Government ignoring potential €800 million savings in health budget

  • IPU again highlights savings if pharmacists allowed to substitute biological medicines for biosimilars
  • €2 million lost a week in potential savings

6 July 2018: The Irish Pharmacy Union (IPU) has called on the Government to allow pharmacists to substitute biological medicines for biosimilars, to help plug overspending at the Department of Health.  It has emerged recently that health overspending will delay a budget surplus and could eat into the potential for tax cuts. Pharmacists have clearly demonstrated that savings are available if steps are taken to address soaring spending on biological medicines but, despite concrete proposals being submitted in September 2017 by the IPU, no action has been taken.

IPU Secretary General Darragh O’Loughlin says failure to implement this proposal is costing €2 million in potential savings every week: “If the Government had heeded IPU advice when we submitted the proposal last September, approximately €80 million could have been saved to date. The IPU is presenting solutions to budget problems, but Government continues to ignore potential savings.”

“Substituting expensive biological medicines with more cost-effective biosimilars would require a legislative change, but could save the Exchequer up to €800 million over 5 years,” said Mr. O’Loughlin, who added “This is the fastest and most effective way to ensure a rapid and meaningful increase in the use of biosimilars”.

Mr. O’Loughlin continued:

“In the absence of specific steps being taken to improve biologic uptake, HSE spending on biologics is expected to reach €900 million by 2020. If this amendment is made, there are potential savings of €370 million over the next 3 years, and up to €800 million over 5 years. In 2017 the Department of Health held a public consultation on a National Biosimilar Medicines Policy, and the IPU made these proposals in our submission in September 2017.”

In 2013 pharmacists began facilitating Government policy on the use of generic medication. Consequently, the use of generic medicines in Ireland increased fivefold, saving the State over €667 million by the end of 2017. As the experience of generic substitution demonstrated, allowing community pharmacists to substitute is the fastest and most effective way to ensure a rapid and meaningful increase in the usage of biosimilars.

“The time to act on this is now, and we’re calling on Minister Harris to amend the Health (Pricing and Supply of Medical Goods) Act 2013 and allow pharmacists to substitute biological medicines with more cost-effective biosimilars”, concluded Mr O’Loughlin.


Further information: Siobhán Kane, IPU Press and Communications Manager, 087 775 1510


Are biosimilars as effective?

The European Medicines Agency (EMA) has acknowledged that there are no clinically meaningful differences between a biosimilar and the reference biological medicine and has stated that the evidence acquired over 10 years of clinical experience shows that biosimilars approved through the EMA can be used as safely and effectively in all their approved indications as other biological medicines. Consequently, there should be no concerns about the safety or efficacy of biosimilars and their increased use should be encouraged.

See European Medicines Agency, Biosimilars in the EU: Information Guide for Healthcare Professionals, 2017 at http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf).

What are the potential savings from biosimilars?

Applied Strategic, a UK consultancy firm with expertise in biosimilar markets, conducted an assessment of the savings opportunity presented by biosimilars in the Irish health system. Using published PCRS data, they concluded that, in the absence of specific steps being taken to improve biosimilar uptake, spending on biologics can be expected to reach €900 million in 2020. Even though biosimilars can provide more cost effective treatment, thus broadening patient access to treatment for a given budget, uptake has been historically low in Ireland, with biosimilars representing less than 10% market share, which is significantly lower than the EU average. Applied Strategic’s assessment of the Irish biologics and biosimilar market identified a potential saving of €370 million over the next 3 years, and up to €800 million over 5 years, with optimum biosimilar entry and penetration.

€62 billion worth of biological medicines are expected to go off patent by 2020 globally, providing significant savings possibilities, and there is already a potential three year saving of €370 million for the Irish health system – none of which will be realised if biosimilar usage in Ireland is not brought to European norms. See Medicines for Ireland Policy Manifesto 2017 at https://www.medicinesforireland.ie/wp-content/uploads/2017/07/Medicines-for-Ireland-Manifesto.pdf)

What legislation governs substituting medicines?

The Health (Pricing and Supply of Medical Goods) Act 2013 lays out the rules and regulations for generic substitution of medicinal products, identified as interchangeable by the Health Products Regulatory Authority (HPRA). Pharmacists have demonstrated that they have the competence and capability to implement this legislation, resulting in a significant increase in the usage of generic medicines in Ireland, from 11% by volume pre-2013 to 53% by 2016.

An amendment to this primary legislation is required to facilitate substitution by a pharmacist from a biological reference product to a biosimilar.

How will it work?

The HPRA does not recommend that patients switch back and forth between a biosimilar and a biological reference medicine. In the IPU’s proposal, a pharmacist, on receiving the initial high tech prescription for a patient, will make the decision to dispense and supply a biosimilar or the biological reference medicine. A note of this will be made in the patient’s medication record (PMR) and, because the patient nominates a single specific pharmacy for their high tech medicine, subsequent supplies will be for the same product and no further switching will occur.