Why are there commercials for prescription drugs
Public Advertising for Prescription Drugs
New framework for advertising
The background to the existing ban on advertising is the fear that patients could be manipulated because they lack the ability to judge the products or measures being advertised. But the changed patient-doctor relationship is forcing an examination of the advertising options that have been permitted up to now. In Europe, for example, it is not allowed to offer the public access to specialist information on prescription drugs on the Internet, while this information is available on American websites.
Politicians are confronted with the different interests and needs of industry, doctors and pharmacists, individual consumers and the public health system as well as health insurance companies and must weigh up the expected positive and negative effects of introducing direct advertising for prescription drugs against each other. With this in mind, an attempt should be made here to develop possible solutions and framework conditions for a new, contemporary drug advertising that takes the interests of all parties into account.
Special features of drug advertising
Advertising generally describes the presentation of messages with the aim of controlling the attitudes and actions of the addressees for the benefit of the advertiser. However, prescription drugs are fundamentally different from everyday necessities.
- Sick consumers are in an "emergency". They are therefore particularly easy to influence and must be viewed as in need of protection.
- Medicines have a strong influence on the state of health of the individual (i.e. effectiveness) and often have serious side effects. The risk-benefit ratio must be assessed in each case.
- Consumers cannot simply buy prescription (Rx) drugs. They have to be prescribed by the doctor.
Pharmaceutical advertising in an international context
DTC (direct-to-consumer) or branded prescription drug advertising is currently only allowed in the United States and New Zealand. The legal basis for DTC advertising in Europe is being examined.
The Internet is an important driver as consumers research more and more health information here. The different legal situations therefore lead to strange phenomena: Many US American manufacturers split their pages into "Information for residents of the USA" and "Others", with the latter pages being empty. However, no one prevents non-Americans from visiting the pages not intended for them.
The medical journals, which are increasingly being published online, represent a further source of information for laypeople. Their contents - including information on medicinal products intended for the specialist public - are usually also accessible to laypeople. How far they are used and understood by them, however, is difficult to estimate [10, 15].
National restrictions and bans are practically impossible to enforce in global media. This requires international guidelines to standardize advertising options. Therefore, the current legal situation in the various countries should first be discussed.
International standard of the WHO
In 1988 the World Health Organization (WHO) developed criteria for regulating pharmaceutical advertising, the "Ethical Criteria for Medicinal Drug Promotion". This is the only international standard to date on this issue. He is critical of the DTC advertising for drugs: It should not be generally allowed for prescription drugs.
Furthermore, the advertising of medicines for serious diseases should be restricted. This is already being implemented in many countries through lists of clinical pictures that are not approved for advertising. In addition, the WHO clearly advocates self-medication on one's own responsibility. She emphasizes that information for the population is extremely important in this context. These guidelines are not binding, but they can serve as a basis for legal regulations [25, 18].
The EU directive on the advertising of medicinal products for human use 92/28 / EEC is strongly based on the German Medicines Advertising Act (HWG) and advocates comparable restrictions. It provides for a ban on DTC advertising for prescription drugs.
Public advertising for non-prescription (OTC = over the counter) drugs should be permitted under certain restrictions. There is a catalog of indications similar to the German HWG, for which public advertising is not possible.
Trend towards more self-medication
In general, there is a growing trend towards self-medication in the EU as consumers increasingly take responsibility for their own health. Responsible self-medication could reduce the number of visits to the doctor and thus lower health costs. At the European level, the AESGP - the European association of manufacturers and depositors of non-prescription drugs - wants to contribute to the further development of responsible self-medication .
At the same time, the European Commission is working on specific liberalizations of the EU directive and proposing expanded information options for HIV, diabetes and asthma patients ("dissemination of information"). Exactly which information may be given to consumers has yet to be clarified in detail; However, package inserts and specialist information are certainly included. The admissibility of this extended information is to be checked in a notification system and accompanied by a national self-regulation system of the pharmaceutical industry [7, 11].
National regulations with advertising bans
However, the regulations in different countries are still completely different:
The UK Pharmaceutical Industry Association, ABPI, has authorized the publication of information on some medicines on the Internet on the grounds that the pharmaceutical industry has the best know-how about medicines. An electronic drug compendium was put online here . However, DTC advertising itself is still prohibited.
In Switzerland only advertising for OTC products is allowed. The introduction of advertising for prescription drugs was rejected because it received little support, not even from the industrial side. This is probably due to the limited size of the Swiss market, for which such advertising expenditure is not worthwhile. Furthermore, cross-border advertising opportunities from Germany are expected as soon as the EU position has changed . On the Internet, Switzerland is striving for practicable framework conditions for the award of a seal of approval for websites of pharmaceutical companies .
DTC advertising has not yet been allowed in Canada either. This legal position is currently being reviewed as much US information is also available in Canada. So far there has been - similar to Germany - a list of diseases in connection with which drugs may not be advertised, and a ban on misleading advertising. At the same time, non-prescription drugs can be advertised to the end user with the name, price and quantity. Certain products may be supplemented with "educational information". There is a voluntary preliminary examination of drug advertising by an organization made up of industry representatives, doctors, medical publishers and consumers .
Prescription drug advertising to consumers is also banned in Australia. However, disease-oriented advertising is permitted without mentioning product names. A relaxation of the ban is unlikely, as there are fears that advertising would focus on new, high-priced drugs, while for old, but still useful drugs, such advertising could not be carried out without drastic and therefore unacceptable price increases.
Current proposals provide that the "Consumer Medicine Information" (comparable to the German information for use) is freely available and z. B. Should be part of press releases. Furthermore, advertising of certain drugs is to be allowed within government education campaigns .
USA: Explosion in advertising spending
In the United States, the legal framework for advertising has been relaxed since the mid-1980s. Branded drug advertising has been permitted since 1997. Formally, the FDA is not required to approve this advertisement, but manufacturers must submit copies and in fact often request prior approval. In 1999 the FDA analyzed 30,000 different advertising materials for consumers, including around 100 TV spots.
In general, there are three types of DTC advertising for pharmaceuticals in the USA:
1. Product advertising under brand names and with detailed product information: Print advertisements must contain a summary including side effects, contraindications, etc., while radio and TV spots have been able to dispense with this brief summary since 1997. Only the main risks and other sources of information (toll-free telephone number, website, etc.) need to be mentioned here.
2. Indication advertising with information on diabetes or similar without mentioning the product.
3. Reminder advertising that is limited to the product name without mentioning the indication and does not have to contain a product summary.
These framework conditions led to an increase in the expenditure for DTC drug advertising (OTC and Rx) from 25 million US dollars in 1988 to 1.8 billion US dollars in 1999 .5 billion US dollars (Fig. 1) . The effects of DTC advertising on the doctor-patient relationship are discussed intensively [16, 20, 3]. However, even fierce critics such as the American Medical Association assume that this form of advertising will continue and that the focus should rather be on the introduction of regulatory frameworks that guarantee a responsible form of advertising.
New Zealand: no increase in advertising spending
In New Zealand, public advertising for prescription drugs has been legal since late 1994, after never having been explicitly banned. According to the Ministry of Health, there had previously been no need for regulation. A test center for DTC advertising has been set up, which is a self-monitoring function of the industry. Your consultation is mandatory; it clears all advertisements for OTC and prescription drugs and is obviously proving its worth.
In 2000, approximately NZ $ 48 million was spent on DTC drug advertising, including about 18 million on prescription drugs. The majority of the expenditure (60%) is invested in TV advertising. The increased advertising for prescription drugs has practically not affected the advertising for OTC products; expenditure here has been more or less stable for years. In New Zealand, DTC advertising includes, on the one hand, brand-specific drug information via mass media such as TV, magazines, and, on the other hand, personalized measures such as letters to patients who have been prescribed certain drugs.
According to New Zealand information, the current literature has not yet proven that DTC advertising increases costs if one also considers the costs saved by drug advertising in other areas of the health system (avoided hospitalizations, etc.) [10, 18].
Pharmaceutical advertising in Germany
In Germany, pharmaceuticals are generally considered to be a special kind of goods that cannot be compared with everyday consumer goods. For this reason, the Heilmittelwerbegesetz (HWG) exists as the only special law for a product-related sub-area of competition law. It also includes advertising messages relating to cosmetics, items and treatments, insofar as they relate to the detection, elimination or alleviation of diseases. In contrast, advertising for all other products is measured solely against the law against unfair competition (UWG) .
At the moment, in Germany, the advertising of prescription drugs is only allowed to specialist groups, while non-prescription drugs can also be advertised to the end consumer. The legislature prohibits public advertising for drugs for the treatment of certain diseases by means of a disease catalog for the HWG. Further bans concern certain advertising methods, such as advertising with before-and-after comparisons and misleading information on the effect and composition of the drug.
In order to make the consumer aware of the special nature of medicinal products, certain mandatory information is required in advertising. When advertising for end consumers, they are mostly limited to the note "For risks and side effects, read the package insert and ask your doctor or pharmacist". More detailed information is mandatory for advertising to specialist groups .
With the entry into force of the law on comparative advertising in September 2000 (implementation of EU Directive 97/55), the prohibition of comparative public advertising for pharmaceuticals was also included in the HWG. This had become necessary because the reformulation of the UWG basically allows comparative advertising. However, laypeople can hardly check comparisons in the complicated field of medical-pharmaceutical relationships and can therefore be manipulated. Only price comparisons for OTC drugs are allowed. Comparative advertising to specialist groups on the basis of Section 2 UWG is generally possible .
Mail order pharmaceuticals
DTC advertising on the Internet is of economic interest primarily because of the mail order business associated with it. German law has so far provided for a mail order ban for pharmacy-only drugs. Accordingly, the HWG prohibits advertising for this unauthorized form of delivery.
The implementation is problematic for providers from abroad who offer their goods and services over the Internet. De facto, there is no legal certainty here. The precedent 0800DocMorris lies with the European Court of Justice for decision.
Meanwhile, the topic of "electronic commerce" is becoming more and more important. Large retail chains and department stores assume that in 2010 20 percent of sales will be generated in this way. In Germany, more than half of all people between the ages of 16 and 69 have access to the Internet, and the trend is rapidly increasing. The topic of health takes a top position among the information retrieved .
Self-medication and advertising
The self-medication market in Germany also confirms the trend towards increasingly self-responsible patients. The ZMG (Zeitung Marketing Gesellschaft) study "Self-medication and advertising", a nationwide representative survey on the use of over-the-counter medicines, confirms the increasing importance of the topic of "health" among consumers.
Fewer and fewer drugs are being prescribed; more and more consumers are using over-the-counter drugs :
- 41% of the respondents justify this with the fact that they do not go to the doctor about every little thing.
- 30% buy their medicines because everything is no longer prescribed
- 26% use the option of self-medication, as a prescription is no longer worthwhile due to the high additional payment.
According to this survey, only two thirds of over-the-counter drugs are bought in pharmacies, and only a fifth of buyers feel they are well advised in pharmacies. According to the results of the ZMG study, the main sources of information for health topics are television (37%), daily newspapers (34%) and pharmacy customer magazines (44%).
28% of the respondents perceive the TV advertising for OTC products as "intrusive", 29% as "exaggerated". With regard to newspaper advertising, only 16% and 15% feel this. Patients who are increasingly responsible for themselves are therefore demanding that pharmaceutical companies provide consumers with information in the form of newspaper advertising (Tab. 1). The industry already takes this into account by increasing advertising expenditure for public advertising and an increasing preference for the "newspaper" medium in advertising expenditure .
The various participants in the pharmaceutical market pursue different interests and therefore have different ideas about how to regulate the advertising of pharmaceuticals to the public. In the second part of this article, the respective point of view of the market participants will be discussed in more detail.
Box text: Consumer Health Care
In March 2001, the first course of the supplementary advanced training course "Consumer Health Care" began at the Humboldt University in Berlin. The participants, who come from different areas of the health care system, deal with the processes of change in the health care markets and investigate the question of the consequences for the consumer as well as for the health professions. Part of the training are project work on current problems in health care, which are to be understood as an offer for discussion and should be published in loose succession.
Further information on the Consumer Health Care course can be found at www.consumer-health-care.de
The literature is published in the 2nd part.
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