electronic prescribing, their GP may issue them with an EPS token, which will include a barcode to allow a pharmacy to retrieve the required information from the NHS spine.
Racist remarks, social media and fitness to practise
Posted: Thursday, March 12th, 2020
At our annual seminar in 2019, barrister Kenneth Hamer spoke about social media in fitness to practise cases. Two recent cases shed further light on how racist remarks may be dealt with and the misuse of social media.
In Professional Standards Authority v Health Professions Council and Roberts, the High Court rejected a challenge by the PSA which challenged a finding that a paramedic’s fitness to practise was not impaired.
The paramedic had decided that a patient should be taken to hospital. When talking to his colleagues, he used a racist acronym to describe the patient’s condition. This was reported to the HPC which regulates paramedics. The paramedic said he was ashamed of his deplorable conduct and had attended courses on cultural awareness. The HPC committee found that the racist epithet was an isolated incident that was unlikely to be repeated.
Mrs Justice Foster held that the test of impairment referred to current impairment and the HPC committee had been entitled to decide that the public interest did not require a finding of impairment.
The case is an interesting contrast to the recent decision in Diggins v Bar Standards Board  EWHC 467 (Admin). Martin Diggins is a non-practising barrister. In 2017, a young black female student posted a message on Twitter that referred to the need for Cambridge University to “decolonize its reading lists and…not to be so arrogant as to assume civilization began with the writing of white men”. Diggins tweeted in reply: “Read it. Now, refuse to perform cunnilingus on shrill negroids who will destroy an academic reputation it has taken aeons to build.” A Disciplinary Panel of the Bar Standards Board found that the tweet amounted to misconduct; it reprimanded Diggins and fined him £1,000.
Diggins appealed to the High Court. Mr Justice Warby held that the Panel’s task was to decide whether the tweet was likely to undermine the trust and confidence reposed by others in Diggins and the Bar. In order to determine this, the Panel had to follow the principles set out by the Supreme Court in Stocker v Stocker ( UKSC 17):
"The judge tasked with deciding how a …tweet on Twitter would be interpreted by a social media user must keep in mind the way in which such … tweets are made and read.
… it is wrong to engage in elaborate analysis of a tweet … this is a casual medium; it is in the nature of conversation rather than carefully chosen expression; and … is pre-eminently one in which the reader reads and passes on.
… Twitter is a fast-moving medium. People will tend to scroll through messages relatively quickly. … The essential message that is being conveyed by a Tweet is likely to be absorbed quickly by the reader."
In short, words used on Twitter should not be the subject of elaborate over-analysis in “the fast-moving and relatively informal context of social media”. On the other hand, this did not mean that a person who is criticised for a tweet can excuse or justify a message merely by saying it was posted casually without thought or inhibition.
The judge rejected Diggins’ claim that a single tweet could not be misconduct. Moreover, the Panel had found that although the tweet was directed to a particular student and the university, it was published to the world at large and the words were seriously offensive to third parties. In contrast to the Roberts case, it was not a momentary lapse that had been acknowledged and apologised for: Diggins had chosen not to delete his tweet. The judge held that, applying ordinary community standards, the words used were “racially charged”
The appeal was dismissed.
PSA's annual review of GPhC performance
Posted: Wednesday, February 19th, 2020
The Professional Standards Authority (PSA) has just published a thorough review of the GPhC’s performance in 2018/19 https://www.professionalstandards.org.uk/docs/default-source/publications/performance-review---gphc-2018-19.pdf?sfvrsn=78c17720_0.
Key points include:
- The GPhC met all the standards of good regulation in relation to Guidance and Standards, Education and Training and Registration.
- The PSA had no concerns about revalidation. Very few registrants left the register because of the introduction of the revalidation process. There was a significant increase in registrants being removed from the register for failing to comply with revalidation requirements, but no apparent reason for the rise.
- The GPhC failed to meet four out of ten standards in relation to its core function of Fitness to Practise –
- In determining whether there is a case to answer, the PSA considered some cases were closed prematurely, and found the reasoning given in some cases was flawed.
- In some cases, the GPhC was not following its own guidance by closing cases at the triage stage even though the GPhC did not lack of jurisdiction to deal with the case.
- In general, the GPhC’s triage handling gave rise to a risk of inconsistent decisions being made.
- There was an Inconsistent approach to health cases, such as inviting a registrant to give undertakings about practising when a decision had been made that there was no evidence of current fitness to practise concerns.
- Registrants were being invited in some cases to accept a warning without being told the wording of the warning.
- When warnings were given, no information was published, which did not provide the public with transparency.
- At over 93 weeks on average from the initial complaint, it is still taking the GPhC too long to bring cases to a final hearing.
- A significant proportion of avoidable delays occurred at the investigation stage, where there was limited evidence of management oversight. There has been concern about fitness to practise delays for years and the position has not improved.
- The PSA found that complainants were not being updated about cases or not sent the decisions in cases in which they had raised a concern.
- At the Investigating Committee stage, the reasons for some decisions were limited and did not addresses all aspects of the case, or the decision heavily reflected the wording of the GPhC’s recommendation with little or no evidence of independent consideration of the case. To an outside observer, this sounds like the Investigating Committee is acting as a rubber stamp, though the PSA was too polite to say so.
- The PSA had no concerns about decisions made at final FtP hearings.
Medicines and Medical Devices Bill receives first reading
Posted: Sunday, February 16th, 2020
The Medicines and Medical Devices Bill received its first reading in the House of Commons on 13 February.
The explanatory note (which is not part of the Bill) can be found here https://publications.parliament.uk/pa/bills/cbill/58-01/0090/en/20090en.pdf
When passed and the Bill becomes an Act, it will provide powers to amend the existing legislation regulating human and veterinary medicines.
Examples of changes to the current law that are suggested in the explanatory note are:
- Requiring marketing authorisation holders to make patient information leaflets available online, so that pharmacists who have had to split a pack can print off further leaflets.
- A national registration scheme for online pharmacies (to replace the existing EU scheme).
- Changing the particulars that must be included in a prescription or the types of prescriptions that can be sent electronically.
- Adding to the list of groups authorised to prescribe, either generally or in a defined set of circumstances. It has been suggested that pharmacists may be one of these groups.
- A national scheme to prevent falsified medicines entering the supply chain, instead of the EU scheme introduced by the Falsified Medicines Directive (which could not work if UK pharmacists cannot access the EU repository as a result of Brexit).
- The list of persons authorised to prescribe veterinary medicines may be added to or reduced.
- The labelling requirements for veterinary medicines may be changed through the introduction of pictograms to replace or supplement some of the written labelling requirements.
The Bill is due to have its second reading on 3 March 2020.
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:
- Assisted suicide and the role of pharmacists in end-of-life care – Andrea James and Natalie Lewis
- Legal and ethical implications of hub & spoke dispensing – Noel Wardle
- Sexual misconduct in healthcare Fitness to Practise cases – Mark Harries QC
- Update on veterinary medicines – Rob Morris
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,
- 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.
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.