AUTH/3244/9/19 - Employee v Leo

Conduct of the Medical Scientific (MSL) Team

  • Received
    13 September 2019
  • Case number
  • Applicable Code year
  • Completed
    20 July 2020
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An anonymous and non-contactable complainant who stated that they were an employee of Leo Pharma complained about the company’s dermatology medical scientific liaison (MSL) team.

The complainant alleged that the MSL team ran promotional meetings but that they did not have to do the ABPI examination within 2 years of starting.

The complainant stated that he/she had seen some of the emails sent by the MSLs to customers alleging that they provided a lot more off-label or pre-licence information on products than was asked for and, in that regard, the MSLs provided unsolicited information. The same was true for the medical information team. The complainant stated that he/she was referring to the launch of Kyntheum in this regard and suggested that Leo should provide copies of its medical information responses sent to customers since launch.

One of the MSLs won an award at the annual conference – a prize which was always given to representatives and which was awarded to representatives in other divisions in 2019. The complainant did not know what metric or criteria was used but giving the award to an MSL blurred the line between sales and medical.

The complainant stated that as a group the MSLs did not really know the difference between their role and that of a representative and that was demonstrated daily in their approach and willingness to run promotional meetings. The complainant queried whether the MSLs had had much compliance training or direction. Leo was taking advantage of the MSLs’ lack of knowledge and using them to promote off-label and pre-licence.

The detailed response from Leo is given below.

The Panel noted that the complainant was anonymous and non-contactable and had provided little information and no documentation to support his/her complaint. As with any complaint, the complainant had the burden of proving his/her complaint on the balance of probabilities; the matter would be judged on the evidence provided by the parties.

The Panel noted that the Code included that all relevant personnel, including representatives and members of staff, and others concerned in any way with the preparation or approval of material or activities covered by the Code, must be fully conversant with the Code and the relevant laws and regulations. The Panel noted from the specimen MSL job description that the MSL role would include the preparation of materials. The Panel noted Leo’s submission that it had a range of detailed procedures and training to ensure compliance with the Code. According to Leo, the MSL team had been briefed and trained on its role which included training on the Code. The Panel did not consider that the complainant had established that the MSL or medical information team had not been trained in line with the requirements of the Code and no breach was ruled.

The Panel noted that a representative was defined as calling on members of the health professions and other relevant decision makers in relation to the promotion of medicines. This was a wide definition and could cover the activities of those employees that companies might not call representatives.

Promotion was defined broadly as any activity undertaken by a pharmaceutical company or with its authority which promoted the administration, consumption, prescription, purchase, recommendation, sale, supply or use of its medicines.

The Panel noted that given the MSLs’ role as described by Leo and the broad definition of promotion in the Code, some of their interactions with health professionals etc, especially those initiated by the company, might be considered promotional. The Panel noted that the status of each such interaction should be considered on its individual merits.

The Panel noted that whilst the Code did not prohibit MSLs and the like from promoting medicines as such, companies must take care to ensure that it was done within the requirements of the Code. Companies would need to be extremely careful to ensure that such promotional activity was very clearly separated from the non-promotional role of an MSL and the like and that the distinction must be clear to health professionals.

The Panel noted Leo’s submission that MSLs were not allowed to run promotional meetings; their role was strictly non-promotional and so they did not promote the prescription, supply, sale or administration of any medicine. The Panel noted that whilst there was no evidence of MSLs running promotional meetings as alleged, according to the MSL SOP and Leo’s submission, MSLs could proactively present predominantly educational information at a speaker meeting which could be organised by Leo (including the sales team), provided the content was not off label. The Panel noted Leo’s submission that any information presented would need to be on-label and within the licensed indication of the product being discussed at the wider meeting and if there was content related to the company’s product, prescribing information was supplied in line with the requirements of the Code. The Panel did not consider such proactive presentations by Leo staff, including MSLs, could be anything other than promotional. That such MSL presentations contained predominantly educational material did not mean that they did not satisfy the broad definition of promotion. The Code required all meetings to have a clear educational content. In any event, context was important and presentation of otherwise non-promotional material in a promotional context could render such non-promotional material promotional. In this regard, the MSL presentations appeared, on occasion, to be an integral part of what were described as sales meetings. The Panel also noted that it was important to bear in mind the impression about the status of the MSL that might be given to the audience at such meetings.

The Panel noted that PMCPA Guidance about Clause 3 included that if, as part of their role, the medical and scientific liaison executives (MSL) and the like promoted licensed products and indications then they were covered by the Code including the specific requirements for representatives. The Panel further noted that non-promotional activities by MSLs were also potentially covered by the Code. In the Panel’s view, noting its comments above, part of the MSL’s role at Leo was promotional and therefore the Panel disagreed with Leo’s submission that its MSLs were not required to take an appropriate examination. It appeared from Leo’s response that its MSLs had not taken such an examination and the Panel therefore ruled a breach of the Code.

The Panel noted its comments and ruling above and considered that failure of the MSLs to take an appropriate examination meant that high standards had not been maintained. A breach of the Code was ruled.

The complainant had provided no specific details and no evidence to support his/her allegations that emails sent by MSLs or medical information to customers provided more off-label or pre-licence information on products than what was asked for.

The Panel noted that the complainant had not established that Leo’s MSLs or medical information department had responded to unsolicited queries such that they were promoting unlicensed medicines or indications and therefore no breaches of the Code were ruled.

With regard to the award being given to an MSL, the Panel noted Leo’s submission that in 2019, each business unit consistently awarded in three categories and details were provided. One category was limited to sales and the other two categories were open to all areas of business including, but not limited to, medical. For each category the business unit head submitted nominations to the senior leadership team. There were winners of these awards in other business units which extended to other non-sales departments. For the two categories not limited to sales, there were no metrics identified. These awards were decided on an informal basis to recognise those attributes not related to sales metrics. The Panel did not consider that the complainant had provided evidence to show that this blurred the lines between sales and medical as alleged and no breach of the Code was ruled.

The Panel noted that a ruling of a breach of Clause 2 of the Code was a sign of particular censure and reserved for such. The Panel noted its rulings of breaches of the Code above. In that regard, the Panel did not consider that the particular circumstances of this case warranted additional censure and therefore no breach of Clause 2 was ruled.