Medical Innovation Bill [HL]

Baroness Masham of Ilton Excerpts

Friday 27th June 2014 Lords Chamber

[Baroness Masham of Ilton (CB)]

My Lords, I feel that the noble Lord, Lord Saatchi, has the very best intentions behind his Bill and I congratulate him on his determination.

I have been in the position a few times when people I loved were dying too early. In such situations, if there is hope with a new medicine or procedure and if the patient wants to try it, as long as it does not cause suffering I am in favour of innovation. I was inspired by a remarkable person I met, Les Halpin, who had motor neurone disease. With only one drug for that deplorable condition, he was a leader in encouraging innovation and to speed up the development of new drugs to help combat conditions such as motor neurone disease.

With the growing realisation of infections becoming resistant to drugs, research and innovation are vital. There is no doubt that when people work together across the world, improvements are made. There have been important advancements with HIV and AIDS, but there is a need for a vaccine and more innovation. With so many people breaking their backs and necks and becoming paralysed, there is a need for innovation to find a way of joining and regenerating the spinal cord. I declare an interest in this.

Legislation sometimes does not do what it is intended to do. My queries are on behalf of patients. I have been in communication with Action Against Medical Accidents—AvMA—and there are some concerns. The Bill will remove a layer of protection and redress for vulnerable patients who are harmed when their doctors act in a way which no other doctor would support. It would encourage unsafe and unaccountable practice by doctors and lead to further tragedies and scandals such as that of Dr Ian Paterson. It would affect all forms of medical treatment, not only in exceptional circumstances such as when all evidence-based treatment options have been exhausted.

The Bill’s provision may have no positive impact on innovation. It will have no effect on funding, research programmes, clinical governance or professional and medical product regulation. Properly considered, the law already protects a doctor against an allegation of negligence if he innovates responsibly. The Medical Defence Union has publicly stated:

“The Secretary of State for Health in a written statement introducing the Medical Innovation (no. 2) Bill stated that doctors wishing to depart from established procedures and carry out an innovative treatment may be fearful of doing so because of the possibility of a clinical negligence claim. We have seen no evidence to suggest that this is the case … Our advice is that there should be no consequences providing there are appropriate safeguards in place, the patient fully understands what is proposed and why the clinician believes it is in their best interests, and they give their fully informed consent … We are happy to reassure doctors that medical innovation should not leave them open to an increased threat of litigation”.

The Bill provides a defence: doctors will not be negligent in relation to any treatment currently regarded at common law as negligent if they take the decision to treat responsibly. While the purpose of the Bill—to promote responsible medical innovation—is laudable, the intentional effect is to deprive patients who are harmed by doctors of a right to redress, even when the doctor has acted in a way that no other doctor would support. It is the rationale behind the Bill that doctors who would currently be regarded as negligent should no longer be held liable.

AvMA is concerned that patients should be afforded protection against irresponsible or negligent doctors. Regrettably, the Bill does not provide adequate protection and could actually encourage unsafe practices, leading to further tragedies and scandals such as that involving Dr Ian Paterson, among others. AvMA is also concerned that patients who agree to treatment that goes beyond the bounds of what is considered acceptable by all responsible bodies of medical opinion are precisely those who require particular protection. The desperate patient who will try anything to be cured or to secure a short extension of their life may be the most vulnerable to exploitation.

Media coverage and statements by supporters of the Bill give the impression that it is designed specifically to open doors to innovative treatments for people with life-threatening conditions for which all evidence-based treatment options have been exhausted. AvMA says that this is not the case. Is it correct that the Bill would apply equally to any form of medical treatment where the doctor convinces the patient that it would be in their best interests to receive it? This could include, for example, cosmetic treatment. I am very keen that there should be a positive effect on innovation, but the safety of patients must be the priority. There should be no loopholes in this legislation to ensure that patients are not put at risk without their knowledge and consent.

I would like to end by saying how important the work of charities is in helping with medical innovation, one of them being Parkinson’s UK. The charity strongly supports more innovation and its adoption into clinical practice so that new and better treatments can be developed to help people with Parkinson’s disease. Any change to the current legislative framework must be driven by clear evidence that the prospect of legislation is currently preventing innovation by doctors. Further clarity is needed on how the Medical Innovation Bill will give priority to informed consent and peer review in order to protect patient safety. Safeguards are needed against unintended consequences such as encouraging reckless innovation and exacerbating the postcode lottery of services.

I have two questions. What evidence is there to suggest that doctors have been discouraged from using innovative treatments for conditions such as Parkinson’s due to concerns about litigation? How many clinical negligence claims in recent years have been linked to innovative medicine? Is not one of the problems the fact that innovative medicine can be very expensive and there are problems around payment? There are many complex conditions, but there should always be honesty and transparency.

[Lord Newby]

My Lords, perhaps I may remind the House of what I said at the start of the debate; namely, that it is a firm convention that the House should rise at around three o’clock on sitting Fridays.