Ireland consults on National Biosimilar Medicines Policy

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Ireland’s Department of Health (DoH) has begun a consultation on its biosimilars policy amid criticism from the country’s pharma industry.

Review committee V15a16

Minister for Health, Simon Harris, announced on 10 August 2017 the launch of a public consultation on biosimilars, with the aim of developing Ireland’s first National Biosimilar Medicines Policy. It is hoped that the new policy will increase the use of these more cost-effective medicines in Ireland.

In the consultation document, the DoH asks for feedback on the need for national, statutory or clinical prescribing guidelines for biosimilars in Ireland. It also requests feedback on prescriber-led switching and pharmacy-led substitution of biosimilars. The DoH also asks whether there could be a role for biosimilar quotas in Ireland. Quotas are already used in some other European countries, such as Germany, Italy and Belgium, to increase uptake of biosimilars. The DoH also asks for comments on whether educational programmes are needed and if so for which groups. Finally, it asks whether incentives and/or disincentives, tendering and internal and/or external referencing pricing could be used in Ireland to increase the uptake of biosimilars.

However, trade organization Medicines for Ireland has criticized the Irish Government’s new Medicines Pricing Agreement, saying that the Health Services Executive could lose out on savings of more than Euros 50 million a year on just three widely used drugs. It cites the ‘blocker clause’ as the main obstacle to increased use of biosimilars. This provision in the agreement forces all brand-name biologicals makers to reduce prices by 30% when a biosimilar competitor enters the market. The Healthcare Enterprise Alliance (HEA), which represents producers of generics and biosimilars, has said that the 30% threshold makes it uneconomic for them to compete. Without competition, HEA says that the drugs will remain at their current higher prices for the period of the agreement.

Across the European Union (EU), Ireland has the second worst record of biosimilar use, and Minister Harris has acknowledged that it had been difficult for medical professionals in the country to accept biosimilars [1].

The consultation on the National Biosimilar Medicines Policy will run for six weeks until 22 September 2017. Comments can be submitted to the DoH via email: or by post: Biosimilar Medicines Consultation, Community Pharmacy Policy Unit, Department of Health, Hawkins House, Dublin 2, D02 VW 90, Ireland.

Submissions received for the consultation will be published on the DoH website and may be used to inform the development of the National Biosimilar Medicines Policy in Ireland.

Related article
EU stands by call for Ireland to reduce drug prices

1. GaBI Online - Generics and Biosimilars Initiative. Ireland to publish biosimilars report []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 8]. Available from:

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Source: Irish Government

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