Life Science Compliance Update

June 09, 2015

The Fifth Asia-Pacific Pharmaceutical Compliance Congress and Best Practices Forum

The Fifth Asia-Pacific Pharmaceutical Compliance Congress and Best Practices Forum will be held on August 17-18, 2015 in Manila, Philippines at the Sofitel Philippine Plaza. Participants may also choose to view the event through a live Internet webcast and will have access for six months.

Topics to be covered include:

  • Training on Compliance and Ethics Basics
  • Hot Asia Pac Compliance Issues
  • Major Asian Country Compliance Updates
  • Building the Compliance Profession
  • Negotiating, Implementing, Managing, Auditing and Monitoring Third Party Relationships
  • Ethical Interactions with Patients
  • Advanced Issues in Anticorruption Compliance
  • Responding to Investigations
  • Clinical Trials Compliance
  • Public Procurement, Tendering, Reimbursement and Pricing Update
  • Global Transparency, Disclosure and Aggregate Spend Update
  • Analytics and Technology Tools for Compliance
  • Compliance Journey for the Nutrition/Consumer Health Sector
  • Risk Identification, Ranking and Management for Diversified Healthcare Companies

Registration information and contact information can be located through these links.

Currently, the event offers the following continuing education opportunities:

  • Accounting Professionals: Approved for up to 14 NASBE CPE credits.
  • Compliance Professionals: The Congress is currently pending approval to offer Compliance Certification Board CCB Credits.
  • Attorneys: The Congress is currently pending approval to offer California and Pennsylvania MCLE Credit.

May 12, 2015

Update on French Sunshine Law

France

The Sunshine Act in the United States is but one physician payment disclosure obligation for manufacturers of drugs and devices to keep track of. We recently wrote about Medicines Australia’s transparency code; additionally, the European Federation of Pharmaceutical Industries and Associations (EFPIA) Disclosure Code sets out self-regulatory industry transparency standards for pharmaceutical companies operating in 33 European countries. Before Australia and EFPIA, however, the country of France instituted a law—the Bertrand Act—that requires companies to make public (1) any “benefits” given to health professionals, such as meals, lodging, donating equipment, etc., and (2) “conventions,” or agreements, between companies and providers, such as for speaking at conferences, research payments involving clinical trial work, training, etc.

A user-friendly, searchable database of the French disclosure information is available here. The law differentiates between what information companies are required to publish in the case of benefits as opposed to agreements. The website has different databases for benefits, “les Avantages,” and agreements—“les Conventions.”

  • For agreements, companies must publish the names of the parties involved, the date of the agreement, the general category of agreement, and a copy of the program of the event if any;
  • For benefits in kind and in cash, directly or indirectly, in addition to the date of the payments, nature of the payments, and names of the health provider recipients, companies must disclose the amount of each benefit provided that the amount of each benefit is greater than or equal to 10 euros.

In May 2013, the French Ministry of Social Affairs and Health announced in a circular that “benefits” would not include remuneration for services rendered (for example, contractual fees for consulting arrangements). The current database reflects this interpretation, as fees are not included on the website of payment transactions.

However, on February 24, 2015, France’s supreme court for administrative justice, the Conseil d’Etat—which examines and offers advice on a wide variety of French bills and decrees—disagreed with this interpretation. They found the exemption from public reporting of remuneration to be groundless, as well as the partial exemption available to companies that manufacture or market contact lenses and tattoo products.  Thus, regarding covered products alone the French law is broader than the U.S. Sunshine Act.  

The French Ministry is in the process of issuing an official amendment to require the publication of remuneration (translation required).  The Amendments are summarized as follows:

  • The amendment provides for the publication of remuneration in respect of interest links to be published on the public website. Excluded from the publication, are "commercial agreements" covered by Articles L.4413 and L.441-7 of France's Commercial Code--that is to say the agreements which have as their object the purchase of products for professional activity, according to the translated amendments.
  • All the published data will available for third parties to download and analyze.
  • Veterinary product manufacturers will also have to publish transfers of value.

Thank you to Bruno Moreau for his summary of the French amendments. 

Saint Louis Avocates, a French law firm, has also published a thorough interpretation of the requirements (the page requires translation). Most notably, they interpret the Counseil d’Etat’s announcement as having retroactive ramifications: “It should be noted that this cancellation is backdated so the impugned provisions of the circular, so that companies that did not report such remuneration relying on the interpretation of the circular are in violation,” states the website (google translated).

An important consideration for companies doing business in France is that the disclosure law complements the "anti-gift" law. A translated version of the French Ministry of Health's website states that the anti-gift law:

prohibits health professionals, students training for health professionals and associations or groups representing them to receive benefits (other than of negligible value) of the share of enterprises selling drugs or products supported by health insurance. This prohibition principle is subject to exceptions: the search for a convention or conference can indeed provide benefits and are subject to supervision by professional bodies.

We will continue to provide updates on the French disclosure law as they are released. 

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