Life Sciences Legal Update : Life Sciences Lawyers & Attorneys : Reed Smith Law Firm : Healthcare, Food and Drug Law, Biotechnology, Privacy, Product Liability

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.

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.