These Regulations relate principally to the circumstances where, for the supply of a health service medicine, a manufacturer or supplier charges in excess of the limit specified in a direction given under section 262(1)(a) of the National Health Service Act 2006 (“NHS Act 2006”).
Regulation 2 provides that in these circumstances the manufacturer or supplier is liable to pay, on demand, a daily penalty to the Secretary of State – and the Schedule contains provisions relating to the calculation of that daily penalty.
Regulation 3 makes provision for the Secretary of State to make a demand for payment by way of issuing a notice to the manufacturer or supplier.
Regulation 4 provides the manufacturer or supplier that has been issued with a penalty notice with a right of appeal, and ensures that the period during which an appeal is ongoing is discounted for the purposes of calculating daily penalties.
Regulation 5 amends the Appeals Regulations by removing the reference to the Council of Tribunals which has been abolished.
Regulation 6 requires the Secretary of State to review the operation and effect of these Regulations and publish a report setting out the conclusions of that review a year after the commencement of these Regulations and annually after that.