Health: Innovative Medicine

Lord Kakkar Excerpts

Tuesday 1st April 2014 Lords Chamber

[Lord Kakkar (CB)]

My Lords, I congratulate the noble Baroness, Lady Thomas of Winchester, on securing this important debate. In so doing, I declare my own interests in healthcare, in particular that I am chairman of UCLPartners and the UK business ambassador for healthcare and life sciences. I, too, congratulate Her Majesty’s Government on their early access scheme, recently announced, which is important for patients and healthcare professionals and in securing the ecosystem around the delivery of life sciences in our country. That is vital not only for the delivery of innovative healthcare, advancing clinical outcomes and improving the ability of our patients to benefit from advances in medical research, but because the life sciences sector in our country plays such an important role in the economy more broadly.

As we have heard from the noble Baroness, Lady Thomas, the scheme is fundamentally driven to ensure that innovative medicines that have undergone a degree of thorough scrutiny by way of clinical evaluation could be made available to patients with life-threatening and debilitating conditions before they would normally have received their full licensing, which is very important. I ask the noble Earl how Her Majesty’s Government plan to ensure equity of access to the scheme, bearing in mind that these innovative products will not, at the stage when they will become available as part of the scheme, have had approval for cost-effectiveness through the processes of the National Institute for Health and Care Excellence. Therefore, it is important that careful attention is paid to ensuring that, if those innovative medicines are to be provided as part of a specialist commissioning infrastructure within NHS England, it is done in such a way that patients throughout the NHS in England can avail themselves of those important innovations, because they will be some of the most vulnerable patients whom we see with life-threatening conditions or chronic disabling and debilitating conditions.

In that regard, I wonder whether the noble Earl can give a view on the potential role that academic health science networks, such as UCLPartners, might play in promoting access to innovative therapies as part of the early access scheme. As part of their original designation and licence obligations, the academic health science networks had to give undertakings with regard to the diffusion at scale of innovation across the populations for which they have responsibility. Do Her Majesty’s Government see a role for the academic health science networks in the early access scheme with regard to those diffusion of innovation obligations? If so, does the noble Earl believe that the arrangements for funding the academic health science networks, bearing in mind that the scheme will run for a number of years, are sufficiently secure?

Beyond the important contributions that Her Majesty’s Government have driven over the past four years in innovation in healthcare, through the development of the academic health science centres and networks and through the promotion of the National Institute for Health Research and its translational medicine research elements, which are vital to the early access scheme by encouraging industry and other biotechnology partners to work with the institute to undertake the research evaluation that will bring those innovative medicines more quickly to bear in the management of patients in the most desperate of circumstances, there is also the important question of the legal framework within which innovation can take place. That relates to innovation not across the system but to an individual clinician innovating for an individual patient and, therefore, the culture of innovation in our healthcare system.

The noble Lord, Lord Saatchi, recently promoted the Medical Innovation Bill, which is intended to address the important question of whether a legal impediment to innovation resulting from an accumulation of case law has changed the way in which clinical practice is discharged. I know that on 22 November 2013 the Secretary of State recognised, in a Written Statement, that there may well indeed be unintended consequences of the way in which case law is now interpreted that will stifle innovation with regard to the individual clinician providing care for the individual patient. As a result, Her Majesty’s Government are currently undertaking a broad consultation on the question of whether a Bill to help to clarify those ambiguities in law is necessary. Can the noble Earl provide some further insights into how the consultation is proceeding and where Her Majesty’s Government’s thinking is with regard not only to dealing—as they have done effectively—with the systems issues about innovation at scale and pace for large populations, but to the ability of individual clinicians to practise innovative care in a responsible and structured framework for the individual patient in front of them, often making use not only of personalised medicine and the revolutions in genomic medicine that will drive individual decision-making for patients, but also of this impressive early access scheme?