CJEU holds that paroxetine settlement agreement was anti-competitive
Posted: Monday, April 13th, 2020
The Court of Justice of the European Union (CJEU) has struck down as anti-competitive an agreement not to put generic paroxetine on the market.
In Generics (UK) Ltd v Competition and Markets Authority (Case C-307/18), the CJEU examined an agreement to settle patent litigation between GlaxoSmithKline, the original manufacturer of the antidepressant paroxetine, and a number of generics manufacturers. Under the terms of settlement, the generics manufacturers undertook not to put generic versions on the market for a specified period. In return, it was agreed that they would receive significant transfers of value.
The CMA had imposed fines of £45m on the companies involved.
In considering whether competition rules had been breached, the CJEU drew a distinction between whether the restriction on competition was the object of the agreement or the effect of the agreement. If it was the object, there was no need to investigate further and the agreement would be struck down. If the restriction was the effect of an agreement, it would be necessary to determine whether an agreement “displayed a sufficient degree of harm to competition”.
In the present case, involving an agreement by the patent holder to make a significant transfer of value to its competitors, the sole consideration for which was their undertaking not to enter the market and to end their challenge to the validity of the patent for paroxetine, restriction on competition was the object of the agreement.
When do convictions for violence merit striking off in fitness to practise cases?
Posted: Monday, April 13th, 2020
It is extremely unusual for a pharmacy fitness to practise case to reach the highest court, so the 2016 case of Khan v General Pharmaceutical Council  UKSC 64 is a rarity. The result of the appeal against the sanction of striking off mayhave surprised at least some of our members. Khan had been convicted of offences involving serious domestic violence including threats to kill, and the GPhC’s Fitness to Practise Committee directed the removal of his name from the register.
The Supreme Court, noted that the offences “did not relate to [Khan’s] professional performance. No patient had been, or was likely to be, put at risk” and considered that the sanction of removal was disproportionate. The Court observed that the Fitness to Practise Committee should have taken into account Khan’s (a) no prior disciplinary history; (b) genuine insight into misconduct; (c) open admissions at an early stage; (d) no actual or potential harm to patients or the public; (e) genuine expression of remorse to committee; and (f) steps taken to prevent recurrence. The Supreme Court held that the appropriate sanction was a 12-month suspension.
Last week’s judgment of Mr Justice Murray in General Medical Council v Saeed  EWHC 830 (Admin) is an interesting contrast to the Khan case. Dr Saeed had been convicted of offences of Controlling and Coercive Behaviour and Assault Occasioning Actual Harm committed against his wife. A prison sentence was imposed, suspended for two years. The Medical Practitioner Tribunal (MPT) imposed a 12-month suspension. The GMC appealed to the High Court against the suspension, arguing that it was unduly lenient. The GMC is one of the few healthcare regulators to have such a right of appeal, and the GMC was criticised by many in the medical profession for exercising this right in the Bawa-Garba case[i] – indeed, the review conducted by a committee chaired by Professor Sir Norman Williams into gross negligence manslaughter after the Bawa-Garba case[ii] recommended that the GMC should lose its right of appeal.
Dr Saeed did not attend the MPT hearing but sent a bundle of documents with a four-page statement in which he acknowledged that his conviction impaired his fitness to practise because of its effect on public confidence in the profession. He recognised that any abuse and aggression, physical or emotional affected public confidence, though he did not admit the allegations leading to his conviction. He had undergone counselling on relationships with a clinical psychologist and provided a certificate to that effect. The MPT found that although Dr Saeed had not demonstrated significant insight, his statement showed he was” able to proactively identify and take steps in order to reflect on and begin to address his unacceptable behaviour.”
Dr Saeed did not attend the hearing of the GMC’s appeal in the High Court, but sent a bundle of documents for the judge to consider. According to the GMC’s indicative sanctions guidance, offences involving violence indicate that erasure from the medical register is appropriate. Mr Justice Murray found that the MPT decision was flawed because it did not explain why the Tribunal had departed from the indicative sanctions guidance and failed to identify the relevant mitigating factors that led to its decision and what weight it gave to each of those factors so as to justify a lesser sanction than erasure.
The GMC’s indicative sanctions guidance, reflecting the High Court decision in Council for the Regulation of Health Care Professionals v General Dental Council, Fleischmann[iii], says “As a general principle, where a doctor has been convicted of a serious criminal offence or offences, they should not be permitted to resume unrestricted practice until they have completed their sentence.”
The GMC’s appeal against the sanction of suspension was also successful because by the time of the MPT hearing Dr Saeed’s suspended sentence had not expired and the MPT had not provide sound reasons for departing from this aspect of the guidance.
The judge stopped short of finding that the only possible outcome was erasure, and sent the case back to the MPT to redetermine the sanction.
[i]  EWCA Civ 1879
[iii]  EWHC 87 (Admin)
Ethical guidance for pharmacists and pharmacy technicians during the Covid-19 pandemic
Posted: Thursday, April 9th, 2020
The Royal Pharmaceiutical Society has published guidance on ethical, professional decision-making during the Covid-19 pandemic. You can access the guidance here https://www.rpharms.com/resources/pharmacy-guides/coronavirus-covid-19/coronavirus-information-for-pharmacists-and-teams/ethical-decision-making . The working group that produced the guidance was chaired by our Vice Chair, Matthew Boyd. Other contriburtors included our members Prof Steve Howard and David Reissner.
Pharmacy market entry applications suspended
Posted: Monday, April 6th, 2020
Since 1987, market entry (sometimes called "control of entry") has been a significant aspect of the pharmacy regulatory scene, dealing with the grant or refusal of applications for inclusion in pharmaceutical lists - colloquiallly referred to as NHS pharmacy contracts. Despite an obligation to determine applications as soon as possible, there have often been delays in processing applications. Now, the Coronavirus has brought processing to a halt in England, with an announcement that the processing of applications has been suspended https://pcse.england.nhs.uk/services/market-entry/
Vicarious liability for employees, non-employees and volunteers
Posted: Monday, April 6th, 2020
Last week, the Supreme Court delivered (virtually) two judgments on vicarious liability – whether an employer or business owner is liable for torts committed by an employee or a non-employee, even though the employer or business owner has not been negligent.
The Morrisons case – the facts
In Wm Morrison Supermarkets plc v Various Claimants  UKSC 12, an employee of the Morrisons supermarket chain, Andrew Skelton, was a senior auditor in the internal audit team. In July 2013, he was disciplined for minor misconduct. Four months later, Morrisons’ auditors requested payroll data. This task was delegated to Skelton who was given access to the names, addresses, gender, dates of birth, phone numbers, national insurance numbers, bank details and salaries of very member of staff. Skelton uploaded the data to a publicly accessible website. He did this from his home. When Morrisons were alerted, they took steps to ensure that the data was removed from the internet, informed all employees and took steps to protect their identities. Morrisons spent more than £2.26m in dealing with the immediate aftermath of the disclosure. Skelton was convicted of a number of offences and sentenced to 8 years’ imprisonment.
Morrisons faced a claim from over 9000 employees who contended that Morrisons were vicariously liable for the breaches by Skelton of the employees’ confidentiality and of the Data Protection Act. Vicarious liability does not require a claimant to prove any negligence on the part of the defendant against whom the claim is made. Cases over the last 20 years, including House of Lords and Supreme Court decisions have clarified when vicarious liability will arise. In particular, the courts have considered what functions or “field of activities” had been entrusted by an employer to an employee and whether there was a sufficient connection between the position in which the employee was employed and the employee’s wrongful conduct to make it right for the employer to be held liable under the principle of social justice.
The legal test
Whether Morrisons was vicariously liable for Skelton’s wrongful acts depended on whether his disclosure of the data was so closely connected with acts he was authorised to do that, for the purposes of the liability of his employer to third parties, his wrongful disclosure may fairly and properly be regarded as done by him while acting in the ordinary course of his employment. The mere fact that Skelton’s employment gave him the opportunity to commit wrongful acts was held not sufficient to warrant the imposition of vicarious liability.
An employee’s motivation in committing a wrongful act may sometimes be relevant: Skelton’s motive – whether he was acting on his employer’s business or for purely personal reasons - was held to be relevant. It was “abundantly clear that Skelton was not engaged in furthering his employer’s business when he committed the wrongdoing in question. On the contrary, he was pursuing a personal vendetta, seeking vengeance for the disciplinary proceedings some months earlier…Skelton’s wrongful conduct was not so closely connected with the acts which he was authorised to do that, for the purposes of Morrison’s liability to third parties, it can fairly and properly be regarded as done by him while acting in the course of although, his employment.”
Can an employer be vicariously liable for data breaches or breach of confidentiality?
The final question was whether an employer could be held vicariously liable for breaches of the Data Protection Act by an employee as a data controller, or for misuse of private information and breach of confidence. The Supreme Court held that an employer could be vicariously liable although Morrisons were not vicariously liable in this particular case.
The Barclays Bank case – the facts
In Barclays Bank plc v Various Claimants  UKSC 13, Barclays were appealing against a ruling that they were vicariously liable for the acts of someone who was not an employee. The late Dr Gordon Bates had been engaged to carry out medical assessments of employees or prospective employees. It was alleged that he had committed sexual assaults on some 126 claimants. It was no longer possible to make a claim against the doctor.
Until 2005, only an employer could be held vicariously liable, which would rule out the possibility that a pharmacy owner could be liable for the negligence of a self-employed locum. In the case of non-employees, earlier cases had looked at the degree of control exercised over the wrongdoer. The question for the court was “whether the tortfeasor is carrying on business on his own account or whether he is in a relationship akin to employment with the defendant.
In this case, Dr Bates was not at any time an employee of the Bank. Nor, viewed objectively, was he anything close to an employee. He was in business on his own account as a medical practitioner.
Barclays’ appeal was allowed.
Volunteers are stepping forward during the Coronavirus pandemic to help pharmacies with medicines deliveries.
In the Barclays Bank case, the Supreme Court recognised that the traditional link between employment and vicarious liability was broken by recent developments such as the “gig” economy.
A court may have to consider on a future occasion whether a pharmacy owner is liable for the negligence of a volunteer who has delivered the wrong medicine or who has breached a patient’s confidentiality.
Misuse of Drugs Regulations to be relaxed
Posted: Friday, April 3rd, 2020
The Home Secretary has written to the Chair of the Advisory Council on the Misuse of Drugs to indicate that the Misuse of Drugs Regulations will be relaxed during the pandemic. You can find the details here https://www.gov.uk/government/publications/letter-to-the-acmd-on-emergency-legislation-to-enable-the-supply-of-controlled-drugs/letter-from-the-home-secretary-to-the-chair-of-the-advisory-council-on-the-misuse-of-drugs
Pandemic-related amendments to NHS Pharmaceutical Services Regulations in England
Posted: Thursday, April 2nd, 2020
Power to suspend terms of service
The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 govern the provision of NHS services by pharmacies in England, with terms of service set out in Schedule 4 to the Regulations. Breaches of the terms of service can result in NHS England serving a remedial notice requiring remedial action, or a breach notice that include the sanction of a withholding of remuneration.
Under the National Health Service (Amendments Relating to the Provision of Primary Care Services During a Pandemic etc.) Regulations 2020 that came into force on 27 March, NHS England has a power, with the agreement of the Secretary of State, to suspend any of the terms of service in an area. In the event of a suspension, no remedial notice or breach notice can be served.
Mandatory home delivery service
The amendment Regulations provide that if NHS England has announced that certain patients are advised to stay away from a pharmacy in a particular area, pharmacies must provide a home delivery service. If approached by a patient who is covered by the advice the pharmacy must provide a home delivery service. The pharmacy must also provide the service if it has not been contacted by the patient if, using “in the ordinary exercise of professional skill and judgement” what is on a prescription indicates that the patient might be covered by the announcement.
The pharmacist must check whether the supply could be made to a patient by a representative of the patient, such as a carer, family member, friend or neighbour. If so, the pharmacy must provide the service through that person.
If there is no representative who can deliver, the home delivery requirement means:
(a) The pharmacy must deliver to the patient’s home or an alternative address agreed with the patient
(b) The pharmacy can arrange delivery using a different pharmacy;
(c) If neither (a) nor (b) is possible, the pharmacy must not dispense a prescription, but must arrange for another pharmacy that can deliver to do the dispensing.
The home delivery requirement will not apply if the patient comes to the pharmacy; and does not apply to distance selling pharmacies.
Normally, pharmacies must supply prescribed medicines with reasonable promptness. In the case of home delivery, this requirement is changed to supplying “within a reasonable timescale”.
Power to dictate core opening hours
In ordinary times, the Pharmaceutical Services Regulations say that pharmacies must be open for at least 40 core hours. The specific 40 hours will have been notified to NHS England. In calculating these 40 core hours, if a pharmacy would normally be open on a Monday or Sunday, it will be treated as being open on Good Friday and Easter Sunday, even if it is closed.
In ordinary times before directing a change to core pharmacy hours, NHSE must
- consider existing supplementary hours; and
- can only direct more than 40 core hours if it is satisfied that the pharmacies affected will receive reasonable remuneration for the additional hours.
Under the amendment Regulations, NHS England can, with the agreement of the Secretary of State, change the core or supplementary opening hours in an area for a specified period. This power overrides the terms of service that apply in ordinary times.
To use this power, NHS England must have the agreement of the Secretary of State and must make an announcement that (paraphrasing) this is related to the pandemic. The change must identify an area and must identify a period.
Failure to open can result in remedial notices, breach notices and a withholding of remuneration. There is a right of appeal to NHS Resolution, but NHS Resolution has been unsympathetic to appeals relating to Christmas closures and other unavoidable closures in the past. It remains to be seen if Pandemic-related non-opening would be treated any differently.
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 constitute retail rather than wholesale supplies, and such supplies do 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.”
The CCGs were held to have acted lawfully and the appeals by Bayer and Novartis were dismissed.
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.
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.