Compatibility of German medicinal products (drugs) law with the EU Product Liability Directive

 

German medicinal products (drugs) law is unique EU-wide – only in Germany does a special liability regime apply for medicinal product liability to the exclusion of the Product Liability Directive (Directive 85/374/EEC). In other Member States, medicinal products liability by comparison also follows the Product Liability Directive. Historically, according to Article 13 of the Product Liability Directive, the stricter liability for risks in the area of pharmaceuticals which had already applied in Germany since 1978 – based on the experience gained from the Thalidomide catastrophe – when the Product Liability Directive was enacted, was not to be affected. The discussion about the conformity of currently applicable German medicinal products liability with the Directive, namely the additional tightening of this legislation in Sections 84 ff. of the German Medicinal Products Act (AMG), is currently being fuelled further. The Opinion of the Advocate General has now been presented in the proceedings instigated by the German Federal Court of Justice (BGH) for a preliminary ruling on this issue.

 

Referral by German Federal Court of Justice (BGH) of 6 March 2013 (Case No. VI ZR 109/12)

With it decision of 6 March 2013, the German Federal Court of Justice referred the question to the European Court of Justice (ECJ) for a preliminary ruling of whether Article 13 of the Product Liability Directive is to be interpreted such that medicinal products liability under German law as a “special liability regime” is not generally affected by the Directive – with the result that the liability regime under national medicinal products law can be developed further – or whether the scope of the prerequisites for liability which existed at the time the Directive was notified (30 July 1985) may not be extended. Since the presumption of a causal connection in Sec. 84(2) of the German Medicinal Products Act (AMG) and the right to disclosure with respect to pharmaceutical companies and authorities pursuant to Sec. 84a of the German Medicinal Products Act (AMG) were introduced with the Second Compensation Amendment Act of 2002 and therefore after the Directive was notified, the question arises of whether these provisions are compatible with the Directive.

 

Opinion of the Advocate General of 11 June 2014 (Case C-310/13 Novo Nordisk Pharma GmbH/S)

The Advocate General commented on this in his Opinion on 11 June 2014. He concluded in his Opinion that Article 13 of the Product Liability Directive was to be interpreted such that claims of persons suffering damage which exceed the level of protection (under the provisions of the Directive) may only be maintained if they already existed at the time the Directive was notified. The Advocate General is therefore in favour of the cut-off date solution, i.e. the creation of new prerequisites for liability after notification of the Directive which deviate from requirements of the Directive is not covered by Article 13 of the Directive. For the sake of clarity, however, he added that the Directive in principle permits national “special liability regulations” to lessen the burden of proof.

 

Impact on the medicinal products liability regulations of Sections 84a and 84(2) of the German Medicinal Products Act (AMG)

The Advocate General explicitly notes that the right to disclosure pursuant to Sec. 84a of the German Medicinal Products Act is to be seen as such a provision which lessens the burden of proof and is therefore compatible with the Directive. The Advocate General did not make any express statement with respect to the presumption of a causal connection in Sec. 84(2) of the German Medicinal Products Act (AMG) because Sec. 84(2) of the German Medicinal Products Act (AMG) was not relevant for the decision in the proceedings before the German Federal Court of Justice (BGH). Sec. 84(2) of the German Medicinal Products Act (AMG) will therefore have to be gauged against the burden of proof provision in Article 4 of the Product Liability Directive. According to widespread opinion (for more information see Handorn, in: Fuhrmann, Klein, Fleischfresser, Arzneimittelrecht (medicinal products law), 2^nd ed. 2014, Sec 27, at para. 71 ff.) the presumption of a causal connection in Sec. 84(2) German Medicinal Products Act (AMG) specifically does not govern a reversal of proof, but a lessening of proof. Accordingly, Sec. 84(2) of the German Medicinal Products Act (AMG) would at least in the opinion of the Advocate General be in line with the Directive.

 

Outlook

It remains to be seen whether the ECJ will follow the Opinion of the Advocate General with respect to the right to disclosure pursuant to Sec. 84a of the German Medicinal Products Act (AMG) and whether it will also comment on the compatibility of the presumption of a causal connection pursuant to Sec. 84(2) of the German Medicinal Products Act (AMG) with the Product Liability Directive.