On 1 January 2007, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) enacted an updated version of the Code of Pharmaceutical Marketing Practices (the Code). Its goal is to ensure the ethical promotion of pharmaceutical products.
The Code recognises that advertising and promotion are an essential way to inform prescribers of the availability and use of new drugs. At the same time, the Code encourages selfregulation, backed up by the internal guidelines of multinational companies, as a means of imposing standards for the advertising and promotional practices of multinational, pharmaceutical companies. Every member of the IFPMA, which includes GlaxoSmithKline, Schering- Plough, Pfizer and other well-known players in the international pharmaceutical market, is now obligated to follow the Code in the international arena where they conduct business. What does this mean for pharmaceutical companies? Will they be facing a new set of rules and new scrutiny? At a minimum, the level of scrutiny and implementation of some new rules will affect their daily operations.
The Code comes into effect almost five years after the PhRMA Code on Interactions with Health Care Professionals (PhRMA Code) was enacted in the United States. Both the IFPMA and the PhRMA Code address inappropriate promotional activities ranging from printed materials, to sponsorships, to gifts, to appropriate venues for events. The IFPMA Code, however, goes further in policing its members. There are a number of differences in the two policies starting with the fact the IFPMA Code is mandatory while the PhRMA Code is purely voluntary.
The IFPMA Code has initiated a complaints procedure whereby any member of the public, health care professional or company can file a complaint alleging a breach of the Code. The complaints process allows for the accused company to respond to the allegations and then an ad hoc group of three individuals from member associations will issue a decision which can be appealed. If the appeal fails, a determination that a breach of the Code has occurred is made public on the IFPMA website. Clearly this public “outing” of companies that violate the Code is meant to have a strong deterrent effect and only time will tell if it works.
Finally, the Code defines what are deemed to be “acceptable gifts” to health care professionals. Not only are gifts of cash or cash equivalents prohibited, but gifts for personal benefit (such as tickets to sporting events, rounds of golf or DVDs) are now expressly prohibited. In addition, the IPFMA has tasked each member association with defining what constitutes “minimal”, or “modest”, or “inexpensive” under the local currency. So, while an item may be deemed “inexpensive” in the Czech Republic, this may not be the case in Germany. This is an area that can easily lead to problems for pharmaceutical companies.
What does this mean for drug manufacturers operating in a global economy? There will be more policing of the promotion of drugs than ever before. IFPMA member companies will need to make sure internal structures and procedures are in place and conduct periodic internal audits of the sales and marketing of drugs to ensure ethical promotional activities.