AUTH/3045/6/18 - Anonymous v Pfizer

Failure to publish joint working executive summary

  • Received
    01 June 2018
  • Case number
    AUTH/3045/6/18
  • Applicable Code year
    2016
  • Completed
    17 January 2019
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    Appeal by respondent
  • Review
    Published in the May 2020 Review

Case Summary

An anonymous, contactable complainant considered that a cancer data project, operating in a named Scottish region, appeared to be a joint working project although it had not been declared as such by the four companies involved including Pfizer.  The complainant stated that the ABPI had, inter alia, published news of the collaboration.  The complainant had not seen relevant details published on Pfizer’s website, noting that an executive summary should be published before such projects start.  If such details were on the website they were not visible and hence transparent – the project was not listed alongside Pfizer’ other joint working projects.

The complainant acknowledged that it might be a very positive joint working project but queried whether, as long as their project was endorsed by the ABPI, member companies did not have to comply with the Code.  The complainant queried whether the ABPI was leading companies to flagrantly bypass the Code.

The detailed response from Pfizer is given below.

The Panel noted that joint working between the NHS and others and the pharmaceutical industry was defined by the Department of Health as situations where, for the benefit of patients, one or more pharmaceutical companies and the NHS pooled skills, experience and/or resources for the joint development and implementation of patient centred projects and shared a commitment to successful delivery.  The relevant supplementary information to the Code described the features of joint working including that it must be for the benefit of patients, but it was expected that the arrangements would also benefit the NHS and the pharmaceutical company or companies involved.  The Code required a formal written agreement to be in place and an executive summary of the joint working agreement to be made publicly available before arrangements were implemented.

The first issue that the Panel had to decide was whether the arrangements referred to by the complainant constituted joint working.

To determine whether an arrangement was joint working one had to consider whether the project was for the benefit of patients.  The Panel noted the benefits for all stakeholders listed in the protocol and considered that these were primarily, although not exclusively, for the benefit of patients.  In the Panel’s view, that there were ancillary benefits to pharmaceutical companies did not preclude the overall arrangements being considered a joint working project even if such benefits primarily influenced a company’s decision to participate.

The Panel noted that according to Pfizer the NHS region had requested that the contract and funding for the project were managed by the ABPI on behalf of the four funding companies.  Relevant email correspondence was provided.  The Panel noted the sensitivities.  The ABPI and the companies had discussed the classification of the project.  Ultimately, and irrespective of such discussions, companies had to take responsibility for the project classification under the Code.  In the Panel’s view, it was clear from an overall evaluation of the contract between the NHS region and the ABPI, and between the ABPI and each individual company, that the ABPI was contracting on behalf of the four companies and the use of a third party did not, in the Panel’s view, mean that the companies could circumvent the requirements of the Code.  In the Panel’s view, the role of the ABPI did not preclude the arrangements being joint working.

In relation to the project at issue, its protocol set out benefits for stakeholders.  Benefits for patients were listed first and described as ‘Improved patient concordance, adherence and benefit from therapy through additional support of data to ensure optimal use of their medicines’; and ‘Better information as a basis for patient specific treatment decisions’.  The first two of three benefits for the regional NHS board were relevant to patients and included an audit framework as a basis for improved quality of care for breast cancer patients across a Scottish region and ‘Improved capture of patient outcomes’.  The four benefits to ABPI/industry included ‘Improved reputation by working jointly with NHS to benefit patients’ and ‘The optimal use of medicines in the appropriate patients which should mean better proactive treatment and management of patients’.

The Panel noted that the four companies had each paid £32,480.50 and that the ABPI SCG had paid £10,000 towards the project giving a total of £139,922.  The NHS had contributed £118,309.50.  In the Panel’s view, the role of the ABPI did not preclude the arrangements being joint working.

The Panel noted Pfizer’s submission that the project was a financial grant which was classified as a MEGS.  It appeared to have been certified as such.  The Panel further noted Pfizer’s submission that its internal policy prevented it from being able to take any form of direct benefit in return for the provision of a grant.  Pfizer would, therefore, not be participating in any piloting of the HTA process.  Only very brief details appeared in the protocol.  This did not appear to be part of Phase 1 of the project with NHS region.  The project included features of joint working, namely: industry and NHS resources had been pooled to implement a project for the benefit of patients; outcomes that would also benefit the NHS and the four companies involved; both the health board and the four companies had made significant financial contributions towards

the project and defined project outcomes were to be measured and documented.  However, not all of the benefits for stakeholders as set out in the protocol were for the benefit of patients.  The Panel noted its comments above in this regard and considered that the benefits as listed in the protocol in relation to Phase 1 of the project could be predominantly characterized as for the benefit of patients.  The Panel considered that the arrangements at Phase 1 of the project in relation to the NHS region were a joint working project and thus an executive summary of the written agreement ought to have been published before the arrangements were implemented.  The Panel ruled breaches of the Code including that high standards had not been maintained.  In the Panel’s view, the circumstances did not warrant a ruling of a breach of Clause 2 which was reserved to indicate particular disapproval of a company’s activities and reserved for such use.  No breach of Clause 2 was ruled.  This ruling was not appealed.

Upon appeal by Pfizer the Appeal Board considered that the documents could have been better worded to more accurately reflect the arrangements and this included the information issued by the ABPI. The Appeal Board noted Pfizer’s submission that the project was a financial grant which was classified as a MEGS.  At the appeal Pfizer submitted that its position on the steering committee was good financial auditing practice to ensure that the grant was spent as agreed. 

The Appeal Board noted that the whole project included features of joint working, namely, the pooling of industry and NHS resources to implement a project with outcomes listed in the protocol for the benefit of patients and the benefit of the NHS and the four companies involved including Pfizer; both the Scottish region health board and the four companies including Pfizer had made a significant financial contribution towards the project; and defined project outcomes were to be measured and documented.  However, the Appeal Board noted that the protocol of agreement was limited to completing Phase 1.  The outcomes of Phase 1 were a data dictionary, a data quality report and example epidemiological, clinical pathway and outcomes reports that would be aggregated and anonymised and only available to the companies when they had been published by the NHS region.  Although referred to in the protocol, Phases 2 and 3 were not part of the current protocol of agreement and there was no agreement or obligation that the company would be involved in them.

The Appeal Board noted that Pfizer in its appeal provided better and further particulars than had been provided to the Panel particularly with regards to the actual outcomes of Phase I and what Pfizer considered to be the misleading nature of the ABPI press release.

The Appeal Board noted that its role was solely to determine whether the activity at issue was joint working thereby triggering the requirement to publish an executive summary.

The Appeal Board noted its comments above and considered that the benefits listed in the protocol in relation to patients would only come about if Phases 2 and 3 were undertaken and completed; there was no patient centred benefit at the end of Phase 1.  The purpose of Phase 1 and its outputs were data centred rather than patient centred.  The Appeal Board considered that the arrangements at Phase 1 of the project in relation to NHS region were not a joint working project and thus no executive summary of the written agreement needed to have been published before the arrangements were implemented.  The Appeal Board ruled no breaches of the Code in this regard.  The appeal on both points was successful.

Following its completion of the consideration of the appeals in Case AUTH/3045/6/18 and Case AUTH/3046/6/18 (AstraZeneca), the Appeal Board noted that the respondent companies in Case AUTH/3043/6/18 (Novartis) and Case AUTH/3044/6/18 (Roche), had accepted the Panel’s rulings of breaches of the Code and had not appealed.  AstraZeneca had appealed Case AUTH/3046/6/18.

The Appeal Board agreed that Novartis and Roche should be contacted and informed of the outcome of the appeals in Case AUTH/3045/6/18 and Case AUTH/3046/6/18.  The PMCPA Constitution and Procedure did not cover this unusual situation where more than one company was involved in the same set of circumstances and the Appeal Board had taken a different view to the Panel.  Novartis and Roche should each be offered the opportunity to appeal out of time and the appeal process would operate in the usual way.  The complainant should also be informed.  The reports for Case AUTH/3043/6/18 and Case AUTH/3044/6/18 should be updated to reflect the situation and to cross refer to the cases which were successfully appealed.  Roche declined the opportunity to appeal.  Novartis appealed and the Appeal Board subsequently ruled no breaches of the Code.