Pharma-NHS joint working
pharmafile | April 22, 2009 | Feature | Research and Development, Sales and Marketing |Â Â ABPI, doctors, industry relationsÂ
An underlying principle for joint working between the NHS and the pharmaceutical industry is that it brings benefits to patients. Transparency and openness are key considerations to the implementation of appropriate joint working.
The ABPI has introduced guidance to provide a framework and greater clarity for pharmaceutical companies about various aspects of joint working between the pharmaceutical industry and the NHS.
Background
For many years, pharmaceutical companies have shown their commitment to improvements in patient care in a variety of ways, for example, by providing medical and educational goods and services and unrestricted educational grants.
More recently, however, the NHS and the pharmaceutical industry have been seeking to extend the nature of these relationships in order to develop higher quality care and improve mutual understanding and trust.
In England, the Department of Health (DH) published its Joint Working Guidance in February 2008 (1), thus confirming the government's wish to see a closer and more mature working relationship between the NHS and the pharmaceutical industry. DH policy on joint working was further emphasised in the Darzi Report (2).
The Joint Working Toolkit, "Moving Beyond Sponsorship: joint working between the NHS and the pharmaceutical industry" (3) produced by the DH and the ABPI in March 2008, provides guidance to help NHS organisations and pharmaceutical companies establish joint working projects. The toolkit also provides a number of template agreements and other documents required to ensure that the governance arrangements are robust.
In order to provide further clarity for companies entering into joint working arrangements, the ABPI has produced new 'Guidance Notes on Joint Working between Pharmaceutical Companies and the NHS and Others for the Benefit of Patients Taking into Consideration the 2008 ABPI Code of Practice for the Pharmaceutical Industry' (4).
Purpose of the guidance
Pharmaceutical companies that are members of the ABPI are required to comply with the ABPI Code (5), which regulates the promotion of prescription medicines and certain other non-promotional activities.
The Code also applies to many non-member companies. The Code states that joint working with the NHS (health authorities, trusts and the like) is permitted if carried out in a manner compatible with the Code.
The ABPI guidance seeks to support appropriate joint working and to provide a framework and greater clarity for pharmaceutical companies. It extends beyond matters covered by the ABPI Code. Copies of the guidance can be viewed on the ABPI website: www.abpi.org.uk
The guidance is not a free-standing 'how to' guide and should be read alongside the relevant national Government policy documents, for example: in England, the Department of Health (DH) "NHS Best Practice Guidance on Joint Working" (6); in Scotland, "A Common Understanding: Guidance on Joint Working between NHS Scotland and the Pharmaceutical Industry 2003" (7) and in Wales, "Guidance for Partnership Working between NHS Organisations, Primary Care Contractors, the Pharmaceutical Industry and the Allied Commercial Sector in Wales 2004" (8).
The guidance is generally written as though the arrangements will be made between a single pharmaceutical company and an NHS organisation. However, it is also intended to cover joint working between several pharmaceutical companies and/or several NHS organisations and also to cover joint working conducted through third party service providers and/or with suppliers of private healthcare.
It is important to note that only informal guidance about compliance with the ABPI Code can be obtained from the Prescription Medicines Code of Practice Authority (PMCPA) which operates the ABPI Code on behalf of the ABPI. The decision as to whether any individual joint working arrangements comply with the Code will be determined by the PMCPA following a complaint. Each case is considered on its own merits.
Definition and scope of joint working
The guidance applies to joint working arrangements between the NHS and one or more pharmaceutical companies. 'Joint working' is defined in the DH Joint Working Guidance and Joint Working Toolkit as:
Situations where, for the benefit of patients, one or more pharmaceutical companies and the NHS pool skills, experience and/or resources for the joint development and implementation of patient centred projects and share a commitment to successful delivery.
Given the significant governance and administrative requirements involved in setting up proper joint working arrangements, it is likely that most projects will be of a significant size and duration – as a guideline, generally involving resources (manpower, materials, funding, etc) in the region of £15,000 – £20,000 and lasting six months or more.
There are a number of non-promotional and/or commercial practices that involve interaction with the NHS and healthcare professionals that are not subject to the joint working guidance. These include clinical trials, package deals, medical and educational goods and services and more – all are subject to applicable laws, regulations, guidance and codes of practice, including the ABPI Code.
Joint working activities
A joint working project may comprise a number of activities including, but not limited to, the following:
* Staff training
* Staff and/or patient education
* Economic analysis
* Nurse services
* Support for guideline implementation
* Funding of project staff requirements (e.g. provision of staff resources)
* Secondments
* Audit
The mutual benefits of joint working
When developing a joint working proposal, it is important to define from the outset the anticipated benefits for all concerned and to ensure that all parties are comfortable with the proposals. As joint working projects are 'business to business' arrangements, it is reasonable and appropriate for both the NHS body and the pharmaceutical company to consider return on investment before committing to any project. Commercial benefit to either party must not be the sole benefit under joint working.
Governance
Governance arrangements are explained in the Joint Working Toolkit. It is important to reiterate, however, that joint working between the pharmaceutical industry and the NHS must be conducted in an open and transparent manner. This will include entering into appropriate joint working agreements, establishing steering groups and consulting with relevant stakeholders about each particular project.
In order to avoid the inappropriate influencing of prescribers, joint working discussions and agreements must take place at an appropriate organisational level within the NHS (e.g. authorised negotiators or signatories of an NHS Trust, Health Board, Primary Care Trust, and/or NHS commissioning group) and the pharmaceutical company (e.g. at senior manager or director level).
However, individual GP practices, hospital departments and health professionals are likely to be intimately involved in the planning and implementation of joint working projects.
Although pharmaceutical companies and individual GP practices or hospital departments may wish, and will continue, to work together, such projects are unlikely to be recognised as joint working projects unless an NHS body (e.g. a PCT or Health Board) is involved.
The NHS is under pressure and changing rapidly. Now that the need for the NHS to engage more fully with the pharmaceutical industry has been recognised, the new ABPI Guidance Notes will provide the basis for appropriate relationships leading to better patient care
(1) "Best practice guidance for joint working between the NHS and the pharmaceutical industry, Department of Health (February 2008) ("DH Joint Working Guidance"). See www.dh.gov.uk
(2) Next Stage Review – High Quality Care for All' (Darzi Report – June 2008) See www.dh.gov.uk
(3) Moving beyond sponsorship: Interactive toolkit for joint working between the NHS and the pharmaceutical industry, Department of Health/ABPI (March 2008) ("Joint Working Toolkit"). See www.dh.gov.uk
(4) ABPI Guidance on Joint Working between Pharmaceutical Companies and the NHS for the Benefit of Patients Taking into Consideration the 2008 ABPI Code of Practice for the Pharmaceutical Industry
(5) ABPI Code of Practice for the Pharmaceutical Industry 2008. See www.pmcpa.org.uk
(6) "Best practice guidance for joint working between the NHS and the pharmaceutical industry, Department of Health (February 2008) ("DH Joint Working Guidance"). See www.dh.gov.uk
(7) A Common Understanding: Guidance on Joint Working between NHS Scotland and the Pharmaceutical Industry 2003. See www.scotland.gov.uk
(8) Guidance for Partnership Working between NHS Organisations, Primary Care Contractors, the Pharmaceutical Industry and the Allied Commercial Sector in Wales 2004. See www.wales.nhs.uk
Martin Anderson is ABPI director, policy and partnerships. Tel: 020 7747 1401; Email: manderson@abpi.org.uk
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