The spirit of “new Labour” strongly supports efforts to align commercial and NHS interests. The use of private funding for capital projects, such as building hospitals, is now well established, although this practice is not without controversy.1 We discuss a different form of private finance initiative—the development of packages for disease management in collaboration with commercial companies. We describe our preliminary experiences from a health authority perspective.
The Clinical Effectiveness Review Group was established in 1995 at Barnet Health Authority to address the implementation of evidence based practice at health authority level. The Director of Public Health (SF) noted that he occasionally received offers from independent organisations of “free” packages of services, directed ultimately at general practices, hospital departments, or community pharmacies. These organisations were pharmaceutical companies, producers of medical equipment, or their agents, which, despite a clear conflict of interests were perceived as offering a potentially important contribution to the health of the population (box B1). Somewhat confusingly, these offers were often presented as “managed care” packages, a term that generally implies a different approach aimed at centralised control and cost containment.2
Summary points
Commercial companies, especially the manufacturers of drugs and medicines, increasingly seek to work in collaboration with NHS service providers to manage particular diseases or problems
With such relations there are risks, but also potential benefits, and it may be more realistic to require all parties to be explicit about their potential conflicts of interest than to impose a blanket ban on negotiations
One London health authority developed and used a set of standards for collaborating with the commercial sector in “managed care” initiatives
The draft proposals could be used with a view to developing definitive guidance for health authorities, primary care groups, and trusts when considering such collaborative relations
We defined commercial packages for disease management as materials or support supplied by a third party in addition to, and capable of being integrated with, services routinely provided in public sector health care. This definition encompasses the provision of educational leaflets, help with training staff, audit, decision support systems, investigations (such as echocardiography), or a specialist clinical service along with a pharmaceutical product.
Written offers of such packages were uncommon at health authority level, but several health authority staff recalled letters, telephone calls, or personal visits from company representatives asking whether there might be interest in further talks. These offers were routinely rejected and were not formally noted or recorded. We suspected, but could not confirm, that similar offers were made commonly to individual general practices. A similar situation had arisen a few years previously when the manufacturers of computer systems for general practitioners offered free packages of information technology in exchange for clinical information; heated debate about the ethical implications occurred, but no clear official guidance was produced.3
We recognised that the unregulated spread of commercial packages for disease management was likely to lead quickly to undesirable and perhaps unethical relations between the pharmaceutical industry and the public sector. Major concerns, including some already raised by the NHS Executive,4 included: legality—the development of “favoured” relations for purchasing from a single company may contravene UK or EU law; confidentiality—disclosure of NHS data to a third party is expressly prohibited except in special circumstances; ethical issues, including those concerning clinical care (for example, if the use of a more effective drug were prohibited by a commercial agreement) and consent (for example, if patient data, even if anonymised, were used for commercially oriented research); ownership of data—who has the “rights” to aggregated patient data held by a third party?; clinical emphasis—for example, a potential distortion of the “holistic” approach to patient care, with an undue focus on drugs or some other product based treatment; and cost escalation—drugs or other product based costs, even if “evidence based,” may divert limited funds from other priority areas.
In an ideal world all commercially motivated offers of help would be rejected. In practice, however, the interests of the private and public sectors may coincide or cooperation may help both sides (box B2).
Methods
Developing quality standards for commercial partnerships
Mindful of both the risks and the potential benefits of commercial partnerships, we set out to develop a benchmark for the scientific and ethical standards that staff in our own health authority could apply to any such offers. We knew that other health authorities had developed criteria for collaborative working with commercial organisations, offering support both for meetings and in areas such as guideline development, but we were unaware of any published document that addressed the whole range of activities encompassed by packages for disease management.
The UK NHS Executive had earlier cautiously welcomed potential private-public sector alliances but had stated that “purchasers and NHS authorities must not make commitments to purchase drugs which exclusively link prescribing to a particular company's products.”4 In the absence of more detailed official guidance we made a draft checklist of quality standards against which we could assess the legitimacy and usefulness of offers (box B3) and some draft recommendations for implementing those that satisfied our criteria (box B4).
The draft quality standards and recommendations, initially drawn up by TG and AH, were discussed and refined at two meetings of the Clinical Effectiveness Review Group and were subsequently approved in draft form by the executive board. We then applied them in a pilot project—the unsolicited offer of a “secondary prevention package” for coronary heart disease by a third party company representing the manufacturer of a lipid lowering drug (third example in box B1).
Results of pilot
The company completed the list of questions we sent them, which was based on the checklist in box B3, and this began a dialogue through which the original offer was changed considerably. The initial proposal had been for an activity that was heavily directed towards cholesterol testing and prescription of statins. After several meetings and letters with reference to the draft guidelines for the “disease management package,” we were able to shape it, with the agreement of the company, into a broader (and, we believed, more evidence based5) secondary prevention initiative. The changes negotiated included:
A more explicit focus on overall cardiovascular risk, with an extended range of initiatives for lifestyle modification
Widening of the entry criteria for secondary prevention to include cerebrovascular and peripheral vascular disease as well as coronary heart disease
Facilitating the review of patients already taking a statin drug to ensure that treatment is targeted appropriately
Incorporation of a locally agreed algorithm for risk factor management (including lipid lowering).
Discussion
We report a single example of how, forearmed with a checklist of quality standards we had constructed previously, we were able to develop a package for disease management that suited both the commercial interests of the sponsor and our own aim to provide evidence based and cost effective care for a group of patients at risk. Health authorities, hospital trusts, and primary care groups are likely to come under increasing pressure to enter into quasicommercial relations with pharmaceutical companies. We suggest that open dialogue, in which all parties explicitly present their conflicts of interest and potential common ground is explored in a structured manner, may produce greater overall health gain than a combination of official condemnation and clandestine liaisons. Healthcare providers should consider modifying the standards and recommendations in this paper as part of their clinical governance programmes.
Acknowledgments
We thank Dr Paul Kamill and Dr Glyn Elwyn for helpful comments on a draft of this manuscript and for suggesting additional references.
Footnotes
Competing interests: None declared.
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