Pharmaceutical Advertising: No Liberalization of Advertising for Prescription Drugs
Pharmaceutical advertising is regulated by the Act on Advertising in the Health Care System [HWG]. Courts regularly must decide which information about prescription drugs (Rx compounds) may also be made available to consumers and the means by which Rx compounds can be advertised. Pursuant to Section 10(1) HWG, advertising outside of professional circles (physicians, dentists, veterinarians, pharmacists and person authorized to deal in such drugs) is not permitted. This year, the European Commission, accompanied by considerable interest in the sector, also took up this question.
At the end of September, the first part of the " Pharmaceutical Package," which concerned the amendment of Directive 2001/83/EC for the creation of a Community Code for Human Drugs (Community Code), was adopted in the European Parliament. It contains new regulations on the prevention of drug counterfeiting, on consumer information about Rx compounds as well as on drug safety oversight (pharmacovigilance). As was already seen in the run-up to the vote, the parliamentarians rejected the original plans of the EU Commission, a far-reaching liberalization of regulations on drug advertising. In particular, they spoke out against relaxing the advertising prohibition on prescription drugs. Acceptance by the Council of Ministers should take place shortly. The new regulations will then become effective 18 months after publication in the Official Journal.
The EU Parliament is not focusing on information coming from the pharmaceutical manufacturer, but rather through the internet portals of independent operators. In Germany, one such portal is run today by Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen [Institute for Quality and Efficiency in Healthcare] (http//www.iqwig.de/). Facts about products, as well as symptoms and non-medicinal treatment alternatives, are to be provided on these internet portals. As before, only information approved by the relevant authorities is to reach patients, thus either the mandatory information pursuant to Section 4 HWG (package insert, "patient information leaflet") or other information already reviewed (professional information pursuant to Section 11a of the Pharmaceutical Act [AMG]).
If companies want to prepare information in a different manner, it must again be reviewed and approved by the authorities. Moreover, in the future the most important information in the package insert must be contained in a clear and understandable manner in a "Fact Box."
With the new Directive, politics stands opposed to the tendencies seen in the last years in the jurisprudence towards liberalizing the law on medical advertising. It remains to be seen whether this jurisprudential trend will continue in light of the new directive. Below, the jurisprudence on permissible advertising for Rx compounds will be outlined and the potential consequences of the current EU legislative process delineated.
The advertising prohibition of Section 10(1) HWG for Rx compounds is aimed in particular at preventing self-medication and not influencing the physician's freedom to write prescriptions. It flanks the prescription obligation under Section 48 AMG. In order to achieve these goals, the advertising concept in medical advertising law is traditionally construed relatively broadly. In this respect, it encompasses each product- and service-related sales advertisement for prescription drugs. Pure company advertising (image advertising), which generally advertises the company's reputation and ability without reference to particular compounds, is not subject to the advertising prohibition. To draw the distinction, the overall appearance of the advertisement, for example, the design, the context of the advertising or the content, is determinative. The borders are often fluid.
If the company is not in the foreground, but a specific compound instead, the pharmaceutical manufacturer is not permitted to appeal to consumers with information about prescription medicines even if it is objective and accurate. The EU Commission has, however, acknowledged the contradiction of this advertising prohibition (also contained in the EU Community Code) as the model of the undeceived European end consumer. This led to the Commission proposal of relaxing the strict information prohibition. It was strongly curtailed in the course of the EU legislative process.
The advertising prohibition of Section 10(1) HWG was partially corrected in jurisprudence to the effect that consumers may be made aware of drug law mandatory requirements. Differentiation must be made, however, as to the ways the information reaches the consumer. Statements contained on the packaging or in the package insert, such as mechanisms of action or indications for use, are unobjectionable. Such a correction of the basic prohibition has not taken place, however, to the extent the information contains an "advertising excess." Exempted are only statements, which the manufacturer is legally obligated to make (cf. Section 11 et seqq. AMG). Any more extensive provision of information is not permitted.
The manufacturers are themselves responsible for ensuring that the statements made are not in violation of medical advertising law. If the Federal Institute for Drugs and Medicinal Products does not object to the documents attached to the approval application or has not used them as grounds for sanction, this still does not necessarily mean the authorities view them as unobjectionable from the point of view of medical advertising law.
A violation of the prohibition on public advertising can arise not only from content but also the type and means of dissemination of the information, even if it is in itself unobjectionable under the principles described above. There is broad consensus in the jurisprudence that the use of the packet insert in display windows, newspapers ads or in TV advertising is not permitted because this information confronts the consumer unsolicited. This will also remain the case in the future. The original proposals of the EU Commission to generally permit dissemination through such push-media in the interest of better consumer information are off the table.
The courts are split on the issue of whether or when the reproduction of a package or package insert on a non-password protected part of an internet page violates the advertising prohibition. Because the internet - unlike push-media - is a passive medium, reproduction of usage information and statements as to indications are considered permissible to some extent.
Thus, the Munich Higher Regional Court classifies the standby of a package insert for retrieval on an internet page whose domain includes the name of the medicine as advertising not subject to medical advertising law because those statements exactly correspond with drug law requirements and are sought out by the end consumers themselves.
Unlike in the case of print or TV advertising, the customer does not randomly come across the advertising. Because the page can be accessed only when the correct product name is entered, the advertising prohibition does not attach under an interpretation in conformance with European law.
The Hamburg Higher Regional Court, on the other hand, still views user information on the internet as advertising, because it raises interest in prescriptions and uses. It is irrelevant that the statements made available are mandatory information under drug law. When using mandatory information there would only be room for a normative correction if the information were necessarily brought to the attention of the consumer as part of the prescription process. Just as voluntary references to prescription drugs, statements on a manufacturer's web page are not made on the basis of any legal obligation.
In light of this difference of opinion, the decision in a preliminary proceeding at the European Court of Justice (ECJ) regarding the presentation of drugs on the internet is awaited even more anxiously. In a July 16, 2009 decision, the Federal Court of Justice ("FCJ") submitted to the Luxembourg justices the question whether Article 88(1)(A) of the Community Code covers public advertising for prescription drugs "if it alone contains all information that the approval authorities were presented with as part of the approval procedure and is already made available to each who acquires the compound, and the information is not presented to the interested party unsolicited, but is only made available on the internet to those who themselves makes the effort to obtain it."
Conclusion: Looking at the view favored in Strasbourg of patient information through independent internet portals, the ECJ decision is extremely topical. It will be a question of whether the ECJ views information from the manufacturer in the interest of the information need of the mature patients as being necessary in addition to the official web portals to be established pursuant to the new guidelines. If the court does not see such a new need, the information landscape will shift sharply to offers from independent providers in respect of prescription drugs on the internet.
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