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Type
House
Session
Year
Department
Member
Primary member
Answering member
Darzi of Denham, Lord (3)
Legislative stage
Legislation
Subject
Publisher
Whether they plan to introduce requirements for patient information leaflets to be prepared to specify the possible risks associated with biosimilar medicines, as appropriate.
Whether they plan to introduce requirements for patient information leaflets to be prepared to specify the possible risks associated with biosimilar medicines, as appropriate.
Asked by
Lord Walton of Detchant
(Crossbench)
Answered by
Lord Darzi of Denham
(Labour)
Type
Written questions
Status
Answered
Answered on
16 January 2008
The Medicines and Healthcare products Regulatory Agency has granted marketing authorisations for the following biosimilar medicines:
Omnitrope (somatropin);
Valtropin (somatropin);
Epoetin alfa hexal, Abseamed, Binocrit (all containing epoetin alfa); and
Silapo, Retacrit (both containing epoetin zeta).
We are not aware of any legal basis for such automatic substitution. Section 58 (2)(a) of the Medicines Act 1968 provides for prescription-only medicines to be sold or supplied only in accordance with a prescription given by an appropriate practitioner. If a branded medicinal product is prescribed, then it must be dispensed. A pharmacist who substitutes another product for a branded drug without first agreeing this with the prescriber would be in breach of medicines legislation.
Patient information leaflets include all the relevant information on usage, side effects etc and reflect the information contained in the Summary of Product Characteristics (SPC). The Government have no plans to call for the introduction of a requirement for patient information leaflets to specify the possible risks associated with the use of biosimilar medicines. If a particular risk is identified in relation to a particular product, the SPC for that product will detail that risk and the patient information leaflet will reflect the SPC.
Subjects
Information; Patients; Prescription drugs; Side effects; Biosimilar medicines
Date
16 January 2008
Reference
1139; 697 c256-7WA
House
House of Lords
Whether they have considered banning the automatic substitution of branded pharmaceutical preparations by comparable biosimilar medicines; and
Whether they have considered banning the automatic substitution of branded pharmaceutical preparations by comparable biosimilar medicines; and
Asked by
Lord Walton of Detchant
(Crossbench)
Answered by
Lord Darzi of Denham
(Labour)
Type
Written questions
Status
Answered
Answered on
16 January 2008
The Medicines and Healthcare products Regulatory Agency has granted marketing authorisations for the following biosimilar medicines:
Omnitrope (somatropin);
Valtropin (somatropin);
Epoetin alfa hexal, Abseamed, Binocrit (all containing epoetin alfa); and
Silapo, Retacrit (both containing epoetin zeta).
We are not aware of any legal basis for such automatic substitution. Section 58 (2)(a) of the Medicines Act 1968 provides for prescription-only medicines to be sold or supplied only in accordance with a prescription given by an appropriate practitioner. If a branded medicinal product is prescribed, then it must be dispensed. A pharmacist who substitutes another product for a branded drug without first agreeing this with the prescriber would be in breach of medicines legislation.
Patient information leaflets include all the relevant information on usage, side effects etc and reflect the information contained in the Summary of Product Characteristics (SPC). The Government have no plans to call for the introduction of a requirement for patient information leaflets to specify the possible risks associated with the use of biosimilar medicines. If a particular risk is identified in relation to a particular product, the SPC for that product will detail that risk and the patient information leaflet will reflect the SPC.
Subjects
Information; Patients; Prescription drugs; Side effects; Biosimilar medicines
Date
16 January 2008
Reference
1138; 697 c256-7WA
House
House of Lords
asked Her Majesty's Government:Which biosimilar medicines have been approved for use in the United Kingdom; and
asked Her Majesty's Government:Which biosimilar medicines have been approved for use in the United Kingdom; and
Asked by
Lord Walton of Detchant
(Crossbench)
Answered by
Lord Darzi of Denham
(Labour)
Type
Written questions
Status
Answered
Answered on
16 January 2008
The Medicines and Healthcare products Regulatory Agency has granted marketing authorisations for the following biosimilar medicines:
Omnitrope (somatropin);
Valtropin (somatropin);
Epoetin alfa hexal, Abseamed, Binocrit (all containing epoetin alfa); and
Silapo, Retacrit (both containing epoetin zeta).
We are not aware of any legal basis for such automatic substitution. Section 58 (2)(a) of the Medicines Act 1968 provides for prescription-only medicines to be sold or supplied only in accordance with a prescription given by an appropriate practitioner. If a branded medicinal product is prescribed, then it must be dispensed. A pharmacist who substitutes another product for a branded drug without first agreeing this with the prescriber would be in breach of medicines legislation.
Patient information leaflets include all the relevant information on usage, side effects etc and reflect the information contained in the Summary of Product Characteristics (SPC). The Government have no plans to call for the introduction of a requirement for patient information leaflets to specify the possible risks associated with the use of biosimilar medicines. If a particular risk is identified in relation to a particular product, the SPC for that product will detail that risk and the patient information leaflet will reflect the SPC.
Subjects
Information; Patients; Prescription drugs; Side effects; Biosimilar medicines
Date
16 January 2008
Reference
1137; 697 c255-7WA
House
House of Lords