The EU pharma reform has taken its biggest step yet. Review your operating model now to limit supply chain disruption and to put in place a strategy that is compliant and tax effective.
Where we are
On 28 September 2026, the Council of the EU adopted its first-reading position on the pharma package. The vote was 26 in favour, none against and one abstention. The new directive on medicinal products for human use looks set to become binding law.
Article 166 is now Article 169
Only the number has changed. Wholesale distribution authorisation holders must still buy supplies, including through financial transactions, only from entities with a valid EU/EEA wholesale distribution or manufacturing authorisation.
What happens next
The European Parliament must still adopt the directive and its companion regulation at second reading. A plenary vote could come as early as 2 October 2026, or in November 2026.
Parliament's Committee on Public Health intends to recommend approving the Council's position without amendments.
Application is expected around 2028, after a transitional period.
Why waiting is the wrong plan
Enforcement is already happening. It is based on case law from Germany, the CJEU and Sweden, and health authorities are examining wholesale arrangements during good distribution practice inspections. Waiting for the directive to apply could leave you exposed well before then.
The Swiss principal model
This is a challenge, not a dead end. Compliant options exist that route every wholesale transaction through EU/EEA authorised entities and keep the benefits of a Swiss centre. Regulatory, tax, transfer pricing and operational questions need to be treated as one design challenge. A redesign typically takes up to 12 months.
The bottom line
Parliament's approval looks like a formality, so the runway has shortened. Now is the time to design a compliant operating model.
Want to find out more? Read the full article here.
Next steps
Let’s discuss together from a cross-functional perspective which adaptations are required in order to establish a regulatory compliant, effective and tax efficient pharma operating model.