Self-regulation codes

The regulations also address the need to ensure that drug information provided by pharmaceutical firms is truthful, balanced, and accurately communicated. As such, it must be consistent with the indications for use and the established performance and limitations. In Europe, the directives do not impose a specific requirement to review advertising or promotional material before it is released. Acceptable standards may be achieved via voluntary codes of practice and self-regulation. However, national authorities must monitor such material and should have the power to act where the need arises. In the U S, the F DA must vet advertising and promotional material before it is released. 

Prescription medicines may only be advertised to healthcare professionals - they may not be advertised to consumers. Advertisements of prescription medicines directed at healthcare professionals are regulated under a self-regulatory Code of Conduct administered by Medicines Australia. First published in 1960, it includes... 

The voluntary self-regulation of the Pharmaceutical Industry or FSA code is based on the recommendations of the collaboration of physicians issued by the German Association of Research-based Pharmaceutical Companies (VFA), the German Federal Association of Pharmaceutical Manufacturers (BAH) and the German Association of the Pharmaceutical Industry (BPI). Although these recommendations have no legal authority, member companies agree to abide by this code. 

The Code of Conduct for Pharmaceutical Advertising (CPA) lays down rules similar to those included in the Medicines Advertising Decree. Most pharmaceutical companies have agreed to comply with this code via the industry association Nefarma. Nefarma and other industry associations have established a self-regulating body (the Code geneemiddelenreclame or CGR). The Minister of Health, Welfare and Sport has stipulated that the rules on advertising should be enforced by the CGR as well as by the Public Health Inspectorate. 

The abandonment of detailed and prescribed regulation in favour of self-regulation sees the lines between forced and voluntary interaction with the community — in terms of looking after the health and safety of individuals — becoming blurred. Desired outcomes are set through codes of practice aimed to assist employers, but these are not mandatory. 

IFRA was established in 1973 by a number of fragrance trade associations and represents over 100 fragrance manufacturers in 15 countries. With its headquarters in Geneva, IFRA represents the scientific and technical expertise of the industry and is responsible for issuing and up-dating the Code of Practice (IFRA, 1973) upon which the whole self-regulation policy is based. IFRA is funded by these fragrance... 

In addition to the provisions of the UK Medicines Act (1962) and European Directives, and other similar mandates, the pharmaceutical industry also carries out a measure of self-regulation through its own industry bodies. For example, in the UK, the Association of British Pharmaceutical Industries (ABPI) operates codes of practice concerning, for example, the promotion of prescription only and OTC products. 

Another important type of ex ante social control is voluntary self-regulation by individual companies, and by industrial associations that develop codes of conduct, voluntary standards, and recommended practices for companies in their business sectors. Both of these forms of self-regulation often provide the technical expertise and proven best practices needed to support governmental regulatory regimes. ... 

The use of codes of practice as a preferred model for the application of regulations has been incorporated into the self-regulation style legislation. The use of codes allows for greater flexibility in the management of occupational health and safety at the operator level. The method of establishing an acceptable code of practice can be somewhat cumbersome, because of the three social partners involved. The legal status of codes of practice varies from jurisdiction to jurisdiction. 

This chapter shows that there are a number of issues and concerns for the protection of individual privacy and integrity arising out of the use of computers and computer networks. In relation to privacy and data protection, a detailed regulatory framework has evolved in the European Union and also in a number of states which, though not members of the EU, are members of the Council of Europe or the OECD. In contrast to this the US has, at present, no generic data protection legislation, as such, but instead relies on sectoral self-regulation by means of codes of practice and similar instruments. 

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