A legislative bill aiming to remove the threat of litigation for doctors who administer innovative treatment to patients, and currently working its way through the UK parliament, is unnecessary and should not become law, according to an audience of mostly medical professionals and lawyers gathered for a debate on the matter at King’s College London on 4 March 2015.
The debate, organised by consumer group HealthWatch UK, pitted pairs of speakers for and against the motion: “This house supports the Medical Innovation Bill”. With 90 votes against and three for, the motion was defeated. There were 13 abstentions.
The Medical Innovation Bill had its first reading in the House of Lords in June 2014 after being put forward by Lord Saatchi as a private members bill following the death of his wife from primary peritoneal cancer three years earlier. Having passed through the House of Lords, the bill must next win the support of the House of Commons if it is to become law, but with little time and widespread opposition to the bill among medical professionals, it is unlikely to happen before the general election in May 2015.
The lead speaker in favour of the bill, Sir Michael Rawlins, chair of the UK Medicines and Healthcare products Regulatory Agency and former chair of the National Institute for Health and Care Excellence (NICE), opened the debate by admitting that he had initially had reservations about the bill, but had changed his mind after speaking with Saatchi. Rawlins had thought that as a doctor he already had powers under Section 9 of the Medicines Act 1968 to offer innovative treatments off licence, but said that he had been wrong.
Rawlins recounted the case of Sam, a young boy with Dravet syndrome (a catastrophic form of infant epilepsy) who was having around 40 seizures a day and who was not responding to conventional anticonvulsants. His father was in the financial position to commission scientists to look for potential treatments and they found evidence that cannabidiol, a naturally occurring antagonist to cannabis, had some effect in animal studies, said Rawlins. Unable to access cannabidiol in the United States, the boy was brought to the UK where the cannabidiol was sourced from GW Pharmaceuticals based in Salisbury and administered privately. Within two days, Sam was experiencing two seizures a day and this has been maintained. Rawlings said that the paediatric neurologist treating Sam wanted to give the treatment to other children, but the NHS hospital said no because it was not proven to be safe or effective.
Nick Ross, a journalist and president of HealthWatch UK, led the arguments against the motion. “This bill is based on false premises,” he said. “It is very unlikely to cure anyone. In fact, it is very likely to be injurious. It will not cut litigation. It will muddy the waters and actually bring more things to court.”
Organisations such as the Royal Medical Colleges, the Royal Pharmaceutical Society, the British Medical Association, Cancer Research UK, the Medical Research Council, the Medical Defence Union and various patient groups have come out against the bill and claim it is unnecessary.
Contrary to any argument that medical science is held back because of fear of litigation, Ross said the regulatory regime in the UK was second only to Germany in its support for medical innovation. Ross contended that data from the Office for National Statistics and Cancer Research UK show rapid and systematic improvement in treatment and survival across a wide range of cancers.
Prescribing drugs off label is routine. “If some [doctors] don’t understand what freedoms they have this is not a reason to have primary legislation, it’s a reason to give them a little bit more training.”
Nigel Poole, a clinical negligence lawyer at Kings Chambers, Manchester, also spoke against the bill. He said that Saatchi’s belief that the best way to hasten responsible innovation is through amending the law of medical negligence is wrong footed. “Whether a doctor is using tried and tested treatment or something completely new the courts apply the same tests: would any rational and responsible body of medical opinion support the treatment as proper practice,” he said. “Lord Saatchi misunderstands the law of medical negligence and I suggest that he misunderstands the true nature of innovation.”
Ross pointed out that “not one penny” of the annual £1.6bn NHS medical negligence bill was paid in claims related to innovation.
Daniel Greenburg, a parliamentary lawyer speaking for the motion, accepted this point but countered that soaring litigation costs were affecting attitudes to innovation in an increasingly risk averse NHS. “Today, neither the doctor nor the patient can have confidence that the common law will vindicate them,” he said. “The bill gives patients and doctors certainty and clarity at the point of treatment.”
But Ross said that the bill was confusing innovation with improvisation. “Uncoordinated trial and error on individual patients will never cure cancer and even if it did we would never know because these aren’t controlled conditions,” he said. “There is a long roll call of dishonour where lack of systematic science did harm.” As examples Ross pointed to giving premature babies oxygen to help them breath better (which blinded thousands of babies), giving corticosteroids to people with serious head injuries, giving thalidomide to pregnant women, and recommending, based on anecdotal evidence, that babies should be laid on their front to prevent choking, which increased cot deaths dramatically.
Greenburg stressed that compulsory data sharing included in the bill would mean that, “for the first time, every positive and negative result of innovative treatments will be shared in an anonymised form”. This, says Greenburg, “will prevent repetition of error. It will trigger new full randomised clinical trials based on the results of innovation”.
But Poole said that the bill does not mandate such a register, but rather says that a doctor must “comply with any professional requirements as to registration of the treatment”. And the General Medical Council has said it has no intention of making any professional requirements, so there will be no register required by this bill.
Quacks and charlatans with treatments to sell that no responsible body of doctors would recommend will benefit, warned Poole. “The law of negligence is a check on those doctors, it is a protection for those patients, checks and protections which this bill seeks to remove. In my job I have represented hundreds of clients whose lives have been ruined by medical negligence and many of whom if this bill had been law would have been deprived of justice. It makes me angry that their voices are not even acknowledged by Lord Saatchi.”
- This story was amended on 17 March 2015 to correct an error in the vote count introduced during editing.