Pharma industry is edging towards transparency
Business opinion: the sector’s mixed record gives little cause for reassurance
GlaxoSmithKline has led the way in relation to Big-Pharma transparency, breaking with its peers on stopping the practice of paying speaking fees to doctors for talking to audiences about its medicines. Photograph: Reuters/Toby Melville
It appears that Big Pharma is waking up to the need for greater transparency in how it conducts business. Since January 1st, pharmaceutical companies have agreed to new rules on sharing clinical data with researchers and patients under guidelines put together by industry trade group, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA).
The move on clinical trial data comes as Britain’s public affairs committee last Friday became the latest to express concerns that information on methods and results of clinical trials is routinely and legally withheld, undermining the ability of “clinicians, researchers and patients to make informed decisions about which treatment is best”.
It also pre-empts moves in the European Union to introduce new rules on sharing such data. Welcoming the move, the European Parliament rapporteur on clinical trials, British Labour MEP Glenis Willmott, said: “For too long, unflattering studies have gone undisclosed. Around half of all trials are never published, usually those with negative or disappointing results.”
The new accord makes no provision, however, for the release of clinical trial data on drugs on the market that were approved before this year, although one major pharma group, GlaxoSmithKline (GSK), has committed to doing so.
GSK has led the way in breaking with its peers on stopping the practice of paying speaking fees to doctors for talking to audiences about its medicines. It will also no longer cover doctors’ travel, accommodation and food costs for attending medical conferences, following the lead of fellow British pharma giant AstraZeneca, and is ending the practice of sales targets being the basis for remuneration of sales staff.
Within hours, Pfizer, Eli Lilly, Sanofi, Bristol-Myers Squibb and Shire publicly refused to back GSK’s approach.
GSK’s move, as it looks to untangle itself from allegations of bribery in its Chinese operations, came just ahead of an updated healthcare professionals’ code from EFPIA , which also came into force last week. This introduces tighter prohibition on gifts (in cash or as benefit in kind) and offers guidance that the value of meals and drinks should not exceed the threshold set by national member associations. Any educational materials provided will have to be “inexpensive” and relevant to the practice of medicine to patient care.
In the United States even more specific regulation is coming into force. The Physician Payments Sunshine Act of 2010 (part of the “Obamacare” initiative, the Patient Protection and Affordable Care Act 2010) lays down rules governing the reporting of marketing behaviour of pharmaceutical companies.