Health (Pricing and Supply of Medical Goods) Act 2013


Number 14 of 2013


HEALTH (PRICING AND SUPPLY OF MEDICAL GOODS) ACT 2013

REVISED

Updated to 16 February 2017


This Revised Act is an administrative consolidation of Health (Pricing and Supply of Medical Goods) Act 2013. It is prepared by the Law Reform Commission in accordance with its function under 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 Health (Miscellaneous Provisions) Act 2017 (1/2017), enacted 16 February 2017, and all statutory instruments up to and including Civil Legal Aid (International Protection Appeals Tribunal) Order 2017 (S.I. No. 81 of 2017), made 15 February 2017, 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 16 February 2017


Introduction

This Revised Act presents the text of the Act as it has been amended since enactment, and preserves the format in which it was passed.

Related legislation

Health Acts 1947 to 2015 : this Act is one of a group of Acts included in this collective citation, to be construed together as one ( Health (General Practitioner Service) Act 2015 (19/2015), s. 4(2)). The Acts in this group are:

Health Act 1947 (28/1947)

Health Act 1953 (26/1953)

Health (Fluoridation of Water Supplies) Act 1960 (46/1960)

Health Act 1970 (1/1970)

Misuse of Drugs Act 1977 (12/1977), s. 36 and s. 42 (in so far as it amends the Health Acts 1947 to 1970)

Health (Family Planning) Act 1979 (20/1979)

Health (Amendment) Act 1986 (10/1986)

Health (Amendment) Act 1987 (3/1987)

Health (Nursing Homes) Act 1990 (23/1990)

Health (Amendment) Act 1991 (15/1991), other than s. 8

Health (Amendment) Act 1994 (11/1994)

Health (Amendment) Act 1996 (15/1996)

Health (Amendment) (No. 2) Act 1996 (23/1996)

Health (Amendment) (No. 3) Act 1996 (32/1996), other than ss. 21 and 22

Health (Provision of Information) Act 1997 (9/1997)

Health (Eastern Regional Health Authority) Act 1999 (13/1999)

Health (Miscellaneous Provisions) Act 2001 (14/2001), except in so far as it relates to the Tobacco (Health Promotion and Protection) Act 1988

Health Act 2004 (42/2004)

Health (Amendment) Act 2005 (3/2005), in so far as it amends the Health Acts 1947 to 2004

Irish Medicines Board (Miscellaneous Provisions) Act 2006 (3/2006), Part 5

Health (Repayment Scheme) Act 2006 (17/2006)

Hepatitis C Compensation Tribunal (Amendment) Act 2006 (22/2006), s. 6

Health (Nursing Homes) (Amendment) Act 2007 (1/2007)

Health Act 2007 (23/2007)

Medical Practitioners Act 2007 (25/2007), s. 57(9)

Health Act 2008 (21/2008)

Health (Miscellaneous Provisions) Act 2009 (25/2009), s. 64

Health (Amendment) Act 2010 (15/2010)

Health (Amendment) (No. 2) Act 2010 (20/2010)

Child Care (Amendment) Act 2011 (19/2011), ss. 35 and 36

Health (Alteration of Criteria for Eligibility) Act 2013 (10/2013)

Health (Pricing and Supply of Medical Goods) Act 2013 (14/2013), s. 30

Health Service Executive (Governance) Act 2013 (23/2013)

Health (Alteration of Criteria for Eligibility) (No. 2) Act 2013 (42/2013)

Local Government Reform Act 2014 (1/2014), s.1(14) and s. 5(6) and sch. 2 part 6 (in so far as they amend the Health (Fluoridation of Water Supplies) Act 1960))

Health Service Executive (Financial Matters) Act 2014 (17/2014)

Health (General Practitioner Service) Act 2014 (28/2014)

Health (General Practitioner Service) Act 2015 (19/2015)

Acts previously included in the group but now repealed are:

Health Act 1954 (23/1954)

Health and Mental Treatment Act 1957 (16/1957), s. 1

Health and Mental Treatment (Amendment) Act 1958 (37/1958), s.1

Health (Homes For Incapacitated Persons) Act 1964 (8/1964)

Health and Mental Treatment (Amendment) Act 1966 (2/1966), s. 1

Health (Mental Services) Act 1981 (17/1981)

Health (Family Planning) (Amendment) Act 1985 (4/1985)

Health (Amendment) Act 2004 (19/2004)

Annotations

This Revised Act is annotated and includes textual and non-textual amendments, statutory instruments made pursuant to the Act and previous affecting provisions.

An explanation of how to read annotations is available at

www.lawreform.ie/annotations.

Material not updated in this revision

Where other legislation is amended by this Act, those amendments may have been superseded by other amendments in other legislation, or the amended legislation may have been repealed or revoked. This information is not represented in this revision but will be reflected in a revision of the amended legislation if one is available.

Where legislation or a fragment of legislation is referred to in annotations, changes to this legislation or fragment may not be reflected in this revision but will be reflected in a revision of the legislation referred to if one is available.

A list of legislative changes to any Act, and to statutory instruments from 1996, may be found linked from the page of the Act or statutory instrument at

www.irishstatutebook.ie.

Acts which affect or previously affected this revision

Health (Miscellaneous Provisions) Act 2017 (1/2017)

All Acts up to and including Health (Miscellaneous Provisions) Act 2017 (1/2017), enacted 16 February 2017, were considered in the preparation of this revision.

Statutory instruments which affect or previously affected this revision

Health (Reimbursement List) (Application Fees) Regulations 2016 (S.I. No. 576 of 2016)

Health Products Regulatory Authority (Fees) Regulations 2014 (S.I. No. 607 of 2014)

Health (Pricing and Supply of Medical Goods) Act 2013 (Commencement) Order 2014 (S.I. No. 205 of 2014)

Health (Pricing and Supply of Medical Goods) Act 2013 (Commencement) Order 2013 (S.I. No. 202 of 2013)

All statutory instruments up to and including Civil Legal Aid (International Protection Appeals Tribunal) Order 2017 (S.I. No. 81 of 2017), made 15 February 2017, were considered in the preparation of this revision.


Number 14 of 2013


HEALTH (PRICING AND SUPPLY OF MEDICAL GOODS) ACT 2013

REVISED

Updated to 16 February 2017


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



Number 14 of 2013


HEALTH (PRICING AND SUPPLY OF MEDICAL GOODS) ACT 2013

REVISED

Updated to 16 February 2017


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: