Professor Lachmann writes about the complicated world of drug litigation
The Empower: Access to Medicine campaign is hugely important and I welcome the fact that it has been launched with such a focus on patients.
The pharmaceutical world is a complicated one that is often obfuscated by legalistic language and hard to pronounce product names.
For a drug to be approved there are a number of hurdles that must be cleared. Testing, trialling, legislation and not to mention cost, all play a part in the restricted flow of drug development. Those costs continue to soar, while the number of drugs approved plummets. One harmful consequence of the huge cost of taking drugs to market is that only large companies with deep pockets can now do so. Small companies, even if they have innovative and promising drug candidates, cannot do so on their own. This is part of the difficulty in getting new drugs for uncommon diseases.
Following changes to drug licensing laws in the mid-1950s (after a tragic incident involving thalidomide) there has been a marked reduction in the public tolerance of risk in regard to all prescribed pharmaceuticals. The public are right to expect high standards, and it is quite understandable that people are wary of the adverse side-effects of certain drugs.
However, this general risk aversion has led to a false perception that most prescription drugs on the shelf are almost entirely safe. Unfortunately this is not (and never will be) the case. This misconception has meant that when things do go wrong people often, if understandably, look for someone to blame. This blame normally involves litigation; and that normally involves significant cost.
Let me be clear I am not here to leap to the rescue of large pharmaceuticals and point the finger at those who take them to court. Where companies or people cause harm by negligence or fraud, they should expect to be called to account. Yet that is not often the case for much of the litigation. The simple fact is where patients suffer harm from a very rare side effect, or where the cause cannot be established, the growing practice of suing the drug company has no obvious justification.
The Consumer Safety Act, that used to govern this area, meant that if a patient agreed to take a medicine that they knew had not been fully tested (and thereby assumed the risk) that would prohibit any claim by the patient if some harm later materialized.
This is no longer the case. That common sense approach was supplanted by the Consumer Protection Act (1987) that introduced the European Product Liability Directive. This introduced a system of strict liability. Strict liability is when a person/company is legally responsible for the damage and loss caused by their acts or omissions regardless of culpability.
It is in fact the fear of litigation that drives a great deal of the regulation of medicines; and therefore a significant amount of the cost behind drug development.
This cost stifles the development of new drugs, drugs that could make a huge difference to people’s lives. But there is a solution that I believe would make a difference:
- Abolish strict liability in this area and replace it with liability based on negligence;
- Revise the definition of negligence so that, in deciding whether it was negligent or not to seek to develop a new drug, account is taken of the consequences of doing nothing as well as the consequences of trying to do something.
- Change the law on waivers so that any patient who is prepared to try a new medicine, together with the risk that it may have unknown side effects, is at liberty to do so;
- Abolish, at least in this area, no win no fee arrangements.
I set out my thoughts more fully in an article in the Quarterly Journal of Medicine: An International Journal of Medicine.
Professor Sir Peter Lachmann FRS FMedSci was President of the UK Academy of Medical Sciences (1998-2002). Sir Peter was the founder President of the UK Academy of Medical Sciences (1998-2002) and has served as its representative on the Inter Academy Medical Panel executive (2000-2006). He has been Biological secretary of the Royal Society (1993-98) and President of the Royal College of Pathologists (1990-93); and served on UNESCO’s international bioethics committee from 1993-98. In these capacities he has become involved with the ethical and policy aspects of medical science, particularly in connection with public health, vaccination, stem cells, transmissible spongiform encephalopathies and genetically modified food crops.
He trained in medicine at Cambridge and University College Hospital and obtained a PhD and ScD at Cambridge in immunology. He is emeritus Sheila Joan Smith Professor of Immunology at the University of Cambridge and a fellow of Christ’s College.