Drug advertising: New directions from Europe
Europe is not making any revolutionary changes when it comes to the advertising of medicines. If the recent proposal to reform the Framework Directive on Medicinal Products 2001/83/EC, adopted by the European Commission on April 26, is confirmed in its current incarnation, little will change in the legal limits on advertising medicines to the public and to doctors. The proposal, which is part of a broader pharmaceutical legislation reform launched in the EU (text available on the European Commission website), does not make substantial changes to communication: Articles 175 to 187 basically reproduce the content of the current Title VIII of the directive (Article 86 et seq.) with any changes mere formalities.
While the general framework for advertising medicinal products will remain largely the same, there are still noteworthy changes:
- the definition of advertising of medicinal products is expanded to include (a) advertising addressed to persons authorized not only to prescribe and dispense medicinal products, but also to administer them (essentially nurses) and (b) advertising relating to medicinal products in general that does not name specific medicinal products (a principle that clearly follows from the recent ruling of the Court of Justice of December 22, 2022, Case C-530/20); and
- pharmacists may also provide free samples of nonprescription drugs (this provision follows from the Court of Justice ruling of June 11, 2020, Case C-786/18).
These provisions strengthen the role of pharmacists and nurses as targets of promotional/communications campaigns for drugs in the wake of rulings from the Court of Justice and the changes made to the Farmindustria Code in April 2022.
There is no doubt that communications aimed at doctors and patients are of critical importance for pharmaceutical companies, and that the increasing use of digital channels to interact with the public and various stakeholders poses new challenges regarding the responsibilities and burdens of pharmaceutical companies that use such tools.
Although the principles and rules underlying proper communication remain those established by the general rules, starting with Directive 2001/83/EC, transposed at the national level in the Medicines Code (Legislative Decree 219/2006), specific contexts for communications on the web (company and third-party websites, blogs, forums, and so on) and on social-media platforms require companies to take additional precautions. They must consider a potentially infinite audience of recipients and the new opportunities for interaction that digital tools offer.
The position of the IFPMA and EFPIA
Internationally, this issue was recently addressed by the Joint Note for Guidance on Social Media and Digital Channels published on September 28 by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). This note outlines the principles for companies to follow when using digital channels, previously set forth in Annex 2 of the EFPIA Code. The document is not binding, but it is a useful guide to applying European and national regulations to pharmaceutical communication in the digital world.
Communication and advertising
Companies that undertake communication campaigns on digital channels must first consider the distinction between merely informational activities and advertising as an action in any way “intended to promote the prescription, supply, sale, or consumption of medicinal products,” as defined in Article 113 of Decree 219/2006 and Article 86 of Directive 2001/83/EC. Indeed, while non-promotional communication is basically unrestricted and not subject to constraints from a strictly regulatory point of view, advertising of medicines is subject to the strict regulation of the Italian Code of Medicines, which in some cases prohibits it and in others imposes ad hoc rules and procedures, depending on whether the advertising is addressed to the public or to doctors. Only nonprescription medicines can be advertised to the public, and that advertising must be authorized in advance by the ministry in accordance with Article 118 of Legislative Decree 219/2006. Materials addressing doctors must be filed in advance with the AIFA (Italian Medicines Agency). The broad scope of the above definition of advertising was reinforced by a recent ruling of the European Court of Justice on December 22, 2022, in Case C-530/20. That ruling classified a sales initiative involving discounts and other promotional offers on drugs as advertising, even though it concerned unspecified drugs and not specific, clearly identified products.
Under an express legislative provision, the following are not advertising of medicinal products:
- labels and package leaflets;
- correspondence answering a specific unsolicited request for information on a particular medicinal product;
- factual information and reference documents concerning, for example, packaging changes, adverse-reaction warnings in the context of pharmacovigilance, and sales catalogues and price lists, provided that no information about a medicinal product is included therein;
- information relating to human health or diseases, provided that it does not reference a medicinal product, even indirectly (disease awareness).
In addition, institutional advertising remains outside the scope of the Code of Medicines. This is advertising that “promotes the image or logo of a company, without covering products that are in any way connected to that company, including indirectly,” as defined by the ministerial guidelines on the advertising of nonprescription drugs.
Transparency about company involvement
Companies that communicate on digital channels are saddled with heavy transparency burdens, as the digital environment is fertile ground for misunderstanding and gray areas in relation to authorship of information addressed to doctors and patients. This includes information published on websites, blogs, forums, and social media belonging to third parties and not directly connected to the company. For these reasons, companies must be fully transparent about the information materials they produce, sponsor, finance, or support in any way, including on the web. They must make clear the following:
- whether the message originates from the company;
- if the message comes from a third party, whether the company has influenced its content in any way;
- whether the relationship is one of mere sponsorship, as represented by the familiar phrase “with the unconditional contribution of” on company-sponsored messages.
The Farmindustria Code of Conduct
This rule is set out in black and white at the international level by the EFPIA code (as well as by the joint note mentioned above), while at the national level it is contained in the Farmindustria Code of Conduct. It requires that any website set up by an Italian company or operating in Italy that addresses the public or Italian organizations clearly identify “the sponsor, the source of all the information on the site, the audience for such information, and the objectives of the site,” and must also guarantee access to areas reserved for medical professionals and pharmacists for all advertising content addressed to them (Article 4. 5), so that such content cannot be accessed by the general public. The AIFA Q&A document on scientific medical information, updated on May 3, specifies that the registration procedure for these reserved areas must use an appropriate means of ascertaining the user’s true identity.
As a general rule, companies are responsible for all content on digital channels, including social media, that has been produced, branded, and/or sponsored by the company or a third party acting on its behalf. Of course, there may be different levels of liability depending on whether the content originates directly or indirectly (commissioned from a third party) from the company, or is independently developed by a third party and then merely sponsored by the company. In the latter case, there may be scenarios in which the liability for incorrect communication is borne entirely by the third party—for instance, if a pharmaceutical company does not view or control the content and merely provides financial support.
Scope of monitoring
The company’s responsibility in the digital environment can also be broken down into IT security, proper monitoring of activities, and pharmacovigilance. With reference to monitoring, the company cannot be generally required to monitor all online content potentially related to its business. However, it must monitor all content on company pages and third-party pages that it commissioned or sponsored. There is also potential liability for independent third-party content, e.g., content on social media, if the content is associated with a hashtag that can be traced to the company and the company has failed to implement appropriate measures after becoming aware of unlawful content.
Role of employees
Regarding liability for content disseminated by employees, possibly on private profiles and accounts, as stated in the IFPMA/EFPIA joint note, generally a company can be held liable if in a message the employee can be reasonably said to appear to be a representative of the company and the company in any way determined, directed, or facilitated dissemination of the message. With regard to pharmacovigilance, the guidelines on Good Pharmacovigilance Practices (GPP) explicitly place the onus on the marketing authorization holder to carry out regular checks and oversight of channels under its management or responsibility to search for potential reports of adverse reactions that should be reported to the authority, offering the holder an opportunity to use the web to facilitate collection of reports of suspected adverse reactions.
Precautions for companies
The main precautionary measure to mitigate the risks of potential corporate liability for content disseminated on the web is to adopt specific guidelines and policies for online communications and pharmacovigilance, including identifying the specific channel of reference when applicable. There may be a need for ad hoc rules for using social media in particular (and also blogs and forums), as it allows ample opportunity for user interaction. This should incorporate employee and third-party service provider training sessions, as well as advance identification of which roles will operate online on behalf of the company.
Agreements with providers
When outsourcing communication services and/or management of corporate platforms to third parties, setting forth the provider’s obligations specifically in the contract is equally important. This starts with specific clauses on the content that may be disseminated on various channels (and content that must not be disseminated). Contracts should also include provisions on damages and compensation for the company in the event of a provider’s failure to meet contractual obligations. Although such clauses, do not a priori exclude company liability with both web users and oversight authorities, they may nevertheless mitigate harmful consequences.