Health (Pricing and Supply of Medical Goods) Act 2013

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Number 14 of 2013

HEALTH (PRICING AND SUPPLY OF MEDICAL GOODS) ACT 2013

ARRANGEMENT OF SECTIONS

PART 1

Preliminary and General

Section

1. Short title, collective citation and commencement.

2. Interpretation.

3. Laying of regulations.

PART 2

Interchangeable Medicinal Products

Chapter 1

Establishment and maintenance of List of Interchangeable Medicinal Products

4. Establishment, etc. of List of Interchangeable Medicinal Products.

5. Maintenance of List of Interchangeable Medicinal Products.

6. Action to be taken by Board where it makes decision under section 5.

Chapter 2

Duties of pharmacists in relation to prescriptions for interchangeable medicinal products under branded name

7. Scenario 1 — retail pharmacy business has in stock branded product named on prescription and one substitute medicinal product of lower cost.

8. Scenario 2 — retail pharmacy business has in stock branded product named on prescription and 2 or more substitute medicinal products of lower cost.

9. Scenario 3 — retail pharmacy business does not have in stock branded product named on prescription but does have in stock one substitute medicinal product of equal or lower cost.

10. Scenario 4 — retail pharmacy business does not have in stock branded product named on prescription but does have in stock 2 or more substitute medicinal products of equal or lower cost.

Chapter 3

Duties of pharmacists in relation to prescriptions for interchangeable medicinal products under common name

11. Action to be taken by pharmacist when presented with prescription for interchangeable medicinal product under common name.

Chapter 4

Miscellaneous

12. No liability of pharmacist, etc., for substitution.

13. Clinical exemptions to substitution.

14. Community pharmacy contractors who participate in relevant schemes.

15. Pharmacist’s discretion not to dispense is preserved.

PART 3

Dispensing of Medicinal Products under Common Name where they are not Interchangeable Medicinal Products

16. Dispensing of medicinal products under common name where they are not interchangeable medicinal products.

PART 4

Items that may be Supplied to Patients under section 59 of Act of 1970

Chapter 1

Establishment and maintenance of Reimbursement List

17. Establishment, etc. of Reimbursement List.

18. Maintenance of Reimbursement List.

19. Action to be taken by Executive where it makes decision under section 18.

Chapter 2

Executive may attach conditions to supply of listed items

20. Conditional supply of listed items.

Chapter 3

Setting of relevant prices for items and listed items

21. Relevant prices of items and listed items.

22. Action to be taken by Executive where it makes decision under section 21.

Chapter 4

Executive to have discretion to supply non-listed items to certain patients

23. Supply of items not on Reimbursement List.

PART 5

Reference Pricing

24. Reference price for listed items which fall within group of interchangeable medicinal products.

25. Action to be taken by Executive where it makes decisions under section 24.

26. Reference prices and patients, etc. who decline or agree substitution.

PART 6

Miscellaneous

27. Appeals to High Court against relevant decisions of Board or Executive.

28. Power to specify form of documents.

29. Fees.

30. Amendment of section 59 of Act of 1970.

31. Amendment of section 1 of Health (Miscellaneous Provisions) Act 2001.

32. Amendment of Act of 2007.

33. Amendment of Dentists Act 1985.

34. Amendment of section 57 of Medical Practitioners Act 2007.

35. Amendment of section 55 of Nurses and Midwives Act 2011.

36. Amendment of section 3 of Irish Medicines Board Act 1995.

SCHEDULE 1

Procedural Provisions Relating to Certain Decisions of Board or Executive under this Act

PART 1

Decisions of Board under section 5

PART 2

Decisions of Executive under section 18

PART 3

Decisions of Executive under section 21

PART 4

Decisions of Executive under section 24

SCHEDULE 2

Substitution of subsections (2) and (3) of section 18 where section 18 (4) or (5) Applies

SCHEDULE 3

Criteria Applicable to Items and Listed Items for Purposes of Executive Making Relevant Decision under section 18

PART 1

Criteria Applicable to Medicinal Products

PART 2

Criteria Applicable to Medical Devices, Foodstuffs for Particular Nutritional Uses and Dietary Foods for Special Medical Purposes

PART 3

General Criteria

Acts Referred to

Number 14 of 2013

HEALTH (PRICING AND SUPPLY OF MEDICAL GOODS) ACT 2013

AN ACT TO ESTABLISH A LIST OF GROUPS OF INTERCHANGEABLE MEDICINAL PRODUCTS WHICH MAY BE SUBSTITUTED FOR EACH OTHER IN ORDER TO ENABLE SAVINGS TO BE MADE FOR PATIENTS OR THE HEALTH SERVICE EXECUTIVE, OR BOTH, WHERE THE LOWER PRICED MEDICINAL PRODUCTS ARE SUPPLIED, TO ESTABLISH A LIST OF DRUGS, MEDICINES AND MEDICAL AND SURGICAL APPLIANCES WHICH MAY BE SUPPLIED UNDER SECTION 59 OF THE HEALTH ACT 1970, TO ESTABLISH MECHANISMS TO SET THE PRICES OF SUCH DRUGS, MEDICINES AND MEDICAL AND SURGICAL APPLIANCES WHERE THEY ARE SO SUPPLIED, TO RENAME THE IRISH MEDICINES BOARD, TO PROVIDE FOR THE CONSEQUENTIAL AMENDMENT OF OTHER ENACTMENTS; AND FOR RELATED MATTERS.

[28th May, 2013]

BE IT ENACTED BY THE OIREACHTAS AS FOLLOWS: