The Branded Health Service Medicines (Costs) (Amendment) Regulations 2024
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Change 1
6 Insertion of new regulation 3B
After regulation 3A (older presentation additional payments) insert— Meaning of newer presentation and older presentation 3B (1) Paragraphs (2) and (3) set out different conditions for items of presentation that are combination medicines and vaccines, but subject to those paragraphs, a newer presentation is an item of presentation supplied for health service use by a manufacturer or supplier who is an originator or originator licensee in respect of that presentation— (a) during the period of time there is an extant supplementary protection certificate for the active ingredient of any relevant medicine with the same relevant virtual therapeutic moiety as the presentation; or (b) where no supplementary protection certificate has been granted in respect of the active ingredient of any relevant medicine with the same relevant virtual therapeutic moiety as the presentation, during the period of 12 years beginning on the date on which the first marketing authorisation was granted for any relevant medicine supplied for health service use that contains the active ingredient with the same relevant virtual therapeutic moiety as the presentation. (2) A presentation that is a combination medicine is a newer presentation when that item of presentation is supplied for health service use by a manufacturer or supplier who is an originator or originator licensee in respect of that presentation and— (a) during the period of time there is at least one extant supplementary protection certificate for the same combination of active ingredients as the unique virtual therapeutic moiety for that combination medicine; or (b) where no supplementary protection certificate has been granted in respect of the combination medicine— (i) during the period of time there is an extant supplementary protection certificate for a relevant medicine that is supplied for health service use containing a constituent active ingredient or combination of constituent active ingredients of the combination medicine, or (ii) where no supplementary protection certificate has been granted for a constituent active ingredient or combination of constituent active ingredients of the combination medicine, during the period of 12 years beginning on the date on which the latest presentation (P1) containing any of those constituent active ingredients was granted a marketing authorisation (that marketing authorisation being the first marketing authorisation granted for a presentation containing it or them), a relevant medicine of P1 also being the first with a marketing authorisation for the virtual therapeutic moiety of that active ingredient. (3) A presentation that is a vaccine is a newer presentation when that item of presentation is supplied for health service use by a manufacturer or supplier who is a vaccine originator or vaccine originator licensee in respect of that presentation— (a) during the period of time there is at least one extant supplementary protection certificate for the vaccine; (b) if no supplementary protection certificate has been granted in respect of an active ingredient of the vaccine and— (i) the vaccine was the first presentation for the relevant virtual therapeutic moiety to be granted a marketing authorisation, during the period of 12 years beginning on the date the first marketing authorisation is granted for the presentation, or (ii) the licensing authority designates an active ingredient of the vaccine as a new active substance, for a period of 12 years from the date the vaccine is first placed on the market for health service use; or (c) if it is a line extension of a presentation to which sub-paragraph (a) or (b) applies, during the period that sub-paragraph (a) or (b) applies to the relevant presentation. (4) An older presentation is any item of presentation that is not a newer presentation. (5) A newer presentation becomes an older presentation on the day after that presentation is no longer capable of satisfying the conditions for being a newer presentation in accordance with paragraphs (1), (2) or (3). (6) Where a presentation is a newer presentation because paragraph (1)(a), (2)(a), (2)(b)(i) or (3)(a) applies, if the relevant supplementary protection certificate— (a) is invalidated for any reason, paragraph (5) applies from the day following the day on which it would have ceased to satisfy the conditions for being a newer presentation in accordance with paragraphs (1), (2) or (3) otherwise than in reliance on the invalidated supplementary protection certificate; (b) lapses as a consequence of the marketing authorisation to which that supplementary protection certificate relates being withdrawn, paragraph (5) applies for the period beginning on the day following the day on which the relevant marketing authorisation was withdrawn and ending on the day before the day on which the relevant marketing authorisation or supplementary protection certificate is reinstated (and so the presentation becomes a newer presentation); or (c) is surrendered, paragraph (5) applies from the day following the day on which the relevant supplementary protection certificate is surrendered. (7) The Secretary of State may, by giving an information notice, require a manufacturer or supplier to provide information to evidence that a presentation has been correctly classified as a newer presentation, older presentation or combination medicine in accordance with this regulation, including to provide any supplementary protection certificate and marketing authorisation data. (8) For the purposes of these Regulations, a combination medicine is a relevant medicine containing two or more active ingredients— (a) that has a unique virtual therapeutic moiety that is distinct from all other virtual therapeutic moieties of any of the constituent active ingredients of the relevant medicine; or (b) in respect of which there is no unique virtual therapeutic moiety specified in the medicines information standard, but the Secretary of State determines, by direction, the relevant medicine is a combination medicine despite not satisfying sub-paragraph (a) for the purpose of determining payments due or other pricing matters in connection with these Regulations to a manufacturer or supplier who supplies the presentation for health service use. (9) In this regulation— “period of time” in relation to a supplementary protection certificate, means the period of time beginning on the day on which the supplementary protection certificate came into force and ending on the day on which the certificate lapses or is surrendered or is invalidated for any reason; “relevant virtual therapeutic moiety” means— the virtual therapeutic moiety associated with an active ingredient, combination of active ingredients or combination medicine, as applicable, for a particular presentation; or where there is no suitable virtual therapeutic moiety in the medicines information standard for the active ingredient or combination of active ingredients for a particular presentation, the Secretary of State may, by direction, give an approximation of a virtual therapeutic moiety for the purpose of determining payments due or other pricing matters in connection with these Regulations to a manufacturer or supplier who supplies the presentation for health service use. (10) This regulation does not apply to a small manufacturer or supplier. .
6 Insertion of new regulation 3B
After regulation 3A (older presentation additional payments) insert— Meaning of newer presentation and older presentation 3B (1) Paragraphs (2) and (3) set out different conditions for items of presentation that are combination medicines and vaccines, but subject to those paragraphs, a newer presentation is an item of presentation supplied for health service use by a manufacturer or supplier who is an originator or originator licensee in respect of that presentation— (a) during the period of time there is an extant supplementary protection certificate for the active ingredient of any relevant medicine with the same relevant virtual therapeutic moiety as the presentation; or (b) where no supplementary protection certificate has been granted in respect of the active ingredient of any relevant medicine with the same relevant virtual therapeutic moiety as the presentation, during the period of 12 years beginning on the date on which the first marketing authorisation was granted for any relevant medicine supplied for health service use that contains the active ingredient with the same relevant virtual therapeutic moiety as the presentation. (2) A presentation that is a combination medicine is a newer presentation when that item of presentation is supplied for health service use by a manufacturer or supplier who is an originator or originator licensee in respect of that presentation and— (a) during the period of time there is at least one extant supplementary protection certificate for the same combination of active ingredients as the unique virtual therapeutic moiety for that combination medicine; or (b) where no supplementary protection certificate has been granted in respect of the combination medicine— (i) during the period of time there is an extant supplementary protection certificate for a relevant medicine that is supplied for health service use containing a constituent active ingredient or combination of constituent active ingredients of the combination medicine, or (ii) where no supplementary protection certificate has been granted for a constituent active ingredient or combination of constituent active ingredients of the combination medicine, during the period of 12 years beginning on the date on which the latest presentation (P1) containing any of those constituent active ingredients was granted a marketing authorisation (that marketing authorisation being the first marketing authorisation granted for a presentation containing it or them), a relevant medicine of P1 also being the first with a marketing authorisation for the virtual therapeutic moiety of that active ingredient. (3) A presentation that is a vaccine is a newer presentation when that item of presentation is supplied for health service use by a manufacturer or supplier who is a vaccine originator or vaccine originator licensee in respect of that presentation— (a) during the period of time there is at least one extant supplementary protection certificate for the vaccine; (b) if no supplementary protection certificate has been granted in respect of an active ingredient of the vaccine and— (i) the vaccine was the first presentation for the relevant virtual therapeutic moiety to be granted a marketing authorisation, during the period of 12 years beginning on the date the first marketing authorisation is granted for the presentation, or (ii) the licensing authority designates an active ingredient of the vaccine as a new active substance, for a period of 12 years from the date the vaccine is first placed on the market for health service use; or (c) if it is a line extension of a presentation to which sub-paragraph (a) or (b) applies, during the period that sub-paragraph (a) or (b) applies to the relevant presentation. (4) An older presentation is any item of presentation that is not a newer presentation. (5) A newer presentation becomes an older presentation on the day after that presentation is no longer capable of satisfying the conditions for being a newer presentation in accordance with paragraphs (1), (2) or (3). (6) Where a presentation is a newer presentation because paragraph (1)(a), (2)(a), (2)(b)(i) or (3)(a) applies, if the relevant supplementary protection certificate— (a) is invalidated for any reason, paragraph (5) applies from the day following the day on which it would have ceased to satisfy the conditions for being a newer presentation in accordance with paragraphs (1), (2) or (3) otherwise than in reliance on the invalidated supplementary protection certificate; (b) lapses as a consequence of the marketing authorisation to which that supplementary protection certificate relates being withdrawn, paragraph (5) applies for the period beginning on the day following the day on which the relevant marketing authorisation was withdrawn and ending on the day before the day on which the relevant marketing authorisation or supplementary protection certificate is reinstated (and so the presentation becomes a newer presentation); or (c) is surrendered, paragraph (5) applies from the day following the day on which the relevant supplementary protection certificate is surrendered. (7) The Secretary of State may, by giving an information notice, require a manufacturer or supplier to provide information to evidence that a presentation has been correctly classified as a newer presentation, older presentation or combination medicine in accordance with this regulation, including to provide any supplementary protection certificate and marketing authorisation data. (8) For the purposes of these Regulations, a combination medicine is a relevant medicine containing two or more active ingredients— (a) that has a unique virtual therapeutic moiety that is distinct from all other virtual therapeutic moieties of any of the constituent active ingredients of the relevant medicine; or (b) in respect of which there is no unique virtual therapeutic moiety specified in the medicines information standard, but the Secretary of State determines, by direction, the relevant medicine is a combination medicine despite not satisfying sub-paragraph (a) for the purpose of determining payments due or other pricing matters in connection with these Regulations to a manufacturer or supplier who supplies the presentation for health service use. (9) In this regulation— “period of time” in relation to a supplementary protection certificate, means the period of time beginning on the day on which the supplementary protection certificate came into force and ending on the day on which the certificate lapses or is surrendered or is invalidated for any reason; “relevant virtual therapeutic moiety” means— the virtual therapeutic moiety associated with an active ingredient, combination of active ingredients or combination medicine, as applicable, for a particular presentation; or where there is no suitable virtual therapeutic moiety in the medicines information standard for the active ingredient or combination of active ingredients for a particular presentation, the Secretary of State may, by direction, give an approximation of a virtual therapeutic moiety for the purpose of determining payments due or other pricing matters in connection with these Regulations to a manufacturer or supplier who supplies the presentation for health service use. (10) This regulation does not apply to a small manufacturer or supplier. .
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