Why use external counsel for an internal investigation rather than the in-house team?

Independence and privilege. An investigation led by outside counsel is structurally separated from the function under review, which supports the credibility of the findings before a board, an auditor or an authority such as Swissmedic. In Switzerland, communications with an external lawyer can attract attorney professional secrecy, whereas an internal compliance file generally does not enjoy the same protection. Independent conduct also reduces the risk that the review itself is challenged as conflicted.

Which Swiss rules govern kickback and benefit concerns in the medicinal-products sector?

The integrity provision in Art. 55 HMG prohibits persons who prescribe, dispense, use or purchase prescription-only medicinal products, and the organizations that employ them, from soliciting, accepting or granting an undue advantage, subject to defined exceptions such as benefits of modest value and equivalent consideration. The transparency obligation in Art. 56 HMG governs the disclosure and pass-through of purchasing discounts and rebates. The healthcare-integrity ordinance (VITH) sets out the operational detail. Corruption involving public-sector actors is separately addressed by Art. 322ter StGB, and private-sector bribery by Art. 322octies StGB.

What does a MedTech distribution-practices audit cover?

It reviews how products reach the market through distributors, agents and tender channels, and tests those arrangements against the competition rules that apply to distribution: for example resale-price and territorial restrictions, rebate and bundling structures, and exclusivity. The audit is confined to distribution practices; GAWEL Legal does not advise on merger control or general cartel matters. The output is a documented assessment of where current arrangements carry legal exposure and how they can be adjusted.

How does pre-acquisition compliance due diligence fit an acquisition timeline?

It is scoped as a discrete phase that runs alongside the commercial and financial reviews. GAWEL Legal reviews the target's integrity and distribution arrangements, historical promotional conduct and any open compliance matters, and reports findings that bear on valuation, representations and post-closing remediation. The work is legal due diligence on the target's compliance position; it is not corporate or transactional structuring, which GAWEL Legal does not provide.

Compliance and investigations

GAWEL Legal conducts internal investigations and compliance audits for pharma and MedTech under the HMG, VITH and StGB, starting with a fixed scoping fee. The work covers confidential reviews of suspected kickbacks, off-label promotion and other healthcare-integrity issues, audits of MedTech distribution practices and pre-acquisition compliance due diligence, led by counsel independent of the function under review, with later phases on a capped fee.

Discuss a confidential matter View scope

A confidential legal review

Define the concern: Scope and legal basis
Establish the facts: Documents and interviews
Report the findings: Assessment and corrective steps

Counsel is independent of the function under review.

Who this is for

Pharma affiliates responding to an internal compliance concern or a whistleblower report
MedTech companies whose distribution practices have come under scrutiny
Private-equity and strategic acquirers of Swiss or German life-sciences targets

Scope

Independent internal investigation:
confidential legal review of a specific concern such as a suspected kickback, off-label promotion, or a benefit that may breach the integrity provision in Art. 55 HMG, led by counsel independent of the function under review
Healthcare-integrity assessment:
testing arrangements against the integrity rule in Art. 55 HMG and the transparency obligation on discounts and rebates in Art. 56 HMG, and against the healthcare-integrity ordinance (VITH)
Corruption-exposure review:
where the facts touch bribery, assessment against the provisions on bribery of public officials (Art. 322ter StGB) and private-sector bribery (Art. 322octies StGB)
EU and German integrity rules:
for arrangements that reach the EU or Germany, assessment against the ban on inducements to prescribers in Art. 94 of Directive 2001/83/EC as transposed nationally, the restrictions on promotional benefits in § 7 of the Heilmittelwerbegesetz, and the healthcare-bribery offenses in § 299a and § 299b of the German Criminal Code
MedTech distribution-practices audit:
review of distributor, agent and tender arrangements against the competition rules that apply to distribution; confined to distribution practices, not merger control or general cartel matters
Pre-acquisition compliance due diligence:
a discrete review of a target's integrity, distribution and promotional conduct, with findings relevant to valuation, representations and post-closing remediation
Findings and remediation:
a documented assessment and recommended corrective steps, delivered in phases

How the work proceeds

Scoping A confidential scoping engagement defines the question, the boundaries of the review and the legal basis.
Fact-gathering Relevant documents are collected and, where appropriate, interviews are conducted by counsel, structured so that attorney professional secrecy can apply.
Legal assessment The facts are assessed against the applicable integrity, distribution and corruption rules.
Reporting The report records findings and recommended corrective steps for the intended recipient: board, auditor or authority.
Remediation support Implementation and any required disclosure are supported under a defined follow-on engagement.

Fees

Fixed scoping + capped phases

Subsequent phases run on a capped fee.

Questions

Why use external counsel for an internal investigation rather than the in-house team?: Independence and privilege. An investigation led by outside counsel is structurally separated from the function under review, which supports the credibility of the findings before a board, an auditor or an authority such as Swissmedic. In Switzerland, communications with an external lawyer can attract attorney professional secrecy, whereas an internal compliance file generally does not enjoy the same protection. Independent conduct also reduces the risk that the review itself is challenged as conflicted.
Which Swiss rules govern kickback and benefit concerns in the medicinal-products sector?: The integrity provision in Art. 55 HMG prohibits persons who prescribe, dispense, use or purchase prescription-only medicinal products, and the organizations that employ them, from soliciting, accepting or granting an undue advantage, subject to defined exceptions such as benefits of modest value and equivalent consideration. The transparency obligation in Art. 56 HMG governs the disclosure and pass-through of purchasing discounts and rebates. The healthcare-integrity ordinance (VITH) sets out the operational detail. Corruption involving public-sector actors is separately addressed by Art. 322ter StGB, and private-sector bribery by Art. 322octies StGB.
What does a MedTech distribution-practices audit cover?: It reviews how products reach the market through distributors, agents and tender channels, and tests those arrangements against the competition rules that apply to distribution: for example resale-price and territorial restrictions, rebate and bundling structures, and exclusivity. The audit is confined to distribution practices; GAWEL Legal does not advise on merger control or general cartel matters. The output is a documented assessment of where current arrangements carry legal exposure and how they can be adjusted.
How does pre-acquisition compliance due diligence fit an acquisition timeline?: It is scoped as a discrete phase that runs alongside the commercial and financial reviews. GAWEL Legal reviews the target's integrity and distribution arrangements, historical promotional conduct and any open compliance matters, and reports findings that bear on valuation, representations and post-closing remediation. The work is legal due diligence on the target's compliance position; it is not corporate or transactional structuring, which GAWEL Legal does not provide.

Discuss your matter

Briefly describe the matter and the legal advice you need.

Discuss a confidential review