Self-regulatory schemes with efficient governance and enforcement procedures have played a significant role within the pharmaceutical sector for many years and have been an effective means of supporting ethical conduct within the industry. EFPIA believes that they continue to serve this important purpose. 
 
In terms of the prevalence of the code of conduct breaches, it is testimony to the efficiency of these self-regulatory systems that misconduct is indeed identified. Depending upon the severity of the breach, the incident is dealt with in line with the requirements of the self-regulatory system of the country in which any such alleged misconduct may have occurred. 
 
It is important to note that due to the nature of self-regulatory systems themselves, they are continually evolving, based on accruing case-law. Therefore, they are updated consistently in terms of both requirements and potential sanctions and fines.
 
Such self-regulatory systems are likely to vary between countries partly because they represent only a single element of the wider regulatory landscape. As such, they may be affected by other aspects of these frameworks, such as legal and/or policy requirements. EFPIA notes that it may not be possible to make a direct comparison between self-regulation instruments in different countries as they may affect certain elements of the pharmaceutical sector in one state and other aspects in another (e.g. OTC medicines). 

Sanctions for Code violations are determined by the relevant National Associations. EFPIA requires the publication of decisions and this transparency plays a key role in continuing to develop best practice, something very much in evidence in Sweden and the UK.