Category Archives: Pharmaceutical

Defective vaccines and burden of proof : no need for scientific consensus to compensate victims and no irrebutable presumption at the expense of the pharmaceutical industry

Judgment
C-621/15
21.06.2017
PartiesJurisdictionFormationJudge RapporteurAdvocate GeneralSubject-matter
Request for a preliminary ruling N. W and others
v.
Sanofi Pasteur MSD SNC and others
Court of Justice2nd ChamberA. PrechalM. BobekLiability for defective products
Keywords“Reference for a preliminary ruling — Directive 85/374/EEC — Liability for defective products — Article 4 — Pharmaceutical laboratories — Vaccination against hepatitis B — Multiple sclerosis — Proof of defect of vaccine and of causal link between the defect and the damage suffered — Burden of proof — Methods of proof — Lack of scientific consensus — Serious, specific and consistent evidence left to the discretion of the court ruling on the merits — Whether permissible — Conditions”
Significant pointsThis request for a preliminary ruling concerned the interpretation of Article 4 of Directive 85/374/EEC on liability for defective products. It involved Mr J. W’s three heirs acting against the pharmaceutical producer Sanofi Pasteur, as well as an independent pension and insurance fund. The applicants invoked Sanofi Pasteur’s liability for an allegedly defective vaccination against hepatitis B produced by the latter that would have led to Mr W’s multiple sclerosis causing his death.

The three members of the family first sought, on the basis of the French Civil Code, compensation for the damage they and Mr W had suffered due to the administration of the vaccine. The main issue in the present case was to prove the causal link between the defect in the product and the damage suffered by the person injured. In this regard, the French Cour de cassation referred three preliminary questions to the CJEU, which had to interpret Article 4 of Directive 85/374 operating a complete harmonisation of the laws, regulations and administrative provisions of the Member States.

According to Article 4 of the aforementioned directive, the burden of proof lied with the victim but no other provision specified how such proof was to be made out. Therefore it was for the national courts to establish the rules in compliance with the principles of procedural autonomy, of equivalence and of effectiveness (para. 25). The CJEU considered that the victim was not obliged to produce in all circumstances certain and irrefutable evidence of the defect, the damage and the causal link between them. In fact national courts were allowed to accept serious, specific and consistent evidence in order to prove, with a sufficiently high degree of probability, that the alleged facts corresponded to the reality of the situation (para. 28 and 43). Especially when, as in the present case, proof based on medical research neither confirmed nor ruled out the existence of a causal link, excluding any method of proof other than certain proof based on medical research would have made it excessively difficult or even impossible to establish producer liability (para. 31).

However national courts had to ensure that the evidence provided was sufficiently serious, specific and consistent to consider that the defect in the product had to be the most plausible explanation for the occurrence of the damage. Accordingly, the defect and the causal link could reasonably be considered as established (para. 37). In the present case, the CJEU judged that the temporal proximity between the administering of a vaccine and the occurrence of the disease, the lack of personal and familial history of that disease and the existence of a significant number of reported cases of the disease occurring following such vaccines being administered were sufficiently serious, specific and consistent in order to discharge the victim’s burden of proof (para. 41).

Finally, for the cases where medical research neither established nor ruled out the existence of a link between the vaccine and the disease, the CJEU added that Article 4 of Directive 85/374 precluded national evidentiary rules that would automatically presume the existence of a causal link between the defect attributed to the vaccine and the damage suffered by the victim if certain predetermined causation-related factual evidence was present (para. 55). Assuming the contrary would create an irrefutable presumption with the risk of compromising the effectiveness of the liability system created by the directive and would be contrary to the principle that the victim had to bear the burden of proof (para. 53).
NoteworthyThis is a very sensitive topic as it implies public health issues as well as the sustainable level of financial responsibility burdening on the pharmaceutical industry which remains one of the key sectors of the European economy. On the one hand, one could criticize the fact that the vaccine producer’s liability had been established even if no scientific proof had been provided to confirm that its vaccine did lead to multiple sclerosis. However, any other conclusion would render the proof excessively difficult for every layperson having become a victim of such medical procedures. On the other hand, the reject by the CJ of an irrebuttable presumption if certain predetermined causation-related factual evidence is present has to be welcomed and is in line with its case law and that of the European Court of Human rights, according to which presumptions of responsibility – at least in criminal matters in a wide sense (including competition law) - must always be rebuttable.

Reference medicinal product – Directive 2001/83/EC

Judgment

C-104/13

23.10.2014

Parties

Jurisdiction

Formation

Judge Rapporteur

Advocate General

Subject-matter

Appeal

Olainfarm AS

v.

Ministry of Health of the Republic of Latvia

CJEU

5th Ch.

D. Svaby

N. Wahl

Directive 2001/83/EC

Key-words

Directive 2001/83/EC — Medicinal products for human use — Marketing authorisation — Article 8(3)(i) — Requirement to attach to the application for authorisation the results of pharmaceutical pre-clinical tests and clinical trials — Derogations relating to pre-clinical tests and clinical trials — Article 10a — Medicinal products of which the active substances have been in well-established medicinal use within the European Union for at least 10 years — Whether it is possible to use a medicinal product for which authorisation has been granted on the basis of the derogation provided for in Article 10a as a reference medicinal product for the purpose of obtaining a marketing authorisation for a generic product Article 10 — Whether the holder of a marketing authorisation for a reference medicinal product has an individual right to oppose the marketing authorisation of a generic of the reference product

Summary

The concept of a ‘reference medicinal product’ within the meaning of Article 10(2)(a) of Directive 2001/83 must be construed as encompassing a medicinal product for which the MA was granted on the basis of Article 10a of the directive. Article 10a of Directive 2001/83  has the effect of exempting the applicant from one of the requirements laid down in Article 8 of the directive for obtaining a MA under Article 6 thereof. Accordingly, a medicinal product for which the MA was granted pursuant to Article 10a of the directive, the applicant for that authorisation having availed himself of the derogation under that provision and also having fulfilled all the other requirements laid down in Article 8 of the directive, must be regarded as a medicinal product authorised under Article 6 of the directive, in accordance with the provision of Article 8 thereof.Directive 2001/83 does not contain any express provision to the effect that a judicial remedy is available to the holder of a MA granted for an original medicinal product to challenge the decision of the competent authority which granted, pursuant to Article 10 of the directive, a MA for a generic medicinal product for which the original product served as the reference product.It should be observed that Article 10 of Directive 2001/83 lays down the conditions under which the holder of a MA for a medicinal product is required to accept that the manufacturer of another medicinal product is entitled to refer to the results of pre-clinical tests and clinical trials contained in the dossier relating to the application for the MA for the former product, rather than perform those tests or trials himself, for the purpose of obtaining a MA for the other medicinal product. It is apparent that that provision confers a concomitant right on the holder of the MA for the former medicinal product to demand that the rights attaching to him by virtue of those conditions are observed. It should therefore be recognised that the holder of a MA for a medicinal product used as a reference product in an application for a MA under Article 10 of Directive 2001/83 is, by virtue of that provision, read in conjunction with Article 47 of the Charter, entitled to judicial protection in so far as concerns respect for his rights.

Noteworthy