Economic aspects of the new Spanish laws on pharmaceutical preparations

Abstract

In this article, we provide readers with a summary of the main economic features of the recently approved Spanish law regarding pharmaceutical preparations entitled the Law of Guarantees and Rational Use of Pharmaceuticals and Health Products (Law 29/2006 of July 26th). We review information on pricing, reference pricing, promotion of generic drugs, public reimbursement, patients' contributions, and penalties. Other aspects of minor economic relevance such as the information on prices shown in the packs and the transparency on the results of clinical trials irrespective of whether these are positive or not, are not addressed in this paper. We conclude with some observations on the new horizons opened up by this new legal framework. We have not included any detailed references to the new law; we merely wish to comment on certain aspects of its application.

The impact of repeated cost containment policies on pharmaceutical expenditure: experience in Spain

“…The health care management system is completely decentralised and regional governments control expenditures and organise health service provision. However, as in many industrialised countries, prices are centrally regulated [2].…”

What If There Was a Stronger Pharmaceutical Price Competition in Spain? When Regulation Has a Similar Effect to Collusion

“…All versions of off-patent drugs, branded and generics, were included in their respective group of bioequivalent drugs once there was at least one generic version of the respective active ingredient. The reference price was determined endogenously as a function of drug prices in the relevant market: for each group a reference price was calculated as the weighted average selling price of the lowest-priced drug accounting for at least 20% of the market (year on year) 1 . This system established the maximum price that could be reimbursed by the NHS for any version of the same drug.…”

“…This system established the maximum price that could be reimbursed by the NHS for any version of the same drug. Whenever the price of a 1 If the difference between this price and the highest price for the group was less than 10%, the reference price was the result of applying a 10% reduction to the highest price. If the difference between the calculated price and the highest priced product was more than 50%, the reference price was exactly 50% of the highest priced product.…”

“…However, this is rarely the final price since the legislation allows other factors to be considered such as the price of the same product in other European countries, the price of drugs that can be considered substitutes or the therapeutic innovation of the medicine. In fact, the legal criterion is that the price has to reflect the therapeutic value of the drug as well as the cost of comparable treatments, the price of the same drug in other countries, and some other political issues such as the contribution to the national economy (Antoñanzas et al, 2007).…”

The challenge of colorectal cancer prevention in Spain

“…diabetes) or in the case of a very expensive drug. On average, the NHS pays 94% of the cost of all drugs prescribed by general practitioners and 100% of drugs prescribed in public hospitals [41]. This highlights the importance of public funding of pharmaceutical products.…”