(LRC Revised)

Number 14 of 2013

HEALTH (PRICING AND SUPPLY OF MEDICAL GOODS) ACT 2013

REVISED

Updated to 1 June 2025

Changes to legislation

as of 10 July 2026, this Act is up to date with all changes known to be in force.

This Revised Act is an administrative consolidation of the

Health (Pricing and Supply of Medical Goods) Act 2013

. It is prepared by the Law Reform Commission in accordance with its function under

the

Law Reform Commission Act 1975

(3/1975) to keep the law under review and to undertake revision and consolidation

of statute law.

All Acts up to and including the

Finance (Provision of Access to Cash Infrastructure) Act 2025

(4/2025), enacted 20 May 2025, and all statutory instruments up to and including

the

Health Insurance (Amendment) and Health (Provision of Menopause Products) Act 2024

(Commencement) Order 2025

(S.I. No. 225 of 2025), made 29 May 2025, were considered in the preparation of this

Revised Act.

Disclaimer: While every care has been taken in the preparation of this Revised Act,

the Law Reform Commission can assume no responsibility for and give no guarantees,

undertakings or warranties concerning the accuracy, completeness or up to date nature

of the information provided and does not accept any liability whatsoever arising from

any errors or omissions. Please notify any errors, omissions and comments by email

to

revisedacts@lawreform.ie.

Number

14

of

2013

HEALTH (PRICING AND SUPPLY OF MEDICAL GOODS) ACT 2013

REVISED

Updated to 1 June 2025

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 s

ection 5

PART 2

Decisions of Executive under s

ection 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

Dentists Act 1985

1985, No. 9

Health (Miscellaneous Provisions) Act 2001

2001, No. 14

Health Act 1970

1970, No. 1

Irish Medicines Board Act 1995

1995, No. 29

Medical Practitioners Act 2007

2007, No. 25

Nurses and Midwives Act 2011

2011, No. 41

Pharmacy Act 2007

2007, No. 20

Number

14

of

2013

HEALTH (PRICING AND SUPPLY OF MEDICAL GOODS) ACT 2013

REVISED

Updated to 1 June 2025

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.

[28

th May

, 2013]

BE IT ENACTED BY THE OIREACHTAS AS FOLLOWS

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 s

ection 5

PART 2

Decisions of Executive under s

ection 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