Washington D.C. partner Rick Robinson and Melbourne partner Bernard O’Shea discuss the US Sunshine Act.
The following article was first published by Pharma in Focus and has been reproduced with permission.
Transparency reports matched to script data
US authorities are matching pharmaco reports of value transfers to healthcare professionals with data on prescribing patterns "to see if there is any correlation between a doctor who is paid the most to the one who prescribes the most" a senior US lawyer has told Pharma in Focus.
With two lots of Sunshine Act data now available it was being matched with data releases from the US government around drug prescribing and utilisation of services, said Rick Robinson global co-head of life sciences and healthcare for Norton Rose Fulbright in Washington DC.
While he emphasised that this matching of data doesn’t show causation, the government was still looking at the data and looking for links, and hospitals were looking for conflict of interest in their medical staff, Mr Robinson said.
He added that greater transparency in reporting alone - just arrived in Australia - will likely have a "dampening" effect on payments/transfers of value to healthcare practitioners.
"Reporting on its own has an impact on giver and receiver," he said, explaining that even before the US Sunshine Act, when pharma and device companies were made to report payments as a result of fraud investigation settlements, "companies were more careful about payments to physicians to make sure they were justified".
"Doctors don’t like the publicity that comes from these publications so in general we are going to see a decline in these payments ... which is one of the intentions of having this information exposed," Mr Robinson said.
There has already been a reduction in payments around meals and entertainment, he added, which have come "way down" from where they used to be.
In Australia, a "drawing back" is already being experienced by Medicines Australia members with the new transparency regime commencing at the start of October.
As agreed with the ACCC when the 18th Code was authorised, the "informed consent" model will operate until October 1, 2016, when the new "reasonable expectation" model will kick in. Currently, doctors will be able to opt out of transparency reporting, and pharma companies will report those transfers of payments in aggregate.
Norton Rose Fulbright Melbourne partner Bernard O'Shea believes we "might see a lot of opt-outs in the first lot".
He pointed out that there is a "grey zone" in reporting under the MA Code, for example, when a pharma company engages a healthcare professional as witness in litigation or who is responsible for reporting if a third party organisation engages HCPs for, say, the production of papers or other education material.
"When the draft reports are sent out to the doctors, those issues will come to the fore ... [and] when they see the dollars reported and categories they are in," Mr O'Shea says. "It will also set the benchmark about what sort of dollars are reported."
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