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Generic Drugs Substitution

Dáil Éireann Debate, Tuesday - 12 November 2013

Tuesday, 12 November 2013

Questions (470)

James Bannon

Question:

470. Deputy James Bannon asked the Minister for Health if his Department has published any drug revisions for the public and medical professionals to clear up the contention that generic drugs are harming patients; and if he will make a statement on the matter. [48177/13]

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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. Under the Act, the Irish Medicines Board (IMB) is responsible for the assessment for interchangeability of medicines. The IMB will review 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 of omeprazole and pravastatin products have also been published (on the 11th and 22nd October, respectively). The IMB will publish subsequent lists for other groups of medicines on an ongoing basis.

Under the legislation, generic substitution is not permitted until the products have been assessed for interchangeability in accordance with the criteria set out in the legislation and the IMB has decided to add the products to the List of Interchangeable Medicines. To further enhance the patient safety aspect of generic substitution, Section 13 of the Bill allows a prescriber to indicate on a prescription that a branded interchangeable medicinal product should, for clinical reasons, not be substituted. Further information on the process for determining interchangeability is available on the IMB's website at www.imb.ie/EN/Human-Medicines/Generic-and-Interchangeable-Medicines.aspx.

It is important to point out that generic medicines must meet exactly the same standards of quality and safety and have the same effect as the originator medicine. All of the generic medicines on the Irish market are required to be properly licensed and meet the requirements of the Irish Medicines Board.

Further information on the safety of generic medicines is available from the IMB website at www.imb.ie/images/uploaded/documents/GenericMedicines.pdf

An information and education campaign, aimed at both health professionals and the public, is continuing. Patient information leaflets are being delivered to all community pharmacies and GP surgeries and further information is available at the following link: www.hse.ie/generics.

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