Transcript Understanding the Proposed Mass Pharmaceutical Marketing Regs

MBC LAW & POLICY
COMMITTEE MEETING
Roger Louis
Senior Vice President,
Chief Compliance Officer
Genzyme Corporation
January 8, 2009
5 Steps Back . . .
Law = Response to “Dash & Dine” “Gas &
Go”
BUT could be interpreted as Way more than a “Gift Ban”
Well beyond “Sales & Marketing”
Well intended (though ambiguous)
law . . .
. . . Unintended consequences
“[P]ortions of this section may sweep too broadly. However,
after careful review if the bill and conversations with
legislative leaders and sponsors, I am persuaded that this
section is not intended to require the disclosure of confidential
proprietary information . . .”
“I am confident that the Department of Public Health will
develop regulations that, consistent with the intent of the
legislation, enhance transparency without requiring the
disclosure of trade secrets and proprietary information…”
- Governor Patrick signing letter
3 Essential Elements
1.
2.
3.
Process
Compliance Program
Substance
Code Do’s & Don’ts
Substance
Public Disclosure
“Economic Benefit”
Unintended Consequences:
Intent = Reduce health care costs
Result = Increase health care costs
e.g. Mandatory disclosure of
rebates & discounts may result
in their elimination (but only in
the Commonwealth)
Suggested Revision
Further clarify definition of “Sales & Marketing Activities”
(These regulations govern sales & marketing practices.)
Follow SEC/Sarbanes Oxley reporting and accounting standards
Already reflected by clinical research exception (it’s a
research & development expense, not sales & marketing)
Discounts & rebates are not sales & marketing expenses. They are
reductions to revenue. If a company treated discounts as a sales
expense they’d violate SEC laws.
Other items