Time to rethink your operating model

If you’ve been following this reform, you’ll remember Article 166. For the first time, it explicitly brought financial transactions within the scope of EU wholesale distribution rules.

Readers comparing the previous draft with the versions published end of September will see that this provision now appears as Article 169. This change results from sequential renumbering as the text moved from a negotiated working draft to the Council’s finalised first reading position, incorporating additions and deletions made across the directive.

The substance to Article 169 (former Article 166) is identical. Wholesale distribution authorisation holders must still procure their supplies, including by financial transactions, only from entities that hold a valid EU/EEA wholesale distribution or manufacturing authorisation.

In practice, you face the same obligation, the same risk, and the same urgency. Only the article number has changed.

The process now moves to the European Parliament. Both the directive and its companion regulation must still be formally adopted by Parliament at second reading before they can enter into force.

There are clear signs that this may move quickly. The Parliament’s Committee on Public Health has already indicated, through a letter from its Chair to the Council, that it intends to recommend approval of the Council’s position without amendments.

Industry trackers currently point to a plenary vote as early as 2 October 2026, while the European Parliament’s own legislative tracker signals an indicative sitting in November 2026. Either way, we’re talking about weeks, not years.

Once adopted, the text will move to signature and publication in the Official Journal. From that point, the clock will start running towards application, expected around 2028 following a transitional period.

It can be tempting to see a two year transitional period as breathing room. It isn’t.

As highlighted in earlier analysis of Article 166, now Article 169, enforcement is already active today. It is grounded in case law from Germany, the Court of Justice of the European Union, and Sweden, which the new directive will simply codify into binding EU wide law.

Health authorities across the EU are already examining wholesale arrangements during good distribution practice inspections. If you wait for the directive to formally apply, you risk being on the wrong side of an inspection well before then.

With the Council vote now complete and Parliament’s approval highly likely, the direction of travel is clear. Only the timeline is still moving. That is why the best moment for action is now, not after publication in the Official Journal.

For organisations using Swiss principal models, this reform understandably raises important questions. But the outlook is not negative.

As earlier PwC coverage set out, the Swiss principal model is not over. Practical, compliant options exist that let you reconfigure how commercial and financial flows are executed. These approaches can make sure every wholesale transaction involving EU/EEA stored medicinal products runs through EU/EEA authorised entities, while still keeping the strategic and economic benefits of a Swiss centre.

Getting there demands treating regulatory, tax, transfer pricing, and operational questions as one combined design challenge rather than separate issues. Redesigning an operating model on this scale typically takes up to 12 months from start to finish.

The Council has set its position. Parliament’s approval looks like a formality rather than a contest. Publication in the Official Journal, and the countdown to application, are now in sight.

If you’re still treating this directive as a distant or theoretical concern, the runway has just shortened. Now is the time to design a compliant operating model, while you still have the time to do it thoroughly and at pace.