On this episode of Great Women in Compliance, Lisa Fine speaks with Stacey Hanna, General Counsel, Ethics & Compliance at Lonza, which is an  integrated solutions provider in the areas of pharma and biotech, and is headquartered in Switzerland. While Stacey started as an attorney, she was in the mergers and acquisition world, and how this influences her approach to ethics and compliance.  She discusses the evolution of her organization’s compliance program and how she works to promote business growth, discussing some real-life examples and strategies to build relationships as a compliance officer. Stacey also discusses evolution in other areas, including work and life complimenting one another and in the compliance space as a whole.
Get involved and continue the dialogue of Great Women in Compliance at  the LinkedIn page Great Women in Compliance Podcast Community. You can listen to the full catalogue of Great Women in Compliance on the Compliance Podcast Network.

Compliance into the Weeds is the only weekly podcast which takes a deep dive into a compliance related topic, literally going into the weeds to more fully explore a subject. In this episode, Matt Kelly (the coolest guy in compliance) and I take a deep dive into the House Financial Services bill, HR 2515, which amends the Dodd-Frank Act to clarify that whistleblowers who report misconduct to their employers and not to the SEC also have protections against retaliation under the law. This bill fixes the US Supreme Court decision in Digital Realty Trust which mandated that whistleblowers had to go to the SEC to obtain Dodd-Frank anti-retaliation protection. Some of the highlights include:

Some of the highlights include:

  • What was the ruling in Digital Realty Trust?
  • Why did it negatively impact whistleblowers, companies and the SEC?
  • What has made whistleblowers and internal reporting so significant?
  • How does the proposed fix benefit whistleblowers, companies and the SEC?
  • Why should businesses get behind this proposed fix?
  • What are the chances it actually is signed into law?

For more reading check out Matt’s blog post “Progress on Whistleblower Fix

Next week, in a five-part podcast series sponsored by Assent Compliance Inc. (Assent), I explore market access for supply chain. During the course of this series, I visit with several members of the Assent team to introduce the topic, consider what market access is, provide an overview of trade compliance, Federal Acquisition Register (FAR) flow downs, the value of continuous monitoring and the origins of laws impacting market access.

What is market access? It turned out the answer was a bit more complicated, as Travis Miller , General Counsel of Assent Compliance explained. He related that market access really means the ability to sell a product into a given market. However, it is up to whomever might be in charge of allowing certain products to enter into the market, dictate what controls are put in place and what the requirements may be for entry. It can be defined by law or industry standards.

Miller stated, “when we think about market access, we take a very pragmatic approach. There are the legal requirements, there are physical steps you have to take to bring a product to market and all of this occurs before we even get to the question if anybody ever wants to buy it.” In the current business environment, the access to global markets is something that companies continually struggle with. They struggle with it from a legal regulation, commercial consumer,  customer and, even now, from a political or geopolitical standpoint.

There is a growing realization that one product may not qualify to be sold into multiple markets. There may be different component, manufacturing, financial or environmental requirements. Now overlay all these different legal or trade requirements on the current social media platforms and you have a situation where a company can get into legal/trade/reputational hot water very quickly. Social media amplifies these issues. Further, different brands can mean very different things in different markets. Miller gave the example of the brand “Made in Germany” which may connote quality and craftsmanship, yet after the Volkswagen (VW) emissions-testing scandal it might mean something very different outside Germany. He said, “if the concept is that German cars are made by cheaters, other folks that are within that same region can encounter enhanced scrutiny and punishment and a negative effect.” A key response is compliance because if “you can’t show that at least you’re not acting in a negative bad way and that you are meeting those industry standards and norms, you may well be assumed to be a cheat as well.”

Interestingly, one business response to the limitations placed on market access have been to “go local”. Miller said, “you see a lot of conglomerates or large brands have really spent an incredible amount of time, wealth and energy is to create the appearance of being local even though they might be an international brand. What they’ve done is they’ve found brands that appeal to or that are domestic in nature and that have that value.” It has now moved to manufacturing and “Supply chains and domestication of producing items are becoming more centralized and localized and specific regions or hubs.”

It is not clear if the era of robust free trade is at an end or if there is a blip brought on by the policies of the Trump Administration. Whichever it might be, it is on the forefront of every company in the international arena and every Board of Directors of those companies. Miller suggested it could be seen as a “rebalancing” of trade in that the United States was clearly the biggest player in international trade. However, with the current US administration, many countries and indeed companies outside the US are looking for more reliable, stable trading partners. He said, “China and the European Union trading block are the two kinds of dominant peers to the United States at this point. As these rebalances and shiftings occur, there is a certain backlash against the perception that these free trade agreement activities have somehow harmed domestic populations. This could well continue for a substantial period of time.”

This insight led me to inquire “do you have any suggestions on best practices to ensure market access for US companies?” Miller believes the restrictions to market access will likely come through additional regulations, as “each market that you want to access has fundamental differences that are reflected in the law they have passed. It also includes how a country may have developed industry standards to comply with those laws. Equally important is  the way that they treat law breakers.” Miller provided a generic example of shipping a product to Europe, as “it’s a single most, influential trading block in the world. They have domestic priorities towards safety, recyclability, the ability to decrease consumption and then domesticate and recyclability and production from waste materials that’s kind of end of life. The have closed loop recycling initiatives.” If your product does not align to those initiatives, it may receive a difficult regulatory reception.

He contrasted the European market with China and the Far East. Here, Miller said the priorities are “sustained domestic economic growth and ability to uplift their population, to invest internally. That is, to use that kind of industrial revolution that they are going through as a way to springboard to greater economic development. This means they will desire intellectual property and they will want your company to be involved in domestic investment. This means you will need to have a local presence; one that is at least partially controlled or if not entirely controlled in many instances by individuals that are loyal to that regime or that country.”

Interestingly, Miller observed that even with political gridlock, international trade can remain robust because if Washington or other national political centers are gridlocked, it can suck all the wind out of the air. This means no new laws are passed and the side effect is that less regulation is passed. One need only consider the US or UK governments about now to confirm this point.

Yet for businesses involved in international trade, the key is how they react. Are company’s nimble and agile enough to take advantage of market opportunities which appear or respond to new regulations? Miller said that as new trade barriers arise, “what’s going to happen is the business is going to have new metrics. An effective business, the kind of business that’s going to continue to exist and is going to thrive in this economy is going to find what that regulation is actually driving it. This means there is an opportunity for efficiency. This will allow companies to be more profitable.”

Miller concluded, “As cost to change and shift focus increases, you may well see companies start to domesticate business. This could lead to increased job markets and lower unemployment. We are seeing companies investing in these new workers.” Another way to consider it is that companies are “recreating themselves in more jurisdictions.” But the key is to have both the information and the metrics to do so. This is where the need for robust Supply Chain information and data comes into play.

For more information on Assent Compliance, check out their website www.assentcompliance.com.


Join Michael Volkov and myself on Friday, May 17  for a nuts and bolts session on how to structure this important component of any best practices compliance department. The webinar is hosted by Hanzo. In this webinar you will learn:

1) Why the intake of a hotline report is a critical start of your investigation protocol.

2) How to effectively set up a triage program for all internal and external reporting.

3) The different levels of investigations you should set up.

4) What type of report you should issue.

5) How and why you should protect the privilege.

The time of the webinar is 2 PM EDT. Registration and additional information is here. Best of all it’s FREE.

This publication contains general information only and is based on the experiences and research of the author. The author is not, by means of this publication, rendering business, legal advice, or other professional advice or services. This publication is not a substitute for such legal advice or services, nor should it be used as a basis for any decision or action that may affect your business. Before making any decision or taking any action that may affect your business, you should consult a qualified legal advisor. The author, his affiliates, and related entities shall not be responsible for any loss sustained by any person or entity that relies on this publication. The Author gives his permission to link, post, distribute, or reference this article for any lawful purpose, provided attribution is made to the author. The author can be reached at tfox@tfoxlaw.com.

© Thomas R. Fox, 2019

How do you keep pace with innovation? Returning to the podcast is Syed Hussain, the Co-Founder & CEO at Liquidity Digital, a blockchain-based FinTech firm that’s building an end-to-end digital security system. How does this work and how can it make our organizations more efficient, more compliant, and more profitable?

The shift to digital
Traditional forms of capital formation are simply not keeping pace with what the capital demands of the markets are. What blockchain enables people to do is take their existing assets, digitize and securitize those assets, and transform them into digital securities. At Liquidity, they’re building a platform that will allow for the issuance of these digital securities, paving the way for capital markets to go and take the digital route.
Benefits of digital security
Digital security is now bringing in opportunities that aren’t possible in the traditional world. Because these things are built on top of blockchain, it is inherently a very, very secure protocol. It’s transparent, as you’re able to store it on an immutable record and can trace any changes and transfers of ownership. It’s also accessible, allowing you to expand out into global markets. And because it’s digital, it’s made extremely efficient through automation, leading to massive cost reductions and a tremendous amount of savings.
Regulations and Innovation
Liquidity works hand in hand with regulators and partners with them: regulators are able to learn about the technology and build regulations around it, as well as helping Liquidity navigate regulatory channels so that while they leverage this new technology, they can make sure everything is compliant.Regulators are being very open-minded in their approach, and are seeing this new technology as something to look forward to that is leading the charge. This is something that is going to bring in massive amounts of innovation, and while innovation is always going to be ahead of regulation, what’s important is that regulations are able to quickly catch up.
As innovators, the responsibility lies with us: we cannot make changes in reaction to regulations. We need to work withregulators so we can innovate proactively and have innovation through regulation.
Syed Hussain (LinkedIn)| Liquidity.Digital (Website)| Twitter

In special bonus episode, I present a full hour’s presentation of a panel discussion I recently chaired at the ECI Impact 2019 conference. The panel consisted of Steve Scarpino, Director, Ethics and Compliance at BP; Suzanne Mitchell, CCO at US Foods; and Karen Clapsaddle, Ethics Director Lockheed Martin. They were all involved in the design and creation of the ECI High Quality Program and had experience with the Framework Assessment. It was a great review of the HQP and discussion of not only the design of the Framework Assessment but how your company might use it going forward.

Some of the highlights included:

  1. The five elements of the HQP;
  2. What are the Framework Assessment maturity curves;
  3. What level of optimization should companies aspire to?
  4. Can the Framework Assessment be used as internal measure;
  5. How much is the Framework Assessment quantitative v. qualitative driven?
  6. Does a company need to meet all the supporting objectives to be assessed as optimizing?
  7. How should you use and communicate maturity levels within your organization?
  8. Is backsliding possible?
  9. Is there a ‘one-size-fits-all’?

For additional resources:

Check out the ECI website here.

More on the ECI High Quality Program.

How to use the Framework Assessment.