Law prohibits endorsing, preferring, supporting or marketing any specific medicine or medical device
06 March 2024 - 17:00
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Unlike other products, medicines are strictly regulated in SA. The Medicines & Related Substances Act frames all communications relating to medicines, and the provisions relating to advertisements, including discussions through which a medicine is “brought to the attention of the public in any manner whatsoever”, with section 18, and regulation 42(1) and (2) prohibiting the advertisement of any schedule 2 to 6 medicine to the public.
Regulation 42(4) prohibits any off-label statements. This means any indication for which a product is not registered for that use by the SA Health Products Regulatory Authority. Contraventions of these provisions are offences in terms of section 29 of the Medicines Act, and could attract fines or even imprisonment.
What is permitted is disease-awareness campaigns, which we as a company fully support as they benefit public health if the public and patients are empowered. Disease-awareness activities may, however, not lead to the support, endorsement or recommendation, specifically or by implication, of any specific schedule 2 to 6 medicine.
Your journalists and/or staff should be able to advise healthcare professionals who appear as speakers, contributors and guests that they are prohibited by the Health Professions Council’s ethical rule 23 from endorsing, preferring, supporting or marketing any specific medicine or medical device.
Thabeng Leping Novo Nordisk SA
JOIN THE DISCUSSION: Send us an email with your comments to letters@businesslive.co.za. Letters of more than 300 words will be edited for length. Anonymous correspondence will not be published. Writers should include a daytime telephone number.
Support our award-winning journalism. The Premium package (digital only) is R30 for the first month and thereafter you pay R129 p/m now ad-free for all subscribers.
LETTER: Doctors must stick to the label
Law prohibits endorsing, preferring, supporting or marketing any specific medicine or medical device
Rishika Sadam’s article refers (“Indian pharma firms start making generic versions of weight-loss jabs”, February 22).
Unlike other products, medicines are strictly regulated in SA. The Medicines & Related Substances Act frames all communications relating to medicines, and the provisions relating to advertisements, including discussions through which a medicine is “brought to the attention of the public in any manner whatsoever”, with section 18, and regulation 42(1) and (2) prohibiting the advertisement of any schedule 2 to 6 medicine to the public.
Regulation 42(4) prohibits any off-label statements. This means any indication for which a product is not registered for that use by the SA Health Products Regulatory Authority. Contraventions of these provisions are offences in terms of section 29 of the Medicines Act, and could attract fines or even imprisonment.
What is permitted is disease-awareness campaigns, which we as a company fully support as they benefit public health if the public and patients are empowered. Disease-awareness activities may, however, not lead to the support, endorsement or recommendation, specifically or by implication, of any specific schedule 2 to 6 medicine.
Your journalists and/or staff should be able to advise healthcare professionals who appear as speakers, contributors and guests that they are prohibited by the Health Professions Council’s ethical rule 23 from endorsing, preferring, supporting or marketing any specific medicine or medical device.
Thabeng Leping
Novo Nordisk SA
JOIN THE DISCUSSION: Send us an email with your comments to letters@businesslive.co.za. Letters of more than 300 words will be edited for length. Anonymous correspondence will not be published. Writers should include a daytime telephone number.
Indian pharma firms start making generic versions of weight-loss jabs
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Indian pharma firms start making generic versions of weight-loss jabs
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