Introduction

On April 28, 2025, Egypt enacted Law No. 13 of 2025 Regulating Medical Liability and Patient Safety, marking a transformative shift in the country’s approach to healthcare governance. This law introduces the first comprehensive legal framework specifically designed to address medical malpractice, aiming to protect patient rights while simultaneously providing healthcare professionals with legal clarity and safeguards. It was published in the Official Gazette and is scheduled to take effect on October 28, 2025, allowing for a transitional period during which institutions and stakeholders can prepare for its implementation.

The significance of this law lies in its departure from prior reliance on general tort and criminal law provisions, which often lacked the specificity needed to assess medical conduct fairly. The new law represents a modern legislative solution that integrates clinical realities into legal evaluation, reflects international standards, and addresses systemic weaknesses. It introduces institutional oversight mechanisms, clarifies the scope of liability, and seeks to reduce the fear driven exodus of medical talent by offering legal protections against arbitrary prosecution.

Historical Context and the Need for Reform

Before the enactment of the new law, Egypt dealt with medical malpractice under the general provisions of the Egyptian Penal and Civil Code. Physicians were frequently exposed to criminal charges, including negligence and manslaughter, even in cases involving unintended harm or procedural complications. The lack of a specialized legal framework discouraged transparency, incentivized defensive medicine, and contributed to growing dissatisfaction within the medical profession. This hostile legal environment created significant deterrents for practitioners and increased the risk of misjudging complex medical decisions through a criminal lens.

In recent years, public and professional pressure for reform intensified. The tragic death of a young girl named Jana in 2022, reportedly due to medical error, captured national attention and highlighted the inadequacy of the existing legal system. Medical syndicates and human rights organizations called for legislation that would clearly distinguish between honest errors, known risks, and gross negligence. These efforts culminated in the drafting of the new law, which was ultimately shaped by a consensus that effective reform must both protect patients and secure a just environment for doctors.

Core Features of Law No. 13 of 2025

At the heart of the new law is a set of definitions that seek to establish a clear threshold for medical liability. It differentiates between a “medical error,” defined as a deviation from recognized medical standards or protocols, and a “known complication,” which is a foreseeable, non-negligent adverse outcome that does not trigger legal liability. The law also introduces the concept of “gross negligence,” referring to serious misconduct involving recklessness, inattention, or practicing under impaired conditions such as substance abuse. These distinctions are designed to ensure that legal consequences are imposed only when medical behavior falls significantly short of professional standards.

The law also creates a Supreme Committee for Medical Liability and Patient Protection under the supervision of the Prime Minister. This body plays a central role in the new system, tasked with reviewing malpractice complaints, providing expert evaluations to courts and prosecutors, and advising on compensation and healthcare reforms. By centralizing medical expertise in the evaluation of malpractice claims, the committee serves as a filter that prevents frivolous or unfounded accusations from progressing into legal proceedings, thereby protecting both judicial efficiency and professional integrity.

Another vital innovation is the introduction of a dual complaint mechanism. Patients or their families now have the option to file complaints directly with the Supreme Committee or proceed independently through the judicial system. This flexible approach is intended to streamline access to justice and reduce procedural delays, while also encouraging early resolution through administrative channels when appropriate. It empowers patients while also allowing medical professionals to benefit from expert-led review before legal escalation.

Law No. 13 also mandates a compulsory medical liability insurance scheme, managed by the government. This fund is designed to compensate victims of medical malpractice, including in cases where clear legal liability may be difficult to establish, such as complications during surgery. The system reflects a shift from an individual liability model to one based on collective, institutional risk-sharing, ensuring that injured parties receive restitution without always having to pursue contentious litigation or prove fault under rigid standards.

Penalties and Legal Safeguards

Law No. 13 of 2025 introduces a measured and structured approach to penalties for medical malpractice, shifting away from Egypt’s previous reliance on criminal sanctions that were often applied inconsistently. One of the most significant reforms is the abolition of pretrial detention for healthcare professionals accused of medical errors, except in cases involving gross negligence or willful misconduct. This marks a departure from past practice where physicians could be imprisoned even before the facts of the case were established. The law emphasizes that medical professionals should not be treated as criminals for mistakes made in good faith or within the bounds of recognized medical practice, thereby aligning legal responses more closely with clinical realities.

The financial penalties under the new law are designed to reflect the severity of the misconduct. Fines for proven malpractice range from EGP 100,000 to EGP 2 million, with the higher end of the scale reserved for instances involving reckless disregard for patient safety, such as operating under the influence or without proper qualifications. In the most serious cases, such as gross negligence leading to death or permanent disability, criminal liability, including imprisonment, may still be imposed, but only after review by the Supreme Committee and in accordance with clearly defined legal standards. Additionally, the law facilitates civil compensation through the mandatory insurance scheme, ensuring that patients receive restitution while sparing doctors from ruinous personal liability. This framework represents a shift toward accountability without disproportionate punishment, aiming to foster trust, reduce litigation, and maintain professional morale.

Impact on Stakeholders

For doctors, Law No. 13 brings much needed relief from the threat of arbitrary or excessive punishment. By providing clearer definitions of professional fault, eliminating pretrial detention, and ensuring that liability is subject to expert review, the law fosters a safer and more predictable legal environment. The mandatory insurance scheme also offers financial protection, allowing practitioners to focus on patient care rather than personal liability. Moreover, the law’s structure links professional accountability to well-defined standards of care, encouraging best practices while avoiding fear-driven avoidance of high-risk cases.

Patients also stand to benefit from the new legal regime. The ability to seek expert assessment from a neutral committee before initiating a court case promotes transparency and consistency in how claims are handled. Compensation is more accessible, particularly in cases where liability is ambiguous, but harm is undeniable. These changes support a more patient-centered model of care, where victims of genuine harm can receive justice without needing to navigate complex or hostile litigation processes.

At the systemic level, Law No. 13 is likely to improve the overall quality of healthcare delivery. By discouraging defensive medicine and promoting professional development through institutional feedback, it incentivizes continuous improvement. The establishment of clear procedures for addressing malpractice claims also reduces the administrative burden on the judiciary, ensuring more efficient resolution of cases and better allocation of public resources.

Nonetheless, for all its promise, the law’s implementation will present challenges. The effectiveness of the Supreme Committee depends on its independence, training, and transparency. Critics have voiced concerns about vague terminology in the law that could still leave room for conflicting interpretations, particularly around the concepts of negligence and error. Additionally, some victims’ rights advocates fear that the administrative structure could inadvertently favor institutions over individuals if oversight is not robust.

Conclusion

Law No. 13 of 2025 is a landmark reform that introduces a more balanced, transparent, and expert-driven approach to medical liability in Egypt. By institutionalizing oversight, defining key legal concepts, and offering civil remedies over punitive sanctions, it marks a shift toward a healthcare system that respects both patient safety and the professional integrity of medical workers. While it does not eliminate all risks or challenges, it provides a foundational legal framework upon which Egypt can continue to build a more just and effective system.

As the law is implemented, it will be crucial for regulators, healthcare institutions, and civil society to monitor its application and advocate for necessary adjustments. Continuous training, procedural clarity, and public awareness will be essential to ensuring the law s goals are fully realized. If applied with diligence and fairness, Law No. 13 has the potential to transform medical accountability in Egypt, reducing injustice while fostering trust in the nation’s healthcare system.