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

Side by side

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Chris Heaton-Harris’ Access to Medical Treatments (Innovation) Bill was touted as the successor to Lord Saatchi’s Medical Innovation Bill, but is it?

The hype suggests that the Access to Medical Treatments (Innovation) Bill, a Private Member’s Bill being taken forward by Chris Heaton-Harris MP, is a direct replacement for Lord Saatchi’s much-derided Medical Innovation Bill (the Saatchi Bill).

However, Saatchi’s original Medical Innovation Bill is still alive and kicking. Not only has it been resurrected in this Parliament, with exactly the same wording that met with overwhelming condemnation from medical, patient protection and research experts in the last Parliament, but Saatchi has proposed a motion to suspend Standing Order 46, bypassing any further Lords scrutiny. If this passes on 30 November 2015, the Bill will be rushed through all stages in the Lords in one day.

If the Heaton-Harris Bill is the successor to the Saatchi Bill, why has Saatchi’s Bill itself been resurrected? Why are there now two Bills?

Illusion

Before going any further, the latest text of the two Bills:

The illusion surrounding the Medical Innovation Bill starts with its title: it is not about ‘innovation’. Similarly, the Access to Medical Treatments (Innovation) Bill has nothing to do with access to medical treatments — whether innovative or not.

They both simply protect a doctor from being sued when a patient is harmed by an otherwise negligent decision to ‘innovate’.

The Heaton-Harris version perpetuates the original’s failure to provide any cogent, coherent definition of what an innovative treatment is. A ‘departure from the existing range of accepted medical treatments’ does not explain its intended interpretation and reveals a startling, persistent failure to understand the daily practice of medicine and the workings of medicines regulation. This may be why such ambiguity has never been clarified despite the several years it has been tossed around.

Purposes

Taking a closer look at this new Bill:

The purpose of this Act is to promote access to innovative medical treatments by—
(a) providing for the establishment of a database of innovative medical treatments, and for access to information contained in the database, and
(b) encouraging responsible innovation by doctors in relation to the carrying out of medical treatment.

It has already been shown that Saatchi’s Bill cannot address the purpose we were told it would — that of encouraging responsible innovation in medical treatment (or its earlier selling point, to cure cancer) — but maybe the Heaton-Harris Bill will succeed where Saatchi’s fails? Maybe there’s a glimmer of hope in this new Bill?

While the Access to Medical Treatments (Innovation) Bill is claimed to be new, it contains much of the wording of Medical Innovation Bill. It’s worth looking at them side by side to see what they have in common and what has been added. (Note that the draft used is one dated 18 September 2015 and is later than the version on Heaton-Harris’ website):

It is surprising that the new Bill has replicated so much of the Medical Innovation Bill, given the consultation feedback and unassailable case against it from patient safety experts, doctors’ representatives, medical research charities, patient groups and more.

Nigel Poole QC has succinctly highlighted many issues with the new Bill. It protects only negligent doctors and fails to take a recent Supreme Court decision on patient consent into account. It waters down Bolam and completely ignores Bolitho, eradicating the standards of the common law tests of negligence.

He also highlights that the two functions on the face of the Bill — a defence for negligence, and the setting up of a database — are wholly independent of each other.

Database

Although much heralded, it was obvious to anyone who actually read Saatchi’s Bill that it did not set up a register of treatments. The new Bill talks about a database, but as with Saatchi’s it does not, by itself, set up any register either.

What this new Bill does is allow the Secretary of State, by regulations, when he so chooses, to tell the Health and Social Care Information Centre (HSCIC) to set up a database.

The Bill is vacant on details about what any database will contain, who would gather the data, whether data entry will be mandatory and, importantly, who will have access to this information. As HSCIC’s care.data woes continue — accompanied by serious concerns about privacy, anonymisation and pseudonymisation, opt-outs, informed consent, access to highly sensitive personal data by research organisations and private companies — this new Bill looks set to fan the already searing flames of this privacy debate.

And, of course, it is vacant on how this database will encourage innovative treatments.

What the Bill does say is that the database will record:

innovative medical treatments carried out by doctors in England

But without defining innovative treatment, how’s a doctor to know when they are innovating?

Whether this new version is a successor or a partner to Saatchi’s Bill, it is still an unmitigated legal mess, a disaster for patients and a disaster for research.