The British Generic Manufacturers Association (BGMA) has sought a judicial review of the Department of Health and Social Care’s (DHSC) decision to negotiate a new Voluntary Scheme for branded medicines with the Association of the British Pharmaceutical Industry (ABPI).
Mark Samuels, Chief Executive of BGMA said: “The Government has decided not to involve the trade body representing these medicine suppliers in its negotiations on the voluntary scheme for branded medicine pricing (VPAS).
“We are deeply concerned by this decision. It has left us no choice but to take legal action.”
“While not all generic drugs fall within VPAS, four out of ten products in the current scheme are branded generics or biosimilars. As the representative trade body for both generic and biosimilar UK manufacturers, we must play a full part in the VPAS negotiations for the next period of the scheme from 2024 to 2028.”
“The VPAS tax has risen five-fold in under two years, an unprecedented tax increase. Yet our sector currently has no input into the negotiations on future schemes or rates; this is untenable as any decisions made on VPAS could significantly define the future of our sector in the UK and its ability to supply the NHS.
The association had raised its full participation in the negotiations with the Government last November.
It said: “We also do not believe ABPI – who are the only party with whom the Government currently negotiates – can adequately represent or balance the interests of the off-patent sector in these negotiations.
“Therefore, in the Government’s continued refusal to allow us to participate fully, we have begun a judicial review process to challenge the decision to exclude us as a full partner in the forthcoming VPAS negotiations.”
Responding to BGMA’s statement, Richard Torbett, Chief Executive of the ABPI said: “We are disappointed that the BGMA has decided to take this action – but we recognise that it has been perpetuated by the extreme challenge placed on all parts of the industry from the surge in the branded medicine payment rates.”
“The ABPI takes our responsibility to represent the entire branded medicine market extremely seriously, consistently engaging and involving the wider life sciences industry and trade associations as we approach the start of formal negotiations.
“Working with the whole industry we have developed and published a positive and pragmatic vision for a new voluntary scheme that supports value for the NHS, medicines access for patients, and economic growth.
“We now look forward to starting detailed discussions with the Government as soon as possible to ensure timely agreement of a new Voluntary Scheme.”
As negotiations progress, the ABPI will update global Chief Executives on progress at key moments in June and September to support them in their 2024 financial planning and investment decisions.