Life Science Compliance Update

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. 

May 06, 2015

New Medicines Australia Code Tightens Transparency Provisions

Australia

On April 24, 2015, the Australian Competition Consumer Commission (ACCC) granted authorization of Edition 18 of the industry trade group, Medicines Australia’s, Code of Conduct. If Medicines Australia members accept the authorization and the conditions, Edition 18 will come into effect on May 16, 2015. The latest Code provisions tighten the transparency requirements for Medicines Australia member companies starting October 1, 2015, and will require physician payment reporting every six months. The Code provisions are similar in policy to the United States Open Payments program, though there are some differences in specifics. 

In Edition 18, Medicines Australia proposed a new reporting regime which requires reporting of "transfers of value" (such as speaking fees, advisory board fees, or sponsorships to attend a conference) made to individual healthcare professionals. 

The ACCC reviewed Medicines Australia's first stab at a reporting law--the Commission both commended the trade group for its transparency initiative, but noted some weaknesses in the law. “Having taken this crucial step, it is important to ensure that the significant benefits of the regime are realised," ACCC stated. "In this context, the ACCC is requiring the regime to be strengthened to ensure that all relevant transfers of value are reported and that the data is accessible." 

Under the new version, the ACCC has imposed a condition that enables reporting of all relevant transfers of value. "This addresses the ACCC’s concern in its draft determination that if a doctor did not consent to the reporting then the individual payment would only be reported in aggregate," states the Commission. "It also avoids healthcare professionals withdrawing their consent to reporting their details after receiving a transfer of value." ACCC states that "Medicines Australia must amend the Code before 1 October 2016 to require the reporting of all transfers of value."    

The ACCC is also requiring the transparency reports compiled by Medicines Australia member companies to be published in a common accessible format and to be available for at least three years. The ACCC also put the onus on the trade group to "establish a central reporting system" for the transfers of value. 

Notably, Australia's Code has a meal cap that excepts from reporting meals under $120.The ACCC said requiring companies to continue to report spending on food and beverages would impose a "significant administrative burden" on companies, but warned that it could reconsider the need for reporting on food and beverage spending if it became aware of "significant (and unreasonable) increases" in such spending. News outlets have focused on this apparent weakness in the reporting categories due to this exception. 

Code Provisions

As noted above, Medicines Australia has a number of updates before the October 1 deadline, but the Code has the following provisions currently:

The following activities would be reported by companies for individual healthcare professionals, by name, with the amount of the payment or transfer of value:

  • Consulting fees and/or speaking fees
  • Sponsorship of a healthcare professional to attend an educational event, including airfares, accommodation and/or registration fees (whether held within or outside Australia).
  • Fees paid to healthcare professional consultants in Australia, or to their employers on their behalf, for specific services rendered by them: consulting fees, accommodation and airfares (whether within or outside Australia).
  • Fees paid to healthcare professionals in their role as Advisory Board members: sitting fees, accommodation and airfares (whether within or outside Australia).
  • Fees paid to healthcare professionals for the purpose of market research ONLY where the identity of the healthcare professional is known to the company.
  • Payment of an educational grant or sponsorship to a specific healthcare professional

The following would not be required to be reported:

  • Hospitality (food and beverages): The cost of any meal (including drinks) provided by a company must be below the defined limit set in the Code ($120 for food and beverages, exclusive of goods and services tax (GST)).
  • Airport ground transfers, taxis, parking fees.
  • Venue costs (e.g. room and/or audio-visual equipment hire).

Companies will be required to indicate the following information:

  • Date of the event or provision of service
  • Name of the healthcare professional
  • Type of healthcare professional (i.e. medical practitioner, pharmacist, nurse practitioner);
  • Principal Practice Address of the healthcare professional;
  • Description of the service (i.e. speaker, Advisory Board member, Chairperson at educational meeting etc);
  • Description of the event (i.e. company sponsored meeting in Australia; independent meeting held in Australia; independent meeting held overseas; etc)
  • Whether the payment was made to the healthcare professional or a third party;
  • The amount of the payment or transfer of value, subdivided into (where relevant) registration fees, travel and accommodation, and fees for service.

We will continue to provide updates to the Australian transparency law, as well as other international reporting requirements. 

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