Select Committee on Health Written Evidence


Memorandum from the King's Fund (PI 81)

  The King's Fund is an independent health charity. In our report Getting the Right Medicines, published in December 2003, the Fund argued that the interests of the pharmaceutical industry had too great an influence on the NHS, mainly because the mechanisms for asserting the public interest in the development of medicines was too weak. We argued that new forms of public/private partnership were required in which the public interest would be given greater weight and that the Department of Health should aim to create a level playing field, by appropriate research commissioning policies, between drugs and other forms of treatment.

  In this memorandum, we develop this argument by focusing on a particular type of health need, those with chronic conditions. Patients with chronic conditions represent the ideal market for the pharmaceutical industry, but the nature of their interest means that only certain fields are investigated and that innovation is biased towards new drugs rather than a search for preventive measures and pays too little regard for other issues such as the long term impacts of specific drug regimes, interactions between drugs for multiple conditions, drug safety, adverse drug reactions, and alternatives to drugs such as diet or other behavioural modification (unless these are considered to be achievable by drug regimes). This bias stems directly from the fact that the companies are focused on only one part of the potential therapy spectrum.

  Furthermore not all long-term conditions are commercially attractive either because the markets they represent are too small or the scope for new drugs is limited for scientific reasons.

  The following comments relate to the headings set out in the Committee's request for evidence.


The conduct of medical research

  These can be taken together. The key issue here is the selection of topics for investigation. As noted above, there are many areas which are not of interest to the industry. Unless the public health interest is clearly articulated and appropriate action taken, these will continue to be neglected.


Professional and patient education

  These two areas can be taken together. The central issue is the balance and objectivity of the information available to the patient and the professional. As things presently stand, the resources available for promoting commercially profitable drugs are much greater than those available for promoting alternatives—ie out of patent or generic drugs or other forms of treatment including cognitive and behavioural therapies.

  The NHS has made significant strides in redressing the balance through local formularies, NHS direct online, support for systematic reviews, establishment of NICE etc. But it has not given substantive support to establishing the effective use of pharmaceuticals in practice within the populations to which they are actually applied which may be very different from those within which they have been trialled or evaluated.[77]

  In the absence of such research, both professionals and patients will remain poorly informed about the consequences of some of their decisions to redress this situation would require trials of drugs in use as opposed to the artificial circumstances of the trials conducted for regulatory purposes. The point also applies to the current policy of encouraging a switch of drugs such as statins from prescription only status to P or GSL status, the long-term consequences of which may or may not be beneficial.


Product evaluation

  These two areas can be taken together. Ensuring safe and effective treatment of chronic disease requires a long term monitoring and evaluation regime.

  The existing requirement for licensing drugs do not entail a requirement that they should be shown to be more cost-effective than existing drugs nor that their long-term effects should be monitored by those seeking the licences. The recently extended yellow card system provides an important source of information, but this is not adequate for detecting all effects of this kind in a systematic way.

  To overcome this deficiency requires a fundamental re-assessment of the role of the regulatory system, designed to place greater emphasis on its role after licensing. Recent changes to the yellow card scheme represent a first step in that direction, but this needs to be supplemented by more systematic long-term monitoring and evaluation. The recently reported study[78] of hospital admissions arising from adverse drug reactions makes the point that drugs can be dangerous to health whatever their regulatory status.

Policy Recommendations

  The basis for any policy recommendations must be an agreed view of how the drug development process should work in the public interest. We propose it should be part of what we term a therapy development process, which in outline would look like the following:

  The diagram has been deliberately drawn in a simplified form but it is sufficient to bring out some key points:

  First, some needs including the needs of particular patient groups, are not identified and there is no systematic mechanism for identifying them.

  Second, there is no mechanism for considering the balance of research effort over the whole health field. This would require not only the capacity to survey what research is or is not being done but also the capacity to commission work in areas found to be neglected.

  Third, the current set of arrangements do not ensure a level playing field between different research and treatment options. The full range of options is not considered because the private sector is restricted by profit considerations and the public sector does not systematically seek to complement it.

  Fourth, the current system is front loaded ie the balance of resources is heavily biased towards the new, rather than the effective use of the existing. The resources going in the later stages, particularly the final one, are small relative to those going into research into new therapeutic options and then subsequently into marketing them to health professionals and individuals. Therefore investment doesn't necessarily match potential health benefit.

  Within the framework suggested by the diagram, there is scope for different divisions of work. The industry could continue to work as now and the public interest could be pursued in a variety of ways, depending on what kind of partnerships can be developed between government and industry. Alternatively the role of the industry could be modified through the introduction of an expanded regulatory and monitoring regime designed to deal with the issues raised above about effective and safe drug usage and the alternatives to drug regimes.

  We do not wish to propose any particular kind of partnership or new regulatory regime. What we do recommend is the Department of Health acknowledges that the existing set of arrangements do not work as well as they might in the public interest. The recent announcement of a research collaborative[79] is a step in the right direction as is the recognition, in the announcement, that there are important gaps in existing public and private research programmes. The next step is for the Department to lead a substantive study of what we have termed the therapy development process of which the drug development process forms part.

  We would like to see the new Director of R&D set out a broad strategy as to what the role and use of NHS R&D funds should be, based on what we see as the failures of the health research economy on the one hand and NHS principles on the other. This should consider the need to apply a set of criteria which are not simply based on the major diseases but which take into account a wider range of considerations including equity, the potential for improved quality of life and the scope for patients to take care of their own condition(s), with or without the use of drugs.

77   BMJ 2004 nsaid. Back

78   BMJ 2004 329 15. Back

79   Department of Health PR2004/XXX. Back

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