AUTH/2649/10/13 - Voluntary admission by GlaxoSmithKline

Retrospective certification of joint working project

  • Received
    31 October 2013
  • Case number
    AUTH/2649/10/13
  • Applicable Code year
    2012
  • Completed
    08 January 2014
  • No breach Clause(s)
    14.1
  • Breach Clause(s)
    2, 9.1 and 14.3
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    Appeal by respondent
  • Review
    February 2014

Case Summary

GlaxoSmithKline voluntarily admitted that materials relating to a joint working project were certified after the project had started.

As Paragraph 5.6 of the Constitution and Procedure required the Director to treat a voluntary admission as a complaint, the matter was taken up with GlaxoSmithKline.

GlaxoSmithKline explained that an ongoing disciplinary process had revealed that material relating to a joint working project, which was due to run from October 2011 to October 2012, was not certified before use. When this oversight was noted in May 2012 corrective action was taken immediately and the materials were certified. GlaxoSmithKline submitted that lack of certification at the proper time was an administrative error by an ex-employee.

The detailed response from GlaxoSmithKline is given below.

The Panel noted that the Code required that material prepared in relation to joint working between the NHS and the pharmaceutical industry be certified before use in its final form, to which no subsequent amendments would be made, by two persons, one of whom must be a registered medical practitioner.

The Panel noted that the joint working project at issue was due to run from October 2011 to October 2012. Relevant materials, however, were not certified until May/June 2012, 7-8 months in to the 12 month project. The joint working project had commenced and the material had been used before it had been certified. A breach of the Code was ruled as acknowledged by GlaxoSmithKline. The Panel considered that the material was not covered by the certification requirements for promotional material and no breach of the Code was ruled in that regard.

The Panel noted the importance of certification and its role in underpinning the self-regulatory compliance system. The Panel considered that as material which should have been certified had been used before final sign-off, high standards had not been maintained. A breach of the Code was ruled.

The Panel noted GlaxoSmithKline's submission that the lack of sign-off was an isolated incident, due to one person's action rather than due to lack of process. The Panel noted, however, that although the individual in question had inexplicably cancelled the job within Zinc, the joint working project had nonetheless gone ahead. In the Panel's view this should not have been possible. The Panel noted GlaxoSmithKline's submission that because the job had been cancelled in Zinc, the executive summary had not been made publicly available before theproject started. In the Panel's view, the requirement to publish the executive summary before the arrangements were implemented, as required by the Code, should have prompted an investigation into the matter at the outset. The lack of certification however, was not noted until May 2012 and although materials were certified retrospectively, senior managers were not informed that company process had not been followed. The matter only came to senior managers' attention in connection with another matter.

The Panel noted that the joint working project at issue involved one particular NHS area working in partnership with GlaxoSmithKline to improve local chronic obstructive pulmonary disease (COPD) healthcare. That the project went ahead without key documents being certified was unacceptable. Given the direct impact that joint working projects must have on patient care, all parties to a joint working agreement must be sure that the arrangements had been robustly scrutinised and signed off at the highest level before implementation. The Panel noted its comments above about the importance of certification and considered that an approval system which could be circumvented such as to allow a joint working project with the NHS to proceed with uncertified materials brought discredit upon, and reduced confidence in the pharmaceutical industry. A breach of Clause 2 was ruled which was appealed.

The Appeal Board noted that this case had arisen from a voluntary admission and GlaxoSmithKline's submission that since this matter had come to light the company had improved its compliance procedures to ensure that such issues could not arise in future. The Appeal Board also noted GlaxoSmithKline's submission that a review of all of its other joint working projects had not revealed any problems similar to those that had occurred with the project at issue in this case.

The Appeal Board noted from the Zinc route map that the head office employee responsible for ensuring that the joint working project at issue was certified, had not completed the certification process. The employee had received the job bag in Zinc, after it had been initially reviewed by a number of people, in September 2011 but did nothing with it until February 2012 when the employee cancelled it for reasons unknown. This individual had left GlaxoSmithKline. In the meantime, the project started in October 2011. The procedure within GlaxoSmithKline at the time, which allowed such projects to start, was that the responsible head office employee would inform the responsible field based employee that the project was certified; no documentation of this exchange was required. (The field based employee had no access to Zinc to check that certification was indeed complete).

Once informed by his/her head office colleague that certification was complete, the field based employee could draw down funds to start the project, which he/she was able to do, albeit in the absence of certification, in this case.

The Appeal Board noted from GlaxoSmithKline at the appeal that as a result of a company reorganisation, an internal audit had discovered that the joint working project had not been certified; materials were thus retrospectively certified in May and June 2012. The Appeal Board was very concerned that, given their key role in compliance, none of the three signatories involved immediately reported the retrospective approval to senior colleagues. In the Appeal Board's view, this lack of action by the signatories compounded the original error. The Appeal Board noted that only when the lack of prior certification of the project arose in mid October 2013 as a result of another matter, did GlaxoSmithKline make a voluntary admission to the PMCPA.

The Appeal Board considered that joint working arrangements with the NHS and pharmaceutical companies were complex and would directly affect patient care. Companies must have robust processes to ensure that such arrangements complied with the Code and were certified before projects started. The Appeal Board did not consider the appropriateness per se of the project at issue which appeared to benefit COPD patients. That this project went ahead without prior certification of the arrangements was completely unsatisfactory. The Appeal Board considered that, at the time, GlaxoSmithKline's compliance procedures, financial controls and structural relationships between head office and the field regarding joint working projects were wholly inadequate.

The Appeal Board considered that by not certifying the joint working project before it started, and its subsequent failings in its compliance procedures, GlaxoSmithKline had brought discredit upon, and reduced confidence in, the pharmaceutical industry. The Appeal Board thus upheld the Panel's ruling of a breach of Clause 2. The appeal on this point was unsuccessful.