A Deadly Hydra

Lord Saatchi’s much-criticised Medical Innovation Bill has risen again, while a second Bill echoes Saatchi under a new name. Both Bills put patients “at grave risk”

13th October 2015

When Lord Saatchi’s Medical Innovation Bill ran out of time in the last Parliament, it was a cause for great relief. A Bill that had been widely condemned by medical and patient protection groups, medical charities and legal experts as both dangerous and unnecessary was no more.

Unfortunately, the Bill is back. Lord Saatchi has resurrected it in exactly the same form in which it met so much expert condemnation, and is currently trying to fast-track it through the Lords using a process usually only employed at times of national emergency. But the danger doesn’t end there, for it now seems the Saatchi Bill is like the hydra of Greek mythology, and when one head is cut off it is replaced by not just one but two more heads, each as dangerous as the old one.

While Saatchi has been trying to sneak his resurrected Bill through the Lords, Chris Heaton-Harris has a new Private Member’s Bill, which is about to receive its second reading on 16th October. This new work – the catchily-titled Access to Medical Treatments (Innovation) Bill – has been the subject of much confusion and speculation, not least because apparently no draft of it existed until very recently. Lord Saatchi himself was very clear that this was his own Bill under a new name. Heaton-Harris, for his part, stated his intention to draw inspiration from Saatchi, but that it was very much his own Bill. He has spoken with a wide range of interested parties, to help guide him towards making this the best Bill it can be, and avoid Saatchi’s mistakes.

An official draft has now been published, a mere four days before the Bill is due to have its Second Reading in the House of Commons, and we can finally see whether Heaton-Harris has succeeded in his aim. Unfortunately, it does not look good.

The database (or not)

The Access to Medical Treatments (Innovation) Bill (AMTIB) is in two parts, which are effectively independent of each other. The first part allows the Health Secretary to make regulations about the creation of a database to record medical treatments.

Now, there are some serious issues to discuss around the creation of medical databases. Who will be allowed access to them? Will they be mandatory? Will a patient have to agree to their data being in the database in order to receive treatment? How anonymous will the data be? What is the purpose of the data being gathered and how will it be used? But we can bypass all of that for now, because the simple fact is that if the Health Secretary was in the mood to create a database, he could do so right now. No new law is required to confer this power, because the Health Secretary already has it.

Rather like the original Saatchi Bill, which carried a provision which said that a doctor must comply with any regulations that may be set up about recording innovative treatments, without actually creating those regulations, AMTIB simply makes a lot of noise about databases, without doing one single thing to change the landscape in which those databases would exist or to put them into effect.

The dark, beating heart of the Saatchi Bill

So far, AMTIB has been a meaningless waste of a few paragraphs, but now we get to the core of the Bill, the second half. And here we see that Heaton-Harris has simply plucked the heart out of the old Saatchi Bill and transplanted it almost entirely unchanged into his own Bill.

It is clear that Heaton-Harris has no more listened to criticism of the Saatchi Bill than Saatchi himself did. All the old problems remain. The Bill fails to define what innovation means, and leaves the scope so wide as to cover treatment for any condition, major or minor, regardless of whether a well-established effective treatment exists. The Bill still attempts to replace well-established tests of responsible practice with a half-hearted box-ticking exercise. In short, it remains a Get Out Of Jail Free card for bad doctors and reckless practice.

Little surprise, then, that the Royal College of Paediatrics & Child Health have today called the Bill “disastrous.” They realise, in a way that neither Saatchi nor Heaton-Harris have, that “the Bill places patients – in particular infants, children and young people – at grave risk”.

José Miola, Professor of Medical Law at Leicester University, has explained in detail why the Saatchi Bill cannot be made to work, and his reasoning applies equally to the near-identical AMTIB. Nigel Poole QC has pointed out that the law has moved on, even if Saatchi and Heaton-Harris can’t see it. And all the while, innovation is going on around us on a daily basis, and there still hasn’t been a single case to confirm these Bill’s central claim – that doctors don’t innovate because they fear being sued. Even the Department of Health own review of barriers to innovation, published last week, does not mention fear of litigation as a barrier. This is a problem that does not in any meaningful sense exist, being “solved” by throwing patients to the wolves, all while the genuine barriers to innovation are overlooked.

As others have pointed out, the Access to Medical Treatments (Innovation) Bill is not about innovation, and it can’t even describe what “innovation” means. It’s not about access to treatments, innovative or otherwise. It doesn’t even establish a database of treatments. All it does is protect negligent doctors who harm their patients by trying out treatments they have no reasonable expectation will work.

Medical bodies, patient protection organisations, legal experts and charities have all spoken out to oppose these dangerous, misguided Bills. They join the National Assembly for Wales, who unanimously opposed it. It is now time for Westminster MPs and the public to join their chorus of outrage.

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