This Charter provides a collective and holistic response to address the many Irish patient concerns expressed about levels of transparency, accountability, quality and fairness in the Irish Health Technology Assessment (HTA) and post-HTA process.
It was developed with a cross-section of the IPPOSI patient membership as well as the support of the Medical Research Charities Group (MRCG) and Rare Disease Ireland (RDI).
It is designed to promote patient empowerment through effective partnership between patient communities and the Irish state agencies responsible for medicines assessment & reimbursement.
The process of assessing and reimbursing new medicines in Ireland has come under major scrutiny in recent years. As more and more innovative medicines are developed, many with expensive price tags, the national agencies in Ireland that are responsible for this area (DoH, HSE, NCPE) have struggled to keep apace with their respective duties and responsibilities.

Tasked with making difficult decisions, the HSE is often portrayed as lacking transparency – at times seeming to respond to the most vocal campaigners and political pressure. This is a situation which is far from ideal, as it can lead to inequitable decision-making and the marginalisation of groups which are not in a position to advocate for themselves or do not agree with pressurised lobbying tactics. Patients are concerned by the unfolding situation and firmly believe that their active involvement in the process can lead to more timely and fairer decisions as well as help to manage the expectations of patient communities. Elsewhere, many national agencies (Canada, England, Scotland, Sweden) have encouraged and supported this involvement and are now firmly wedded to progressing patient involvement.

In recent years, Irish patient communities and national agencies have taken a number of important steps in the journey towards effective patient involvement in Health Technology Assessment (HTA) and post-HTA (reimbursement) decision-making. Patients have indicated their willingness to get involved, with many applying to undertake specific training and education to improve their understanding of how medicines are developed, assessed and made available to patients.

National agencies have started to review their policies and processes, with many opting to carve out new and improved spaces for the patient voice. In particular, the NCPE has made notable improvements; including the introduction in 2015 of a template for patient submissions to assessment committees, the employment of a Stakeholder Engagement Lead for Rare Diseases in 2018, the ongoing delivery of a patient education module on health technology assessment (in collaboration with IPPOSI), and a public consultation in late 2018 to fine-tune the patient submission process. NCPE is also transparent with respect to the timelines and status of assessments, and efforts are underway to make information more readily available and to communicate more proactively with patients.

The HSE has been less forthcoming and challenges exist in ensuring patient involvement in decision-making at this level, as patients remain excluded from (and unaware of) the work of the Corporate Pharmaceutical Unit, the Drugs Committee and the Leadership Team. Initial work to involve patients in the area of Rare Diseases has begun within the Rare Disease Technology Review Group.

The challenge now is for all stakeholders to come together to build upon this initial work, to bring all partners into the fold, and to align and manage our different expectations for the future.

Purpose

Our goal is a multi-stakeholder, person-centred medicines assessment and reimbursement process for Ireland. We hope the Charter can contribute positively to the achievement of this vision. Specifically, we hope that the Charter will:

  • provide patients with a basic understanding of their rights and responsibilities
  • summarise – in a coordinated way – the range of patient requests and demands
  • assist national agencies to deliver on their responsibilities to meaningfully include patients
  • serve as a basis for the development of national agencies’ strategies to involve patients & the public
  • be incorporated into the education programmes used to train public sector health officials

With the right political, institutional and community commitment, we believe many of the Charter’s provisions are achievable within the next five years. We acknowledge that some provisions may be ambitious in light of current available resources, but rather than fall at the first hurdle, we ask national agencies and patient communities to work together to call for adequate resources to implement these provisions, and to find creative interim solutions. We believe that success lies in collectively acknowledging that the meaningful involvement of patients in the assessment and reimbursement of medicines in Ireland will improve the decision-making process. Patients, the public and agencies themselves stand to benefit from the resulting social gain.

Disclaimer

‘Conflicts of Interest’

In the interests of impartiality, transparency and accountability, for any of the opportunities outlined within the Charter document, ‘expert advisers representing the patient and carer voice’ should adhere to relevant codes of conduct and practice for declarations of interest. This would include the need for any patient/carer representative to recuse themselves from any involvement on an application for reimbursement in their respective disease/condition area (i.e. patient with a heart condition should not be reviewing an application for a new heart medicine etc.)

The proposal to develop a Charter was initiated by IPPOSI – a patient-led platform between patients, science and industry – which has long explored the role of patients in the medicines assessment and reimbursement process in Ireland. In proposing a Charter, IPPOSI seeks to collate many of the proposals put forward over the last ten years by patient organisations into one comprehensive, coherent and compelling document.

In 2017 and 2018, IPPOSI – in partnership with the MRCG – invited its members to attend three workshops on the topic of access to medicines. Two ‘Drug Iceberg’ reports detailed conclusions from the workshop discussions, and several of the report’s recommendations have informed various provisions contained within the Charter. A Third report is due in Spring 2019.

In 2018, IPPOSI members agreed on an Annual Theme of ‘Access to Medicines’. An 11-member IPPOSI Board Sub-Group from patient, science and industry members and a network of Research & Advocacy Officers from eight lrish patient organisations were established to feed into the Charter development process.

In May 2018, IPPOSI consulted the patient representatives of the EUPATI National Platform in Ireland, and later in the same month, IPPOSI invited three health technology assessment agencies (Canada, Scotland, and Sweden) – identified as leading on the topic of patient involvement – to share their experience with members via a webinar.

In July 2018, IPPOSI invited its patient members to provide their comment and feedback on a first public draft of the Charter and to express their interest in becoming signatories.

In September 2018, two IPPOSI representatives traveled with the NCPE to meet the Scottish Medicines Consortium (SMC) Patient Involvement Team and to observe the consideration of evidence at the SMC Patient and Clinician Engagement (PACE) meeting.

In October and November IPPOSI engaged (separately) members of the HSE Corporate Pharmaceutical Unit (CPU) team and the NCPE on the draft text.

The IPPOSI Board approved the final version of the Charter in December 2018 for publication and dissemination.

This ‘Patient Charter’ was initiated in 2018 to, for the first time in the Republic of Ireland, deliver the patient / service user perspective on what should be expected from the existing process to assess & reimburse new medicines and to guide the development of appropriate patient involvement processes, led by the Dept. of Health, the HSE and the NCPE.

In Q1 2019, IPPOSI will launch an expression of interest among charter signatories with the objective of convening a working group to provide impetus and oversight for timely implementation of the charter recommendations.