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AUTH/2979/9/17 - Anonymous, non-contactable complainant v PharmaMar

Case number:AUTH/2979/9/17
Case ref:Anonymous, non-contactable complainant v PharmaMar
Description:Certification and Promotion of Yondelis
Breach:Breaches Clauses 2, 3.2, 7.2, 7.4, 9.1, 12.1 and 14.1, Audit, Public reprimand, Corrective statement
Appeal:No appeal
Status:Breach ruled, Audit, Public reprimand, Corrective statement
Review:To be published in the Review
Received:18/09/2017
Case Summary:
An anonymous, non-contactable complainant who described him/herself as a health professional complained about a ‘Meetings Highlights’ document with the disclaimer ‘This newsletter has been funded by an unrestricted educational grant provided by PharmaMar S.A.  PharmaMar S.A has not been involved in the production, review or distribution of this material’.  The document was on the website of the British Sarcoma Group (BSG).  The complainant alleged that PharmaMar had been involved in the preparation of the material which referred to the off-label, early use of its medicine Yondelis (trabectedin).

The complainant also listed a number of promotional materials which he/she had been informed had not been certified.  The complainant alleged that one piece of material unfairly compared Yondelis with a competitor and another contained unsubstantiated claims.

The detailed response from PharmaMar is given below.

With regard to the Meetings Highlights document, the Panel noted that it was possible for a company to sponsor material, produced by a third party, which mentioned its own products, and not be liable under the Code for its contents, but only if, inter alia, there had been a strictly arm’s length arrangement between the parties.  In practical terms the arrangements must be such that there could be no possibility that the pharmaceutical company had been able to exert any influence or control over the final content of the material.

The Panel considered that the initial arrangements for the production of the Meetings Highlights document were such that PharmaMar was responsible for the content.  There was no arm’s length arrangement.  The Panel did not change its view based on the amendments to the arrangements such that PharmaMar gave the money to BSG so that it could deal with the medical writer etc after the document had been drafted and the company realised the difficulties with the references in the document to the unlicensed use of Yondelis.  The Panel also noted that the Meeting Highlights document had been used by the company for a promotional purpose.

The Panel considered that the Meeting Highlights document was the responsibility of PharmaMar and as it promoted a medicine for an unlicensed use, the Panel ruled a breach of the Code as acknowledged by the company.  The disguised promotional nature of the document was compounded by the inclusion of the disclaimer noted above which was not an accurate description of the company’s role.  The Panel ruled a breach of the Code as acknowledged by PharmaMar.

The Panel ruled that high standards had not been maintained in breach of the Code as acknowledged by the company.  The Panel considered that the circumstances brought discredit upon, and reduced confidence in, the pharmaceutical industry and a breach of Clause 2 was ruled as acknowledged by the company.

The Panel was extremely concerned that the circumstances showed a very poor understanding of the Code.  It was also concerned that an email from a senior executive provided by the complainant showed a disregard for the Code.  The Panel noted, however, that this email could not be located on the company’s server.  PharmaMar submitted that thus its origin and authenticity were not clear.  The senior executive in question denied sending the email at issue.

The Panel upheld the allegations of an unfair comparison of Yondelis vs a competitor and of unsubstantiated claims.  Breaches of the Code were ruled.

The Panel was concerned about PharmaMar’s arrangements for certification.  There was no standard operating procedure and no records of the certificates for the items listed by the complainant.  The company could not demonstrate their date of first use or that the materials had been certified.  The Panel therefore ruled a breach of the Code as acknowledged by the company.

The Panel considered that high standards had not been maintained and that the circumstances brought discredit upon, and reduced confidence in, the pharmaceutical industry.  Breaches of the Code were ruled including Clause 2.

The Panel was extremely concerned about the conduct of senior employees and the lack of procedures for certification which it considered warranted consideration by the Code of Practice Appeal Board.  The Panel therefore decided, in accordance with Paragraph 8.2 of the Constitution and Procedure, to report PharmaMar to the Appeal Board.

The Panel also decided that in accordance with Paragraph 7.1 of the Constitution and Procedure PharmaMar should suspend use of the Meeting Highlights document pending the final outcome of the case.

The Appeal Board considered that this case raised serious concerns about PharmaMar’s processes and Code knowledge.  The Appeal Board queried how such a fundamental failure of compliance on what should be well understood principles of the Code could occur.  The Appeal Board considered that PharmaMar’s investigation into this issue was wholly inadequate.  The Appeal Board noted that in response to questioning, PharmaMar stated that its investigation into this case had comprised an IT investigation run by human resources, which found no record of two of the emails provided by the complainant.  PharmaMar had provided no documentary evidence to verify its IT investigations.

The Appeal Board noted that the PharmaMar representatives submitted that the company had taken advice on this issue from its external review agency yet it provided no documentary evidence to support this.

It was wholly unclear why the HR investigation had focussed on the narrow point about the veracity of the two emails rather than giving any consideration to the broader and significant compliance issues pertaining to the newsletter.  It was inexplicable that those matters had not been addressed and the Appeal Board queried whether the company truly understood the gravity of the situation including the importance of self-regulation.

The Appeal Board noted that the company had provided no record that the member of staff had provided the advice that the company stated it had subsequently followed and that had led to the failings and breaches of the Code.  The Appeal Board noted that in response to questioning PharmaMar stated that the member of staff to whom responsibility for the Code was delegated was not a registered signatory.  When asked what Code training the company had given the answers were unsatisfactory and vague.

The Appeal Board noted that it appeared that the review process was not carried out correctly.  The Appeal Board noted that the company’s external agency had provided external medical review and in that regard the Code only required one signatory.  The company’s online approval system did not keep a record of medical certification.  PharmaMar had acknowledged that it had failed to certify promotional items.  The Appeal Board noted the company’s submission that all materials were withdrawn and subject to recertification.  The Appeal Board considered that it was shocking that PharmaMar had chosen to delegate responsibility for compliance with the Code without confirming the credentials and knowledge of the individual concerned.  The Appeal Board was concerned with the company’s lack of process around certification.  The Appeal Board considered that the certification process, correctly implemented, underpinned self-regulation.  It appeared that there were serious issues regarding PharmaMar’s arrangements.  The Appeal Board considered that the level of Code expertise within the company appeared to be very poor given the fundamental errors and the company’s apparent lack of preparation for the report.

The Appeal Board noted the circumstances that gave rise to this case and the company’s poor approach to compliance as set out in the Panel’s ruling.  The Appeal Board noted that PharmaMar had now commissioned a gap analysis to identify, and thereafter start to address, compliance failings.

The Appeal Board decided that in accordance with Paragraph 11.3 of the Constitution and Procedure, PharmaMar should be publicly reprimanded for failing to make any meaningful effort to undertake a thorough investigation and to provide evidence to support its position.  There were significant omissions in its documentation and the company was unable to provide adequate responses to the Appeal Board questions.  Such an approach raised grave concerns about the importance attached to compliance and self-regulation by the company.  The Appeal Board also decided to require an audit of PharmaMar’s procedures in relation to the Code.  The audit would take place as early as practicable in early 2018 and on receipt of the report, the Appeal Board would consider whether further sanctions were necessary.

The Appeal Board also decided to require PharmaMar to issue a corrective statement to all attendees to the BSG conference and its organisers.  [The corrective statement, which was agreed by the Appeal Board prior to use, appears at the end of this report].

On receipt of the report for the February 2018 audit the Appeal Board noted the poor internal communication at PharmaMar UK and with its Spanish head office.  The Appeal Board considered that PharmaMar in the UK had a very limited compliance structure, compliance expertise and Code knowledge.  Leadership on compliance needed to urgently improve.  The company lacked many of the basic systems that a company required.  It was essential that all staff took an active role in compliance.   

The Appeal Board noted that the report of the audit highlighted many issues and concerns to be addressed including certification, attention to detail, updating and introduction of standard operating procedures (SOPs) and training. Significant and sustained commitment by all staff was required to address these issues.  On receipt of further information in May and June 2018 the Appeal Board decided that PharmaMar should be re-audited in October 2018.  On receipt of the report for the re-audit the Appeal Board would decide whether further sanctions were necessary.