AUTH/2862/8/16 - Anonymous, non-contactable v Takeda

Engagement of consultant and his/her training and consultancy company

  • Received
    03 August 2016
  • Case number
    AUTH/2862/8/16
  • Applicable Code year
    2014
  • Completed
    09 January 2017
  • No breach Clause(s)
    18.1, 19.1, 19.2, 21 and 23.1
  • Breach Clause(s)
    2, 9.1, 18.1 and 18.6
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    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 Takeda. 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. Reference was made to Takeda's product. 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 Takeda's 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. 

In relation to the audits in a named CCG the Panel noted the allegation that patients were either initiated or switched onto the sponsor's product with little consideration given to other therapies and that surgeries exhibited irregular use of a sponsor's product. Reference was made to abnormally high sales of Takeda's product. The Panel noted the relevant requirements of the Code about switch and therapy review programmes. 

The Panel noted Takeda's submission that when it received the complaint it did not know of any funds provided to the named health professional or the training and consultancy company for audits but during the investigation of the complaint it became aware that the named health professional had delivered two therapy reviews commissioned by clinicians who had received support for those reviews from Takeda in 2015. The Panel noted that Takeda had made a grant to large health centre to run nurse clinics at 11 local practices. Another grant was paid for a similar nurse led clinic at a medical centre based within a different CCG. 

The grant request from the medical centre explained that it would work with a company it had previously worked with to deliver the clinics; the company was not named. The service provider and its status was not identified in any of the materials for the medical centre. The Panel noted that according to Takeda in each case the practice had initially raised its need for funding with either the representative and/ or his/her line manager who each advised that an application be made to the company. 

The Panel did not accept that Takeda only found out that the named health professional and the training and consultancy company were involved with the audits when it investigated this complaint. Indeed the Panel noted that in relation to the review at the medical centre Takeda paid the monies in October 2015 directly to the training and consultancy company rather than the medical centre. In the Panel's view, at the latest, either on payment to the training and consultancy company (in relation to the medical centre) or when the therapy reviews were taking place, individuals at Takeda were aware of the involvement of the training and consultancy company. 

Takeda had stated that it could not comment on any correlation between the training and consultancy company activity and prescribing but noted that its product's use was significant within one of the CCGs where the therapy review took place before the grant request and that the medicine was by a significant margin the least expensive in its class available in the UK. 

The Panel first had to consider Takeda's responsibility for the audits. Noting the level of contact between the parties, previous discussions about the need for audits and advice from field based staff to apply for funding the Panel queried the company's submission that the funding requests were unsolicited. The Panel noted the grant agreements for each therapy review stated that the grant was not an inducement to, or reward for recommending or taking any decisions favourable to Takeda's products or services. The agreements also referred to the NHS body providing a brief report to Takeda on request or as agreed by the parties. The accompanying letters to the practices, however, stated only that Takeda would be extremely interested to hear about the outcomes but that the NHS body was not obliged to provide such details. In addition, the agreement for the health centre stated that it was fully responsible for all aspects of the event; there was no similar statement in the agreement with the medical centre. 

The Panel considered that on the available evidence neither audit was a Takeda activity and thus the clause of the Code that applied to the provision of medical and educational goods and services provided by the company did not apply. No breach of the Code was ruled. The Panel noted that the Code described the circumstances in which a medical and educational good and service could be provided as a donation, grant or benefit in kind. The Panel considered that it was beholden on the company to undertake due diligence when making a restricted use grant for a therapy review to a GP practice or group of practices. This was especially important when the restricted use grant was for an audit in an area where the company had a commercial interest. Such due diligence should ensure, inter alia, that the arrangements were not and could not be perceived as an inducement to prescribe. 

Whilst the Panel had concerns about Takeda's governance of the restricted use grants it nonetheless noted that the complainant bore the burden of proof. The Panel did not consider that the complainant had established that provision of funds and/or the arrangements for the therapy reviews were such that they were a switch service or otherwise an inducement to prescribe as alleged. No breach was ruled. 

The Panel noted that Takeda paid for an exhibition stand at a one day clinical awareness course run by the training and consultancy company. Other companies also exhibited. The Panel noted that an email regarding sponsorship from representative 1 to representative 2 referred to the named health professional doing extra clinics in certain cases and helping and supporting representative 1 with [Takeda's product] in a named area by 'convincing GP practices to switch and use the [Takeda's product] family'. The meeting at issue was referred to as one which the named health professional had asked the representatives to support and 'in return [the named health profession] has agreed that he/she will advocate, and help and support us in our cause in primary care with the [Takeda's product] family'. Representative 2 was asked to contact the named health professional. The email in question was copied to the representatives' line manager and the direct report of representative 1, a primary care representative. The Panel noted Takeda's submission that the senior line manager asked representative 1 to refer the proposal to a senior director but failed to recognise that the email suggested a link between the provision of funding and advocacy and support for Takeda's product. Takeda had not stated whether the senior director saw the original email and, if so, what he/she did with the email or who sanctioned the payment. The representatives gave differing accounts of a subsequent meeting with the named health professional to discuss funding of the course at issue. Representative 1 stated that the named health professional made it clear that he/ she would advocate Takeda's product in return for funding. This was denied by representative 2. A customer relations management (CRM) report for a subsequent meeting with the named health professional stated that he/she agreed to help via speaker meetings to endorse Takeda's product across the region. The Panel also noted Takeda's submission that when it paid for the exhibition stand space, it did not take adequate steps to ensure that it did not exceed fair market value. The Panel considered that given the link between funding and support for Takeda's product as stated in the email, the payment was contrary to the Code and breaches were ruled. The company had failed to maintain high standards and a further breach was ruled. 

​The Panel was very concerned that despite the senior line manager being copied into the email in question no steps were taken by senior staff to review the initial arrangements or otherwise prevent payment. The level of payment was not assessed to make sure it did not exceed fair market value. In addition, the Panel noted that an inducement to prescribe was listed in the supplementary information to Clause 2 as an example of an activity likely to lead to a breach of the Code. The Panel considered that the impression created by the email brought discredit upon and reduced confidence in the pharmaceutical industry. A breach of Clause 2 was ruled. 

The Panel noted its rulings of breaches of the Code in relation to the arrangements and impression created by the email. The Panel considered all the circumstances surrounding the meeting with the named health professional very carefully including that the representatives gave differing accounts of that meeting. The Panel also noted that a ruling of a breach of Clause 2 would be the subject of an advertisement in the medical, pharmacy and nursing press. Taking all the circumstances into account, and on balance, the Panel decided not to report Takeda to the Code of Practice Appeal Board on this point for it to consider whether further sanctions were warranted. 

The Panel considered that the complainant had not established on the balance of probabilities that there was any evidence to show that the engagement of the named health professional to speak at the two promotional meetings in 2015 was an inducement to prescribe. No breach of the Code was ruled. Nonetheless, the Panel considered that his/her contemporaneous engagement in non-promotional and promotional roles either personally or via the training and consultancy company was not compatible. It did not appear that the company had undertaken any due diligence in this regard. High standards had not been maintained and a breach of the Code was ruled. 

​The Panel noted that Takeda had also been asked to respond to the requirements of the Code about relationships and contracts with certain organisations: there was no evidence before the Panel that Takeda had engaged in any such activity and thus no breach was ruled.​​