Launch of the New French State Portal Allows for Electronic Information Disclosure by Health Care Companies

Reed Smith’s Global Regulatory Enforcement Law blog features a post on the recent launch of the new state portal in France. "The implementation of the French transparency regulation: first good news?," written by Reed Smith partner Daniel Kadar, discusses how the portal will allow health care companies to more easily disclose transparency information to the French government as required by the French Sunshine Act. The portal is thought to be “more customer friendly” for health care companies in that it provides three possible methods for the disclosure and transfer of information.

France: All Bodies Hosting Personal Medical Data Must Apply for Official Accreditation or Work With An Officially Accredited Data Host

This post was written by Daniel Kadar.

As a champion for the protection of personally identifiable information and with broad definitions for the concepts of personal and medical data, France has established a very specific set of policies requiring that all bodies hosting medical data must apply for official accreditation or work with an accredited medical data host. When medical data is hosted during a prevention, diagnosis or treatment activity – the scope of which covers most of the activities of the health care industry, which is experiencing and will experience a considerable development with telemedicine in the broad sense – the issue of the accreditation of the hosting services will be raised. To learn more about situations requiring the use of authorized hosting services in France, read our client alert.

French Ministry of Health Publishes Application Decree for "French Sunshine Act"; Requires Disclosure of Agreements With and Payments to Health Care Practitioners Dating Back to January 1, 2012

Reed Smith’s Global Regulatory Enforcement Law blog features a post on the recent publication of the application decree to the “French Sunshine Act” by the French Ministry of Health.  “A Brave New World? The ‘French Sunshine Act’ imposes online disclosure of contracts with HCPs, as well as of payments of ‘advantages’ to HCPs, dating back to 01 January 2012,” written by Daniel Kadar, discusses the specific ways and means that health care companies must disclose agreements with and “advantages” (payment or hospitality, including payment of a contractual fee) provided to health care practitioners ("HCPs") in order to comply with the application decree.  Information to be disclosed dates back 18 months, to January 1, 2012, and the first disclosure requirement is set for June 1, 2013.  According to Mr. Kadar, this tight timeframe raises compliance issues and has industry calling for reconsideration.

How to Mitigate Compliance Requirements and Code of Conduct Obligations with Data Protection Regulation: Reed Smith Paris Provided Some Illustrative Examples

As reported on our Global Regulatory Enforcement Blog, Reed Smith Paris partner Daniel Kadar and counsel Séverine Martel hosted on 25 October 2012, a new edition of the conference cycle organized by Reed Smith Paris with the European American Chamber of Commerce, dedicated to the mitigation of Compliance obligations, particularly as set forth in Codes of Conduct, with data protection requirements.

The panel, which included compliance directors of French health care giant SANOFI and General Electric Health, brought examples of how to mitigate compliance obligations, in particular as set forth in Codes of Conduct most International organisations have now adopted, with applicable data protection regulation.  The first example was dedicated to the New French Health Care Regulation and its transparency and disclosure requirements as to the existence (and the financial range) of agreements between the health care and cosmetics industry with health care professionals (including Medicine students), showing that the disclosure of financial and private information (such as the home address for the medicine students) had to be managed carefully with respect to the data owner’s information and access rights.  To read the full post, click here.

Health Care Companies Operating in France to be Subject to New Sunshine/Transparency Rules

This post was written by Marina Cousté, Benoît Charot, François Jonquères and Daniel Kadar.

Health care and cosmetic companies operating in France are subject to new transparency requirements, comparable to the U.S. "Sunshine Act," that were adopted in December 2011. As discussed in a recent posting on Reed Smith's Global Regulatory Enforcement Law Blog, in addition to imposing a general disclosure obligation on any company manufacturing or commercializing products with a medical or cosmetic purpose, the new law sets forth new pharmacovigilance requirements and provides more stringent rules concerning the advertisement of drugs and medical and diagnostics devices.
 

Data Protection Within the Framework of the Regulation No. 1924/2006 on Nutrition and Health Claims Made on Foods of 20 December 2006

This article, written by Reed Smith attorneys Paule Drouault-Gardrat and Juliette Peterka, was first published in Insights, the conference bleue newsletter.  Reprinted with permission.

Article 21 of the Regulation No. 1924/2006 on nutrition and health claims made on foods of 20 December 2006 provides data protection for applicants who wish to register a nutritional or health claim not included in the Community list. The Community list of authorized health or nutrition claims will be established on the basis of proposals made by Member States with the assent of the Commission before 31 January 2010.

 

The difficulty is that if a manufacturer wants to use a claim which is not listed, it will have to proceed to a scientific evaluation of the claim. This raises two types of issues. Firstly, this is quite expensive. Consequently, this will cause small and middle sized companies to increase their costs every time they consider using a new claim. The second issue relates to the protection of the company’s private data. The Commission thus decides to provide data protection to new applicants, under Article 21 of the Regulation No. 1924/2006.

 

Article 21 provides that “the scientific data and other information in the application required under Article 15(3) may not be used for the benefit of a subsequent applicant for a period of five years from the date of authorization, unless the subsequent applicant has agreed with the prior applicant that such data and information may be used, where:

(a) the scientific data and other information has been designated as proprietary by the prior applicant at the time the prior application was made; and

(b) the prior applicant had exclusive right of reference to the proprietary data at the time the prior application was made; and

(c) the health claim could not have been authorized without the submission of the proprietary data by the prior applicant.

In other words, the applicant becomes the exclusive user of the claim and of the data submitted to the Commission. The protection is quite broad since “the scientific data and other information […] may not be used for the benefit of a subsequent applicant.” The Regulation does not specify which data ought to be protected. But the scope of Article 21 probably encompasses the results of research funded by the applicant.

Similarly to data exclusivity of the data of Marketing Authorization files for medicinal products, the aim of such provision is to protect the applicant which has taken the initiative to launch and finance research in order to obtain results significant enough to justify the use of a health or nutritional claim on a specific food product.

The protection is meant to last for a five-year period, starting from the date of the individual Community authorization. Unless the applicant has specifically given its authorization, it is strictly forbidden for the Commission to refer to data and information contained in its application, to authorize a subsequent applicant to use the same health or nutritional claim.

Thus, once a new nutritional and health claim is registered in the Community list, and if the claim could not have been authorized without submission of such data, the applicant is then the sole holder of the right to use the data and the health or nutritional claim for a period of five years.

However, a subsequent applicant may be authorized by the prior applicant to use the health or nutritional claim. Moreover, if another company asks for the authorization to use the same claim but on different scientific data, then it will be able to use the said health or nutritional claim.

Still, the claim will not be usable by other manufacturers which are not able to establish the same justifications. The latter will have to await the end of the time period to be authorized to use the data legitimately, unless the Commission decides that the registration on the Community list could have been done without submission of these data:

“unless and until the Commission takes as decision on whether a claim could be or could have been included in the list provided for in Article 14 or, where appropriate, Article 13 without the submission of data designated as proprietary by the prior applicant.”

In addition, if a competitor eventually establishes that the data was not essential to justify the claim or if the exclusive property of the applicant is questioned, the Commission will have to decide whether or not the conditions of use of the claim have to be modified.

In view of the above, it seems that the data protection granted by Article 21 is a step forward for the applicant of a new nutritional or health claim. Nevertheless, as for medicinal products, its implementation may give raise in the future to interpretation issues and consequently litigations.

Pharmaceutical Parallel Trade Ruling in the European Court of Justice and Pharmaceutical Product Liability Rulings in France

Markets outside the United States are increasingly important for life sciences companies, and this post includes articles by Reed Smith lawyers regarding two developments in Europe. 

The first is by Edward Miller, entitled "Sidestepping the Issue", republished with permission from the International Clinical Trials e-book (registration required).  This article discusses a ruling by the European Court of Justice, holding that pharmaceutical companies can refuse to fill "unusual" orders from distributors who seek to profit by buying drugs for countries with low reimbursement prices, and shipping them for sale in countries with high prices - but falling short of the standard advocated by the pharmaceutical company defendant in that case. 

The second article is by Paule Drouault-Gardrat and Julie Gottenberg regarding French Supreme Court rulings earlier this year on causation in product liability cases.  First published in the August edition of Insights, the conference bleue newsletter, the article is reprinted with permission here:


Product liability case-laws in the pharmaceutical sector: The French Civil Supreme Court held important rulings on the causality issue

On 22 May 2008, the French Civil Supreme Court handed down a series of judgments relating to the liability of pharmaceutical companies for defective products once again focusing on the causal link, one of the legal prerequisites to a successful product liability claim.

According to both French Law and the European Directive 85/374/EEC on defective products, a claim for defective product requires three cumulative conditions: a defective product, an injury and a causal link between the two.

The five case-laws at stake relate to hepatitis B vaccines allegedly connected with multiple sclerosis[1] or ulcerative colitis[2].

Prior case-law

In light of the uncertainties concerning the etiology of multiple scleroses and the absence of clear-cut scientific conclusions, the Civil Supreme Court refused in two decisions dated 2003[3] to recognize any causal link between the hepatitis B vaccine and the occurrence of multiple scleroses.

Accordingly, said Court reversed the rulings of the appellate courts which had wrongly based their holdings on a series of presumptions. The Civil Supreme Court overruled the appellate decisions for "breach of the law" thus asserting that such a causal link is not even demonstrable.

In other words, such overruling did not condemn a failure to demonstrate the causal link in the specific case but was rather based on the theoretical observation that a causal link could not be established.

Hence, the Civil Supreme Court decided that the "judicial truth" should be aligned with the scientific standpoint.

It was unanimously understood from these 2003 precedents that in hepatitis B vaccines cases, the proof of the causal link through presumptions could not be successful.

The 2008 case-laws

The Civil Supreme Court acknowledges for the first time here that in hepatitis B vaccine cases, the causal link can be evidenced by means of presumptions provided that they are "serious, precise and convergent".

The presumptions must be supported by detailed elements which are appreciated on a case-by-case basis but not through general scientific studies, either statistic or probabilistic.

This new position is less favorable to the pharmaceutical companies since the existence of a causal link is no longer excluded from scratch.

In fact, however, it remains uneasy for the plaintiffs to succeed. Indeed, amongst the five analyzed case-laws:

  • the Civil Supreme Court overruled the appellate rulings only because the appellate courts neglected to assess the presumptions related the causal link[4].
  • the referral to the Civil Supreme Court was rejected in two cases as the appellate judges had rightly assessed the presumptions put forward and concluded to the absence of any causal link[5].

Comparative approach and the French dual legal system

As you may know, France has a dual legal system: the administrative judicial order, headed by the Administrative Supreme Court (« Conseil d’Etat »), dealing with the compliance with Public Law[6] and the civil judicial order, headed by the Civil Supreme Court (« Cour de Cassation »), dealing with the compliance with Private Law[7].

Claims for defective products are filed with civil or administrative courts depending on the factual context (e.g status of the hospitals or of healthcare professionals).

In this regard, still today, the competent civil and administrative courts do not have the same position on the causality issue in hepatitis B cases.

Indeed, in certain circumstances where the scientific experts do not exclude the possibility of a causal link between hepatitis B vaccines and multiple scleroses, the Administrative Supreme Court may conclude to the liability of the manufacturer[8]. The key issue in such a rationale is the acknowledgment, by the Administrative Supreme Court, of the reversal of the burden of proof hereby requiring the manufacturer to establish that its vaccine is harmless.

As for the Civil Supreme Court, it considers that "the absence of scientific certainty on the harmlessness of the vaccine does not lead to a presumption of defectiveness"[9]. Thus, in civil cases, the burden of proof still lies on the plaintiffs.

To summarize the situation as it now, if the latest civil case-law dealing with hepatitis B are less favorable to the pharmaceutical companies than before, they still remain less in favor of the claimants than the current administrative case-law.



[1]  Decisions of the 1 st Civil division of the Supreme Court dated May 22, 2008 n°05-20.317, n°06-10.967, n°06-14.952, n°06-18.848.

 

[2] Decision of the 1 st Civil division of the Supreme Court dated May 22, 2008 n°05-10.593.

[3] Decisions of the 1 st Civil division of the Supreme Court dated September 23, 2003 n°01-13.063 and n°01-13.64.

[4] Decision of the 1 st Civil division of the Supreme Court dated May 22, 2008 n° 06.10.967, n° 05-20.317, n° 06.14.952.

[5] Decision of the 1 st Civil division of the Supreme Court dated May 22, 2008 n° 06-18.848 and n° 05-10.953.

[6] Law governing relationships between individuals and the State.

[7] Law governing relationships between individuals.

[8] Decision of the Administrative Supreme Court dated March 9, 2007 n° 267635.

[9] Decision of the 1 st Civil division of the French Supreme Court dated May 22, 2008 n° 06-18.848.