Health (Pricing and Supply of Medical Goods) Act 2013

• (7) Section 59(2) of the Act of 1970 applies to the following expenditure:

• (a) expenditure on a relevant listed item if, and only if, the relevant listed item is priced at or below the reference price;

• (b) expenditure on a relevant listed item which is priced above the reference price if, and only if, the medicinal product is the subject of a clinical exemption; and

• (c) expenditure on a relevant listed item which is priced above the reference price but only up to the reference price.

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

25.— (1) The Executive shall, as soon as is practicable after making a relevant decision (but, in any case, not later than 4 weeks before the relevant decision takes effect), give notice in writing of the relevant decision, together with its reasons for the relevant decision, to the suppliers of the relevant listed items which fall within the relevant group of interchangeable medicinal products the subject of the relevant decision.

• (2) The Executive may, in a relevant decision, specify a date, or the occurrence of an event, from which the relevant decision shall take effect.

• (3) Part 4 of Schedule 1 shall have effect where the Executive proposes to make a relevant decision.

• (4) In this section and Part 4 of Schedule 1 “relevant decision” means a decision of the Executive to set a reference price for a relevant group of interchangeable medicinal products.

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

26.— A patient, to whom a relevant scheme applies and to whom (or to a person acting on the patient’s behalf) an offer referred to in Chapter 2 of Part 2 is made, who—

• (a) either—

• (i) does not agree to the substitution the subject of the offer, or

• (ii) agrees to the substitution the subject of the offer,

and

• (b) is dispensed the branded product or a substitute medicinal product (and notwithstanding that, in the case of an offer which falls within section 9(2) or 10(2), the pharmacist could not have dispensed the branded product),

shall, if the medicinal product so dispensed is a listed item which falls within a group of interchangeable medicinal products for which a reference price has been set and the ingredient cost of the medicinal product is higher than that reference price, be liable to pay under that relevant scheme (by whatever means, taking into account the nature of the relevant scheme and how it operates in relation to that patient) to the retail pharmacy business concerned the difference (or part thereof) between that reference price and that ingredient cost and also pay to that retail pharmacy business any other related cost arising under the relevant scheme.

PART 6 Miscellaneous

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

27.— (1) 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.

• (2) The High Court may, on the hearing of an appeal under subsection (1) by a relevant person—

• (a) do any of the following:

• (i) confirm the relevant decision the subject of the appeal;

• (ii) cancel the relevant decision and replace it with such other decision which the relevant body could have made under this Act and which the Court considers appropriate;

• (iii) remit the matter to the relevant body for further consideration,

• (b) give the relevant body such directions as the Court considers appropriate, and

• (c) direct how the costs of the appeal are to be borne.

• (3) An appeal may not be brought from a decision of the High Court under this section except by its leave.

• (4) An appeal under subsection (1) against a relevant decision shall not suspend the coming into operation of the relevant decision.

• (5) In this section—

“relevant body”, in relation to a relevant decision, means whichever of the Board or the Executive made the relevant decision;

“relevant decision” means a relevant decision within the meaning of section 6(6), 19(8), 22(4) or 25(4);

“relevant notification”, in relation to the notification of a relevant person of a relevant decision, means the giving of a notice under section 6(1), 19 (1), 22(1) or 25(1), as the case requires, to the relevant person of the relevant decision;

“relevant person”, in relation to a relevant decision, means any person who has been notified under section 6(1), 19(1), 22(1) or 25(1), as the case requires, of the relevant decision.

28. Power to specify form of documents.

28.— (1) The relevant body may specify the form of documents required for the purposes of the relevant provisions of this Act as the relevant body thinks fit.

• (2) The relevant body’s power under subsection (1) may be exercised in such a way as to—

• (a) include in the specified form of any document referred to in that subsection a statutory declaration—

• (i) to be made by the person completing the form, and

• (ii) as to whether the particulars contained in the form are true and correct to the best of that person’s knowledge and belief,

and

• (b) specify 2 or more forms of any document referred to in that subsection, whether as alternatives, or to provide for particular circumstances or particular cases, as the relevant body thinks fit.

• (3) The form of a document specified under this section shall be—

• (a) completed in accordance with such directions and instructions as are specified in the document,

• (b) accompanied by such other documents as are specified in the document, and

• (c) if the completed document is required to be provided to—

• (i) the relevant body,

• (ii) another person on behalf of the relevant body, or

• (iii) any other person,

so provided in the manner (if any) specified in the document.

• (4) In this section—

“relevant body” means—

• (a) the Board, or

• (b) the Executive;

“relevant provisions of this Act”, in relation to a relevant body, means—

• (a) the provisions of Part 2 and Part 1 of Schedule 1 where the relevant body is the Board, and

• (b) the provisions of this Act other than the provisions of Part 2 and Part 1 of Schedule 1 where the relevant body is the Executive.

29. Fees.

29.— (1) The Minister for Health may, with the consent of the Minister for Public Expenditure and Reform, prescribe by regulations the fees to be paid to—

• (a) the Board—

• (i) by the authorisation holders of medicinal products, or a class of such authorisation holders, who make applications (or applications which fall within a class of applications) under section 5(1) to the Board requesting the Board to add the medicinal products to a group of interchangeable medicinal products or to add a group of medicinal products to the List of Interchangeable Medicinal Products, and

• (ii) in respect of the reasonable administrative costs of the Board in performing its functions under section 5 in respect of such applications,

or

• (b) the Executive—

• (i) by the suppliers of items, or a class of such suppliers, who make applications (or applications which fall within a class of applications) under section 18(1) to the Executive requesting the Executive to add the items to the Reimbursement List, and

• (ii) in respect of the reasonable administrative costs of the Executive in performing its functions under section 18 in respect of such applications.

• (2) Fees received by the Board or the Executive under regulations made under this section shall be paid into or disposed of for the benefit of the Exchequer in such manner as the Minister for Public Expenditure and Reform may direct.

30. Amendment of section 59 of Act of 1970.

30.— Section 59 of the Act of 1970 is amended—

• (a) in subsection (1)—

• (i) by substituting “Subject to sections 20 and 23 of the Health (Pricing and Supply of Medical Goods) Act 2013, a” for “A”, and

• (ii) by inserting “, for the time being on the Reimbursement List within the meaning of section 2(1) of that Act,” after “surgical appliances”,

• (b) in subsection (2), by inserting “, for the time being on the Reimbursement List within the meaning of section 2(1) of the Health (Pricing and Supply of Medical Goods) Act 2013,” after “expenditure on drugs, medicines and medical and surgical appliances”,

• (c) in subsection (3), by inserting “, for the time being on the Reimbursement List within the meaning of section 2(1) of the Health (Pricing and Supply of Medical Goods) Act 2013,” after “surgical appliances,”, and

• (d) by adding the following after subsection (4):

• “(5) Nothing in this section shall be construed to affect the operation of section 26 of the Health (Pricing and Supply of Medical Goods) Act 2013.”.

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

31.— Section 1(1) of the Health (Miscellaneous Provisions) Act 2001 is amended by deleting paragraph (b).

32. Amendment of Act of 2007.

32.— The Pharmacy Act 2007 is amended—

• (a) in section 7(1) by substituting the following for paragraph (e):

• “(e) to—

  • (i) supervise compliance with this Act and the instruments made under it, and

  • (ii) supervise compliance by pharmacists with Chapters 2 and 3 of Part 2, and Part 3, of the Health (Pricing and Supply of Medical Goods) Act 2013.”,

• (b) in section 18 by inserting the following after subsection (1):

• “(1A) Regulations made under this section may impose duties on—

  • (a) a pharmacy owner,

  • (b) a pharmacist acting in the capacity specified in section 27(b), 28(a) or 29(b), and who is in personal control of the management and administration of the sale and supply of medicinal products, either where such control is exercised in respect of a single retail pharmacy business or in respect of a number of such businesses, or

  • (c) a pharmacist acting in the capacity specified in section 27(c), 28(b) or 29(c), who is in whole-time charge of the carrying on of the retail pharmacy business concerned,

  to supervise, in the retail pharmacy business or retail pharmacy businesses in respect of which he or she is the pharmacy owner or such pharmacist, as the case may be, compliance by pharmacists with Chapters 2 and 3 of Part 2, and Part 3, of the Health (Pricing and Supply of Medical Goods) Act 2013.”,

and

• (c) in section 35(1) by inserting the following after paragraph (e):

• “(ea) a failure to comply with Chapter 2 or 3 of Part 2, or Part 3, of the Health (Pricing and Supply of Medical Goods) Act 2013,

• (eb) a failure to comply with any duties referred to in section 18(1A) imposed on the pharmacist by regulations made under section 18.”,

and

• (d) in section 36(1)—

• (i) in paragraph (a), by deleting “and 2006, or” and substituting “and 2006,”,

• (ii) in paragraph (c)(ii), by deleting “paragraph (b).” and substituting “paragraph (b),” and

• (iii) by inserting the following after paragraph (c):

“or

• (d) the pharmacy owner has failed to comply with any of the duties referred to in section 18(1A) imposed on the pharmacy owner by regulations made under section 18.”.

33. Amendment of Dentists Act 1985.

33.— The Dentists Act 1985 is amended—

• (a) in section 38(1) by substituting the following for paragraphs (a) and (b):

• “(a) his alleged professional misconduct,

• (b) his alleged unfitness to engage in such practice by reason of physical or mental disability, or

• (c) his alleged failure to comply with regulations made under section 13 (2) of the Health (Pricing and Supply of Medical Goods) Act 2013,”,

• (b) in section 38(3) by substituting the following for paragraph (b):

• “(b) the Registrar, or any other person with the leave of the Fitness to Practise Committee, shall present to that Committee the evidence of—

  • (i) the alleged professional misconduct,

  • (ii) the alleged unfitness to practise by reason of physical or mental disability, or

  • (iii) the alleged failure to comply with regulations referred to in subsection (1)(c),

  as the case may be,”,

• (c) in section 38(3)(c) by substituting the following for subparagraph (i) and (ii):

• “(i) the alleged professional misconduct of the registered dentist,

• (ii) the fitness or otherwise of that dentist to engage in the practice of dentistry by reason of his or her alleged physical or mental disability, or

• (iii) the alleged failure to comply with regulations referred to in subsection (1)(c),”,

• (d) in section 38(5) by substituting the following for paragraphs (a) and (b):

• “(a) guilty of professional misconduct,

• (b) unfit to engage in the practice of dentistry because of physical or mental disability, or

• (c) guilty of a failure to comply with regulations referred to in subsection (1)(c),”,

and

• (e) in section 39(1) by substituting the following for paragraph (a):

• “(a) has been found by the Fitness to Practise Committee, on the basis of an inquiry and report under section 38—

  • (i) to be guilty of professional misconduct,

  • (ii) to be unfit to engage in the practice of dentistry because of physical or mental disability, or

  • (iii) to be guilty of a failure to comply with the regulations referred to in section 38(1)(c),

  as the case may be, or”.

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

34.— Section 57(1) of the Medical Practitioners Act 2007 is amended by inserting the following after paragraph (f):

• “(fa) a failure to comply with regulations made under section 13 (2) of the Health (Pricing and Supply of Medical Goods) Act 2013,”.

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

35.— Section 55(1) of the Nurses and Midwives Act 2011 is amended by inserting the following after paragraph (g):

• “(ga) a failure to comply with regulations made under section 13 (2) of the Health (Pricing and Supply of Medical Goods) Act 2013,”.

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

36.— Section 3 of the Irish Medicines Board Act 1995 is amended by inserting the following after subsection (3):

• “(4) The body that, immediately before the commencement of section 36 of the Health (Pricing and Supply of Medical Goods) Act 2013, was known as the Irish Medicines Board shall, from such commencement, cease to be known by that name and instead be known as the Health Products Regulatory Authority.”.

SCHEDULE 1 Procedural Provisions Relating to Certain Decisions of Board or Executive under this Act

Section 6.

PART 1 Decisions of Board under section 5

• (a) a statement of the proposal of the Board,

• (b) a statement setting out the reasons on which the proposal of the Board is based, and

• (c) a statement that each relevant person has the right to make representations in writing (in this Part referred to as “relevant representations”) to the Board with respect to the proposal within a period of 28 days after the relevant person concerned received the notice or such longer period as the Board permits in any particular case.

• (a) implement the proposal without modifications,

• (b) subject to paragraph 4, propose modifications to the proposal, or

• (c) decline to implement the proposal.

PART 2 Decisions of Executive under section 18

Section 19.

• (a) a statement of the proposal of the Executive,

• (b) a statement setting out the reasons on which the proposal of the Executive is based,

• (c) a statement that the supplier of the item or the listed item the subject of the proposal has the right to make representations in writing (in this Part referred to as “relevant representations”) to the Executive with respect to the proposal within a period of 28 days after the supplier received the notice or such longer period as the Executive permits in any particular case, and

• (d) a statement that, if such supplier so wishes, he or she may give the Executive a notice in writing, within the period referred to in subparagraph (c), stating that he or she will not be making any relevant representations.

• (a) implement the proposal without modifications,

• (b) subject to paragraph 4, propose modifications to the proposal, or

• (c) decline to implement the proposal.

PART 3 Decisions of Executive under section 21

Section 22.

• (a) a statement of the proposal of the Executive,

• (b) a statement setting out the reasons on which the proposal of the Executive is based, and

• (c) a statement that the supplier of the item the subject of the proposal has the right to make representations in writing (in this Part referred to as “relevant representations”) to the Executive with respect to the proposal within a period of 28 days after the supplier of the listed item received the notice or such longer period as the Executive permits in any particular case.

• (a) implement the proposal without modifications,

• (b) subject to paragraph 4, propose modifications to the proposal, or

• (c) decline to implement the proposal.

PART 4 Decisions of Executive under section 24

Section 25.

• (a) a statement of the proposal of the Executive,

• (b) a statement setting out the reasons on which the proposal of the Executive is based, and

(c a statement that each supplier of the interchangeable medicinal products which fall within the group of interchangeable medicinal products the subject of the proposal has the right to make representations in writing (in this Part referred to as “relevant representations”) to the Executive with respect to the proposal within a period of 28 days after the supplier concerned received the notice or such longer period as the Executive permits in any particular case.

• (a) implement the proposal without modifications,

• (b) subject to paragraph 4, propose modifications to the proposal, or

• (c) decline to implement the proposal.

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

Section 18.

• (2) Subject to this section and section 19, the Executive shall determine the deemed application by—

• (a) retaining the listed item the subject of the deemed application on the Reimbursement List subject to any conditions attached to such retention in accordance with section 20, or

• (b) removing the listed item the subject of the deemed application from the Reimbursement List.

• (3) Where the Executive is unable to determine a deemed application under subsection (2) because it requires information from the supplier concerned—

• (a) the Executive shall give notice in writing to the supplier specifying the information that it requires from the supplier in order to so determine the application, and

• (b) if the supplier fails to give the information to the Executive within 60 days of being given the notice referred to in paragraph (a), the Executive shall remove the listed item the subject of the deemed application from the Reimbursement List.

SCHEDULE 3 Criteria Applicable to Items and Listed Items for Purposes of Executive Making Relevant Decision under section 18

Section 19.

PART 1 Criteria Applicable to Medicinal Products

• (a) must be suitable for use under the supervision of a general medical practitioner or other relevant health professional and not be restricted to hospital or medical specialist use,

• (b) subject to paragraph 2, must not be advertised or promoted directly to the public,

• (c) must not be for the purpose of obtaining a cosmetic effect,

• (d) F5[subject to paragraph 2,] must be such that it is ordinarily supplied to the public only on foot of a prescription, and

• F6[(e) must have an authorisation referred to in paragraph (a) or (b)(i), (ii), (iii) or (iv) of the definition of ‘authorisation holder’ in section 2(1).]

• (a) patient safety, or

• (b) public health.

PART 2 Criteria Applicable to Medical Devices, Foodstuffs for Particular Nutritional Uses and Dietary Foods for Special Medical Purposes

• (a) must be suitable for use under the supervision of a general medical practitioner or other relevant health professional and not be restricted to hospital or medical specialist use,

• (b) subject to paragraph 2, must not be advertised or promoted to the public, and

• (c) must not be for the purpose of obtaining a cosmetic effect.

• (a) patient safety, or

• (b) public health.

PART 3 General Criteria

The Executive shall have regard to—

• (a) the health needs of the public,

• (b) the cost-effectiveness of meeting health needs by supplying the item concerned rather than providing other health services,

• (c) the availability and suitability of items for supply or reimbursement, or both, under section 59 of the Act of 1970,

• (d) 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,

• (e) the potential or actual budget impact of the item or listed item,

• (f) the clinical need for the item or listed item,

• (g) the appropriate level of clinical supervision required in relation to the item to ensure patient safety,

• (h) 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

• (i) the resources available to the Executive.

Footnotes