UK Bribery Act

So Many Anticorruption Laws, So Little Training Time

NXLevel Compliance Team , , , , , , , , , , , ,

On January 12th, Zimmer Biomet reached a $30 million settlement with the Department of Justice and the Securities and Exchange Commission over business activities in Mexico. A few days later, an $800 million multijurisdictional settlement was announced with Rolls-Royce. That case involved the United Kingdom, the United States and Brazil, with the UK’s Serious Fraud Office (SFO) taking the investigative lead. Clearly, enforcement agencies around the globe remain committed to aggressively investigating and pursuing bribery cases.

In years past, the Foreign Corrupt Practices Act (FCPA) was the primary enforcement tool for anticorruption efforts around the world, and companies were wise to focus their resources on that legislation. As the Rolls-Royce settlement reminds us though, other countries are actively pursuing enforcement of their own laws. Simply covering the requirements of the FCPA in ABAC training is no longer practical or advisable.

Our clients are in the process of developing or strengthening their ABAC programs, and training is an important part of their efforts. With the overall volume of compliance training rising every year, we offer a few tips for maximizing the impact of ABAC training.

  1. Address common concepts one time. Training should be structured to first address the common concepts across all anticorruption laws. For example, most laws define a “bribe” and a “foreign official” similarly and most define the same type of actions as illegal. In addition, most laws do not absolve companies of responsibility of actions conducted by third parties. There is no need to cover each of these concepts in conjunction with each law. Doing so makes the content redundant, and only serves to make the training more cumbersome and frustrating for the learners. By presenting this common content from a wider perspective, in context of all bribery laws and principles, you establish a base of knowledge as the starting point, before delving into the particulars associated with each of the laws.
  2. Address specific laws individually. The nuances from country to country are plentiful and can be tricky. For example, learners need to know that the FCPA includes a “books and records provision,” and the UKBA punishes a company for failure to prevent bribery. After the common concepts are sufficiently covered, training then needs to address the specific aspects of each law, separately. Otherwise, those details will be lost in a sea of definitions or concepts that the learners were already presented in relation to other laws.
  3. Reinforce key concepts and laws via micro-learning. On-going reinforcement is key. When developing training plans, integrate micro-learning tools like mini modules and learning sprints (mini assessments) across the learner’s timelines. As an example, topics that affect how the learners conduct their daily business activities need to be addressed through scenario-based, more targeted tools, not just in the foundational training.

As the list of global anticorruption laws has multiplied, we’ve put the principles into practice and updated our Compliance Foundations™ module, Global Anticorruption Laws, with the content restructured to maximize learner engagement. If you’re in the process of developing, or updating, your global anticorruption training, we’re happy to share a content outline of our module and speak with you about our experience. Just contact my colleague Dan O’Connor at doconnor@nxlevelsolutions.com.

Thanks for reading!

Lauren Barnett
Compliance Content Specialist
PharmaCertify™ by NXLevel Solutions

Compliance News in Review, January 27, 2017

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The Serious Fraud Office leads the charge on Rolls-Royce’s multi-jurisdictional bribery settlement; the FDA releases new draft guidance; and a new transparency law is on the way in Maine.

While most obscure, strange, and funny “holidays” may be dismissed as whimsy, and fodder for creative water cooler conversations, Chocolate Cake Day is one that we here at the News in Review celebrate with vigor and enthusiasm. From Devil’s Food to Black Forest, we look forward to marking the occasion with more than one variation on theme. In fact, why not just make a weekend of it? Meanwhile, if a day dedicated to the splendors of chocolate cake isn’t sweet enough for you, we offer a delectable morsel of a different type, with this edition of the Compliance News in Review.

Rolls-Royce is getting its just desserts on three continents. The company recently entered into a $800 million multi-jurisdictional settlement with the UK’s Serious Fraud Office (SFO), the Department of Justice (DOJ) in the U.S. and Brazil’s Ministério Público Federal, to resolve charges it paid bribes to foreign officials in Eastern Europe, the Middle East, South America and Asia. In a twist on the usual tale, the SFO, not the DOJ was the agency spearheading the investigation. In addition to the financial penalties paid to each country, Rolls-Royce entered into deferred prosecution agreements with the U.K. and US governments, and a leniency agreement with Brazil.

The FDA is working on a new recipe for sharing healthcare economic information (HCEI). The agency released draft guidance for the sharing of HCEI with payors, formulary committees and similar entities. The guidance includes questions and answers about sharing HCEI related to investigational products with payors. The comment period for the draft guidance began January 17 and will remain open for 90 days.

On the state level, a legislator in Maine read a newspaper report about the increase in promotional spending by companies that manufacture opiods, and decided to introduce a law intended to curtail gifts from the industry to physicians. The language in the bill is based on the Minnesota gift prohibition law

Anticorruption efforts around the world are moving full steam ahead in 2017 and the fact that the SFO is spearheading investigational efforts presents a new twist. We don’t know yet if this is the start of a new trend, but we do know the SFO has the means to investigate and resolve large cases like the one with Rolls-Royce. Since the passage of the UK Bribery Act in 2011, the news around potential investigations has been quiet, but that is clearly changing. Like the U.S. Foreign Corrupt Practices Act, the UK Bribery Act has a wide reach.

Now is the time to review the training components of your anticorruption program to ensure employees, vendors and other third parties are being trained regularly about bribery laws and your company’s policies. Is that training engaging and based on real-world scenarios? Is deployment spaced over time to maximize effectiveness and retention? Have you mixed in smaller, more-focused micro-learning to reinforce topics like “identifying red flags?” Taking proactive steps now will strengthen help reduce risk and strengthen your culture around the globe for years to come.

With that, we put the wraps on this tasty edition of the Compliance News in Review. Until next time, we say, “let them (and us) eat cake!”

Thanks for reading and have a great weekend!

Compliance News in “Preview”

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As we wistfully wish 2016 a fond farewell, we welcome 2017 and wonder what compliance surprises, developments, and news the year might hold. What will be the hot topics debated around the water cooler in your office? The team at the Compliance News in Review has dusted off its crystal ball once again and we offer a few suggestions on what we see as the hot topics for 2017.

Drug Pricing Transparency

Drug pricing was at the top of the list in 2016. CEOs were brought before Congressional panels to explain exorbitant price hikes, and in several states, laws were proposed that will companies to disclose factors related to drug pricing for certain drugs. Vermont was the only state to pass such legislation, but California has reintroduced the bill for this session. The federal government also got in on the act with a bipartisan bill introduced in the Senate. While some of the fervor has quieted, we don’t think we’ve heard the last of pricing transparency. The passage of Vermont’s law could be the catalyst other states need to get their own laws passed.

Off-label Guidance/Revised Regulations

We don’t expect to see new guidance or regulations in 2017, but the FDA did at least start a conversation with the industry in 2016. A two-day meeting with stakeholders in November resulted in a list of diverse statements and opinions from companies, the medical community, and patient groups. The meeting with stakeholders was a step in the right direction, but a few high-profile cases (Caronia, Amarin, and Pacira) that resulted in wins for the industry, only led to more confusion and questions. We are cautiously optimistic that the FDA will at least continue the conversation and somewhat clarify the regulations.

Warning Letters and Notice of Violation Letters

The FDA’s Office of Prescription Drug Promotion (OPDP) wasn’t very active in 2016…until December, that is. At the end of the year, the agency made up for lost time by sending six letters for non-compliance with drug promotion regulations, signaling (in our humble opinion) a more aggressive approach in 2017. Most of the letters that were sent in December were related to the use of digital media.

Bribery and Corruption Enforcement

In 2016, several companies settled with the Department of Justice over Foreign Corrupt Practices Act (FCPA) violations. Most notable was a $500 million plus settlement with Teva that occurred near the end of the year. We expect to see more settlements this year, with half a dozen life sciences companies already under investigation for FCPA violations, according to the most recent Corporate Investigations List on the FCPA Blog. One wonders if the Serious Fraud Office (SFO) will join the trend as well and pursue more UK Bribery Act cases now that the agency has dipped its feet into the pool of U.S.-style Deferred Prosecution Agreements. We wouldn’t be surprised to see SFO dive right into the deep end.

The 2017 year in life sciences compliance looks to be an interesting one, and we’ll be tracking the news and headlines through our Compliance News in Review updates. Don’t forget to “follow” our blog so you don’t miss any news or our tips and best practices for building and deploying the compliance training you need to reduce risk and strengthen your compliance culture.

Thanks for reading and best wishes for a compliant and successful 2017!

Notes and News from the Seventeenth Annual Pharmaceutical and Medical Device Compliance Congress

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If the overriding theme of the Seventeenth Pharmaceutical and Medical Device Compliance Congress could be summed up in three phrases, they might be “partnering with the businesses,” “a seat at the table,” and “a principles-based approach to compliance.” On that last one – note the change from “values-based approach” to “principles-based approach.”

Watching recent conferences (and the industry in general) evolve to the point where these themes are at the forefront is refreshing and encouraging. As someone who has worked in life sciences compliance training for ten years, I’ve looked forward to the shift to an all-inclusive approach that considers all ideas and voices in the organization, and ultimately leads to the creation of more valuable and engaging compliance training. Below are a few of my observations and highlights from this year’s conference. The conference organizers offer the opportunity to purchase an archive of individual sessions or the full conference at www.pharmacongress.com. You can preview video clips of those sessions at www.pharmacongress.com/post-con-individual.html.

CCO Roundtable

The Chief Compliance Officer Roundtable on Day 1 featured industry leaders sharing lessons on building and executing a modern and effective compliance program. The panel included representatives from both the pharmaceutical and medical device industries and the conversation focused on two concepts: the practice of thinking from a perspective of risk (the “gestalt of risk,” as one panelist defined it), and the need to focus on what is meaningful to the business when developing and executing a compliance example. One speaker used the example of monitoring sample dates, and how that practice is not necessarily worthwhile to the business. That same panelist emphasized the need for hiring individuals with business experience when staffing compliance positions. Another looked at compliance training as what employees “should stop doing based on prioritized risk.”

Finally, one panelist stressed “prevention” over “detection” and how his staff uses data analytics to help identify problems based on the area of risk. “Defining guardrails, and risk tolerance, is necessary to get out in front of the issues,” he said.

FCPA Enforcement

During the FCPA Enforcement Panel, Joseph Beemsterboer, JD of the Department of Justice, Terry Price, JD of the SEC, and Gejaa Gobena, JD, of Hogan Lovells, discussed the growing number of cases related to the Foreign Corrupt Practices Act. To this point in Fiscal 2016, 24 FCPA cases have been filed, 6 of them against pharmaceutical companies. 85-90% of the 24 cases were related to conduct in China. Pharmaceutical and medical device industries represent such a significant portion of these cases because large numbers of their employees must interact with foreign officials, according to one of the presenters.

Anti-bribery

Day 2 opened with a much-anticipated session titled Behind the Bribe: Multiple Real-World Perspectives on How Foreign Bribery Occurs, Is Investigated, and Could Be Prevented. Regulators emphasized that anti-bribery remains an area of focus, “we are still seeing the same behaviors, and issues with gifts, travel, and entertainment,” according to one panelist. The FBI representative made it clear that the Agency is “committed to going after global bribery” and the “storm that is coming” will focus on the prosecution of individuals. “Culture is critical,” he said, “just publishing a video from the CEO doesn’t cut it anymore.”

The panel included former executive, Richard Bistrong, who spent time in prison for conspiring to bribe officials to win contracts from the United Nations, and spent 2.5 years as a government witness. Mr. Bistrong stressed the need for diligence as foreign cultures can be misleading. Distributors will often sign FCPA documents, then do something else in the practice. “Don’t let get the business done, drown out how to get the business done,” was one of his key points.

First Amendment Update

During the Truthful and Non-Misleading Communications and Recent First Amendment Cases session, a panel of industry attorneys discussed and debated the ambiguity regarding off-label promotion in FDA policy. After revealing the reasoning behind the FDA’s policy (patient safety and advancement of science), a lively discussion led to speculation that the Agency’s recent public hearing and announcement in the Federal Register signals gridlock and tension among leadership. This lack of direction is what led companies such as Amarin and Pacira to believe they needed to litigate their cases, according to one attorney. The session closed with the moderator asking each panelist if he or she thought the FDA would publish any clear guidance in the next year. The responses ranged from “I just don’t know,” to “highly unlikely,” to “no, they’re not.” Don’t expect clarification anytime soon folks.

Managed Markets

The Compliance Considerations for the Managed Markets Business opened with panelists first defining their definition of managed markets and how it differed for each of their companies. The bottom line was that no matter the particulars, it is defined as the functions responsible for “ensuring patients have access to the therapies the physicians write.” One industry representative said her company defines healthcare professionals to include anyone paying for the products, and another included anyone who can influence prescribing decisions – making compliance policies and the regulations pertinent to the managed markets business.

The expanded movement to the use of specialty pharmacies creates more risk, according to the panel, and companies are thinking about those issues in more detail after Novartis’ Corporate Integrity Agreement was made public. Pharmacy Benefit Managers (PBMs), Patient Assistant Programs (PAPs) and Reimbursement HUBs were covered as well, with the panelists stressing that government is starting to examine the relationships established through these entities, and companies need to be aware that laws never meant for managed markets are now being applied to that sector of the industry. As an example, one panelist mentioned, “the data that goes back and forth with charities is a risk area, and measures need to be put in place to ensure it is not used inappropriately by anyone involved with the data.” The session ended with a compelling question from the audience, “how do you ensure copay cards aren’t used for off-label purposes?” The answer came down to extensive monitoring to make sure that anyone who was supposed to be excluded was indeed excluded.

Compliance Training

As the compliance training division of NXLevel Solutions, the PharmaCertify™ team is always eager to attend sessions such as this conference’s What’s New for Training Programs. Since our mission is to help life sciences companies strengthen their compliance cultures and reduce risk, we are always encouraged to hear pharmaceutical and medical device professionals espousing techniques that support that goal. This session was no exception. While each company varied in the particular details, the panelists’ remarks made it clear that a true movement toward a blended approach to compliance, spread across a learner’s timeline, is growing. As one professional described it, “training to the right people, with the right content, the right amount of times.”

While panelists varied on the degree of live training over computer-based training, most agreed that the use of small vignettes, or small “bursts of information,” as one described them, are critical. The live training options included a Family Feud type game rolled out on a regular basis to streaming scenarios. The millennial generation was referenced, and the need for mentoring programs and live training that makes millennials’ transition into the industry a more compliant one.

Training content was a focal point, with one panelist stating “you have to make the content relevant, so people can do their jobs,” as he stressed the need to survey the learners on what else they actually want to learn about, along with questions about whether or not they feel more knowledgeable and if they have the support of their managers.

And let’s not forget about culture and tone of the organization – at the top, middle, and bottom. For example, training needs to emphasize that employees should feel comfortable reporting violations and asking questions.

The PharmaCertify™ compliance training professionals and subject matter experts are always anxious to discuss your compliance training curriculum and plans. To discover how we can help evolve your approach to training, contact Dan O’Connor at doconnor@nxlevelsolutions.com or visit http://www.pharmacertify.com/ to learn more about our products and services.

Compliance 2.0

It’s time for “partnering with the business” and “a seat at the table!” During the Compliance 2.0: Shared Ownership of Effective Compliance Across Business Functions presentation, six panelists (representatives from compliance and business) detailed case studies on how their companies made compliance concepts and programs more concrete and effective. Throughout each example, the importance of bringing the business into the planning from the start was stressed. One team who used the development of a new monitoring tool as their example said, “you have to know and understand the business in order to build a tool that meets their needs as well as your needs.”

One particularly interesting panelist was recently added to his company’s compliance team from the field, as part of the organization’s efforts to foster a strategic relationship between the business and compliance. He represented a compelling example of how that type of program is an opportunity to “infuse ethics and compliance into the company when the business pulls him back,” as he effectively put it. As another eloquently stated, “we have to raise our business partner’s compliance IQ and we can’t do that by ourselves.”

“Access to leadership” was referenced as a key component of Compliance 2.0, as more than one panelist discussed the need for those involved to feel comfortable questioning everything from leadership as the initiatives got started.

Beyond Transparency

My final breakout session was Beyond Transparency: HCP Interaction Risk Management. The session was centered on the use of data and how the transparency data can be used to track issues, then leveraging the auditing results to enhance policies and create more training. One panelist addressed it succinctly when he said, “our goal is to get to the point to where we use data to identify issues faster.” Another used the example of speaker programs and how the data could be used to raise questions about the number of times an individual HCP attended a speaker program, and raise the question of whether that was a concern.

The audience was reminded that “transparency isn’t just TOV data, it refers to sample data as well, and there is a need to overlay sample data with TOV data to reveal more than occasional interactions with one HCP.”

With representatives from both large and small companies on the panel, much of the discussion centered on the tools needed to keep the data organized and up-to-date. One panelist summarized it nicely, “when you do your hiring, make sure you find a person with excellent Microsoft Excel skills.”

The Evolution of Compliance Programs

The first presentation during the closing plenary session, Driving the Evolution of Compliance Programs into Systems Supporting Business Integrity, covered the oft-referenced theme of a “principles-based approach to compliance.” Representatives from three different companies touted the benefits of moving away from a “rules-based approach.”

As a foundation, in a principles-based system, decisions are not based on policy, but more on how individuals think and make decisions. “They need to be given the skills to make decisions,” according to one Vice President of Compliance, and “they need to be empowered to make those decisions and it’s a cultural shift for all stakeholders.” This is approach requires “a high level of trust and respect by leadership for the rank and file,” one panelist noted; and, he pointed out, writing shorter and more concise policies associated with such an approach takes discipline and time – quoting Winston Churchill, he referenced, “I would have written a much shorter speech if I had the time.”

The shift isn’t an easy one and the panelists stressed the need to “get leadership’s buy-in and help them see that a rules-based policy was holding the company back and the new policy will help patients, caregivers, and shareholders.” When an audience member asked “what kind of practical training would you offer to support such a shift,” the panel responded with “go back to the guiding principles of honor, trust, and integrity.”

Summary

While we weren’t able to attend all the sessions at the Seventeenth Annual Pharmaceutical and Medical Device Compliance Congress, we couldn’t help but be impressed with the level of content the conference provided to an audience hungry for any best practices and advice they could garner from their colleagues and subject matter experts. From a vendor standpoint, the foot traffic on the exhibit floor was steady and we appreciated the unique opportunity to engage current and prospective clients in meaningful conversation about their compliance programs and how we can help strengthen their compliance culture and reduce risk.

I welcome your thoughts and feedback. Please contact me at smurphy@nxlevelsolutions.com.

Thanks for reading and stay compliant!

Sean Murphy, Product and Marketing Manager, PharmaCertify™ by NXLevel Solutions

The Pharmaceutical and Medical Device Compliance Congress: A Preview

NXLevel Compliance Team , , , , , , , , , , , , , , , , ,

The Seventeenth Annual Pharmaceutical and Medical Device Compliance Congress gets underway in just a few short weeks. The annual gathering provides an opportunity for industry professionals and experts to learn from one another and hear from representatives of enforcement agencies. Whether your focus is international compliance, U.S. compliance, transparency, or risk assessment, the conference has something for everyone. We’ve reviewed the agenda and compiled a list of what we see as some the most compelling presentations.

Several sessions focus on compliance issues in managed markets. The preconference Managed Markets 101 review covers private payer systems, market access programs, and government payer systems. The session should provide helpful content and practical examples for those needing to train managed market personnel and salespeople.

If you’re not able to attend the preconference, there are also two managed markets mini summits on Day 2. The morning session covers compliance issues affecting managed markets in general and the afternoon one is focused on audit and monitoring issues. We expect both to spark worthwhile discussions among panel and audience members.

The Pharmaceutical Compliance Forum planners always do a great job of scheduling a variety of sessions dealing with compliance issues in markets outside of the U.S. This year is no exception, with preconference, plenary, and breakout sessions addressing global issues. Since the first transparency reports were filed by EFPIA members over the summer, unpacking what has been learned from the data, and discussing the challenges faced by companies thus far, will be of interest to anyone involved in global transparency.

We are also interested in the keynote address on Day 1 by Sophie Peresson, LLM, MA, Director of Pharmaceuticals & Healthcare Programme for Transparency International. (FYI – the printed brochure has this listed as the keynote for Day 2, but the website has it scheduled as the second keynote on Day 1.) The organization, well-known for its work addressing corruption, recently focused its attention on the pharmaceutical industry, so Ms. Peresson’s presentation should be valuable for companies mapping their future transparency training plans.

Finally the day two mini-summit titled, “Reimbursement Support, Patient Assistance Programs, Coupons, and Charitable Foundations” is another one on our radar. Enforcement agencies have sharpened their focus on these programs, and the area could be the next target for investigators. The panel includes both industry and legal professionals.

Now, we’re interested in your opinion. If you’re attending the conference, stop by the PharmaCertify™ booth in the exhibit hall between sessions and let us know what you think of the sessions and speakers. While you’re there, don’t forget to enter our drawing for a Bose® Soundlink® Bluetooth® speaker.

See you in Washington and stay compliant!

Compliance News in Review, September 15, 2016

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Illinois tackles illegal drug promotion by Insys; the ABPI calls out two member companies for breaking promotion rules; the Australian legislature shines a light on corporate crime and Medicines Australia reports on payments to doctors; and AstraZeneca settles with the SEC…all in this edition of the Compliance News in Review.

You had to know it wasn’t far away when “pumpkin spice everything” started appearing on store shelves. After the long hot summer, the staff here at the Compliance News in Review couldn’t be more excited that football is back, and cooler days with it (hopefully). Whether you’re a fan of college, or the league where they play for pay, the season is short, but that’s what makes it so special. Yes. football is now our focus, but not so much that we won’t continue to provide you with all the life sciences compliance news fit to blog. So, strike up the band, we’re ready to take the field on this edition of the Compliance News in Review.

The Illinois Attorney General is lining up against Insys. The state has filed suit against the company for illegal marketing of its fentanyl drug. The drug is approved for treating pain in cancer patients, but the AG alleges the company has been marketing the drug for treatment of other types of pain. The company also encouraged doctors to write prescriptions for higher, more expensive doses of its product, despite FDA recommendations to use the lowest dose of opioids possible, according to the suit.

The Association of the British Pharmaceutical Industry (ABPI) threw a flag on Hospira and Napp Pharmaceuticals. The organization has accused the companies of breaking the rules regarding promotion of biosimilars. An investigation found that Napp Pharmaceuticals made inappropriate payments to physicians attending a meeting that was deemed an advisory board. Hospira allegedly invited U.K. doctors to attend a meeting outside the U.K., which was a not a genuine advisory board, where their drug was promoted.

The Australian legislature will huddle about the state of its anticorruption law. After two Australian companies were implicated in a case involving the bribery of foreign officials, a member of the Australian senate decided to relaunch a committee to address corporate corruption. The mission of the committee is to improve Australia’s response to corporate crime and the senator noted that compared to bribery laws in the U.S. and U.K., Australia’s law is inadequate.

The “score” regarding industry payments to physicians in Australia has been posted for public review. Between October 2015 and April 2016 doctors received $8.5 million from industry according to a report from Medicines Australia. The organization says this report provides patients with more information than ever before about the relationship between doctors and the industry, and that the organization’s “standards for ethical and transparency will improve the Australian health care system.”

Thanks to an “ineligible receiver” call from the officials at the SEC, AstraZeneca has agreed to pay $5.5 million to resolve FCPA related charges. The SEC alleged that the company did not have proper internal controls in place related to interactions with foreign officials – mostly healthcare providers – in its China and Russian subsidiaries. The agency contends that improper payments, in the form of cash, travel, and gifts, were documented as bona fide business expenses. While AstraZeneca did not admit or deny any wrongdoing, it did cooperate fully with the investigation.

This week’s review had a decidedly foreign flavor. Where compliance outside the U.S. is concerned, we recall a quote from Pulp Fiction (bet you never thought a Tarantino film would ever be referenced in blog post about compliance) when Vincent Vega is discussing the differences between European countries and the U.S. “They have everything there we have here. It’s just a little bit different.” The same can be said for compliance issues. While the principles or requirements related to drug promotion may be the same here and abroad for the most part, there are small differences between what is permitted in the U.S. and what is permitted around the world. Life sciences companies must train employees about practices that are appropriate when conducting business outside the U.S., particularly in their interactions with non-U.S. HCPs.

With that, the time has expired on this edition of the Compliance News in Review. Don’t forget to click that blue button on the right to “follow” our blog so you’ll receive notifications when we post new content.

Until next time, stay compliant and enjoy the games!

Making the Most of Face-to-Face Time with Learners

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by Lauren Barnett

Time in front of learners is a valuable commodity. Everyone throughout your organization is busy with his or her designated responsibilities, and the demands on a learner’s time makes scheduling training time challenging. If the learners are field-based,  the opportunities for face-to-face time are limited and everyone is scrambling for their share. So compliance trainers need to make the most of live training time in order for learners to walk away with an understanding of how the policies, rules and regulations affect their jobs day-in and day-out.

Effective and targeted compliance eLearning is one solution. Deploying eLearning before the live session gives trainers the ability to focus their live training time on the application of policies, and any changes in the working environment that might affect the exact interpretation of the rules.  It also allows the trainers more time to delve into learners’ questions about how to handle the situations they face.

Don’t Forget the WIIFM

When learners come to a live session with a baseline knowledge, trainers can utilize role-playing scenarios or interactive games to make the foundational knowledge presented in the eLearning more meaningful. This approach sharpens the WIIFM (What’s in It for Me) in the learner’s mind. When learners understand how the laws and regulations actually affect their daily activities, the information “sticks” even more and the potential for behavior change is stronger.

The Landscape Might Change 

While laws, regulations and policies may not change often, the environment in which learners operate is fluid. Using eLearning courses for foundational training, before the live session, allows trainers to spend that face-to-face time discussing any changes in the company business or the industry. For example, over time, an off-label use of a product may emerge, or a company may enter into a foreign market, creating new risks and/or laws that have to be addressed through training. By deploying eLearning to cover any new laws or policy basics, trainers can use their live time to discuss the more specific details of how those changes are played out in the field.

Leave Time for the Gray Areas

Inevitably, the application of compliance policies and regulations is sometimes left open to interpretation. The nature of those policies can leave those in the field mired in confusion and lost as to how to apply related policies. When you train the foundational knowledge through eLearning, face-to-face training time can be used as an opportunity to answer those questions and educate the learners about how to conduct themselves in a compliant manner. That type of feedback and dialogue represents a major step toward reducing risk and strengthening your compliance culture, as staff learn how to apply the principles, even when there isn’t a ready-made answer in the policy.

Make it Stick

Face-to-face time with learners is a valuable and precious commodity, and as a trainer, you need to seek methods for making that time as rewarding as possible. Deploying a baseline of eLearning courses, such as those found in the PharmaCertify Compliance Foundations™ curriculum, frees the trainer to spend that time detailing how the laws, regulations, and policies affect the learners’ daily activities. When learners understand compliance is not a set of draconian rules, but rather integral facets of what they do daily, the information is more likely to stick with learners and drive more ethical and compliant behavior.

Lauren Barnett is a Compliance Training Content Specialist for the PharmaCertify™ division of NXLevel Solutions. When she is not identifying subjects for the company’s Compliance Foundations™ suite of off-the-shelf eLearning modules, or working with clients to create custom training content, she can be found gleefully volunteering for her daughter’s high school band and theater programs.

Compliance News in Review, July 26, 2016

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Executives on trial, an FCA settlement, a “clarification” to a change in the District of Columbia detailer law, and an Open Payments open forum…all in this edition of the Compliance News in Review.

What do Teddy Roosevelt, Rob Lowe, and a chair have in common? They have all provided some rather famous, if not infamous, moments at the national conventions of the Democratic and Republican parties. Part pep rally, part three-ring circus, and part critical component in the fabric of this great democracy, the conventions are underway, and they have certainly provided entertaining television during the doldrums of summer. If your senses need a break from the constant barrage of politicking and speechmaking, let us gavel in all compliance news fit to blog, with this edition of the Compliance News in Review.

Guilty or not guilty? It was a little bit of both for two executives from Acclarent, who were on trial for selling misbranded and adulterated medical devices. The jury found the pair guilty of misdemeanor charges distributing misbranded and adulterated devices, but acquitted them of felony charges. Lawyers for both defendants said they felt confident that their clients would eventually be cleared on the misdemeanor counts.

Speaking of Acclarent, the company agreed to pay $18 million to settle allegations that it caused false claims to be submitted to government health programs. The government contended the Acclarent marketed one of its devices for a use that was rejected by the FDA.

The Washington D.C. Department of Health (DOH) released an FAQ sheet that was about as clear as most political speeches. The document is intended to provide guidance regarding a recent change to the D.C. detailer law. Unfortunately, it may have raised as many questions as it answered. The DOH recently made a change establishing that anyone engaged in detailing for less than 30 consecutive days did not have to obtain a license. Confusion seems to center on the Department’s definition of “consecutive.” The FAQ states that the exemption applies to those “individuals, such as speakers at a conference, who come to the District once a year, or other persons that come once a year for a short duration of time of less than 30 consecutive days.”” Makes sense right? But the FAQ also states the exemption is not meant to cover an individual who may come to the District for a few days, more than once during a calendar year. So how many visits to D.C. require registration as a licensed detailer? Stay tuned.

The Centers for Medicare and Medicaid Services (CMS) is conducting a “focus group,” of sorts. The agency is conducting a stakeholder forum on August 2 to solicit feedback on rulemaking and potential improvements to Open Payments. The forum is intended to give stakeholders an additional opportunity to comment on the recent questions posted by CMS about Open Payments in the proposed 2017 Physician Fee Schedule.

Well, that’s a wrap on this politically-charged edition of the Compliance News in Review. We now return you to your regularly scheduled convention coverage.

Stay compliant!

Compliance News in Review, July 14, 2016

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The Serious Fraud Office has its second application for a DPA approved, CMS solicits feedback, and experts are dismissed from an advisory panel due to perceived conflicts.

It’s hot, it’s humid, and the editorial staff at the New Jersey AND Georgia offices of the Compliance News in Review is already desperately seeking safety from the sun’s intense rays. The dog days of summer have arrived with gusto. If you’re looking for a good reason to spend a few more minutes in the comfortable confines of an air conditioned office or home, we suggest a deep dive into the cool waters of this edition of the CNIR, and all of the compliance news fit to blog.

Deferred Prosecution Agreements (DPAs) seem to be no sweat for the Serious Fraud Office (SFO). The agency has had its second application for a DPA approved in a case that involves violations of the UK Bribery Act. The company involved agreed to pay $8.48 million in fines and disgorgement. It must also report annually on its third-party intermediary transactions and compliance programs, and continue to cooperate with the SFO. The DPA remains in effect until 2020, but it may be terminated in 2018 if the company meets its financial obligations by then.

The Centers for Medicare and Medicaid Services (CMS) is basking in the Sunshine these days. In the proposed 2017 Physician Fee schedule, the agency solicited feedback for a number of questions related to the Open Payments program. The questions cover record retention, issues related to teaching hospitals, and the nature of payment categorization. Of particular note, the agency is seeking feedback about the benefits of pre-vetting payments with covered recipients and issues related to uploading data to Open Payments.

In an indication that their relationships with industry were a little too hot to handle, several experts have been removed from a panel that is responsible for advising the FDA about painkillers. The panel was created by the National Academies of Science, Engineering and Medicine, a larger advisory group to the FDA. The removal of the panel members appears to have been spurred by a letter Senator Ron Wyden sent to the Academy of Medicine complaining that some panelists had received support (in the form of grants) from pharmaceutical companies. One panelist, Dr. Mary Lynn McPherson, says the support in question did not go to her directly, it went to the university where she is on staff, and was in the form of unrestricted grants so the pharmaceutical companies never had input on how the money was used. Another of the dismissed panelists, Dr. Gregory Terman, says he was removed because the nonprofit group he heads received funding from several pharmaceutical companies. Terman says his association with the nonprofit was well known, and he has gone out of his way to avoid conflicts of interest.

The last story serves as a reminder that much of the data regarding the relationship between healthcare professionals and the industry is presented with little context as to the nature and reasons for the payments. HCPs are understandably sensitive about receiving certain transfers of value, and they have questions about how those TOVs are disclosed. Your transparency training should remind learners that they need to be sensitive about these concerns, and educate them on the proper protocol for addressing HCP questions about data.

With that, we close this mid-summer edition of the Compliance News in Review. Stay compliant and stay cool.

Buy or Build: Is Off-the-Shelf or Custom Online Compliance Training Right for You?

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During a recent compliance conference panel session, a chief compliance officer from a mid-size pharmaceutical company proclaimed, “I only use custom for online training,” and “off-the-shelf just doesn’t meet my content needs.” She went on to explain that with custom-developed training, she could target specific topics and include company-specific policies in a way that she never could with off-the-shelf.

Fair point, but she failed to take into consideration that while custom-developed training can indeed be built to focus on the compliance content she needs to cover, well-built, flexible off-the-shelf training provides a solid foundation of knowledge, which can then be supplemented with targeted, custom micro-learning in the future, as gaps and custom needs demand.

Start with Off-the-Shelf

Small to mid-size pharmaceutical and medical device companies need effective training covering core topics such as off-label promotion, transparency, gifts and meals, and adverse events, but the training resources and budgets available to many compliance departments, which often consist of a staff of one or two, are quite limited. Instructionally sound, industry-focused, off-the-shelf training can easily and quickly provide core compliance training, without draining your limited resources and time.

For obvious reasons, off-the-shelf, even when tailored to include your specific policies and contact information, can be deployed more quickly than a fully custom training course. Review times are shortened and less demanding, and when a need for training on a specific topic (e.g., speaker presentations) is identified, off-the-shelf gives you the flexibility to deploy rapidly while the topic is still top of mind to your learners. Moreover, with quality off-the-shelf training, content is developed by someone with specific knowledge of the industry, and expertise in commercial compliance. Therefore, your time isn’t consumed with being the primary subject matter expert.

A Time and Place for Custom

This is a need for custom online learning in an effective compliance training curriculum – one that addresses all of your organizational risks and truly helps to build a positive compliance culture. The most recent research points to the importance of spacing learning over time and providing review and reinforcement exercises after the initial training is launched to improve retention. As educational psychologist Steven Just, Ed.D., founder and former CEO of the assessment company, Pedagogue, writes, “To learn, you must cognitively act upon the learning materials, and to retain what you have learned, you must actively re-engage with the learning repeatedly over a period of time.” Starting with off-the-shelf, then mixing in smaller, more cost effective, custom mini modules and interactivities (video scenarios, games, assessments) over time and across a well thought out compliance training plan, has been proven to support on-going behavior change – a key objective in the world of commercial compliance.

Summary

While custom online compliance training should certainly play a role in the on-going execution of your compliance training plan, launching a foundation of targeted, off-the-shelf courses to address important topics to a broad audience represents a rational and cost-effective starting point for any life sciences company’s compliance training curriculum.

Don’t forget to “follow” the PharmaCertify™ blog by clicking the blue link on the right so you don’t miss our updates. Coming soon, The Right Stuff: What Compliance Topics to Cover in Your Product Launch Training.

Thanks for reading and stay compliant!

Sean Murphy, Product and Marketing Manager PharmaCertify by NXLevel Solutions