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Medicinal Products Reimbursement

Dáil Éireann Debate, Tuesday - 10 October 2017

Tuesday, 10 October 2017

Ceisteanna (436, 437, 438, 439)

Marc MacSharry

Ceist:

436. Deputy Marc MacSharry asked the Minister for Health if a High Court appeal as set out under section 27 of the Health (Pricing and Supply of Medical Goods) Act 2013 is the only mechanism for a pharmaceutical company to seek reimbursement of a medicine in circumstances in which the HSE has decided not to reimburse the medicine; and if he will make a statement on the matter. [42313/17]

Amharc ar fhreagra

Marc MacSharry

Ceist:

437. Deputy Marc MacSharry asked the Minister for Health his plans to establish an independent review mechanism to review appeals by pharmaceutical companies in circumstances in which the HSE has decided not to reimburse their medicinal products; and if he will make a statement on the matter. [42314/17]

Amharc ar fhreagra

Marc MacSharry

Ceist:

438. Deputy Marc MacSharry asked the Minister for Health the difference in approach taken by Irish and other European assessors of a medicine's clinical and cost effectiveness with regard to treatments for rare disease in circumstances in which certain medicines are readily available in over 22 other European countries but have been refused access here; and if he will make a statement on the matter. [42315/17]

Amharc ar fhreagra

Marc MacSharry

Ceist:

439. Deputy Marc MacSharry asked the Minister for Health the role the US Food and Drug Administration, FDA, has in assessing a medicine for reimbursement here under the Health (Pricing and Supply of Medical Goods) Act 2013; if a conflicting position between the FDA and the European Medicines Authority has a material role in assessing such medicines; and if he will make a statement on the matter. [42316/17]

Amharc ar fhreagra

Freagraí scríofa

I propose to take Questions Nos. 436 to 439, inclusive, together.

The assessment process for medicines in Ireland is a statutory process in line with the Health (Pricing and Supply of Medical Goods) Act 2013 ("the 2013 Act"). Other European countries assess treatments in line with the statutory or administrative approaches in place in their individual country and there is no single model in place across Europe.

The 2013 Act, provides, inter alia, for the establishment and maintenance of a publicly accessible list of all medicines which may be reimbursed by the HSE pursuant to the various community drugs schemes.

The process and procedures which apply when the HSE receives an application from a manufacturer to add a medicine to the list are also set out in the 2013 Act. Section 18 of the 2013 Act allows a supplier of an item to apply to the HSE requesting the HSE to add the item to the Reimbursement List. The HSE shall determine the application after consulting such experts (if any) as it thinks fit by adding the item to the Reimbursement List or refusing to add the item, the subject of the application to the Reimbursement List.

Section 19(4) of the 2013 Act prohibits the HSE from making a relevant decision under section 18, "except in accordance with the criteria specified in Schedule 3", that apply to the item the subject of the relevant decision.

Schedule 3 sets out the criteria applicable to items and listed items for the purposes of the HSE making a relevant decision under section 18.

Part 3 of schedule 3 requires the HSE to have regard to the following criteria:

1. the health needs of the public;

2. the cost-effectiveness of meeting health needs by supplying the item concerned rather than providing other health services;

3. the availability and suitability of items for supply or reimbursement;

4. the proposed costs, benefits and risks of the item or listed item relative to therapeutically similar items or listed items provided in other health service settings and the level of certainty in relation to the evidence of those costs, benefits and risks;

5. the potential or actual budget impact of the item or listed item;

6. the clinical need for the item or listed item;

7. the appropriate level of clinical supervision required in relation to the item to ensure patient safety;

8. the efficacy (performance in trial), effectiveness (performance in real situations) and added therapeutic benefit against existing standards of treatment (how much better it treats a condition than existing therapies); and

9. the resources available to the HSE.

Section 27 of the 2013 Act allows that a, "relevant person aggrieved by a relevant decision may, within 30 days from the date on which the relevant person was given the relevant notification, appeal to the High Court against the relevant decision".

In legislating for the establishment and maintenance of a Reimbursement List under the 2013 Act, the Oireachtas did not legislate for an alternative independent review mechanism and I have no plans to amend the 2013 Act to provide for the establishment of one at this time.

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