Development risk defence

To complicate matters in some countries, liability may also arise in tort without proof of fault. This is known as strict liability. An important example of strict liability for pharmaceutical companies is what is commonly referred to as the European Products Liability Directive , which introduced a Europe-wide scheme of strict liability for defective products, (see Chapter 52 on Pharmaceutical Product Liability ). As liability is strict, the defences that are available in the legislation are most important. The UK legislation, for example, includes a development risk defence. This essentially means that, if the state of scientific knowledge was such that the producer could not have discovered the defect, this will provide a defence to the claim. 

The most contentious defence contained in the Act is usually called the development risks defence. Under this defence,the producer of a defective product will have a defence if he can show that the state of scientific and technical knowledge at the relevant time was not such that a producer of products of the same description might be expected to have discovered the defect if it had existed in his products while they were under his control. Under the Directive, the Council of Ministers has the right to remove this defence following a review of its operation in the middle of 1995. 

The Act specifically makes it a defence that the product was supplied other than by way of the defendant s business, e.g. by gift. It also provides for a development risks defence, i.e. that the defect was not one that the defendant was aware of at the time given the state of scientific and technical knowledge then prevailing. 

In the Abouzaid case above Mothercare sought to rely on the development risk defence since there was no record of a comparable accident at the time of supply. The defence failed because, as the court put it, the defect was present whether or not previous accidents had occurred. 

No known risk that the microbes could develop a defence against Cell link. 

It involves a bottom-up assessment of each hazard and is focused on the post hazard horizon The sequence of intermediate conditions identified is termed the hazard development scenario . Defences against potential escalation (the defence may be equipment, procedure or circumstance) are referred to as Barriers . The Consequences of a hazard are categorised into three broad categories, Safety, Cotmnercial and Enviromnental. An example of basic Cause- Consequence risk model structure is given in Figure 3-12. 

The normal method of calculation for company funds is to use the capital asset pricing model (CAPM). This was developed by share analysts keen to have a defence against accusations of negligence in selecting shares for clients as a means of assessing the real value of any share, in the form of risk and desirability. It essentially demonstrates one version of the direct proportionality between risk and return. 

In this paper methods are critically reviewed, developed and explored on how to deal with this problem and how to include them in a risk analysis of coastal-and fluvial floods. An investigation of accepted risks in the coastal and fluvial flood-prone areas is made to answer the question if safe is safe enough and to define the acceptable risk levels. A risk-based approach in defining optimal safety levels of water defence system is developed. Application is made to define the optimal safety standmd for a case of coastal flood defences in Nam Dinh province, Vietnam. 

Economic risk analysis showed that the actual safety standards in design of coastal flood defences of the Vietnamese case study (1/20 years) are not safe enough in views of the current Vietnamese development. An optimal choice of the acceptable risk level was found at a return period of 100 years. This is in good agreement with the upper bound of the societal acceptable risk level of Vietnam. 

J. Perry Robinson, Chemical Weapons Proliferation , pp.22-4, and Chemical Weapons Proliferation Security Risks , in J. Pascal Zanders and E. Remade (eds). Chemical Weapons Proliferation (Brussels Vrije Universiteit Brussel, 1991), pp.69-92 E. Harris, Chemical Weapons Proliferation in the Developing World , in RUSI and Brassey s, Defence Yearbook 1989 (London Brassey s, 1989), pp.67-88 R. Jeffrey Smith, Agency Gets Last Word on Poison Gas , p.A23. 

Paradoxically, the risk of chemical warfare could even be enhanced by signing the Convention, that is, if nations are lulled into a false sense of security and let their chemical defences lapse. Research and development programmes will have to be preserved to minimise the possibilities of armed forces being surprised by new forms of chemical or biological attack in future battles. Improvements in NBC equipment and training will have to be sustained to raise the demands upon any would-be violator and to offset, at least partially, the consequences of non-compliance by adversaries. Finally, these defensive measures should be complemented throughout the ten years of a Convention by the retention of a eredible deterrent to chemical attack. 

In Switzerland, with its high population density, a safety concept based on Quantitative Risk Analyses (QRA) was developed nearly 30 years ago for the storage of ammunition and explosives within the Swiss Department of Defence [1, 2]. This QRA concept takes into account not only the effects of an accidental explosion but also its probability. It has proven to be a very useful instrument, allowing the actual hazards of such installations to be calculated in terms of fatalities, taking into account site-specific conditions, such as the number... 

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