The recent amendments to pharmaceutical policy in Spain have been introduced to ensure that the needs of patients are more adequately addressed. This legislation was introduced with the aim of guaranteeing the quality of all benefits being provided by the “Sistema Nacional de Salud” (The Spanish National Health System), ensuring better protections for the rational use of medications and ensuring that access to medications is done through a more effective system with tighter safety controls.

This restated legislation was adopted as a result of the recent recession and new EU Regulations. It is aimed at granting special relevance to the Spanish National Health System (“Sistema Nacional de Salud”) and introducing and guaranteeing a continual system of monitoring the benefit versus risk equation for the authorization of medicinal products.

With this in mind, the Spanish Government recently introduced a Royal Legislative Decree (1/2015 of 24 July 2015), that approved the new amended text of the consolidated legislation that will guarantee the rational use of medication and healthcare products. This new text has incorporated, modified and amended previous legislation connected to the Law 29/2006 (July 26 2006) on the guarantee and rational use of medicines and medical devices. The aim of this new law will be to regularise, clarify and harmonise certain provisions.

Main amendments

Several of the amendments are purely technical, such as the requirements relating to guarantees of quality, safety and efficacy of medicines and healthcare products. The most significant amendments to the legislation have been made regarding the proposed improvements to pharmaceutical expenditure control.

In Spain, the pharmaceutical expenditures of the National Health System are particularly high. The recession in Spain has forced the Government to incorporate more efficient policies regarding healthcare expenditure. One of the key measures introduced in this respect was the Royal Decree-Law 16/2012 of 20 April 2012. This legislation introduced urgently needed measures to ensure the sustainability of the National Health System and to improve the quality and security of healthcare benefits. Some of the key reforms included:

  • rationalisation of pharmaceutical finance which involved excluding from public funding medicines intended for the treatments of minor symptoms; and
  • introduction of a system of structured modifications to the pricing of medications which involved the introduction of a new cost effective scheme.

EU Regulations

A further relevant reform was assimilated through the Law 10/2013 of 24 July 2013. The main aim of this law was to incorporate the elements of Directive 2010/84/EU of the European Parliament and of the Council, on pharmacovigilance and Directive 2011/62/UE on preventing entry into the legal supply chain of falsified medicinal products. In addition to the incorporation of the proposed European provisions several additional amendments were also incorporated, these included:

  • the introduction of a clearer system for procedure and quality control of the “Agencia Española de Medicamentos y Productos Sanitarios” (Spanish Agency for Medications and Healthcare Products); and
  • amendments concerning therapeutic positioning reporting to be used as a tool for a proper and efficient use of medicaments.

A missed opportunity for clarification?

The offering of premiums, gifts, bonuses or discounts in order to promote or sell medical products to the public is considered to be a serious infringement of the law. It is therefore regrettable that the amended legislation has missed the opportunity to clarify the extent of this prohibition.

Summary

In summary, this new legislation has consolidated several existing laws through the redrafting of certain legal provisions and precedents and the incorporation of new provisions to the former Law of 29/2006. This has ensured that the law surrounding the field of the usage of medications and healthcare products is clearer and more protected and that the finances available are put to better use.