Health (Pricing and Supply of Medical Goods) Act 2013

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

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

PART 1

Decisions of Board under section 5

1. Subject to paragraph 2, where the Board proposes to make a relevant decision, it shall give notice in writing of the proposal to each person (in this Part referred to as a “relevant person”) it would, if the proposal were implemented, be required under section 6(1) to give notice of the relevant decision.

2. A notice under paragraph 1 shall include—

(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.

3. The Board shall, after considering the relevant representations (if any)—

(a) implement the proposal without modifications,

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

(c) decline to implement the proposal.

4. If the Board, after considering the relevant representations, wishes to propose modifications to the proposal (including any proposal to which this paragraph has previously applied), then this Part shall have effect with respect to the proposal as modified by the Board as it has effect with respect to the proposal before such modification.

PART 2 Decisions of Executive under section 18

PART 2

Decisions of Executive under section 18

Section 19.

1. Subject to paragraph 2, where the Executive proposes to make a relevant decision, it shall give notice in writing of the proposal to the supplier of the item or listed item the subject of the proposal.

2. A notice under paragraph 1 shall include—

(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.

3. The Executive shall, after considering the relevant representations (if any) or after being given a notice referred to in subparagraph (d) of paragraph 2—

(a) implement the proposal without modifications,

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

(c) decline to implement the proposal.

4. If the Executive, after considering the relevant representations, wishes to propose modifications to the proposal (including any proposal to which this paragraph has previously applied), then this Part shall have effect with respect to the proposal as modified by the Executive as it has effect with respect to the proposal before such modification.

PART 3 Decisions of Executive under section 21

PART 3

Decisions of Executive under section 21

Section 22.

1. Subject to paragraph 2, where the Executive proposes to make a relevant decision, it shall give notice in writing of the proposal to the supplier of the listed item the subject of the proposal.

2. A notice under paragraph 2 shall include—

(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.

3. The Executive shall, after considering the relevant representations (if any)—

(a) implement the proposal without modifications,

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

(c) decline to implement the proposal.

4. If the Executive, after considering the relevant representations, wishes to propose modifications to the proposal (including any proposal to which this paragraph previously applied), then this Part shall have effect with respect to the proposal as modified by the Executive as it has effect with respect to the proposal before such modification.

PART 4 Decisions of Executive under section 24

PART 4

Decisions of Executive under section 24

Section 25.

1. Subject to paragraph 2, where the Executive proposes to make a relevant decision, it shall give notice in writing of the proposal to the suppliers of the interchangeable medicinal products which fall within the group of interchangeable medicinal products the subject of the proposal.

2. A notice under paragraph 2 shall include—

(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.

3. The Executive shall, after considering the relevant representations (if any)—

(a) implement the proposal without modifications,

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

(c) decline to implement the proposal.

4. If the Executive, after considering the relevant representations, wishes to propose modifications to the proposal (including any proposal to which this paragraph has previously applied), then this Part shall have effect with respect to the proposal as modified by the Executive as it has effect with respect to the proposal before such modification.

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

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

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

PART 1

Criteria Applicable to Medicinal Products

1. The medicinal product—

(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) must be such that it is ordinarily supplied to the public only on foot of a prescription, and

(e) must have a marketing authorisation referred to in paragraph (a) of the definition of “authorisation holder” in section 2(1).

2. The Executive may disapply the criterion referred to in paragraph 1(b) in the case of a particular medicinal product if it is satisfied that to disapply that criterion in that case is in the interests of—

(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

PART 2

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

1. The medical device, foodstuff for a particular nutritional use or dietary food for a special medical purpose—

(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.

2. The Executive may disapply the criterion referred to in paragraph 1(b) in the case of a particular medical device, foodstuff for a particular nutritional use or dietary food for a special medical purpose if it is satisfied that to disapply that criterion in that case is in the interests of—

(a) patient safety, or

(b) public health.

PART 3 General Criteria

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.