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Evid Based Complement Alternat Med. Published online Nov Abstract 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 laeeque online dating 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 laeeque online dating comply due to the deterrent fear of legal prosecution and a sense of duty.
Debate continues about how best to ensure compliance of target groups with government regulations. Some argue that governments must guarantee that regulations are effectively enforced through appropriate monitoring and sanctions 1 , 2. Others believe that target groups will comply with regulations, regardless of government actions. Despite this, regulatory scholars have traditionally studied the enforcement strategy of the agency responsible for implementing regulations 4 , 5.
More recent accounts have focused on the compliance of target groups with regulations. For example, Laeeque et al. One question that remains is why do firms attempt to comply with regulations? This paper sheds light on the debate by exploring the motivations of Canadian firms for complying with the NHP Regulations.
Understanding what variables motivate industry compliance can help inform the implementation and enforcement stages of the Regulations 7. NHPs, now a subcategory of drugs, are defined in the Regulations as products such as vitamins, minerals, homeopathic medicines and others. The most important aspect of the regulations is the requirement for pre-market approval from the Natural Health Products Directorate NHPD of Health Canada for all NHP products new to the Canadian market and re-approval of all existing products during a 6 year transition period.
This number is granted upon submission of a product licence application PLA , which demonstrates the safety, quality and efficacy of the product. The first compliance deadline for submitting a PLA for high-risk products was June 30, In addition to completing PLAs for each of their products, companies that manufacture, package, label or import NHPs were required to apply for site licenses by December 31, GMPs were developed to be appropriate for NHPs, and include standards on cleanliness, quality assurance and record-keeping.
For example, the company must have clear procedures in place to maintain distribution records and facilitate product recalls. The BIT defined small business as firms with less than 20 employees, medium size firms as having 20—49 employees, and large firms as greater than 50 employees.
The NHP Regulations represent a significant change in regulatory burden for this industry. In many cases, companies need to make significant changes in their operations.
It is important to note that the data collection for this study was in the first year of a 6 year phase-in of the new regulations. At this time, there was much concern over how NHP companies would respond to the new standards. Thus, company motivations to make these changes appeared important to explore. Four main compliance motivations identified in the literature are as follows: Motivations for Compliance Deterrent Fears General deterrence theory is based on the assumption that businesses are profit-driven and that regulatory compliance at the firm level occurs when non-compliance costs, through the form of fines, sanctions or imprisonment, exceed compliance costs 9.
Deterrent fears develop from the fear of negative outcomes due to non-compliance with regulations. Fear can be either specific, due to enforcement actions on individual firms, or general, from the regulations.
General deterrence fears include: No research has been conducted on deterrence and compliance behavior during the early implementation stage of regulations.
Duty to Comply An important aspect of effective regulations is that citizens feel a need for the regulations, and that firms recognize their responsibility to comply. This motivation reflects the value system of the regulated individuals. Two factors are important in this motivation: Inherent in the obligation to conform to regulations is that the regulated firms understand the need for regulation in order to prevent public harm 7 , Duty to comply with regulations has also been called normative motivation, moral or ideological compliance, or perceived obligation.
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