Advising with empathy and experience

Medical innovation bill defeated.

A legislative bill aiming to remove the threat of litigation for doctors who administer innovative treatment to patients is unnecessary and should not become law, an audience comprising  mostly medical professionals and lawyers has voted in a debate at King’s College London.

The debate, in March, organised by consumer group, HealthWatch UK, defeated the motion “This house supports the Medical Innovation Bill” by 90 votes to three with 13 abstentions.

The Medical Innovation Bill had its first House of Lords reading in June 2014 after being put forward by Lord Saatchi as a private members bill after his wife’s death  from primary peritoneal cancer.

Lead speaker in favour of the bill, chair of the UK Medicines and Healthcare products Regulatory Agency, and former chair of the National Institute for Health and Care Excellence (NICE), Sir Michael Rawlins, said that he had initially had reservations about the bill, but had changed his mind after speaking with Saatchi.

He 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 had been wrong.

Rawlins recounted the case of Sam, a young boy with Dravet syndrome, a catastrophic form of infant epilepsy, who was having 40 seizures a day and was not responding to conventional anticonvulsants. His father commissioned 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 US, the boy was brought to the UK where the cannabidiol was sourced and administered privately. Within two days, Sam was having only two seizures a day, which has been maintained. Rawlings said that the paediatric neurologist treating Sam wanted to give the treatment to other children, but the NHS hospital refused because it was not proven safe or effective.

President of HealthWatch UK, journalist Nick Ross led arguments against the motion. He said that 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 opposed the bill.

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. Data from the Office for National Statistics and Cancer Research UK shows 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 for primary legislation, it’s a reason to give them more training.” He added that “not one penny” of the annual £1.6bn NHS medical negligence bill was paid in claims related to innovation.

A clinical negligence lawyer at Kings Chambers, Manchester, Nigel Poole, also opposed the bill. He said: “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. Lord Saatchi misunderstands the law of medical negligence and I suggest that he misunderstands the true nature of innovation.”

A parliamentary lawyer speaking for the motion, Daniel Greenburg, accepted this point but countered that soaring litigation costs were affecting attitudes to innovation in an increasingly risk-averse NHS.

He said: “Today, neither the doctor nor the patient can have confidence that the common law will vindicate them. The bill gives patients and doctors certainty and clarity at the point of treatment.”  

But Nick 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. There is a long roll call of dishonour where lack of systematic science did harm.”

As examples he cited 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”. He said that this “will prevent repetition of error. It will trigger new full randomised clinical trials based on the results of innovation.”

However,  Poole said that the bill does not mandate such a register but says that a doctor must “comply with any professional requirements as to registration of the treatment.” The General Medical Council has said it has no intention of making any professional requirements, so there will be no register required by the bill.

Quacks and charlatans with treatments to sell, that no responsible body of doctors would recommend, would 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.”