Clause 20 - Joint Working
Joint working between one or more pharmaceutical companies and the NHS and others is acceptable provided that this is carried out in a manner compatible with the Code. Joint working must always benefit patients.
A formal written agreement must be in place and an executive summary of the joint working agreement must be made publicly available before arrangements are implemented.
Transfers of value made by companies in connection with joint working must be publicly disclosed.
Clause 20 Joint Working
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 to successful delivery.
Each party must make a significant contribution and the outcomes must be measured. Treatments must be in line with nationally accepted clinical guidance where such exists. Joint working between the pharmaceutical industry and the NHS must be conducted in an open and transparent manner. Joint working must be for the benefit of patients but it is expected that the arrangements will also benefit the NHS and the pharmaceutical company or companies involved. Joint working differs from the situation where pharmaceutical companies simply provide funds for a specific event or programme.
The Department of Health has issued Best practice guidance on joint working between the NHS and pharmaceutical industry and other relevant commercial organisations. The Department of Health and the ABPI have jointly issued Moving beyond sponsorship: interactive toolkit for joint working between the NHS and the pharmaceutical industry.
The ABPI has produced guidance notes on joint working between pharmaceutical companies and the NHS and others for the benefit of patients. The ABPI Guidance refers to the requirements of the Code but goes well beyond them.
When considering joint working, companies should take account of the guidance which has been issued by the ABPI and the Department of Health. Joint working is acceptable in principle provided that it is carried out in conformity with the Code. In particular, it 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 any and all of the benefits of joint working which are due to the NHS, go not to individuals or practices but to an NHS or other organisation.
A joint working agreement can be based on the use of a particular medicine of a company party to the agreement, but only if the requirements below are complied with and only if the parties have satisfied themselves that the use of the medicine will enhance patient care. Goods and services provided by the company as part of the joint working agreement must be relevant to the medicines involved and the agreement as a whole must be fair and reasonable. Any goods and services provided by the company must themselves contribute to patient care.
The written agreement must cover the following points:
- the name of the joint working project, the parties to the agreement, the date and the term of the agreement
- the expected benefits for patients, the NHS and the pharmaceutical company; patient benefits should always be stated first and patient outcomes should be measured
- an outline of the financial arrangements
- the roles and responsibilities of the NHS and the pharmaceutical company 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 joint 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 joint 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 an executive summary of the joint working agreement, for example on a clearly defined website or section of a website, such as on the company’s or companies’ website; the NHS organisation should also be encouraged to publish this.
The requirement to make the executive summary public applies to joint working projects started on or after 1 May 2011 or ongoing on that date.
Attention is drawn to the certification requirements set out in Clause 14.3 which apply to material relating to joint working including the project initiation documentation and the executive summary of the joint working agreement. Only the final documents etc for any joint working project need be certified. All documents etc used during the development of the project should be of the same standard as certified material but there is no requirement to certify such materials. The joint working agreement does not need to be certified.
Clause 19.2 is relevant to a joint working agreement between a pharmaceutical company and the NHS which does not involve the use and purchase of any of the company’s medicines.
Although the ABPI Guidance is aimed principally at joint working between pharmaceutical companies and the NHS, it also covers joint working conducted though third party service providers and/or with suppliers of private healthcare.
More detail as to the requirements for joint working is provided in the ABPI Guidance which should be consulted when joint working is contemplated.
Joint 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 18.1.
Clause 20 Disclosure
The information required by Clause 20 as to transfers of value must be publicly disclosed in relation to transfers of value made in 2015 and each calendar year thereafter, giving in each case the financial amount or value and the name of the recipient.
Companies must ensure that the amount spent on joint working projects is made public irrespective of whether the value is transferred to a healthcare organisation or some other funding model is used.
Disclosure must be carried out in accordance with Clause 24.
Please check the date of the Code that applies to the Case that you are looking at. The date of the complaint may vary from the activity/material alleged to have been in breach.