Digital Pharmaceutical Communication in the EU Part 2: Legal Issues

In March 2011, the European Commission launched a public consultation on an eHealth Action Plan for the period 2012-2020 that would update the first eHealth Action Plan adopted in 2004.¹ This was preceded by the adoption, in December 2009, of the Council of the European Union Conclusions on safe and efficient healthcare through eHealth, in which the Council recognized the possible contribution of eHealth to healthcare systems.²

In the first installment of this three-part series on eHealth systems and services in the EU, we examined the necessary and progressive adaptation of rules relating to pharmaceutical communication in the context of the Internet. In particular, we explained that, while the flexibility of digital media provided companies with new ways to communicate with healthcare stakeholders more rapidly and at reduced costs, and made it easier to provide up-to-date, complete and verifiable information, it also had resulted in greater legal risks for pharmaceutical companies. We also addressed the specific risks to patient privacy and security entailed by the use of electronic media.

In part 2, we look at specific issues associated with the development of collaborative websites with Web 2.0 features.

Legal Issues in Collaborative Health Websites

The development of collaborative websites and the use of mobile communication devices, such as standard mobile phones, smartphones and tablet computers, to support communication on health issues offer new marketing opportunities. However, despite the well-publicized benefits of using social media, there are regulatory and legal considerations due to the digital and collaborative nature of this medium.

Web 2.0 offers many opportunities for patients, healthcare providers and other stakeholders to generate content, and interact with this content and with other people on collaborative websites, including discussion forums, social networking sites, file sharing sites, wikis and blogs. Facilitating a discussion forum on a third-party website (e.g., a Facebook page or Twitter account) or hosting one of their own can help pharmaceutical and device companies engage with healthcare professionals and patients to gather insights into a particular disease state or class of treatments. Collaborative Health Websites also provide for renewed opportunities for pharmaceutical companies to market their products and engage consumers, in so far as their collaborative features enable them to directly answer questions regarding their products, or obtain consumer feedback and ideas for product development.

But the difficulty in monitoring the interactions between companies, healthcare professionals and patients on collaborative websites raises some legal issues, in particular due to the lack of global oversight of those websites and reduced monitoring over who can access the information that is being published or over who can generate content, resulting in increased liability risks for pharmaceutical companies.

Interactions with the Public on Collaborative Websites

Given the lack of oversight of collaborative websites, health authorities have been reluctant to authorize communications by drug and device companies to the public via such media for fear that the rules relating to communication on medicinal products could be more easily circumvented by the companies themselves or by third parties.

Promotion of Medicinal Products on Social Media

In a decision on 8 July 2011, the French National Agency for the Safety of Medicines and Health Products refused to authorize the creation of a promotional page for a line of hair care products on Facebook.³ Among the reasons given to justify the refusal was the possibility that users would share content or comments that might infringe the rules of the French Code of Public Health. Specifically, "friends" of the users of the promotional page might view their posts and events, and users might employ features such as the "like" button that could constitute a claim of recovery (prohibited by article R.5122-4 of the Code of Public Health), or the "people you may know" feature, which could give access to the profiles of influential people/key opinion leaders and lead to the assumption that they are recommending the product, in breach of article R.5122-4 of the Code of Public Health.

Non-Promotional Communication

Even communications that are not considered promotional may raise some concerns. Discussion forums on health issues should be restricted to health professionals, according to the charter of France's National Agency for the Safetyof Medicines andHealth Products on pharmaceutical companies' online communications, which adapts the rules regarding drug advertising to the Internet.

The features specific to collaborative websites make it difficult for companies to comply with the rules governing patient support and education programs. In France, for instance, patient therapeutic education or assistance programs must be offered and monitored by a physician, and there can be no direct contact between the firm sponsoring such programs and the patients.⁴ Such restrictions may be difficult to implement on a website with interactive content.

Likewise, regulators could oppose the posting of factual informative announcements on social media websites, for instance, communication about a pharmacovigilance concern on a company's corporate Facebook page. On this particular point, the Association of the British Pharmaceutical Industry, while not completely opposing this type of communication, recommended that, when companies are describing adverse events on a social media sites, whether corporate or not, they should only permit one-way communication and restrict interactive dialogue or the creation of user-generated content.⁵

Participation of healthcare professionals in discussion forums involving patients could be interpreted as teleconsulting. Should pharmaceutical companies wish to provide the services of a health professional on the discussion platform they manage, they would need to verify that such activity complies with the numerous restrictions relating to medical consulting.

Interactions with Health Professionals

In contrast with its position against the use of collaborative websites to communicate to the public, the French National Agency for the Safety of Medicines and Health Products authorizes discussion forums for professionals. The French charter, however, requires a Marketing Authorization Holder to designate a person responsible for monitoring discussions on such a forum. The Health on the Net Foundation has developed a set of guidelines for collaborative health websites, whether they are solely intended for health professionals or are also accessible to the general public.⁶

In addition, since engaging with healthcare professionals or key opinion leaders on collaborative websites could be considered an attempt by a pharmaceutical or device company to unduly influence them, all interactions should comply with all applicable regulations and code of good practices, relating in particular to the restriction of gifts given by industry to professionals and rules against bribery.^{7, 8} However, compliance with these regulations on the Internet requires clarification.

Corporate Liability Associated with Collaborative Health Websites

When using collaborative websites to communicate with health professionals, the general public or with patients, companies are subject to extensive liability and obligations.

Liability for Infringements by Users

When they host a discussion forum on their own website or facilitate a discussion on a social media site, pharmaceutical and device companies, acting as "editors of a communication service," can be held liable for other users' infringements of the specific rules on drug advertising or of the more general rules of commercial and competition laws, in accordance with regulations regarding intermediary service providers and with applicable pharmaceutical regulations.⁹

For instance, if forum participants criticize a product commercialized by another company, the organization sponsoring the site or the discussion could be accused of trade libel or unfair competition. The liability of a site publisher could also arise from participants' infringement of rules regarding the promotion of drugs, for instance if a healthcare practitioner discusses the off-label use of a drug.

Because of the links created by collaborative websites, a product-related discussion by health professionals on a forum or discussion platform hosted or sponsored by a pharmaceutical or device company could be regarded as advertising. This is the view of the French National Agency for the Safety of Medicines and Health Products and professional associations such as the Association of the French Pharmaceutical Industry (LEEM) and the Association of the British Pharmaceutical Industry.^{10, 11, 12} Pursuant to the European Court of Justice's rulings/jurisprudence, the dissemination by a third party of information about a medicinal product, including its therapeutic or prophylactic properties, could be regarded as advertising, even if the third party in question is acting on its own initiative and completely independently, de jure and de facto, of the manufacturer and the seller of such a medicinal product.¹³

The opportunity for any user to edit content on a collaborative website under the management or responsibility of a pharmaceutical company, or even on a third-party collaborative website such as Wikipedia, may also generate an obligation for the company to correct misleading or false information about a product, which could give rise to a claim under defective product liability laws.

Also, any website (for instance, a patient or professional association website) chosen by a company to link to from its website should stand up to scrutiny.

Extended Pharmacovigilance Obligations for Companies Facilitating or Hosting a Discussion

As the development of the collaborative web facilitates reporting of adverse drug reactions, they may extend the pharmacovigilance obligations that fall on manufacturers. Indeed, under the European guidelines regarding pharmacovigilance, Market Authorization Holders must "regularly screen websites under their management or responsibility for potential reports on adverse reactions. The Marketing Authorization Holder is not expected to screen external websites for information on adverse reactions. However, if a Marketing Authorization Holder becomes aware of an adverse reaction on any other website, the Marketing Authorization Holder should review the case and determine whether it should be reported in expedited manner. The Marketing Authorization Holder should consider utilising their websites to facilitate adverse reaction collection, e.g., by providing adverse reaction forms for reporting or by providing appropriate contact details for direct communication."¹⁴

References

1. European Commission. "Digital Agenda for Europe." http://ec.europa.eu/digital-agenda/en/about-health. Accessed 12 December 2012.
2. Conclusions on Safe and Efficient Healthcare through eHealth. http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/111613.pdf. Accessed 12 December 2012.
3. Agence française de sécurité sanitaire des produits de santé, Commission chargée du contrôle de la publicité et des recommandations sur le bon usage, Décision du 8 Juillet 2011. ( Decision of the French National Agency for the Safety of Medicines and Health Products Commission on the control of advertising regarding the product Prioderm)
4. French Code of Public Health, articles L. 1161-1 et seq.
5. Association of the British Pharmaceutical Industry, Guidance notes on the management of adverse events and product complaints pharmaceutical company sponsored websites. http://www.abpi.org.uk/our-work/library/guidelines/Pages/safety-data-websites.aspx Accessed 2 May 2013.
6. Health on the Net Foundation. http://www.hon.ch/cgi-bin/HONcode/guidelines_comments_en.pl. Accessed 12 December 2012.
7. See for instance, French Code of Public Health, article L. 4113-6; Code of Practice for the Pharmaceutical Industry 2012, The Association of the British Pharmaceutical Industry.
8. See for instance, French Criminal Code, articles 445-1 et seq.; UK Bribery Act 2010. 
9. Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market ('Directive on electronic commerce'). See also, Loi n° 2004-575 du 21 juin 2004 pour la confiance dans l'économie numérique.
10. Agence française de sécurité sanitaire des produits de santé, Commission chargée du contrôle de la publicité et des recommandations sur le bon usage, Décision du 12 Février 2008. (Decision of the French National Agency for the Safety of Medicines and Health Products Commission on the control of advertising regarding the product Prosoft (Helikit).
11. Direction de l'évaluation de la publicité, des produits cosmétiques et des biocides, Charte pour la communication sur Internet des entreprises pharmaceutiques, mise à jour 2010.
12. Digital Communication, Prescription Medicines Code of Practice Authority (PMCA), (April 2011).
13. ECJ, April 2, 2009, (Damgaard) Case C-421/07. See also, the amended Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards information to the general public on medicinal products subject to medical prescription, "Advertising of medicinal products shall include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products by the marketing authorisation holder directly or indirectly through a third party acting on his behalf or following his instructions".
14. Eudralex, Volume 9A - Information on Adverse Reactions from the Internet.http://ec.europa.eu/health/documents/eudralex/index_en.htm. Accessed 12 December 2012.