Seán Kyne (Galway West, Fine Gael)
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1122. To ask the Minister for Health the progress made to date on the introduction of generic medication; and if there will be an obligation on persons on the long-term illness scheme or with medical cards to accept generic medicines. [46280/13]

Alex White (Dublin South, Labour)
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The Health (Pricing and Supply of Medical Goods) Act 2013, which came into operation on the 24th of June, introduces a system of generic substitution and reference pricing. This legislation will promote price competition among suppliers and ensure that lower prices are paid for these medicines resulting in further savings for both taxpayers and patients.

Under the Act, the Irish Medicines Board (IMB) is responsible for the assessment for interchangeability of medicines. Generic substitution will be introduced incrementally with the IMB prioritising those medicines which will achieve the greatest savings for patients and the State. The Board is in the process of reviewing an initial 20 active substances, which equates to approximately 1,500 individual medicines. They include statins, proton pump inhibitors, angiotensin-converting-enzyme (ACE) inhibitors and angiotensin II receptor blockers.

The first List of Interchangeable Medicines, containing groups of atorvastatin products, was published by the IMB on the 7th August. The second and third lists containing groups of esomeprazole and rosuvastatin products were published on the 20th and 24th September, respectively. The fourth and fifth lists containing groups ofomeprazole and pravastatin products have also been published (on the 11th and 22nd October, respectively).

Once the IMB has assessed the initial 20 priority products, then a further list of priority products will be identified and assessed by the IMB and the process will continue until all medicinal products on the reimbursable list have been assessed.

Once a List of Interchangeable Medicines is published by the IMB a two stage price reduction process gets underway. First, under the terms of the 2012 APMI Agreement, the price of all relevant products fall by 20%, e.g. atorvastatin prices were reduced from 1st September and esomeprazole and rosuvastatin prices were reduced from 1st October. Secondly, the legislation also provides that the HSE may set a reference price for each group of interchangeable products published on the List of Interchangeable Products with a view to introducing further significant price cuts.

Reference pricing involves the setting of a common reimbursement price, or reference price, for a group of interchangeable medicines. It means that one reference price is set for each group or list of interchangeable medicines, and this is the price that the HSE will reimburse to pharmacies for all medicines in the group, regardless of the individual medicine’s prices. The first reference price (for atorvastatin products) was introduced on the 1st of November.

Reference prices are being introduced on a phased basis. The HSE is currently in the process of setting reference prices for esomeprazole products which, it is anticipated, will apply from 1st December 2013.

Under the legislation, a pharmacist shall offer the patient the opportunity to agree to the pharmacist substituting the prescribed product for a substitute product (from within a group of interchangeable products) which is in stock and is the lowest cost to the patient or the State. If the product offered is at or below the reference price then the legislation does not impose any unavoidable costs on the patient. However, if the patient wishes to have the more expensive product, then he/she will be liable for the difference between the reference price and the price of the product.

The IMB will only add a medicine to the List of Interchangeable Medicines if it meets all the qualifying criteria and can be safely substituted for each of the medicines which fall within a group of interchangeable medicines.

Occasionally circumstances may arise where due to an individual patient issue or characteristic that it may not be advisable to switch between different brands of a medicine even if the medicine is included in a group of interchangeable medicines. When this arises a prescriber will be able to indicate on a prescription that substitution should not take place. A pharmacist will then dispense the medicine indicated on the prescription.