A Common Understanding 2025

7.The groundwork: 10 steps

Step 1: Project Scoping

Stakeholders from the NHS in Scotland, the pharmaceutical industry and potentially other organisations need to identify projects and initiatives that will enhance patient care or are for the benefit of patients or alternatively benefit the NHS and, as a minimum, maintain patient care.

These projects are often drawn from data analysis or feedback, which highlight an area of proven patient or clinical need.

Potential project partners must consider the project’s desired benefits and outcomes, in addition to its sustainability and how it could be replicated or scaled up, if successful.

At this point, it is also worth investigating if other healthcare organisations have successfully tackled a similar challenge and, if so, whether it may be more appropriate to learn from/replicate/modify their work than to initiate a completely new project. Amongst other resources, the ABPI publishes an NHS-Industry Partnership Case Studies Repository, where projects are available to search.¹²

Step 2: Check Against Criteria

Potential partner organisations should collectively review the following checklist and satisfy themselves that each criterion will be met under the project.

If the answer to any red question in the checklist is “no”, the project is not a collaborative working project as defined by the ABPI Code of Practice and appropriate action will be required to address any identified areas before proceeding further.

If adequate changes to the project cannot be made, then partners should consider an alternative approach. This may be through the provision of grants and/or donations. If the only requirement is for industry funding, then a grant request may be appropriate as defined in Clause 23 of the 2024 ABPI Code (Donations and Grants).

A negative response to any amber question signals potential issues that should be addressed to encourage successful and timely project delivery.

Does the project that is being proposed fit the criteria?

• If you answer no to any red question, the project is not collaborative working as defined by the Code.
• If you answered no to any amber question, you should consider how you are going to address that question to convert it into a yes.

Collaborative working:

1: Does the project meet any of the following criteria:

• benefit patients?
• enhance patient care?
• benefit the NHS and, as a minimum, maintains patient care?

Yes: This may be a collaborative working project – go to Q2

No: Consider another form of support

Red Questions:

2: Do all parties acknowledge that the arrangement may benefit the NHS and company partner(s) involved?

3: Are any subsequent benefits at an organisational level and not specific to any individual?

4: Is there a significant contribution of pooled resources from all parties, which may include people, finance and equipment wholly or partly dedicated to the project?

5: Is there a shared commitment to joint development, implementation, and successful delivery?

6: Will anonymised, aggregated, outcome data be measured, documented and published?

7: Are all partners committed to publishing an executive summary of the collaborative working agreement?

8: Are all proposed treatments involved in line with national guidance, where it exists?

9: Will all activities be conducted in an open and transparent manner?

10: Has an exit strategy and any contingency arrangements been agreed?

Amber Questions:

11: Will the project be managed by a team including representatives of industry, NHS and any appropriate third-party representation?

12: Do all parties and their respective organisations have appropriate skills and capabilities in place to manage the project?

13: Have all partner organisations got clear procedures in place for reviewing and approving collaborative projects?

14: Are all parties aware of and committed to Working Together on the Ten Step Process?

15: Are all partners clear on who within their organisation is the signatory to ensure the relevant documents can be approved?

Step 3: Developing the Project Concept Framework

When entering into a partnership initiative, industry and NHS organisations need to ensure they are working within a robust governance framework to ensure the project aligns with their organisations’ goals and legal processes.

At this stage, a project team or steering committee is established, comprising all relevant stakeholders and active participants. This team will oversee and manage the project, ensuring its success while operating within the agreed parameters. All members of the project team or steering committee must declare any conflicts of interest.

The project team should establish an agreed project methodology and a regular meeting schedule to facilitate initial decision-making, maintain project progress and address any issues. Meetings should be action-oriented, with clear agendas, defined decision points and documented minutes.

In addition to the project team, a governance committee or Internal Review Committee (IRC) should be established to review the principles of the project against the checklist criteria and ensure that the project has been reviewed by each participating organisation’s management and experts.

Within pharmaceutical companies, governance expertise will be provided by legal, medical, compliance and healthcare engagement functions. Within NHS organisations, governance will usually be provided within existing governance arrangements.

At this stage, it is recommended that a Project Concept Framework is developed, outlining the project’s purpose, objectives, resource impact and timelines. It must be approved by all relevant parties to support progression to the project setup stage. An example of a best practice Project Concept Form can be found in Appendix 1.

At this stage, it is vital that good communication between all stakeholders is maintained to align and manage expectations, refine the outcomes and objectives of the project and confirm the inputs into the project from each organisation. It is important to set realistic timescales and deadlines, and to complete a stakeholder map, communication plan and data collection plan, which will help align all stakeholders within the project.

Step 4: Draft Project Initiation Document (PID)

Once the necessary criteria have been met, the project team and project committee should develop and approve a Project Initiation Document (PID) to ensure a shared understanding of the project’s objectives, governance framework and a clear exit strategy outlining each party’s responsibilities in the event of project termination. The PID is a key document that defines the project requirements before implementation, and the final agreed version should be kept on record for reference by all parties. It includes, but may not be limited to:

• Aims and objectives
• Benefits to patients/NHS/pharmaceutical company partner(s)
• Principal activities and accountabilities
• Composition of the steering group and project group
• Timelines and project milestones
• Description of pooled resources
• Plans for monitoring and evaluation
• Communications plan
• Process for project amendment, should this be required
• Defined exit strategy (for all parties).

An example of a best practice PID can be found in Appendix 2.

It is important to note that PIDs will, at times, need to be updated following the initiation of the project. This can be addressed via a Project Amendment Form (appendix 3).

Step 5: Seeking Approval

Timelines for this stage can vary depending on the complexity of both the project and the organisations concerned. It is important to maintain communication between all stakeholders at this stage and to manage expectations. If an organisation seeking to enter a collaborative working project does not have an established governance committee, IRC or similar, it must identify relevant stakeholders with appropriate authority to approve the project.

Step 6: Complete the PID

The project team reconvenes to discuss and implement actions from the governance committee or IRC’s review. In some instances, the collaborative project team may have to return to their governance committee or IRC to gain further comment before completing the PID.

Step 7: Sign the Agreement

Once all the governance signatories have approved the PID, all organisations sign the written agreement. The project team produces an executive summary using content from the written agreement. The executive summary is published on the respective company’s/companies’ website(s) for the duration of the project at a minimum, with other stakeholders encouraged to do the same. The project should not commence until the executive summary has been published by the industry partner/s.

Pharmaceutical companies must certify (under the ABPI Code) certain material relating to collaborative working projects, including the PID and the executive summary.

A recommended executive summary framework is highlighted in appendix 4.

A checklist for use during the development of the project agreement is a key tool and is included in appendix 5.

Step 8: Project Commences

The project begins once the agreement has been signed by all parties and the executive summary has been published on (at least) the industry partner(s) website(s). To monitor project progress effectively, partners should refer to the outcomes outlined in the PID and executive summary.

Step 9: Project Monitoring and Delivery

To monitor project progress effectively, partners should refer to the outcomes outlined in the PID and executive summary. It is critical that baseline measurements and the method and frequency of monitoring progress and outcomes are determined at the outset of the project. Monitoring of agreed measures begins and may include:

• Increased numbers of appropriately diagnosed or treated patients
• Changes to patient satisfaction/experience levels
• Patient-reported outcomes
• Improved patient concordance and adherence to therapy
• Reduced wastage
• System efficiency measures e.g., waiting times, touchpoints which may also link to patient experience indicators
• Proportionate use of appropriate treatment for patients, aligned to local or national guidance
• Proxy patient outcomes.

Regular review meetings should be set up at for the duration of the project to monitor progress against objectives and milestones and to ensure that people/resource allocation is fit for purpose.

Timelines should also be monitored, and plans put in place if an overrun or delay looks likely. This can be in the form of a letter of amendment or extension.

Step 10: Project Completion

Learning is most valuable when it is documented and preserved beyond the conclusion of the project, ideally within the outcome report. In addition to evaluating the project’s results, it is beneficial to assess its overall operation to identify successes and challenges. These insights can then be applied to the design and management of future projects, ensuring continuous improvement and enhanced effectiveness.

As stated in the ABPI Code of Practice, all parties should publish outcomes promptly, within six months (an example framework outcomes report can be viewed in appendix 6). Local NHS organisations are encouraged to do the same. To promote and expand successful collaborations in healthcare, these outcome reports should be shared with ABPI for their NHS-Industry Partnership Case Studies Library to support more partnerships.¹³

To ensure that partnerships are transparent, transfers of value related to collaborative working projects must also be disclosed by the industry partner via the Disclosure UK database.¹⁴