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

Rearranging the Deckchairs

How the Lords Couldn’t Fix the Saatchi Bill

  • Despite claims that the Medical Innovation Bill has been fully amended and is now strengthened, it remains unfit for purpose.
  • The vast majority of amendments offered by Lord Saatchi’s colleagues to try to remedy the many faults of the bill were discarded.
  • Of the more than 2000 words of amendments independently proposed by Lord Saatchi’s colleagues, only 7 words were accepted into the bill. Even those 7 words were deletions rather than additions.
  • Despite claims the bill had cross-party amendment, no text was added to the bill that didn’t have Saatchi’s name attached to it.
  • The bill is still opposed by the vast weight of medical, medical protection, research and patient organisations.

I hope this will be the last of my essay-length posts on the subject of the Saatchi Bill. I expect you hope this too. Over the past few months, we’ve looked into pretty much every aspect of this bill, how it fails to protect doctors from litigation as claimed, how it fails to protect patients. How it risks genuine research and offers nothing in return. How it does nothing about the costs of negligence litigation and how it has been misleadingly marketed.

There’s one area I’d still like to look at, and that’s the claims that the bill has been amended and improved during its passage through the House of Lords, and that it is somehow as a result now fit for purpose. This is an especially relevant area to examine because, as I write, a furious campaign (with the emphasis on “furious”) is being waged by the Saatchi team to browbeat Parliament into giving the bill extra debating time in the Commons, based at least in part on the assertion that the bill has already been properly debated and amended by the Lords.

In this post, I’ll show that the claim that the bill is now fixed is as false as all the other claims that Saatchi and his team have made for their bill.

First port of call is to note that none of the medical, medical protection, research and patient organisations that were opposed to the bill at the outset have changed their minds. They’ve seen the amended bill, and they believe it is stillunfit for purpose. It still attempts to solve the wrong problem, in the process putting patients at risk by kicking away their protections.

So what did happen in the House of Lords, and why might it all have gone wrong?

I’m going to use as my starting point these statements made by Lord Saatchi via the bill’s “media partner” (The Telegraph) just after the bill cleared the Lords:

It has been roundly debated, challenged, amended, honed, tightened, clarified and improved by my colleagues on all sides of the House. Honest opposition to elements of it — no one has objected to the principle of the legislation — have now had their concerns met.

I’m particularly grateful to the Labour front bench and Lords Winston and Turnberg — both eminent doctors; Lord Pannick QC, a renowned legal mind; and Lord Hunt, who comes from a stellar medical background. They have debated the Bill and laid helpful amendments that have strengthened it.

First comment here: Saatchi uses a sleight of hand when he says “no one has objected to the principle of the legislation”. The only principle he can truthfully be referring to here is the encouragement of responsible innovation. Since everybody wants that, he describes everybody as supporting the principle of the legislation. That doesn’t really give us a true picture, because it seriously misrepresents the nature of the opposition, who aren’t against innovation, they’re against the method Saatchi wants to use to try to stimulate it. They think it will be at best ineffective and at worst actively harmful. What he’s doing here is like me saying to you “I plan to solve the housing crisis by burning down all the trees. Everybody supports the principle of my argument (solving the housing crisis), therefore everybody agrees with my plan (burn down all the trees).” The opposition, which Lord Saatchi airily waves away as “dishonest”, has been covered in detail elsewhere, so I’m not going to revisit it again now.

Instead, let’s look at the claim that the bill has been “debated, challenged, amended, honed, tightened, clarified and improved by my colleagues on all sides of the House.” Beyond the abuse of his thesaurus, what is Saatchi telling us here, and can we check to see if it’s true?

When I started writing this article, it was with the intention of going through every amendment, analysing each for its purpose, summarising the debate around it in the House of Lords, recording its final fate, and then seeing if its message related to the ongoing concerns of the medical, medical protection, patient and research organisations who still oppose the bill. After about 3000 words, though, it became clear that to go through every amendment in such detail would result in an analysis even longer than the text of the House of Lords transcripts it was based on, and you’d still need to go through those transcripts yourself if you wanted to be sure I was representing them to you correctly. You’ve been very patient with me so far, but that seemed to be pushing my luck. It would also have taken me until the heat death of the universe to finish, so I’ve decided to try a different tack.

What I’m going to do instead is some numberage.

If Saatchi’s claim that colleagues on all sides of the house had a hand in improving the bill is true, I suggest we should expect to see a decent number of amendments being proposed by people other than Lord Saatchi, and for a good proportion of those amendments to be passed. I don’t know what proportion to expect with a bill of this nature, so I’m going to compare the number of amendments passed under non-Saatchi Lords with Saatchi’s own amendments, to see if there is any sort of parity. If a good proportion of amendments from other people were accepted and incorporated into the bill, it would be evidence that Saatchi did indeed listen to concerns and adopted the suggestions made to him.

Since Lord Saatchi has helpfully given us a list of Lords he says have “laid helpful amendments”, we can also look to see if that is borne out in the record. Did those Lords (or indeed any other peers) make a significant number of changes that survived to the final version that left the Lords?

Also, it occurs to me that some amendments may be more important than others. Some of the 56 amendments are very short — just one or two words — and others run to several paragraphs. So I’m also going to use word count — words added and removed by each amendment — as a crude proxy for their significance, to see if that tells us anything about the balance of amendments as the bill passed through the Lords.

Finally, I’m going to summarise the nature of the debate on the amendments and to pick out some common themes in the way they were handled. I’m going to try to limit how much I quote, because frankly so much of what’s in there is dynamite that it’s difficult to pick out the best bits. If you don’t trust my summary, read the transcripts. In fact, if you do trust my summary you should still read the transcripts. You should read the transcripts, is what I’m saying.

Here they are:

Amendments presented at Committee Stage

Transcript of Committee Stage (24th October 2014)

Amendments presented at Report Stage

Transcript of Report Stage (12th December 2014)

Amendments presented at Third Reading

Transcript of Third Reading (23rd January 2015)

The numbers

There were a total of 56 amendments tabled at three stages: 39 at Committee Stage, 15 at Report, and 2 at Third Reading. Of these, 23 had Saatchi’s name attached, and the remaining 33 were from other peers.

First, let’s look at how many of Saatchi and non-Saatchi amendments passed:

figure1

This is pretty stark. All but one of Saatchi’s amendments passed, only one non-Saatchi amendment made it through. That’s a 96% success rate for Saatchi, and a 97% failure rate for everybody else. Here it is in pie chart form:

pie1

I could just stop here, job done. But why stop just when we’re hating it?

Let’s take a look at the amendment record for the Lords that Saatchi claims have “laid helpful amendments that have strengthened” the bill. Here’s the record for all amendments those Lords put their names to, including ones that also had Saatchi’s name on.

figure3

Lords Winston, Pannick and Hunt all had only one amendment passed. Even Turnberg, who managed four, still got barely a fifth of his amendments passed. Hunt scores 33%, but this is only one amendment. But when we take away the amendments co-signed by Saatchi, the picture is revealed to be even worse:

figure4

In terms of amendments laid on their own initiative (i.e. without Saatchi’s name on as well), Winston, Turnberg and Pannick only got one amendment through each, and Hunt didn’t get any.

Actually, the picture is even worse than that. Winston, Turnberg and Pannick didn’t get one amendment through each; it’s only one amendment between them,Amendment 4 at Committee Stage. We’ll come back to that amendment shortly.

Word Count

I warned you I’d look at word count as well, so here’s the same analysis done for the number of words in each amendment. This is a sum of all words added and removed by each amendment, and the figure was calculated by simply pasting the amendment into Word and checking the word count.

Here goes:

figure2

Here the contrast between Saatchi and non-Saatchi amendments becomes even more stark. Only 0.3% of the words proposed by peers other than Saatchi made it into the bill, only 7 words out of 2031 proposed. The pie chart:

pie2

And the breakdown by individual Lords:

figure5

Once again, Turnberg and Pannick appear to be doing best, with a whopping 6% and 23% of their words adopted, but once again…

figure6

…when Saatchi’s amendments are excluded, the true level of independent influence is revealed. Winston, Turnberg and Pannick got only 7 words into the bill between them.

Again, it’s even worse than those figures would suggest, because not only did these four peers only manage to muster seven words between them, it’s the removal of seven words. Here’s the amendment, in full:

Page 1, line 3, leave out “(and accordingly to deter reckless irresponsible innovation)”

That’s it. The removal of seven words. For all Lord Saatchi’s claims of “laying helpful amendments that have strengthened the bill”, this is what it all came down to.

Now, Turnberg and Hunt did between them add their names to three of Saatchi’s amendments, a total of 56 more words. But that’s still less than 2% of the words proposed in amendments, and less than 7% of the words actually passed. This does not seem to me to be a significant contribution.

Meanwhile, Lord Winston, arguably the bill’s strongest critic, who spoke against it at every session, proposed 15 amendments totalling 889 words, and got only one amendment of 7 words passed.

The Amendment Debates

The thing that comes through most clearly when reading the transcripts again is how strongly each proposer initially argued for their respective amendments. In many cases, several peers lined up to support each other and emphasise the importance of the changes they put forward. To this extent, Lord Saatchi’s claim that the bill has been challenged is true.

But then it all seems to fall apart. Almost every amendment proposed by anybody other than Saatchi was deflected by one or more means. This could be by reassurance that the bill already contained adequate coverage for the matter in question, by reassurance that it would be considered and brought back later after Lord Saatchi or the Department of Health had considered it, or by appeal to the authority of eminent and learned Lords who (it was claimed) knew all about the subject.

For example, Amendments 2 and 7 at Committee Stage — which sought to reintroduce a test of responsible treatment lacking in the bill — were answered by Lord Saatchi and Earl Howe (speaking for the Department of Health in support of the bill). They gave reassurances that the bill preserved a test of responsible treatment that was equivalent to the current law, and on that reassurance the proposers didn’t press their amendments.

Lord Turnberg was adamant of the importance of this matter:

Amendment 7 is absolutely critical, as it is for precisely these vulnerable people, desperate to try anything, that we have to have in place processes and mechanisms to protect them from unethical practitioners who may take advantage of their vulnerability.

He continued:

[The doctor] should make sure that other doctors looking after that patient who have an interest in that patient will agree with him and he should have the agreement of another expert in the field. He should have not just consulted that person but obtained their agreement—not just to take account of that person’s views

Saatchi responded:

I believe that it is similar to my amendments in the sense that they both replace the existing conditions for the operation of the defence to negligence under the Bill with an alternative set of conditions. I understand that the noble Lord is trying to find a set of conditions that limit the opportunity for the Bill to be misused by quacks. As I have said, my amendments, proposed by Sir Bruce Keogh and the Secretary of State following consultation, have the same purpose.

It has later transpired that this reassurance was not sound; the bill does not preserve the spirit or substance of the Bolam and Bolitho tests for responsible treatment.

Failure to follow through

Another characteristic of the discussion is that the Lords grumbled about important issues and then, when those issues failed to be addressed… nothing. They just stopped complaining about them.

This, coupled with an almost complete aversion to “dividing the house” — forcing a vote on an amendment — meant that Saatchi had an almost totally free ride. There was only one vote on an amendment. Several peers tabled numerous amendments: Lord Winston put his name to 15, Turnberg 19, for example. Each of these just fizzled out when either Saatchi or the Government asked them not to press their case. It is hard for an outsider watching the debate or reading the transcript to escape the conclusion that a rigorous and thorough testing and improvement of a bill is difficult in circumstances of such unwillingness to tackle issues directly, particularly when the other party is so strong-willed.

Authority

Another problem with the debate is how much reliance appears to have been placed on authority figures, particularly on the views of Lord Woolf, who apparently had extensive experience of the problems of litigation faced by innovative doctors. Unfortunately, his memory on this subject turned out to beimperfect, and he has not subsequently been able to cite a single case. He seems to feel it somewhat impertinent that anybody should even ask.

Content

Ultimately, the transcripts show a lot of discontent, and a lot of concern, but Saatchi’s noble colleagues seem to have been powerless to do anything about it.

Lord Hunt (at Report):

I thank all noble Lords for taking part in this short but interesting debate. I say to the noble Lord, Lord Saatchi, about the conference that his noble friends suggest, that it is all well and good to have a conference after a Bill has been enacted, but in my judgment that is too late in relation to his Bill. He needs to engage with the professional medical bodies before the Bill goes to the other House; otherwise, he risks enacting a Bill, if he is able to do so, that will start with a huge defect—all the main medical bodies are opposed to it. I urge him to try to reach consensus with those bodies as the Bill goes through.

I’ll finish by looking more closely at two amendments, the final two that were presented at Third Reading. I’ll do Amendment 2 first.

Amendment 2: The Innovation Register

This is the amendment:

Page 1, line 24, at end insert — “ comply with any professional requirements as to registration of the treatment under the provisions of this Act with a scheme for capturing the results of innovative treatment (including positive and negative results and information about small-scale treatments and patients’ experiences),”

The requirement for an innovation register, which Lord Saatchi maintained was an important aim of his bill, was nevertheless nowhere to be found on the bill as it arrived in the Lords. The matter was aired in the bill’s first debate — the <href=”#14062743000565″ >Second Reading, where Lords called for a register to be included in the bill. Lord Saatchi agreed on its importance, but clearly not enough to ensure that any of the 15 amendments he put forward to the next stage addressed the point. It was left to others to table amendments to describe an innovation register at the Committee Stage.

At Committee Stage, numerous Lords emphasised the need for a register. Lord Saatchi spoke again on the need for innovation to be recorded. Yet both amendments targeted at this requirement failed to make it into the draft bill. Earl Howe, speaking for the Department of Health, said the Government didn’t think it is necessary to have a register in the bill, but promised to “explore this issue further and constructively with the relevant professional bodies.” and on the assurances given by Saatchi and Howe the amendments were withdrawn.

However, there was again no amendment offered for Report Stage by either Saatchi or the Government. Again it was left to other Lords to table amendments to create an innovation register.

At Report stage, there were yet again repeated calls by Lords for a register to be included in the bill and for it to be compulsory. Baroness Jolly, speaking for the Government, said that the Government felt there was no need to have a compulsory register. Bizarrely, one of her arguments was that “the act of putting something into legislation does not guarantee that doctors will adhere to it.” She went on to say “At the moment, it is not the intention that it should be compulsory, but it should be such that doctors would not dream of not recording on the register.” Lord Forsyth responded that it was “rather extraordinary to argue that there should not be some record of success or failure.” Lord Hunt skewered the problem:

I am disappointed by the Government’s response. This was meant to be a constructive amendment, which I think meets the needs. The Minister is not in favour of compulsion. She said at one stage that she thought that, even if you enacted a provision, there is no guarantee that doctors would use it, but she said later that she wanted a position where doctors would not dream of not registering with a scheme. That seems inconsistent.

Finally, Lord Hunt had had enough. “I will bring this back at Third Reading and I will press it unless we get an absolute assurance that there will be a compulsory register.” That amendment was finally brought back at Third Reading, Saatchi added his name to it and it was passed, in the only example through the entire bill of any amendment actually going to a vote.

While this amendment did eventually make it into the bill, it was only through repeated effort from other Lords. Saatchi, despite repeated protestations that it was something he felt was essential, did not do anything to make it happen.

Ironically, given the amount of effort expended on this amendment, it is an ineffective one. As Nigel Poole QC has pointed out, the amendment does not actually create a register, it merely requires an innovating doctor to use one if it exists and if their professional regulations require them to use it. You can see the pointlessness of the amendment: not only does it not put anything in place to create the innovation register, even if there were such a register the amendment would make no difference. It only applies if a doctor is bound by their professional requirements to use a register, in which case they’d have to use it whether this bill existed or not.

Also since the GMC, the only organisation who could issue guidance to make doctors use a register, weren’t told about this, don’t think it’s appropriate, and don’t think they could enforce it even if it were made a requirement, it’s unlikely ever to happen.

Amendment 1: Lord Winston

At the end of the Report Stage, Lord Winston (perhaps the most vocal and dogged critic of the bill) was still trying to reach some sort of agreement with Lord Saatchi, and they met to see if they could find some common ground. The result of that discussion led to Amendment 1 at the Third Reading, and perhaps one of the most shameful episodes of the entire process.

The Department of Health (usually represented by Earl Howe) and Lord Saatchi’s Medical Innovation Bill team worked closely together. Indeed, as they say on the bill’s website:

It was in the clear and mutual interests of the DoH and the MIB teams to work together to gather opinion and was part of the ‘one team’ philosophy developed by the DoH and the MIB team.

Given that “one team” philosophy, what happened at Third Reading is very hard to explain.

Winston and Saatchi met, and agreed an amendment which went as follows:

Page 1, line 10, at end insert “(for the purpose of ensuring that the proposed treatment would command the respect of a representative body of responsible medical opinion, having regard to the needs of patient safety).”

It wasn’t immediately clear why Lord Saatchi would put his name to this amendment, because the effect of it would quite likely be to largely neuter the bill. It would probably have put Bolam and Bolitho back where the bill team had claimed they had been all along, preserved as protections for patients, but in the process would have stopped the bill from actually having any function. So anyway, Lord Winston, supported by Lord Saatchi, proposed this amendment that would have hollowed out Saatchi’s own bill.

And Earl Howe, the Innovation Bill’s “one team” partner, killed it.

The Government opposed this amendment and Lord Winston, as with 31 of the 32 other amendments proposed by Lords other than Saatchi, felt he could not divide the House by pressing it to a vote.

I want to be very clear on what I say next. The reason why I want to be clear is that as I write I can look back and see a number of places where people wrote things, and the things that they wrote are not there any more. So I want to be clear that what happened to Lord Winston’s amendment appears to have been entirely an unfortunate accident.

But what an accident it was. At this crucial last moment, with a crucial amendment, Saatchi and his entire team appear to have taken their collective eyes off the ball and failed to communicate with their “one team” partners the Department of Health. It would seem that they failed to grasp that the DoH would oppose this amendment, and that whatever Lord Saatchi agreed with Lord Winston would be irrelevant, because it wasn’t going to pass.

Lord Saatchi proposed 22 other amendments during the bill’s passage through the Lords, and for every one of them he managed to find a form of words that satisfied the Government sufficiently to allow them to pass. To fail to do so with this last amendment seems — well — not very competent.

The bill team have repeatedly made clear that they wanted this amendment to pass, that they are disappointed it didn’t, but it is their fault it failed. They didn’t do the work necessary to ensure it passed. And they are still not doing the work. When they tweet this:

withdraw2

…I’m left wondering why Michael Ellis, who is on the team, putting the bill forward in the House of Commons on Saatchi’s behalf, couldn’t have proposed it as an amendment himself.

If they really want it, that is.

Flailing in the Dark

There is another issue particular to this bill. The bill’s professional opponents say that the basic premise of what Lord Saatchi is trying to do is false. As the group of MPs who wrote to the Telegraph last week put it, the bill is misconceived in fact and law. Saatchi, his opponents say, does not understand the environment in which he is trying to legislate. Given this, it would not be at all surprising to find that amendments proposed by Lord Saatchi don’t actually address the concerns of his critics. He doesn’t understand those concerns, so he is unlikely to be able to devise effective solutions to address them himself.

And this is what we have seen. The bill remains unfixed, and it therefore remains widely opposed. Though it may be that some of the withdrawn amendments may be reintroduced in the Commons (if it ever gets debating time there), it cannot at this stage be said that the Saatchi Bill is at all ready to see the light of day.