Can cost justify prescribing unlicensed medicines? Court of Appeal answers this and other questions
Posted: Sunday, March 29th, 2020
The Court of Appeal has just handed down its judgment in Bayer PLC and Novartis Pharmaceuticals UK Ltd v NHS Darlington CCG and others  EWCA Civ 449.
The Court addressed a number of issues, including:
- In terms of the requirements for a marketing authorisation, manufacturer’s licence or wholesale dealer’s licence (WDA), when is a medicinal product placed on the market?
- Is a WDA required to supply a medicinal product to a hospital for administration to a particular patient?
- If a medicinal product is modified, but a manufacturing licence is not needed because there is a prescription for that particular patient, when must the person who carries out the modification have the prescription?
- Under section 10 of the Medicines Act 1968, there is an exemption from the need for a manufacturing licence for anything done in a hospital or pharmacy under the supervision of a pharmacist. Can this exemption be relied on when medicines are assembled in bulk?
- Does the preparation and supply of syringes from one hospital (or pharmacy) to another come within the exemption in the Medicines Act for “dispensing”?
- If a medicinal product is being modified in large volumes, does the person who does the modifying need to be able to identify a particular product as allocated to a particular named patient.
- Can clinicians prescribe a medicine off-label when there is a suitable licensed medicine available?
- If so, can they do it if the reason for using an unlicensed medicine is cost rather than a clinical reason?
- Was a CCG policy that encouraged the use of an unlicensed medicinal product unlawful?
Darlington CCG and a number of other CCGs, all of which were also Defendants, had adopted a policy that the NHS Trusts from which they commissioned services should use Avastin as the preferred treatment for a form of the eye disease, macular degeneration (WAMD).
WAMD is very common. Avastin was originally developed for the treatment of colorectal cancer and it is licensed for such treatment in the UK. It has been found to be effective in the treatment of WAMD, but no application has been made to license its use in the UK to treat WAMD. Indeed, its formal Summary of Product Characteristics says it is not formulated for intravitreal use.
Avastin is supplied in glass vials. For treating colorectal cancer, the contents of the vial are diluted before administration. To treat WAMD, however, Avastin is not diluted and the contents of a vial are put into a large number of syringes for injection. Under EU law, this is repackaging.
Use of a medicine for a purpose other than the one(s) specified in a licence is generally described as “off-label”. Off-label use of a drug is not necessarily safe or otherwise inappropriate provided that the clinician takes full responsibility for the decision to use it.
There are two licensed products for the treatment of WAMD, Eylea for which Bayer holds the marketing authorisation and Lucentis for which Novartis holds the marketing authorisation in Europe. The evidence before the court was that Avastin was just as safe and effective as Eylea and Lucentis for the treatment of WAMD, but Eylea costs about £800 per injection and Lucentis costs about £550, whereas Avastin costs about £28.
Standard conditions require NHS Trusts to co-operate with CCGs, so they are required to take the CCG’s policy into account.
Bayer and Novartis sued the twelve CCGs and alleged that implementation of the policy would lead to breaches of EU legislation – the Medicines Directive - regulating the marketing and manufacture of medicines, and would also breach the Human Medicines Regulations.
There are exemptions in the Directive from the need for a marketing authorisation. These include medicinal products prepared in a pharmacy in accordance with a prescription for an individual patient; and any medicinal product prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied by patients of the pharmacy.
Ordinarily, preparing, dividing up or changing packaging or presentation – which is done when Avastin is used for WAMD – requires a marketing authorisation.
The Court held that:
- the process of “placing on the market” comes to an end at the point where a clinician prescribes the product for a particular patient. Once a product is under the control of a treating doctor, what happens to the product is “downstream” of the scope of the Medicines Directive. Thus, any subsequent transfer of the product is not part of placing it on the market but is essentially part of the clinical process.
- It follows that someone who divides or repackages Avastin or alters its presentation, without modifying the product, does not require a marketing authorisation so long as it is done on the basis of an individual prescription. “Modifying” means changing the substance of the medicinal product ie changing its biological, chemical or physical state in a way which might significantly affect its quality, efficacy or safety. A risk of contamination because of poor quality control was immaterial to the need for a licence: such processes were under the control of doctors and/or pharmacists who are subject to separate professional regulation. However, any hospital pharmacy that undertook syringe filling would have to give careful thought to how to ensure its processes are safe and accord with any professional rules.
- The person who carries out the modification does not need to have the prescription in their hands at the moment the Avastin is prepared or supplied. It is enough to be informed that the prescription exists – though the prescription must actually be existence.
- The person who fills syringes with Avastin does not have to point to a particular syringe and identify it as allocated to a particular patient. It would be enough if 20 syringes are being prepared and they are covered from the start by 20 existing prescriptions.
- Similarly, a manufacturing authorisation is not required to divide Avastin (the term “compounding” is used in the judgment) so long as this is done in a dispensing pharmacy or by a person legally authorised to do the compounding and this is done solely for retail supply.
- Section 10(1) of the Medicines Act 1968 contains exemptions from the need for a manufacturer’s licence for anything done in a registered pharmacy or hospital under the supervision of a pharmacist, consisting of:
(a) preparing or dispensing a medicinal product in accordance with a prescription; or
(b) assembling a medicinal product in a hospital or pharmacy under the supervision of a pharmacist.
- Novartis argued that “preparation” did not cover the bulk filling of syringes. of products. The Court rejected this and held that section 10 was “perfectly apt” to cover preparing syringes in bulk. The Court also held that when syringes were filled in a pharmacy or hospital and supplied to a hospital for a patient to whom it had been prescribed, this was “dispensing”.
- Novartis additionally argued that when Avastin syringes were prepared in one hospital and supplied to another hospital, a wholesale dealer’s licence was required. The Directive defines “wholesale distribution” in a way that excludes supplies to the public, so supplies to a hospital for administration to a particular patient constitutes retail rather than wholesale supply, and such supplies to not require a wholesale dealer’s licence.
- The word “dispensing” does not appear often in legislation, and is not defined. The Court held that the term covered the preparation of syringes and supply by one hospital to another in response to individual prescriptions.
- The GMC had clarified its position on off-label prescribing, and stated that “doctors must…use resources efficiently for the benefit of patients and the public”. The GMC added that “the treatment options that can be offered to patients may be affected by limits on resources”. Specifically in relation to Avastin, the Chief Executive of the GMC had said that a prescribing decision would not raise fitness to practise issues so long as the broader principles of GMC guidance were followed. In view of this evidence, the Court concluded that clinicians are not prohibited from prescribing an unlicensed drug simply because there are licensed alternatives. As the Court put it:
“There is nothing inherently illegitimate in prescribing decisions being influenced by cost considerations where the evidence shows no differences in efficacy or safety.”
Coronavirus Bill 2020 - emergency powers
Posted: Sunday, March 22nd, 2020
The Government has introduced the Coronavirus Bill 2020 to provide emergency powers to deal with the current crisis. Amongst other things, according to the Department of Health & Social Care, when the Bill is passed:
- For example, dentists and GP practice nurses may be asked to assist staff in NHS hospitals in administering injections and medication that would normally only be administered by hospital medics. Although pharmacists are not mentioned here, potentially they may also be asked to do this.
- Requests may be made of staff in relation to the services they provide in response to a coronavirus outbreak. DHSC expects that this might include the temporary alteration of some practices to enable effective healthcare to continue to be administered across the wider sector. For example, dentists and GP practice nurses may be asked to assist staff in NHS hospitals in administering injections and medication that would normally only be administered by hospital medics. Although, again, pharmacists are not mentioned here, potentially they may also be asked to do this. DHSC expects that such changes to the normal, routine practices of healthcare professionals would only persist for the duration of the response.
- Clause 10 of the Bill contains an indemnity clause that allows the Secretary of State (in relation to the NHS for England) and the Welsh Ministers (in relation to the NHS for Wales) to provide indemnity for clinical negligence liabilities of healthcare professionals and others arising from NHS activities carried out as part of the response to a coronavirus outbreak. Alternatively, the clause allows the Secretary of State or the Welsh Ministers to arrange for such indemnity to be provided by a person authorised by the Secretary of State or the Welsh Ministers. Clause 11 makes similar provision for Scotland and clause 12 for Northern Ireland. Such indemnities will only be available to the extent that the liabilities in question are not already covered by indemnity arrangements.
- The intention behind the indemnity clause is to ensure that, in the exceptional circumstances that might arise in a coronavirus outbreak, sufficient indemnity arrangements are in place to cover all NHS activities required to respond to the outbreak. The clause will provide indemnity for clinical negligence liabilities arising from NHS activities connected to the diagnosis, care and treatment of those who have been diagnosed as having coronavirus disease or who are suspected, or who are at risk, of having the disease. It will also cover healthcare professionals and others providing NHS business-as-usual activities (connected to the diagnosis, care or treatment of a patient) that a person is asked to carry out in consequence of the outbreak, including where such activities are outside the scope of their usual day-to-day practices.
- The Biill empowers the Registrar of the Pharmaceutical Society of Northern Ireland to register as pharmacists fit and proper persons who are suitably experienced if a state of emergency is declared. The Bill does not need to make similar provision in relation to England, Wales and Scotland because such powers already exist in the Pharmacy Order 2010.
The Bill provides that, when passed as the Coronavirus Act 2020, the powers it contains will lapse after two years unless a power to extend the period is activated.
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.
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.