Drug company disclosure a step closer
Drug companies will be required to publicly disclose substantial gifts, payments and subsidies provided to individual doctors and other health professionals, including air fares, honoraria, conference registrations and accommodation under voluntary rules being considered by the consumer watchdog.
Under a Code of Conduct prepared by peak pharmaceutical industry body Medicines Australia (MA) in consultation with stakeholder groups including the AMA, the details of all “transfers of value” between drug companies and individual health professionals that are covered by contracts will be published.
The Code, which will apply to companies that are members of MA, is the culmination of an extensive and exhaustive year-long process of consultation and revision involving representatives from industry, the medical profession and consumers, including Associate Professor Robyn Langham, who represented the AMA on the Code Review Panel set up by Medicines Australia.
In a submission to the Australian Competition and Consumer Commission (ACCC) in support of the draft Code, the AMA said it embodied a “realistic and common sense approach”, particularly in the absence of evidence about whether or how the information might influence patients.
“At this point in time, these reporting requirements are philosophically based,” the AMA said. “There is no evidence yet of their positive or negative impact on health care systems or health care decisions.”
It said drug companies reporting under the Code would still need to obtain permission from health practitioners before publicly disclosing information about them, as stipulated under the Privacy Act 2008.
A/Professor Langham, who is Head of Nephrology at Melbourne’s St Vincent’s Hospital, said developing the Code had been a major undertaking for all involved. Since August last year there have been monthly face-to-face meetings of the 12-member Panel, as well as several forums with medical practitioners, consumers and other stakeholders and painstaking assessment of numerous submissions.
While A/Professor Langham was paid by MA for the time she committed to the Panel’s work, her involvement stemmed from a long-standing belief in the importance of disclosure to a robust, trusting and ethical relationship between medical practitioners and their patients.
Like GPs and some other practitioners, her line of work has involved developing on-going relationships with her patients – a circumstance A/Professor Langham said underlined the importance of dealing with patients ethically and openly.
“I see it as an important part of the day-to-day work that doctors do,” she said. “The concept of transparency is critical to the way patients see us as a profession.”
In devising the updated version of the Code, the Panel sought to arrive at a level of disclosure that would reassure patients that they were being treated respectfully and ethically without imposing costs on companies and practitioners that were so great that they would deter them from signing up.
The balance struck in the Code has not satisfied some.
The Consumers’ Health Forum, which had direct input into the design of the Code through representation on the Review Panel, has nonetheless heavily criticised the proposal put to the ACCC for approval.
Forum Chief Executive Officer Adam Stankevicius said the Code failed to establish the degree of transparency required to safeguard the interests of patients, and instead embodied the “tendency of the medical profession to avoid disclosing information that may be in their patient’s or the public’s interest”.
Critics have often made reference to the United States, where legislation has been enacted requiring full disclosure of all payments, gifts and other ‘transfers of value’ made by drug companies to doctors, including transactions as minor as a cup of coffee or sharing a research paper.
But the situation in the US is different in two critical aspects – the disclosure regime is mandatory, and it is supported by government funding, neither of which applies in Australia.
Instead, A/Professor Langham said, the Review Panel paid close attention to arrangements in Europe, where conditions were much more similar to those in Australia.
Under the revised Code, Medicines Australia members will be required to publicly report ‘transfers of value’ to individual health practitioners, including speaking fees; sponsorship to attend conferences and courses (airfares, accommodation, registration fees);
consulting payments; fees paid to sit on Advisory Boards; market research fees; and education grants.
The final design of the Code was heavily influenced by the fact that it was voluntary, raising the risk that drug companies and practitioners could simply ignore it if it was too burdensome to implement, and that the nation’s privacy laws raised doubts about what could and could not be publicly disclosed.
Working within these constraints, the Code has embraced a level of disclosure below that stipulated in the US but consistent, the Panel believes, with protecting the interest of patients. MA member companies will be required to disclose transfers of significant value covered by a contract, which would typically include travel, accommodation and registration expenses for attending international conferences, as well as honoraria and stipends.
The push to revise the Code came from the ACCC, which in December 2012 gave the MA two years to come up with a framework to improve the transparency of payments made to individual doctors. The MA submitted the draft Code on 2 July and expects the Commission to adjudicate in the next six months, giving time to implement the new transparent reporting requirements from October 2015.
A/Professor Langham said the Code was not the end of the process, but rather an important first step.
She said one of the difficulties confronting the Panel was the lack of international experience and evidence to draw up on regarding what disclosure regimes worked, and admitted to considerable uncertainty how the Code might be adopted and operate in practice.
“Doctors have the opportunity to opt out of public reporting, and it is unknown whether that is going to be widespread practise,” she said.
Other hurdles are more technical in nature – how to collate and present the details of doctor payments and sponsorships provided by the drug companies, and devising a unique identifier for each practitioner to ensure transactions are not incorrectly attributed.
Either way, A/Professor Langham remains keen to be involved in developing a robust system of disclosure that will sustain and enhance the trust and confidence that underpins healthy doctor-patient relationships.
The AMA’s submission to the ACCC regarding the draft MA Code of Conduct can be viewed at: submission-medicines-australia-revised-code-conduct-a…