The Health (Pricing and Supply of Medicines) Act 2013, which was commenced in June of last year, provides the statutory basis for the introduction of a system of generic substitution and reference pricing. Under the legislation, the Irish Medicines Board (IMB) has statutory responsibility for establishing and maintaining a list of interchangeable medical products. In doing so, the IMB 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. In addition, 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. 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 Health Service Executive (HSE) will reimburse to pharmacists for all medicines in the group, regardless of the individual medicine's prices.
Eligible patients using State drug schemes like the Medical Card or Drugs Payment Scheme will not face any additional costs for products prices 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. In cases where substitution is prohibited for clinical reasons, patients will not face any additional costs if the prescribed product costs more than the reference price. The HSE is responsible for the administration of the primary care schemes, therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.