Important Q2 Compliance and Transparency Developments and Updates

07.27.16 | By Andy Bender

AMERICAS TRANSPARENCY

Significant Payments of Other Sorts (“SPOOS”) are a part of the FDA’s financial disclosure regulations, not CMS’s open payments requirements.  “SPOOS” include payments made by a sponsor of a clinical study to an investigator/institution to support activities of the investigator and must be reported when these payments are $25,000 or more.

The FDA also requires that any person submitting a drug for marketing uses should disclose the financial interests tied to a clinical investigator involved in the conduct of clinical trial. The intent of the rule is to disclose the compensation to a clinical investigator who could be influenced by the outcome of the study.

What does this mean for our clients? They should be aware that there is a disclosure requirement related to the payments made to an investigator/institution of a covered study, and that the threshold is $25,000.

Another change to note is that ten Canadian pharmaceutical companies have agreed to start disclosing their total payments made to doctors and medical associations annually starting in 2017. The details of how they are going to disclose the expenses have not been decided, but we are glad to see the global trend towards more transparency. Read our April 2016 blog post about it here.

GLOBAL TRANSPARENCY

The European Federation of Pharmaceutical Industry Associations (EFPIA), Europe’s supranational pharmaceutical trade association, closed the inaugural reporting period for transparency disclosures on June 30, 2016.  Several changes to the requirements have already been made, and questions and concerns remain for amendments likely to be implemented later this year.

Some important recent EU transparency changes:

  • Two weeks before the deadline, the Netherlands ethics consortium, CGR, issued a press release stating that Dutch companies must disclose R&D payments separately, since they were not previously captured.  These disclosures must be made using the standard EFPIA template form.
  • The Spanish industry association, Farmaindustria, recently made their consent requirement less onerous in a May 26, 2016 press release.  Explicit consent is no longer required and companies may now simply inform the HCP that the transfer will be disclosed.  Farmaindustria has published a draft code that is pending adoption, which incorporates these changes, and will apply to ToV from January 2017 onward.

Anticipated changes, or draft amendments in progress:

  • Greece plans to amend its consent requirement, adopting a policy similar to the recent Spanish change that allows for complete individual disclosure.
  • Scotland has draft legislation in place to adopt disclosure obligations.
  • Romania, Slovakia, and Turkey may replace the EFPIA requirements with their own national disclosure rules.

Read more about the first EFPIA reports from the Polaris Insights blog here.

PRE-NOTIFICATION

The responsibility of our clients to appropriately track and manage relationships with HCP/Os does not just begin when a payment or transfer of value is made. In fact, there are a wide ranging set of regulations and industry guidance that mandate action in the form of notifications prior to the signing of a contract. These regulations currently span across several countries in Europe depending on whether the manufacturer is working within the medical device or pharmaceutical space, including: France, Italy, Belgium, Denmark. For example, in Italy, there are engagements that trigger a notification to the Italian Health Products Agency 60 days prior to an event. Think about the planning impact this has on our clients and their internal processes.

OUS ABAC/FCPA

Germany and France: leading and catching up to global ABAC best practices

Germany’s new ABAC law closes loopholes created by a 2012 German Federal Supreme Court decision, which ruled that it is not a criminal offense to offer bribes to private HCPs. The ruling also criminalizes giving and taking bribes in the healthcare sector and specifically applies to all HCPs that require a state-certification to carry out their jobs.  Thus, Germany goes even further than the US Anti-Kickback Statute as it prohibits all acceptance or grant of a benefit in exchange for the HCP’s unfair preference to a competitor and does not require government funds to be implicated; but still falls behind in private sector whistleblower protection/incentives. France, on the other hand, is stepping up its ABAC game and is predicted to pass the “Sapin II bill” which provides for (1) a French Agency dedicated to preventing corruption (the APC), (2) whistleblower protections (but not financial incentives), (3) obligatory corporate compliance programs, (4) new penalties, (5) extraterritorial reach (similar to the US FCPA), (6) a French DPA, and more.

What does this mean for our clients? Pharmaceutical and medical device companies operating in Germany and France OR having interactions with German HCPs should be vigilant of: (1) post market surveillance studies and monitoring registries; (2) pharma/device-provided homecare services; (3) invitations to educational events; (4) all focus arrangements with HCPs; (5) offering/granting any benefits to HCPs for referring patients to access programs; and (6) offering/granting discounts to HCPs for patient products if the discount isn’t passed on to the patient.

PRIVACY/DATA PROTECTION

Last week, the EU passed the EU-US Privacy Shield, an updated framework to the EU-US Safe Harbor Agreement, which provides greater protections and transparency on how personal data is transferred, used and protected.  The Privacy Shield framework was created in response to a 2012 court finding that the Safe Harbor regime did not provide adequate consumer protection due to U.S. surveillance programs.

What does this mean for our clients? The new Privacy Shield includes the same seven principles as the Safe Harbor and also includes additional, and potentially more onerous requirements such as: (1) heightened transfer requirements, (2) stronger supervision and enforcement by the Department of Commerce and the FTC, (3) new redress timelines and process for misuse of data, and (4) a redress process for U.S. government indiscriminate access/surveillance.

Certifying to comply with the Privacy Shield is entirely voluntary and the decision to proceed will depend on some factors including (1) business needs; (2) scope of global footprint; (3) exposure to EU citizens, workforce, outsourcing and cloud usage; (4) maturity of company’s data privacy program and vendor management tracking; (5) type and sensitivity of data and data elements; and (6) whether the company is in a highly regulated industry.

Healthcare is a highly regulated industry, thus it is a priority that Polaris and our clients keep a pulse on the implementation and enforcement of the Privacy Shield to prevent any potential non-compliance. Click here to view an article about how companies can satisfy the seven principles.

US REGULATORY, ANTI-KICKBACK, FALSE CLAIMS AND CIAs

Two major focus areas for US enforcement bodies so far in 2016 have been (1) the importance of corporate business culture and (2) executive accountability. These two focus areas are interrelated and summed up by a refrain echoed by recent corporate integrity agreements and prosecution documents: culture is key and starts at the top. 

A recent settlement highlighted that many of the ongoing kickback schemes and other illicit practices at the company were a direct result of a corporate culture and executive leadership that in the least tolerated, or, in some cases, allegedly sanctioned risky or illegal behaviors.

FAIR MARKET VALUE

In general, a commercial fair market value (FMV) transaction is between a willing “buyer” and a willing “seller,” each with knowledge of the relevant underlying facts and neither party is compelled by other factors to close the deal.  In the healthcare sector this last feature is especially important and unless the terms of a consulting agreement between AcmePharma and Dr. Bender, for example, truly represents the FMV it could violate the law (e.g. the Anti-Kickback Statute or Stark law).

Determining FMV rates for our clients’ interactions with HCP/Os is one of Polaris PMP’s core offerings, which constitutes a backbone of HCPM and HIP. Polaris’ FMV team will work on both US and international FMV rates for HCPs and other related professionals, such as medical and pharmacy directors.  Throughout the year, we will be updating our master data file as new survey data become available.

For information on how Polaris can help solve your compliance and transparency challenges, click here or call +1 212 502 1870.