HC Deb 14 December 1982 vol 34 cc159-60 5.34 pm
Mr. Jack Ashley (Stoke-on-Trent, South)

I beg to move, That leave be given to bring in a Bill to provide for the imposition of strict liability for compensation on the manufacturers of medical drugs. Millions of people have been helped by medical drugs which rank among the wonders of this modern age. They are extremely complex and remarkably potent, and they have cured illnesses and saved life on a massive scale. However, there is a minority who have been gravely damaged by drugs. They are the victims—usually the unwitting victims—of a drug mishap, and they are in great need.

At present, compensation will be given only to those people not only if they can prove that they were damaged by the drug, but if they can also prove negligence by the manufacturer. As the family of thalidomide victims found to their great anguish, this can lead to years of struggle and litigation. Negligence is virtually impossible to prove, because it requires highly specialist knowledge of drug testing and preparation, and knowledge of the internal operations of a drug company—something that no ordinary individual can obtain. Most people soon give up, because the fight is an unequal and unfair one. So the law, which in theory is neutral, favours the drug companies in practice, and is therefore unjust to injured individuals.

My proposed Bill seeks to redress the balance by imposing strict liability on the companies for damage caused by their drugs. It would remove the requirement for a drug-damaged victim to prove negligence. So long as a person could prove that the drug caused the damage, compensation would follow.

I recognise that drugs are a unique product, insofar as risk and effectiveness are often inextricably linked. So it is important to be precise about the circumstances in which stricter liability would apply. This Bill would not provide compensation for every headache and tummy upset caused by drugs. Most drugs, even the ordinary aspirin, can have minor side effects, and it would be unreasonable to impose liability for every one.

The circumstances in which I believe that there should be strict liability are those recommended by the Law Commission. In other words, the drug should comply with a standard of reasonable safety that a person is entitled to expect, and the standard of safety should be determined objectively, having regard to all the circumstances in which the product is put into circulation, including, in particular, any instruction or warnings that accompany it.

Sometimes the risks which are known to the drug companies are not emphasised, and this Bill would encourage them to make sure that risks are clearly, accurately and prominently displayed.

The Bill would apply to those cases where there were inadequate warnings of risks. It would also apply when the incidence or severity of drug damage was unreasonably high or unforeseen. The companies would not be allowed a defence that their drugs were not defective in the light of scientific knowledge when they were developed. To permit that defence would create so large a loophole in the compensation cover as to allow victims of another thalidomide disaster to slip through.

When there is drug damage, there is a clear choice between either allowing the damaged person to suffer without financial help or imposing an obligation on the drug company to pay on the basis of strict liability. The companies should accept responsibility because they are the only people able to control the quality and safety of the product and who are best able to ensure against claims. That is not only my view, but the view of the careful, cautious and conservative Law Commission which recommended the strict liability of the pharmaceutical industry, as did the Pearson Royal Commission and as, for that matter, did the European Commission.

Of course, some drug companies will not welcome this proposal, although the wiser ones will. They will know that the whole drug industry is being tainted by the hostile response of some companies to people damaged by their products. The public is becoming very worried about what appears to be a series of drug disasters. Those drug companies opposed to the Bill will claim that future research will be affected by the cost if strict liability is imposed. That is nonsense, and they know it. There is already strict liability in such European countries as Germany and Sweden, and also in the USA. There is no evidence whatever that research has been affected in those countries. In addition, the drug companies constantly assure us that the risks are slight, so that the costs are unlikely to be high.

When the Pearson Royal Commission reported I was not in favour of creating special categories because I hoped for a comprehensive no-fault compensation scheme. I have now changed my mind because, although I still hope for that, I recognise that that will not be instituted in the short term. In the meantime, we must accept the present compensation framework. However, that is no reason for not making progress within it. It is now time to make provision for those damaged by medical drugs, and an effective means of doing so is to impose strict liability on the manufacturers.

Before I sit down, I must register the strongest possible objection to the absence of any Minister from the Department of Health and Social Security while I present this important Bill which affects the many people who are damaged by drugs. The behaviour of the Department of Health and Social Security is scandalous.

Question put and agreed to.

Bill ordered to be brought in by Mr. Jack Ashley, Mr. Andrew F. Bennett, Mr. Tom Benyon, Mr. Ioan Evans, Mr. William Hamilton, Mr. John Hannam, Mr. Laurie Pavitt, Mr. David Stoddart and Mr. Dafydd Wigley.