Do the financial arrangements for joint working need to be included in the Executive Summary?

Medical and educational goods and services (MEGS) provided under Clause 19 of the 2019 Code are likely to fall under donations in Clause 23 or collaborative working in Clause 20 of the 2021 Code. Companies wishing to continue with ongoing MEGS from 1 July 2021 can do so until 31 December 2021 under the 2021 Code without the need for them to be reclassified as either a donation or collaborative working and comply with any new requirements as a result of this change. Thus there is a six month transition period for MEGS.

If the collaborative working involves services, then the supplementary information to Clause 23 Donations and Grants should be considered.

Collaborative working between the pharmaceutical industry, healthcare organisations and others must be conducted in an open and transparent manner and must either enhance patient care or be for the benefit of patients or, alternatively, benefit the NHS and, as a minimum, maintain patient care. It is expected that the arrangements will also benefit the NHS and the pharmaceutical company or companies involved. Treatments, when mentioned, must be in line with nationally accepted clinical guidance where such exists. Collaborative working differs from the situation where pharmaceutical companies provide funds in the form of a grant for a specific event or programme.

Collaborative working between the pharmaceutical industry, healthcare organisations and others may, in addition, involve working with a patient organisation. In such circumstances, the arrangements for the patient organisation involvement must comply with Clause 27 and is likely to be a contracted service, as set out in Clause 27.5.

Collaborative working is acceptable in principle provided that it is carried out in a manner compatible with the Code. Collaborative working must not constitute an inducement to health professionals or other relevant decision makers to prescribe, supply, recommend, buy or sell any medicine. It must, therefore, always be ensured that none of the benefits of any collaborative working project go to these individuals or their practices. If the collaborative working is a joint working project and there are benefits which are due to the NHS, these must go to an NHS or similar organisation.

The use of a particular medicine of a company party to a collaborative working agreement is not prohibited provided all parties are satisfied that the use of the medicine is appropriate and that the requirements for collaborative working are met.

Resources provided by the company to deliver the collaborative working project must be relevant and the agreement as a whole must be fair and reasonable. Any resources provided by the company must themselves contribute to either patient care or healthcare.

The written agreement should cover the following points:

• the name of the collaborative working project, the parties to the agreement, the date and the term of the agreement

• the expected benefits for patients, the population or user groups, the NHS, pharmaceutical company and other organisation(s) as applicable; benefits should always be stated first, and outcomes should be measured

• an outline of the financial arrangements

• the roles and responsibilities of the NHS, the pharmaceutical company and other organisations and how the success of the project will be measured, when and by whom; all aspects of input should be included

• the planned publication of any data or outcomes

• if a pharmaceutical company enters into a collaborative working agreement on the basis that its product is already included in an appropriate place on the local formulary, a clear reference to this should be included in the collaborative working agreement so that all the parties are clear as to what has been agreed

• contingency arrangements to cover possible unforeseen circumstances such as changes to summaries of product characteristics and updated clinical guidance; agreements should include a dispute resolution clause and disengagement/exit criteria, including an acknowledgement by the parties that the project might need to be amended or stopped if a breach of the Code is ruled

• publication by the company of a summary of the collaborative working agreement, for example, on a clearly defined website or section of a website, such as on the company’s or companies’ websites; the healthcare organisation(s) and other parties involved in the collaboration should also be encouraged to publish this

• outcomes should be published by all parties as soon as possible and usually within six months of the project’s completion, so that other NHS organisations and others can learn from and potentially replicate the initiative. Companies should publish the outcomes on their websites.

Collaborative working should be distinguished from straightforward sales where medicines are simply sold and there are no accompanying goods and services etc and from package deals and outcome or risk sharing agreements as defined in the supplementary information to Clause 19.1.

Joint working as defined by the Department of Health and first introduced in the Code in 2008 is a form of collaborative working as set out in Clause 20.

The Department of Health defines joint working between the NHS and the pharmaceutical industry 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 for successful delivery. Each party must make a significant contribution and the outcomes must be measured. Treatments, when mentioned, must be in line with nationally accepted clinical guidance where such exists.

In addition to the certification requirements set out in Clause 20.3, the joint working project initiation document must also be certified.

The Department of Health has issued best practice guidance on joint working between the NHS and pharmaceutical industry and other relevant commercial organisations. The ABPI has produced guidance notes on joint working between pharmaceutical companies and the NHS and others for the benefit of patients with separate guidance for England, Scotland and Wales. When considering joint working, companies should take account of the applicable guidance.

Collaborative working which relies on benefiting the NHS and maintaining patient care will not meet the requirements for a joint working project.

The information required by Clause 20.5 as to transfers of value must be publicly disclosed annually, giving in each case the financial amount or value and the name of the recipient.

Companies must ensure that the amount spent on collaborative working projects is made public irrespective of whether the value is transferred to a healthcare organisation etc or some other funding model is used. Disclosure must be carried out in accordance with Clause 28.