The Public and Third Sector Law Reports
[2019] PTSR 922
Queen’s Bench Division
Regina (Bayer plc)
v
NHS Darlington Clinical Commissioning Group and othersRegina (Novartis Pharmaceuticals UK Ltd)
v
NHS Darlington Clinical Commissioning Group and others
[2018] EWHC 2465 (Admin)
2018 July 10, 11, 13, 16;Sept 21
Whipple J
National Health Service— Medicinal products— Commissioning policy— Clinical commissioning groups adopting policy on treatment of eye condition— Policy recommending use of particular product as preferred option for certain patients— Market authorisation for product only covering use for cancer treatment whereas claimants’ rival products having market authorisation specific to opthalmic use— Product recommended in policy used “off-label” by dividing original vials into smaller doses for injection into eye— Whether policy lawful— Whether contrary to European Union law—
EU Treaty
, art 4(3)EU
—
Parliament and Council Directive 2001/83/EC (as amended by Parliament and Council Directive 2004/27/EC, art 1), arts 2(1), 3, 5, 6(1)
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