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.
Lord Winston (Lab)
This is a Bill of colossal importance and to truncate speeches to six minutes, even though it is a Friday, seems to be highly undesirable. It needs to be discussed because there are many implications behind this piece of possible legislation.
Lord Newby
My Lords, I am not in any sense trying to curtail the debate. I am reminding noble Lords of the conventions of the House. My experience of listening to debates is that those in which the speeches last for six minutes can be among the best we have.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, I begin, as other speakers have, by congratulating my noble friend Lord Saatchi on bringing forward this Bill and on the inspiring way in which he introduced it. I am sure that he will agree that we have been treated to a debate of remarkable quality. It is of course primarily for my noble friend to respond to the speeches we have heard. It falls to me simply to add a few observations from the Government’s point of view.
It is difficult to approach the theme of the Bill without being mindful of the past and what our forebears have handed down to us. This country has a proud history of medical discovery and innovation. In the 19th century, John Snow’s reasoned approach to a cholera outbreak in Soho gave birth to the discipline of epidemiology. Just across London, at St Mary’s Hospital, the 20th century saw the discovery of penicillin by Alexander Fleming—an advance in medical practice that has saved many millions of lives. Today, in the 21st century, the NHS remains at the pioneering edge of health and care.
Exactly a week ago, in this House, I launched the Assisted Living Innovation Platform, putting the NHS at the forefront of using leading-edge technology in healthcare. At the Health Service Journal innovation summit this week, Innovation Connect and Innovation Exchange were launched—websites that make it easier to connect NHS organisations with both industry and NHS innovators. Also, the establishment of 15 academic health science networks continues to support the uptake and diffusion of innovation.
The UK is also proud to host modern and cutting-edge facilities such as the Manchester Citylabs campus. Partnerships between NHS, industry and academia are pushing the boundaries of medical research, generating growth in the economy and helping NHS patients receive world-class care. Notable examples include the Anglia Ruskin MedTech Campus and the Northern Health Science Alliance.
Innovation is of course especially important in tackling the scourge of cancer, the disease that has been the particular focus of my noble friend Lord Saatchi and his Bill. The Government invest in a wide range of research into the causes of cancer, its prevention, screening, diagnosis and therapy, as well as the organisation and delivery of services. Investment in cancer research by the National Institute for Health Research increased from £101 million in 2010-11 to £133 million in 2012-13. Through the NIHR Clinical Research Network, the proportion of patients entering cancer clinical trials and studies is more than double that in any other country for which data exist, including the United States. Annual recruitment in England to cancer studies is nearly 100,000. In August 2011, the Government announced an £800 million investment over five years in a series of NIHR biomedical research centres and units. This includes £61.5 million funding for the Royal Marsden Institute of Cancer Research’s Biomedical Research Centre. The NIHR funds 14 experimental cancer medicine centres across England, with joint funding from Cancer Research UK. Those centres bring together laboratory and clinical patient-based research to speed up the development of new cancer therapies and to individualise patient treatment. In 2012-13, the centres attracted more than £16 million of new funding from commercial partnerships.
The Government invested £23 million, aimed at increasing the capacity of radiotherapy centres in England to deliver intensity modulated radiotherapy—IMRT—so that it can be offered from April 2013 to all patients who might benefit. IMRT is a targeted type of radiotherapy, particularly useful for cancers in the head and neck. I assure my noble friend and the House that our priority is to ensure that all patients, including those with rare and life-threatening or limiting conditions, have access to new and effective treatments on terms that represent value to the NHS and the taxpayer.
However, it is important to bear in mind that patients with rare conditions deserve the same quality, safety and efficacy in medicines as those who have more common conditions. Indeed, I can say in particular to the noble Baroness, Lady Wheeler, that it was partly with this in mind that we announced the early access to medicines scheme on 14 March 2014. Our hope is that the scheme, which launched on 7 April this year and will operate within the current medicines regulatory structure, could give patients with these conditions access much sooner to medicines that may help to treat their conditions. In particular, a promising innovative medicine or PIM designation will provide a positive early signal to industry of the regulator’s views, which will be particularly valuable to SMEs, as well as providing valuable real-world data to companies for use in subsequent health technology appraisal processes.
By giving patients early access to the next generation of medicines before they are licensed, this scheme could help seriously ill patients in areas of unmet clinical need. We continue to support the existing incentives offered at EU level to encourage the development of medicines for small numbers of patients, or “orphan” medicines as they are known, and the development of the Commission’s plans for adaptive licensing, including its launch of the EMA adaptive licensing pilot on 19 March.
Clearly, the development of new and better treatments in cancer care is a noble aim. That is the goal of the Bill, although, as noble Lords have pointed out, its provisions extend to all care, not just cancer care. This House has considered previous versions before: in the previous Session of Parliament the Government decided that this important issue merited a full and open consultation. That consultation ran from February to April this year and the Government received a large number of responses, ranging from detailed submissions by professional bodies, to the personal views of patients and clinicians. We aim to publish a summary of the consultation responses before the House rises for the summer. The Government worked closely with my noble friend Lord Saatchi on the consultation and it was as a result of the consultation that he made revisions to his Bill. If I may say so to him, it is to his credit that he listened to concerns that the Bill could give rogue doctors licence to practise unsafe medicine, and so acted to increase safeguards in the Bill.
I shall deal briefly with one or two questions raised by noble Lords during the debate. My noble friend Lord Blencathra asked why doctors in the US have much greater freedom to prescribe a drug for an off-label indication than doctors in this country. He cited a GMC guideline that he said made it exceedingly difficult for off-label prescribing to take place. I hope my noble friend will forgive me for not knowing the intricacies of the US system, but I do know that General Medical Council guidance on prescribing is clear that clinicians may prescribe a medicine outside its licensed indication where they judge it is necessary to do so to meet the specific needs of a patient.
The noble Baroness, Lady O’Neill of Bengarve, asked whether the Department of Health was considering a wider review of evidence about clinical trials to encourage patient involvement. Since 2006, the National Institute for Health Research has funded and supported the organisation INVOLVE to advance and promote public involvement in research, including involvement in trials and research studies, from design to publication of results. I also understand that the National Institute for Health Research is conducting a review of public involvement in research called Breaking Boundaries. I would encourage the noble Baroness to involve herself in that work.
The noble Baroness, Lady Emerton, asked about the possibility of vicarious liability for other professionals in a multidisciplinary team. If we look at the way litigation happens, it is hospitals that are sued. We do not expect other MDT professionals to be liable as individuals. In any event, as the Bill is currently drafted, their involvement could be expected to be too remote to found any claim of negligence.
Noble Lords have highlighted the need to strike a proper balance between innovation and safeguards. That balance is a delicate one. Clearly, patient safety is vital and we would all agree that rogue doctors seeking to take advantage of patients with evidence-free treatments must be stopped. Yet a necessary focus on patient safety must not stifle responsible innovation. Doctors should have the confidence to innovate, particularly where existing approaches have been exhausted and where there is no plausible alternative. It is therefore important that the Bill does not create new bureaucratic burdens that could actually decrease innovation, acting against its expressed purpose.
The Bill, as presented, gives a role to multidisciplinary teams in overseeing innovation. This is a solution that Sir Bruce Keogh, national medical director for NHS England, and I do not consider appropriate. Multidisciplinary team meetings involve busy clinical discussions that would struggle to focus on the evidence base for innovative treatments. They are not statutory bodies and their membership varies from specialism to specialism. They may be prone to being under the sway of a dominant consultant. Research and evidence suggest that, while MDTs as a whole are a good thing, their quality can be variable.
For those reasons, Sir Bruce Keogh, through his work with the medical community, has concluded that a focus on MDTs in the Bill is inappropriate. Instead, the Government believe that oversight should come from other doctors with experience and expertise in dealing with the condition in question, in line with the existing Bolam test for clinical negligence. For that reason, the Government believe that amendments are needed to the Bill so that it can as closely as possible reflect the desire to, as my noble friend put it, “bring forward” the Bolam test.
I hope and believe that we can work constructively with my noble friend Lord Saatchi to ensure that the final version of his Bill strikes the correct and necessary balance between safeguarding patients and encouraging innovation as it progresses.