The 2024 ABPI Code of Practice exists to regulate the promotion of prescription medicines to UK health professionals, industry interactions with health professionals, and the provision of information about prescription-only medicines to the public.

NHS-industry partnerships allow NHS organisations and the pharmaceutical industry to collaborate for patients’ benefit. Joint working was recognised by the Welsh Government when it issued a Welsh Health Circular (WHC) in 2005 ‘Guidance for partnership working between NHS organisations, primary care contractors, the pharmaceutical industry and the allied commercial sector in Wales’.¹

Since then, multiple publications have acknowledged the value of external expertise in helping NHS organisations overcome challenges. This includes providing additional skills and resources to achieve patient benefits beyond that which NHS organisations could deliver alone. These partnerships bring industry skills and expertise to improve appropriate patient access to innovative treatments, support project management and enhance the efficient delivery of healthcare services.

Partnerships can be formed between a single NHS organisation and a single pharmaceutical company, or multiples of either. In general, there is a trade-off between the advantages of greater scale in working with multiple partners, as seen through regional working in Wales, and the added complexity of gaining agreement across multiple organisations.

While patient organisations cannot directly be included in collaborative working arrangements, they may be contracted to deliver a service to support an element of such collaborative working.

There are two types of NHS-industry partnership: collaborative working and joint working projects. These partnerships involve cooperation between industry and local NHS organisations across primary, secondary and system-level healthcare settings.

1. Guide to collaborative working between NHS organisations, primary care contractors and the pharmaceutical industry

Collaborative and joint-working approaches: a comparison

As noted in the comparison table, one of the key benefits of collaborative working is the ‘triple-win’ - benefiting patients, healthcare organisations including the NHS, and pharmaceutical companies. Benefits for pharmaceutical companies in embarking upon collaborative working can be myriad, from gaining experience in partnering with an NHS organisation, to an increase in patient identification and prescribing in accordance with national and local guidelines. Most importantly however, and in accordance with Clause 20 of the ABPI Code of Practice, such benefits must not constitute an inducement to health professionals or other relevant decision makers to prescribe, supply, recommend, buy or sell a medicine. A key safeguard here is the requirement in the ABPI Code of Practice to have a have a summary of the collaborative working agreement publicly available before arrangements are implemented.

It is also worth noting that in embarking upon collaborative working with NHS organisations, companies will have no direct contact with patients, or with identifiable patient level data.

The ABPI Code of Practice

The 2024 ABPI Code of Practice exists to regulate the promotion of prescription medicines to UK health professionals, industry interactions with health professionals, and the provision of information about prescription-only medicines to the public.

It is administered by the Prescription Medicines Code of Practice Authority (PMCPA) and is the cornerstone of the UK system of industry self-regulation. All NHS-industry partnerships are bound by the ABPI Code of Practice.

Multi-partner considerations

Collaborative working projects between a single healthcare organisation and a single pharmaceutical company are common. Less common but still possible are cross-sector projects involving more than one healthcare organisation and/or more than one pharmaceutical company. 

Cross-sector projects between one or more healthcare organisation and one or more pharmaceutical company are often more complex. This is because each individual organisation has its own governance and approvals processes, which can lengthen the timelines for project set-up and implementation. In addition, ABPI members are actual or potential competitors in certain therapy areas and are therefore subject to stringent competition law safeguards that must also be reflected in any agreement on working together. A shared desire to improve patient outcomes through a collaboration will not justify anticompetitive conduct, such as the illegal exchange of sensitive information between competitors or other types of collusive practices. Multi-partner considerations

There should be a lead contracting party, identified by job role, in each sector in a cross-sector project where there are multiple healthcare organisations or to have an individual contract with each organisation involved.

Where there is more than one contracting party on each side of the cross-sector project, steps should be taken to understand the differing legislative competence, governance processes and timelines involved.

Given that the legal risk and opportunities for error are higher when multiple organisations are involved in the same collaboration, it is best to agree rules of engagement upfront, which can be recorded in the agreement. Such rules should set out clear governance principles, such as:

• All project meetings will only take place if at least one representative of each party can attend
  
  
• Minutes of all meetings will be taken, approved by all participants, and kept on record for an agreed period after the completion of the project
  
  
• All project participants will receive a briefing on competition law rules and will be asked to sign a competition compliance and non-disclosure statement.

If the nature of the project would require specific discussion on topics of the utmost sensitivity such as costs, patient information, potential tendering opportunities, R&D activities etc., the parties should consider having a specialist competition lawyer attend the meetings.

Key stages of the project lifecycle

The figure below outlines the stages of a partnership, from planning to delivery and monitoring:

Where can partnership projects originate?

In Wales, partnerships can originate from across the NHS in Wales, as well as from the pharmaceutical industry. The table below sets out some suggestions. Both parties can discuss initial project ideas with the Life Sciences Hub Wales.²

Key resource: Scoping decision guide

At the start of a partnership, NHS and industry organisations need to identify unmet needs to support clinical outcomes. Industry partners often align their capabilities with NHS goals or issues identified through health data analysis.

This process includes community engagement and patient feedback to identify opportunities for improvement. Colleagues should use these questions to explore and develop the scope of a project, to ensure the aims are clear and the entire lifecycle of the project has been considered.

Key resource: Checklist for determining if a project is collaborative working, joint working or neither

To help identify if a project is a collaborative or joint-working project, an
assessment of the project scope and aims should be undertaken, which can be supported by completing the checklist below.

If the answer to any red questions on the checklist is ‘No’, the project is not a collaborative or joint–working arrangement, and will need to be modified before proceeding. If changes cannot be made, prospective partners should consider an alternative approach, such as a research collaboration or a donation/grant, as described in Clause 23 of the ABPI Code of Practice.

If the answer to any amber questions is ‘No’, this signals an issue or risk that should be addressed to encourage successful and timely project delivery.

Key resource: Project Concept Framework

The key recommended documentation for stage 1 is a Project Concept Framework, 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.

View a case study demonstrating the step-by-step implementation of a project in a primary care setting.

Project setup and governance structures

At this stage, a project team or steering committee is formed, including all involved parties and active participants. This team will guide and manage the project, being responsible for its success and operating within the agreed limits.

The members of this project team may differ depending on the care setting. The team should be ‘right sized’ to be both effective and inclusive.

All project team or steering committee members must declare any conflicts of interest.³ Those with a conflict should not vote on related matters. These declarations should be recorded in the meeting minutes. Either party can object to someone’s involvement due to a conflict of interest.

The project team should agree on a project methodology. PRINCE2 (Projects In Controlled Environments) is perhaps the best known and most widely used, but the methodology may vary depending on the complexity of the project. The team should also agree on a regular meeting schedule to make initial decisions, keep the project on track, and manage any issues. Meetings should be action-oriented, with clear agendas, decision points, and minutes recorded.

When considering project resourcing, all parties must commit to detailing the resources they will contribute to the project, which could include finances, skills, or experience. These contributions should go beyond normal day-to-day roles, like funding additional staff or clinics. Assigning a monetary value to healthcare resources is challenging, but it should be clear that contributions from partners should be comparable and proportionate. If the collaboration aims to address organisational constraints within the NHS in Wales, precautions must be taken when using pharmaceutical funding to retain staff. Any staff paid through industry funding should operate under the control of an organisation within the NHS in Wales, be time limited and outlined in collaborative working documentation, with clear employment law compliance. Exit strategies for industry-funded posts should be outlined in project documents.

3. In the NHS in Wales, conflicts of interest are addressed through a combination of policies, guidance, and procedures. Staff are expected to declare any interests that could potentially influence their decision-making or create a conflict with their NHS duties. This includes outside employment, financial interests, and personal relationships that could create a conflict.

Key resource: Project team/steering committee members (non-exhaustive)

Who should be in a project team/project steering committee? (non-exhaustive)

Due to the non-promotional nature of collaborative working projects, careful consideration should be given to the industry stakeholder job roles within their company, particularly with regards to sales or promotional roles.

Key resource: Steps to build trust

Trust and transparency is fundamental to any partnership, especially during the early scoping phase. All parties should ensure that they work towards engendering trust, which can be supported through the following steps:

Key resource: Project initiation document (PID)

Once the necessary criteria have been fulfilled, the project team should develop and approve a project initiation document (PID) to ensure a shared understanding of the project’s outcomes, its governance framework and to provide a clear exit strategy that details the overall responsibility of each party if the project needs to be terminated.

The PID is a key document that sets out requirements ahead of project implementation and the agreed copy should be kept on record for both parties’ reference.

Confidentiality of patient information must be maintained in all partnerships, as outlined in the PID. This includes respecting the confidentiality of project-related information and not sharing it beyond the project’s scope. The PID should be collaboratively created by relevant individuals from all partnering organisations.

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 (see implementation section).

The PID must be certified by the industry partner and be approved by both the project team also the relevant governance committee(s) – see page 28 for further details.

Accelerating transformation: Project initiation document template

*Clause 20 of the ABPI Code states that collaborative working, including its implementation, must have and be able to demonstrate the pooling of skills, experience and/or resources from all of the parties involved for the joint development and implementation of patient and/or healthcare centred projects. There must be a shared commitment to successful delivery from all parties, and each party must make a significant contribution.

Establishing a robust governance framework

Stakeholder engagement

Patient engagement

Please note: Any collaborative or joint-working agreements must be entered into with legal, corporate entities and not with any individual member of staff across primary, secondary and system-level settings.

Project delivery and evaluation