Regulatory Watch: France – Moving Transparency from a Stand-alone, “Must-Do” Process to a Tool for Compliance Programs

04.18.17 | By Caroline Franco

Over the past six months, France has been a hotspot for anti-corruption-related regulatory and investigation activities.

In December 2016, France passed a new anti-corruption law, Sapin II[1], which outlined the elements of a robust compliance program. These elements include: (1) clear policies, processes and procedures to preemptively mitigate and retroactively remediate corruption risks; (2) risk assessments detailing and prioritizing these risks; (3) reporting mechanisms and procedures for internal reporting of suspected illicit activity; and (4) training on anti-corruption policies and potential risks.  France also expanded transparency reporting requirements for Life Sciences companies with the passage of two new decrees in December 2016 and March 2017[2].

Additionally, just last month Jean-Jacques Mourad[3], a cardiologist and political advisor to presidential candidate Emmanuel Macron, resigned following accusations that payments he received from the pharmaceutical company Servier represented a conflict of interest. These accusations emerged from analyses conducted on the French public transfers of values database[4], which demonstrates that French transparency data is being utilized by the public to assess industry relationships with healthcare providers, especially those with political influence.  Thus, it is only a matter of time before French authorities – like their U.S. counterparts – begin to leverage transparency data for enforcement investigations.

In this environment, it is important for French Life Sciences Companies to understand their “transparency footprint”.  Companies must ensure that their payment practices align with the ethical principles stated in their policies and procedures, as well as the applicable laws, regulations and industry guidance.  This necessitates a comprehensive and proactive approach to risk management and risk mitigation.  Moreover, the use of transparency analytics is a highly effective and efficient tool to inform such risk-based compliance decision-making.

Globally, we have seen clients use transparency data to inform many compliance functions, including:

  • Targeting auditing and monitoring efforts based on key risk indicators;
  • Leveraging internal system data and historical transparency data to identify outliers in real time;
  • Benchmarking common value-transfer activities against industry data, to support standard FMV analysis;
  • Developing a geographical view of company activity to evaluate risks per region, country and even at a city level.

CASE STUDY: USING INDIVIDUAL HCP PAYMENT DATA TO INFORM COMPLIANCE PROCESS DECISIONS

A Life Sciences company wishes to review the payments it has made to a French healthcare professional (HCP) over the last two years using French transparency data. The company has engaged the HCP in various activities over the course of 2016. This HCP works for a French hospital and is subject to strict activity-accumulations rules[5].

Based on the company’s analysis, the total amount spent on the HCP was within the 2016 annual payment cap for work outside of their normal duties. However, there were significant inconsistencies in the rates paid to the HCP across the various engagements.  Additionally, the local team discovered that direct and indirect payments to this HCP were made by company affiliates, notably through CROs.

Thus, this analysis helped the Life Sciences company to better understand its risk areas (harmonization of payments, indirect and cross-border payments) and to implement a corrective and preventative action plan.

This brief case study demonstrates how life sciences companies in France can proactively analyze their transparency footprints and review individual HCP relationships. By using innovative data analyses, companies can support risk-based compliance operations to help meet Sapin 2 and other regulations but also enhance their own business activities.

For more information about how Polaris’ technology and consulting solutions, can help your Life Sciences company, contact us or visit our website.

 

[1] https://www.legifrance.gouv.fr/eli/loi/2016/12/9/2016-1691/jo/texte

[2] https://www.legifrance.gouv.fr/eli/decret/2016/12/28/AFSX1637582D/jo/texte; https://www.legifrance.gouv.fr/eli/arrete/2017/3/22/AFSP1709245A/jo

[3] http://www.lemonde.fr/election-presidentielle-2017/article/2017/03/07/soupconne-de-conflit-d-interets-avec-le-laboratoire-servier-un-membre-de-l-equipe-de-campagne-de-macron-demissionne_5090643_4854003.html

[4] https://www.data.gouv.fr/fr/datasets/transparence-sante-1/

[5] https://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000000504704