Written answers

Tuesday, 20 April 2010

Department of Health and Children

Generic Drugs

9:00 pm

Photo of Jan O'SullivanJan O'Sullivan (Limerick East, Labour)
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Question 229: To ask the Minister for Health and Children if she will exclude certain drugs from the reference pricing and generic substitution scheme when there is evidence that the generic does not have similar outcomes, including the proposed substitution of alendronate for the branded drugs Fosamax and Actonel, about which research is available on the website of the Irish Osteoporosis Society. [15910/10]

Photo of Seán Ó FearghaílSeán Ó Fearghaíl (Kildare South, Fianna Fail)
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Question 285: To ask the Minister for Health and Children her views on correspondence (details supplied); and if she will make a statement on the matter. [14855/10]

Photo of Richard BrutonRichard Bruton (Dublin North Central, Fine Gael)
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Question 306: To ask the Minister for Health and Children if her attention has been drawn to concerns that independent research (details supplied) suggests that patients with osteoporosis experience 50% less improvement in the DXA bone density scan when taking generic alendronate than on branded Fosamax; if this will be taken into account in deciding whether pharmacists can switch from prescribed branded products to generic equivalents under her Departments Generic Substitute initiative. [15022/10]

Photo of Deirdre CluneDeirdre Clune (Cork South Central, Fine Gael)
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Question 316: To ask the Minister for Health and Children if her attention has been drawn to the concerns of the Irish Osteoporosis Society that generic alternative drugs used to treat osteoporosis are not as effective as prescription drugs; if she will consider excluding osteoporosis drugs from the proposed reference pricing and generic substitution drugs programme; and if she will make a statement on the matter. [15049/10]

Photo of Finian McGrathFinian McGrath (Dublin North Central, Independent)
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Question 407: To ask the Minister for Health and Children if she will support a matter (details supplied). [15524/10]

Photo of Mary HarneyMary Harney (Dublin Mid West, Independent)
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I propose to take Questions Nos. 229, 285, 306, 316 and 407 together.

I have decided to introduce a system of reference pricing combined with generic substitution under the GMS and community drugs schemes. This will promote price competition and deliver ongoing savings for both the State and for patients.

A working group, made up of officials and healthcare professionals from my Department and the HSE, is setting out proposed steps for implementing this initiative. I expect to see significant progress on this in 2010, including the identification of legislative and administrative changes required to give it effect in 2011.

There are currently 12 products containing the active ingredient alendronic acid reimbursed under the GMS and community drugs schemes. All of these products have received marketing authorisation from the Irish Medicines Board. All medicinal products (whether originator or generic) authorised for placing on the Irish market are subject to the same requirements of quality, safety and efficacy.

There are some categories of medicines that are not suitable for substitution. In addition, there are also certain circumstances where an individual patient should receive a particular product. With a system of generic substitution it is important that all decisions about the interchangeability of medicines are evidence-based and take into account best practice elsewhere. It is envisaged that an expert group would provide guidance on this matter.

The joint Department/HSE working group has consulted with a wide range of stakeholders over the past number of months. The Irish Osteoporosis Society has brought to the group's attention research in relation to alendronic acid. This will be taken into account when the list of interchangeable medicines is being drawn up.

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