The Health (Pricing and Supply of Medical Goods) Bill 2012 has been published and will be introduced in the Seanad on July 19.
The Bill provides for the introduction of a system of generic substitution and reference pricing. The main objectives of this Bill are to promote competition between suppliers of interchangeable medicines and to ensure value for money in the supply of medicines and other prescribed items to patients under Section 59 of the Health Act 1970.
Under the current system, when a specific brand of medicine is prescribed for a patient, a pharmacist can only supply that particular brand. The Bill permits pharmacists to substitute medicines which have been designated as interchangeable by the Irish Medicines Board.
A generic medicine is a medicine that is similar to an original, brand named medicine. It has the same active substances as the original medicine and is made to the same standard to make sure it is safe and effective. A generic medicine must meet exactly the same standards of quality and safety and have the same effect as the original medicine. Substitution will only be allowed where it is safe to do so.
Reference pricing involves the setting of a common reimbursement price, or reference price, for a group of interchangeable medicines. Eligible patients 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. 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 Bill also sets out statutory procedures governing the supply, reimbursement and pricing of medicines and other items to patients under the GMS and community drugs schemes. The Bill will allow the HSE to attach conditions to the supply of certain items, provided that any restrictions are evidence-based and in the interests of patients and ensuring value for money.