Misleading Advertisement and its regulation in the EU Medicine Promotion legal framework

Promotion of medicine is “any activity undertaken by a pharmaceutical company or with its authority which promotes the administration, consumption, prescription, purchase, recommendation, sale, supply or use of its medicine’’. Given the billions of dollars spent during drug development, a pharmaceutical company must be able to make a profit in order to sustain its self, as such, a good promotion strategy to market the product is paramount to the success of the company. The promotion of medicine might take several forms, such as journal and direct mail advertising, activities of representatives, the supply of samples, provision of inducements within the legal framework, provision of hospitality for promotional purposes, sponsorship of promotional or scientific meetings and other sales promotion in whatever form. Advertising of medicine is acceptable as long as it follows the standards of practice. According to the UK MHRA, the “society demands that advertising of any commodity, service or anything that may be of interest to the consumer, should be of a high standard and should not include anything that could cause serious or widespread offence, create unrealistic expectations in the consumer or be misleading’’. The European Union (EU) has a harmonized European Community (EC) policy on medicine advertisement with legislation and code of conduct as incorporated in the principles set out in the WHO Ethical Criteria for Medicinal Drug Promotion, the IFPMA code of practice, the EFPIA Code of Promotion on Prescription-Only Medicines, and Directive 2001/83/EC on the community code relating to medicinal products for human use, as amended by Directive 2004/27/EC3. Aside from the European legislation on advertising, each Member State also has national bodies responsible for the monitoring and enforcement to ensure compliance with the rules. For example, the United Kingdom MHRA uses both its national and European legislation to monitor advertising activities in the UK.