Medical Innovation Bill [HL]

Baroness Wheeler Excerpts

Friday 27th June 2014 Lords Chamber

[Baroness Wheeler (Lab)]

My Lords, I, too, pay tribute to the noble Lord, Lord Saatchi, for his courage and determination in bringing the Bill forward. This House has an excellent record in making sure that the importance of NHS innovation and research is kept to the fore of our debates, and in its scrutiny of health and social care legislation, including, most recently, ensuring that both the Health Research Authority and Health Education England have the key duty to promote innovation and research at the heart of their statutory responsibilities and duties.

As all speakers today have said, there is strong support for the principles and intent of what the noble Lord is trying to achieve and widespread respect for the dignified and very powerful and moving contribution and arguments he put forward. There is also full recognition that the Bill raises key issues over how innovation and research can best be pursued which need to be addressed.

Labour has always strongly supported efforts to bring innovative treatments to patients faster and underlined the need for a major effort by government to address the barriers and bureaucracy that prevent progress being made and ensure that innovations are rapidly transcribed into practice. As we know, the consultation on the Bill was conducted on the previous draft of the Bill. Many of the respondents to the consultation rightly underline their desire to see new and innovative medical treatments in the NHS and support the efforts of the noble Lord, Lord Saatchi, to achieve this. We all want to achieve this aim, and the question before us today is how and whether the changes proposed will help achieve this.

Having been a Member of the House for four years now, and like other noble Lords, I cannot recall another occasion when I have received such a huge amount of solid background briefings, legal documents and advice. I have certainly never before experienced such a powerful and overwhelming “home-straits” push from the sponsor of a Private Member’s Bill. The final 60-page briefing of the noble Lord, Lord Saatchi, sets out his belief that the two major concerns of opponents to the Bill are, first, that there is insufficient evidence that the Bill is needed; and, secondly, that the Bill may encourage quackery. The noble Lord, Lord Saatchi, believes that the fear of litigation or disciplinary proceedings stops doctors adopting innovative treatments and reinforces the culture of fear and defensive medicine in a risk-averse NHS.

In July 2013, in response to an Oral Question from the noble Lord, Lord Saatchi, on the costs of medical litigation, the Minister has previously commented that he has seen,

“no evidence that a particularly large or indeed significant element of that bill relates to medical innovation”.—[Official Report, 15/7/13; col. 524.]

Will the Minister update the House on the latest Department of Health information concerning medical litigation costs and any further research that has been conducted by the department on how the increasing litigation bill impacts on medical innovation?

The noble Lord, Lord Saatchi, also argues that the Bill would provide legal clarity and confidence for doctors when they wish to innovate and that without a change in the law many doctors feel compelled to stick to the well worn path of standardised treatments. He has endeavoured to set out under the Bill essential safeguards and an accountable and transparent system for doctors to follow when deciding whether and how to innovate. Our understanding from press reports was that Sir Bruce Keogh, the NHS medical director, had been asked by the Secretary of State, Jeremy Hunt, to set out the process and framework of how the new legislation could work in practice. That, of course, is vital to consideration of the Bill. We now understand that he has been working on amendments to the Bill itself, and I look forward to hearing further from the Minister on this.

Jeremy Hunt’s Written Statement in the Commons on 22 November last year committed the Government to seeking to,

“legislate at the earliest opportunity, subject to the results of the consultation”—[Official Report, Commons, 22/11/13; col. 66WS]—

on the Bill. I look forward to hearing from the Minister what support the Government are giving to the Bill before us, given the changes to the Bill after the consultation. Will the Government be publishing a formal response to the consultation? Do they undertake to make time for the Bill in this Session of Parliament, as the noble Lord, Lord Saatchi, wants to see?

Finally, in his Statement Jeremy Hunt also supported the contention in the Bill of the threat of litigation against doctors but recognised that as just “one … barrier” to medical innovation. The noble Lord, Lord Saatchi, has made it clear that he, too, sees his Bill in that context; and it is important that, whatever the shape of any final legislation, the House acknowledges that too. Medical innovation and the adoption of new treatments require the whole NHS making research and innovation its business—as was so powerfully set out in the Association of Medical Research Charities’ excellent 2013 report, Our Vision for Research in the NHS, which was the subject of a debate in the House initiated by my noble friend Lord Turnberg and referred to by him earlier.

In response to that debate, the Minister’s follow-up letter of July 2013 to my noble friend contends that,

“the current system allows for medics to initiate novel treatments as long as they are in the best interests of patients and with the patient consent”.

That view is supported by the majority of the bodies representing the medical profession and other health organisations which responded to the consultation. During the AMRC debate, the Minister also reported to the House, in very helpful detail, the actions being taken by the various NHS bodies to address the current obstacles to innovation. Sir Robert Francis, a strong opponent of the Bill in its current form, sums up these obstacles in his very concise and to-the-point way as,

“overzealous bureaucracy, scarcity of resources, ethical reservations and decision-making processes”.

What have the Government done to address these obstacles, so fully identified in debates in this House, and the frustrations expressed that the existing processes and pathways are not being fully used? How have they promoted early access schemes to introduce new drugs and treatments? Take-up by health authorities has been painfully slow, so what are the latest figures? What is the latest position on take-up figures on other key measures designed to speed up getting research and innovation transcribed into practice, such as named patient schemes and adaptive licensing schemes? Are the Government satisfied that the Health Research Authority’s new process for speeding up approval for clinical trials is achieving this? How is the variation across NHS trusts in the take-up of NICE-approved technology appraisals and of the actions outlined in the UK life sciences strategy being addressed?

The issue of whether the current law needs to be changed involves complex legal arguments which have been ably set out by the noble Lord, Lord Saatchi, both today and in his briefing documents, and expertly supported by the noble and learned Lords, Lord Mackay and Lord Woolf, and other speakers. These have been equally expertly refuted by noble Lords with deep concerns about the Bill, as well as by the many organisations that have expressed reservations and opposition. They argue strongly that no change in the law is necessary, that a different change is needed and that any additional support required by doctors should be achieved through guidance on good practice, not through legislation.

I look forward to hearing the Government’s view on the proposed changes to the law. The Opposition will be seeking their own legal advice as the Bill progresses. On that issue, I emphasise that Labour’s strong wish and hope is that the Bill should proceed to full Committee scrutiny. The issues raised are crucial, and my understanding is that the noble Lord, Lord Saatchi, is keen to ensure that, rather than any rushed process, there will be a full debate and scrutiny after today.

The noble Lord, Lord Saatchi, is to be commended on his concern to ensure that the importance of patient consent to treatment is firmly embedded in the Bill and that his proposed change in the law would not affect this. As the Bill progresses we will want to see further measures that ensure that decisions on innovative and new treatments are made with sufficient regard to efficacy and patient safety. In this debate we have heard of concerns expressed by the some of the key patient safety organisations about the Bill.

Noble Lords will know that Action against Medical Research has contended that, although having good intentions, the Bill could have the gravest “unintended consequences” by removing a layer of protection and redress for vulnerable patients who are harmed when their doctors act in a way that no other doctor would support. AvMR says that it would also encourage unsafe and unaccountable practice by doctors and lead to further scandals and tragedies. Sir Robert Francis’s concern is that the Bill removes protection from patients and a right to redress without any adequate safeguards. The noble Lord, Lord Saatchi, addressed many of these concerns in his opening speech, and I look forward to hearing the Minister’s response to the AvMR, Sir Robert Francis’s concerns on patient safety and warnings from the medical organisations about safeguarding patients. How do the Government propose to address these concerns?

There is strong concern over how the doctor’s “responsible officer”, referred to in the Bill, is to be identified. What is the Government’s response to this? What is the Government’s view on how this proposed new law will facilitate and help achieve the major culture change that is needed in the NHS among staff at all levels to ensure that research and innovation is everybody’s business? The survey accompanying the AMRC vision report set out the extent and scale of change among staff and patients that needs to happen to achieve the Government’s goal of,

“every clinician a researcher and every willing patient a research participant”.

In summary, we support the principle of the Bill; we support the desired effect that the noble Lord, Lord Saatchi, wishes to achieve; and we want to have the Bill seen and considered in the context of the urgent need to make real progress on tackling the obstacles and barriers that stop the existing laws and processes which support the introduction of new and innovative treatments being fully used and effective. I look forward to hearing from the Minister how he proposes to proceed.