11.—(1) A manufacturer or supplier intending to make an application for a price increase under this regulation must record and keep for a period of six years the information required for such an application under this regulation.
(2) Subject to paragraph (3), the Secretary of State must within a period of 90 days, following an application made under paragraphs (4) to (6), confirm or increase the maximum price of a presentation by direction to that manufacturer or supplier.
(3) Where the number of applications received by the Secretary of State under this regulation makes it impracticable for the Secretary of State to confirm or increase the maximum price, the Secretary of State may extend that period for a further 60 days and must notify the manufacturer or supplier if this is the case within the 90 day period.
(4) A request by a manufacturer or supplier to the Secretary of State for an increase of the maximum price of a presentation must be made in writing and must—
(a)specify the presentation in respect of which the request is made;
(b)state the reasons for the request;
(c)specify the proposed increased maximum price; and
(d)include any relevant information relating to the factors set out under paragraphs (7)(a) to (e), (f)(i), (f)(ii), (g)(i), (g)(ii) and (h).
(5) Within 28 days of receiving the information set out at paragraph (4), the Secretary of State must give the manufacturer or supplier an information notice specifying the information required in relation to any of the relevant factors set out under paragraph (7)(f)(iii), (f)(iv), (g)(iii) and (g)(iv).
(6) Where further information relating to factors listed at paragraph (7) is required, the Secretary of State must within 28 days of receiving the information under paragraph (5) notify, and where appropriate, by giving an information notice, the manufacturer or supplier that further information is required.
(7) In determining whether to increase the maximum price for a presentation under this regulation, the Secretary of State may have regard to, amongst other factors, the following factors—
(a)the clinical need for the presentation at the time that the application under paragraph (4) is received by the Secretary of State and during the period that the application is being considered by the Secretary of State;
(b)the price and associated operational costs of therapeutically equivalent or comparable medicines to that presentation at the time that the application under paragraph (4) is received by the Secretary of State and during the period that the application is being considered by the Secretary of State;
(c)the price and associated operational costs of the presentation in the European Economic Area and any other markets if it is available elsewhere in the world at the time that the application under paragraph (4) is received by the Secretary of State and during the period that the application is being considered by the Secretary of State;
(d)the date on which the patent protection period for each indication of the presentation expires;
(e)the total profit of the manufacturer or supplier before interest charges and taxes for their previous accounting reference period as set out in the manufacturer’s or supplier’s individual accounts;
(f)in respect of the presentation—
(i)for the latest complete financial year, or where the application is made by a new manufacturer or supplier, up to the latest complete month in the current financial year, the total quantity of items supplied and the total net sales income,
(ii)for the three financial years which follow the most recent one referred to in sub-paragraph (f)(i), estimates of the total quantity to be supplied and the total net sales income,
(iii)the reasonableness of the estimated costs for the latest complete financial year, or where the application is made by a new manufacturer or supplier, the reasonableness of the estimated costs up to the latest complete month in the current financial year, including—
(aa)manufacturing and supply costs,
(bb)research and development costs,
(cc)operational costs, and
(dd)any other costs,
(iv)the reasonableness of the estimated costs over the period of the first three financial years which follow the most recent one referred to in sub-paragraph (f)(iii), or where the patent protection period expires before the end of the three financial years, the period until the date of the expiration of the patent protection period from the first financial year following the most recent one referred to in subparagraph (f)(iii), including—
(aa)manufacturing and supply costs,
(bb)research and development costs,
(cc)operational costs, and
(dd)any other costs;
(g)in respect of all of the manufacturer’s or supplier’s presentations—
(i)for the latest complete financial year, or where the application is made by a new manufacturer or supplier, until the end of the latest complete month in the current financial year, the total quantity of items supplied and the total net sales income,
(ii)for the first three financial years which follow the most recent one referred to in sub-paragraph (g)(i), estimates of the total quantity of items to be supplied and the total net sales income,
(iii)the reasonableness of the estimated costs for the latest complete financial year, or where the application is made by a new manufacturer or supplier, the reasonableness of the estimated costs up to the latest complete month in the current financial year, including—
(aa)manufacturing and supply costs,
(bb)research and development costs,
(cc)operational costs, and
(dd)any other costs,
(iv)the reasonableness of the estimated costs over the period of the first three financial years which follow the most recent one referred to in sub-paragraph (g)(iii), or where the patent protection period of the presentation with respect to the presentation that the application is made under this regulation expires before the end of the three financial years, the period until the date of the expiration of the patent protection period from the first financial year following the most recent one referred to in paragraph (g)(iii), including—
(aa)manufacturing and supply costs,
(bb)research and development costs,
(cc)operational costs, and
(dd)any other costs;
(h)the price at which the manufacturer’s or supplier’s reasonable costs for the presentation, as determined by the Secretary of State would be met;
(i)the estimated total net sales income after deduction of reasonable costs as determined by the Secretary of State over the most recent complete financial year, or where the application is made by a new manufacturer or supplier, until the end of the latest complete month in the current financial year, and the following three financial years—
(i)if the presentation was supplied at its current maximum price, and
(ii)if the presentation was supplied at the proposed increase in maximum price.
(8) For the purposes of this regulation, where there is more than one patent protection period with respect to the presentation that the application under this regulation is made, the patent protection period which expires on the latest date will apply.