IPPOSI – the Irish Platform for Patient Organisations, Science & Industry – welcomes the publication today (Friday, Feb 24th, 2023) of the ‘Mazars report’ commissioned by the government in 2019 to examine the governance arrangements around the HSE’s drug assessment and reimbursement process.
The report has been published in full by Minister for Health, Stephen Donnelly, who has announced the establishment of an implementation Working Group which will seek to progress the report recommendations, as well as any further developments since the report was commissioned, to bring about further improvements to the process.
The Minister has also written a letter of determination to the HSE to implement two of the report recommendations – an online tracker of applications going through the process, as well as the introduction of indicative timelines for a medicine to complete the application/approval process.
As the largest network of patient groups and advocates in the country, together with our patient members, we welcome the recommendations to increase the transparency of the process and call on the government for a person-centred approach to medicines assessment and reimbursement in Ireland, starting by co-designing the reform agenda with patients and establishing two-way communication between patients and policy makers.
It is obvious from the report that the government should allocate additional resources to the state mechanisms involved in leading on the assessment and reimbursement of new medicines, including the NCPE and the HSE Drugs Group. However, this needs to be performed according to a National Medicines Strategy to plan for sustainable access to medicines. The government should ensure the timely implementation of changes proposed at the EU level across the health technology assessment process.
What the report does not address, and where a ‘gaping hole’ in the process remains, is the data infrastructure needed to gather evidence to support either the assessment and reimbursement of new medicines or to support the de-authorisation of existing medicines which are shown to under-perform against clinical or patient outcomes. To build a flexible, responsive and innovative process, the government should work with industry and with patient registries (where available) to create a portfolio of ‘deal options’ which can be considered when an application for a new medicine is received.
Also, with Rare Disease Day around the corner on February 28th, the government should design a unique route for rare disease medicines to access the Irish market in a timely way.
Speaking on the publication of the report, Derick Mitchell IPPOSI CEO stated that ‘although long overdue, the publication of this report is an important step in the reform of our medicines access process in Ireland. The report findings are sensible and practical, and need consideration in the Irish context. The fact that many other countries, including our near neighbours in Scotland, have many of these reforms already in place is a cause for concern for many patient groups’, he said.
IPPOSI looks forward to engaging with the new working group in 2023 as part of its consultation with patient groups. Previous IPPOSI work in the area is available at the links below:
- IPPOSI EU consultation response to HTA, Jan 2022
- IPPOSI EU consultation response to the revision of the general pharmaceutical legislation, Dec 2021
- IPPOSI EU consultation response to the revision of the rules on medicines for children and rare diseases, July 2021
- IPPOSI recommendations for the renegotiation of the agreement between IPHA and DoH, May 2021
- IPPOSI Access to Medicine Digital Discussion Report, Sept 2020
- IPPOSI EU consultation response to the pharmaceutical strategy, Sept 2020
- IPPOSI Charter for Patient Involvement in Medicines Assessment and Reimbursement, Feb 2019
- IPPOSI consultation response to the NCPE patient submission template, May 2018
- Drug Iceberg Report 2.0, Feb 2018
- Drug Iceberg Report 1.0, Aug 2017
The Mazars report, as well as the governments implementation approach, is available at the links below:
Ministerial Press Release: