Press Release

Plans to increase access to cost-effective biosimilar medicines move forward with opening of public consultation – Minister Harris

Ireland’s first National Biosimilar Medicines Policy aims to deliver more for patients and taxpayers

Minister for Health, Simon Harris, TD, today announced the opening of a public consultation on biosimilar medicines. The consultation will inform the development of Ireland’s first National Biosimilar Medicines Policy, with the aim of increasing the use of these more cost-effective medicines in Ireland.

Speaking today, Minister Harris said, “It is vital that we ensure patients have access to a sustainable supply of safe and effective medicines. Ireland can capitalise on the new biosimilar medicines being brought to market and deliver more for patients and taxpayers. At a time when we are trying to balance access to new medicines with affordability, it is critical that we have policies in place to increase the use of cheaper, equally effective biosimilars as one part of the solution.

“I set the development of a new National Biosimilar Medicines Policy as a priority in 2017 and I am delighted to now be moving forward with this consultation process. I very much welcome engagement from all stakeholders, including patients, healthcare professionals, suppliers and regulatory bodies.

“An evidence-based National Biosimilar Medicines Policy will provide clarity and certainty to the health service, industry and patients on the use of biosimilars and will ensure that Government remains focused on its commitment to deliver greater value for our pharmaceutical spend.”

The consultation paper is available online at and the closing date for submissions is 22 September 2017.


Notes to Editors

A biological medicine is made from living organisms, such as bacteria or yeast.

A biosimilar is a biological medicine that is highly similar to an approved biological medicine (the reference medicine). Biosimilars can only be authorised for use once the patent for the reference medicine has expired. They have no clinically meaningful differences from the reference medicine. However, as for generic medicines, they are typically less expensive to bring to market than the reference medicine, due to lower research and development costs.

As a result of the lower costs and competition for market share, they are generally priced at a significant discount to the reference medicine. The European Medicines Agency (EMA) states that ‘Biosimilar competition can offer advantages to EU healthcare systems, as it is expected to improve patients’ access to safe and effective biological medicines with proven quality’.

The public consultation will take place over an six-week period ending 22 September.

Submissions can be made by downloading the consultation paper and responding via or by post to the Department; or by requesting a copy of the consultation paper from the Department and returning it by post.