AUTH/3195/4/19 - Anonymous v Chiesi

Sponsored therapy review services

  • Received
    30 April 2019
  • Case number
    AUTH/3195/4/19
  • Applicable Code year
    2016
  • Completed
    14 October 2020
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    Appeal by complainants

Case Summary

An anonymous contactable group, which described itself as consisting of GPs, NHS leaders, pharmacists, NHS patients and current staff from a named third party providing therapy review services, complained about a number of therapy review services provided by that third party on behalf of a number of pharmaceutical companies, including Chiesi Limited. The Chiesi service at issue was related to chronic obstructive pulmonary disease (COPD).

Chiesi marketed Atimos Modulite (formoterol), Fostair (formoterol/beclometasone), and Trimbow (beclomethasone/formoterol/glycopyrronium bromide) used in the treatment of certain patients with COPD.

The complainants stated that a therapy review service sponsored by a pharmaceutical company would, in the majority of cases, lead to an increase in prescribing of that pharmaceutical company’s medicines; a fact widely known and accepted within the healthcare industry. It also followed that a therapy review service programme which did not demonstrate an increase in prescribing of the product of the sponsoring company would not lead to ongoing financial investment from the sponsoring company.

In order to remain profitable, the named third party service provider had to retain pharmaceutical companies as clients by providing them with a ‘return on investment’ when it delivered therapy review services. It did this by coaching its pharmacists on what it called ‘client value’ which was a guise for ‘return on investment’. The complainant stated that the named third party service provider had historically done this verbally, being careful not to put anything in writing. Like most untoward activities however the truth was eventually exposed. There was now written proof that the named third party service provider linked its therapy review services to the products of the sponsoring pharmaceutical company. This was commercial bias.

The complainants stated that their complaint was based on an internal email sent by a very senior employee at the named third party service provider to the entire clinical team dated 14 August 2018. The complainants alleged that within the email there were several links made between pharmaceutical company product and therapy review service which was totally unacceptable and represented clear breaches of the Code.

The complainants stated that regardless of whether some of the services referred to were currently ‘live’ or not, the confidence and integrity of the pharmaceutical companies involved, along with the Code had already been breached by the sending of the email.

The complainants referred to a number of companies and used the example of linking some named products to some named companies as implying that other therapy reviews listed where no product was mentioned had a clear and obvious link to client product/therapy priorities. There was a number of cross referrals within the letter of complaint.

The email read as follows with regard to the involvement of Chiesi:

‘The contract has been signed and materials are already in the approval process with the next meeting scheduled for this week, so we hope to have further news on a “go-live date” very soon.’

Another extract from the email (final paragraph), provided to Chiesi was as follows:

‘As the business evolves a constant challenge will be to transition and integrate client product/therapy priorities into our internal resource and schedules. The addition of new client such as [three named companies-not Chiesi] also add in the additional challenge of new clinical training. Whilst not every aspect will run exactly to plan the list above illustrates clearly that our reputation […]continues to grow and that our objectives of expansion and diversification are on track.’

The complainants noted the wording of the final paragraph of the email and submitted that it was not Code compliant for an ‘independent’ clinical service provider to email its pharmacists about integrating client product/therapy priorities into its internal resources and schedules. The complainants alleged that this was an attempt to influence the pharmacists and set the expectation for client product where there should be no link at all. The wording implied that the therapy reviews named in the email had a clear and obvious link to ‘client product/therapy priorities’.

As Chiesi was referred to within the email, a breach of Clause 2 was alleged.

By operating in this way, the therapy review services were misleading, deceptive and unlawful. The services were not transparent to those who used them or to patients who had their notes accessed and medicines altered without their consent or knowledge of this bias.

The complainants stated that the matter was being reported to the NHS Counter Fraud Authority. The activities would soon be highlighted in the pharmaceutical and mainstream media as it was in the public interest. The public needed to know that GPs were being misled into signing up to ‘independent’ reviews and that patients had had their treatments changed by the named third party service provider which had a hidden agenda to provide a return on investment to the pharmaceutical companies which paid its wages in order for it to make a profit as a business. The NHS and the public needed protecting from this.

The detailed response from Chiesi is given below.

The Panel noted that before considering each individual case, there were general points relevant to the therapy review services and the email in question which in its view were relevant to all of the cases and these are given below. Each individual case would be considered on its own merits.

In the Panel’s view, the overall impression of the email was such that in the view of the author the therapy services carried out by the third party were inextricably linked to the products of the sponsoring companies. It was extremely concerning that in places the email linked the service to particular products or only offered the service in practices where the formulary did not preclude the company’s product. This and the reminder regarding developing the business including the phrase ‘integrate client product/therapy priorities’ could link company products to a therapy review service. Even where a particular product was not mentioned by name it was extremely likely that the company’s product would be linked to the relevant therapy review, as understandably many of the recipients might see integrating client product/therapy priorities as increased prescribing of the company’s medicines. The important consideration for the Panel was the effect and influence of the email in question in relation to all the other arrangements for each therapy review. The Panel noted it comments with regard to the impression of the entire email but noted that the email did not refer to a specific Chiesi medicine nor link the Chiesi therapy review service to a specific medicine.

The Panel noted Chiesi’s submission that the therapy review service in question had been established to drive quality improvement for patients with COPD through proactive patient identification and pharmacist-led review, to optimise COPD management in line with best practice: the Global Initiative for Chronic Obstructive Lung Disease (GOLD) report; guidelines from the National Institute for Health and Care Excellence (NICE); and practice-defined COPD management framework. One of the objectives stated in the clinical protocol included proactive identification of patients who might benefit from optimisation of current COPD management (pharmacological or non-pharmacological) in line with national and local guidelines and practice-defined COPD management framework.

The lead GP was required to complete the practice-defined COPD management framework in which individual formulations to be considered and which were in line with local formulary. For each therapy class, three formulation options could be entered. The GP specified individual formulations supported by the practice and which COPD guideline/report (GOLD/NICE), local pathway and local formulary (where applicable) to follow. The GP was also required to complete a specification to support non-pharmacological interventions.

The Panel noted the documents provided by Chiesi regarding the arrangements including that the service was provided where a need had been identified for the review of patients with COPD and associated therapeutic management of the disease. The named third party service provider pharmacists could also offer the COPD patient review service to GP practices that expressed an interest in it. If a practice asked about the COPD review service during a promotional call, the representative could give a brief description and provide a service introduction document and might choose to attend the practice the first day of the review to facilitate introduction of the named third party service provider pharmacist.

The Panel further noted that the clinical protocol stated that whilst the service was funded and organised on behalf of Chiesi, any change in COPD management arising from the patient review process remained the choice and sole decision of the lead GP and offering of the service would not be conditional on the prescribing of any Chiesi Ltd product or services. All interventions made by the named third party service provider pharmacist were made according to the lead GP/authorised clinician’s direction and authority. The pharmacists involved would have a thorough working knowledge of the relevant guidelines, reports, and key principles of COPD management and received training.

The clinical protocol stated that upon completion of the project anonymised summary data would be provided to Chiesi in order to monitor the level of benefit to the NHS and its patients. The example report provided by Chiesi included, inter alia, a summary of recommendations and interventions following pharmacist led clinics by medicine class. It did not refer to any specific medicine. The Panel noted that Chiesi was not the only company to market a medicine in any of the classes listed in the report.

The Panel noted Chiesi’s submission that reference to ‘client product/therapy priorities’ in the named third party service provider’s email was an entirely reasonable part of the business update to indicate where future areas of clinical expertise would need to be developed or enhanced within the teams expected to operate the service. Chiesi firmly rejected the allegation that this was linked to Chiesi’s products.

The Panel further noted Chiesi’s submission that the named third party service provider sent internal communications to ensure its staff knew about the product ranges marketed by its client companies to meet pharmacovigilance obligations. The Panel noted Chiesi’s submission that none of the certified service materials that were used with NHS staff to deliver the services made any link to any individual product or product range.

The Panel noted Chiesi’s submission that there was a daily rate for a clinical pharmacist to carry out the therapy review service, there was no additional remuneration or bonus associated with sales of any kind.

Whilst the Panel had concerns including about how the email portrayed the named third party service provider therapy services and its effects on its pharmacists and other staff, it nonetheless noted that the complainant bore the burden of proof. On the balance of probabilities, it was not unreasonable that some, if not all, of the named third party service provider pharmacists would associate the Chiesi therapy review with Chiesi products particularly based on the email at issue. However, taking all the circumstances into account, including its view that Chiesi’s written arrangements for the review did not appear to amount to a switch to a Chiesi medicine, the Panel did not consider that the complainant had established, on the balance of probabilities, that the email demonstrated that the arrangements for the COPD therapy review service supported by Chiesi were such that they failed to meet the requirements for medical and educational goods and services in the Code. Nor had the complainants provided evidence that the therapy review constituted disguised promotion. The Panel therefore ruled no breaches of the Code.

In the Panel’s view, Chiesi had been let down by its third party . The Panel had serious concerns about the impression given by the entire email. However, it did not consider that in the particular circumstances of this case the complainants had provided evidence to show that Chiesi had failed to maintain high standards and no breach of the Code was ruled. This ruling was upheld following an appeal from the complainant.

Given its rulings of no breach of the Code the Panel consequently ruled that there was no breach of Clause 2.