Medical Innovation Bill [HL]

Baroness Butler-Sloss Excerpts

Friday 24th October 2014 Lords Chamber

[Lord Turnberg]

My Lords, I strongly support Amendment 2 in the name of the noble Lord, Lord Pannick, for inserting the word “reasonable” for all the cogent reasons that he has given. Amendment 3 follows on from my earlier Amendment 1, which defines “relevant condition” and does not need further discussion here. I am very pleased to see that we have the agreement of the noble Lord, Lord Saatchi, that the word “reckless” will disappear from the Bill.

[Baroness Butler-Sloss (CB)]

My Lords, I strongly support the Bill as it is drafted. I am relieved that the noble Lord, Lord Saatchi, produced a short Bill; I hope that the House does not think that it was a bad idea to suggest that a short Bill might be more attractive than a longer one. For that reason I am not at all happy about the various amendments that were in the first part of our discussions today.

I do have reservations about the words in brackets in Clause 1(1), and I take the view that the noble Lord, Lord Pannick, is probably right to say that they should be excluded.

[Baroness Finlay of Llandaff]

My Lords, I added my name to the amendment deleting “reckless” because I felt quite strongly that it detracted from the overall intention of the Bill. This is not about reckless innovation; it certainly must deter irresponsible innovation, but it is about encouraging responsible innovation. I also added my name to Amendment 3, on treatment for the “relevant conditions”, because many of these patients who are seriously ill will have multiple co-morbidities and may have many things happening to them. This Bill is aimed, as far as I have understood, at the principal condition—the condition for which patients are often desperate for some innovative treatment. It should not inadvertently allow lots of other strange things to be presented to patients to cope with many of the other co-morbidities that they may have.

My feeling about that comes particularly from my own specialty, which the House knows is palliative medicine, where we see time and again patients who are very emotionally vulnerable, psychologically fragile and potentially in despair, so they are unable to make sense of what is going on. In that state, they are quite vulnerable to people presenting all kinds of strange treatments with false claims. I will give a specific example from my own practice. We came across a group of patients on a ward who all had small crystals by their bed, and we discovered that a member of staff strongly believed that holding on to these crystals would shrink the patients’ cancers. The evidence for it was absolutely zilch; I think that the patients had paid to have the crystals given to them. That type of so-called experimentation is completely outside the scope of the Bill—and must be outside its scope. That is why it struck me that the wording about the relevant medical condition should feature in the Bill, because of the potential for exploitation otherwise.

--- Later in debate ---

[Baroness Butler-Sloss]

It seems to me that if one is going to have Amendment 6, instead of saying that it “means”, it should say that it “includes”. That would then leave open everything else that might come in as medical innovation.

[Earl Howe]

This group of amendments seeks to define innovation and the scope of the Bill. This is a uniquely difficult task as innovation is, in essence, about constant improvement, change and progression. It is essential that in the act of defining we do not inadvertently limit responsible innovation. I ask the Committee to take on board the point neatly made by my noble and learned friend Lord Mackay.

Amendment 8 to Clause 1(2) in the name of my noble friend Lord Saatchi limits the scope of the Bill to situations where a doctor departs from,

“the existing range of accepted”,

medical treatments for a condition. This will be well understood by doctors, who are best placed to know whether they are following accepted treatments. This amendment also ensures that the Bill applies only to medical treatment.

A further provision, Clause 1(4)(a), ensures that the Bill applies not to research but only to the care of individuals. This exclusion of research is sufficient to achieve the same effect as Amendment 6 in the name of the noble Lord, Lord Winston. I hope that that clarifies that point for the noble Baroness, Lady Wheeler.

The Bill’s definition of innovation allows for situations in which doctors choose to carry out no treatment in the best interests of the patient. The definition of innovation in medical treatment proposed by the noble Lord, Lord Winston, would exclude that. I hope that that point, if no other, will give him pause when he decides what to do with Amendment 6.

There is another basic point to make here. Defining innovation on the face of the Bill would restrict the application of the Bill and could risk uncertainty for doctors as to whether the protection offered by the Bill would extend to the treatment that they are proposing. It is important that the scope of the Bill is clear to the medical profession.

Moving on to Amendment 28, the Government do not believe this to be necessary. The Government are already fully committed to promoting innovation which can save and improve lives. The Committee may be aware that NHS England has a full programme of initiatives to unblock innovation and disseminate the benefits to the NHS and beyond—something that the Government fully support. These include Innovation Connect, a programme to help innovators in the health service and industry to realise their ideas, embed them into clinical practice and exploit new opportunities in international markets, NHS innovation challenge prizes to encourage, recognise and reward front-line innovation and drive the spread and adoption of these innovations across the NHS, and the NICE Implementation Collaborative, which supports work streams by providing essential support to overcome identified barriers to innovation. Those are just some examples.

My noble friend Lord Blencathra asked in particular about off-label treatments. Without repeating the answer that I gave earlier to the noble Baroness, Lady Masham, on a similar issue, the Bill sets out a series of steps which doctors can choose to take when innovating to give them confidence that they have acted responsibly and with the intention of reducing the risk to doctors of successful claims of clinical negligence. With that threat diminished, the intended effect is that doctors will be confident to innovate appropriately and responsibly. That applies in full measure to off-label treatments. I would say as an aside that the cancer drugs fund, which has enabled access to a number of novel medicines, including off-label treatments, has benefited more than 55,000 patients since September 2010. So the decision on whether to prescribe unlicensed or off-label medicines will remain a matter for the doctor or prescriber who has clinical responsibility for the patient’s care, taking into account their individual clinical circumstances.

In response to the noble Baroness, Lady Masham, about funding, I should make the simple point that the Bill does not add any extra funding for drugs. Funding may be a consideration in certain circumstances, but the Bill does not affect the situation one way or the other.

I hope that noble Lords will take into account the Government’s view that innovation is best defined as a departure from the standard range of existing medical treatments, and that on reflection the Committee will not accept Amendments 6 and 28.