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 (fourth?) draft of the Medical Innovation Bill

Drafts of the Medical Innovation Bill are strewn everywhere.

Even before its latest incarnation, there had been several previous attempts by Lord Saatchi to get his Bill through both Houses; at one time, there were Bills simultaneously weaving their tortuous route through both the House of Commons and the House of Lords under a rarely used No. 2 bill procedure, used to speed urgent Bills through both Houses in parallel rather than serially.

The current foray into scrutiny and democracy for the Bill started on 05 June this year when the Bill was first read in the House of Lords. The second reading followed on 27 June and it is scheduled for the Committee Stage on 27 October. The text of the Bill as it was introduced and discussed so far can be found here.

Since then, there have been five sets of amendments — some longer than the Bill itself. A full list of them can be found here: Current Medical Innovation Bill and amendments.

The latest amendments were, according to Dominic Nutt, the Bill campaign’s Director of Communications:

made by [Department of Health] – agreed, adopted and laid before Parliament by Lord Saatchi.

So, what does the Bill look like now with Saatchi’s amendments?

Some amendments simply add or delete an odd (but important) word or phrase, but others are more substantial, deleting whole subsections, replacing others and adding in a completely new section.

The full extent of the amendments can be seen in this Word document with changes tracked (ignoring the introductory text and the application section at the end). The red underlined text is what the amendments add and the deleted text is shown by strikethrough, also in red. The text in black is all that remains of the draft Bill as last introduced into the Lords.

Consolidated

This gives the following as the effective text of the fourth attempt the Saatchi Bill team have had at writing their one-page Bill (again ignoring the introductory text and the application section at the end):

1 Responsible innovation

(1) The purpose of this Act is to encourage responsible innovation in medical treatment (and accordingly to deter irresponsible innovation).

(2) It is not negligent for a doctor to depart from the existing range of accepted medical treatments for a condition if the decision to do so is taken responsibly.

(3) For the purposes of taking a responsible decision to depart from the existing range of accepted medical treatments for a condition, the doctor must in particular—

(a) obtain the views of one or more appropriately qualified doctors in relation to the proposed treatment,

(b) take full account of the views obtained under paragraph (a) (and do so in a way in which any responsible doctor would be expected to take account of such views),

(c) obtain any consents required by law to the carrying out of the proposed treatment,

(d) consider—

(i) any opinions or requests expressed by or in relation to the patient,

(ii) the risks and benefits that are, or can reasonably be expected to be, associated with the proposed treatment, the treatments that fall within the existing range of accepted medical treatments for the condition, and not carrying out any of those treatments, and

(iii) any other matter that it is necessary for the doctor to consider in order to reach a clinical judgement, and

(e) take such other steps as are necessary to secure that the decision is made in a way which is accountable and transparent.

(4) For the purposes of subsection (3)(a), a doctor is appropriately qualified if he or she has appropriate expertise and experience in dealing with patients with the condition in question.

(5) Nothing in this section—

(a) permits a doctor to carry out treatment for the purposes of research or for any purpose other than the best interests of the patient, or

(6) In this Act—

(a) “doctor” means a registered medical practitioner;

(b) a reference to treatment of a condition includes a reference to its management (and a reference to treatment includes a reference to inaction).

2 Effect on existing law

(1) Nothing in section 1 affects any rule of the common law to the effect that a departure from the existing range of accepted medical treatments for a condition is not negligent if supported by a responsible body of medical opinion.

(2) Accordingly—

(a) where a doctor departs from the existing range of accepted medical treatments for a condition, it is for the doctor to decide whether to do so in accordance with section 1 or in reliance on any rule of the common law referred to in subsection (1);

(b) a departure from the existing range of accepted medical treatments for a condition is not negligent merely because the decision to depart from that range of treatments was taken otherwise than in accordance with section 1.

Of course, this is just how the Bill’s team want it to look with their latest amendments. There are four other sets of amendments that the HoL Committee have to debate. Those are the ones tabled:

  • By Lord Winston 10/07/2014
  • By Lord Pannick, Lord Winston, Lord Turnberg 11/07/2014
  • By Lord Turnberg, Lord Pannick, Baroness Emerton 15/07/2014
  • By Lord Turnberg 05/08/2014

It remains to be seen if further amendments are tabled before the Committee Stage in six weeks and what the final Bill (if it survives) looks like.