'Launch or lose protection' and the parallel-trade safeguards in the EU pharmaceutical package

Where it stands

Adopted by the Council on 28 September 2026, awaiting Parliament’s second-reading vote in November 2026 and publication by the end of the year. Member States may apply the launch mechanism to products authorised from twelve months after entry into force, so from late 2027; the general application date is late 2028.

The mechanism

The Commission’s original proposal tied two extra years of market protection to launching in all Member States. The compromise replaces that with a country-by-country lever.

1. Within one year of a marketing authorisation being granted, a Member State may ask the holder to file for pricing and reimbursement there, to meet its procurement requirements, or to agree a roll-out plan.
2. If, three years after that request, the product has not been launched and continuously supplied in that Member State, the product’s regulatory market protection, and any orphan-exclusivity extension that depends on launch, lapses in that Member State only.
3. From then, generic and biosimilar applications referring to the product may be validated in that Member State from the sixth year of data protection rather than the eighth, which is up to two years earlier than elsewhere.

The company can avoid the lapse by launching, by agreeing a roll-out plan, or by showing the Member State did not make the request in time. The protection elsewhere is untouched.

The parallel-trade safeguards

Because a product that has lost protection in one country but not its neighbours is an invitation to parallel trade, the compromise adds three provisions:

• A Member State may require a wholesaler that is not the marketing authorisation holder to notify the source Member State of its intention to parallel-trade a product out of it.
• The source Member State may restrict exports of that product on public-health grounds, under the Regulation’s general provision on supply.
• Wholesalers must keep records for three years of generics and biosimilars they export to Member States where protection has lapsed.

The Council describes the aim as ensuring the supply obligation “is not used as an opportunity for parallel trade”. One further proposal did not survive: Parliament had sought to let Member States require parallel imports to be put into new outer packaging. That power is not in the adopted text, so the Court of Justice’s 2022 case law on when a parallel importer may rebox, covered in its own note, continues to govern.

What it means if you are…

A parallel trader. Two new powers point at you. A notification duty to the source country can be imposed, and the source country can restrict exports of the product in question. Both are optional for Member States and limited to the product whose protection has lapsed, but they will be used in the low-price countries that are the usual sources. The reboxing power is gone, which is the better news: the packaging rules stay as the courts have set them.

A generics or launch planner. The mechanism creates country-specific early windows. A product an originator chose not to launch in a smaller Member State may lose market protection there in year six rather than year eight, and the generic application there can be validated early. That makes the originator’s launch record per country a piece of data to track from 2027, and makes the protection date a per-country question rather than an EU-wide one.

A buyer. Where a product’s protection lapses early, the generic arrives early, and the price in that country moves ahead of its neighbours. Procurement in smaller Member States gains a lever it did not have.

What to watch

The Official Journal text and the final article numbers; which Member States issue requests once the mechanism applies in 2027; and the first product to lose protection in one country, which will be the first test of the export-restriction power.