EFPIA Basics: 6 RULES OF THUMB every pharma marketer should live by.

Pharmaceutical promotion is governed by strict, science-based rules designed to protect patients and ensure ethical communication. The EFPIA Code is the backbone of these standards. Here are six essential rules of thumb every medical writer and promoter must understand. Check how many of these you already know.

DISCLAIMER. These rules do not represent the whole EFPIA code, full document is available here: EFPIA CODE OF PRACTICE 2019 (Last visited on 30.11.2025.)

RULE 1. If it is not in the SmPC, boot it.

Any indication that is not listed in the SmPC (Summary of Product Characteristics) is considered off-label, even if it is strongly recommended in clinical guidelines. As a promoter, you cannot promote indications that fall outside the SmPC. Ideally, you should quote indications directly from the SmPC.

Example: Semaglutide (a.k.a. Ozempic) is indicated only for the treatment of Type 2 diabetes. Meaning - it cannot be promoted as a weight-loss drug in the EU. (Source: SmPC Ozempic, Last visited 30.11.2025)

RULE 2. If there is a claim, be ready to substantiate it like in a court of law.

This is especially important when comparing a product to competitors - where the ground becomes very slippery. When possible, rely on head-to-head studies, although these are seldom performed because unfavourable results can undermine the product’s unique selling proposition. If no head-to-head data exists, comparing efficacy or other endpoints becomes risky. Only high-quality or meta-analyses, and the latest clinical guidelines can help you substantiate a competitive claim.

Example: Saying “Drug A lowers HbA1c more effectively than Drug B” requires either a head-to-head RCT, or a strong meta-analysis. A single observational study is not enough.

RULE 3. Beware of unsafe words.

Beware of unsafe words.

Avoid using the word “safe” unless it is strictly within the context of a comparative statement (e.g., when safety endpoints differ between drugs in the same study). No medicinal product is 100% safe, even drinking too much water can have adverse consequences, let alone chemical compounds.

The word “new” can only be applied to products that have been available or promoted for less than one year.

Example: Don't say: “This drug is completely safe.”

Say: “In RCT (Randomised Clinical Trial) X, Drug A showed fewer gastrointestinal side effects than Drug B.”

RULE 4. Choose the strictest rule to follow.

National rules vary between countries, so always check your target country’s regulatory guidelines. When national rules are vague but the EFPIA Code is specific - or vice versa -follow the stricter requirement. This places you in the safest regulatory position.

When promoting in countries outside the EU (e.g., the US), only national rules apply. EU laws have no jurisdiction there.

Example: If EFPIA requires a disclaimer but the national code does not, include the disclaimer anyway. Safer is better.

RULE 5. Comply with GDPR when distributing promotion.

If you distribute promotions via channels that use personal information - email, phone number, WhatsApp - you must have clear consent, unless the information is publicly available (e.g., listed on the hospital website). Always include an unsubscribe or opt-out mechanism. GDPR fines can reach 4% of annual global revenue - and yes, major companies have paid them.

Example: Sending a promotional newsletter to a doctor because you found their email in a CRM from 2018 is not compliant unless you have a documented consent.

Check how you comply with this official GDPR Checklist for Data Controllers.

RULE 6. Put patients first - always.

This is where commercial needs must remain separate from science. They cannot mix when conducting or planning clinical studies. Forget about promotion during the study phase. If you must mobilise medical representatives, proceed with extreme caution - the EFPIA Code requires proper training and involvement of med reps strictly in an administrative capacity. All promotional activities must follow Good Clinical Practice (GCP) and Good Pharmaceutical Practice (GPP) principles.

Example: When choosing endpoints for a study, base them on similar studies, not on suggestions from commercial bodies.

Following EFPIA rules is not just about avoiding fines - it builds credibility, protects patients, and keeps your brand’s reputation clean. Ethical promotion is good science, good business, and good medicine.