UK Drugmakers Unveil A New Code Of Conduct
5 CommentsBy Ed Silverman // May 9th, 2008 // 1:37 pm
Drugmakers must do more to encourage side-effect reporting under a new industry code of practice published by the Association of British Pharmaceutical Industry. As of November, new promotional info must explicitly and “prominently” state that “adverse events should be reported” and provide details of the website to contact with concerns.
What else? Drugmakers will have to make publicly available a short description of financial and significant indirect support of patient groups; and sponsorship declarations must accurately reflect the nature of the company’s involvement.
Pharma must have a contract for health professionals and others employed as consultants, and are “strongly encouraged” to require consultants to declare this as an interest. And drugmakers are “encouraged” to publicly disclose available info about donations and grants to institutions supporting healthcare and research.
The code also requires drugmakers, for the first time, to make public details of all clinical trials they conduct for experimental meds. And all “non-interventional” studies that take place after regulatory approval – which can be a pretext for marketing – should be conducted only for genuine scientific reasons. These must be subject to ethical approval.
In addition, samples should be limited in number and never used to promote usage, and further clamps down on the use of “extravagant” venues or hospitality by companies for health practitioners. Even quizzes used for training should not result in the distribution of prizes, according to the code. You can read the complete code right here.
Matthew Holford
The ABPI has had a marketing code in place for some years, but I think one should remember that the ABPI is not a regulator - it represents the interests of the industry (eg, it “lobbies” NICE, when NICE isn’t, as far as the industry is concerned). Similarly, the UK press has a code of conduct, which relates to respecting privacy, and whatnot, but sanctions are limited to public censure, and as far as I know, the ABPI is the same.
The things that ABPI has implemented, here, sound good, but my reaction is guarded, to say the least - whomever pays the piper, and all that. Also, as we saw recently, the industry has scant regard for patient safety, even if it is assessed to have operated within the letter of the Law (I’m talking about GSK, again). Ultimately, it is the industry’s attitude to this factor that will dictate its conduct, not ABPI codes, I think.
Matt
Bob Freeman
Matthew, everything is relative, I suppose. Over the years I’ve been far more impressed with the ABPI and its member firms than I have with PhRMA. Back some years ago I was in corporate when our UK affiliate ran afoul of ABPI’s marketing code and, if nothing else, it is quite embarassing to be called out publicly. (Our affiliate ran some print ads stressing cost-effectiveness and that violated an agreement that cost/price was not a proper promotion. Those were pre-NICE days obviously)
Yes, ABPI does lobby but that’s what all trade associations do, and, again, it’s not as excessive as PhRMA’s in my opinion.
Matthew Holford
Bob, as you say: everything’s relative. We have several quite high-profile cases within the past few years (I’m thinking Vioxx, Avandia and Seroxat, and I don’t doubt that I could find others, if I chose), where manufacturers have withheld data from consumers, knowing that their drugs had the potential to do damage to patients.
Public censure is nothing, in these instances, and quite clearly has absolutely no impact on the way the companies do business, which, to quote the Senate Finance Committee’s report into the intimidation of John Buse is “less than stellar. People such as Garnier will still be invited to advise Texture and Shrub, when they should be very explicitly shown the window seat. Bob, they are doing precisely the opposite of what they say they’re doing, and there is no excuse for that, however one dresses it up.
Matt
Bob Freeman
Matthew, I defer to your experience and judgement. I’m not following the UK and ABPI closely as I once did. I appreciate the comments and will find time to try to catch up.
From my own experience, affiliates often pursue their own agendas especially in marketing practices. That statement does not, of course, condone fraudulent or unethical behavior.
truthman30
UK drug makers unveil new code of conduct..
Did anyone care to mention the issue of ethic as part of this proposed new code?…