My Proposals for the 2016 #SCCEcei – What’s Your Fave?

I’m really excited about the three panel proposals I submitted last night to the Society of Corporate Compliance and Ethics (SCCE), for its 2016 Compliance and Ethics Institute. Thanks to Amy Hutchens, JD, CCEP, Page Motes and Heather Powell for joining in.

Our proposed topics were:

  1. An advance workshop on drafting and negotiating contracts with compliance provisions — this would take the next step from the compliance contract panels that Amy and I did at the CEI in 2014 and this year.
  2. “The Good Reasons Why People Do the Wrong Things” — Exploring the frequent instances when people follow their own ethical code and choose to break rules. (Think about teachers or nurses following their deep ethic of care.) The lesson: it’s not just greed or “bad guys” that lead to misconduct.
  3. “Fostering a Speak-Up Culture: What Really Works” — Now more than ever, it’s critical for compliance professionals and business leaders to focus on what, objectively, has worked best to foster and maintain a culture in which people report suspected wrongdoing freely, constructively, and internally. So how do you make that happen?

I wish they’d let us do all three of them! So tell me, what’s your favorite?IMG_3426

Tone at the Very Top: The Umpire Strikes Back

The other shoe has dropped.

I wrote last month about concerns that the Justice Department may have gotten off to the wrong foot, tone-wise, following its “Yates Memo” declaration that it intended to prosecute individuals within companies for their organization’s wrongdoing.

But, as Mike Volkov so well summarizes, the top enforcer on this playing field quickly found a case with which to make its point. On October 29th, the DOJ announced a $125 Million criminal settlement with pharmaceutical company Warner Chilcott (once Galen, now Actavis). In the same breath, Justice also announced criminal charges against four company employees — including the company’s former president. According to the release, several other employees have already pled guilty or been indicted on criminal charges. The cases arise from Warner Chilcott’s payment of kickbacks to physicians to induce them to prescribe its drugs.

DOJ’s press release makes its intended message explicit:

“Pharmaceutical company executives and employees should not be involved with treatment decisions or submissions to a patient’s insurance company.  Today’s enforcement actions demonstrate that the government will seek not only to hold companies accountable, but will identify and charge corporate officials responsible for the fraud.”

Interesting, and not surprising, that Justice struck this blow in the healthcare industry. Pharma and Medical Technology have been the industries on the bleeding edge of enforcement (and internal compliance efforts) since the 90’s (at least).

In commenting on my earlier post about the tone being struck by the DOJ, Scott Killingsworth pointed out that “the DOJ will tell you what they are going to do, and then by golly they will do it.” I agreed, and I speculated that the Department must be “itching” to prosecute some company executives. Not that it took much in the way of powers of prediction, but it looks like we were right. Executives and companies who ignore the Yates Memo do so at their peril.

 

When Contracts and Compliance Collide: Lessons Learned

As important as it usually is that “Compliance” be independent from “Legal,” there are realms in which it’s best when those two functions are full collaborative partners. One of those is the realm of contracts with third parties.

Twitter pix of SCCE panel 15-1005That was an inescapable take-away from a session on October 5th at the SCCE’s annual Compliance and Ethics Institute: “Peer-to-Peer Compliance: Are Y
our Contract Clauses Running Offense and Defense For Your Ethics and Compliance Program
?” I had the honor of presenting the session, with Amy Hutchens of CLEARresources. I also had a complete blast, pretending to negotiate typical clauses with Amy, fielding questions about covenants that troubled SCCE colleagues in the audience, and sharing our lessons-learned.

Lessons such as?

  • That the intersection (collision?) of transactional law and corporate compliance is happening more often, as companies pay more attention to the risks their third-party relationships can pose, and authorities from the Sentencing Commission to the FDA voice their expectation that these risks be managed contractually.
  • That a careless clause can damage the structure or credibility of a company’s compliance regime – but a legal department engaging in zero-sum negotiations, without benefit of a partner from compliance, might miss that risk.
  • That there are two strategic extremes for the company in the “prime contractor” role, each of which can be problematic: Unyieldingly insist on the most favorable language for your side, and eager vendors may agree even though they know they cannot follow the contract they signed. Take an overly flexible position, open to each vendor’s full range of concerns, and your resources may get nibbled to death while you wind up with no predictable consistency among your agreements.

What’s an enlightened company to do? First, consider your goal – is it to get a signed document full of hard-ball victories, or to have third-parties who are actually working with your guidance to engage in compliant behavior? Assuming it is the latter, your company may be better served by living its core values even in its negotiating style, and by taking a firm, comprehensive, but reasonable form of contract to market. And for that to happen, “Legal” and “Compliance” must work together, and understand the other’s issues.

If you missed the session at the CEI – or if you missed the CEI altogether – no worries. We are reprising the session in the form of an SCCE Webinar, on Tuesday, October 13th. Please join us!

Contracts and Compliance: Two SCCE Panels

After a few days of worrying about Nor’Easters and Hurricane Joaquin, it appears that the Lord is willing and that the creek will not rise – so I will be joining some 1600+ of my compliance and ethics colleagues at the annual Compliance and Ethics Institute of the Society of Corporate Ethics and Compliance (SCCE).

If you are coming as well, I hope you will join Amy Hutchens and me at 1:30 on Monday, October 5th, to explore the increasingly frequent intersection (collision?) of transactional law and corporate compliance.

Our program is titled, “Peer-to-Peer Compliance: Are Your Contract Clauses Running
Offense and Defense For Your Ethics and Compliance Program?” (If you’re keeping track, it’s session #205.)

And even if you are not coming to #SCCEcei, good news! You can still catch our panel, in the form of an SCCE Webinar, on Tuesday, October 13th.

This is our updated remix of the well-received panel we did at the 2014 #SCCEcei. Part of what makes it so much fun is that Amy and I begin the hour by engaging in mock negotiations. Amy plays the lawyer for the big multinational company, I play the lawyer for the smaller vendor/supplier, and we go at it hammer-and-tong over issues like:

  • Which Code of Conduct should apply to a Vendor?
  • What training requirements can a general contractor “push down”?
  • What sales incentives are appropriate?
  • How can a smaller entity resist onerous auditing. monitoring, and indemnification requirements ?

(OK, I  might have shown my character’s bias in that last bullet point.)

After the negotiations, we’ll offer some lessons we’ve learned as compliance-minded transactional lawyers and in-house counsel. Then we’ll open it up to questions, and to any thorny contract clauses with which you might want to challenge us.

This year, we will also spend some of our time on the phenomena of “Quality Agreements,” which are increasingly common for contract manufacturing in the life sciences.

Our point is, when it comes to your company’s routine contracts, the right clause can really bolster your E&C program – and the wrong clause can wreck all your careful work. The trick is knowing which is which, and playing offense and defense so that the contractual playing field leaves your client best positioned for success. That’s something that is not going to happen unless the “legal” and the “compliance” camps in a company work together, and understand the other’s issues.

Live or on the web, I hope you’ll join us!