by Belen Diego

MADRID, Oct 27 (APM) - The Spanish ministry of health has introducing pricing talks with players before it publishes a draft of a new pricing and reimbursement regulation, switching from its historical approach of publishing and then negotiating around the feedback from interested parties, APM was told on Monday.

In a phone interview, Ángel Luis Rodríguez de la Cuerda, director general of Spain’s generic manufacturers association AESEG, said the association has been informed they will be included in talks on upcoming regulation beforehand. Talks are expected to start very soon, he said.

Up until now, the ministry of health usually disclosed drafts of new regulation, with players such as lobby group Farmaindustria, pharmacists associations, generic manufacturers and others presenting amendments afterwards.

Drafts were then rejigged at the ministry’s criteria and sent to the council of state. With the council’s green light they went back to the ministry of health and finally to the council of ministers, which formally signs off new regulation.

Rodríguez de la Cuerda, who talked to a senior ministry official and head of the pricing commission Agustín Rivero late last week, these new ways will certainly help forge a consensus but could delay the new regulation by several months.

“It is good news that the ministry is willing to get closer to players in the pharma sector, with biotech association ASEBIO, branded pharma group Farmaindustria, pharmacists associations and others included in talks beforehand. However, since Rivero also said they will discuss the new regulation with autonomous regions, also beforehand, it means the first draft will probably be made public by March or April next year”, he said.

AESEG is lobbying for generics to be promoted over branded drugs as a reward for reducing the price of branded drugs and cutting the drugs bill, a specific system to promote generics and specific regulation of biosimilars. (APMMA 39778)

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