Health (Pricing and Supply of Medical Goods) Act 2013

SCHEDULE 1

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

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

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

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

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.