Continued long waits for new medicines in Ireland means Minister Donnelly’s new Working Group must deliver change

• In 2022, it took on average 567 days from EMA authorisation to availability to patients of new innovative medicines in Ireland, among the slowest in western Europe.
• A better process for assessments must go alongside new funding allocated each year by Government.

Friday 28^th April 2023: Ireland is once again one of the slowest countries in Western Europe to reimburse and make available new innovative medicines to patients, according to figures gathered by data analysts IQVIA for EFPIA, the European pharmaceutical industry body.

The survey of 37 European countries, including 27 in the European Union, covers the full four years between 2018 and 2021 analysing 168 innovative medicines authorised for use by the European Medicines Agency (EMA).  Key points this year are:

• While it takes on average 517 days, post EMA authorisation, to make a new medicine routinely available across European countries, in Ireland it takes 567 days.
• This time has lengthened in Ireland since 2020: up almost 100 days from 477 three years ago.  This is despite the welcome allocation of new funds for new medicines by the Government.
• The number of days it takes for new cancer medicines to be made available to patients has increased to 673 post EMA authorisation for Ireland.  This wait of nearly two years is far too long for cancer patients as availability of new medicines is a recognised contributor to Ireland’s improved survival rates in cancer. Many other countries can make these medicines available faster to patients, as quickly as 102 days, while still managing budgets and doing value for money assessments.
• Only six of 37 European countries take longer than Ireland to reimburse orphan medicines for rare diseases, of which 95% do not have a recognised medical treatment.  It currently takes on average 877 days from EMA market authorisation of orphan medicines for them to become available to Irish patients.

The number of days taken depends both on the timing of companies’ applications and the decision-making processes of health authorities.  In Ireland, the figures suggest that between 25% and 30% of the timing is attributable to IPHA member companies’ timing of applications for the reimbursement of a medicine to the HSE after the product has been granted EMA market authorisation.  The bulk of the timing is taken by the State’s assessment and decision-making process, which typically includes price negotiations with companies.

Longer timelines to availability mean a lower standard of care than could be available for Irish patients, and thus poorer patient outcomes than otherwise could be achieved. The experience of other countries demonstrates that improved partnerships between health authorities and pharmaceutical companies are possible and should become a policy priority in Ireland.

IPHA is keen to work with Government and State bodies to improve the process.  We have welcomed the publication by Minister Donnelly of the Mazars Report in February, and we are looking forward to engaging with the Department of Health Working Group, established to reform the reimbursement system and to report back to the Minister within six months.

Oliver O’Connor, Chief Executive of the Irish Pharmaceutical Healthcare Association, said: “Over the past three budgets, the Government has allocated almost €100 million to new medicines. The figures released today show how urgent it is now to improve the reimbursement system so that new medicines are available to patients and their doctors faster.  Process reform has to go alongside new funding.  That’s why we have welcomed the Minister’s new Working Group to build out recommendations from and beyond the Mazars report.  We have welcomed the recommendations on transparency already approved by the Minister and look forward to working on further improvements.

“The lengthening timelines demonstrate that there is a significant job to be done to make innovative medicines available faster to Irish patients.   In particular, there is a serious issue with the timelines in relation to orphan medicines and medicines for cancer care.  We have six months to agree new practical steps and then start implementing.  IPHA member companies are ready to collaborate with all stakeholders through the Working Group to ensure this happens sooner rather than later.”

-ENDS-

Editor’s Note

The above survey is based on newly authorised new active substances for innovative medicines only during the time period outlined. It does not routinely measure extensions of use to existing medicines, nor does it include generics or biosimilar treatments.

The timelines above are inclusive of the following:

• The time industry takes to submit an application to the HSE once EMA approval is received.
• The time taken to conduct pharmacoeconomic assessments in Ireland, including company time responding to questions.
• The time taken for commercial contract negotiations, consideration for the HSE Drugs Group and consideration by the HSE’s Executive Management Team.
• (Where applicable) the time taken to develop prescribing guidelines and Managed Access Protocols by the HSE’s Medicines Management Programme.

Its health importance is underlined in that new treatments made available through the reimbursement system represent improvements in the standard of healthcare being provided to patients.

For media interviews and queries contact:

Eimear O’Leary, IPHA Director of Communications and Advocacy

086 397 1653 | eimearoleary@ipha.ie