The regulatory landscape in the EMEA region
As innovations in global healthcare continue to be explored, there is a heightened urgency among industry professionals to understand the rules of clinical trial recruitment, how they vary by region and what they mean for using digital channels such as online advertising, search engine marketing and social media to engage prospective participants.
This column, the second in a series comparing regulatory landscapes around the world, focuses on EMEA, which covers Europe, the Middle East and Africa.
In the commercialization of biopharmaceutical products, direct-to-patient promotion is generally restricted in EMEA. This has created some confusion when it comes to trial recruitment, particularly with regard to the use of digital and social channels. But throughout most of EMEA, the ability to promote clinical trials directly to patients is consistently allowed. And in many countries, the use of digital and social channels is not expressly restricted. The key is that communications cannot promote a company or product, nor imply any therapeutic benefit.
EMEA has two types of countries: those that allow use of digital and social, and those that set limits. The countries I call the “allowers” still require adherence to the same patient recruitment guidelines established for conventional channels. Belgium, like most countries in EMEA, approves promotions through an Ethics Committee (EC) composed of physicians subject to the ethical rules issued by the Physicians’ Association. Bulgaria stipulates advertisements may not contain medical terminology and must be understandable for the participant.
Throughout Scandinavia, recruitment is allowed via the internet or social media. Scandinavian rules focus on the tone of promotions: wording should be neutral and informative and shall not include value-laden expressions or arouse unrealistic expectations. Finland stipulates there be sufficient time for reflection before deciding to participate. There also is a widely accepted view of digital. Denmark, for instance, requires promotions include a web address if using web sites for recruitment.
Online recruitment currently occurs in France, and certain ECs and the professional association of physicians (Ordre national des médecins) have acknowledged the increased use of digital communications in recruitment. Only Switzerland has called out specific restrictions on the use of no-name advertisements, such as QR codes with no accompanying copy.
The countries I refer to as the “limiters” combine a rigid, rules-based approach with subjective reviews. In Austria, approvals for recruitment activities are granted on a case-by-case basis, dependent on product type. While there are no explicit restrictions on digital advertising, there are general provisions of unfair competition laws and guidelines issued by medical facilities—notably that promotions must not be misleading, aggressive or unfair, and should include the name and address of the clinical investigator, purpose of the study, overview of inclusion criteria, direct and honest description of potential incentives to participate, location and a contact person.
In Hungary, a CRO may not recruit patients directly, but it may organize recruitment through the healthcare service provider conducting the trial, patient or professional organizations or sponsor. Online recruitment is allowed, and healthcare service providers may recruit patients via their own homepages. No rules against Facebook and Twitter exist, but there must be a clear link to the homepage of the research site/sponsor/patient organization. Recruiting patients in the course of a professional lecture or presentation is not allowed.
The Israeli Ministry of Health (MOH) Guidelines for Clinical Trials in Human Subjects permit only mass media advertisement of clinical trials in written format, which must follow “Form 10,” a one-page standardized form. Where a different text is required, it must be approved in advance by the MOH. Use of rich content in the digital space would not be permissible.
Spanish law does not specify which media may be used, or what restrictions apply. Both depend on the nature of the trial. Approval of media and advertisement is determined on a case-by-case basis by the relevant EC. Spanish legislation requires companies to submit a description of the recruitment strategy and, if by advertisement, information about the media, copies of the ads, procedures to take care of subjects responding to the ads and rules for the collection and treatment of their personal data.
South Africa requires submission of recruitment advertisements and media plans for review by the EC. While there is little precedent for digital and social media in recruitment, the growth in mobile adoption has led to calls for greater use of mobile applications to improve health access and outcomes. This will be a region to watch closely as governments react to dynamic changes in technology and disease.
In Turkey, there is no clear prohibition of recruiting patients online, but in practice there are no examples of any advertisements other than posters and brochures in healthcare institutions. Sponsors are hesitant about whether it would be permissible to advertise for patient recruitment other than in healthcare institutions. As there is no clear rule on advertising trials, there also is no clear restriction on recruitment. If we assume advertising is permissible, general rules relating to consumer protection apply.
Matthew Howes is head of strategic services at inVentiv Digital + Innovation, the digital center of excellence for inVentiv Health.
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