Madrid, March 25th 2014.– After the approval of the Royal Decree regulating the Reference Price System, at the Council of ministers meeting on March 21st, FARMAINDUSTRIA considers that it represents a step forward as far as the regulatory framework is concerned, and also for the necessary regulatory stability that the pharmaceutical sector needs, while generating important savings for the Spanish National Health System (SNS). The Decree regulates the reference price system and homogenous groups of medicines in the SNS.

The Royal Decree plays a fundamental role which provides the SNS with savings using two in-struments: on the one hand, homogeneous groups, which align monthly to the lowest price level of presentations with those medicines that have the same active ingredient, dose, administration route, and size of package, and for which interchanging is possible in the dispensing act; on the other hand, an annual reference Price Order which extends the price revision to all presentations sharing the same active ingredient.

As for the new features, we can highlight those medicines that have been authorised for more than ten-years to be incorporated to the system, given there is, at least, a reimbursed medicine which is different from the original and its licenses. Likewise, the moderating criteria is also worth mentioning (1.60 euro threshold and weighed prices) with the objective of avoiding price cuts which would make the marketing of some presentations impossible, even when said criteria will not be applied when this same presentation is marketed in another Member State of the European Union at a lower price. In this case, the price of the latter product then becomes the new maximum industrial price of the presentation.

Regional Procedures

Additionally, the Royal Decree regulates the official Nomenclator of the SNS’ pharmaceutical provision as a data base which contains information of all authorized medicines in Spain, capturing the date of their effective commercialization, which is a key aspect for the correct application of the reference prices. The information contained in the Nomenclator should contribute to unifying the procedures used by different autonomous regions as far as Pharmaceutical provision is concerned.

FARMAINDUSTRIA considers it positive that the new system respects intellectual property rights, but it also highlights the high impacts that they will bring to the sector which will be added to those which have also affected it over the last few years due to the four Royal Decree Laws approved since 2010, so to guarantee the sustainability of the SNS, which have led to reductions of public pharmaceutical expenditure by 28% since that year.