AUTH/2539/11/12 - Pharmacosmos A/S v Vifor Pharma

Contracts with Health Professionals

  • Received
    07 November 2012
  • Case number
    AUTH/2539/11/12
  • Applicable Code year
    2012
  • Completed
    22 January 2013
  • No breach Clause(s)
    20.1
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    May 2013

Case Summary

Pharmacosmos A/S complained that exclusivity clauses in Vifor Pharma's consultancy contracts with health professionals were in breach of the Code.

Pharmacosmos alleged that several physicians had stated that they were unable to undertake consultancy work on behalf of Pharmacosmos as this would place them in breach of a pre-existing contract with Vifor.

Pharmacosmos was concerned that some of Vifor's consultancy arrangements with NHS service providers (organisations and individuals) were such that they constituted 'retainer' arrangements of the type banned by the Code and the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) and European Federation of Pharmaceutical Industries Associations (EFPIA) Codes. Whilst the confidential nature of some consultancy work was recognised there were clearly practical and legal issues that arose from exclusivity clauses including competition law, and barriers to market penetration. There were also patient safety issues and practical considerations for the NHS.

Pharmacosmos was conscious that it had not cited a specific example; however this complaint was based on the wording of the final inter-company response from Vifor:

'We cannot comment on whether or not individuals can work on projects for both Vifor and Pharmacosmos at the same time as it will depend on the terms of their particular contracts in question'.

Pharmacosmos considered this was a clear admission that some contracts contained exclusivity clauses. Pharmacosmos sought confirmation that these were reserved for the most appropriate scenarios and did not, for example routinely prevent health professionals from speaking at meetings or attending advisory boards, etc, organised by other companies.

Pharmacosmos did not wish to interfere with the fair and reasonable contracting arrangements between Vifor and its suppliers and did not seek commercially sensitive information. However it was clear that exclusivity clauses were in use and depending on the wording of such clauses, a breach of the Code was therefore likely.

Pharmacosmos noted the requirements in the Code about the use of consultants and believed that these requirements should limit the use of exclusivity clauses to all but the most important confidential matters and should be used in highly specific and very limited circumstances.

Pharmacosmos submitted that it would be difficult to establish a need for an exclusivity clause as part of a speaker contract, for example, without implying an obligation on the part of the consultant.

Pharmacosmos stated that further considerations then arose as to why certain individuals were selected for the consultancy services – was it because the service was genuinely needed and the individual was the most appropriate, or was it to block that individual's availability to other companies.

Pharmacosmos stated there was recent case precedent whereby a complaint could be raised on the suspicion of inappropriate activity, even though the company complainant could not furnish detailed evidence (Cases AUTH/2479/2/12 and AUTH/2480/2/12). In those cases the complainants suspected inappropriate activity at a symposium but had not seen the slides or been present on the day. The case report indicated that the PMCPA sought copies of the slides and made a judgement based on the material reviewed.

 Recognising the delicate nature of this complaint, Pharmacosmos stated that it had no desire to be sent copies of any template or specific contracts used by Vifor. Pharmacosmos hoped that the Authority would consider asking to see a random selection of recent and current contracts used by Vifor in addition to its general templates for routine consultancy arrangements.

The detailed response from Vifor Pharma is given below.

The Panel noted that its role was to consider the case in relation to the requirements of the Code rather than the IFPMA Code of Practice, the EFPIA Code on the Promotion of Prescription-Only Medicines to, and interactions with Healthcare Professionals or UK competition law.

The Panel noted Pharmacosmos' submission that its complaint was based on anecdotal feedback and its reference to Cases AUTH/2479/2/12 and AUTH/2480/2/12. The Panel considered that the nature of the evidence provided in those cases was very different to the present case. Turning to the present case, the Panel noted that the complainant had to establish its complaint on the balance of probabilities. The Panel would consider the evidence provided by both parties.

The Panel noted Pharmacosmos' allegation that some of the consultancy agreements between Vifor and health professionals and Vifor and NHS organisations were such that they constituted 'retainer' arrangements that were banned by, interalia, the Code. However, the Panel noted that the Code did not refer to retainer arrangements or exclusivity clauses and did not, per se, prevent such clauses in consultancy contracts. The Panel further noted that Pharmacosmos had submitted that there were some limited situations where exclusivity was appropriate. Vifor acknowledged that a small number of contracts between UK health professionals and its global organisation contained justifiable exclusivity clauses.

The Panel noted that consultancy agreements would necessarily cover legitimate commercial and business matters beyond the compliance requirements listed in the Code. Matters such as exclusivity terms would not be covered by the Code unless they otherwise rendered an agreement in breach of its requirements.

The Panel noted that Pharmacosmos had implied that some of the contracts between Vifor and health professionals existed to stop that individual working with any other company and that no genuine service to Vifor from the consultant was expected. The Panel noted that Pharmacosmos stated that several physicians were unable to undertake consultancy work for the company as that would place them in breach of a pre-existing contract with Vifor. Pharmacosmos had not identified those physicians or provided any evidence that their contract did not require the physicians to provide a genuine service to Vifor. The Panel noted that it had not seen any of Vifor's current consultancy agreements but noted that Vifors standard operating procedures (SOP), Contracts with Healthcare Professionals, clearly referred to all of the criteria for consultancy listed in the Code and the template contract contained a section headed 'Services' wherein the details of the consulting services could be added. The Panel noted that none of Vifor's standard operating procedure (SOP) template agreements contained exclusivity provisions. The Panel further noted Vifor's submission that no health professional retained by Vifor UK had such clauses in their agreements. A very small number of existing consultancy agreements between UK health professionals and global colleagues contained such provisions. The Panel noted that Pharmacosmos had accepted that exclusivity clauses were not unacceptable per se.

The Panel considered that Pharmacosmos had not, on the balance of probabilities, established that Vifor had used exclusivity clauses in the absence of expecting a genuine service for which there was a legitimate need, from the individual concerned. The Panel ruled no breach of the Code.