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).
Clinical trials
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.
Bribery allegations
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.
Since last August, drug companies have been obliged to collate detailed information on “transfers of value”. This means any gift or payment over the value of $10 to a doctor, including donation of medical textbooks, journal reprints, expenses incurred in continuing medical education that is not accredited, and research grants or other funding.
The doctor’s name, the amount, date and form of payment, and what it is for – such as consulting fees or gifts– are reported to the Centers for Medicare and Medicaid Services and will be published for the first time in September.
European measures
The European trade body has introduced similar measures, but in a voluntary code of conduct. From 2016, companies will have to publish on their websites the amount paid to each doctor or healthcare group with whom they worked in the previous year and for what the money was paid.
Some European countries have been more proactive in clamping down on drug firms’ marketing practices. France recently passed legislation in the area, as did Slovakia. Britain and Denmark are drawing up their own disclosure codes, and the Netherlands already has one.
Despite the importance of the pharma sector to the Irish economy, and increasing awareness of the need for greater disclosure by the companies involved, Ireland is notable in its absence from any list of jurisdictions taking initiatives to improve transparency in the sector.
Settlements
Announcing the EFPIA move last summer, Richard Bergstrom, the group's director general, said: "There are certain practices that just have to stop."
The practices he refers to have led to a litany of settlements between drug companies and regulators in recent years, with attendant adverse publicity. In the US, according to the Financial Times, fines from prosecutions against the industry reached $20 billion between 1991 and 2010.
Since then, companies have been hit with further penalties totalling more than $13 billion, including a payment of $3 billion last year from GSK for aggressive marketing practices.
The Financial Times reported last May that 12 companies paid doctors in the US more than $1 billion in 2012, according to an analysis done for the paper by consultancy PharmaShine. Some specialists received more than $100,000 a year each.
The sector’s mixed record gives little cause for reassurance. Still, for now, in some small but significant battles, the consumer is winning.
