As every year since the creation of the reference price system back in 2014, the Spanish Ministry of Health published the new Reference Price Order Order SND/1308/2021 (“Order”) on 29 November 2021. The reference price system consists of the annual revision of the maximum price at which medicinal products included in the National Health System portfolio are financed. Our team already analyzed the draft Order published on 14 July 2021, and the final text barely differs from the draft.
Last June, the Superior Court of Justice of the Basque Country delivered a decision with wide repercussion with regards to advertising of medicinal products by pharmaceutical companies. The decision ruled on an appeal filed by Farmaindustria (the Spanish trade association bringing together innovative pharmaceutical companies) against a regional Order regulating the advertising of pharmaceutical products through medical sales representatives in the context of the Basque Health System.
On 12 August 2021, the Spanish Agency of Medicinal Products and Medical Devices published a briefing note on the new regulatory framework applicable to antiseptics intended for the disinfection of the surgical site prior to surgery or to the injection point. Said products had been regarded by the Spanish regulator as biocidal products until the publication of a Resolution dated 2 June 2021 which reclassified them as medicinal products.