New Changes Proposed in France’s Sunshine Law

03.12.14 | By Greg Hawley

Adjustments Would Address French Life Sciences Sector’s Concerns Over Rushed Deadline Reporting Requirements And Will Simplify Process

France is reevaluating how they require their life sciences sector to report aggregate spend data. France is exploring potential modifications in its Sunshine Law, also known as the Bertrand Law, as reported on Feb. 27th in Loi Bertrand’s Le Blog.

According to the report, the French Health Ministry has circulated a draft decree of several proposed key changes to the French Sunshine Law among life sciences and healthcare system stakeholders in France for review. Overall, the suggested alterations in the law would significantly simplify how aggregate spend data is reported and substantially extend the deadlines for reporting requirements.

Specifically, the reforms in the law would address:

  • Reporting Extensions For HCP Agreements – Would go from the current 15 days after an agreement is signed to six month interval reports (August 1 and February 1) on the government central portal; This category of data would now be reported at the same time and in the same way that benefits data is reported
  • Narrowing of Data Reporting Requirements to HCPs Only – Would go from requiring reporting of benefits and agreements to all healthcare entities – HCPs and HCOs– to only those made with HCPs (including healthcare students)
  • Reduction of Data Fields in Reporting Process – Certain data fields that were previously designated as mandatory for reporting would no longer be required; These specifically are an HCP’s “Title” and “Qualification”
  • Date Changes for Resubmission: Data for reportable benefits and agreements that occurred between January 1, 2012 to June 30, 2013, which companies were required to publish on their own website, would need to be reposted on the government central portal by August 1, 2015.

We feel these potential changes to France’s aggregate spend reporting requirements could simplify the compliance process there, reducing the types and volume of data mandated for reporting as well as significantly easing deadlines, thereby alleviating some burdens on French life sciences company operations, while ensuring the integrity of data collected and reported.

Extending reporting deadlines for HCP agreements to six months from 15 days, for instance, will greatly reduce the tremendous strain on life sciences organizations’ legal and contract processing teams that they have long complained about, so that they will have more time to ensure accuracy of reporting, collect stakeholder sign-off and check they are in compliance with privacy law.

The changes will also address criticisms of the French Sunshine Law regulations that too broad a group of recipients were being mandated as reportable data, which had included payments to entities like foundations, physicians’ organizations and even associations representing students under current parameters. Companies there have been having a tough time identifying which payments are reportable and which are not, as a result. Isolating benefits and agreements reporting to HCPs only will make that task a little easier.

Though it’s still only a proposed amendment at this point, we’re reasonably confident these changes in France’s aggregate spend laws will be approved as the life sciences sector there will hardly object. Even though the proposal doesn’t give a specific timeline for implementing the changes, we are expecting that the amended rule will officially come out before the next reporting deadline there in August of this year. Wishful thinking? Maybe not.

If you have any questions about these changes, or the French Sunshine Law in general, please contact Greg Hawley or Polaris Global Transparency. A copy of the draft decree (in French) can be found here.