Medical Liability in Assisted Reproduction in Spain

Assisted reproduction is today one of the most promising areas of medicine as many couples struggle with conception. It is also one of the most legally complex areas. Every year, thousands of people in Spain visit specialised clinics with the hope of starting a family. However, when treatment does not achieve the expected outcome or complications arise, questions about potential medical liability may emerge.

To what extent is a doctor or clinic responsible for an unsuccessful result? What happens if a patient believes they were not properly informed? Giambrone and Partners provides a clear explanation of patients’ rights and professionals’ obligations in assisted reproduction treatments, according to Spanish law.

Spanish Law on Assisted Reproduction

Law 14/2006 on assisted human reproduction techniques regulates in detail how these treatments should be conducted. It stipulates that procedures may only be carried out in authorised centres and with the patient’s prior, free and informed consent.

Additionally, the doctor must provide comprehensive information about the procedure, clearly outlining its purpose, potential risks and the actual success rates and providing information on available alternatives.

This information is essential as it enables patients to make decisions freely and knowledgeably. If the information provided is insufficient or unclear, civil liability may arise on the part of the professional or clinic, even if the treatment was technically performed correctly.

Obligation of Means, Not Result

An important concept to clarify is that medicine is generally based on an obligation of means, not of result. This means that the doctor commits to acting with the utmost diligence and in accordance with good medical practice (lex artis) but cannot guarantee the success of the treatment.

In fertility treatments, many biological and personal factors lie beyond medical control. Therefore, an unsuccessful result does not automatically constitute negligence.

However, medical liability may exist if it can be shown that the professional acted incorrectly, failed to follow proper protocols, or did not adequately inform the patient of the risks and real chances of success.

The Role of Informed Consent

Informed consent is a fundamental part of assisted reproduction treatments. Before any procedure begins, the clinic must ensure that the patient:

• Has received a clear, comprehensive explanation tailored to their case;
• Understands the risks and possible complications;
• Knows the actual success rates and available alternatives;
• Signs a specific consent form rather than a generic one.
   

Simply providing a standard form for the patient to sign is not sufficient. The law requires effective communication between the doctor and the patient. Failure to meet this requirement may result in liability for inadequate information, even if the treatment itself was technically correct.

Situations That May Give Rise to Liability

Spanish courts have dealt with various cases involving medical negligence in assisted reproduction. Common scenarios include:

• Loss or mislabelling of biological samples;
• Errors in genetic selection or pre-diagnosis;
• Failure to inform about relevant risks;
• Incorrect handling of embryos or gametes;
• Failures in storage or custody of biological material.

In all these cases, it is crucial to determine whether the professional acted in accordance with lex artis, i.e., accepted medical standards. If deficient performance or inadequate information is proven, civil or even criminal liability may arise.

How Medical Liability is Determined

For medical liability to be established, three basic criterion must be met:

1. Damage or harm must have occurred to the patient;
2. The harm must directly result from medical action;
3. The professional or clinic must have acted negligently or contrary to lex artis.

The burden of proof usually lies with the patient. However, if the clinic has not properly maintained clinical documentation or informed consent, the courts may shift the burden of proof, requiring the clinic to demonstrate that it acted correctly.

The Importance of Medical Documentation

Medical records and laboratory reports are essential in resolving any dispute. All medical actions must be documented including hormonal monitoring, embryo development, administered doses, incidents, intermediate results, etc.

Incomplete or inaccurate documentation may be interpreted as a lack of diligence. Clinics and professionals must therefore take particular care in recording and preserving all treatment-related data.

Ethics and Responsibility: Beyond Legal Aspects

Assisted reproduction involves not only medical and legal considerations but also ethical and emotional ones. Patients place their trust and most personal expectations in professionals, who carry significant responsibility in guiding them through this process.

Transparency, empathy and honesty are essential to prevent conflicts. Clearly explaining realistic chances of success and scientific limitations helps manage expectations and reinforces trust between doctor and patient.

Protecting Your Rights as a Patient

If you have undergone assisted reproduction treatment and believe an error or lack of information has occurred, it is advisable to:

• Request your complete medical records. This is your right and may be key to clarifying the situation;
• Seek specialised legal advice. Lawyers experienced in medical liability can assess whether negligence or lex artis violations occurred;
• Collect all documentation (emails, consent forms, estimates, reports);
• Consider mediation or administrative claims before pursuing legal action, if possible

Having appropriate legal support can make a significant difference to the financial consequences and liability.

In Summary

Medical liability in assisted reproduction seeks to balance patients’ rights with professionals’ legal protection. Doctors cannot guarantee results, but they must act with the highest diligence and provide complete, transparent information.

Similarly, patients should know their rights, demand clear communication, and preserve all documentation related to their treatment. A responsible, ethical, and transparent approach is the best way to protect both health and trust in advances in reproductive medicine.

Should you wish to know more about seeking reparations following a medical procedure please click here.