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Establishing A System Of Public Health Surveillance, Which Identifies Risk Situations, Collects, Updates, Analyses And Disseminates Data On Communicable Diseases And Other Public Health Risks, As Well As Prepares Contingency Plans Vis-À-Vis Is Located

Original Language Title: Institui um sistema de vigilância em saúde pública, que identifica situações de risco, recolhe, actualiza, analisa e divulga os dados relativos a doenças transmissíveis e outros riscos em saúde pública, bem como prepara planos de contingência face a situa

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CHAIR OF THE COUNCIL OF MINISTERS

Proposal for Law No. 258 /X/4.

1

Exhibition of Motives

The prevention and control of risks in public health have had, to date, been as a diploma

regulator, the Law No. 2036 of August 9, 1949, which only versa on diseases

contagious in terms that were inherent in the social and scientific conjuncture of the era in which

has been published, for more than 50 years.

Thus, the updating of the legal regime in force, so as to cover all the

communicable diseases and too many risks to public health, and to institute a true and

modern system of epidemiological surveillance, scientifically grounded, while

public health instrument, with a view to continuous monitoring and regular analysis

of determinant phenomena of the health of populations.

It is considered to constitute public health risk the increased probability of occurrences

that can harm the health of human populations, at the level of their physical medium,

biological and social, with special relief for the communicable diseases that can

represent a serious and direct danger in the national territory or propagate at the level

international. In this area, it stands out, in the topicality and the title of example, diseases

infectious-contagious as the acquired immunodeficiency syndrome (AIDS), certain

viral hepatitis, multidrug-resistant tuberculosis, acute respiratory distress syndrome and influenza by

new subtype of viruses.

CHAIR OF THE COUNCIL OF MINISTERS

Proposal for Law No. 258 /X/4.

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As a systematization of the World Health Organization (WHO), they are still classified

as diseases and public health risks, liable for surveillance, a number of others

phenomena of physical, biological and social media, such as resistance and multiresistance of the

bacteria to antibiotics, chronic diseases such as dyslipidaias, the bioterrorist threat,

migratory flows, childhood obesity and ill-treatment of children.

On the other hand, the integration of Portugal into European and world surveillance structures

epidemiological, mainly at the level of the European Union and WHO, contributes to harmonize

policies and actions in this area, taking into account that the movements of globalization can

transforming infectious agents into worldwide threats.

In this area, it is up to highlight actions aimed at the creation and development of networks

of early detection, surveillance and control of certain communicable diseases in space

and within the framework of the European Union, finding itself already in place in our legal order to

Decision No 2119 /98/CE of the European Parliament and of the Council of September 24 of

1998, establishing a network for epidemiological surveillance and disease control

communicable in the Community, and still the Regulation (EC) No 851/2004 of Parliament

European and Council, of April 21, 2004, which creates a European Centre for

Prevention and control of diseases, in which Portugal participates.

WHO's role in global alert in the event of an outbreak and response to

public health occurrences of international scope, in accordance with their

mandate, it has been being strengthened, finding itself mundane from a global instrument

fundamental against the international spread of diseases, which is the Regulation

International Sanitary (RSI). This Regulation is in force in the legal order

national since June 15, 2007 at the last wording adopted by the 58 th Assembly

World of Health on May 23, 2005 and in the terms provided for in Article 22 of the

Constitution of the WHO.

CHAIR OF THE COUNCIL OF MINISTERS

Proposal for Law No. 258 /X/4.

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Underscored the importance that it continues to redress the RSI as a global instrument

fundamental against the international spread of diseases, above all in control and

surveillance of ports and airports, the present proposed law comes to institute for the territory

national a system of structured surveillance in molds identical to those deriving from the

application of that Regulation, taking advantage of synergies in the information and reporting processes

organization of resources with a view to enhancing the ability to detect, evaluate, notify and

declare the occurrences deemed to be of risk to public health.

The new organic laws of the Ministry of Health, passed in the year 2007, recognize the

importance, at the level of proximity, of the actions of surveillance, prevention and control of

communicable diseases. Effectively, epidemiological surveillance does not compete only

Directorate-General for Health and the National Institute of Health Dr. Ricardo Jorge, I. P., but

also to the basic structures articulated with the national health care network

primaries, specifically the public health departments of regional administrations

of health and the public health units of clusters of health centres.

Also with special relevance in this area, they have been exercising skills as

health authorities, at the national, regional and municipal level, to which it competes the decision of

state intervention in the defence of public health, the prevention of disease and promotion

and health protection, alongside the monitoring of risk factors and situations likely to

cause or accentuate serious damage to the health of citizens or agglomerates

population.

Effectively, modern requirements for the prevention and control of communicable diseases

and other risks in public health, entail establishing a framework of duties within the framework of

joint responsibility of citizens, society and the state in the defence and protection of the

CHAIR OF THE COUNCIL OF MINISTERS

Proposal for Law No. 258 /X/4.

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health, while right of individuals and the community.

Realizing the general principles laid down in the Health Basics Act, promotion and advocacy

of public health are carried out through structures and public authorities,

in particular the member of the Government responsible for the area of health, the Director-General of the

health (DGS), health authorities, public health clinicians and practitioners of

health in general, with involvement of civil society organisations, in particular

creating sentinel entities for the global system of alerts.

This proposed law institutes a system for surveillance in public health, while

set up organised in network of entities and measures, sensing you assigned competences of

surveillance, alertness and response, for the early detection of phenomena involving risk to the

public health, with speedy, rigorous and effective data transmission, on par with notification

compulsory from certain diseases by the epidemiological surveillance officers,

health professionals and responsible laboratories.

Having as a priority the immediate exchange of data and information in order to guarantee the

protection of the population, this system is based on an information system that aims to

abetting the global situations already provided for by the WHO as diseases under surveillance duty,

in addition to others deemed relevant in the light of the national epidemiological pattern.

A National Public Health Council is set up, with advisory functions of the Government,

integrating two specialized, surveillance and emergency commissions, where they have seat

the first responsible of national health structures. This organism works

integrated into the organization of already existing public health services in administrations

regional health and in the clusters of health centres, as well as in the activity of the

health authorities there seated,

In particular, the use of modern information technologies and

communication, with particular emphasis on telematics and communication means

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Proposal for Law No. 258 /X/4.

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based on the Internet , with a view to the greatest effectiveness and swiftness of the National System of

Information for Epidemiological Surveillance (SINAVE).

Alongside the prevention and control measures, it has become essential to ensure the defence and

protection of personal data. Effectively, health information, being an asset

essential strategic for the prevention and control of public health risks, as well

integrates the private life of the people to which it concerns, which requires strict observance of

rules of confidentiality and security in treatment.

The present proposed law provides for the approval of a contingency plan for the

epidemics and taken of exception measures in serious situations.

Finally, a sanctionatory regime is imposed for violation of the reporting duties

mandatory of the diseases thus classified at each time by dispatch from the DGS, well

as of the communication duties of alerts.

In summary, the present proposal of law corresponds to a public health priority, which

needs a global and coordinated approach at the national and international level, so

to identify risk situations for public health, to collect, update, analyse and disseminate

the data concerning these risks, as well as cooperate, in these areas, with the organisms

national and international with priority assigned to communicable diseases.

The self-governing bodies of the Autonomous Regions and the Commission were heard

National Data Protection.

Thus:

Under the terms of the paragraph d) of Article 197 (1) of the Constitution, the Government presents to the

Assembly of the Republic the following proposal for a law:

CHAIR OF THE COUNCIL OF MINISTERS

Proposal for Law No. 258 /X/4.

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CHAPTER I

Object and scope of application

Article 1.

Subject

1-A present law establishes a system of surveillance in public health, through the

organization of a set of entities from the public, private and social sectors

developing public health activities, as per their respective organic laws and

statutory assignments, applying measures for prevention, alertness, control and response,

relatively to communicable diseases, in particular infectious diseases, to other risks

for public health with a view to ensuring the right of citizens to the defence and protection of the

health.

2-For the purposes of the provisions of the preceding paragraph, a nationwide network is set up

involving the public health operative services, the laboratories, the authorities of

health and other entities from the public, private and social sectors, whose participants

contribute to a national system of epidemiological surveillance information,

named SINAVE.

Article 2.

Scope of application

1-A This Law applies to all entities, from the public, private and social sector,

established or by providing services, in the national territory, that develop activity

CHAIR OF THE COUNCIL OF MINISTERS

Proposal for Law No. 258 /X/4.

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of collection, analysis, interpretation and systematic and continuous dissemination of data from

health, or carry out epidemiological studies, concerning communicable diseases and

other risks in public health.

2-A implementation of measures with the aim of preventing and containing the spread of the

communicable diseases and other risks to public health, by the entities

public in the exercise of the powers and functions under this Act, including the

conduct of epidemiological investigations pursued by the health authorities

competent and analysis of their respective risk factors, subject to the scheme of

health information and personal data protection information.

CHAPTER II

Organization and operation of the surveillance system in public health

Article 3.

Organization

1-The surveillance system in public health is aimed at monitoring the state

of health of populations over time, and aims to determine the risk of transmission

of any disease, or other health phenomena, as well as the prevention of its

entry or propagation in Portuguese territory, upon control of its genesis and

evolution.

2-A The methodology of defining the process of continuous public health surveillance is

established by portaria of the member of the Government responsible for the area of health, under

proposal of the National Health Authority (ASN), articulating the exercise of the

competencies of the following entities:

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Proposal for Law No. 258 /X/4.

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a) Directorate-General for Health (DGS);

b) National Institute of Health Ricardo Jorge, I. P. (INSRJ, I. P.);

c) Health authorities;

d) Public health services seated in regional health administrations;

e) Public health services, together of the localities, seated in the groupings of

health centres or in local health units.

3-The entities covered by the regulation provided for in the preceding paragraph shall compete for the

systematic collection, consolidation and evaluation of morbidity data, mortality and

determinants of health in the national territory, as well as other essential data to the

fulfillment of the target set out in paragraph 1.

4-For the purposes of this Law, the essential data for health information processing

public include clinical descriptions, laboratory results, sources and types of risks,

number of human cases and deaths, conditions that determine the spread of the

illness and applied measures, as well as any other information that furnaces

means of proof on the basis of established and accepted scientific methods.

Article 4.

National Public Health Council

1-The National Public Health Council (CNSP) is set up, designated by the member of the

government responsible for the area of health that presides, with faculty of delegation in the

director-general of health (DGS), composed of a maximum of 20 members, designated

in representation of the public, private and social sectors, including the academic areas and

CHAIR OF THE COUNCIL OF MINISTERS

Proposal for Law No. 258 /X/4.

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scientific, with advisory functions of the Government in the context of prevention and control

of communicable diseases and other risks to public health and, in particular, to

analysis and evaluation of serious situations, particularly large epidemic outbreaks of large

scale and pandemics, we compete to substantiate the proposed declaration of the state of

emergency, by public calamity.

2-The CNSP comprises two specialized committees:

a) Coordinating Committee on Epidemiological Surveillance;

b) Executive Board of Emergency.

3-The CNSP draws up its regulation, predicting, in the same, its way of

functioning, to be approved at the first meeting.

4-The members of the CNSP exercise their duties unpaid.

Article 5.

Coordinating Committee on Epidemiological Surveillance

1-A The Coordinating Committee on Epidemiological Surveillance (CCVE) works as a

specialist commission of the CNSP and visa, on the basis of the reciprocal consultations and the

information provided by the entities that integrate the surveillance system into health

public, the coordination of preventive measures concerning communicable diseases and

too much public health risks, in the fulfillment of the principles enshrined in the

present law and in the technical and scientific standards arising from the centres of surveillance

european and international reference to which Portugal belongs in every moment.

2-A CCVE ensures consistency and complementarity between programmes and actions

initiated in its scope of intervention, including statistical information, projects of

research, technological development, mainly telematic means and

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Proposal for Law No. 258 /X/4.

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based on the internet , for the exchange of data, implementing all the links

necessary for the networks of the European Union and other international surveillance networks

epidemiological to which Portugal belongs, articulating them with the SINAVE.

3-The entities contributing to CCVE integrate themselves into a national network of

information and communication and transmits, through the SINAVE, data concerning:

a) Emergence or resurgence of cases of communicable diseases, together

with the information regarding the diagnostic and control measures applied;

b) Evolution of epidemiological studies in relation to which they have the

responsibility for the collection of information;

c) Insolithic, unexpected or outbreaks of communicable diseases of origin

unknown;

d) Mechanisms and procedures, existing or proposed, for the prevention of diseases

communicable, particularly in emergency situations;

4-A CCVE presents to the CNSP annual activity reports and carries out an assessment

of the information network every five years, giving special attention to its

structural and functional capacity, as well as to the effective use of resources

available.

5-A CCVE is composed, by the following entities:

a) Director General of Health, who chairs;

b) Director of the National Institute of Health Dr. Ricardo Jorge, I. P.;

c) Health authorities of the autonomous regions;

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Proposal for Law No. 258 /X/4.

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d) Directors of the public health departments of regional administrations of

health;

e) Director General of Veterinarian;

f) Director of the National Laboratory for Veterinary Research (LNIV).

6-The President of the CCVE, on his or her initiative or on a proposal from any member, may

invite other entities to participate in the meetings of the Commission, appoint a

Technical Group of Epidemiological Surveillance, for the coadjuvar in that scope.

Article 6.

National Information System of Epidemiological Surveillance

1-A Information management of epidemiological surveillance of occurrences in health and

respective specificities in the scope of each communicable disease and too much risk in

public health is ensured through the SINAVE, whose operativity is of competence

of CCVE.

2-A CCVE may, when it considers it necessary for the guarantee of health protection

of the citizens, to include in the scope and procedures for the implementation of the guidelines of the

SINAVE, any entities carrying out acts of health surveillance, with a view to the

surveillance of diseases and incidents associated with health care, as well as of

chronic diseases or social phenomena with direct repercussion in public health.

3-Civil registration services collaborate with CCVE, in the framework of the SINAVE, so

to make available, with recourse to the electronic means of the services themselves, the

data relating to the birth and mortality required for surveillance activities

CHAIR OF THE COUNCIL OF MINISTERS

Proposal for Law No. 258 /X/4.

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epidemiological.

Article 7.

Emergency Executive Board

1-A Emergency Executive Board (EEC) intervenes in emergency situations of

public health, by determination of the president of the CNSP, when one occurs

occurrence or imminent threat of phenomena concerning communicable diseases and

other health risks, whose characteristics may come to cause serious consequences

for public health.

2-Compete, in particular, to the EEC:

a) Evaluate, within 48 hours, all communications from occurrences of

emergency, with treatment of the immediate information in the SINAVE;

b) Draw up analysis report to be submitted to the CNSP, in cases of public calamity

that justifies declaration of the state of emergency.

3-A the committee shall draw up a national response plan, which provides in particular to

creation of teams to respond to the occurrences that may constitute a

public health emergency of national scope, as well as ensure availability,

at any time, from a service that allows immediate communication with the

regional and municipal-level public health services.

4-For the purposes of this Law, any public health emergency shall be deemed to be

extraordinary occurrence that constitutes a risk to public health by virtue of the

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Proposal for Law No. 258 /X/4.

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increased probability of dissemination of signs, symptoms or diseases requiring

a coordinated national response.

5-A The Executive Board of Emergency is composed of the following entities:

a) Director General of Health, who chairs;

b) Chairpersons of the governing boards of regional health administrations;

c) Health authorities of the autonomous regions;

d) Chairman of the Governing Board of the National Institute of Medical Emergency,

I. P.;

e) Chairman of the Governing Board of the National Institute of Health Dr. Ricardo

Jorge, I. P.;

f) Chairman of the Directive Board of the INFARMED-National Authority of the

Medicine and Health Products, I. P.;

g) Chairman of the National Civil Protection Authority.

6-The President of the EEC may, on his or her initiative or on a proposal from any Member,

invite other entities to participate in the meetings of the Commission, for organisation

of the response measures to be adopted in the face of emergency situations in public health.

Article 8.

Integrated network of information and communication

1-A This Law creates a network for epidemiological surveillance for prevention and control

of communicable diseases and other risks in public health, having on the basis of

need to institute a determined form of collection of necessary information.

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Proposal for Law No. 258 /X/4.

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2-Compete to DGS, in the quality of National Health Authority (ASN), organize the

network provided for in the preceding paragraph with permanent connection, by the appropriate means,

with the health authorities responsible for the determination of the necessary measures to

implementation of an early warning and response system.

3-A ASN approves the regulation of organization of the activities of sector entities

public, private or social, which integrate the network provided for in paragraph 1 by forecasting a form

effective articulation with a view to gaining a centralized knowledge of the whole

information on communicable diseases and too much risk for public health, at level

national.

Article 9.

Operation of the integrated network of information and communication

To ensure the effective operation of the network with regard to surveillance

epidemiological and with a view to standardizing information in that scope, it is incumbent on the DGS

determine, upon dispatching, the following:

a) Methods of epidemiological and microbiological surveillance;

b) Communicable diseases and other risks that are to be covered by the network of

information and communication;

c) Criteria for the selection of such diseases, taking into account the networks of collaboration

existing on surveillance;

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Proposal for Law No. 258 /X/4.

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d) Definition of cases, especially of clinical and microbiological characteristics;

e) Nature and type of data and information to be collected and transmitted by the

entities / authorities integrated into the network provided for in Article 8;

f) Guidelines on the protective measures to be adopted in emergency situations;

g) Guidelines on information and guides of correct practices for use of the

populations;

h) Technical means necessary and appropriate to the disclosure procedures and

treatment of data in a comparable and compatible way.

Article 10.

Sentinel entities

1-Considered, for the purposes of this Law, sentinel entities, all of

public, private and social sector entities, which have competences or

develop activities for early detection of risks, outbreaks, epidemics, or other

type of public health emergencies and which have concluded, for the purpose of

immediate transmission of alerts, collaboration protocols in the framework of the system of

public health surveillance provided for in Article 3, or that they already perform, by

any other form, such functions from a time prior to the entry into force of the

present law.

2-The articulation regime of sentinel entities is defined, after advice from the CNPD,

by regulation to be approved by the DGS.

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Proposal for Law No. 258 /X/4.

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Article 11.

Partnerships and accreditation

The formalization of a cross-sectoral network, as provided for in Articles 8 to 10, imposes

an accreditation process for the effect of those entities, as per internal standards

for such elaborated by the relevant quality DGS quality services, in

set with other central services and under advice from CCVE.

Chapter III

Measures for the prevention and control of communicable diseases and other risks in

public health

Article 12.

Competence

Compete for ASN, lead the actions and programmes in the area of prevention and control of the

communicable diseases and too much risk in public health, coadjured by the rest

regional and municipal level health authorities.

Article 13.

Detection and reporting of occurrences in public health

1-The activities of notification, verification and collaboration, in the framework of surveillance

epidemiological, should be developed through the structures and national resources

of the public health operative services.

2-The occurrences involving levels of morbidity or mortality higher than the

expected for the period and place considered, should be, as soon as known,

communicated by the entities that integrate the network, to the health authorities, well to the

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Proposal for Law No. 258 /X/4.

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responsible for local structures, namely the Executive Director of the ACES or the

board of directors of the ULS of the relevant geographical area, which they must apply,

of immediate, appropriate preliminary measures of control.

3-ARS ensure their respective public health response capacity to confirm the

state of the occurrences notified and support or enforce, immediately, measures

control complementary and, if considered to be of emergency, communicate all data

essential at the national level for the EEC, for evaluation in the terms set out in the a) from the

n Article 7 (2)

4-For the purposes of this article, the criteria that determine the existence of a

emergency settlement in anticipation of any serious repercussions on health

public, as well as the unusual or unexpected character, of an extraordinary occurrence,

with increased probability of dissemination of exposure to the identified problem.

Article 14.

Response in public health

The entities that integrate the surveillance system in public health should observe,

in the face of an emergency, the following response procedures, as per the guidelines of the

DGS:

a) Quickly determine the necessary control measures with a view to preventing the

propagation;

b) Make available specialist staff, laboratory analysis of samples and their respective

logistical support;

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Proposal for Law No. 258 /X/4.

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c) Provide assistance on site in order to supplement local investigations;

d) Ensure a direct operational link with health authorities and others

responsible, with the aim of approving and enforcing the containment and

control;

e) To ensure, by the most effective means of communication available, the connection with the

hospitals, health centres, airports, ports, laboratories and other areas

key operational;

f) To ensure, twenty-four hours a day, the measures referred to above.

Article 15.

National contingency action plan for epidemics

1-The DGS elaborates and updates a national contingency action plan for the

epidemics, to be approved by the CNSP.

2-The plan of action mentioned in the preceding paragraph shall, in particular, contemplate the

following procedures:

a) Prevention and control to be applied on the whole of national territory;

b) Communication between health professionals and populations;

c) Reduction of environmental risks potentiating dissemination;

d) Conditions of exception as to the need for the slaughter of animals and start-up

plant species;

e) Safety conditions for the storage, transport and distribution of

organic products and medicines in accordance with national standards and

applicable international.

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Article 16.

Mandatory notification

1-Compete to the member of the Government responsible for the area of health to approve, by portaria

and on proposal of the CNSP, the regulation of mandatory disease notification

communicable and other risks in public health.

2-The regulation referred to in the preceding paragraph defines, in relation to the diseases subject to

mandatory notification, whether clinical or laboratory, to health authorities,

determined by dispatching from the DGS, the notification process and the methodology of

introduction of data in the SINAVE, as well as the following procedures:

a) Identification of cases of possible disease, probable or confirmed;

b) Enquiries and identification of situations of default, clinical and laboratory;

c) Protection of personal data of patients and confidentiality of information from

health.

3-The regulation shall subject to the mandatory notification duty regime all the

health professionals who are active in SNS, in the private or social sector,

as well as those responsible for laboratories.

4-The regulation provided for in paragraph 1 is revised and updated where necessary under

proposal of the DGS.

CHAPTER IV

Measures of exception

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Proposal for Law No. 258 /X/4.

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Article 17.

Exceptional regulatory power

1-In accordance with the stipulation on the basis of the Act XX of Law No. 48/90 of August 24, the

member of the Government responsible for the area of health can take exception measures

indispensable in the event of an emergency in public health, including the restriction, the

suspension or closure of activities or the separation of persons who do not

are sick, means of transport or goods, which have been exposed, from

form to prevent the eventual spread of infection or contamination.

2-The member of the Government responsible for the area of health, on a proposal from the DGS, as

national health authority, may issue guidelines and regulatory standards in the

exercise of the powers of authority, with immediate executive force, in the framework of

emergency situations in public health with the purpose of making enforceable the

contingency standards for epidemics or other measures considered

indispensable whose effectiveness depends on the celerity in its implementation.

3-The measures and guidelines provided for in the preceding paragraphs are coordinated, when

necessary, with the member of the Government responsible for the areas of internal security and

civil protection, specifically in the case of the mobilization and preparedness of the

internal safety and protection and relief devices.

Article 18.

Situations of public calamity

In cases where gravity justifies it and taking into account preventive mechanisms and

of the reaction provided for in the Civil Protection Bases Act, the Government presents, after

proposal of the CNSP, based on report from the EEC, to the President of the Republic, document

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Proposal for Law No. 258 /X/4.

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with a view to the declaration of the state of emergency, by public calamity, in the terms of the

Constitution.

CHAPTER V

Confidentiality and processing of personal data

Article 19.

Databases

1-The databases, constituted for the purpose of compliance with the provisions laid down

in this Act, they must be notified to the CNPD in accordance with the general law.

2-Those responsible for the processing of the data referred to in the preceding paragraph shall be

expressly designated by dispatching of the DGS, within the internal organization of the

respective services, and they compete to ensure compliance with the quality of the data,

particularly the conditions of security and confidentiality.

3-The persons covered by the provisions of the preceding paragraph, as well as all those

that, in the performance of their duties, they have knowledge of the personal data processed

within the framework of the SINAVE, they are obliged to professional secrecy, even after the term

of his duties.

Article 20.

Personal data

1-The processing of information developed in the context of prevention and control of

communicable diseases and too much risk in public health, in everything as it is not

regulated in this Law, shall be governed by the general schemes applicable to data protection

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personal and health information.

2-Information received by SINAVE, pursuant to this Law, is dealt with in

compliance with the provisions of the previous number, including the analysis of results of

medical examinations and verification of health documents, with the purpose of determining

whether the state of health of the person poses a potential risk to public health.

3-The holder of the data has the right to obtain from the DGS the information available in the

SINAVE concerning the processing and purpose of collection of your personal data, well

as the guarantee that inaccurate or incomplete data is eliminated or

rectified.

4-When internal disclosure and processing of personal data in the SINAVE se

show fundamental for the purpose of assessment and risk management in public health, is

guaranteed that the personal data:

a) They are necessary, essential and suitable for the purpose of their collection;

b) They are accurate and up-to-date,

c) They are not kept in addition to the time required;

d) They are treated by skilled health professionals, when necessary for the

purpose of exercise of preventive medicine, acts of medical diagnosis, of

provision of care or medical treatment or still of management of services of

health.

CHAPTER VI

Sanctionatory regime

Article 21.

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Counter-ordering

1-Constituent counter-ordinations very serious, punishable, in the case of natural persons,

with fine of € 250 a € 20000, and in the case of legal persons, with fine of

€ 20000 a € 50000:

a) The failure to comply with the duty of immediate transmission of alert, provided for in paragraph 1 of the

article 10;

b) Failure to comply with the duty of compulsory notification, provided for in Article 3 (3)

16.

2-There is non-compliance with the duties provided for in the preceding paragraph whenever the

thank you do not practise the act due within 48 hours of the knowledge of the

underlying facts.

Article 22.

Processing and application

1-A the monitoring of the compliance of the rules laid down in this Law shall compete with

territorially competent health authority, without prejudice to the skills

assigned by law to the Inspectorate-General of Activities in Health (IGAS).

2-A The instruction of counterordinance processes competes with the DGS, within its

assignments, to whom the autos are to be sent by the authorities of

health.

3-The situations of non-compliance with this Law shall be communicated to the authority of

territorially competent health, by citizens or entities, of the public sector,

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Proposal for Law No. 258 /X/4.

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private or social that identifies them.

4-A The gracious complaint of the application of the fines provided for in the previous article does not have

suspensive effect.

5-The applied counter-ordinations are informed to the professional orders and units of

respective health, for the effects taken by convenient, including disciplining.

6-A The application of the accessory fines and feathers compete with the Directorate General of Health.

Article 23.

Fate of fines

The value of the fines imposed on the counter-ordinations provided for in this Law reverses:

a) 60% for the State;

b) 40% for the DGS.

CHAPTER VII

Final provisions

Article 24.

Abrogation standard

The Act No 2036 of August 9, 1949 and the respective provisions shall be repealed.

regulatory.

Article 25.

Regulation

The regulation of this Law must be approved and published within 90 days after the

its entry into force.

Article 26.

CHAIR OF THE COUNCIL OF MINISTERS

Proposal for Law No. 258 /X/4.

25

Entry into force

This Law shall come into force 30 days after its publication.

Seen and approved in Council of Ministers of March 11, 2009

The Prime Minister

The Minister of the Presidency

The Minister of Parliamentary Affairs