Compliance of Disease Awareness Campaigns in Printed Dutch Media with National and International Regulatory Guidelines

Abstract

BackgroundThe European legislation prohibits prescription-only medicines' advertising but allows pharmaceutical companies to provide information to the public on health and diseases, provided there is no direct or indirect reference to a pharmaceutical product. Various forms of promotion have become increasingly common in Europe including “disease-oriented” campaigns.ObjectivesTo explore examples of disease awareness campaigns by pharmaceutical companies in the Netherlands, by assessing their compliance with the World Health Organization (WHO) Ethical Criteria for medicinal drug promotion and the Dutch guidelines for provision of information by pharmaceutical companies.MethodsMaterials referring to health/disease and treatments published in the most widely circulated newspapers and magazines were collected from March to May 2012. An evaluation tool was developed based on relevant underlying principles from the WHO ethical criteria and Dutch self-regulation guidelines. Collected disease awareness advertisements were used to pilot the evaluation tool and to explore the consistency of information provided with the WHO and Dutch criteria.FindingsEighty materials met our inclusion criteria; 71 were published in newspapers and 9 in magazines. The large majority were news items but 21 were disease awareness advertisements, of which 5 were duplicates. Fifteen out of the 16 disease awareness campaigns were non-compliant with current guidelines mainly due to lack of balance (n = 12), absence of listed author and/or sponsor (n = 8), use of misleading or incomplete information (n = 5) and use of promotional information (n = 5). None mentioned a pharmaceutical product directly.ConclusionDisease Awareness Campaigns are present in Dutch printed media. Although no brand names were mentioned, the lack of compliance of disease awareness campaigns with the current regulations is alarming. There were information deficiencies and evidence of information bias. A key concern is that the context in which the information is provided, mostly through indirect referral, is likely to support treatment with the sponsor's product.

Impact of a direct-to-consumer information campaign on prescription patterns for overactive bladder

“…Third, we could not evaluate the severity of overactive bladder because such information was unavailable in our data set. In addition, the limited data availability did not allow us to analyze the DTCI impacts on other patterns including total volume of prescriptions or adherence to treatment [ 5 – 7 ]. Therefore, further studies are needed to evaluate the impact of the DTCI campaign by incorporating these limitations.…”

“…Direct-to-consumer campaigns sponsored by the pharmaceutical industry, including direct-to-consumer advertising (DTCA) and direct-to-consumer information (DTCI) campaigns, have been a recent focus of prescription drug-use promotion in developed countries [ 1 – 4 ]. DTCA campaigns directly promote specific brand name medications, whereas DTCI campaigns are aimed at informing people about seeking healthcare services but should not directly promote specific drugs [ 4 – 7 ].…”

“…Spending for DTCA campaigns has increased from USD 1.2 billion in 1998 to USD 4.5 billion in 2009 in the US [ 1 , 4 ]. In many countries including Japan, where direct brand name drug promotion has been prohibited, DTCI campaigns (also known as disease awareness campaigns) have rapidly increased [ 5 – 7 ]. The current Japanese government regulations prohibit a DTCA campaign due to its direct promotion of a specific drug, but do not prohibit a DTCI campaign without such direct promotion of a specific drug.…”

“…As a result, pharmaceutical industries are practically able to conduct DTCI campaigns in Japan. Although DTCI campaigns, including public awareness campaigns for specific diseases, are distinguished from the advertisement of specific drugs by law and permitted in many settings, some recent reports raised concerns about their potential advertising effects [ 6 , 7 ]. However, little is known about how DTCI campaigns affect the patterns of prescription of treatment drugs.…”

Regulating Direct-to-Consumer Drug Information: A Case Study of Eli Lilly’s Canadian 40over40 Erectile Dysfunction Campaign

“…A study from Leonardo Alves et al (2014) demonstrated that there is low compliance with self-regulation guidelines in the Netherlands. Even if their study was focused on the print media, the authors raised questions about the growing interest for online drug information and the importance of evaluating "the content and quality of disease awareness websites" to determine the effect on consumer behaviour (Leonardo Alves et al 2014: 8).…”