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Good Harvest

New DoH guidance for joint working between the NHS and pharma promotes fertile partnerships that promise better patient care

Crops rising from the groundIn February, the Department of Health (DoH) Pharmacy and Industry Group published guidance to the NHS on best practice for joint working between the NHS and the pharmaceutical industry. This document has gone out to a very senior cluster of NHS managers, including CEOs in all NHS organisations, medical directors, nursing directors, finance directors and allied health profession leads. The recommendations it provides are not earth shattering, but should help constructive discussion between companies and the NHS as we move into an era where it is likely that non NHS providers will bid for NHS contracts, especially in primary care.

There are some examples of existing joint partnerships, but they are few in number. Historically, the image of the industry in the NHS has been, at best, benign and, at worst, full of suspicion. Despite government policy towards greater plurality of provision in the NHS to drive up patient choice, many private companies have been frustrated by an overly complicated approach to partnership with NHS bodies and the apparent lack of any ability on the part of the NHS to make commercial decisions.

This is set to change as PCTs in England divest themselves of provider functions and focus on commissioning only, and as more NHS Trusts, including PCT providers, shift towards foundation trust status, where greater emphasis on a more business orientated model will become standard practice. In this climate, the guidance brings welcomed clarity to discussions.

The guidance replaces EL(94)94 - Commercial Approaches to the NHS Regarding Disease Management. It seems amazing that this issue has not been addressed sooner, considering the NHS market has changed so rapidly, but better late than never.

It would seem that the days of NHS bodies refusing to have dialogue with pharmaceutical companies is over

The guidance does not apply to research and development activity with NHS partners. It does, however, actively encourage NHS organisations to consider opportunities for joint working with pharmaceutical companies where advantages of better patient care can be demonstrated. It would seem that the days of NHS bodies refusing to have dialogue with pharma companies are over. The guidance states that the development of effective and clinically appropriate joint working can contribute to building an NHS that is truly a beacon to the world. Warm words indeed.

The guidance suggests that NHS organisations should consider four criteria when evaluating joint schemes, namely:

  • Does the scheme meet patient and NHS needs?
  • Does the idea make services more accessible?
  • Can the idea provide sustainable clinical benefits?
  • Is the scheme highly cost effective?

The guidance suggests that the word partnership illustrates a wide variety of arrangements for joint activities between the NHS and industry. Joint working differs from sponsorship, where a pharma company simply provides funds for a specific event or work programme. The guidance also aims to ensure the NHS achieves the best possible healthcare (within resources available) and helps NHS employers and staff maintain ethical standards in conducting NHS business. This suggests that where a company can provide compelling evidence that it can work with the NHS to deliver better value for money and better quality, NHS bodies can no longer ignore such issues. This is a welcome change in policy, which needs to permeate NHS culture.

The guidance is clear; any partnership between the industry and the NHS must be conducted in an open and transparent manner. One assumes this would mean that any plans should be open to public scrutiny at a local level and that hiding behind commercial confidentiality provisions will not be appropriate, unless absolutely vital and proved. All partnership activities must demonstrate mutual benefit and describe the length of any arrangement, the potential benefits to patients and the perceived benefits for all parties, before any joint working is entered into.

Joint working is defined as situations where, for the benefit of patients, organisations pool skills, experience and/or resources for the joint development and implementation of patient centred projects and share a joint commitment to successful delivery.

This is a very broad definition and allows a wide range of ideas to be considered, particularly for better management of health outcomes in many long term conditions such as mental health, diabetes, HIV/AIDS and asthma. In mental health, for example, we know that physical health outcomes are poor for people living with serious long term illnesses. Could an NHS provider team up with a pharma partner to undertake better medicines management and provide better management of physical health for a vulnerable population on issues such as weight, diet, smoking cessation/management, use of alcohol/substances, lifestyle choices and blood, and other clinical monitoring?

The guidance offers some core values, drawn from the NHS Code of Conduct, which all stakeholders must consider.

  1. Accountability - everything done by those who work in the NHS must be able to stand the  test of scrutiny by parliament, public judgements of propriety and professional codes of conduct.
  2. Probity - there should be an absolute standard of honesty in dealing with NHS assets and the use of information acquired in the course of NHS duties must demonstrate integrity.
  3. Openness - there should be sufficient transparency about NHS activities to promote confidence between the NHS, its staff, patients and the public.

Companies wanting to begin a working relationship with the NHS to deliver better services to patients will need to demonstrate high standards of practice and total compliance with the standards set by the ABPI. One must also assume that membership of the ABPI and adherence to its standards are a requirement for entering into partnerships with the NHS. Non NHS partners will be expected to adhere to the standards expected of NHS staff under this guidance and by the standards set out in Commercial Sponsorship, Ethical Standards for the NHS and Standards of Business Conduct for NHS Staff, both issued by the DoH in 2000.

The guidance is new and has the potential to herald better working beyond sponsorship between the NHS and industry

The guidance also informs NHS staff how a complaint against a pharma company can be lodged with the Director of the Prescription Medicines Code of Practice Authority through

NHS employers are required to monitor any contracts and ensure the following:

  • All NHS staff are familiar with the guidance
  • Contract negotiations are conducted with the ethos and values in the guidance
  • All funding agreements are recorded and monitored
  • Confidentiality of information received by staff is respected
  • NHS bodies share their experiences of working with pharma with other NHS bodies
  • Local guidance takes into account the impact of joint working with other stakeholders, eg local government and voluntary sector
  • Joint arrangements are at a corporate level not with an individual.

It must also be establish how clinical and financial outcomes will be risk assessed.

NHS bodies are advised that any contract with a company should contain an effective exit strategy and what the impact of the conclusion of any deal will be. This should also cover the implications of the early termination of a contract, should this be needed. The guidance will be reviewed and/or renewed within five years and a best practice toolkit to augment this guidance will be issued to the NHS and industry by March, 2008.

The toolkit, entitled Moving Beyond Sponsorship: joint working between the NHS and pharmaceutical industry will be issued for consultation shortly. Details of this consultation will be available on the DoH and ABPI websites. The toolkit will contain practical examples of where the NHS and the industry have worked well together, with a view to spreading best practice. It is being designed to give clarity and a solid foundation on which to develop joint working arrangements. Companies with examples of positive schemes or good ideas for schemes may want to put them forward for possible inclusion in the toolkit. Recognition of good involvement with the NHS might prove a good soft marketing strategy. Further information on the guidance and related matters can be obtained from The Medicines, Pharmacy and Industry Group, Industry Branch, Room 402 Skipton House, London or via email

The guidance is supported by a useful annex that draws upon previous and existing codes and documents relevant to the subject of joint working arrangements.

It is crucial that companies brief all their staff on this important development. Partnerships can be brokered at local, regional and national levels so organisations will need to ensure that staff at every level are appropriately informed. As the NHS has now been given explicit guidance on working beyond sponsorship, it will open up opportunities for better disease management ideas, especially in primary care. Companies must consult with their staff for good schemes and proposals (many of which will be local).

The relationships between companies and key clinical leaders may also be an important area of focus. Key clinical leaders will not necessarily get to see this new guidance, so briefing these people might also prove useful in generating ideas for better joint working.

Crucially this guidance is saying, explicitly, that it is alright for the NHS and pharma companies to work together where benefits to patients and good value for money can be achieved. The skills needed to think beyond selling medicines to hospital consultants and GPs will be different to those involved in a purely sales role and it will be essential that teams are familiar with this guidance and understand the wider needs of the NHS customer base.

The guidance will take time to permeate the NHS, but by summer it should begin to bed in. It will be important for companies to test the water and see if this guidance actually makes the relationship between the NHS and pharma easier and delivers good schemes to improve patient care. If the guidance does what it states, then doing honest and open business with the NHS should become easier.

The broad definitions in this guidance suggest there should be a less suspicious and hostile attitude towards the industry and that all areas of NHS activity are open to discussion.

If a company is going to enter into a partnership deal with the NHS, then the level of scrutiny from various stakeholders will be complex. The NHS is subject to detailed monitoring by the Overview and Scrutiny Committees of local government. This is a committee of elected councillors that has powers to call local NHS bodies to account. Companies may also be subject to inquiries from parliament through the Health Select Committee or the Public Accounts Committee. In addition, one must assume that the ABPI will be monitoring activities based on this guidance. In entering into NHS partnerships, companies will need to think clearly about how much public scrutiny of their commercial activities they are prepared to accept in doing such business.

The guidance is new and has the potential to herald better working beyond sponsorship between the NHS and industry. That is clearly the thinking behind the guidance. The problem is that it is guidance, not an executive letter. In effect, guidance can be ignored, but it would be unwise for NHS bodies to ignore such guidance without having very clear reasons. It will, therefore, be crucial for pharma companies to monitor the impact of this guidance in the short and medium term. If within two years there is hard evidence of successful partnerships delivering real results for patients, the taxpayer, the NHS and companies, then the guidance will have done its job well. If, on the other hand, the guidance has little or no impact and the industry remains blocked by inertia, indifference or hostility then it will be important that both the DoH and ABPI be made aware of this. Honest and open relationships based on trust between the NHS and pharma could offer patients a better experience.

Let's hope the guidance achieves this.

AUTHOR: Ray Rowden is a health policy analyst and former special adviser to the Commons Health Select Committee

4th March 2008


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