At the meeting of the WTO Committee on Technical Barriers to Trade (hereinafter, TBT Committee) held on 13–14 June 2012, Argentina voiced its concerns over a measure adopted by Spain restricting imports of biodiesel products into its territory. These concerns were reiterated, jointly with Indonesia, at the meeting of the WTO Council for Trade in Goods of 22 June 2012. On 17 August 2012, Argentina fi led a request for WTO consultations with the European Union (hereinafter, the EU) and Spain, targeting Spain’s restrictions.

The present Flash News Report sets outs recent EU regulatory law developments (as of 25 June 2012) which pharmaceutical companies should be aware of in the areas of Pharmacovigilance, Information on Medicines, Pricing and Reimbursement, EU Data Protection and Advanced Therapy Medicinal Products.

Case T-262/20 Microban International Ltd and Microban (Europe) Ltd v. Commission

The conditions for bringing direct actions before the EU General Court have been opened under Article 263, fourth paragraph, of the Treaty on the Functioning of the European Union (“TFEU”) through the introduction of less restrictive rules on legal standing for private applicants challenging regulatory acts. The term “regulatory act” covers all acts of general application apart from legislative acts and includes implementing measures adopted by the European Commission under the comitology procedure. Initial case law provides welcome guidance on the application of the new rules on standing but questions still remain (author's headnote).

The dispute over ractopamine in the Codex Alimenta-rius Commission (CAC) exemplifi es changes in Codex proceedings. In its early days, the CAC resembled to an honourable Club of senior food safety offi cials aim-ing at setting food standards in a consensual manner. However, with the WTO connexion established in 1995, CAC proceedings are overshadowed by looming trade disputes and increasingly decided by majority voting. The tendency towards majority voting in the CAC may ultimately undermine the universality of food safety standards and the legitimacy of the CAC as an inter-national standard setting body.

The test of EU antidumping expiry review is the likely continuation or recurrence of the dumping. In this case, the General Court (Second Chamber) of the Court of Justice of the European Union found that the European Council made manifest assessment errors of facts in using the continuation test to extend antidumping duties on the non-dumping applicant. However, due to the high discretion of the Council and the Court in making antidumping decisions, it is not a rigid rule that the non-dumping producers shall be exempt from the duties in the expiry review.

Case C-442/09, Bablok and Others (not yet reported)

An old German proverb says: What the farmer doesn't know he doesn't eat. In the case of the Bablok decision delivered by the European Court of Justice on 6 September 2011, it is not the farmers, but the judges who seem to be wary about the unknown. According to their judgement, substances derived from genetically modified plants require market authorisation to be placed on the market as food, even if the substance itself is not fertile anymore. Since the Court takes the view that pollen is an ingredient of honey rather than a natural component, honey contaminated with pollen from genetically modified organisms will fall within the classification of foodstuffs requiring marketing authorisation. So whenever a bee collects pollen from a genetically modified plant, this can make the entire honey harvest unmarketable. Not even the slightest contamination will be tolerated, irrespective of whether it was intentional. Because the prohibition to put unauthorised honey on the market applies abstractly, regardless of whether there is a concrete risk for the health of consumers, the judgement will have considerable impact on the coexistence of conventional, ecological and genetically-modified farming.

In September 2011, the World Trade Organization (WTO) released the report of a panel tasked with considering a complaint brought by Indonesia concerning prohibitions on certain flavored tobacco products implemented by the United States (US). The panel concluded that the US violated WTO law and recommended that the US be asked to bring its laws into conformity with WTO law.

The US appealed the panel's decision. The Appellate Body of the WTO upheld the panel report on April 4, 2012. This case note gives a brief overview of the Appellate Body's report and examines the implications for tobacco control and public health more generally.

Case C-34/10 Brüstle v. Greenpeace

1. 1. Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions must be interpreted as meaning that:

2. – any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’;

3. – it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of Directive 98/44.

4. 2. The exclusion from patentability concerning the use of human embryos for industrial or commercial purposes set out in Article 6(2)(c) of Directive 98/44 also covers the use of human embryos for purposes of scientific research, only use for therapeutic or diagnostic purposes which is applied to the human embryo and is useful to it being patentable.

5. 3. Article 6(2)(c) of Directive 98/44 excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.

Judgment of the Court (fifth Chamber) of 1 March 2012 (reference for preliminary ruling), Case C—166/11: Ángel Lorenzo González Alonso v Nationale Nederlanden Vida Cía. de Seguros y Reaseguros, S.A.E. (Spain)**

A contract concluded away from business premises, under which life assurance is offered in return for payment of a monthly premium to be invested, in varying proportions, in fixed-rate investments, variable-rate investments and financial investment products of the company offering the contract, falls outside the scope of Council Directive 85/577/ EEC of 20 December 1985, to protect the consumer in respect to contracts negotiated away from business premises, in accordance with Article 3(2)(d) thereof (official headnote).

Case C-442/10, Churchill Insurance Company Limited v Benjamin Wilkinson and Tracy Evans v Equity Claims Limited [2011] ECR I-00000

Article 3 No. 1 of Council Directive on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles, and to the enforcement of the obligation to insure against such liability, as amended, codified and repealed by Directive 2009/103/EC, OJ L - 103, of 02.05.1972. pp. 1–6. [First Motor Insurance Directive]

Article 2 No. 1 of Second Council Directive 84/5/EEC of 30 December 1983 on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles, as amended, codified and repealed by Directive 2009/103/EC, OJ L – 8, of 11.01.1984. pp. 17–20. [Second Motor Insurance Directive]

Article 1 No. 1 of Third Council Directive 90/232/EEC of 14 May 1990 on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles, as amended, codified and repealed by Directive 2009/103/EC, OJ L – 129, of 19.05.1990. pp. 33–35. [Third Motor Insurance Directive]