Health (pricing and supply of medical goods) act 2013

• Enactment Date: 28 May 2013
• Act Number: 14

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
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
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:
PART 1 Preliminary and General
	Short title, collective citation and commencement.	1.— (1) This Act may be cited as the Health (Pricing and Supply of Medical Goods) Act 2013.
	(2) The Health Acts 1947 to 2011 and section 30 may be cited together as the Health Acts 1947 to 2013.
	(3) This Act shall come into operation on such day or days as the Minister may appoint by order or orders either generally or with reference to any particular purpose or provision, and different days may be so appointed for different purposes and different provisions.
	Interpretation.	2.— (1) In this Act—
	“Act of 1970” means the Health Act 1970 ;
	“Act of 2007” means the Pharmacy Act 2007 ;
	“authorisation holder”—
	(a) means the holder of a marketing authorisation granted pursuant to Regulation 10(1) of the Medicinal Products (Control of Placing on the Market) Regulations 2007 ( S.I. No. 540 of 2007 ), and
	(b) includes the holder of—
	(i) a product authorisation within the meaning of those Regulations,
	(ii) a parallel import licence within the meaning of those Regulations,
	(iii) an authorisation granted by the Commission of the European Community under—
	(I) Council Regulation (EEC) No. 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, 1 or
	(II) Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency 2 ,
	or
	(iv) an authorisation granted by the Board under Article 126a of Directive 2001/83/EC;
	“Board” means the Irish Medicines Board;
	“brand name”, in relation to a medicinal product, means—
	(a) a medicinal product marketed in the State under a name (not being a common name) which identifies the medicinal product to the extent that no other medicinal product is marketed in the State under that name, or
	(b) a medicinal product marketed in the State under a common name in conjunction with another name (which may be the name of the pharmaceutical company connected with the medicinal product) which identifies the medicinal product to the extent that no other medicinal product is marketed in the State under those names,
	and references in this Act to “branded” shall be construed accordingly;
	“branded product” means a branded interchangeable medicinal product named on a prescription referred to in section 7 (1), 8 (1), 9 (1) or 10 (1);
	“clinical exemption”, in relation to a branded interchangeable medicinal product named on a prescription, means an exemption under section 13 (1), in so far as that prescription is concerned, from the medicinal product being substituted by a substitute medicinal product;
	“common name”, in relation to a medicinal product, includes any of the following:
	(a) the international non-proprietary name of the medicinal product;
	(b) the scientific name of the medicinal product;
	(c) if the medicinal product contains only one active substance, the name of the active substance;
	(d) if the medicinal product contains 2 or more active substances, the names of each of the active substances;
	“community pharmacy contractor” means a pharmacist, company or other body corporate, or partnership, who has entered into an agreement with the Executive to provide community pharmacy services to eligible persons under section 59 of the Act of 1970;
	“deemed application” means an application referred to in section 18 (4) or (5);
	“deemed condition” means a condition which is attached to a deemed listed item by virtue of the operation of section 17 (5) only;
	“deemed listed item” means a listed item which is on the Reimbursement List by virtue of the operation of section 17 (5) only;
	“dietary food for a special medical purpose” means a food—
	(a) specifically processed or formulated, and intended—
	(i) for the dietary management of patients, and
	(ii) to be used under medicinal supervision,

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