Proceedings of the Ninth International Conference of Drug Regulatory Authorities (ICDRA) - Berlin, Germany 25-29 April 1999
(1999; 102 pages) Ver el documento en el formato PDF
Índice de contenido
Abrir esta carpeta y ver su contenidoOpening Ceremony
Abrir esta carpeta y ver su contenidoGood regulatory practice
Abrir esta carpeta y ver su contenidoGood certification practice
Abrir esta carpeta y ver su contenidoCounterfeit drugs: challenges and solutions
Abrir esta carpeta y ver su contenidoCurrent issues in regulation and quality
Abrir esta carpeta y ver su contenidoInternational Conference on Harmonization: implementation and implications
Abrir esta carpeta y ver su contenidoDrug utilization studies
Abrir esta carpeta y ver su contenidoInternational Conference on Harmonization and the common technical document
Abrir esta carpeta y ver su contenidoKeynote address
Cerrar esta carpetaGlobal and national efforts to reduce tobacco use
Ver el documentoHow national authorities can promote non-smoking: experience from a European Union country
Ver el documentoInternational implications of the regulation of nicotine products
Ver el documentoPublic health responsibilities of nicotine regulation
Ver el documentoDiscussion
Ver el documentoRecommendations
Abrir esta carpeta y ver su contenidoElectronic communication in the regulatory process
Abrir esta carpeta y ver su contenidoTransparency in monitoring the safety of medicines
Abrir esta carpeta y ver su contenidoPharmaceutical products for use in special groups
Abrir esta carpeta y ver su contenidoNeed for Bioequivalence
Abrir esta carpeta y ver su contenidoAntimicrobial resistance: battling the bugs
Abrir esta carpeta y ver su contenidoSafety issues of plasma-derived medicinal products
Abrir esta carpeta y ver su contenidoHerbal medicines
Abrir esta carpeta y ver su contenidoRegulation and access to essential drugs
Ver el documentoParticipants
Ver el documentoBack cover
 

International implications of the regulation of nicotine products

Mr D. Sweanor, Canada

Of the various forms of nicotine-containing products, tobacco, the most harmful (dirtiest) nicotine delivery system, is the least regulated. Tobacco products are cheap, widely promoted and easy to get, whereas alternative nicotine preparations are subject to strict regulatory control as pharmaceutical products.

This has created the “nicotine maintenance monopoly” in which nicotine causes dependence and the delivery vehicle causes the disease and the existing regulatory system forces all who want or need nicotine on an ongoing basis to get it from tobacco products. The health toll is quite high, but the potential to reduce this health toll is also significant, as most of the 1.15 billion cigarette smokers want to quit, or otherwise reduce harm.

Thus, there is a huge potential market but the present legal environment does not allow ´clean’ alternatives to replace the ´dirty’ nicotine delivery system. Regulatory change would be required to promote greater access to nicotine dependence treatment products and a wider range of indicated uses of these products for smoking reduction, temporary abstinence and longer-term substitution.

Only then will tobacco companies lose the ´nicotine maintenance monopoly’. To this end, drug regulators should enter into dialogue with nicotine experts, tobacco control experts and pharmaceutical companies.

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Última actualización: le 3 mayo 2013