Developments in Spain on promotion of authorized medicinal products pending pricing & reimbursement

The debate in Spain on the possibility of promoting medicinal products in the period between marketing authorization and pricing & reimbursement has recently taken on a special prominence. The Spanish market has been following a particularly conservative approach in this respect, equating, for promotional purposes, “unauthorized medicinal product” with “authorized medicinal product pending pricing & reimbursement,” which has led the industry to be especially careful with certain activities in the period between marketing authorization and pricing & reimbursement.

The days of this debate could be numbered. Recently, the High Court of Justice of the Basque Country, following an appeal brought by Farmaindustria (Spanish association that brings together the innovators’ industry), has ruled in favor of such promotion. The High Court of Justice has relied on the wording of the applicable laws, which, in line with the provisions of Directive 2001/83/EC, prohibits the "advertising of a medicinal product which has not been granted with the marketing authorization.” In this sense, according to the High Court of Justice, if the promotion of an authorized medicinal product is not allowed, "patients and society in general will suffer the risk of not enjoying the developments in this field in the shortest possible time.” It also recalls that "health authorities will direct their actions towards implementing an agile, efficient and independent system that ensures health care professionals receive scientific, up-to-date and objective information on medicinal products and medical devices.”

Although this ruling is not final and could be appealed, and even though we still find elements in the Spanish regulations that may generate some confusion in this regard, there is no doubt that we are facing a significant milestone. Proof of this is that Farmaindustria has swiftly produced a new version of the industry code nuancing the more conservative approach mentioned above (and generally followed by the industry in the past). Farmaindustria now makes it clear that "in cases where, following marketing authorization, a decision on pricing & reimbursement is pending within the National Health System, the promotion of a new medicinal product or a new indication does not entail an infringement of the code, provided that the advertising aimed at health care professionals entitled to prescribe or dispense medicinal products includes information about this particular situation.”

In terms of next steps, and with all due caution, we encourage the pharmaceutical industry to review its strategy on promotion of medicinal products. Please contact us should you have any questions.

 

Authored by Álvaro Abad

 

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