On 17 January 2011, the European Commission launched , a monitoring exercise of patent settlements in the pharmaceutical sector for the second time after the Pharmaceutical sector inquiry of 2009. As was the case for the first monitoring exercise launched in January 2010, a number of pharmaceutical companies were asked to submit copies of their patent settlement agreements concluded in the European Economic Area (EEA), together with any relevant annex, amendment or related agreement.

The rationale for the monitoring exercise derives from some of the findings of the Pharmaceutical Sector Inquiry, which had highlighted the possibility that some of the agreements reached by originators and generics to settle IP-related disputes (generally believed to be efficiency-enhancing tools to save money on litigation costs), may in fact turn out to have anticompetitive effects on the market. This is particularly the case for so-called “reverse payment agreements”. These are settlements that involve a payment (in direct or indirect form) flowing in a direction that intuitively appears “reverse”, as money is paid by the patent holder (the originator) to the alleged infringer – a generic firm.

Good regulation is essential, to protect employees, consumers and the public, as well as the environment. To argue that the market should be allowed to be the determinant of working conditions, together with a bit of exhortation to employers to behave decently, is to accept the Victorian approach that allowed children to work in coal mines.

The massive problems in the finance sector recently also show only too well the impact of weak regulation and de-regulation.

That said, Governments do not always get it right when they do regulate and there is undoubtedly some regulation that is no longer necessary, or is out of date, or is over-complicated or hard to enforce. Neither have Governments showed themselves to be very good at assessing public risk or balancing public health and environment protection with innovation and growth. As the former Risk and Regulation Advisory Council suggested, risk is often assessed through the prism of media sensationalism, political point scoring, civil service attachment to legislation and “risk mongers” such as insurance companies that have a vested interest in talking up risk.

On 14 April 2010 the Icelandic volcano, Eyjafjallajökull, erupted resulting in a volcanic ash cloud across European airspace. The ash cloud caused a moratorium on flying and concerns over health effects to vulnerable populations. Not even a year since the volcanic ash cloud; on 11 March 2011 a massive 9.0-magnitude earthquake occurred near the northeastern coast of Japan, creating extremely destructive tsunami waves which hit Japan just minutes after the earthquake, triggering evacuations and warnings across the Pacific Ocean. The disaster also led to concerns over nuclear power plant meltdowns in the affected areas and risk of radiation. High perceived risks associated with the Japanese tsunami and volcanic ash crisis are examples of scenarios where accurate and timely health and safety communications are vital for effective emergency response. However, communications immediately following such events face unique challenges. This report describes the challenges faced in terms of crisis communication immediately following high perceived risk events and positions the example case studies in the context of an existing crisis communication paradigm.

In the recent Grand River Enterprises case, United States public health regulations on protection from tobacco products successfully withstood a challenge by Canadian Native American investors under NAFTA chapter 11 arbitration. The arbitrators carefully weighed the investors’ rights and the regulatory freedom of the host state under the NAFTA rules. The treatment of other norms of international law on the protection of indigenous peoples, however, merits some criticism.

Case T-29/05, Deltafina SpA v. Commission and Alliance One International, Inc., formerly Standard Commercial Corp. and Others v. Commission

The General Court partially annuls the Commission's decision on Case COMP/C.38.238/B.2 and reduces the amount of the fine imposed by the Commission on Deltafina SpA from EUR 1 188 000 to EUR 6 120 000 (author's headnote).

Article 30(2) of Directive 2002/22/EC of the European Parliament and of the Council of 7 March 2002 on universal service and users’ rights relating to electronic communications networks and services (Universal Service Directive [USD]) is to be interpreted as obliging the national regulatory authority to take account of the costs incurred by mobile telephone network operators in implementing the number portability service when it assesses whether the direct charge to subscribers for the use of that service is a disincentive. However, it retains the power to fix the maximum amount of that charge levied by operators at a level below the costs incurred by them, when a charge calculated only on the basis of those costs is liable to dissuade users from making use of the portability facility (official headnote).

The case discusses the “Test-Achats” judgment of the ECJ in the overall context of the EU-non-discrimination principle in relations traditionally governed by private law and party autonomy. This principle has come from employment law and has been extended to consumption matters, at least with regard to such incriminated characteristics as gender, ethnic origin, and nationality. Even if the consequences of the ECJ judgment on the insurance market, including protection of insured persons themselves, by imposing “unisex”-tariffs from 21.12.2012 on may be viewed critically, the Court only draws the legal consequences of a prior decision of the EU legislator which cannot be delayed for an indefinite time span by the Member States (author's headnote).

Council Decision 2008/633/JHA on access for consultation of the Visa Information System for the purposes of prevention, detection and investigation of terrorist offences and other serious criminal offences must be read as a development of the Schengen acquis and not merely as a measure as to police cooperation, preventing the United Kingdom and Ireland from participating in adopting the measure (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 [email protected].

Despite the initial delay in Spain in the adoption and development of a better regulation policy compared to other OECD countries, in the last few years significant advances have taken place, as pointed out in the 2010 OECD report “Better Regulation in Europe. Spain”.

In this context, the initiatives promoted by the Autonomous Communities – Spanish subnational levels of government – are also very important, since they have wide powers for the development of their own public regulatory reform policies. In fact, the first Spanish experience of the introduction of regulatory impact assessment in the legal rulemaking process took place in Catalonia, which has been a pioneer in the integration of administrative simplification policies – applied since the early 90s – in addition to its administrative burden reduction strategy.