In November 2010, members of the Association of the British Pharmaceutical Industry (ABPI) voted in favour of changes to its Code of Practice, with a view to breaking down ‘barriers to trust’ between healthcare professionals and the pharma. The amendments apply to clauses regarding consultant payments and meeting sponsorship.
Under the new 2011 Code, pharma companies must report financial details (including registration fees, costs of accommodation and travel) when sponsoring healthcare professionals to attend meetings organized by third parties, and declare fees paid to consultants for services such as chairing and speaking at meetings and participation in advisory boards. The practise of giving promotional gifts is also to be strongly curtailed, although pharma companies can still give branded products to HCPs to pass onto their patients.
The amendments were fanfared by a number of assured pronouncements by APBI late last year. Writing in PMLive in October 2010, the ABPI’s ‘Director of Trust’ Andrew Powrie-Smith maintained that “success will not be measured on our ability to hang on to past practices, but on how we meet stakeholders’ expectations going forward.” He added: “We have to earn our stakeholders’ trust and then work hard to keep it, which places an increased emphasis on our behaviours and actions not only being appropriate, but also being recognised as such.” Simon Jose, the Association’s President, followed this (in a November press release from APBI) with: “This vote is a strong symbolic indicator of change and a positive step towards increasing trust in industry as a partner in the healthcare system.”
The timing of the APBI amendments is interesting in that they arrive at more or less hand in hand with the UK’s new Bribery Act. (The ABPI Code becomes ‘operational’ in May; the Bribery Act comes into effect in April). The Bribery Act introduces four offences (two of which are new to the statute books): making a bribe, accepting a bribe, bribing a foreign public official and — of particular interest to pharma — failing to prevent bribery at a corporate level. (This point, wrote Steve Gray on Pharmaphorum [September 20, 2010] “encompasses not just employees, but any agents carrying out an activity to win or retain business for a company.” Or, as his colleague Paul Tunnah puts it, “senior executives are being asked to take greater responsibility for what actually happens on the front-line of the business.”) The upshot is that pharma companies in the UK are suddenly faced with a transparency ‘double whammy’. So what — aside from the apparent arrival of a climate in which the UK pharma industry no longer appears to be trusted to trust itself — are the implications of this?
Even when waxing lyrical over the ethical importance of its Code changes, ABPI’s Andrew Powrie-Smith conceded that he recognized that their implementation “will present some challenges to individual companies.” The Ethical Medicines Industry Group (EMIG) responded by taking particular exception to the clause on promotional items. EMIG complained about the lack of clarification on what types of promotional items were to be excluded in the APBI ban and expressed concern that the distribution of allowable promotional items is not separated from the role of the medical representative. Adding that that the new clauses “will make the UK market the most restricted promotional environment for pharmaceuticals,” EMIG went on: “This will place smaller and medium sized companies with the majority of their turnover in the UK at a considerable disadvantage compared with similar companies abroad.”
Further, EMIG claimed there was no evidence that ABPI’s proposals would enhance trust between HCPs and industry: “Indeed, many doctors could react negatively to the suggestion that the provision of inexpensive branding items might influence their prescribing behavior.”
A Cegedim survey into regulatory compliance trends published in November 2010 proposed that European pharma will be required to follow more closely the more mature US model in responding to the changes brought about by the implementation of the Bribery Act and the new ABPI Code (which, after all, impose a model of disclosure that has existed in the US for many years). While highlighting that 93% of its respondents agreed that “regulatory compliance will become a major challenge in Europe,” the Cegedim study pointed to wide agreement in Europe, for example, for the uptake of US methods of tracking promotional spend.
However, the UK developments come at a point where the US is preparing for even stricter transparency legislation in the shape of the Sunshine Act. If, as it is suggested, Europe is three to five years behind the US on compliance issues, then the UK’s new transparency laws could just signal the beginning of an increasingly draconian era. And while the challenges they present may be addressed on the ground level by a wholesale adoption of US operational-based compliance solutions, the cultural after-taste — for a country whose pharma companies have enjoyed a history of self-policing — will be harder to take.