TY - JOUR
T1 - Implications for pharmaceutical companies and clinicians from the Bayer v NHS judgement: an increasing budgetary focus for both
AU - Hyry, Hanna I.
AU - Roos, Jonathan C. P.
PY - 2018
Y1 - 2018
N2 - The English High Court recently dismissed the Bayer pharmaceutical company’s challenge against a regional clinical commissioning group’s policy allowing NHS Trusts to use a cheaper, but unlicensed, alternative to a sight preserving eye treatment. This makes sober reading for companies marketing “on-label” sales of medicines which are more expensive than off-label or unlicensed alternatives. Unsurprisingly, Bayer has sought to appeal the judgement. The Court has also created legal uncertainty for the NHS: the test for lawfulness is shifted from the Clinical Commission Groups and their policies to individual trusts which must ensure that every unlicensed use is lawful. This could generate legal action against NHS Trusts and ironically drive up costs for the public purse. What is clear is that the Court’s conclusions were heavily influenced by fiscal constraints which it accepted as a legitimate counterweight to the commercial interests of pharmaceutical companies. It also appears to establish in law the duty for doctors to have concern for the wider societal costs of prescribed treatments. This article summarises this complex judgement and offers advice for navigating the increasing focus on limited budgets, both for companies and physicians.
AB - The English High Court recently dismissed the Bayer pharmaceutical company’s challenge against a regional clinical commissioning group’s policy allowing NHS Trusts to use a cheaper, but unlicensed, alternative to a sight preserving eye treatment. This makes sober reading for companies marketing “on-label” sales of medicines which are more expensive than off-label or unlicensed alternatives. Unsurprisingly, Bayer has sought to appeal the judgement. The Court has also created legal uncertainty for the NHS: the test for lawfulness is shifted from the Clinical Commission Groups and their policies to individual trusts which must ensure that every unlicensed use is lawful. This could generate legal action against NHS Trusts and ironically drive up costs for the public purse. What is clear is that the Court’s conclusions were heavily influenced by fiscal constraints which it accepted as a legitimate counterweight to the commercial interests of pharmaceutical companies. It also appears to establish in law the duty for doctors to have concern for the wider societal costs of prescribed treatments. This article summarises this complex judgement and offers advice for navigating the increasing focus on limited budgets, both for companies and physicians.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85057529616&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/30498264
U2 - 10.1038/s41433-018-0280-3
DO - 10.1038/s41433-018-0280-3
M3 - Article
C2 - 30498264
JO - Eye (Basingstoke)
JF - Eye (Basingstoke)
SN - 0950-222X
ER -