Where to begin: News
What is in the diary, the cases every later one is read against, and the rule changes landing this year. Each list is short and in reading order.
What is coming up
The diary: the judgments, references, hearings and expiries due over the next year, revised each quarter.
- 1
Watch list · 4 min read · 25 October 2026
Watch list, Q4 2026: the decisions and dates in the diary
- 2
Watch list · 4 min read · 25 October 2026
Biosimilar entry in Europe, autumn 2026: what launched, what settled, what is blocked
- 3
Regulatory changes · 5 min read · 25 October 2026
Export restrictions on medicines, country by country: the position in autumn 2026
Cases that set the rules
The decisions that every later case is read against: what a regulator may ask of an importer, how a pack may be changed, when a licence lapses, what an SPC can cover.
- 1
Case notes · 4 min read · 20 May 1976
De Peijper: the regulator may not make a parallel importer resupply a dossier it already holds
- 2
Case notes · 5 min read · 11 July 1996
Bristol-Myers Squibb v Paranova: the five conditions every repackaged parallel import still has to meet
- 3
Case notes · 4 min read · 25 November 2021
Delfarma: a parallel import licence cannot die automatically when the reference licence lapses
- 4
Case notes · 2 min read · 19 December 2024 (joined cases C-119/22 and C-149/22)
Combination-product SPCs: the CJEU's 2024 test, and why the combination is the weak point
- 5
Case notes · 8 min read · 26 February 2015 (NHS order); 14 November 2018 (UK Supreme Court); 27 January 2015 and 14 April and 3 November 2017 (Netherlands); 2 April 2015 (Hamburg); 5 May 2017 and 9 January 2019 (Düsseldorf); 4 December 2024 (Munich); 13 May 2025 (UPC)
Skinny labels: why carving out the patented indication reduces the risk but does not remove it
- 6
Case notes · 2 min read · 26 June 2024 (Hamburg); 20 December 2024 (Court of Appeal); 19 June 2025 (rehearing refused)
Eculizumab (Soliris) biosimilars: the UPC's first pharma injunction decisions went to the biosimilars
Changes that bite this year
The rule changes already in force or landing within twelve months, and what each does to sourcing, launch timing and supply.
- 1
Regulatory changes · 3 min read · 25 October 2026
The UK keeps 'UK+' exhaustion: EEA parallel imports stay lawful, exports to the EEA do not
- 2
Regulatory changes · 4 min read · 24 October 2026
The EU pharmaceutical package: what the reform changes for exclusivity, and when
- 3
Regulatory changes · 3 min read · 25 October 2026
The Windsor Framework for parallel importers: UK-wide licences, the 'UK Only' label, and the end of EU safety features on import packs
- 4
Regulatory changes · 3 min read · 25 October 2026
Germany 2027: a 15.5% manufacturer rebate that applies to imports, and pharmacy-level biosimilar substitution
- 5
Regulatory changes · 3 min read · 25 October 2026
UK branded medicines pricing after the US deal: VPAG's 15% cap, the statutory scheme at 16.5%, and NICE's new threshold
Looking for the other half? Where to begin: Guides