French Law No 2011-2012 on the Strengthening of Health Protection for Medicinal and Health Products, dated 29 December 2011 (known as the French Sunshine Act), imposes new disclosure obligations to health products companies. Without publication of the implementing decree, the disclosure conditions remain undetermined, although Article 2 of the act had specified that this disclosure obligation would be enforceable as of 1 August 2012. The French Ministry of Health recently issued a press release announcing the establishment of a working group to ensure that the implementing decree is published no later than October 2012. At such time the criminal sanctions provided for by the act may be applied.
Adopted following the Mediator® case, French Law No 2011-2012 on the Strengthening of Health Protection for Medicinal and Health Products (the Law), dated 29 December 2011, aims to establish a “French Sunshine Act” ensuring the transparency of decision-making in the health field. In particular, the Law imposes a new general disclosure obligation with respect to all agreements that health products companies may enter into and any advantages in kind or in cash provided by these companies to health care professionals (HCPs).
These new disclosure obligations remain unenforceable until the publication of a decree that details these obligations. A draft decree was subject to examination by the French Supreme Administrative Court (Conseil d’Etat), but still has not been published. As a result, many questions remain regarding the implementation of the disclosure obligations as well as the reasons for the delayed publication of the decree. Questions pertain in particular to the fact that the Law has a broader scope than the US Sunshine Act, and that the publication of the decree, as currently intended, raises issues about the legality of the disclosure conditions with regard to the principle of proportionality.
Declaration Scheme Willing to Be “Broader and More Transparent" than US Sunshine Act
The Law seems to widely extend the scope of its inspiration, the US Sunshine Act. Whereas companies subject to the US Sunshine Act are manufacturers of drugs and devices covered by federal health programmes only, the Law applies to any company manufacturing or commercialising medicinal products, medical devices, cosmetic products, essential oils, human and animal tissues or cells, contact lenses, tattoo products or test devices, or associated services. Of particular note in this definition, the term “medical devices” embraces virtually all diagnostic and therapeutic devices. The term “associated services” is also vague and thus potentially has very broad application, including to distributors, advertising companies and logistics companies.
The Law states that covered recipients are HCPs, associations of HCPs, medical students who are going to become HCPs, associations of medical students, associations of health system users, clinics and hospitals, foundations, medical societies and advisory societies, and companies operating in the health products sectors (including publishing companies, broadcasters of radio or television services, publishers of public online communications services, publishers of prescription products, and legal entities providing training sessions for the covered HCPs). Yet again, the Law applies to a broader range of practitioners and entities than the US Sunshine Act, which applies only to payments to physicians and teaching hospitals (and physician ownership in manufacturers and group purchasing organisations).
The disclosure obligation, as stated in the Law, includes any agreements or advantages in kind or in cash, direct or indirect. Therefore, companies would have to disclose the following:
- “Hospitality conventions”, i.e., invitations of individual HCPs to scientific or medical events for which companies pay the related costs (such as registration fees, travel costs, meals and accommodation expenses)
- Agreements of any nature, including research and development contracts (clinical trials, observational studies), other consultancy agreements (speaker, advisory boards), and aids or grants in any form
- Any benefit in cash or in kind, including any gift offered to a covered recipient and any lunch offered to HCPs by a medical sales representative after a medical visit
Disclosure Conditions: from Transparency to Disproportion
Regarding the disclosure conditions, the draft decree has a particularly broad approach, exceeding largely the requirement of the US Sunshine Act. It is therefore possible to question the legality of those requirements. Where the US Sunshine Act requires an annual report to the US Centers for Medicare & Medicaid Services, the draft decree states that companies will have to disclose the information 15 days after the signing date of a contract or the date at which the advantage has been granted. Companies will have to disclose the information free of charge through an accessible page of their website or through a register with the required forms available to the public. Companies will also be required to submit information, without delay, to the professional order having disciplinary power over the HCP (ordres professionnels).
Further, according to the draft decree, the information that must be disclosed is very broad. For any agreement entered into with HCPs, medical students and legal persons, companies must disclose the following:
- The name and address, as well as qualification and specialty (if applicable), for individual HCPs
- The date of the contract
- The purpose of the contract
- The agenda of the event, as well as the identification of the services provided by the company and the related costs of such services
As for the benefits provided to HCPs, medical students and legal persons, companies must disclose the following:
- The name and address, as well as qualification and specialty (if applicable)
- The date on which the benefits were granted, and the nature and value of the benefits
- The reasons why the benefits were granted
In view of these requirements, it is likely that the decree would have been challenged before the Conseil d’Etat based on the violation of the principle of proportionality. First, a disproportion may result from the extension of the disclosure obligation to include the names and addresses of the covered recipients, which could affect their fundamental right to privacy. Such a challenge may be reinforced by the argument that the decree is not in conformity with European Law, particularly Article 8 of the CEDH that guarantees the right to respect of privacy (e.g., EUJC, 9 November 2010, Volker und Markus Schecke GbR (C-92/09) and Hartmut Eifert, C-93/09).
Second, a disproportion may also result from the requirement of the disclosure to the public of “financial information”. The draft decree specifies that business secrecy is not a valid reason to exempt the companies from respecting the disclosure obligations. However, the Commission pour l’accès aux documents administratifs (the French Commission on Access to Administrative Documents, or CADA) considers that the principle of business secrecy covers trade secrets, strategic financial information and business strategy (CADA, Report No 9, 1999, p. 32). For instance, the CADA has considered that the communication of the turnover of pharmaceutical companies (CADA, Opinion, 6 January 2005, No 20050114) are matters covered by the principle of business secrecy.
Alternatively, if the decree was not challenged before the Conseil d’Etat, it still would have been possible to litigate the other individual regulatory measures implemented in pursuance of the Law, by means of “a priority question of constitutionality” (Question prioritaire de constitutionnalité, or QPC). The QPC allows any party to a legal action to raise the constitutionality of a provision of a law before any ordinary court if the law was not directly challenged before the French Constitutional Council (Conseil constitutionnel).
Given the jurisprudence of the Conseil constitutionnel and of the Conseil d’Etat, it comes as no surprise that the decree has not yet been published and that the Ministry of Health has started to rewrite the former draft.