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The Branded Health Service Medicines (Costs) Regulations 2018

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Regulations 6, 16 and 26

SCHEDULE 5Penalties

This schedule has no associated Explanatory Memorandum

1.  Subject to paragraph 2, the daily penalty payable by a manufacturer or supplier must be calculated by reference to—

(a)the entry in column (1) of table 1 within which the total value of its net sales income for total supply of all presentations falls;

(b)the amount specified in column (2) opposite that entry in respect of each day of the contravention; and

(c)the amount specified in column (3) opposite that entry in respect of each subsequent day of that contravention.

Table 1

Column (1)

Total values of its net sales income for the total supply of all presentations in most recent complete financial year or if not available, total estimate value of its net sales income for its current financial year

Column (2)

Daily penalty for first 14 days

Column (3)

Daily penalty for subsequent days

Less than £100 million£2,500£5,000
£100 million or more£5,000£10,000

2.  Where the Secretary of State is unable to reasonably determine the net sales income specified in the first column of table 1, the daily penalty payable by a manufacturer or supplier must be calculated by reference to—

(a)the manufacturer or supplier’s Total United Kingdom sales in column (1) of table 2;

(b)the amount specified in column (2) opposite that entry in respect of each day of the contravention; and

(c)the amount specified in column (3) opposite that entry in respect of each subsequent day of that contravention.

Table 2

Column (1)

Total United Kingdom sales

Column (2)

Daily penalty for first 14 days

Column (3)

Daily penalty for subsequent days

Less than £100 million£2,500£5,000
£100 million or more£5,000£10,000

3.  Subject to paragraph 4, for the purposes of table 2, the Total United Kingdom sales will be calculated at the time the penalty becomes payable by reference to the manufacturer’s or supplier’s total sales in the United Kingdom as shown in its statutory audited accounts or where the manufacturer or supplier does not have statutory audited accounts, its individual accounts, for its most recent complete financial year.

4.  For the purposes of table 2, the Total United Kingdom sales of a new manufacturer or supplier will be assumed to be less than £100 million.

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