Bill that rewrites the rules on medicines and health products

Automatic summary, not yet reviewed

1. The bill would replace the current rules on medicines and health products with a new law, to adapt them to the scientific, technical and European changes of recent years.
2. It strengthens the guarantee that pharmacies, distributors and laboratories supply the market. If there is a risk of shortage, the Spanish Agency may take measures, and the Government may adopt economic measures for orphan and strategic medicines.
3. It keeps the ban on selling prescription medicines online or by mail, but allows home delivery to the patient when their clinical situation, dependency or distance justifies it, with health safeguards.
4. It bans professionals who prescribe or dispense from having direct financial interests in the manufacture or sale of medicines, and bans offering them gifts, premiums or prohibited discounts.
5. No industrially made medicine could be sold without authorization from the Spanish Agency for Medicines and Health Products, which will require quality, safety, efficacy, identification and proper information. The authorization lasts five years and is renewed if the benefit/risk balance remains favorable.
6. It establishes prescribing by active ingredient: in general, doctors will prescribe using the common name of the active ingredient, and patients may choose among the medicines in the same group at the pharmacy, paying the difference if they pick a more expensive one.
7. It creates a system to assess medicines and health products as health technologies, which will guide decisions on inclusion, funding, pricing or withdrawal within the National Health System.
8. It regulates what users pay at the pharmacy: percentages based on income (from 10% to 60% of the retail price), with monthly caps and exemptions for groups such as minimum vital income recipients or minors with disabilities.

Who it affects

• Patients and the public: The rules on prescribing, dispensing, home delivery and what is paid at the pharmacy for funded medicines would change.
• Pharmacies and pharmacists: New duties on dispensing, patient information, substitution during shortages and waste management.
• Pharmaceutical companies and manufacturers: New requirements on authorization, supply, pricing, public funding and traceability.
• Health professionals: Rules on conflicts of interest, prescribing by active ingredient and responsibilities in rational use.
• Veterinarians and farmers: The regulation of veterinary medicines is completed: prescription, dispensing and sale.

Words worth knowing

Agencia

The Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios), the public body that authorizes and monitors medicines.

Relación beneficio/riesgo

Benefit/risk balance: comparing what a medicine provides in benefits against the possible harm it can cause.

Agrupación homogénea

A group of medicines with the same active ingredient and dose, considered interchangeable with each other.

Medicamento estratégico

A strategic medicine: an essential medicine whose availability must never fail, so it receives special protections.

Farmacovigilancia

Pharmacovigilance: monitoring the safety of medicines once they are in use, especially adverse reactions.

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