The manufacturer of a substance that is used safely and, in more than 99.9% of cases, used as an intermediate (and thereforeis exempted from the authorisation procedure) is deemed to have no legal grounds for claiming the suspension of the inclusion of that substance in the Candidate List for lack of urgency. Its mere inclusion should not automatically result in any significant damages to the manufacturer, neither should the Candidate List serve as a regulatory blacklist (official headnote).

This section updates readers on the latest developments in pharmaceutical law, giving information on legislation and case law on various matters (such as clinical and pre-clinical trials, drug approval and marketing authorisation, the role of regulatory agencies) and providing analysis on how and to what extent they might affect health and security of the individual as well as in industry.

Case C-218/09 SGS Belgium NV v. Belgisch Interventieen Restitutiebureau and Others [2010] nyr

Article 5(3) of Commission Regulation (EEC) No 3665/87 of 27 November 1987 laying down common detailed rules for the application of the system of export refunds on agricultural products, as amended by Commission Regulation (EC) No 1384/95 of 19 June 1995, must be interpreted as meaning that damage to a consignment of beef in the conditions described by the national court does not constitute force majeure within the meaning of that provision (official headnote).

Under Section II of the Rules of Conduct for the DSU, the institutional affiliation of experts may be considered as an element that casts doubts on their impartiality and independence. Under Articles 5.1 and 5.7 of the SPS Agreement, the level of protection that a particular country is ready to tolerate may inform risk assessment and have an impact on the determination of insufficiency of scientific evidence. In a situation in which there is sufficient scientific evidence for performance of risk assessment in one of the international standard setting-organizations, one may still find insufficiency as provided by Article 5.7 if new data puts into question the relationship between the relevant scientific evidence and the conclusions in relation to risk, thereby not permitting the performance of a sufficiently objective assessment of risk (authors’ headnote).

The external presentation of medicinal products is fundamental in ensuring their safe use from a regulatory perspective. Indeed, the primary purpose of labeling and packaging of medicine is the clear identification of the conditions for safe use.

Case C-246/07 Commission v. Sweden nyr

1. 1. Unilateral proposals in the context of an international legal framework regarding alterations of that framework may be interpreted as dissociation from the common strategy within the Council (author’s headnote).

2. 2. If such dissociation has (legal) consequences for the Union, it compromises the principle of unity in the international representation of the Union and its Member States and weakens their negotiating power with regard to other parties to the Convention concerned. In such a case, there is a breach of the duty of cooperation in good faith under Article 10 EC (author’s headnote).

3. 3. By unilaterally proposing that a substance be listed in Annex A to the Stockholm Convention on Persistent Organic Pollutants, the Kingdom of Sweden failed to fulfil its obligations under Article 10 EC** (official headnote).

1. The concept of ‘monomer substances’ in Article 6 (3) of Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No. 793/93 and Commission Regulation (EC) No. 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, relates only to reacted monomers which are integrated in polymers (official headnote).

2. Article 6 (3) of Regulation (EC) No. 1907/2006 infringes neither the principle of proportionality nor the principle of equal treatment (author's headnote).

This section discusses issues related to risk communication across a range of publicly perceived highrisk industries (such as pharmaceuticals, nuclear, oil, etc.). It reports critically and provides analysis on risk communication as an outcome of risk research within these industries. Contributions are intended to include methods working towards the advancement of risk perception research and describe any lessons learned for successfully communicating to the public about risk.

The section on WTO law highlights the interface between international trade law and national risk regulation. It is meant to cover cases and other legal developments regarding the SPS, TBT and TRIPS Agreements and the general exceptions in both GATT 1994 and GATS as well as to inform about pertinent developments in recognized international standardization bodies and international law. Of recurrent interest in this area are questions of whether precautionary policies can be justified under WTO law, the standard of review with which panels and the Appellate Body assess scientific evidence and the extent to which policy can and should influence risk regulation.

The Austrian Umweltsenat is a court or tribunal for the purposes of Article 234 EC. The Environmental Impact Assessment (EIA) Directive is to be interpreted as meaning that a Member State has to subject a transboundary project to environmental impact assessment (EIA) even if the size of the project on its own territory does not reach the threshold for an assessment as defined in Annex I of the EIA Directive but the threshold is exceeded when parts of the project that are located in another State are taken into account (author’s headnote).

Case C-392/08 European Commission v. Kingdom of Spain nyr

Failing to draw up external emergency plans for all relevant establishments in accordance with Directive 96/82/EC on the control of major accident hazards involving dangerous substances may result in a Member State being deemed to have failed to fulfil its obligations under Article 11(1)(c) thereof (author's headnote).

Case C-428/08, Monsanto Technology [2010]

The Biotech Directive does not provide for absolute patent protection of DNA sequences. Protection is subject and restricted to the disclosed function (or purpose) of a gene; if the function is not fulfilled at the time of the alleged infringement the protection is therefore suspended. National law may not depart from the protection conferred by the Directive due to its exhaustive character (author's headnote).

The Book Reviews section will introduce you to the latest and most interesting books on a wide range of topics pertaining to the law and policy of risk regulation. EJRR Book Reviews will strive to be present in every edition and will accept reviews from all disciplines. For further information on the submission of reviews please contact the Book Reviews Editor at david.hornsby@wits.ac.za.

Joined Cases C-471/07 and C-472/07 AGIM and Others [2010] ECR I-00000

1. 1. The Member States determine, in compliance with the objective of transparency pursued by Council Directive 89/105/EEC and the requirements laid down by Article 4(1) of that Directive, the criteria on the basis of which the review of macro-economic conditions which is referred to in that provision is to be carried out, provided that those criteria are based on objective and verifiable factors (author's headnote).

2. 2. Article 4(1) of Directive 89/105, so far as its subject matter is concerned, is not sufficiently precise to have direct effect for the purposes of the national legal systems of the Member States (author's headnote).

3. 3. Article 4(1) of Directive 89/105 must be interpreted as meaning that a Member State may, 18 months after the end of a general price freeze in respect of refundable medicinal products which lasted eight years, adopt a new measure freezing the prices of medicinal products without carrying out the review of macro-economic conditions which is provided for in that provision (official headnote).