Where to begin: Guides
Short reading orders for a reader new to a subject. Each takes under an hour, and each piece stands on its own if you only want one.
Tracking when a product opens up
The dates that decide when a medicine opens to competition, how each is calculated, and why the register date is not the launch date.
- 1
Explainers · 2 min read
One product, five clocks: the dates that decide when a medicine opens up
- 2
Explainers · 4 min read
Patent cover, data exclusivity and market protection: three clocks, one product
- 3
Explainers · 4 min read
Supplementary protection certificates: how the SPC term is calculated
- 4
Explainers · 3 min read
Paediatric extensions: the extra six months, and how to check for one
- 5
Explainers · 3 min read
Why the expiry date is not the launch date in Europe (and what is)
- 6
Explainers · 2 min read
Why published patent-expiry lists disagree, and how to check a date yourself
Launching a generic or biosimilar
What has to happen between the last clock and the first supply, and how the courts are used to clear the way or to block it.
- 1
Explainers · 4 min read
The generic development timeline in Europe: how long each step takes and when the exclusivity clocks bite
- 2
Explainers · 6 min read
The Bolar exemption: what a generic may do while the patent is still running, and what it may not
- 3
Explainers · 4 min read
From SPC expiry to first generic supply: the work in between, in the UK and Europe
- 4
Explainers · 5 min read
Clearing the path, launching at risk and preliminary injunctions: how generic launches are fought in the UK, Germany and the UPC
- 5
Explainers · 4 min read
Biosimilars in Europe: the exclusivity rules, the pathway and why launch timing differs from small molecules
How medicines are licensed
The routes to a marketing authorisation, the legal bases, how a licence lapses, and the licences that let a product move between markets.
- 1
Explainers · 3 min read
Centralised, decentralised, mutual recognition, national: the four routes and what they mean for exclusivity dates
- 2
Explainers · 6 min read
Full, generic, hybrid, biosimilar, well-established use, fixed combination, informed consent: the legal basis of a marketing authorisation and what it tells you
- 3
Explainers · 6 min read
The sunset clause: how a marketing authorisation dies of disuse, and when the three years start
- 4
Explainers · 12 min read
UK parallel import licences: simple, standard and complex applications, what each needs, and the law behind them
- 5
Explainers · 4 min read
Unlicensed medicines: the routes in the UK and Europe (specials, imports, named-patient and compassionate use)
Reading a published price
Which price a national list shows, what sits between it and what anyone pays, and how to compare across countries without being misled.
- 1
Prices · 5 min read
How medicine list prices are published across Europe: who publishes what, and which price it is
- 2
Prices · 2 min read
Ex-factory, wholesale, pharmacy, reimbursement: which price is which
- 3
Prices · 2 min read
List price versus net price: what national lists show, and what they leave out
- 4
Prices · 3 min read
Wholesale and pharmacy margins on medicines in Europe: how the mark-ups work
- 5
Prices · 3 min read
VAT on medicines in Europe: rates, traps, and how to handle them in a comparison
- 6
Prices · 3 min read
External reference pricing in Europe: the basics, and why list prices ripple
Looking for the other half? Where to begin: News