Local compliance support for pharmaceutical and biotech companies working in Germany, connecting German law and the FSA's self-regulatory codes to your global governance, with a named DACH business partner.
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Local expertise · Global delivery
For international pharmaceutical and biotech companies with German activities, DACH teams working within a global compliance model, and companies preparing their first German launch. Start from the activities you plan in Germany and whether your company is an FSA member.
German requirements come from two directions: statutory law, including the HWG and the healthcare anti-corruption offences in the Criminal Code, which applies to everyone, and the FSA codes, which bind member companies. A global policy often treats these as one layer. Teams also need to record why each HCP engagement is needed and how its compensation was set, so the same file supports an HWG review, an FSA code check and disclosure.
From requirements to action
Working with our DACH business partner, we can map your German activities against the HWG, §§ 299a–299b StGB and the relevant FSA codes, then build the result into your SOPs, approval routes and disclosure process. Outputs can include an activity register, a responsibility matrix, review templates and a prioritised action plan. Where German legal advice is required, we identify that need before delivery.
What we can take on
What this gives you
Germany requirements built into your global processes
A named local partner for questions and escalation
Local support without unnecessary fixed headcount
The rules in Germany
A short guide to the main legal and self-regulatory frameworks. Each summary links to its official source below.
The FSA (Freiwillige Selbstkontrolle für die Arzneimittelindustrie e.V.) is the industry's self-regulatory body; its member companies account for around 75% of the German pharmaceutical market. Its codes cover collaboration with healthcare professionals and medical institutions (FSA-Kodex Fachkreise), cooperation with patient organisations (FSA-Kodex Patientenorganisationen) and transparency (FSA-Transparenzkodex). Breaches can lead to fines and, in serious cases, public reprimands.
The Heilmittelwerbegesetz (HWG) governs advertising in the healthcare sector. Section 7 prohibits offering, announcing or granting gifts and other promotional benefits, and prohibits healthcare professionals from accepting them, subject to narrow exceptions such as items of low value.
The German Criminal Code makes it an offence for a healthcare professional to request or accept an advantage (§ 299a), and for anyone to offer or grant one (§ 299b), in return for unfairly favouring another party when prescribing medicines, medical aids or devices, purchasing them for direct use, or referring patients or examination material.
Under the FSA-Transparenzkodex, member companies commit to transparency about their collaboration with healthcare professionals and healthcare organisations, alongside the EFPIA Code disclosure framework that applies across Europe.
Your local partner
Hans provides compliance business-partner support across DACH, bringing local context into global governance and operating models.
This overview is informational and does not constitute legal advice. Scope and application should be confirmed for the organisation, market, activity and counterparty in question. Sources checked September 2026.
Questions, answered
The FSA codes bind FSA member companies. Whether and how they apply to you depends on membership and your activities in Germany, and we confirm this at the start of each engagement. German law, including the HWG and the StGB, applies regardless of membership.
Yes. We review planned engagements, hospitality and promotional items against the HWG, the relevant FSA code and your global policy, and document the rationale and approvals.
Not necessarily. Many compliance-support needs can be met through a named local business partner working within your global compliance model. The right set-up depends on your legal obligations and activities.
We will listen, ask a few questions and recommend the right scope—without obligation or pressure.
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