There is still no consensus on whether medical writing or editorial services support from pharma companies should be reported under the Sunshine Act.
That was one of the major take-home messages from last week's European Meeting of the International Society for Medical Publications Professionals (ISMPP), which saw publication-focused representatives from Pfizer, AstraZeneca (AZ) and Shire discuss their take on the Sunshine Act.
Having been passed into US law in 2010 as part of President Obama's Patient Protection and Affordable Care Act (PPACA), the Sunshine Act was implemented in August last year.
It introduced new legislation that, from this year, requires manufacturers of drugs, devices or medical supplies to report to the Centers for Medicare & Medicaid Services (CMS), on an annual basis, payments – or transfers of value - made to physicians.
However, there has been a lack of clarity as to what should and should not be reported, including the medical writing support provided by pharma companies to authors of clinical studies.
As heard at the ISMPP event, both Pfizer and AstraZeneca have taken the stance that they should report medical writing support under the Sunshine Act, while Shire does not.
Justifying her company's view, AstraZeneca's publications operations lead Gillian Hill said that, for primary research from company-sponsored studies, publication support was both of value for the author as well as the pharma company.
Regarding the practical implication of this, Hill described how the company ascribes a value to the author support provided by pharma companies.
“We have taken an average fair market value approach,” said Hill. “We've gone through and conducted what we believe to be a very robust evaluation process, and we've done this based on actual data we've collected. We now have a fair average market price for each of the main publication types and they vary according to the level of support.”
Pfizer has taken a similar approach, both with its decision that publication support is a transfer of value as well as to how this is worked out, according to Lorna Fay, senior director of the company's publications management team.
However, Fay was keen to make the point that this was the company's “current opinion” and things could change.
“There are ongoing discussions as to whether our approach will remain,” she said. “We really don't know where it will end up.”
Shire's viewpoint – as discussed by director of global publications Antonia Panayi - was simpler, taking the approach that medical writing support for Shire-sponsored studies was only of benefit for the pharma company and so there was no transfer of value to the physician.
“There is no transfer of value to physicians or authors beyond what has already been paid as part of their contractual agreement for the trial,” said Panayi. “This is because Shire is deriving the benefit not the authors.”
She added: “We did recognise there may be kudos for the authorship, but how do you quantify this? We didn't see it as tangible benefit.”
Responding to a question on whether Shire is still collecting this data 'being the scenes' in case it had to be reported, Panayi said the company was, but it was “comfortable” with its current approach.