ABPI response to charity joint statement on the Voluntary Scheme

The ABPI welcomes this Joint Statement and shares patient charities’ ambition for a new Voluntary Scheme that sees ‘people and communities benefit from new treatments, the NHS able to make the best use of its budget, and the UK [as] an attractive location for global life sciences research investment’.

The ABPI has been clear in its report ‘At the Crossroads: How a new deal can deliver for patients, the NHS and the economy’ that industry believes the current approach has failed.

Our vision is for a new, more ambitious Voluntary Scheme which:

1. Delivers a sustainable approach to medicines provision
2. Maximises the potential of the UK life sciences industry as an engine for growth
3. Ensures rapid patient access and adoption of new medicines in partnership with a dynamic, independent post-Brexit regulatory system with MHRA and NICE
4. Improves health outcomes and productivity for the whole country, including through equitable adoption and uptake of future healthcare innovation

We look forward to working with patient groups and the government to achieve this.

ABPI's Response to patient charities' six key tests

The ABPI acknowledges the six key tests that have been set out in the Charity Joint Statement and share our response to each below:

1. Focus on people and their needs at all stages of negotiation and design of the new scheme, based on meaningful engagement with communities.

The ABPI has consistently supported and advocated for the principle of wide and meaningful consultation with stakeholders, including patient organisations, on the development of a new Voluntary Scheme. We have written to the Department of Health and Social Care to support patient groups being involved in Chapter 3 discussions focusing on access, uptake and outcomes, while maintaining the confidentiality of the negotiations.

2. Ensure faster and equitable access to new, innovative, and effective medicines.

This must be a central objective for any new Voluntary Scheme, as we argue in our report referenced above. To help achieve this objective, Chapter 3 of the current Scheme will need to be updated. The ABPI has also proposed that, subject to a commercially competitive rate being agreed, the industry could additionally fund a ‘Medicines Equity Partnership’. The partnership could be used to provide additional financial support to local systems to address the drivers of variable uptake, with healthcare systems able to apply for funding directly. We would welcome feedback on this proposal.

The Joint Statement additionally calls for:

• A roadmap for the future of NICE, setting out how it will work with organisations to implement improvements. The ABPI is also seeking clarity on this with NICE and we are aware that a framework is in development that will set out how NICE will manage modular updates to the Manual for Health Technology Evaluation.
• A new system for assessing medicines that fall in the gap between standard and highly specialised technology appraisals. After the NICE Methods Review, the ABPI was clear that challenges remained for rare disease medicines which do not meet the HST entry criteria nor will benefit from the new severity modifier. Monitoring the impact of the changes NICE has made and continuing to explore further evolution of NICE’s methods is a high priority for us.

3. Ensure transparency in how decisions around medicines access are made.

The ABPI is already conducting work on this issue outside of the scope of the Voluntary Scheme negotiations and is keen to discuss these issues in more detail with patient organisations.

4. Enable innovations in how drugs are priced to deliver value for the health system and for people.

The Joint Statement has asked that the next Voluntary Scheme supports the NHS to make use of more innovative approaches to pricing. The ABPI strongly supports this proposal, and there is an opportunity to consider how this can best be taken forwards. We would welcome further patient group engagement on this as part of the negotiation workshops.

5. Support action to enhance NHS data collection to make the best use of medicines.

The Joint Statement calls for the new Voluntary Scheme to ensure NHS, NICE, MHRA and industry align their data requirements and data collection. The ABPI endorses this recommendation. Truly realising the potential of NHS data to identify unmet clinical need, support MHRA and NICE requirements and understand the safety, effectiveness and outcomes of new medicines once they are in use, necessitates a coordinated approach. We are working with system partners to ensure greater understanding of needs, what is feasible to deliver and learnings from best practice.    

In addition, we have set out proposals in ‘At the Crossroads’ for an industry-funded investment facility. The investment facility, which seeks to benefit patients and the NHS through enhanced clinical research capability and more equitable medicines access, could be used to increase opportunities for patients to participate in clinical trials by establishing a UK real-world data recruitment service.

6. Facilitate a joined-up approach to medicines which brings together relevant stakeholders around a single strategy for improving medicines access

The Joint Statement calls for a government-led review of the current strengths and weaknesses in how medicines are approved and funded in the UK, as well as the establishment of a new multi-agency approach.

The ABPI agrees with the need for a streamlined system of medicines regulation, access and approval. The ABPI also supports the call for a formal review to reflect on changes that have been made to the UK’s processes for medicines regulation, reimbursement and uptake within the NHS. Only with an eco-system that is joined up and supporting patients and the healthcare system can we meet the ambitions of the Life Sciences Vision and NHS’s priorities.