European strict product liability

New European Strict Product Liability Law Affecting Biotech Products... 

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. 

Biotechnology companies already anguishing over U.S. product liability concerns, as well as the lack of available coverage, are now facing strict liability laws in Europe. On July 25, the European Economic Community adopted new liability laws for defective products which member states "shall bring into force, not later than three years from the date of notification of this Directive," that is by July 25, 1988. 

Strict liability has also been adopted at least partly in a large numbo of other European countries. For example the foQowing laws are based on strict liability Belgian Law on Toxic Waste (1974) and on the control of organisms harmful to plants and plant products... 

Strict liability was established in the European Union to protect consumers (users and operators) from defective products. Directive 85/374/EEC changes the old approach of proving negligence to a new emphasis of strict liability on the manufacturer s part. Consumers can now initiate civil actions themselves, without the need to prove negligence. All producers involved in the production process are liable, insofar as the finished product, component, or raw material they supply is defective. The consumer can take simultaneous action against all parties involved in the supply chain. Moreover, the directive does not set any financial ceiling on the manufacturer s liability. 

The Consumer Protection Act, 1987, was enacted in the UK to fulfil obligations to implement a European Directive designed to protect consumers across member states. It introduces so-called strict liability (as opposed to fault liability in contract and tort) for defective products supplied in the course of a business. Where damage is caused by a defect in a product then the producer is liable to compensate the injured party whether or not he is at fault (Falla, 1997). 

---