The Health (Pricing and Supply of Medicines) Act 2013 provides the statutory basis for the introduction of a system of generic substitution and reference pricing.
Under the legislation, the Health Products Regulatory Authority (HPRA) has statutory responsibility for establishing and maintaining a list of interchangeable medical products. In doing so, the HPRA is required to have regard to a comprehensive set of qualifying conditions, all of which must be complied with before a decision is taken to make a medicinal product interchangeable.
Reference pricing involves the setting of a common reimbursement price, or reference price, for a group of interchangeable products. It means that one reference price is set for each group or list of interchangeable medicines, and this is the price the HSE will reimburse to pharmacists for all medicines in the group, regardless of the individual medicine's prices.
For any medicine that is listed as being interchangeable the legislation provides that a Pharmacist may offer a generic or alternative version of the branded medicine which is set at the reference price. Eligible patients using State drug schemes like the Medical Card or Drugs Payment Scheme will not face any additional costs for products priced at or below the reference price. If a patient would like to receive a particular brand that costs more than the reference price then the patient will have to pay the additional cost of that product.
Section 13 of the Act provides that where a branded interchangeable product is prescribed for a patient and the prescriber is satisfied that the medicinal product, should for clinical reasons, be exempted from substitution, the prescriber shall write 'Do not Substitute' on the prescription. In these cases, the pharmacist must dispense what is written on the prescription, i.e. is not permitted to substitute with any product in the same group of interchangeable products and patients will not face any additional costs if the prescribed product costs more than the reference price.
