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What it is

Proposal to improve access to rare disease medicines

Admitted step 2 of 7 · Unfinished

It is a members’ bill. Introduced by parliamentary groups, the Senate, regional governments or citizens. It was introduced on 28 February 2023. Introduced by: Grupo Parlamentario VOX.

Official title: Private member's bill amending Royal Legislative Decree 1/2015, of 24 July, approving the consolidated text of the Law on guarantees and rational use of medicines and medical devices and Royal Decree 1030/2006, of 15 September, regarding rare diseases and orphan and ultra-orphan medicines.

Follow this law

Source: Congreso de los Diputados, file 122/000311· updated 11 Nov

Automatic summary, not yet reviewed

  1. The bill would exclude medicines declared orphan or ultra-orphan from reference pricing, and would bar them from being included in reference price groups.
  2. When setting prices for these medicines, the Interministerial Commission on Medicine Prices would have to consider the small number of patients, the return on research investment, and the medium and long-term savings for the National Health System.
  3. People who take multiple medicines for chronic conditions, or who have a disability, dependency or a rare disease, would be exempt from the patient share of outpatient medicine costs.
  4. The Ministry of Health would have six months to create a special procedure for authorizing, funding and setting prices for these medicines, aiming for fast and equal access across the country.
  5. The newborn screening program would be updated: the list of diseases screened at birth would be reviewed yearly, and an information system and an annual technical report on the program's performance would be created.
  6. The Government could issue the rules needed to apply the law within six months. The law would take effect on January 1, 2023.

Who it affects

  • People with rare diseases: Faster access to treatments and exemption from their share of medicine costs.
  • Patients with chronic conditions, disabilities or dependency who take multiple medicines: They would be exempt from the outpatient pharmacy copayment.
  • Newborns and their families: More early detection tests in the newborn screening program.
  • The pharmaceutical industry: Greater incentives to research and market orphan medicines in Spain.
  • Pharmacists: Rules on when they must substitute a prescribed medicine with a cheaper one.

Words worth knowing

Medicamento huérfano (orphan medicine)
A medicine to treat or prevent a life-threatening or chronically debilitating disease that affects few people.
Medicamento ultrahuérfano (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 maximum price covered by the National Health System.
Cribado neonatal (newborn screening)
Tests done on babies in their first days of life to detect diseases and treat them as early as possible.
Aportación (patient share)
The part of the medicine price the patient pays when picking up a prescription.

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 unfinished.

  1. Introduced28 February 2023Someone registers the text in the Congreso.
  2. Admitted7 March 2023The Bureau of the Congreso accepts it and, for a members’ bill, the plenary decides whether to consider it.
  3. Amendmentsnot reachedGroups propose changes.
  4. Committeenot reachedA committee goes through the text in detail.
  5. Plenarynot reachedAll 350 deputies vote.
  6. Senatenot reachedThe Senate can pass it, amend it or veto it.
  7. BOEnot reachedIt is published in the Official State Gazette (BOE) and comes into force.
See the 6 official steps on a timeline
Feb 2023Mar 202311. 28 February 2023: Presentación22. 7 March 2023: Boletín Oficial de las Cortes Generales Publicación desde 07/03/2023 hasta 10/03/202333. 7 March 2023: Calificación44. 10 March 2023: Gobierno Contestación desde 10/03/2023 hasta 20/04/202355. 20 April 2023: Pleno Toma en consideración desde 20/04/2023 hasta 27/04/202366. 27 April 2023: Concluido - (Decaído) desde 27/04/2023 hasta 03/05/2023

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.

It has not been presented again yet.

Sources

Where does all this come from?

  • 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.

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