The Spanish National Markets and Competition Commission (CNMC) recently launched a study on the regulation of the wholesale distribution and marketing of medicinal products in Spain. Interested parties are invited to submit their comments to the CNMC at estudios@cnmc.es.

The study is triggered by the CNCM’s acknowledgment that, despite the specific characteristics of the pharmaceutical sector requiring regulatory intervention namely to protect public health, any restrictions must be necessary and proportionate to the need to ensure the functioning of a competitive market.

The study aims at identifying and analysing potential restrictions on competition arising from the structure and functioning of the Spanish pharmaceutical market, as well as any restrictions on market access and business activities deriving from the existing regulatory framework.

The study will address the highly regulated system for calculating prices and margins as well as special pricing regimes. It will also assess alternative mechanisms – such as centralized purchasing schemes and tender auctions – and their impact on prices and administrative efficiency, as well as their potential benefits on competition and better regulation.

In 2015, the CNMC conducted a Study on the market for the retail distribution of medicinal products in Spain. The CNMC expects that any recommendations resulting from the new upstream study will improve competition in the downstream retail market, thus reinforcing the recommendations set out in the CNMC’s 2015 study.