Please can you give an overview of the Medical Innovation Bill tabled by Lord Saatchi?
The intention of the Medical Innovation Bill is to encourage and support doctors to explore new medicines for their patients when they believe existing options are no longer achieving good outcomes.
The Bill’s supporters believe it will stimulate responsible innovation in treatment above-and-beyond that possible currently, and that it will increase the speed at which new medicines are made available in the clinic.
What is the reasoning behind this Bill?
Proponents of the Bill believe that current access to new or experimental medicines is too restrictive and doctors are worried about damage to their reputations and the fear of ligation, which stifles their ability to act in their patients’ best interests.
Currently, to what extent are doctors able to innovate outside the context of trials?
Licensed medicines can be used for conditions and diseases not indicated in the license, and for which the therapy was not originally tested for, provided the patient’s doctor has sound reasoning for its use in this non-licensed setting.
This so-called ‘off-label’ use is commonplace, especially among paediatric patients or for patients facing end-of-life where all existing licensed options, as dictated by prevailing regulations and clinical guidelines, have been exhausted and the patients’ long-term prognosis and wellbeing is looking increasingly grave.
Proper monitoring, reporting, and appraisal of off-label use can be extremely insightful in to future new indications.
For non-licensed, experimental treatments, access to these medicines beyond clinical trials can sometimes be sought via compassionate access programmes.
Furthermore, it is well-known that patient outcomes are often considerably better if they are enrolled on to a clinical trial, and in oncology, where there are a great number of trials ongoing at any one time, trial enrolment is often one of the key objectives in many patients’ treatment plans.
Why have some oncologists opposed the Bill?
Many oncologists feel this Bill undermines evidence-based medicine and the accepted standards defined in treatment guidelines.
There is considerable concern that certain vulnerable groups of patients will be exposed to undue harm.
There is consensus that the provisions being put forward in the Bill are simply not needed and that doctors are well-equipped under the current prevailing practice norms to best care for their patients without subjecting them to unjustified risks.
What are your thoughts on the Bill?
The Medical Innovation Bill will undermine the accepted modern standards in the practice of medicine—standards that allow doctors and patients to jointly agree on the best course of action for ongoing care, based on the best available therapies, and in accordance with accepted treatment guidelines as determined by leading international medical associations and care providers.
This Bill would take us back to an outmoded paternalistic approach to medicine that neither doctors nor patients want.
It is a Bill that many in the medical professional are against, which by implication questions the premise of the proposed law.
It is pertinent to remember that doctors are only interested in the best possible care for their patients, and as indicated by the letter written to The Times by 100 prominent UK oncologists calling for the Bill to be rejected, the conditions under which medicine is currently practiced allows them to meet that objective in a safe and collaborative way.
At what stage is the Saatchi Bill currently at and what do you think the future holds for its progress?
The Bill is still some way off from becoming law. It has had two readings in the House of Lords, and has been through the Committee stage.
A revised version of the Bill is scheduled for additional debate in House of Lords on December 12, 2014, and then it will go to a third, and final, reading.
If it survives these additional steps of scrutiny, it will then move to the House of Commons for a similar process of multiple readings and committee stages.
With regards to the future, making predictions is a hazardous game, but at this stage the vocal opposition from medical professionals and from an increasing proportion of the general public—who would prefer to have doctors make decisions on medical requirements rather than politicians—suggests that the Bill’s progress will be far from easy. The Lancet Oncology’s opinion is this Bill should never be enshrined in law.
Where can readers find more information?
Full details about the Bill can be found at www.parliament.uk and in our editorial at www.thelancet.com.
About Dr David Collingridge
Dr David Collingridge has been Editor-in-Chief of The Lancet Oncology since March 2002, and is also the Publishing Director for The Lancet’s Specialty Journals.
Prior to his appointments at The Lancet, he gained a PhD in Tumour Biology from the Gray Cancer Institute/University College London, UK, and held research posts in the Department of Therapeutic Radiology, Yale University, CT, USA, and in the PET Oncology Group, Imperial College School of Medicine, Hammersmith Hospital, London, UK.
Dr Collingridge has published numerous peer-review articles, editorials, opinion pieces, and news reports, and has co-authored a text book on radiobiology.
He currently also holds the position of Clinical Associate Professor of Radiation Medicine at Hofstra North Shore-LIJ School of Medicine, Lake Success, NY, USA.