In
line with the European Federation of Pharmaceutical Industries and Associations
(EFPIA) Disclosure Code, June will see member companies across Europe required
to publish data concerning their 2015 transfer-of-value transactions to
healthcare professionals (HCPs). The EFPIA Code has been looming for four years
and much of Europe appears to be ready for the imminent deadline.
In
France and Denmark, for example, disclosure of payments on a central platform
is already a legislative requirement: in the UK, the Association of the British
Pharmaceutical Industry (ABPI) began disclosing aggregate payments to HCPs in
2014; and in Portugal, US “Sunshine”-type rules took effect in February 2013.
European
companies have also had over a year to monitor the US experience of the
physician payment program, which went live in September 2014. The Sunshine Act
was, of course, tailored to a market with it own particular challenges, but US
pharma’s experience of Open Payments has, nonetheless, flagged up some useful
pointers, and European companies would do well to take heed.
US
problems concerning consistency of reporting, for example, will likely be
amplified across Europe, and the media’s focus on and reaction to some of the
data is something for which European life sciences organizations should
be prepared.
Code concerns
Ahead
of those challenges, however, is the concern that some countries and companies
may not be ready for the EFPIA Code to come into force at the end of June. In
November last year, results from a pan-European survey on customer data in the
life sciences industry by Veeva stated that two-thirds (73%) of companies
surveyed said they did not have the data to successfully manage HCP activity
across borders, with 66% revealing that their data resided in “multiple
systems” that are not yet integrated.
Speaking
to Pharm Exec, Veeva’s Guillaume Roussel explained that companies have
been developing their information systems incrementally over time, “just adding
new systems on top of older ones,” and this “has created an architecture that
is difficult to streamline from a transparency
perspective.” However, countering the somewhat alarming findings of his
company’s survey, Roussel believes that companies will be ready to meet the
EFPIA reporting deadline, as many of them are implementing “temporary
solutions.” But, he adds, “The question is, at what cost?” He explains:
“Companies are investing tremendous amount of time and resources in order to
get to the point of reporting, but this is not sustainable over time.”
EFPIA’s
Communications Director Andrew Powrie-Smith suggests that a survey of the
industry’s disclosure efforts published more than six months ahead of the Code
deadline might better have asked who will be ready, rather than who is
ready. Making an agreeable analogy, he asked attendees at a meeting in early
December, “Who is ready for Christmas?” Not too surprisingly, no hands went up;
most of the audience simply proffered a slightly nervous chuckle.
Powrie-Smith’s point was thus made, although one could argue that leaving a
short time to buy gifts, defrost a frozen turkey, and decorate a tree is not
really comparable to the pressure of a last-minute completion of all the legal
and administrative legwork needed to fulfill the requirements of the Disclosure
Code.
Nevertheless,
Powrie-Smith later told Pharm Exec, “We must remember that it’s a requirement
that EFPIA companies are ready by a certain date, and companies are taking this
requirement seriously. All our companies have been working hard, and that
process continues until the end of June.” He does concede, however, that we can
expect to see reporting inconsistencies at the “go-live” date: “You’re looking
at countries that can be very different in terms of their cultural,
socioeconomic and legal frameworks, so you’re going to have variances.”
Ironically, Veeva’s Roussel says that adoption of EFPIA guidelines “is actually
very consistent across the board—there is no striking difference between north
and south, or east and west.”
Indeed,
some measure of inconsistent reporting is virtually guaranteed when the
European data is published; even the US’s one-language, one-culture market
still has a way to go before it has this problem in hand. When the US’s Open
Payments system went live in September 2014, “one of the things that was most notable
was the inconsistency across companies in how they interpreted things and in
how they chose to report them,” notes Christine Bradshaw, Vice President,
Porzio Life Sciences, LLC.
While
Bradshaw believes companies were reporting in good faith, the inconsistencies
“made it very difficult to look at one company’s information and compare it to
another’s, to answer questions such as who’s spending more on research, who’s
spending more on commercial, what do the fees look like for consulting
agreements, things like that.” This was particularly frustrating, she adds, not
just because making the data transparent and accessible for analytics were key
among objectives of the Sunshine Act in the first place, but also because of
the “exorbitant amount of time and money” companies had spent in getting ready
for it.
In
Europe, in terms of analysis of the data, Powrie-Smith agrees that “we’re going
to see the same thing in the short term.” But, he adds, “that’s one of the
benefits of the transparency project as a whole: we get to see at a detailed
level what a relationship looks like and understand it better.”
Of
course, a wider public understanding of industry–HCP relationships is one of
the overriding social goals of the shift toward transparency. But amid the general
lack of understanding among the public at present, we can be certain that new
systems of openness will bring a new level of critical scrutiny, at least in
the short term. Where pharma has seen many incremental changes in the way that
industry and HCPs work together over the last decade, Powrie-Smith points out
that the push for full disclosure of transfer of value “is more of a
transformational step, a significant change, so inevitably it’s going to put a
level of focus on relationships that hasn’t been there in the past.”
He
anticipates questions like “what are these payments for, what’s this
relationship about, what is an advisory board, why do people speak at
meetings?” But it is the industry’s job, he says, “to explain how those
relationships work, what the value is, who benefits, and so everyone can see
what those relationships are and have confidence in them.”