Patricia Ryan (Kildare South, Sinn Fein)
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209. To ask the Minister for Health how people on medical cards can be charged extortionate amounts of money for generic medicines as they are told the original form is out of stock. [15728/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the community drug schemes.

The 2013 Act permits community pharmacists to dispense generic medicines where a brand name medicine has been prescribed, provided they have been designated as interchangeable by the Health Products Regulatory Authority.

Under the 2013 Act, pharmacists are obliged to offer the lowest cost product on interchangeable list. Reference pricing means a single reimbursement price, or reference price, for a group of interchangeable medicines that are on the reimbursement list. This is the maximum price that the HSE will pay community pharmacies for all medicines in this group, regardless of the individual medicines’ price.

Under the 2013 Act, all marketing authorisation holders must apply to the HSE to add their medicine onto the reimbursement list. If a generic manufacturer chooses not to apply to the HSE, their medicine will not be listed for reimbursement by the HSE under the community drug schemes.

Exempt Medicinal Products (EMPs), which are not licensed by the Health Products Regulatory Authority or European Medicines Agency, may be available on an exceptional basis under Discretionary Hardship Arrangements and the Drugs Payment Scheme (DPS).