Royal Decree-Law 16/2012 introduced several reforms to the Spanish reference pricing system.

The Health Ministry has attempted to improve several of these reforms through the Administrative Order for Revision of the Groups and Prices of the Reference Pricing System. The approval of this administrative order requires an obligatory but non-binding ruling of the Council of State. The Council of State issued such ruling on June 13 2013.(1)

In its ruling, the Council of State rejected the possibility of introducing legislative innovations to the reference pricing system through an administrative order issued by the Health Ministry. In particular, the Council of State established that legislative innovations must be made through a royal decree approved by the government, thus completing the regulatory process for royal decrees. Furthermore, the Council of State established that there were some issues that were not dealt with in the administrative order, but which should be handled in an eventual royal decree.

Among the issues dealt with by the administrative order to be established by the royal decree are:

  • the mechanisms for guaranteeing "pharmacy offices supplying medicines of 'minor price'" (Article 93.4 of the Medicine Act);
  • the decision to establish correction factors to fix prices in the pricing reference groups according to the legal rules for determination;
  • the rules on price deduction for medicines sold to the National Health System through pharmacies; and
  • the price co-existence rules.

Among the issues excluded from the administrative order and suggested to be introduced by the Council of State in a royal decree are establishing:

  • a quarterly update of "minor prices"; and
  • a threshold level price (this was not included in the administrative order project, although it was included in the previous regulation; its lack of inclusion has been criticised by laboratories, autonomous communities and even state institutions, such as the Technical General Secretariat of the Ministry of Industry, Energy and Tourism).

At present, the Health Ministry is working on the draft Royal Decree on Pricing Regulations, which will affect several issues arising from the price and reimbursement system. It is hoped that the draft decree will cover the questions that the Council of State said should be established by royal decree.

For further information on this topic please contact Teresa Mercadal Menchaca or María Sanz Bustillo at Bird & Bird by telephone (+34 91 790 6000), fax (+34 91 790 6011) or email (teresa.mercadal@twobirds.com).

Endnotes

(1) See www.boe.es/buscar/doc.php?coleccion=consejo_estado&id=2013-587.