After the initial introduction of the Regime Jurídico do Erro Médico (RJEM, Law 5/2016) to the Macau Legislative Assembly in 2013, and the ensuing internal examinations and consultations with various sectors (eg, the medical, legal and insurance communities), the RJEM will enter into force on February 26 2017.
Before the RJEM, Macau's legal system had no specific legislation regarding medical error and relied on piecemeal legislation and general rules. Approaches to the subject were inconsistent – for example, civil liability pertaining to medical error was governed by different sets of rules (contractual and extra-contractual liability rules) and courts (Base Judicial Court and Administrative Court), depending on whether the healthcare provider belonged to the private or public sector.
The driving forces behind the RJEM's enactment include:
- a lack of knowledge about the occurrence of medical error;
- difficulty obtaining proof;
- consistency of the liability rules and competent courts; and
- availability of alternative dispute resolution.
Definition of 'medical error' The RJEM provides for the definition of 'medical error' in Article 3:
"For the purposes of this law, a medical error is the fact that a medical act has been committed, in violation of legal statutes, instructions, ethical principles, professional technical knowledge or general rules in the area of health, that causes damage to the physical or psychological health of the patient, whether by action or by omission."
Patient protection Under the RJEM, healthcare providers have the duty to inform and patients have the right not to be informed. Healthcare providers must inform patients of:
- clinical situations;
- medical treatment measures; and
- associated risks.
Patients can exercise their right to refuse to be informed in writing. In both cases, the RJEM offers some exceptions that can relieve or restrict the respective duty and rights. In case of death or where the patient cannot express such through his or her will, the possibility to extend access to information may be available to those vested with legitimacy, including:
- spouses and descendants;
- other relatives up to the fourth degree; and
- the public prosecutor, in the absence of the above.
Healthcare providers are mandated to register, manage, maintain and dispose of patients' medical records. Such medical records must be kept for a minimum period of 10 years from the last date of entry. Should the patient be a minor, the minimum period is extended a further two years on the patient becoming an adult. At the request of the patients or others vested with legitimacy, healthcare providers must provide medical records within 10 days, charging a fee determined by the chief executive. The relevant instruction on the registration, management, maintenance and disposal of medical records will be determined by the Macau Health Service (MHS).
As healthcare providers become aware or suspect an occurrence of medical error, they are charged with the duty to notify the MHS within 24 hours. Thereafter, the MHS can request healthcare providers to submit a detailed report within a timeframe determined by the MHS. Subsequent measures, which are guided by the principles of necessity, proportionality and adequacy, will be taken by healthcare providers and the MHS, depending on the certainty of the occurrence of medical error.
Investigation Committee of Medical Error The RJEM foresees the creation of the Investigation Committee of Medical Error, whose principal functions are to research and investigate the verification of medical error. The committee will be made up of seven individuals nominated by the chief executive – five foreign or local medical professionals and two local legal professionals. Each professional must have a minimum of 10 years' experience in the respective field and adequate deontological standing to be part of the independent committee.
At the request of healthcare providers, patients or others vested with legitimacy, along with due payment and, in some instances, at the request of the court made in accordance with the Macau Civil Procedural Code, the committee will commission an expert report on whether a medical error has occurred. During the report stage, the committee has particular investigatory and evidence gathering powers, including:
- entering the premises and facilities of healthcare providers and remaining there until the conclusion of the investigation; and
- ordering healthcare providers, patients and other persons or entities that can contribute to the investigation to give a deposition and statements and to present any necessary documents, information and data for the investigation.
Further exemption from the obligation of confidentiality is provided to healthcare providers and other persons or entities that participate in the investigation when the committee is exercising its abovementioned powers.
The expert report should be concluded 90 days after the request has been received. However, that period can be extended a number of times due to the complexity of the investigation. The findings of the expert report do not prevent other means of investigation and it is susceptible to challenges when healthcare providers, patients or others vested with legitimacy consider that the report is flawed by error, omission, uncertainty or contradiction, or that the findings are not duly substantiated. Thus, when submitted to the court, its value as evidence is at the court's discretion.
Liability rules and competent court The RJEM consolidates inconsistent approaches to healthcare providers' civil liability pertaining to medical error into one applicable solution (known as the 'extra-contractual liability rule'). The RJEM provides clarity regarding joint responsibility in case of a plurality of wrongdoers and a right of recourse against other wrongdoers proportional to their respective share of faults and consequences arising therefrom and regarding the responsibility of the principal.
The RJEM has made the Judicial Base Court the competent entity for all legal proceedings pertaining to civil liability regarding medical error. This has resolved the divergence which previously directed legal proceedings against public entities to the Administrative Court.
Alternative dispute resolution The RJEM has also mandated the creation of the Centre of Mediation of Medical Disputes, which provides mediation as a voluntary alternative dispute resolution procedure for medical error. Mediators will be nominated by the chief executive.
The implementation and execution of the RJEM had long puzzled the medical, insurance and legal sectors, as the necessary supplementary provisions were left without regulation following its publication in August 2016.
Fortunately, the government's effort to fill the gaps of the RJEM and its supplementary provisions before it enters into force has been vigorous.
The provisions, published in the Official Gazette on February 20 2017, include:
- the functioning of the Investigative Committee of Medical Error (Administrative Regulation 3/2017);
- the functioning of the Centre of Mediation of Medical Disputes (Administrative Regulation 4/2017);
- mandatory liability insurance (Administrative Regulation 5/2017, Executive Order 45/2017 and Executive Order 46/2017);
- the fees for obtaining medical records (Dispatch of Chief Executive 27/2017); and
- the fees for requesting an expert report (Dispatch of Chief Executive No. 28/2017).
The RJEM is a sensible reaction by the government to the problems and injustice caused by medical error and how it is handled. Hopefully its effectiveness can be proven with experience.
For further information on this topic please contact Pedro Cortés or Calvin Tinlop Chui at Rato, Ling, Lei & Cortés Advogados by telephone (+853 2856 2322) or email (firstname.lastname@example.org or email@example.com). The Rato, Ling, Lei & Cortés Advogados website can be accessed at www.lektou.com.
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