What it is
Price cuts for generic drugs and spending adjustments in public health
It is a royal decree-law. It was introduced on 26 March 2010. Introduced by: Gobierno.
Official title: Royal Decree-Law 4/2010, of 26 March, on the rationalization of pharmaceutical expenditure charged to the National Health System.
Source: Congreso de los Diputados, file 130/000027· updated 11 Nov
Automatic summary, not yet reviewed
- The factory price of generic drugs funded by the National Health System goes down. The cut depends on the gap between the reference price and the retail price, on a scale from 5% to 30%. Generics not included in the reference price system get a 30% cut.
- The cuts do not apply to drugs whose retail price, taxes included, is equal to or below 3.12 euros. No affected drug may fall below that price after the reduction.
- It sets how and when the cuts apply: labs must supply at the new factory price within fifteen calendar days after the price list is published. Wholesalers may keep selling old stock at the old price until May 31, 2010 and pharmacies until June 30, 2010. Prescriptions are billed at old prices until June 30, 2010.
- It amends Law 29/2006 to better control spending: when setting prices, prices across the European Union will be considered, prices can be reviewed without fixed deadlines, the reference price system is simplified using the lowest cost per treatment per day, and the cut for drugs without a generic in Spain is raised from 20% to 30% when a cheaper generic or Biosimilar A drug similar to an already approved biological drug, usually at a lower price. exists in the European Union.
- It updates the margins pharmacies earn for dispensing drugs and creates a joint deduction scale on their monthly bill, which can reach 20% depending on sales volume. MUFACE, MUGEJU and ISFAS are also included in prescription data management.
- The Ministry may limit the dispensing of certain drugs to Hospital Pharmacy Services for non-hospitalized patients, without prior approval, in order to better monitor and control their use.
Who it affects
- Manufacturers of generic drugs: They must cut the factory price of their drugs and supply them at the new price within fifteen days.
- Pharmacies: They can sell old stock at the old price only until June 30, 2010, and their margins and deductions are updated.
- Wholesalers: They may sell old stock at the old price until May 31, 2010 and return to labs the stock with the old price on the packaging.
- Drug manufacturers, importers and suppliers: They must pay in a percentage of their sales to the National Health System every four months, with reductions based on their Profarma program rating.
- Patients and mutual funds such as MUFACE, MUGEJU and ISFAS: Prescriptions are billed at old prices until June 30, 2010, and these mutual funds are included in prescription data management.
Words worth knowing
- Precio industrial (factory price)
- The price at which the lab sells the drug, before distribution and pharmacy margins and taxes.
- Precio de referencia (reference price)
- The maximum amount the National Health System pays for a group of drugs with the same active ingredient.
- Medicamento genérico (generic drug)
- A drug with the same active ingredient as another already approved, identified by that substance's name.
- Biosimilar
- A drug similar to an already approved biological drug, usually at a lower price.
- Visado (prior approval)
- A prior check by an inspecting physician before a drug can be dispensed at public expense.
It summarizes the law as published in the BOE. It is written by artificial intelligence and may contain mistakes: the official text is what counts. Read the official text · How we make summaries
Where it stands
How far did it get?
It took 7 of 7 steps. It reached BOE, and today it is passed.
- Introduced26 March 2010Someone registers the text in the Congreso.
- Admitted6 April 2010The Bureau of the Congreso accepts it and, for a members’ bill, the plenary decides whether to consider it.
- Amendmentsno dateGroups propose changes.
- Committeeno dateA committee goes through the text in detail.
- Plenary6 April 2010All 350 deputies vote.
- Senateno dateThe Senate can pass it, amend it or veto it.
- BOEno dateIt is published in the Official State Gazette (BOE) and comes into force.
See the 4 official steps on a timeline
Was there a plenary vote?
We have no plenary vote linked to this law in the Congreso’s data.
What happens next
What happens now?
It is law, or will be once published in the BOE. It comes into force on the date its own text sets.
Published in the BOE: Royal Decree-Law 4/2010, of 26 March, on the rationalization of pharmaceutical expenditure charged to the National Health System.
Sources
Where does all this come from?
- Congreso de los Diputados, file 130/000027
Official title, type, author, dates and stage.
Retrieved 11 November 2026
- BOE, BOE-A-2010-5030
The law as published.
Retrieved 11 November 2026
- The data comes from the open files of the Congreso, the Senate and the BOE, unaltered.
- Each deputy’s province is the one of their seat on the day of the vote.
- We only say “passed” or “rejected” when the majority needed is certain; otherwise we say which side had more votes.