Regulations of the Ethics Committee for Health

Article 1 | Scope

1. The Health Ethics Committee of MALO CLINIC, SA (CES), in its actions, is governed, especially, by the provisions set forth in Decree-Law No. 80/2018, of 15 October, without prejudice to any further applicable provisions established by Law, Deontological Codes, and International Guidelines and Declarations. 2. This Regulation contains the norms, rules of operation, and structure of the CES.

Article 2 | Responsibilities

1. The CES is a consultative body of MALO CLINIC, with technical and scientific independence, tasked with contributing to the observance of principles of ethics and bioethics in the provision of health care and the conduct of clinical research.

2. The CES must ensure compliance with the ethical standards required in the provision of health care and, in particular, in the practice of medicine to guarantee the utmost dignity in procedures and the highest respect for individuals and their rights.

Article 3 | Competencies

It is particularly incumbent upon the CES:

a) To monitor the procedures and practices of MALO CLINIC with a view to ensuring compliance with ethical standards, safeguarding the principle of the dignity and integrity of the human person;

b) To issue opinions, reports, recommendations, and proposals on ethical issues related to the activities of MALO CLINIC, with a view to the best clinical practices and the reception and support of clients;

c) To advocate for the respect of the rights and duties of clients and health professionals;

d) To promote the dissemination of bioethics within MALO CLINIC;

e) To issue opinions on the scientific and ethical adequacy of researchers for conducting clinical research studies;

f) To evaluate the methodological, ethical, and legal aspects of the clinical research studies submitted to it and to issue opinions on their execution;

g) To undertake, within MALO CLINIC, studies reflecting on ethical and bioethical issues, disseminate them accordingly, and promote a culture of pedagogy and training.

Article 4 | Composition

1. The CES that constitutes the scope of this regulation is composed of nine members, including the president and the vice-president.

2. The members of the CES have training in different areas, including dental medicine, oral hygiene, nursing, pharmacy, dental assistant, dental prosthetics, medicine, and law, with experience and recognized merit, with at least two being external to MALO CLINIC.

3. Among the members of the CES, the president and vice-president shall be elected, with coordination of the work assigned to the former, and in their absence or impediments, to the latter.

4. The CES may, when justified, request the collaboration of other technicians, without voting rights.

Article 5 | Mandate

1. The members of the CES shall not receive any remuneration and are appointed by a resolution of the management body of MALO CLINIC for a term of four years, renewable once for an equal period.

2. Any expenses incurred by the members of the CES in the scope of their responsibilities will, however, be borne by MALO CLINIC.

3. The functions of the members of the CES cease under the following circumstances:

a) At the end of the term of office;

b) Upon taking office in another position or function incompatible with the exercise of the functions of a member of the Ethics Committee;

c) By resignation, by letter addressed to the management body of MALO CLINIC, with knowledge to the CES;

d) By resolution of the management body of MALO CLINIC, after hearing the CES, based on a breach of the duties of a member of the CES.

A breach of the duties of a member of the Ethics Committee is considered, in particular, an unjustified absence, three consecutive times, from regularly convened meetings.

Article 6 | Operation

1. The CES meets at the invitation of the president or, in their absence or impediments, the vice-president, whenever justified at least once a month, or extraordinarily at the request of any of its members.

2. In order to validly deliberate, at CES meetings, it is necessary that at least five members are present.

3. In case of a tie in any voting, the president has the casting vote;

4. Any member of the CES is prohibited from voting when matters related to them are being discussed.

5. The representation of the CES and its articulation with the bodies of MALO CLINIC and with third parties is the responsibility of the president and, in their absence or impediments, the vice-president.

6. At the initiative of the president, when the nature of the matter justifies it, and taking into account the composition of the CES and the specificity of the subject in question, specialized commissions may be established to prepare opinions or reports on the matters expressly submitted to them. These commissions will cease after their completion.

7. Minutes of all meetings will be recorded by the secretary assigned from MALO CLINIC to the CES and, in their absence, by the member of the CES designated by the president.

8. Any opinions, suggestions, or simple guidelines from the CES will always be conveyed in writing and with knowledge to the management body of MALO CLINIC.

Article 7 | Rights of Members

The rights of CES members are:

a) To obtain from the management body the information deemed pertinent;

b) To participate in meetings and votes;

c) To attend training actions considered of interest within the scope of the CES, in coordination with the management body;

d) To be exempt from their activities, within MALO CLINIC, during the periods allocated to the CES members.

Article 8 | Duties

It is the duty of all members of the CES to strive for the observance of rigorous principles of ethics and bioethics and, specifically, for each one:

a) To perform their mandate with care and diligence;

b) To maintain confidentiality about the matters discussed, without prejudice to those that must be disclosed;

c) To participate actively, aiming for the CES's objectives, collaborating with the other members and meeting deadlines for completing the work;

d) To remain updated on ethical and bioethical issues and to express their views on the matters on the agenda of the meetings.

The duty of confidentiality stated in item b) extends to all those who attend (at request, by invitation, or by assignment) the actions of the CES.

Article 9 | Logistical, Administrative, and Financial Support

1. MALO CLINIC will provide the logistical, administrative, and financial support necessary for the proper functioning of the CES.

2. There should be an area on the MALO CLINIC website where its composition, meeting schedule, activities, produced opinions, internal regulations, and identification of projects or clinical research studies under evaluation, where applicable, are listed.

Article 10 | National Network of Health Ethics Committees

The Health Ethics Committee (CES), by virtue of its responsibilities, is part of the National Network of Health Ethics Committees (RNCES), as provided for in Law No. 21/2014, of 16 April, as amended, and is therefore committed to collaborating, whenever necessary, with the respective coordinating entity.

Article 11 | Annual Report

The CES must prepare an annual report, at the end of each calendar year, regarding the activities carried out, which shall be sent to the management body of MALO CLINIC by 15 February of the following year to which it refers, and must be placed in the ethics committee area on the MALO CLINIC website and in the RNCES.

Article 12 | Final Provisions

1. This regulation of the CES may be amended at any time, provided that there are valid reasons for doing so.

2. Any amendment to this regulation requires prior approval from the administration.

3. The internal regulation of the functioning of the CES, after being approved, will be disseminated in the area of the respective ethics committee on the institution's website.

Approved by the Health Ethics Committee of MALO CLINIC S.A. Ratified by the Board of Directors of MALO CLINIC S.A. March 2022.