What it is
Bill to speed up access to orphan medicines
Admitted step 2 of 7· LapsedIt is a members’ bill. Introduced by parliamentary groups, the Senate, regional governments or citizens. It was introduced on 28 February 2024. Introduced by: Grupo Parlamentario VOX.
Official title: Private member's bill amending the consolidated text of the Law on Guarantees and Rational Use of Medicines and Medical Devices and Royal Decree 1030/2006, of 15 September, approved by Royal Legislative Decree 1/2015, of 24 July, regarding Rare Diseases and Orphan and Ultra-orphan Medicines.
Source: Congreso de los Diputados, file 122/000060· updated 11 Nov
Automatic summary, not yet reviewed
- The bill would create a special procedure to authorize, fund and set prices for orphan and ultra-orphan medicines. The Ministry of Health would have six months to set it up.
- It would keep these medicines out of reference price groups, so that research is not discouraged.
- It would require the Interministerial Commission on Medicine Prices to consider, when setting prices, the small number of patients, the return on research investment and the savings for the National Health System.
- It would exempt people who take many medicines, have chronic conditions, disabilities, dependency or rare diseases from paying the patient share of medicine costs.
- It would set by law the diseases included in newborn screening and have the Ministry of Health review the list every year to add new tests.
- The law would take effect on January 1 of the year after its approval, so its budget impact would apply to the following fiscal year.
Who it affects
- People with rare diseases: Faster and more equal access to these medicines, and exemption from the patient share if they have rare diseases.
- Ministry of Health and the National Health System: Special funding and pricing procedure, and broader, more uniform newborn screening.
- Pharmaceutical industry: Greater incentive to research and market these medicines in Spain.
- Pharmacies and pharmacists: They would stop substituting certain prescribed medicines and would apply the new pricing rules.
Words worth knowing
- Medicamento huérfano (orphan medicine)
- A medicine to treat or prevent rare, life-threatening or seriously debilitating diseases.
- Medicamento ultra-huérfano (ultra-orphan medicine)
- A medicine for diseases affecting fewer than 1 in 50,000 people.
- Precios de referencia (reference prices)
- A system that groups equivalent medicines and sets a common maximum price for funding them.
- Cribado neonatal (newborn screening)
- Tests done on babies in their first days of life to detect diseases early.
- Aportación (patient share)
- The part of the medicine price the user pays when picking it up at the pharmacy.
It summarizes the text as it was introduced. 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 2 of 7 steps. It reached Admitted, and today it is lapsed.
- Introduced28 February 2024Someone registers the text in the Congreso.
- Admitted5 March 2024The Bureau of the Congreso accepts it and, for a members’ bill, the plenary decides whether to consider it.
- Amendmentsnot reachedGroups propose changes.
- Committeenot reachedA committee goes through the text in detail.
- Plenarynot reachedAll 350 deputies vote.
- Senatenot reachedThe Senate can pass it, amend it or veto it.
- BOEnot reachedIt is published in the Official State Gazette (BOE) and comes into force.
See the 6 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?
The legislature ended before it finished. To go on, someone would have to introduce it again in the new Cortes.
Sources
Where does all this come from?
- Congreso de los Diputados, file 122/000060
Official title, type, author, dates and stage.
Retrieved 11 November 2026
- Congreso de los Diputados, procedure
The date of each step, with its official wording.
Retrieved 12 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 never say “passed” because of a vote: the files do not say which majority was needed.