Jill Davies from Shoosmiths's medical negligence team calls for anyone with influence to ensure that the Saatchi and Heaton-Harris Bills never make it to the statute book.
I believe that 16 October and 30 November 2015 are crucial dates for patient safety.
The first is when back bench MP Chris Heaton-Harris' Access to Medical Treatments (Innovation) Bill gets its second reading in the House of Commons and the second is when the original, resurrected, Saatchi Bill, may be rushed through all stages in the Lords in one day and passed into law without any further detailed or informed debate.
The Heaton-Harris Access to Medical Treatments (Innovation) Bill is virtually identical to the original Saatchi proposals in all but name. The original Bill which may be rushed through the Lords on 30 November remains as flawed as it ever was.
I would call on anyone with influence inside and outside Parliament to ensure both Bills never make it to the statute book. They will not change the behaviour of the vast majority of doctors who are responsible, skilled and caring professionals but will legitimise and encourage irresponsible doctors, quacks and charlatans. The losers will be the injured patients.
The Bill's supporters were bitterly disappointed when it failed first time round although its many opponents expressed alarm that it got as far as it did.
It's that same original Bill which purported to 'encourage innovative treatments' that has been reintroduced with exactly the same wording as before. I fear that if a motion to suspend the House of Lords Standing Order 46 (no two stages of a Bill can be taken on one day) passes on 30 November it could become law.
I believe strongly that both Bills have no bearing on improving access to treatment, innovative or not, and however well intentioned they may be, they are misguided and will simply protect a doctor from being sued when a patient is harmed by an otherwise negligent decision to use an 'innovative treatment'.
They are fundamentally flawed because they ignore the Hippocratic principle of 'first do no harm' and as a consequence I would suggest that they are not only illogical and unnecessary, they are also potentially dangerous.
Neither Bill contains any cogent or coherent definition of exactly what an 'innovative treatment' is other than describing it as a 'departure from the existing range of accepted medical treatments'. Doctors could not be found negligent if the decision to indulge in even the most unproven or irrational treatment was 'taken responsibly' – whatever that means.
So, both Bills would not only give the green light to the 'innovative use' of new and untested drugs, but also to other 'non-standard' treatments such as cupping, bleeding, healing crystals, psychic surgery, or any other outlandish 'departure from accepted medical practice' providing the decision to do so was 'taken responsibly'.
I and many others maintain that neither the Saatchi nor the Heaton-Harris Bill are really needed to enable daring medical research or to progress the development of effective therapies. Indeed, I would suggest that the real obstacles to the adoption of innovation in the NHS are issues around regulatory complexity and funding – issues that neither Bill addresses.
Maybe doctors don't fully appreciate the freedoms they do currently have? The test for medical negligence under existing legislation sets the bar really high and could not be clearer. A doctor who treats a patient in a way which was not rational or which no other doctor would accept as responsible, will be judged to be negligent.
All that a doctor need do to avoid such a charge is to find an expert colleague or professional body whose opinion is subject to logical analysis and are willing to testify that they would have done the same thing in the same circumstances.
In my opinion, these Bills are therefore not only a solution to a problem that does not exist but also cynically play on the hopes and fears of desperate people willing to risk anything, no matter how experimental or unproven a treatment may be or how small its chance of success.
There must be some practical benefit for the patient and a reasonable expectation that a therapy will work. I can see no justification for indulging in procedures that are new or unconventional just for their own sake and then expect the patient or their family to have no redress when things go wrong.