No seats left at the table: High Court dismisses British Generic Manufacturers’ Association’s judicial review claim

11/07/23

Mr Justice Turner has dismissed a judicial review claim brought by the British Generic Manufacturer’s Association (“BGMA”), seeking to force the Secretary of State for Health and Social Care to appoint it as an “industry body” to negotiate the next voluntary pricing scheme for NHS branded medicines.

The Secretary of State has negotiated successive voluntary pricing schemes for branded medicines with the Association of the British Pharmaceutical Industry (“ABPI”) since the 1950s. The current scheme – the VPAS – is shortly to expire. The total NHS spend under the VPAS in 2021-22 was £13.6 billion.

The BGMA argued that the VPAS has been particularly punitive, in its effect, as regards manufacturers of generic branded medicines. It argued that the ABPI is not capable of representing the interests of generic manufacturers because its sole interest was to promote the interests of producers of branded originator drugs. As a result, it sought an order from the High Court requiring the Secretary of State to appoint it as an “industry body” (as described in s. 261 of the NHS Act 2006) alongside the ABPI. It argued that it was necessary to grant the BGMA a seat at the table, and a chance to veto the scheme if it is not satisfactory, in order to ensure that the interests of manufacturers of branded generics were not overlooked.

Mr Justice Turner dismissed the claim at an expedited rolled up hearing. He held that:

• The relevant test, when assessing the exercise of the Secretary of State’s common law power to make a voluntary scheme (as described in the NHS Act 2006), was conventional Wednesbury reasonableness.
• The Secretary of State acted reasonably when he concluded that the ABPI was capable of representing the interests of companies that manufacture both generic and originator medicines. The majority of its members supply generic medicines and its membership accounts for a greater share of generic medicine sales under the VPAS than the BGMA.
• The ABPI has an established record of acting in an “All-Industry” fashion, where appropriate, including when negotiating successive voluntary schemes.

The Judgment can be found here.