The Canadian Natural Health Products (NHP) regulations: industry compliance motivations.

This qualitative study explores corporations' motivations to comply with new natural health products (NHP) Regulations in Canada. Interviews were conducted with representatives from 20 Canadian NHP companies. Findings show that the rationale for compliance differs for large compared to small and medium-sized enterprises (SMEs). Large firms are motivated to comply with the regulations because of the deterrent fear of negative media coverage, social motivations, ability to comply and maintaining a competitive market advantage. In contrast, SMEs are motivated to comply due to the deterrent fear of legal prosecution and a sense of duty.

The Canadian Natural Health Products (NHP) regulations: industry perceptions and compliance factors.

BACKGROUND: The use of natural health products, such as vitamins, minerals, and herbs, by Canadians has been increasing with time. As a result of consumer concern about the quality of these products, the Canadian Department of Health created the Natural Health Products (NHP) Regulations. The new Canadian regulations raise questions about whether and how the NHP industry will be able to comply and what impact they will have on market structure. The objectives of this study were to explore who in the interview sample is complying with Canada's new NHP Regulations (i.e., submitted product licensing applications on time); and explore the factors that affect regulatory compliance. METHODS: Twenty key informant interviews were conducted with employees of the NHP industry. The structured interviews focused on the level of satisfaction with the Regulations and perceptions of compliance and non-compliance. Interviews were tape recorded and then transcribed verbatim. Data were independently coded, using qualitative content analysis. Team meetings were held after every three to four interviews to discuss emerging themes. RESULTS: The major finding of this study is that most (17 out of 20) companies interviewed were beginning to comply with the new regulatory regime. The factors that contribute to likelihood of regulatory compliance were: perceptions and knowledge of the regulations and business size. CONCLUSION: The Canadian case can be instructive for other countries seeking to implement regulatory standards for natural health products. An unintended consequence of the Canadian NHP regulations may be the exit of smaller firms, leading to industry consolidation.

Expanding drug access in Brazil: lessons for Latin America and Canada.

This paper discusses Brazil's efforts to provide essential medicines for its population while meeting international trade obligations. In the 1950s and 1960s, Brazil's pharmaceutical industry was largely overtaken by foreign companies. To counteract this, Brazil enacted a law in 1971 that allowed the production of patented drugs in order to provide affordable medicines, encourage research and development, and reduce dependency on imports. Eventually, pressure from the United States government (through tariffs and sanctions) drove Brazil to introduce pharmaceutical patent laws. Local interests prevailed, however, through Brazil's liberal interpretation of the TRIPS Agreement, which included a provision that pharmaceutical products must be "worked" or manufactured locally or the government could turn to the use of compulsory licensing. Brazil's willingness to use the threat of compulsory licensing compelled drug companies to lower HIV/AIDS drug prices substantially. Finally, the paper discusses how Canada can facilitate improving drug access in Latin America through helping Brazil expand its role as a manufacturer and providing medicines to countries without manufacturing capabilities.

The dilemma of intellectual property rights for pharmaceuticals: the tension between ensuring access of the poor to medicines and committing to international agreements.

In this paper, we provide an overview of how the outcomes of the Uruguay Round affected the application of pharmaceutical intellectual property rights globally. Second, we explain how specific pharmaceutical policy tools can help developing states mitigate the worst effects of the TRIPS Agreement. Third, we put forward solutions that could be implemented by the World Bank to help overcome the divide between creating private incentives for research and development of innovative medicines and ensuring access of the poor to medicine. Fourth, we evaluate these solutions on the basis of utilitarian considerations and urge that equitable pricing is morally preferable to the other solutions.