A homecare services pharmacist alleged that Merck Serono was involved in the aggressive promotion of Mavenclad (cladribine), a linked dispensing and delivery service and a patient support programme. Mavenclad was indicated for the treatment of adults with highly active relapsing multiple sclerosis (MS).
The complainant noted that on 1 October, the local Merck Serono representative emailed a named homecare service provider stating that the local provision of a clinical service to patients had been agreed and that that organisation should meet with employees of a named health board to implement it.
The complainant explained that although a homecare service for the provision of Mavenclad had been approved locally in September 2019, that decision had not officially been communicated to anyone. Without that official communication, Merck Serono could not state that a homecare service had been agreed. The complainant stated that before 1 October, he/she had not met anyone from Merck Serono, nor received any requests to discuss the implementation of such a service. Without such a meeting, no-one from Merck Serono could obtain any authority to contact an independent third party on either the complainant’s or the health board’s behalf to request the introduction of any clinical service. Such authority would always be given in writing, which was not done on this occasion.
The complainant noted that part of the discussion regarding the service focussed on the use of Mavenclad in a 17-year old patient. Mavenclad was used in a relatively small cohort of patients, and this was the only new patient potentially being considered for treatment at the time. As such use would not be in accordance with the terms of its marketing authorization, the complainant alleged that the promotional activities to implement the homecare service were in breach of the Code.
The complainant alleged that Merck Serono’s actions were intended to circumvent local policies and procedures by influencing local stakeholders to implement a clinical service not in accordance with due process. The policies and procedures of the health board were designed to ensure that all medicines were prescribed appropriately, safely and effectively and that adequate governance procedures were always strictly adhered to. The complainant alleged that where a pharmaceutical company sought to impair the effectiveness of local policies, it necessarily followed that this might potentially prejudice patient care, in breach of Clause 2.
The complainant stated that commercial relationships between Merck Serono and the named homecare service provider should be clear and transparent and in that regard he/she referred to the representative’s email of 1 October. The complainant asked for the contents of any such contract to be disclosed.
The complainant noted that procurement of a medicine via a homecare service meant that VAT was not applied and at the current NHS list price that represented a saving of £409.45 per tablet. The complainant alleged that promotion of the homecare service constituted a substantial financial incentive to prescribe.
The complainant further alleged that the conduct of the Merck Serono representative was unethical, with the potential to damage the internal working relationships between health professionals within the health board.
Additionally, the homecare service was provided with an optional ‘add-on’ of a named patient support programme, an entirely separate service which was not dependent upon the ‘dispense and deliver’ service. Promotional material distributed by the homecare service provider referred specifically to Mavenclad not to Merck Serono’s sponsorship. Likewise, on the website the large font gave the homecare service provider as a valid UK email contact point, and so an uninformed user might assume that this was the service provider’s-managed service, despite the site being owned and managed by Merck Serono.
The complainant stated that he/she was currently only able to procure Mavenclad directly via wholesale dealing or via the homecare service provider. He/she did not consider it necessary for a pharmaceutical company to place restrictive commercial arrangements on procurement and supply which distorted the market, reduced competition and limited patient choice. The complainant referred to national good practice guidelines, which Merck claimed to follow, which stated that for homecare services, companies should offer at least two providers wherever possible and appropriate.
Mavenclad was an oral tablet which could be dispensed by any registered pharmacy contractor, of which the homecare service provider was but one of many. The complainant considered that the absence of any other dispensing and delivery service options was unacceptable and without any just rationale. The health board had requested Mavenclad to be made available via alternative providers, but this had not yet been implemented.
The complainant noted that the health board currently had a separate service level agreement with each homecare service provider under which it monitored performance and enforced quality improvements. However, a single procurement option removed market competition and the health board’s ability to enact the sanction of changing provider in the event of a sub-standard service. That being the case, then the failing of any third-party in respect of delivering an acceptable clinical service would necessarily become a failing of the pharmaceutical company to adhere to the Code – including, in particular, Clause 2 by reducing confidence in the industry.
The detailed response from Merck Serono is given below.
The Panel noted Merck Serono’s submission that as part of the promotion of Mavenclad, its representatives informed health professionals, where relevant, of the associated homecare dispense and delivery service and the patient support programme; representatives did not tell health professionals about the homecare delivery service or the patient support programme in isolation from the promotion of Mavenclad. The Panel did not consider that the complainant had shown that Merck Serono was engaged in aggressive promotion as alleged. No breaches of the Code were ruled in that regard.
The Panel noted that in July, Merck Serono’s representative met a local hospital pharmacist and in September medical information sent a letter to him/her about the use of Mavenclad in a 17-year old. The letter appeared to have been sent in direct response to the pharmacist’s enquiry about such use. Meanwhile, the representative had also met a local consultant at a conference sometime in September. The Panel noted Merck Serono’s submission that both the pharmacist and the consultant were interested in the homecare dispense and delivery service and the representative followed up on this by referring that interest to the homecare service provider in a short email of 1 October. That Panel noted, however, that the email stated that the two health professionals had agreed to go ahead with the homecare service rather than referring to them being interested in it; the representative asked the homecare service provider to meet with the pharmacist and the homecare pharmacist (assumed by the Panel to be the complainant) to make the necessary arrangements. Contact details were provided for the pharmacist and consultant but not for the complainant despite his/her overall responsibility for homecare and prescribing support. In a second email of 1 October the representative contacted a number of people at the health board, including the pharmacist and the consultant stating that he/she had asked the homecare service provider to contact the pharmacist and the complainant about the implementation of the homecare delivery service, but again did not copy in the complainant. The service provider however, contacted the complainant on the same day (1 October), forwarding the message from the representative and asking whether it and the complainant should meet. This appeared to be the first that the complainant knew about the conversations which had taken place between the representative and the two health professionals.
The Panel noted that, apparently separate to the conversations between the representative and the two health professionals, the local health board was deciding whether to officially approve the homecare service offered by Merck Serono. The service was approved at a meeting in September but, as of 1 October when the complainant received the email from the homecare service provider, that position had not been more widely communicated within the health board. In that regard, it appeared to the Panel that two conversations (the health board’s and the representative’s) were progressing in parallel without either knowing about the other. The Panel thus did not consider that the representative’s reference to ‘the homecare service’ in his/her email to the homecare service provider was a reference to the health board’s decision – it seemed coincidental given that from the complainant’s account, the representative was unlikely to know about that decision. The representative did not refer to the health board or to an ‘agreed homecare service’, but to the pharmacist and consultant agreeing to go ahead with the homecare service. The Panel noted Merck Serono’s submission that it did not receive confirmation from the homecare service provider until 31 October that the health board had signed up for the homecare service. On balance, the Panel did not consider that the representative’s reference to the homecare service misleadingly implied that such a service had been approved or agreed by the health board as alleged – the service was referred to generically as the service available from Merck Serono. No breach of the Code was ruled. The Panel considered that high standards in that regard had been maintained and no breaches of the Code were ruled including of Clause 2.
The Panel was extremely concerned to note Merck Serono’s submission that as its representatives did not usually interact with homecare pharmacists, it would not expect the complainant to know about their promotional activities. The Panel noted that the representative had not kept the complainant informed despite his/her role within the health board for homecare and prescribing support and responsibility for the implementation and monitoring of those services. The Panel queried how, by not interacting with those responsible for homecare services and the like, representatives would know about the relevant policies in place at any particular establishment. By not engaging with the complainant, the Panel considered that the representative had not maintained a high standard of ethical conduct, albeit an action apparently condoned by the company. A breach of the Code was ruled. On the balance of probabilities, the Panel thus considered that the representative had not complied with the local arrangements in force regarding the introduction of a homecare service; a breach of the Code was ruled. The Panel considered that by accepting that its representatives would not interact with homecare pharmacists, Merck Serono had not maintained high standards. A breach of the Code was ruled. The Panel considered that to ensure high quality patient care it was of utmost importance to comply with local policies and to keep key health professionals informed about ongoing discussions with staff which would impinge directly on their areas of responsibility; in accepting that its representatives would not usually interact with those with direct responsibility within a health service for homecare services, Merck Serono had brought discredit upon, and reduced confidence in, the pharmaceutical industry. A breach of Clause 2 was ruled.
The Panel noted the allegation that the discussion of the use of Mavenclad in a 17-year old promoted the medicine for use in an unlicensed patient population. The Panel noted, however, that the medical information letter to the pharmacist about the use of Mavenclad in an adolescent appeared to have been prompted by an enquiry from the pharmacist; it did not appear to be the proactive promotion of such use. The complainant had provided no evidence of off-licence promotion. No breaches of the Code were ruled including no breach of Clause 2.
The Panel noted the complainant’s allegation that the commercial relationship between Merck Serono and the homecare service provider should have been clear and transparent in the representative’s email of 1 October. The Panel assumed that the email in question was the one forwarded to the complainant by the homecare service provider and not the email provided by Merck Serono. The Panel noted that the representative’s email of 1 October was written to the homecare service provider, not to the complainant and so no statement explaining the relationship between Merck Serono (the sender) and the service provider (the recipient) was necessary. No breaches of the Code were ruled including Clause 2.
In the Panel’s view, there was no information before it to suggest that the arrangements between Merck Serono and the homecare service provider were inappropriate. No breach of the Code was ruled.
The Panel did not consider that the matter in question was a joint working project – it was the straightforward provision of a service by Merck Serono. The Panel ruled no breach of the Code related to joint working. No breaches of the Code were ruled including Clause 2.
The Panel noted the allegation that promotion of the homecare service constituted a substantial financial incentive to prescribe. The Panel noted, however, that the VAT position advantages in supplying Mavenclad through a homecare service (a saving of £409.45 per tablet) did not represent a personal advantage for any individual. No breaches of the Code were ruled including Clause 2.
The Panel noted the allegation that promotional material distributed by the homecare service provider referred to Mavenclad but not to Merck’s sponsorship. The promotional literature provided by the complainant clearly referred to the homecare service provider and appeared to be material from it. The leaflet began by introducing ‘our adveva Patient Support Programme for Mavenclad’ followed by ‘We are delighted to announce that [third party] has been selected as the UK distributor and homecare provider for Merck’s Multiple Sclerosis (MS) drug, Mavenclad’. Who ‘we’ was, was not stated – given the reference to ‘Merck’s MS drug’ it appeared to be an organisation other than Merck Serono and given the clear reference to the homecare service provider, readers would assume that the material was independently written by that organisation. The Code required all material relating to medicines and their uses which was sponsored by a pharmaceutical company to clearly indicate that it had been sponsored by that company. In the Panel view, the material provided implied that the service provider had been independently appointed by an unstated third party and was acting independently of Merck Serono which was not so. The only reference to Merck was as the manufacturer of Mavenclad. The Panel considered that readers would not immediately understand the relationship between Merck Serono and the homecare service provider and breaches of the Code were ruled including that high standards had not been maintained. The Panel considered that, on balance, the circumstances did not warrant a ruling of a breach of Clause 2 and ruled accordingly.
The Panel noted the complainant’s reference to restrictive commercial arrangements on the procurement and supply of Mavenclad given that the homecare service was only available from one service provider; national good practice guidelines stated that ‘Manufacturers should offer a minimum of two different Homecare Providers for each Manufacturer Funded Homecare Medicines Service wherever possible and appropriate’. In that regard, the Panel noted Merck Serono’s submission that following discussions with the relevant national guidelines committee, it was agreed that because Mavenclad was only dispensed four times over two years, it was not chronic homecare and so Merck did not need to appoint another homecare service provider. The Panel considered that high standards had been maintained; no breach of the Code was ruled. The Panel also ruled no breach of Clause 2 of the Code.