Regulatory Changes

NHS Reference Prices for Medicines 2026: What Changes for Pharmacies and Laboratories

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Equipo Editorial CambiosLegales
Oct 7, 2026 7 min 3 views

Key data

RegulationOrder SND/1053/2026, of October 1
PublicationOctober 7, 2026
Entry into forceOctober 7, 2026 (same day as publication)
Affected partiesPharmaceutical laboratories, pharmacies, distributors and patients with medicines financed by the NHS
CategoryRegulatory Changes
Year2026
New pharmacy sets15 (F514 to F528)
New hospital sets11 (P206 to P216)
Additional legal basisLaw 7/2025 (exemptions and upward coefficients for strategic medicines)
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Pharmacies, laboratories and distributors have new ceiling prices to respect from October 7, 2026. The Order SND/1053/2026 updates the reference price system of the National Health System, a tool that the Ministry of Health reviews annually to control public pharmaceutical spending. This year, the reform goes beyond the usual review: the Law 7/2025 introduces the possibility of exempting drugs from the system or applying upward coefficients for strategic medicines, opening a new avenue to protect the supply of critical products.

15
New pharmacy sets (F514–F528)
11
New hospital sets (P206–P216)
7/10/2026
Date of immediate entry into force

What does this regulation establish?

The NHS reference price system groups equivalent medicines into "sets" and sets a ceiling price (reference PVP) that determines how much the Social Security finances. If the laboratory sells above that price, the patient pays the difference. If it sells below or at the exact price, the NHS covers the part that corresponds to it according to the patient's copayment.

Order SND/1053/2026 carries out three types of actions on the system:

  • Creation of new pharmacy sets: F514, F515, F516, F517, F518, F519, F520, F521, F522, F523, F524, F525, F526, F527 and F528.
  • Creation of new hospital sets: P206, P207, P208, P209, P210, P211, P212, P213, P214, P215 and P216.
  • Review of existing sets: update of the reference PVP of already existing sets and removal of those that no longer meet legal requirements.

Additionally, Law 7/2025 has introduced two new mechanisms that this Order applies for the first time:

  • Exemption from the system: certain drugs may be excluded from the reference price system if their strategic nature justifies it.
  • Upward coefficients: for strategic medicines, a reference price higher than the minimum of the set can be set, in order to guarantee supply.
  • Protection of WHO essential medicines: drugs included in the World Health Organization's list of essential medicines are exempt from downward revision, avoiding shortages due to price pressure.

Economic and operational impact

The annual review of reference prices has a direct effect on the margin of laboratories whose products are included in new sets or see their ceiling price reduced. For pharmacies, the impact is operational: they must update their billing and dispensing systems to reflect the new PVP from the first day of entry into force.

The 26 new sets created this year mean that medicines that until now were financed without a reference price ceiling are now subject to price competition within their group. This puts downward pressure on the prices of laboratories included in those sets.

On the other hand, the possibility of applying upward coefficients for strategic medicines is a novelty that can benefit laboratories with products critical to the health system, by allowing them to maintain more sustainable prices without leaving public financing.

Removed sets—those that no longer meet requirements—mean that affected medicines exit the reference price system, which can mean both an opportunity (greater price freedom) and a risk (review of their financing status).

Who does it affect?

  • Pharmaceutical laboratories: must review whether any of their products are included in the new sets F514–F528 or P206–P216, or whether their existing sets have seen their ceiling price modified. If the reference PVP falls below their current price, they must decide whether to adapt the price or accept that the patient will pay the difference.
  • Pharmacies: obliged to dispense at the reference price when the medicine is in a set and the laboratory has adapted its price. They must update their management systems with the new PVP published in the annexes of the Order.
  • Pharmaceutical distributors: the distribution chain must reflect the new prices in its tariffs and delivery notes from October 7, 2026.
  • Patients with financed medicines: if their medicine enters a new set and the laboratory does not adapt the price, they will pay the difference between the selling price and the reference price, in addition to their usual copayment.

Practical example

A laboratory has a medicine that until now was financed without an assigned reference set. With Order SND/1053/2026, that medicine is included in the new set F521, together with other therapeutic equivalents. The reference PVP set for F521 in the Order's annex is lower than the laboratory's current selling price.

The laboratory has two options: (a) adapt its PVP to the reference price of the set so that the NHS finances its part entirely and the patient does not pay a difference, or (b) maintain its current price, in which case the patient must pay the difference between both prices in addition to their copayment. In markets with high generic competition, option (b) usually translates into loss of dispensing share.

In the case of a medicine included in the WHO's list of essentials that was in an existing set, the Order guarantees that its reference price cannot be revised downward, protecting the laboratory against price pressures that could compromise supply.

Do you need to track this and other regulations?

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What should companies do now?

  1. Identify affected products: review whether any medicine in the portfolio is included in the new sets F514–F528 (pharmacy) or P206–P216 (hospital), or whether any existing set has changed its ceiling price.
  2. Consult the Order's annexes: the specific reference PVP are published in the annexes of the Order SND/1053/2026 in the BOE. It is the definitive source for each set.
  3. Decide the pricing strategy: for each product included in a new set or with a revised ceiling price, decide whether to adapt the PVP or maintain the current price accepting that the patient will pay the difference.
  4. Update billing and dispensing systems: pharmacies and distributors must reflect the new PVP in their systems from October 7, 2026, the date of immediate entry into force.
  5. Evaluate if exemption or upward coefficient applies: if any product can be considered strategic under Law 7/2025, assess with specialized advice whether it is appropriate to request exemption from the system or the application of an upward coefficient.
  6. Verify the status of WHO essential medicines: if any product is on the WHO's list of essentials, confirm that its reference price has not been revised downward and document it for possible claims.

Frequently asked questions

How many new sets does Order SND/1053/2026 create and what are their codes?

The Order creates 26 new sets: 15 pharmacy (F514, F515, F516, F517, F518, F519, F520, F521, F522, F523, F524, F525, F526, F527 and F528) and 11 hospital (P206, P207, P208, P209, P210, P211, P212, P213, P214, P215 and P216). The specific reference PVP for each set are published in the Order's annexes in the BOE.

From when are the new reference prices mandatory?

Order SND/1053/2026 entered into force on the same day as its publication in the BOE: October 7, 2026. There is no transitional period: pharmacies, laboratories and distributors must apply the new PVP from that date.

What happens if a laboratory does not adapt its price to the new reference price?

If the laboratory maintains a price higher than the reference PVP set for its set, the NHS only finances up to the reference price. The patient must pay the difference between the selling price and the reference price, in addition to their usual copayment. In practice, this usually reduces the dispensing of the product compared to competitors that do adapt their price.

What are WHO essential medicines and why are they protected?

They are medicines included in the World Health Organization's list of essential medicines, considered essential to meet the basic health needs of the population. Order SND/1053/2026 exempts them from downward revision in their reference prices to ensure that laboratories do not abandon their manufacture or distribution due to price pressure.

What innovations does Law 7/2025 introduce in the reference price system?

Law 7/2025 allows two new mechanisms that this Order applies for the first time: (1) exempt drugs from the system of reference prices when their strategic nature justifies it, and (2) apply upward coefficients to the reference price of strategic medicines to guarantee their supply. Both measures seek to prevent shortages of products critical to the NHS.

Official source

Consult complete regulation in official source

Notice: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://www.boe.es/diario_boe/txt.php?id=BOE-A-2026-20825



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