Two appeal boards
As we look ahead to the 2011 Code, which goes live in January, most of the focus is understandably on the changes that will be made to the marketing rules. What is new, what is no longer allowed, is there finally some guidance about digital media?
However there are some constitutional changes taking effect as well, which could actually have a greater impact on pharmaceutical companies than the changes to the clauses themselves.
Two interrelated changes are worthy of note here. The first is that the PMCPA will increase in size from three to four people. The second is that the membership structure of the Appeal Board is changing.
The first change is very welcome. The intention is that for each case there will still be three members of the Panel, however the fourth member of the PMCPA will have responsibility for collating all the information about an individual case. This means that those ruling on the case will not have been exposed to the parties in the information-collating phase. Thus the decision is taken completely free from any considerations that interacting with the parties will inevitably subconsciously introduce. This separation between logistics and ruling will enhance the Panel’s hard-won reputation for independence.
The second change is more puzzling and more uncertain in its impact. The make-up of the Appeal Board is changing so that there are more lay members and fewer industry members, with an absolute requirement that an individual Appeal Board must always comprise a greater number of non-industry members (lay and NHS) than industry. This means that in every case, the majority of decision-makers about difficult cases will not currently be working within the industry – and may have never done so.
“The make-up of the Appeal Board is changing so that there are more lay members and fewer industry members…”
The very existence of an Appeal Board is to be warmly welcomed. The industry does not receive enough credit for the transparent nature in which it addresses allegations of sub-standard practice. However it is important that the Appeal Board and the Panel are working to the same basic understanding of what is acceptable. Some Appeals will, of course, be successful, however, the difference between Panel and Appeal Board positions might reasonably be expected to be one of refinement, and hopefully not completely different positions on a similar subject. If the majority of decision-makers have limited industry experience, how will that affect the decisions they take?
We decided to examine the extent to which the Panel’s thinking was currently aligned with the Appeal Board and then to repeat the exercise in 12 months to see if there were any differences. It is obvious that this is far from being a scientific exercise, however it proved enlightening.
We took a random 3-month period (May–July 2010) and assessed all the cases published in that month. None of the six cases in May or the two cases published in July was taken to Appeal, either by the defendant or complainant.
However the situation was markedly different in June. Of the 10 published cases, 5 were taken to Appeal – all of the Appeals were successful in overturning Panel rulings.
In case 2262 , the company was alleged to have organized an inappropriate overnight stay for GPs at a luxury hotel in order to convince them to become investigators in a trial1. The Panel ruled breaches of Clause 19.1 (hospitality), 19.3 (for failing to declare the event was sponsored), 9.1 (for failing to maintain high standards) and clause 2 (for bringing the industry into disrepute). The meeting was run by the principal investigator using funds derived from the study budget. However the Appeal overturned all the Panel rulings, arguing that there was a high degree of independence built into the organization of the event.
Case 2272 also saw the Appeal Board overturned rulings of Clause 2 and 9.12. Here the Panel considered an innovative cash rebate scheme. A condition of the scheme was that the rebate was paid into a fund administered by executives of the NHS organisation. The fund was to be used to further the interests of patient care. The panel decided that the rebate was a donation that was inextricably linked to the product – thus a breach of clause 18.5. The appeal board disagreed and overturned all the breaches on the grounds that there was no evidence that prescribers had been influenced by the scheme.
June also saw the gargantuan case that involved around 600 allegations related to a product launch phase3. It is difficult to be precise about the exact numbers of allegations and breaches owing to the sheer size and construction of the case, however around 124 breaches ruled by the Panel were appealed by the defendant. Of these, 111 were overturned at Appeal, including 2*Clause 2 and 9*Clause 9.1.
In case 2289 , the Appeal Board overturned five of the Panel’s rulings in relation to Clause 7 whilst upholding two others – all related to promotional claims targeted at a specialist audience4. Case 2291 also related to promotional claims5. Here the difference of opinion between the Panel and Appeal Board was whether claims made in a graph, based on one study, could be substantiated by other clinical papers also referenced on the page. The Appeal Board overturned both the appealed Panel rulings.
In total, of the five cases referred to the Appeal Board in the 3 months we reviewed, the Appeal Board overturned Panel decisions in every single case. The Decisions in relation to clause 7 are perhaps more understandable than other rulings given the subjective nature of interpretation of some promotional claims. However, three of the cases involved overturning rules of clauses 9.1 and clause 2. Given the seriousness of these particular clauses, the difference in opinion between the Appeal Board and Panel is of some surprise. In total, of the c128 breaches referred to the Appeal Board during the three months, only c15 were upheld. Therefore the Panel and Appeal Board were unaligned in their interpretation in 100% of Appealed cases and 88% of the appealed decisions.
“in the 3 months we reviewed, the Appeal Board overturned Panel decisions in every single case.”
The reasons for the differences in interpretation of the Code between the Appeal Board and Panel are unclear. Nor is it clear whether there is a fundamental shift in tolerance or attitude that one or the other is unaware of. Minor variations are understandable. However, the scale of the difference was surprising.
It is also not possible to draw conclusions as to how the changes in the construction of the Appeal Board will affect the alignment. However it is not unreasonable to surmise that the new structure of the Appeal Board, with a greater number of non-industry members will have to work harder to understand the application of the code in individual scenarios, owing to having less industry experience than is currently the case. What is not clear is whether the reduced industry experience will help or hinder the decision-making.
The full reports of all cases can be found on the PMCPA website. One-page summaries are also available from www.pharmacasearchive.com.
As always, comments are warmly welcomed.
1. Case AUTH/2262/9/09 Media/Director v Pfizer
2. Case AUTH/2272/10/09 Alcon v Allergan
3. Case AUTH/2272/10/09 Lilly v Novo Nordisk
4. Case AUTH/2289/12/09 MSD v Alcon
5. Case AUTH/2291/1/10 Hospital Consultant v Flynn
About the author:
Steve Gray is Managing Director of Compliance Hub, recognized provider of consultancy and training in industry Codes of Practice. He can be reached at email@example.com.
What changes can the industry expect with the 2011 Code?