Marketing claims under medical review: a workflow for several languages
In healthcare, every claim and every form touches regulation. I run content in local languages through translation checks and medical claims rules. What follows is a workflow for claims, translations and forms, and a short list of checks.
Two audiences, two sets of rules
In the EU, Directive 2001/83/EC requires Member States to prohibit advertising prescription-only medicines to the general public (Article 88(1)(a)). Advertising to healthcare professionals is allowed within the rules of the directive and of national law, and industry codes add further detail. Clinics, laboratories and other health services are not medicines. Their claims about safety and results are still regulated, and the rules differ by country. Start by listing, for each piece of content, who will read it and which country’s rules apply.
One claims library
Keep every approved claim in one list. Writers draw from it, and a new claim goes through review before anyone uses it. Each entry records:
| Field | Why it matters |
|---|---|
| Wording in each language | Translations match the approved text |
| Source (study, label, certificate) | The reviewer can check it |
| Approved by, and date | There is a record of who decided |
| Review date | Claims expire when evidence or certificates change |
| Where it is used | You can find every page and ad when a claim changes |
When a claim changes or is withdrawn, the library shows every page, ad and email that uses it, and you update them in one pass.
Local languages
A translation is not a copy of the original. Each language version is checked against the library, and a glossary of approved terms stops the same medical term from being translated in three different ways. Where the claims are medical, the reviewer should be someone who knows the subject and reads the language.
The workflow
- Draft from the library.
- Check the draft against the approved claims and terms.
- Send anything new to medical review.
- Check forms and data collection for privacy.
- Publish.
- Log what was approved, by whom and when.
Text that is unchanged from the library does not need medical review again. That keeps the review for the content that actually changed.
Forms count as content
Every form that collects health or contact data has a purpose, a consent text and a retention period. Review them together with the claims. GDPR treats data concerning health as a special category (Article 9), so a form that asks about a condition needs a valid legal basis, for example explicit consent.
Where AI fits
AI assistants can draft and translate text, and check it against approved terminology and claims rules. They should not approve anything: a person signs off. The usage rules say which kinds of content an assistant may touch. The assistants I set up work in several languages and from approved terminology and claims rules.
In pharma terms, this is medical, legal and regulatory review, often shortened to MLR. My experience is running content through claims and translation checks in healthcare, not inside a pharmaceutical MLR system, so I do not describe any company’s process.
What to check first
- Is there one list of approved claims, or is the wording scattered across files?
- Does every claim have a source and a review date?
- Who checks translations, and against what?
- Are forms and consent texts reviewed together with the content?
- Is it logged who approved what, and when?