Webinar: Ensuring Promotional Materials’ Compliance in Europe

In our industry, advertising of medicinal products is held to even higher standards than in other industries due to the potential impact on consumer health.

The Directive (2001/83/EC) outlines the requirements for advertising medicinal products. While this directive sets out the goals that all EU countries must achieve, each individual member state has the freedom to interpret some concepts differently or have additional requirements, resulting in a granularity of requirements across the EU.

In addition to legal requirements, the pharmaceutical industry has committed to complying with additional self-regulatory codes to improve transparency and ethical standards in communications and interactions with stakeholders such as healthcare professionals (HCPs), healthcare organizations, and patient organizations.

What Constitutes a Promotion

Before we delve into the granularity of requirements for promotional materials and advertising of medicinal products, it is important to define what constitutes a promotion.

According to the Directive on Medicinal Products, advertising of medicinal products includes any form of door-to-door information, canvassing activity, or inducement designed to promote the prescription, supply, sale, or consumption of medicinal products. This includes specific activities such as advertising to the general public or to healthcare professionals, medical sales representatives visiting healthcare professionals, and sponsorship of promotional meetings or scientific congresses.

However, not all activities related to medicinal products are considered advertising. For instance, labelling and non-promotional communication to answer specific unsolicited questions are excluded from the definition. Additionally, factual and informative announcements that do not include product claims, and health or disease awareness campaigns that do not reference medicinal products are also not considered advertising.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) defines promotion as any activity undertaken, organized, or sponsored by a member company that promotes the prescription, supply, sale, administration, recommendation, or consumption of its medicinal products.

Further Considerations for Compliance

In the highly regulated world of pharmaceuticals, compliance is key. One misstep in promoting a medicinal product could result in serious consequences for the company, including hefty fines and damage to its reputation. While European and local legislation is legally binding and compliance is non-negotiable, applicability of code of ethics established by self-governing bodies may vary for non-member companies. However, unethical advertising (even when not illegal) can still have serious implications.

Disguised promotion is strictly forbidden. Any promotional material sponsored by a company must clearly indicate that it has been sponsored, and must not resemble independent editorial matter. Clinical assessments, post-marketing surveillance, post-authorization studies, or similar activities must be conducted with a primarily scientific or educational purpose rather that “pretend activities” which act as disguised promotion.

It is only allowed to promote medicinal products with marketing authorization in a specific country. All parts of advertising must comply with the particulars listed in the summary of product characteristics. Promotion must be accurate, balanced, fair, objective, and sufficiently complete. It must be based on an up-to-date evaluation of all relevant evidence and reflect that evidence clearly. All promotional materials shall be designed with target audience in mind (general public or health care professionals). The contents of the advertising will largely depend on the target audience, as the requirements are very different.

The Marketing Authorization Holder (MAH) must keep a sample of all advertisements emanating from their undertaking, along with a statement indicating the persons to whom it is addressed, the method of dissemination, and the date of first dissemination. The company must establish a scientific service responsible for information about its medicinal products, including a medical doctor or pharmacist responsible for approving any promotional material before release. This person must certify that the material complies with the Applicable Code(s) and any relevant laws and regulations, is consistent with the summary of product characteristics, and is a fair and truthful presentation of the facts.

National Considerations

Member States have varying requirements for marketing materials, mandatory claims and involvement of governing bodies in oversight also differs significantly. Minimum information to be kept available and retention periods for marketing materials, need for notification or approval of materials by NCA, national definition of HCP shall be considered before any promotional activity takes place. Materials approved for use in one country may not necessarily be acceptable in another market, thus marketing strategies might require tweaking to suit local market standards.

Moreover, there are also risks associated with materials which are not considered promotional. For example, corporate materials or press releases shall be carefully assessed if they constitute promotional elements (and how they are disseminated) if they discuss Rx products, as promotion of prescription-only medicines is not allowed to general public in EU. Another example is public health campaigns – they are not considered promotional unless they have any reference, even indirect, to medicinal product. Therefore these materials must be carefully reviewed to make sure that they are qualified correctly.

Summary

Pharmaceutical companies must carefully navigate complex regulations and guidelines as well as “grey-areas” when marketing their products. Compliance is non-negotiable, and any missteps could result in serious consequences, therefore all decisions require thorough understanding of country specific requirements and risk assessment.

For more information, be sure to check the webinar on this topic below and here you can read other news.