Stop the Saatchi Bill

Driven by an extraordinary two-year PR campaign on social media and a supportive newspaper partner, this all started as Lord Saatchi’s Medical Innovation Bill, metamorphosed through several versions, and was resurrected under a new name by Chris Heaton-Harris, before finally clearing its last hurdle in the Lords this week to become the Access to Medical Treatments (Innovation) Act.
Pretty much the only thing they share is the word 'Innovation' in the title.

One day, it may be possible for politicians to ask the people who actually work in the medical field: what are the problems you face, and how can we help you overcome them?

One day, politicians may actually listen to the answers they receive, and thus try to tackle genuine problems rather than imagined ones.

One day, politicians, medics, researchers, lawyers, patient groups, charities, and the public, may work together to overcome the barriers to the development and provision of new treatments.

But it is not this day.

Read more: Not this day

The Saatchi Bill would not preserve the Bolam Test

Guest post by Nigel Poole QC

I had understood the point of the Saatchi Bill as being to re-write the Bolam test of what constitutes clinical negligence. Lord Saatchi has claimed that the existing common law of clinical negligence is an obstacle to finding a cure for cancer. So, it is surprising to read a commentary on the new draft Medical Innovation Bill introduced into the House of Lords on 5 June 2014, by the draftsman, Daniel Greenberg claiming that the bill preserves the Bolam test. (Note: the updated Briefing Note, dated 10 June, has had Annex C: Legal Analysis inserted with no further explanation, but references to Annexes in the document have not been updated — Admin)

Currently the courts apply the Bolam test to determine whether or not treatment is negligent. Provided a doctor acts in accordance with a responsible body of medical opinion he or she is not negligent even if there are other bodies of opinion which would not support their actions. Thus 95% of doctors might not support the treatment but if there is a responsible minority of 5% who would, then the doctor is not negligent in giving that treatment. There will often be a range of responsible opinion. Only if the doctor steps outside that range can they be found negligent. Only if by doing so they cause harm to the patient will they be found liable in law.

The Medical Innovation Bill seeks to re-write the Bolam test. Clause 1(2) says:

It is not negligent for a doctor to decide to depart from the existing range of accepted treatments for a condition if the decision is taken in accordance with a process which is accountable, transparent and allows full consideration of all relevant matters.

So, if a doctor provides treatment which no responsible body of doctors would support, or even which no other doctor at all would support, he/she will not be negligent under the bill, provided certain requirements about the decision making process are met.

The new clause 1(4)(b) states:

Nothing in this section—
… (b) abolishes any rule of the common law in accordance with which a decision to innovate is not negligent if supported by a responsible body of medical opinion.

Very clearly this is a preservation of the common law rule of what is not negligent. In other words, if the treatment is one which would be supported by a responsible body of medical opinion it will still not be negligent even if the doctor has not met with the decision process requirements.

Treatment which is not negligent at common law will remain not negligent but treatment which the common law regards as negligent will no longer be negligent if this bill is passed. The test as to what is negligent is not preserved, it is fundamentally altered by clause 1(2).

It is with some surprise therefore that I read Daniel Greenberg says this under the heading “Preservation of Bolam”:

Some commentators on earlier drafts of the Bill were worried that it would be construed as replacing the existing law of medical negligence in its entirety. Although other commentators were satisfied that it did not, the opportunity has been taken in this draft to avoid the possibility of confusion. … Clause 1(4)(b) therefore expressly preserves the existing common law rule that looks at whether a decision is supported by a responsible body of medical opinion.

Since the whole point of the bill is to change the common law test of negligence I cannot understand why this claim has been made. Furthermore clause 1(4) refers to a “decision to innovate” whereas clause 1(2) refers to a decision “to depart from the existing range of accepted treatments.” Innovation is not defined.

To preserve the Bolam test clause 1(4)(b) should read:

Nothing in this section abolishes any common law rule as to whether a doctor’s treatment is negligent or not negligent.

But if so, the whole bill would be rendered pointless.

The second reading of this bill in the House of Lords is due to take place on 27 June.

If this is the guidance members of the House are receiving then vulnerable patients will lose out.