Not allowing pharmacists to substitute expensive biological medicines with more cost-effective alternatives is a “missed opportunity” for the State to save hundreds of millions of euros.
The Irish Pharmacy Union has estimated that €370m in potential savings has already been lost since 2017.
It wants Health Minister Stephen Donnelly to change legislation to allow pharmacists to substitute expensive biological medicines with more cost-effective alternatives, called biosimilars.
The union points out that substitution is already working well with generic medicines, with over €1bn in savings made since 2013.
IPU vice-president Eoghan Hanly said allowing pharmacists to substitute biological medicines with biosimilars will ensure a rapid increase in the use of biosimilars.
However, the new biosimilars guide from the Health Products and Regulatory Authority was a “missed opportunity” to let pharmacists substitute biological medicines with biosimilars.
Mr Hanley has described the current situation as a “massive own goal” for the health service.
“The finances of the health service have never been in great shape and the ongoing pandemic will only make that worse,” he warned.
An analysis commissioned for the IPU three years ago identified the hundreds of millions of euro that could be saved but it was “wasted” opportunity.
The Department of Health conducted a public consultation on a national biosimilar medicines policy and the IPU showed how €370m in savings was possible but no action was taken.
“There are no clinically meaningful differences between a biosimilar and reference biological medicine and increased use of biosimilars would result in significant savings,” said Mr Hanly.
“Despite this, uptake has been extremely low in Ireland, with biosimilars representing less than 10% of the market share, which is far below the EU average.”
In 2013, pharmacists began to follow Government policy on the use of generic medicines, increasing their use from 17% to over 40% and saving over €1bn for the State.
The IPU wants Mr Donnelly to amend the Health (Pricing and Supply of Medical Goods) Act 2013 so pharmacists can substitute a biological reference product with a biosimilar.
“Every week that the Government fails to implement this proposal is costing roughly €2m in potential savings foregone,” said Mr Healy.
A biosimilar medicine is highly similar to another biological medicine that already has a marketing authorisation and has been approved for use in patients.
Biosimilars contain a version of the active substance of an already approved medicine.
The European Medicines Agency has acknowledged that there are no clinically meaningful differences between a biosimilar and the reference biological medicine.
The EMA has stated that the evidence acquired over 10 years of clinical experience shows that biosimilars approved through the agency can be used safely and effectively in all their approved indications as other biological medicines.
By the end of this year, an estimated €62bn worth of biological medicines globally are expected to go off-patent, providing significant savings possibilities.