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Product Regulation & Liability

Spain: Allowing the non-presential dispensing of medicines and medical devices

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In brief

At the end of June, the new Royal Decree 5/2023 was published, introducing various health and social measures. Among the different legislative changes that have taken place, the most important is the modification of the Law on Guarantees and Rational Use of Medicines and Medical Devices. From now on, the autonomous communities are allowed to establish measures for dispensing medicines and medical devices remotely if there are circumstances that justify it due to the situation of the patients. At the end of June, the new Royal Decree 5/2023 was published, introducing various health and social measures. Among the different legislative changes that have taken place, the most important is the modification of the Law on Guarantees and Rational Use of Medicines and Medical Devices. From now on, the autonomous communities are allowed to establish measures for dispensing medicines and medical devices remotely if there are circumstances that justify it due to the situation of the patients.

In more detail

On 29 June 2023 Royal Decree-Law 5/2023 was published in the Official State Gazette. This regulation adopts multiple health, social and economic measures.

Among all the amendments introduced by the Royal Decree, it is worth highlighting article 207 of Royal Decree-Law 5/2023, which amends the Law on Guarantees and Rational Use of Medicines and Medical Devices. Specifically, a new section has been introduced to article 3 of the Law on Guarantees, which deals with the supply and dispensing of medicines and medical devices, allowing the competent bodies of the autonomous communities to establish measures to dispense medicines and medical devices in a non-presential manner, provided that there are exceptional health circumstances or that this is necessary due to the patient’s dependence, vulnerability, risk or distance from pharmacies or the pharmacy services of hospitals and health centers.

By means of this amendment, patient care shall be guaranteed through the delivery of medicines and medical devices to the patient’s home or a health center closer to their home. Likewise, the pharmacy service in charge of dispensing these medicines and medical devices will be responsible for carrying out the follow-up until the products reach their destination, and must ensure that during the transport and delivery of these products their quality is not altered and that they are adequately preserved.

It is important to mention that similar provisions on the dispensing of medicinal products were already introduced into the national legal system through certain temporary regulations to combat COVID-19. These regulations aimed at optimal monitoring of patient care as well as bringing medication closer to the patient when needed. Said measures reflected a notable improvement in the management of pharmaceutical dispensing to patients, and now these provisions have been confirmed and extended to all kind of patients who require them.

For more information on all the amendments introduced, you can consult the full text of the Royal Decree by clicking on this link.

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Author

Montserrat has extensive experience in pharmaceutical and health law, as well as in compliance, contract law, licensing, competition law and acquisitions in the pharmaceutical sector. She is the coordinator of the healthcare practice in the Barcelona office.
She assists healthcare companies throughout the life cycle of healthcare products (drugs, IVD and medical devices, combination products, cosmetics and food supplements), from R&D to commercialization and more specifically in the areas of clinical trials (agreements, regulatory procedures, processing of personal data), market access (pricing and reimbursement), products and companies regulations (MA/CE-marking, vigilances, required licenses, product classification, labelling), commercial relations between healthcare industries (distribution, (co)promotion, manufacturing, supply, licensing, partnership agreements), relations with healthcare professionals and/or patients including compliance (anti-gift and transparency laws); communication and advertising, e-health (connected devices, telemedicine, hosting of health data) and product liability. Her practice encompasses both advisory and litigation matters.
She also has considerable experience in the drafting of codes of professional ethics and conducting compliance audits, and advising on advertising and promotion of medicines and medical devices, including via the internet, online advertising and social media. Montserrat advises on a wide range of agreements related to the pharmaceutical industry, such as license and distribution agreements, clinical trial agreements, and supply and manufacturing agreements.

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