Prescribed Drugs (Compensation) (Hansard, 17 July 1990)

§ Sir Michael McNair-Wilson (Newbury)
I beg to move,
That leave be given to bring in a Bill to provide statutory rights to compensation to sufferers from serious side effects from prescribed drugs; and for connected purposes. Alongside, and complementary to, the great advances in medical science—[Interruption.]

§ Mr. Speaker
Order. Would those hon. Members who do not propose to remain in the Chamber please leave quietly?

§ Sir Michael McNair-Wilson
Alongside, and complementary to, the great advances in medical science and surgery that have taken place in the past 50 years has been the introduction of new drugs which, in their efficiency and effectiveness, have helped to banish so many of the illnesses that were common when I was a boy. Diphtheria, measles, scarlet fever and even tuberculosis, which were once the scourges of our nation's health, are now of little consequence. I name those diseases; I could easily name a dozen others that have ceased to be serious and epidemic illnesses—[Interruption.]

§ Mr. Tony Banks (Newham, North-West)
On a point of order, Mr. Speaker. I apologise to the hon. Member for Newbury (Sir M. McNair-Wilson), but I cannot hear a word that he is saying. This motion is very important.

§ Mr. Speaker
I quite agree that it is important. I have already appealed to hon. Members to leave quietly, and I appeal to those hon. Members remaining in the Chamber to listen to what the hon. Gentleman has to say.

§ Sir Michael McNair-Wilson
As it notches up its successes, the pharmaceutical industry has moved on to tackle new challenges and, as I speak, the Committee on Safety of Medicines—the watchdog body that decides when a drug has progressed sufficiently through its clinical trials to be licensed—is considering between 10 and 20 new drugs for which the manufacturers are seeking a licence. A licence is sometimes thought to mean that all the known side effects of the drug have been established. That is not so. As Professor Bill Asscher, the chairman of the Committee on Safety of Medicines, said recently in a "World at One" news programme: The policy has always been to advise Ministers to license drugs early so that the Committee can study them after they are being used, by proper post-marketing surveillance. He pointed out that a licence means that, in clinical trials, a drug has been found to be effective, safe and of quality. But he added:
You don't know until you've used a drug in a very large number of people precisely what problems there might be. Professor Asscher then explained that his committee relied on a voluntary reporting scheme whereby GPs fill in yellow cards commenting on any unexpected side effects that they notice when using a new drug. The monitoring scheme produced 20,000 reports last year, and is continually being assessed by the committee. The scheme depends on the diligence of the GPs, and makes one realise that the fact that a drug has been licensed in no way guarantees that it will not create harmful side effects. If it does, what recourse to compensation is open to the victim? In theory, the Consumer Protection (Registration of Professional Chemists) Act 1988 could be called in aid, as it imposes a liability on manufacturers of defective products without the need to prove negligence. However, 862 I am told that the cost of a complex drug claim would be prohibitive for a family not on legal aid. That must be wrong.
A drug is a product. An analogy could be drawn between a new drug and a new car: both will have been rigorously tested by their manufacturers before going on sale. In the case of the new car, it will have been driven for thousands of miles before appearing in the showroom. However, if, after it is available to the public, it begins to show unsuspected faults, the manufacturer will recall the model and have the defects put right.
At that point my analogy breaks down. It is possible to recall a car and put it right, but what about someone who has been severely damaged by the side effects of a drug? I mean lasting damage, not just a massive skin-peeling rash like the one that I developed after being given a particular medicine in hospital but of which there is now no trace. I am referring to serious, drug-induced side effects. Thalidomide is the classic example, but it is not an isolated case; other examples are Opren the arthritis drug, Myodil, the heart drug Pexid and the steroid Prednisolone. People who were given high dosages of steroids in the 1960s now have bodies cruelly deformed by their side effects. They will carry those abnormalities to the grave.
The latest addition to the list of drugs giving serious cause for worry is another heart drug called Corwin. It was licensed in May 1988; by 1989, the monitoring system used by the Committee on Safety of Medicines had shown that the drug could cause deterioration in patients with severe heart failure. Other information from the yellow-card "adverse drug reaction" monitoring scheme indicated that it was sometimes being used inappropriately in such patients. In January this year, the Committee on Safety of Medicines made recommendations severely restricting the use of Corwin. It is continuing to monitor the situation.
The exact number of people suffering from severe drug-induced side effects is not easy to establish. Professor Asscher is reported to have stated that 7 per cent. of all admissions to hospital are due to the serious side effects of modern medicines. By anyone's standards, it is a matter for concern. Yet our pharmaceutical industry seems indifferent to the question of compensation, refusing to admit liability and effectively challenging the victims to sue if they can afford it—of course most of them cannot. Just occasionally, one of the drug companies seems willing to accept its responsibility: in the 1970s, ICI set up a £10 million voluntary compensation scheme for victims of its heart drug Eraldin.
Then there is Danny Heffernan, now 23 years old and only 4 ft 4 in tall. He discovered that his stunted growth was caused by very high dosages of steroids. After an 11-year battle he persuaded Glaxo, the makers of the drug that had affected him, to offer an out-of-court settlement.
I do not believe that the present situation is good enough, especially as we now know that licensing by the Committee on Safety of Medicines in no way certifies that a drug is free of side effects. To that extent, I believe that Parliament should insist that our pharmaceutical companies set up a compensation fund. I suggest that they should be required by law to do so.
I believe that we should use the West German example for the sort of law that I have in mind. The West German drug law of 1976 has a section that reads: If as a result of the administration of a drug intended for human use which was distributed to the consumer within the purview of the law … a person is killed or the body or the 863 health of a person is considerably injured the pharmaceutical entrepreneur who placed the drug on the market within the purview of this law shall be obliged to compensate for the harm caused to the injured party. The Germans have that law. The Swedes and the Finns have comprehensive pharmaceutical injury insurance schemes, designed to compensate for injuries caused by drugs. Drug importers and manufacturers share the cost of funding the scheme. I can see no reason why we should not follow those examples. I hope that the House will give me leave to bring in my Bill.