AUTH/3355/5/20 - Contactable Ex Employee v Britannia

Conduct in relation to payments to health professionals, meetings in India, alleged failure to disclose information to the PMCPA and investigator led clinical trials

  • Received
    22 May 2020
  • Case number
    AUTH/3355/5/20
  • Applicable Code year
    2019
  • Completed
    Interim case report
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
    Audit of company’s procedures
    Advertisement
    Public reprimand
  • Appeal
    No appeal

Case Summary

INTERIM CASE REPORT

An interim case report has been published in this case as the final report was delayed because the Code of Practice Appeal Board had required an audit of the Britannia Pharmaceuticals Ltd’s procedures in relation to the Code (Paragraph 11.3 of the Constitution and Procedure refers).

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A complainant complained about arrangements at Britannia Pharmaceuticals UK in relation to a number of matters which were considered as follows.

The detailed response from Britannia is given below.

1 Payments to Health Professionals

The complainant stated that over the last 4 years, Britannia had paid health professionals above the fair market value (FMV), not in keeping with its standard operating procedures (SOPs). The same speakers were used for promotional meetings, presenting almost identical slide sets. The complainant further stated that when compliance refused to sign-off on ‘prep time’, the speakers (under instruction from Britannia) added in a couple of slides or attended ‘briefing meetings’ (usually a quick phone call or discussion at the venue) to justify ‘prep time’ rates. This issue had been raised but no action was taken to stop it.

The Panel noted that Britannia’s review of all health professional payments made under consultancy was based on the records that were electronically accessible; the company planned to check its hard copy files once Covid restrictions were lifted.

The Panel noted Britannia’s submission that it had reviewed the arrangements from electronic records for the 10 health professionals who were most frequently engaged with Britannia on both global and UK-based projects. Details were provided.

The Panel noted Britannia’s submission that it found no evidence of inflated payments to health professionals and the rates paid were in keeping with its standard operating procedures (SOPs) using predetermined internal hourly rates which reflected the consultant’s professional status and expertise. The Panel considered that the payment of the same amount of paid preparation time for when the same slides or essentially similar slides were used as that paid when a new presentation developed was unacceptable as the payment was not in relation to the work needing to be done. The Panel was very concerned that Britannia had made payments to health professionals for preparation time where it was not warranted nor required. In the Panel’s view, the payments in these instances did not reflect the fair market value of the services provided.

The Panel was further concerned to note Britannia’s submission that there were also clear examples of payments having been made to health professionals without a contract in place. It was very concerning that not all contracts were viewed by someone with the necessary expertise to understand the Code and other requirements for such activities.

The Panel ruled breaches of the Code as acknowledged by Britannia including that Britannia had failed to maintain high standards in this regard. The Panel considered that Britannia had brought discredit upon, and reduced confidence in, the pharmaceutical industry and a breach of Clause 2 was ruled as acknowledged by Britannia.

2 Meetings alleged to be unapproved

The complainant noted that the PMCPA had previously dealt with a complaint regarding the senior Britannia leaders’ trip to India in 2018 with two UK key opinion leaders. It was a complete surprise to the rest of the organisation, as the individuals mentioned had gone to a conference in Hong Kong (International Congress of Parkinson’s Disease and Movement Disorders). The complainant stated that the Britannia leaders and the UK KOLs went on a promotional launch campaign, as evidenced by two YouTube videos.

The complainant stated that the meetings were not approved, although two UK health professionals were used to promote the use of Britannia’s products. Britannia made promises of launching the products in India, and then decided not to.

The complainant stated that this behaviour was not acceptable (raising the hopes of patients and their carers) and cast a shadow on all of pharma. STADA (Britannia’s parent company) ordered an internal investigation, but the report and findings were buried. The complainant was confident that the internal investigation report was not provided to the PMCPA.

The Panel noted that the documentation for the first health professional had been signed by him/her after the meetings had taken place but had not been signed by Britannia nor had it been provided in the company’s response to Case AUTH/3302/1/20. It was not clear from Britannia’s response in this case whether the second health professional had signed a contract. However, the company’s response to Case AUTH/3302/1/20, which also referred to a meeting in India, included a signed contract with the second health professional which had been signed by the second health professional before the meetings and Britannia after the meetings. The Panel noted, however, that there was no specific allegation regarding the contracts for the two UK key opinion leaders. Whilst the approval of overseas meetings might include certification of the arrangements in relation to UK health professional speakers, it appeared to the Panel that the complainant’s allegation was limited to the approval of the meetings themselves.

The Panel considered that with regard to certification of the meetings, the alleged promotion of the product in India to an Indian audience was not within the scope of the UK Code and therefore ruled no breach of the Code.

The Panel considered that it was most unfortunate that it appeared that Britannia had given health professionals and others in India the impression that the company would supply its product in India. The Panel noted Britannia’s submission that the meetings were exploratory and the decision was taken not to proceed. The Panel, however, noted its comment above that the matter was not one within the scope of the UK Code and therefore ruled no breach of the Code in this regard.

The Panel noted its ruling that the meetings in India were not within the scope of the UK Code and considered that whilst it was important that companies provided full and frank responses to the Authority, on balance, in relation to the circumstances of this case, including that the complaint was not considered to be within the scope of the Code, failing to provide the information in relation to the report ordered by STADA and details of the contract with the second UK health professional was not a breach of the Code. The Panel thus ruled no breaches of the Code in this regard including Clause 2.

The parties were informed of the Panel’s decision and the complainant appealed the Panel’s out of scope of the UK Code ruling to an independent referee who decided to refer the matter back to the Panel for its consideration.

The complainant provided further comment.

The Panel noted that the 2016 Code would apply to this allegation as this was the relevant Code at the time of the meetings in question.

The Panel noted the principle of activities carried out by a UK company being covered by the ABPI Code, regardless of whether or not UK health professionals attended, only applied to activities in Europe as set out in the supplementary information. This requirement of the ABPI Code was from the EFPIA Code which was limited to activities which took place in Europe. A promotional meeting for French health professionals only, which took place in France and was organised by a UK company, would be potentially covered by the ABPI Code as a result of the implementation of the EFPIA Code requirement in the ABPI Code. There was no similar requirement for meetings held outside the UK but not in Europe. In such instances, whether the content of a meeting held outside the UK and not in Europe was subject to the ABPI Code would depend on whether UK delegates attended that meeting.

The Panel did not accept the complainant’s view that the Code would apply conversely to the content of the meetings held in India for Indian delegates.

The Panel noted that two UK health professionals provided a service to Britannia and that service was clearly covered by the ABPI Code. The Panel considered, however, that the complaint was about the meetings and their content and not about the speakers and the arrangements in that regard as such.

The Panel noted that the Code required that meetings which involved travel outside the UK where a UK company funded UK delegates be certified. It also required that meetings involving travel outside the UK that were wholly or mainly for UK delegates must also be certified. The Panel noted that neither of these situations applied in this case.

The Panel considered that the allegation was in relation to the approval of the content of the meetings and not in relation to the approval of the arrangements for the speakers. As there were no UK delegates at the meetings, the company did not have to certify the content of the meetings. The Panel thus ruled no breach of the 2016 Code.

On the available information, it appeared from the two YouTube videos provided by the complainant that Britannia had given health professionals and others in India the impression that the company would supply its product in India. In one of the YouTube videos a Britannia employee stated that Britannia was working to move from a compassionate use programme to full registration in the course of the following year. The Panel was concerned that health professionals and others might be disappointed about the decision not to launch the products in India. The Panel noted, however, Britannia’s submission that it had visited a private hospital group in India to discuss named patient supply of apomorphine in 2018 and in early 2019, Britannia progressed a plan to supply named patient supply to the hospital group but during this time a local Indian company completed local registration of apomorphine for Parkinson’s Disease. Britannia therefore decided not to proceed with named patient supply.

With regard to the content of the meetings, the Panel considered that on the available information they appeared to be promotional meetings for Indian health professionals in India. As the attendees were not UK health professionals, the Panel ruled no breach of the Code in relation to the allegation regarding the content of the meetings.

The Panel noted that there was no information before it about why senior Britannia leaders not informing the rest of the UK organisation about the meetings in India was in breach of the Code. Providing the relevant requirements of the Code were met, it was not, in itself, a breach of the Code for senior staff not to notify the rest of the UK organisation about its activities. In addition, the Panel noted its ruling above about the content of the meeting in India and therefore ruled no breach of the Code in relation to these allegations.

With regard to the complainant’s concern that Britannia had not shared with the PMCPA the report of an internal investigation ordered by its parent company, STADA, the Panel noted Britannia’s submission that Britannia had carried out a review of the supply opportunity and compliance requirements but concluded it was not possible to proceed because a local product was registered on the market. The Panel did not consider that Britannia’s alleged failure to provide the PMCPA with a copy of a report in relation to the meeting in India would, in itself, be a breach of the Code. The Panel considered that the complainant had not discharged his/her burden of proof that not providing the report to the PMCPA was, on the balance of probabilities, a breach of the Code and ruled no breach of the Code in that regard. The Panel noted, however, that in Case AUTH/3302/1/20 Britannia submitted that a single UK health professional was present with the support of Britannia Pharmaceuticals at 3 hospital centres in India to evaluate the capability of these centres to prescribe its therapy and give an introductory lecture to the therapy. The Panel was concerned that Britannia had not referred to, or provided, the contract with the second UK health professional in its response to Case AUTH/3302/1/20. The Panel considered that Britannia’s failure to refer to the contract with the second health professional in Case AUTH/3302/1/20 meant that it had failed to maintain high standards and a breach of the Code was ruled.

The Panel noted its rulings above about the content of the meetings in India and did not consider that the particular circumstances of this case warranted a ruling of a breach of Clause 2 which was a sign of particular censure reserved for such use and therefore ruled no breach of Clause 2.

3 Investigator led clinical trials

The complainant alleged that Britannia did not have proper standard operating procedures dealing with investigator-led clinical trials or non-interventional studies. Since 2015, health professionals who required funding would be given the necessary funds through medical and educational goods and services (MEGS). The marketing and medical teams at the time did attempt to raise their concerns, but these were not taken seriously by the Britannia management committee.

The complainant stated that although he/she did not have access to company data, there were two trials (funded by Britannia), links to which were provided, that did not follow any procedures (as there were none at Britannia). The complainant stated that this was a small example of trials that were approved without due process. There was another clinical trial (proposed towards the end of 2018) funded by Britannia without any contracts or process before funds were paid.

The complainant further stated that he/she had realised that Britannia did not have appropriate SOPs to assess clinical trials or to ensure that patients were not harmed.

The Panel noted that the allegations referred to investigator-led trials and non-interventional studies. Britannia responded in relation to investigator-led trials supported by the company and that these were a mixture of interventional and non-interventional studies. The nine studies listed by Britannia appeared to have been funded by the company and carried out in the UK other than the one trial to be carried out in mainland Europe.

The Panel noted that Britannia could only locate electronic records for one of the two studies on the website identified by the complainant. The complainant had made a general allegation about the arrangements for studies.

The Panel noted Britannia’s submission that it was clear from its investigation that in relation to investigator-led trials, Britannia had historically provided support and/or funding through the MEGS process which it now recognised was not appropriate.

The Panel was extremely concerned that Britannia had not considered patient safety when approving investigator-led trials; its pharmacovigilance colleagues were not engaged to address the safety aspect of the studies despite Britannia’s submission that there were processes in place within the pharmacovigilance department.

The Panel noted Britannia’s submission that in relation to the studies, the company failed to consider patient safety and to have the relevant approval processes in place. The Panel, therefore, ruled breaches of the Code including that high standards had not been maintained as acknowledged by Britannia.

The Panel considered that Britannia had brought discredit upon, and reduced confidence in, the pharmaceutical industry and ruled a breach of Clause 2 as acknowledged by Britannia.

The Panel noted Britannia’s voluntary admission that these investigator-led clinical trials were not appropriately disclosed in breach of the Code was taken up in Case AUTH/3490/3/21.

Following its consideration of this case, the Panel decided that as Britannia’s conduct, particularly in relation to Points 1 and 3 above raised concerns about the company’s procedures, it warranted consideration by the Appeal Board. The Panel decided to report Britannia to the Appeal Board under Paragraph 8.2 of the Constitution and Procedure.

The Appeal Board noted that Britannia had provided brief details about its compliance plan and it had apologised for its failings.

The Appeal Board noted Britannia’s submission that it had made a number of improvements and that the compliance structure had been strengthened over the last three years. The company was planning an external compliance audit in October 2021 to act as a benchmark to be repeated in a year.

The Appeal Board was extremely concerned about the multiple failings and Britannia’s lack of control, checks and oversight that had led to the rulings in this case including two separate rulings of a breach of Clause 2. In accordance with Paragraph 11.3 of the Constitution and Procedure, the Appeal Board decided to require an audit of Britannia’s procedures in relation to the Code. The audit should take place as soon as possible and those undertaking the audit should have access to the results of the external compliance audit. On receipt of the report of the audit, the Appeal Board would consider whether further sanctions were necessary.

At its meeting on 16 December 2021 the Appeal Board noted from the report of the November 2021 audit that Britannia was now working to develop a compliance framework and part of this was a move to an electronic system for the review of materials. It appeared that the staff did not have extensive experience in compliance and that the company decided to make changes following the complaints received by the PMCPA rather than recognising its short comings and acting upon them.

The Appeal Board noted Britannia’s comments that it was deeply surprised that those carrying out the audit were concerned about an apparent lack of compliance framework, standard operating procedures (SOPs), training and guidance. The Appeal Board considered that this highlighted Britannia’s lack of understanding of the seriousness of the situation. Britannia accepted that there were, historically, many failings in the organisation, these were described as people, process and culture failings. Much reliance appeared to be placed on a new member of staff. The Appeal Board was concerned that a senior member of staff was not providing sufficient leadership with regard to compliance and the audit and did not appear to be truly engaged in the process. The Appeal Board noted that there was no mention of the actions to be taken by the company in relation to the recommendations in the audit report. Britannia’s comment that it had not committed to use an external provider to repeat a second review of materials a year after the first review was inconsistent with comments made by a senior Britannia employee at the Appeal Board meeting on 1 October 2021. At that meeting a slide headed ‘Continuation of Compliance Plan 2021’ and a time point ‘Oct 2020 External Compliance Audit’ were referred to by a senior Britannia employee who stated that ‘We have invited an external audit partner to complete an external compliance audit on us which we are looking forward to seeing where we are, and we will use this as a benchmark and re-audit in a year or so to see if we’ve made improvements… ‘. The Appeal Board noted that Britannia had not provided the third party report when first requested and it had been necessary for the PMCPA to ask again for that material. In this regard the Appeal Board questioned Britannia’s commitment to self regulation.

The Appeal Board asked the PMCPA to send Britannia a detailed response to the company’s comments on the audit report.

The Appeal Board noted the number of concerns highlighted in recent cases and considered that there appeared to be a number of serious issues with the arrangements within Britannia which might impact on patient safety. The Appeal Board noted from the audit report that the company had identified an error in the prescribing information which was described by some staff as a critical patient safety issue.

The Appeal Board noted that the audit report highlighted a number of other areas of concern including control of materials and activities, meetings and nurse activities.

The Appeal Board had grave concerns about the situation. It decided that in accordance with Paragraph 11.3 of the Constitution and Procedure, Britannia should be publicly reprimanded for its failure to have the necessary control of its activities with regard to compliance with the Code and its failure to provide a third party report when first requested. The Appeal Board also decided that Britannia should be re-audited. The Appeal Board decided that the re-audit should take place in six months’ time at which point it expected the company to demonstrate significant progress. On receipt of the report for that re-audit the Appeal Board would decide whether further sanctions were necessary.

Given the exceptional circumstances of this matter, including the scale and seriousness of the difficulties at Britannia, the Appeal Board requested that certain senior employees should be invited to attend an Appeal Board meeting to discuss the Appeal Board’s concerns. Prior to that meeting the company should provide its compliance action plan for addressing the issues identified in the audit report including a response to each of the recommendations.

At the Appeal Board meeting on 10 March 2022 Britannia submitted that it absolutely understood the seriousness of compliance and it was committed to making the relevant changes and improvements required. In its response it wanted to clearly demonstrate the improvements and changes it had made as an organisation thus far and commitment ongoing. Britannia submitted that the senior employee was fully involved and engaged in activities and correspondence with the PMCPA. Examples were given.

Britannia provided details of its compliance action plan following the PMCPA’s recommendations in the report of the audit and provided details of the actions/mitigation steps. The Appeal Board noted that it had previously decided that Britannia should be re-audited in June/July 2022 and its expectation that Britannia demonstrate significant progress at the re-audit.

The Appeal Board noted the materials provided including the details in Britannia’s compliance strategy for 2022.

One of the reasons the Appeal Board had publicly reprimanded Britannia was that it had not provided a copy of the third party report. In this regard Britannia explained that the reason for the delay was that it had been provided with a draft which it wanted to comment on before the third party finalised the report which would then be provided to the PMCPA.

The Appeal Board noted the second reason it had publicly reprimanded Britannia was for its failure to have the necessary control of its activities with regard to compliance with the Code. The Appeal Board was now encouraged that it appeared that Britannia had started to undertake compliance initiatives including job bag audits, a deviation process, a speak up speak out campaign, the appointment of compliance champions etc, and that the parent company was informed and investment had been made available for compliance resource.

The Appeal Board welcomed the progress that appeared to have been made so far. The Appeal Board still had concerns and requested that Britannia develop a governance framework going forward. The Appeal Board looked forward to the necessary improvements being demonstrated in the re-audit in June/July 2022 and did not consider that any further sanctions were required at this stage.