On 20 March, the BMJ published an article entitled ‘Generic drugs: protest group was not quite what it seemed’. In accordance with the Authority’s Constitution and Procedure, the matter was taken up with Norgine as a complaint by the Director.
The article was about an alleged lack of transparency with regard to Norgine’s role in the publication of a letter in The Times (24 February). The letter was headed ‘Patient wellbeing at risk from substituted generic medicines’. The article claimed that the letter, which had been signed by several doctors and representatives of patient groups, decried generics and pleaded for doctors’ choice to prescribe branded drugs to be paramount. The letter was written in response to the Department of Health’s (DoH’s) consultation on prescribing which proposed automatic generic substitution. The article claimed that Norgine considered that it would be under direct threat as a result of increased use of generics.
The author of the article in the BMJ stated that far from being a spontaneous protest from a group of patients and health professionals, the letter to The Times had been coordinated by a public relations (PR) agency on behalf of Norgine. The article alleged that the agency had searched the published literature for articles written in support of prescribing branded medicines and then invited the authors of those articles to sign a letter protesting against generic substitution. The article stated, however, that the chief operating officer of Norgine did not add his name to the list of signatories.
There seemed to be a lack of transparency.
The author further noted that the letter in The Times had been signed on behalf of three patient organisations which received funding from various pharmaceutical companies and some of the doctors who had signed the letter also advised pharmaceutical companies or received research funding from them.
The detailed response from Norgine is given below.
The Panel first had to decide whether or not the matter was subject to the Code. The Code applied to the promotion of medicines to health professionals and to appropriate administrative staff. The Code also applied to certain areas that were non-promotional, including the provision of information to the public about prescription only medicines. The Code defined promotion and stated that the term promotion did not include information relating to human health or diseases provided there was no reference either direct or indirect, to specific medicines.
The Panel noted that the letter in question referred to prescribed medicines, it focussed on differences between branded and generic medicines and the possible adverse effects on patient wellbeing if pharmacists could automatically substitute a generic medicine even if the doctor had written a prescription for a specific brand. The letter was signed by senior figures from several patient organisations, individual health professionals and others including a previous Director General of the ABPI. No medicine was mentioned by name or unique identifying feature. The Panel noted that it might be argued that the removal of automatic generic substitution would benefit companies by increasing/maintaining the use of branded products ie it would promote the prescription, supply, sale or administration of their medicines. However, given the intended audience, the public, and the content of the letter in question, the Panel decided that the letter to The Times was not 'promotion' as defined in the Code. The letter referred a number of times to prescribing and although not explicitly solely about prescription only medicines such medicines would be covered by the letter. Thus, although not promotional, the Panel considered that the letter was subject to the Code as it was information about prescription only medicines aimed at the public.
The Panel noted that the Code required that material relating to medicines and their uses, whether promotional in nature or not, which was sponsored by a pharmaceutical company must clearly indicate that it had been sponsored by that company. The supplementary information required a declaration to reflect the nature of the company’s involvement. The Code did not specifically mention lobbying activities but in the Panel’s view if such activities resulted in materials relating to medicines and their uses then the Code applied. In the Panel’s view the letter to The Times in contrasting branded and generic medicines clearly referred to medicines and their uses. Norgine’s role in the development and production of the letter meant that it was responsible for it under the Code and that Norgine had sponsored the letter. The Code required transparency about pharmaceutical company activities so that readers of the material were aware of such involvement.
The Panel noted Norgine’s submission that all of the signatories to the letter knew about Norgine’s role in the development and production of the letter. In the Panel’s view it was equally important that those reading the published letter were also aware of Norgine’s role. There was no mention of Norgine either in the published letter itself or as a signatory to the letter. Nor was there any indication of any pharmaceutical company involvement. In the Panel's view the majority of those reading the letter in The Times would have viewed it differently if they had known that it had been sponsored by a pharmaceutical company with an interest in the views expressed. The Panel considered that by not making its role clear Norgine had failed to comply with the Code and a breach was ruled. The Panel considered that Norgine had therefore failed to maintain high standards and a further breach was ruled.
The Panel noted that every case had to be considered on its own merits. The Code covered pharmaceutical company relationships with patient organisations and applied to patient organisations and the like when such activities were supported by pharmaceutical companies. In this case the campaign in question was initiated and funded by Norgine. The suggestion that a letter be written to The Times, signed by clinicians and patient group representatives, had come from a company-organised roundtable meeting of key journalists to gather their views on how awareness of the issues involved could be raised amongst the general public. Potential signatories to the letter were identified by Norgine or its PR agency; some had been previously identified to sign a consensus document whilst others were contacted only to sign the letter. The Panel noted that where the letter was signed by individuals from patient organisations the organisation was also named and the signatory’s position within the organisation stated ie Chair, President, etc. Individuals with no stated involvement with patient organisations had also signed the letter. The Panel queried whether the letter was developed and produced as a result of a formal interaction between Norgine and the patient organisations or as a more personal interaction with individuals operating wholly independently from their patient organisation. However, as patient organisations were named, and the senior position of each signatory within the organisation given, there was an implication that each organisation formally endorsed the letter. This would certainly be the impression given to readers. Readers would not know from the published letter that a pharmaceutical company was also involved. The Panel considered that Norgine had not made its involvement with the patient organisations named in the letter clear. The Panel ruled a breach of the Code. The Code required wording to accurately reflect the nature of a pharmaceutical company's involvement in the declaration of sponsorship and, in the context of relationships with patient organisations, covered all material sponsored by a pharmaceutical company.
Norgine's role in the development and production of the published letter was not clear and a breach of the Code was ruled.
Upon appeal by Norgine, the Appeal Board noted that the letter in question referred to prescribed medicines, it focussed on differences between branded and generic medicines and what might happen to patients if pharmacists could automatically substitute a generic medicine even if a specific brand had been prescribed. No medicine was mentioned by name or unique identifying feature. The letter referred a number of times to prescribing and although not explicitly solely about prescription only medicines such medicines would be covered by the letter. Thus, the Appeal Board considered that the letter was subject to the Code as it was information about prescription only medicines aimed at the public.
The letter to The Times, in contrasting branded and generic medicines, clearly referred to medicines and their uses. The letter had been written as a direct result of a campaign orchestrated by Norgine. Norgine had underwritten the costs of the letter being written. The Code required transparency about pharmaceutical company activities so that readers of the material were aware of any such involvement. The letter itself did not refer to Norgine’s involvement and no one from Norgine had signed the letter. In the Appeal Board's view those reading the letter in The Times should have been able to do so in the knowledge that a pharmaceutical company with a vested interest had been involved in its creation. Disclosure in this regard would have allowed the reader to form his own fully informed opinion of the views expressed. The Appeal Board considered that by not making its role clear Norgine had failed to comply with the Code and it upheld the Panel’s ruling of a breach.
The campaign in question was initiated and funded by Norgine. The suggestion that a letter be written to The Times, signed by clinicians and patient organisation representatives, had come from a company-organised roundtable meeting of key journalists to gather their views on how awareness of the issues involved could be raised amongst the general public. Potential signatories to the letter were identified by Norgine or its PR agency; some had been previously identified to sign a consensus document whilst others were contacted only to sign the letter. The Appeal Board noted from Norgine’s representatives at the appeal that each signatory chose which title to use when signing the letter; some chose to refer to their role in a named patient organisation ie Chair, President, etc. Individuals with no stated involvement with patient organisations had also signed the letter. The Appeal Board considered that as patient organisations were named, and the senior position of each signatory within the organisation given, readers would assume that each organisation formally endorsed the letter. The Appeal Board considered that in any event, by deliberately not providing any indication of its involvement with the production of the letter, Norgine had not made its involvement with the patient organisations noted in the letter clear to those reading it. The Appeal Board upheld the Panel’s ruling of a breach of the Code.
The Appeal Board considered that the Code required wording to accurately reflect the nature of a pharmaceutical company's involvement in the declaration of sponsorship from the outset. Norgine's role in the development and production of the letter was not made clear to readers of The Times. The Appeal Board upheld the Panel’s ruling of a breach of the Code.
The Appeal Board noted that the letter was directed at the public and thus it was important that the public were fully informed as to who was behind it; Norgine, by not declaring its involvement in the creation of the letter had therefore failed to maintain high standards and the Appeal Board upheld the Panel’s ruling of a breach of the Code.
http://www.pmcpa.org.uk/files/2308%2027%20October.pdf
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