Lord Willis of Knaresborough
Main Page: Lord Willis of Knaresborough (Liberal Democrat - Life peer)My Lords, I first declare an interest as the chair of the Association of Medical Research Charities. Judging by the number and passion of the communications that I and other Members have received you could be forgiven for believing this Bill was drafted in Hades by the most malevolent lawyers urged on by Ministers hell-bent on destroying the whole of the National Health Service. It simply is not that at all. Many of the same arguments were deployed against the Darzi health reforms of the previous Government—in fact many of the demons now being prayed in aid by the noble Baroness, Lady Kennedy, and others were Labour creations. The fact they were does not mean they were wrong or ill conceived, and the same can be said for much of the current Bill. It is our job to ensure that we scrutinise it fully and we are only just starting that process.
However, then as now, it was the failure to communicate what the reforms were trying to achieve that was at the heart of the discontent, not the motives to improve our health service. It is the confusion and complexity of these reforms that my noble friend must address if he is to convince the House that benign evolution rather than malevolent dogma lies at the heart of this Bill. However, evolution must not imply a lack of urgency or boldness. We can discuss organising commissioning groups in whatever configuration we like but, unless we can deliver to our clinicians the fruits of the most productive health and medical research base in the world, they will lack the tools that they need to truly deliver 21st-century health and social care.
Put simply, if patients are to be the new focus, as the Minister rightly says, they must be the beneficiaries of the work of our research community. In 1975, Milstein and Kohler at the MRC lab in Cambridge developed monoclonal antibodies, able to target individual proteins in the body. Following clinical trials using the NHS database, the technology was made available for therapeutic use and today monoclonal antibodies account for one-third of all new treatments, including ground-breaking cancer therapies such as Herceptin and Rituxan. Closer to home, few in your Lordships’ House will not live longer and healthier as a result of the work of the MRC scientists and the British Heart Foundation, whose large-scale study using NHS patients revealed the relationship between cholesterol and heart disease. Today the wide-scale prescription of inexpensive statins not only reduces the risk of cardiovascular disease for millions but substantially reduces costs for the NHS.
Whether it is the use of induced pluripotent stem cells to find a cure for Parkinson’s disease or stem cells to regenerate bone and cartilage in arthritic patients, translating research into clinical practice faster is what will really make a difference to patients, whoever they are and wherever they come from in our NHS. How right the noble Lord, Lord Darzi, was when he said in his excellent speech this morning that “healthcare resides at the edge of science”. Yet this Bill is woefully weak on scientific research and the use of the NHS database. True, we now have Clause 5, which places a duty on the Secretary of State to promote research. A parallel duty to promote research is placed on the NHS Commissioning Board and the clinical commissioning groups—but this is merely window-dressing, without real substance.
The UK's universities and hospitals, vibrant medical science industries, strong health research charities and a unified healthcare system have all contributed to our status as a world leader in health research. Recent surveys by MORI for my organisation have shown that 72 per cent of patients are willing to join clinical trials and 80 per cent would consider allowing researchers to access their medical records. But efforts to do so are seriously undermined by an overly complex regulatory and governance environment. It takes an average of 621 days to recruit the first patient to a cancer trial, according to CRUK, largely because the regulatory environment has evolved in a piecemeal manner over several years as new regulatory bodies have been introduced. The net effect is a fragmented process characterised by multiple layers of bureaucracy, uncertainty in the interpretation of individual legislation and guidance, a lack of trust within the system, and duplication and overlap of responsibilities.
Most importantly, there is absolutely no evidence that these measures have enhanced the safety or well-being of patients or protected the public. Quite the opposite—duplication in obtaining permissions from NHS trusts and other regulators simply creates confusion and unnecessary delays. As a result of this “one size fits all” approach, there has been a fall in the UK's global share of patients in clinical trials and an increase in the time and cost of navigating the UK's complex research approval processes. That flies in the face of the idea that we get better outcomes for our patients.
In short, the current situation is stifling research, driving medical science overseas and seriously disadvantaging the very UK patients whose lot we in this House want improved. This Bill could and should deal with these issues by translating into statute the recommendations of the Academy of Medical Sciences. At the centre of its proposals was the creation of a new single research regulator to oversee and manage the regulation and governance of all health research; to deliver on opportunities to reduce complexity, costs, timeliness and inefficiency; and to build confidence in the conduct and value of health research. What is frustrating is that the Government are so supportive of that approach, but there is no sense of urgency to actually deliver. The promise of a Bill at some future date is simply not acceptable unless the Minister can put on record, when he winds up tomorrow, that it will be in the next Queen’s Speech.
Setting up a health research authority as a special health authority is welcome but, apart from finding a home for the Medical Ethics Service, it answers few of the fundamental questions raised by the Academy of Medical Sciences. Equally, plans to improve the NHS R&D permissions process by making future funding conditional on NHS trusts meeting new approval timelines is very welcome, but how autonomous trusts will be persuaded to fast-track approvals is far from clear. What if the new commissioning groups say, “Research is not our priority”? How will the Secretary of State, without those powers, deal with exactly that? During Committee, I hope that amendments will come forward to consider setting up a new authority, though I recognise that unpicking our existing governance framework in order to streamline it will require a phased approach, the transition of several functions, and therefore co-ordination between a number of bodies. It will also mean dealing with the fall-out from the Public Bodies Bill, which seems to have been forgotten, and dismantling organisations such as the Human Tissue Authority and the Human Fertilisation and Embryology Authority. However, the academy has created a clear vision so that all those involved in undertaking research are clear on the end-point we are aiming for, and what is expected of them during the transition.
My noble friend has said that he wants to listen and that he wants to make necessary improvements to this Bill. He can become a hero in the medical community. He can become a god among patients, if he listens and takes our advice—and that is probably the best advice that he is going to get today.