AUTH/2865/8/16 - Anonymous, non-contactable v Sanofi

Engagement of consultant and his/her training and consultancy company

  • Received
    03 August 2016
  • Case number
    AUTH/2865/8/16
  • Applicable Code year
    2016
  • Completed
    19 December 2016
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    no appeal
  • Review
    Published in the February 2017 Review

Case Summary

An anonymous, non-contactable complainant raised concerns about a therapy area specific training and consultancy company and its owner, a health professional who delivered services including practice audits, health professional mentoring, education and classroom based training workshops funded by a number of named pharmaceutical companies including Sanofi. These services had been delivered in a number of named clinical commissioning groups (CCGs) in one area. In addition, the health professional was a specialist nurse employed on a contractual basis by a number of NHS organisations including a city based community healthcare organisation (CHO). In his/her role as a nurse within that organisation the health professional had prescribing responsibility and influence within one of the CCGs named by the complainant. 

The complainant alleged that the training and consultancy company had conducted industry funded clinical audits in several GP surgeries in the area in question which were identifiable as they had highly irregular use of the sponsoring company's product. The patients of several surgeries in one CCG were either initiated onto or switched to the sponsor's medicine with little consideration given to alternative therapies. The pattern of disproportionate increases in product sales could be directly linked back to the pharmaceutical company which had funded the training and consultancy company. 

The complainant referred to a series of accredited training workshops delivered by the training and consultancy company in partnership with a named CCG which was completely funded by industry. The complainant was concerned about the potential substantial financial support to the training and consultancy company for these workshops due to reservations about the ethics of that organisation and because its owner was directly contracted to the local city based CHO. In the complainant's view industry's financial support for these courses was staggering and could be perceived as an attempt to 'buy the business'. 

The complainant alleged that the training and consultancy company had told pharmaceutical companies that if they failed to provide support, their products would not be used in the CCG in which he/she had prescribing responsibility. The complainant stated that his/her company's local representative felt highly pressured to offer funding as he/she had been threatened that if he/she failed to support training events the health professional in question would simply get the money from another pharmaceutical company. The complainant stated that this highly coercive behaviour was completely unacceptable and he/she assumed that similar pressure had been exerted on other pharmaceutical companies. In addition, the complainant noted that services provided by industry were in some cases very similar to the offerings developed by the training and consultancy company and alleged that the health professional in question had left individuals in no doubt that if their company attempted to partner in CCGs where he/she wanted to deliver programmes there could be consequences for their sales in the area in which he/she had prescribing responsibility.

The detailed response from Sanofi is given below. 

The Panel had no contact details for the complainant and so could not ask him/her for further details. The complainant had the burden of proving his/her complaint on the balance of probabilities; he/she had not provided any evidence in support of the allegations. 

The Panel noted that the complainant began by stating that he/she wished to complain about the conduct of the training and consultancy company and subsequently referred to its owner. In this regard the Panel noted that the Code applied solely to the conduct of pharmaceutical companies.

The Panel considered that the scope of the complaint included the engagement of the health professional in question and/or the activities of his/ her company with health professionals, whether the company's activities were delivered by its owner or other individuals. However, when considering such matters the totality of a pharmaceutical company's interactions with the health professional in question would nonetheless be relevant. 

The Panel noted that the complainant had provided a website address for the training and consultancy company which named the health professional in question as the Director and another health professional as the nurse liaison lead. The Panel noted that the named health professional was contracted by the NHS to work at a number of GP surgeries in addition to his/her role at the city based CHO. 

The Panel noted Sanofi had only worked with the training and consultancy company to provide a patient management and nurse advisor service for patients. The Panel noted that according to the Service Operating Procedure the service was a medical and educational goods and service (MEGS) which included a review of patients' current treatment regimen in line with locally agreed guidance and ran from early 2014 until February 2015. 

The Panel noted that although the named health professional originally requested the service and that it be delivered by his/her training and consultancy company, the service was described in the consultancy services agreements as a service to medicine developed by Sanofi. Sanofi was thus responsible under the Code for it. The agreements stated that the role of the training and consultancy company was to deliver the service and undertake patient assessment clinics. 

The Panel noted that according to the service operating procedure the service was to be offered, unrestricted, to local practices upon health care provider request by an NHS outcome manager (NOM) if the practice satisfied certain criteria. If the NOM was satisfied that these criteria were met a Sanofi medical manager would then contact the named health professional who would deliver the service as set out in the service operating procedur via his/her training and consultancy company. 

The Panel noted that the objective of the service was to help patients effectively improve control of their condition and reduce their risk of complications. According to the service operating procedure, specialist nurses employed by the training and consultancy company, or the named health professional in question, individually assessed patients and reviewed their treatment in line with locally agreed guidance provided by the practice so that there was clarity on treatment. Th locally agreed guidance would include national guidance/treatment pathways. An agreement between the training and consultancy company and each individual practice provided that 'the practice would at all times retain clinical responsibility for the management of patients under its care includin but without limitation all prescribing decisions and patient management'.

The Panel noted Sanofi's submission that local sale data showed that the service did not directly affect the uptake of Sanofi products in those practices tha received the service. Taking all the circumstances into account the Panel considered that the complainant had not established that the provision and operation of the management and nurse adviso service was an inducement to prescribe or otherwis contrary to the Code as alleged. High standards ha been maintained. No breaches of the Code were ruled including no breach of Clause 2. 

​​There was no evidence that Sanofi had employed the named health professional as a consultant. No breach of the Code was ruled.​