Sandra McLellan
Question:30. Deputy Sandra McLellan asked the Minister for Health the timeframe for the full roll-out of reference pricing and generic substitution; and if he will make a statement on the matter. [40048/13]
View answerThursday, 26 September 2013
Questions (30)
Written answers
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 20th and 24th September respectively. It is expected that the initial list of 20 priority products will have been assessed by the IMB by June 2014. At this point 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. 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. It is expected that the first reference price for atorvastatin products will be implemented by November and, subsequently, reference prices for esomeprazole and rosuvastatin products will be implemented by the HSE in accordance with the timelines set out in the legislation. Reference prices will ensure that generic prices in Ireland will fall towards European norms.