Bayer Plc & Anor v NHS Darlington CCG & Ors

Bayer Plc & Anor v NHS Darlington CCG & Ors

The policy is lawful provided compounded Avastin is prepared and supplied by NHS hospital pharmacies in accordance with the Apozyt exemption: no modification of the medicinal product, supply solely on the basis of individual prior prescriptions, and retail supply by or under the supervision of a pharmacist. The...

Source-derived case information.

Parties
Appellant: Bayer PLC; Appellant: Novartis Pharmaceuticals UK Limited; Respondent: NHS Darlington CCG; Respondent: NHS Durham Dales, Easington & Sedgefield CCG; Respondent: NHS Hambleton, Richmondshire & Whitby CCG; Respondent: NHS Hartlepool & Stockton CCG; Respondent: NHS Newcastle Gateshead CCG; Respondent: NHS North Cumbria CCG; Respondent: NHS North Durham CCG; Respondent: NHS Northumberland CCG; Respondent: NHS North Tyneside CCG; Respondent: NHS South Tees CCG; Respondent: NHS South Tyneside CCG; Respondent: NHS Sunderland CCG; Interested Party: Roche Products Limited; Interested Party: Secretary of State for Health and Social Care; Interested Party: Association of the British Pharmaceutical Industry; Interested Party: NHS England; Interested Party: General Pharmaceutical Council
Jurisdiction
England and Wales
Judgment Date
25 March 2020
Procedural Posture
Civil Appeal / Court of Appeal Judgment on Appeal From High Court (administrative Court)
Outcome
Appeal dismissed; policy upheld as lawful.
Legal Topics
Judicial Review, Marketing Authorisation of Medicines, Off Label Use of Medicines, Public Procurement in Healthcare, Interpretation of EU Directives, Pharmacy Regulation
Administrative Law Health Law EU Law Pharmaceutical Law Judicial Review Marketing Authorisation of Medicines Off Label Use of Medicines Public Procurement in Healthcare +2 more

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Summary, issues, holding and outcome

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Parties

Bayer PLC

Appellant

Novartis Pharmaceuticals UK Limited

Appellant

NHS Darlington CCG

Respondent

NHS Durham Dales, Easington & Sedgefield CCG

Respondent

NHS Hambleton, Richmondshire & Whitby CCG

Respondent

NHS Hartlepool & Stockton CCG

Respondent

NHS Newcastle Gateshead CCG

Respondent

NHS North Cumbria CCG

Respondent

NHS North Durham CCG

Respondent

NHS Northumberland CCG

Respondent

NHS North Tyneside CCG

Respondent

NHS South Tees CCG

Respondent

NHS South Tyneside CCG

Respondent

NHS Sunderland CCG

Respondent

Roche Products Limited

Interested Party

Secretary of State for Health and Social Care

Interested Party

Association of the British Pharmaceutical Industry

Interested Party

NHS England

Interested Party

General Pharmaceutical Council

Interested Party

Procedural Posture

Civil Appeal / Court of Appeal Judgment on Appeal From High Court (administrative Court)

Legal Issues

  1. 1 Whether the NHS CCGs' policy to prefer Avastin (off-label) for wet age-related macular degeneration (WAMD) is lawful under EU and domestic medicines law
  2. 2 Whether compounded bevacizumab (CB) supply requires a marketing or manufacturing authorisation under EU Directive 2001/83/EC and UK implementing law
  3. 3 Whether the policy undermines the EU regulatory scheme for medicines

Ratio Decidendi

The policy is lawful provided compounded Avastin is prepared and supplied by NHS hospital pharmacies in accordance with the Apozyt exemption: no modification of the medicinal product, supply solely on the basis of individual prior prescriptions, and retail supply by or under the supervision of a pharmacist. The policy does not require or encourage unlawful acts, does not undermine the EU regulatory scheme, and is not contrary to GMC guidance. The lawfulness of supply by commercial entities is unclear but does not render the policy unlawful as lawful routes exist.

Court Disposition

Appeal dismissed; policy upheld as lawful.

Orders

  • The appeal is dismissed.
  • The policy of the NHS CCGs to prefer Avastin for WAMD is lawful provided compounded Avastin is supplied in accordance with the Apozyt exemption.