Medical Innovation Bill [HL]

Earl Howe Excerpts

Friday 27th June 2014 Lords Chamber

[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.