Transparency in Life Sciences - Transcript
Michael Loucks: The industry has to provide the details on all of the financial relationships with all of its physician customers. All of that is going to be posted on websites in searchable form and the industry has to expect that that database will be extensively looked at by law enforcement and by the whistleblower bar. There could be financial fallout from perfectly lawful arrangements, simply because the public may view amount of money paid to physician as too high when in reality, it is perfectly appropriate. I think there will be significant scrutiny abroad on the payments by life sciences companies to physicians in other countries that will be viewed rightly or wrongly as potentially implicating the Foreign Corrupt Practices Act.
Yogesh Bahl: Over the past two years, actually, we have been having conversations with companies around the pending legislation as it relates to transparency and the companies that we are working with are focused on getting it right and really the question is, what does getting it right mean?
Jeremy Perisho: Soon we think about, you know, the U.S. Sunshine Act and you think about transparency. What do you say?
Erik Eglite: One, I think our Federal government wants to get a sense of what is the relationship between pharma and the medical community. They are not quite sure. They know it is extensive. The other thing is, I think they want to also not embarrass physicians but make them think twice before they take money from pharmaceutical companies because now they will be listed on the website.
Rosland McLeod: If you are a consumer and you are not really educated on why Dr. Jones is getting all of this money, and always companies are hiring her because she is fantastic and you are just thinking that is my, you know, neurologist or what have you. Maybe there is a reason Dr. Jones is getting all of this money or maybe not. It just brings into play a conflictive interest even if it is not real.
Michael Loucks: When I was a prosecutor, we would use the billing patterns of providers to look for people. It should be investigated because their billing patterns were aberrant. They were the highest biller of a particular procedure code and maybe a perfectly valid reason for that to happen for doctor to switch all his patients from one product to another. On other hand, it might be because the second company offered the doctor a kickback. Those are the kind of patterns that I know law enforcement looks for and those are the kind of the patterns that a smart compliance program should also look for as the data becomes available.
Rosland McLeod: What I found, you know, over the course of my career is that there is a whole lot of physicians that are being paid on the R&D side and for so long everybody was hyper-focused on, you know, are we getting them as consultants for commercial, but what about those folks that you are doing on that side as well and is there a conflict.
Matt D’Ambrosio: We talk a lot about R&D, but I think what people tend to miss sometimes is the D point of that, the development side. So, I think everybody understands research and has this vision of physicians or chemists working in a lab somewhere, but then when you look at cost and the development process and taking something through the full FDI approval process, you know, maybe as we start to disclose the cost involved with that, people understand you need investment that we are making in health care and in these products.
Erik Eglite: And there may be a problem right now because I think what will be disclosed as of now with the proposed rules may not provide enough context as to what this payment was for they will just see a large number and oh my goodness, they are in the pocket of pharmaceutical industry, which may necessarily be the case at all.
Michael Loucks: There has been a trend towards more and more whistleblower cases where the conduct is less clear and where the rules are less clear than the whistleblower cases that were done in the past. I think businesses need to be more aggressive about defending themselves where the investigation appears to be either on thin factual grounds or focused on strict liability.
Yogesh Bahl: What many companies are focused on is global transparency, really understanding how they are interacting with various types of intermediaries like health care practitioners in their business.
Jeremy Perisho: As you think about going global, you know what does it mean. You know you have the language barrier, you have various types of technology, and you have numerous ways in which people comment and pay for relationships.
Erik Eglite: From our end, the best you can do is the due diligence. Find out who are working with, make sure they are credible or reputable, and you have to contractually obligate them to make sure that they do things the way you want them to do.
Rosland McLeod: If that individual also happens to pay, you know, in a country where the medicine is government, now we are really in a big spot.
Michael Loucks: You know, you got to have the same care that you use in the U.S. to assure compliance. You are going to have to make sure that you have investigative forensic and legal advocates. In other words, a moderately sized biologics company is not going to have the resources to look at the data and sort it and figure out where potential problems may lie.
Yogesh Bahl: One of the big takeaways that I found in having these discussions with various companies is take a look at the different silos within your compliance of organization. Companies maybe at times should step back and say we are doing all of these things. Is there a way that we can synchronize within our company all of these efforts so that if we are creating some sort of payment tracking mechanism for aggregate spend, how can we use that payment tracking mechanism to prevent corruption risk.
Jeremy Perisho: Where are we going forward? Where we are going to go next?
Matt D’Ambrosio: When I think what I always try and do as a compliance professional and I think where we add value and really try and separate ourselves from legal is just advising the company in doing what is right, maybe not necessarily just what is legal or being more in the spirit of law as opposed to the letter of law.
Erik Eglite: I think it is important to say that the number one thing is set policies, make sure your policies are well written, make sure they cover everything that could possibly come up, get buying for them. I think, once if the commercial regulatory, everyone buys into it, it is easy to enforce.
Rosland McLeod: Everything is on a continuum of risk, right. You can’t run a business unless you take risk, but then looking at that risk, where we willing play as an organization those are the kinds of things I am always trying to stay ahead of, how do we bake this into something that is going to be, you know, the right thing for everybody.
Michael Loucks: One of the hallmarks of a compliant business in the life sciences industry is one with very good leadership that stresses and urges a culture of compliance and those businesses who have strong leadership on that will be best positioned to deal with the problems. It does not mean you are not going to have problems, it just means that your organization is going to be well positioned to deal with an evitable fallout from them when those problems erupt.
Yogesh Bahl: What I would like to see companies do is a more proactive balancing of managing risks and creating innovation. It is not compliance. It is not that piece of the company that is focused on getting it right, it is actually making sure that everyone in the company believes that they need to do the right thing for the right reason. Fundamentally, that is what is getting it right means.