Explanatory note

These Regulations, which apply to the United Kingdom, amend the Branded Health Service Medicines (Costs) Regulations 2018 (“the Statutory Scheme Regulations”).

Regulation 2(2) inserts a definition of biological medicinal product and amends the definition of “relevant medicine” so that the payment mechanism, price control, information requirement and enforcement provisions all apply to all biological medicinal products, whether or not the biological medicinal product is a branded medicine.

Regulation 2(3)(b) and (c) insert a table in regulation 3(1) of the Statutory Scheme Regulations. The table sets out the percentage of its nets sales income that the manufacturer or supplier must pay to the Secretary of State for the applicable periods. Regulation 2(4) amends the payment percentage in regulation 4 of the Statutory Scheme Regulations, which applies to deemed net sales income, in a similar way.

Regulation 2(3)(a) and (d) makes clear that where there is an amendment to the payment percentages specified in the table, the amended payment percentage will apply to the sales of presentations supplied under a contract entered into on or after 1st January 2019, including where the manufacturer or supplier enters into a contract with a contracting authority based on a framework agreement on or after 1st January 2019 or enters into a public contract on or after 1st January 2019. However, a manufacturer or supplier that entered into a contract with a contracting authority based on a framework agreement or entered into a public contract on or after 1 April 2018 but before these Regulations came into force will be required to pay 7.80% on the net sales income from products supplied under those contracts throughout the length of those contracts. Before these Regulations came into force, this was the applicable percentage for all net sales income and deemed net sales income.

Regulation 2(5) and (6) update the corresponding information requirements in the Statutory Scheme Regulations, and requires manufacturers and suppliers to provide details of the framework agreements and public contracts, and details of the sales.