House of Commons - Health

Select Committee on Health Fifth Report

5 What the Government proposes to do

44. The Department has recognised that improvements are required in the development and introduction of new medical technologies. It has already started to address the current situation through a number of initiatives, such as the Healthcare Industries Task Force. Dr Harvey told us that the Department would generate an impetus "to catch up with those other countries, whose innovation and entrepreneurial culture is possibly indicated more in terms of how they deliver services now."[56]

45. The Healthcare Industries Task Force was established to explore issues of common interest and identify opportunities for co-operation between the Government and the healthcare industry that would bring benefits for patients and service users, health and social care services and industry.[57] It was a year-long initiative, launched in October 2003. With a wide-ranging and complex agenda the key issue was how to improve patient access to healthcare products, particularly beneficial new technologies. It also examined the development of practical measures to stimulate more innovation in the industry and the NHS, and the modernisation of NHS procurement.[58] The Task Force published its report, Better health through partnership: A programme for action[59], in November 2004.

46. The report outlined an ambitious work programme that included:

a modernised Device Evaluation Service which will be managed by the NHS Procurement and Supply Agency (PASA) - target date 1 April 2005
development of an Innovation Centre to stimulate and promote innovation in the NHS as part of an appropriate organisation
piloted Healthcare Technology Co-operatives as academic centres of excellence - pioneering specialist treatments and techniques
building R&D capacity for medical devices through UK Clinical Research Collaboration Research
improved training and education of NHS staff on the use of medical devices
maximising the UK's influence in regulatory matters in the EU and worldwide
a focused export strategy for the UK healthcare sector
more informed, efficient procurement
better communication with patients and the public on the valuable role played by healthcare products in our daily lives
a new data collection system to gain a clearer picture of the industry and its performance.

47. The Device Evaluation Service, currently part of the Medicines and Healthcare products Regulatory Agency (MHRA), evaluates medical devices and equipment used for pathology, diagnostic imaging, life support and assistive technology[60]. The aim is to provide independent and impartial advice to inform purchasing decisions and encourage the safe use of medical devices based on technical assessment and user comments. The DES "is of particular interest to anyone involved in the purchase, management or use of medical devices." It enables users to select the most suitable devices for their needs, provides information to purchasers of supplies and encourages the safe use of equipment. The Service also contributes to the improved equipment design and performance of medical devices.[61]

48. The HITF report recommended that the DES should move from the MHRA to the NHS Purchasing and Supply Agency with effect from 1 April 2005. Sir Christopher O'Donnell told us that the DES was being moved to PASA "to make it an integral part of that service, so that it gives the service the ability actually not just to make unit-cost based decisions but to look at how value and innovation can be brought to bear."[62] The role of the DES would then be to inform procurement decisions, and encourage and support the uptake of useful, safe, innovative products and procedures used in health and social care. It would:

develop a new device evaluation service to integrate and strengthen horizon scanning, and the assessment of value and effective performance of new and enhanced healthcare technologies, devices and related procedures;
develop nationally accepted methodologies and toolkits for device evaluation that can be used locally to ensure consistency of approach whilst facilitating decision-making at the appropriate level;
and consider how best to ensure speed of evaluation, a 'once only' approach and prompt sharing of outputs with stakeholders throughout the health and social care system and industry.[63]

49. The Department informed us that the new DES would be at the hub of a wide-ranging network, joining industry with NHS clinicians and purchasers, with access to expertise in the field.[64] Sir Christopher O'Donnell said: "a company brings something that is a product in production, appropriately signed off in terms of the quality assurance standards related to the EU Directive and so on, that device can then be evaluated - and evaluated once, not evaluated 246 times or whatever the number happens to be at the available centres."[65]

50. In its memorandum, however the ABHI stated that there were a number of threats to the successful implementation of the HITF report that could prevent fair and appropriate access to treatments and technologies for patients. The two identified threats were:

Unclear accountability for each output's implementation;
and an NHS preference for short-term savings to be made, at the expense of long-term advantages for patients.[66]

51. We welcome the initiatives in regard to a relocated and revised DES. However, Professor Sir James Underwood, of the Royal College of Pathologists, suggested that there should be a single regulatory framework for all diagnostic tests, whether Point-of-Care Testing or laboratory based.[67] There is also a need for a system of reporting with regard to the utility and limitations of telehealthcare systems or other devices that are 'near to patient'. It is clear that this will not be the responsibility of the reshaped DES, and there is currently no national 'clearing house, where this information might be lodged. This may well be a function for the Healthcare Commission.

52. The Government's report on the reconfiguration of Arm's Length Bodies[68] announced that the Department was combining the work of the NHS Modernisation Agency, the NHS Leadership Centre and the NHS University into a single NHS Institute for Learning, Skills and Innovation (NILSI). The NILSI will promote excellence and innovation across the health and social care system and enhance service delivery in the NHS. The Department further informed us that the Institute would assume a leadership role in the implementation and delivery of change in the NHS and manage the new Innovation Centre.[69]

53. Dr Felicity Harvey told us that the NILSI would be "a strategic oversight for training and development of staff."[70] However, she continued by informing us that the HITF had not had sufficient time to get "to really get to the bottom of" the whole area of training and development. The MHRA are already looking at the development of a medical device driving licence that looks at modules of training that people require for individual devices. This is shortly to be piloted in conjunction with the Royal Colleges. Dr Harvey also informed us that industry provides a "huge amount of training for clinicians around the use of devices".[71] With the preponderance of different models of devices it is important for patient safety that users of the equipment are trained on all of the devices. She told us that the Department has recognised that it needs to work with the Royal Colleges, with Skills for Health, and with NILSI to develop a coherent strategic way forward.

54. The Government has proposed some improvements to training, but these will not be sufficient. The Department should ensure that adequate training is in place to enable greater benefits to be derived from new technologies. To encourage greater familiarity with the possibilities and opportunities as well as limitations and risks of telemedicine, training should be modified in those specialist areas that are most likely to be primary users of telehealthcare such as pathology and radiology. Medical schools as well as the professional bodies should develop programmes to ensure effective training is put in place. Training in telecare for health care assistants working for social services and in the community also requires improvement to gain full benefits of new technologies.

55. In its memorandum the ABHI stated: "effective procurement by the NHS is at the heart of successful delivery of medical technology to patients."[72] The Department stated:

NHS procurement is being brought into line with Government policy with the aim of ensuring the purchase of high-value products that perform effectively. The sharing of best practice between local purchasers and commissioners is improving the quality of decision-making, and the development of regional procurement hubs is enabling better value-for-money procurement. Centrally-managed procurement of high investment medical equipment continues to ensure that the NHS benefits from such programmes.[73]

Because of the short-comings in the current arrangements for purchasing within the NHS, the Department is incorporating the recommendations made in the HITF report relating to purchasing into the redesign of PASA. Dr Harvey informed us of three pilot collaborative procurement hubs[74] which are seen as "being very important in terms of purchasing for the future."[75]

56. We were told that enormous efforts have been made by the Department to design and implement a system of Payment by Results (PbR) to "create a fair transparent system for paying NHS hospitals and other NHS service providers."[76] The Medical Technology Group pointed out in its memorandum that, while PbR promises to bring new efficiency and improved performance, the current transition to Healthcare Resource Groups (HRG) as the central method of achieving payment by results in English hospitals risks the use of tariffs that do not reflect the true costs of patient care for a number of critical technologies.[77] The ABHI informed us that tariffs for medical technologies are set according to the national reference cost for each HRG. In its memorandum it stated that: "some procedure payments appear to be so inadequate, they would fail to cover the cost of the technology alone."[78] We questioned Mr Wilkinson about this subject. He replied that the members of his organisation had:

some concerns … in terms of implementation and the capacity of the system at the moment to generate accurate, reliable tariffs. There is also a concern that if this massive process of generating large numbers of tariffs is slow then new technologies will not be reflected in the tariffs, or they will be reflected very late.[79]

57. The Medical Technology Group also voiced concerns. They pointed out that tariffs are calculated on the previous two year data submitted by hospitals. They had concerns about inaccuracies in data being used to determine tariffs and that for newer technologies two years data will not be available to calculate the true cost of the tariff.[80]

58. In July 2004 Dr John Reid MP, Secretary of State for Health, announced a new set of national targets. Included in the new targets was an 18 week maximum wait from start time to treatment by 2008.[81] The Payment by Results scheme has been said to provide an incentive for new technologies, given its tie-in with the 18 week treatment target for patients (thereby encouraging Trusts to select those technologies and devices that can speed up care to meet the 18 week target). Devices that enable this to happen should be a key priority for the new DES. Given that in some cases the Trust that purchases and invests in new technologies may not necessarily be the beneficiary (or sole beneficiary), we recommend that the Department should build into the PbR tariff an incentive payment to offset these development and on-going costs.

59. There is a need to differentiate tariffs for specialised devices/technologies and those that relate to basic care provision to ensure that the reimbursement structure properly reflects the level of complexity and pattern of use of new medical technologies.

60. We welcome the initiatives already undertaken by the Department in this area. Now it must ensure that it devotes adequate attention and resources to rectifying the currently unstructured adoption of new medical technologies.

61. We recommend that the Government in addition to its current proposals should address the following issues of concern to the Committee:

problems relating to the inability to transfer budgets between holders;
lack of clinical engagement and clinical champions;
the impact of practice based commissioning on procurement; and
an NHS preference for short-term savings to be made as opposed to long-term advantages for patients.

56 Q 57 Back

57 Better health through partnership: a programme for action, Healthcare Industries Task Force, November 2004, p iii Back

58 Ev 35 Back

59 Better health through partnership: a programme for action, Healthcare Industries Task Force, November 2004 Back

60 Assistive technology - Any item, piece of equipment, or system, whether acquired commercially, modified, or customized, that is commonly used to increase, maintain, or improve functional capabilities of individuals with disabilities. Back

61 Device Evaluation Service Information, http://www.medical-devices.gov.uk/mda Back

62 Q 64 Back

63 Better health through partnership: a programme for action, Healthcare Industries Task Force, November 2004, p 1 Back

64 Ev 35 Back

65 Q 64 Back

66 Ev 6 Back

67 Q 32 Back