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PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th 1 explanatory memorandum the prevention and control of risks in public health have been, until now, as the Ordinance Law No. 2036, of 9 August 1949, which only deals with the contagious diseases in terms that were inherent in the social and scientific context of the era in which it was published For more than 50 years. It is necessary to update the existing legal regime, to cover all communicable diseases and other risks to public health, and to establish a true and modern system of epidemiological surveillance, scientifically grounded, as an instrument of public health, with a view to ongoing monitoring and regular analysis of the determinants of health of populations. It is considered to constitute a public health risk to increased probability of occurrences that may affect the health of human populations, the level of your physical, biological and social medium, with emphasis on communicable diseases that can pose a serious danger and live on national territory or spread internationally. In this area, the most important at present and for example, infectious diseases such as the acquired immunodeficiency syndrome (AIDS), certain viral hepatitis, tuberculosis, acute respiratory syndrome multiresistente and by new influenza virus subtype.
PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th 2 As systematization of the World Health Organization (who), are still classified as diseases and public health risks, monitoring, a number of other phenomena of the physical, biological and social media, as resistance and multiresistance of bacteria to antibiotics, chronic diseases as dislipidémias, the Bioterror threat migratory flows, childhood obesity and the mistreatment of children. On the other hand, the integration of Portugal in the European and global structures of epidemiological surveillance, especially at the level of the European Union and the World Health Organization, contributes to harmonize policies and actions in this area, given that globalization movements can transform infectious agents in global threats. In this field, it is necessary to emphasize the actions aimed at the creation and development of networks for early detection, surveillance and control of communicable diseases in space and in the framework of the European Union, already in place in our legal order decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the community and Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for disease prevention and control, in which Portugal participates. The role of who in the field of global warning in the event of an outbreak and response in the face of public health events of international concern in accordance with your mandate, has been reinforced and is fitted with a key global instrument against the international spread of diseases, which is the International Health Regulations (IHR). This Regulation is in effect in the national legal order since June 15 2007 in 58.ª as adopted by the World Health Assembly on 23 May 2005 and in accordance with article 22 of the Constitution of who.
PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th 3 Underlined the importance that continues to be the global instrument fundamental RSI against the international spread of diseases, particularly in the control and surveillance of the ports and airports, this Bill comes set up for the country a structured surveillance system in a way identical to the ones that derive from the application of that Regulation by leveraging synergies in the processes of information and organization of resources to strengthen the capacity to detect, assess, notify and declare the events considered to be of risk to public health. The new organic law of the Ministry of health, adopted in the year 2007, recognize the importance, in terms of proximity, of surveillance, prevention and control of communicable diseases. Indeed, epidemiological surveillance is not just the Directorate-General for health and national institutes of Health Dr. Ricardo Jorge, I. P., but also to the basic structures linked to the national network of primary health care, including public health departments, regional health authorities and public health units of the groupings of health centres. Also with special relevance in this area, have been exercising powers of health authorities at national, regional and municipal levels, to which competes the decision of State intervention in public health, prevention of disease and the promotion and protection of health, control of risk factors and situations likely to cause serious damage to health or outline of citizens or of the villages. Indeed, the modern requirements of prevention and control of communicable diseases and other public health risks, involve establishing a framework of duties under the joint responsibility of citizens, society and State in the defence and protection of the PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th 4 health, while rights of individuals and the community. Performing the General principles laid out in the health framework law, the promotion and the protection of public health are made through structures and public authorities, in particular the Member of Government responsible for the area of health, the director-general of health (DGS), the health authorities, public health physicians and health professionals in General, with involvement of civil society organizations in particular creating entities for the global system sentry alerts. This Bill establishes a public health surveillance system, while set network entities and organized measures, powers of surveillance, alert and response, for early detection of phenomena involving risk to public health, with rapid data transmission, rigorous and effective, in addition to the mandatory reporting of certain diseases by the epidemiological surveillance agents , health care professionals and laboratories. Having as a priority the immediate exchange of data and information in order to ensure the protection of the population, this system is based on a system of information that aims to encompass the global situations already foreseen by the who as diseases under surveillance duty, in addition to other relevant in the light of the considered default national epidemiological. It's created a National Council of Public Health, with advisory functions of the Government, integrating two specialized committees for monitoring and emergency, where sit the first leaders of national health structures. This organism works integrated into the Organization of existing public health services in regional health authorities and groupings of health centers, as well as in the activity of the health authorities there based, Recommends, in particular, the use of modern information and communication technologies, with particular reference to the telematico communication and PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th 5 based on Internet with a view to greater efficiency and speed of the national information System for epidemiological surveillance (SINAVE).
In addition to the measures of prevention and control, has proved to be essential to ensure the defence and protection of personal data. Indeed, health information, being a strategic resource vital to the prevention and control of public health risks, also integrates the private life of the persons concerned, which requires strict observance of rules of confidentiality and security in the treatment. This Bill provides for the adoption of a contingency plan for epidemics and exceptional measures in serious situations. Finally, a system of penalties for breach of the duties of compulsory notification of diseases thus classified in each moment by order of the DGS, as well as the duty of communication of alerts. In short, this Bill is a public health priority, which requires a global and coordinated approach at national and international level, in order to identify situations of risk to public health, collect, update, analyse and disseminate data on these risks, as well as cooperate in these areas, with national and international bodies with priority given to communicable diseases. Were heard the Government organs of the autonomous regions and the National Commission for Data Protection. So: under d) of paragraph 1 of article 197 of the Constitution, the Government presents to the Assembly of the Republic the following Bill: PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th 6
Chapter I subject matter and scope Article 1 subject-matter 1-this law establishes a system of public health surveillance, through the Organization of a set of entities of the public, private and social sectors by developing public health activities, as their organic laws and statutory assignments, applying preventive measures, alert, and response control for communicable diseases , in particular drug-related infectious diseases, other risks to public health, with a view to ensuring the right of citizens to the defence and protection of health. 2-For the purposes of the preceding paragraph, is created a national network involving the operating services of public health laboratories, health authorities and other entities of public, private and social sectors, whose participants contribute to a national information system for epidemiological surveillance, named SINAVE. Article 2 scope 1-this law applies to all entities, public sector, social and private, established or providing services in the national territory, to develop activity PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th of 7 collection, analysis, interpretation and dissemination of data from continuous and systematic health or epidemiological studies relating to communicable diseases and other public health risks.
2-the application of measures to prevent and stop the spread of communicable diseases and other risks to public health, by public authorities in the exercise of powers and functions under this Act, including conducting epidemiological investigations pursued by the competent health authorities and analysis of its risk factors, are subject to the system of health information and personal data protection. CHAPTER II Organization and functioning of the public health surveillance system article 3 1-Organization the public health surveillance system is aimed at monitoring the health status 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 your entry or spread in Portuguese territory by controlling your Genesis and evolution. 2-process definition methodology for monitoring public health is established by order of the Member of Government responsible for the area of health, on a proposal from the National Health Authority (ASN), linking the exercise of the powers of the following entities: PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th 8 a) Directorate-General of health (DGS); b) Ricardo Jorge National Institute of health, i. p. (INSRJ, I. P.); c) Health Authorities; d) public health services based on the regional health administrations;
and) public health services, with the locations, based on groupings of health centres or in local health units. 3-The entities covered by the regulation provided for in the preceding paragraph are competing for the systematic collection, consolidation, and data assessment of morbidity, mortality and health determinants in the national territory, as well as other data that is essential to the fulfilment of the objective provided for in paragraph 1. 4-for the purposes of this law, the essential data for public health information including clinical descriptions, laboratory results, sources and types of risks, the number of human cases and deaths, conditions that determine the spread of the disease and measures implemented, as well as any other information you provide evidence based on established and accepted scientific methods. Article 4 National Board of public health 1-is created the National Health Council (CNSP), appointed by the Member of Government responsible for health care that presides, with faculty of delegation to the director-general of health (DGS), composed of a maximum of 20 members, appointed on behalf of public, private and social sectors, including the academic areas and PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th scientific 9 , with advisory functions of the Government under the prevention and control of communicable diseases and other risks to public health and, in particular, for analysis and evaluation of serious situations, particularly large-scale epidemic outbreaks and pandemics, competing you support proposal for declaration of a State of emergency, by public calamity. 2-the CNSP comprises two committees: the) Commission Coordinator of epidemiologic surveillance; b) emergency Executive Committee. 3-the CNSP elaborates the regulation, your in the same, your mode of operation, to be adopted at the first meeting. 4-members of CNSP shall carry out their duties in a non-remunerated. Article 5 Commission of epidemiological surveillance Coordinator 1-the Coordinating Committee of epidemiological surveillance (CCVE) works as a Committee of CNSP and visa, based on the consultations and the information provided by the entities that are part of the system of public health surveillance, coordination of preventive measures concerning communicable diseases and other health risks, in fulfilment of the principles established in this law and in the technical and scientific standards from the European monitoring centres and the Portugal international reference that belongs in every moment. 2-the CCVE ensures consistency and complementarity between the programmes and the initiate actions in your mandate, including statistical information, research projects, technological development, especially telematic media and PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th 10 internet-based, for the exchange of data, implementing all the necessary links to the networks of the European Union and other international epidemiological surveillance networks to which Portugal belongs , articulating them with the SINAVE. 3-the entities that contribute to integrate with a network CCVE national information and communication and convey through SINAVE, data relating to: a) appearance or resurgence of cases of communicable diseases, along with information regarding diagnostic and control measures applied;
b) evolution of epidemiological studies which have the responsibility of collecting information; c) unusual, unexpected Phenomena or outbreaks of communicable diseases of unknown origin; d) mechanisms and procedures, existing or proposed, for the prevention of communicable diseases, in particular in emergency situations; 4-the CCVE presents the CNSP annual activity reports and an assessment of the data network every five years, with special attention to your structural and functional capacity, as well as the effective use of available resources. 5-the CCVE is composed by the following entities: a) Director-General of health, who chairs; b) Director of the National Institute of health, i. p.; c) Health Authorities of the autonomous regions;
PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th 11 d) Directors of the departments of public health regional health authorities; e) Director General of veterinary medicine; f) Director of the National Veterinary Research Laboratory (DIAGNOSTIC REPORTS). 6-the President of CCVE, for your initiative or on a proposal from a member, may invite other entities to participate in meetings of the Commission, appoint a technical group of epidemiological surveillance, to assist in this context.
Article 6 National information system for epidemiological surveillance 1-information management of epidemiological surveillance of health events and their specifics under each communicable disease and other risks in public health is ensured through the functioning SINAVE, which falls within the competence of the CCVE. 2-the CCVE can, when it considers it necessary for the protection of health of citizens, including in the framework and procedures for the implementation of the guidelines of SINAVE, any entities who carry out acts of health surveillance for disease surveillance and incidents associated with health care, as well as chronic diseases or social phenomena with direct impact on public health. 3-civil registration services collaborate with CCVE, under the SINAVE, so as to make available, with electronic means of services, data on birth rate and mortality surveillance activities required for PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th 12. Article 7-1 Emergency Executive Committee the Executive Committee (EEC) intervenes in emergency public health situations, by determining the President of CNSP, if there is an occurrence or imminent threat of phenomena relating to communicable diseases and other health risks, the characteristics of which are likely to cause serious public health consequences.
2-it is, in particular, the EEC: a) Evaluate, within 48 hours, all communication of emergency occurrences, with treatment of immediate information on SINAVE; b) Elaborate the analysis report to be submitted to CNSP, in cases of public calamity that warrant Declaration of a State of emergency. 3-the Commission shall draw up a national response plan, which envisages, in particular, the creation of teams to respond to events that may constitute a public health emergency, as well as ensuring the availability, at any time, a service that enables instant communication with public health services of regional and municipal level. 4-for the purposes of this law, any public health emergency extraordinary occurrence that constitutes a risk to public health due to the PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th 13 probability increased dissemination of signs, symptoms or diseases requiring a coordinated national response. 5-the emergency Executive Committee consists of the following entities: a) Director-General of health, who chairs; b) Presidents of the Councils governing regional health authorities; c) Health Authorities of the autonomous regions; d) President of the Governing Board of the National Institute of medical emergency, I. P.; and) President of the directive Council of the National Institute of health, i. p.;
f) President of the Governing Board of the National Authority of the INFARMED-Medicine and health products, I. P.; g) President of the National Civil Protection Authority. 6-the President of the EEC may, for your initiative or on the proposal of any Member, invite other entities to participate in meetings of the Committee, for organizing the response measures to be taken vis-à-vis emergency situations in public health. Article 8 information and communication network 1-this law creates a network for the epidemiological surveillance for the prevention and control of communicable diseases and other risks in public health, based on the need to establish a certain form of collection of necessary information.
PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th 14 2-it is the DGS, in quality of National Health Authority (ASN), to organize the network provided for in the preceding paragraph with permanent connection, by appropriate means, with the health authorities responsible for the determination of the measures necessary for the implementation of an early warning and response system. 3-the NSA approves the regulation of organization of the activities of public sector entities, private or social, forming part of the network referred to in paragraph 1, by providing for an effective coordination with a view to obtaining a centralized knowledge all the information on communicable diseases and other risks to public health, at the national level.
Article 9 operation of the integrated network of information and communication to ensure the effective functioning of the network as regards epidemiological surveillance and in order to standardize information in this context, the duties and responsibilities of the DGS, by order, determine the following: a) epidemiological and microbiological surveillance methods; b) communicable diseases and other risks that must be covered by the information and communication network; c) criteria for selection of these diseases, taking into account the existing collaborative networks of surveillance;
PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th 15 d) case definitions, in particular clinical and microbiological characteristics; e) nature and type of data and information to be collected and transmitted by the entities/authorities involved in network provided for in article 8; f) guidelines on the protective measures to be taken in emergency situations; g) guidelines on information and guides to good practice for use of the populations; h) necessary technical Means and appropriate procedures for disclosure and treatment of data comparable and compatible.
Article 10-1 Sentinel Entities shall be deemed, for the purposes of this law, Sentry, all public sector entities, social and private, who have skills or activities of early detection of risks, outbreaks, epidemics, or other public health emergencies and who have concluded, for the purpose of immediate transmission of alerts, protocols of collaboration within the public health surveillance system referred to in article 3 or play, otherwise, such functions from a time prior to the entry into force of this law. 2-the system of articulation of entities is defined, after opinion of the CNPD, by regulation, to be approved by the DGS.
PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th 16 Article 11 .° partnership 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 internal standards for such drawn up by the competent departments in the field of quality of the DGS, in conjunction with other central services and under CCVE's opinion. Chapter III measures for prevention and control of communicable diseases and other risks in public health article 12 Competence ASN shall lead the actions and programmes in the area of prevention and control of communicable diseases and other risks in public health, assisted by other health authorities at regional and municipal level.
Article 13 detection and communication of public health occurrences 1-notification activities, verification and cooperation, within the framework of epidemiological surveillance, should be developed through national structures and resources of public health operating services. 2-occurrences involving levels of morbidity or mortality greater than those expected for the period and location considered, should be as soon as known, communicated by the entities that make up the network, health authorities to the PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th 17 responsible of local structures, in particular the executive director of ACES or the boards of Directors of the relevant geographical area ULS , which shall apply immediately, preliminary control measures appropriate. 3-The ARS ensures its public health response capacity to confirm the status of notified cases and support or implement immediately further measures to control and, if considered an emergency, report all critical data at national level to the EEC for evaluation under the conditions laid down in point (a)) of paragraph 2 of article 7 4-for the purposes of this article the criteria that determine the existence of an emergency are based on anticipation of any serious repercussions on public health, as well as the unusual or unexpected nature, an extraordinary occurrence, with increased probability of widespread exposure to the problem identified.
Article 14 public health response entities that are part of the system of public health surveillance shall observe, in an emergency, the following response procedures as guidelines of DGS: a) quickly determine the necessary control measures to prevent the spread; b) Provide specialized personnel, laboratory analysis of samples and their logistical support;
PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th 18 c) on-the-spot assistance to complement the local investigations; d) Ensure a direct operational link with the health authorities and other officials, with the aim to adopt and apply the containment and control measures; e) Ensure, by the most effective means of communication available, the connection with hospitals, health centers, airports, seaports, laboratories and other key operational areas; f) Ensure, 24 hours a day, the measures referred to above. Article 15 national contingency action plan for epidemics 1-the DGS develops and updates a national contingency action plan for epidemics, to be approved by CNSP. 2-the action plan mentioned in paragraph 1 may cover, in particular, the following: a) prevention and control to be applied throughout the national territory; b) communication between health professionals and populations; c) reduction of environmental risks the spread enhancers; d) exceptional Conditions on the need to slaughter of animals and plant species start; and safety Conditions) storage, transport and distribution of organic products and medicines in accordance with national and international standards applicable.
PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th 19
Article 16 Notification mandatory 1-it is the Member of Government responsible for the area of health, by order and at the proposal of CNSP, regulation of mandatory reporting of communicable diseases and other public health risks. 2-the regulation referred to in the preceding paragraph shall, in relation to the diseases subject to compulsory notification, whether the clinic wants health authorities laboratory, determined by order of the DGS, the notification process and the methodology of data entry in SINAVE, as well as the following: a) identification of possible disease cases, probable or confirmed; b) investigation and identification of situations of non-compliance, clinical and laboratory; c) protection of personal data and confidentiality of patient health information.
3-the regulation should be subject to mandatory notification duty regime all healthcare professionals engaged in activity in the NHS, private or social sector, as well as those responsible for laboratories. 4-the regulation provided for in paragraph 1 is revised and updated where appropriate on a proposal from the DGS. CHAPTER IV Measures of exception PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th 20 article 17 regulatory power exceptional 1-according to the stipulated in the Base XX of Act No. 48/90, of 24 August, the Member of Government responsible for the area of health can take measures indispensable exception in emergencies in public health , including the restriction, suspension or termination of activities or the separation of people who are not sick, conveyances or goods which have been exposed, in order to prevent the possible spread of infection or contamination. 2-the Member of Government responsible for the area of health, upon a proposal by the DGS, as national health authority, may issue guidelines and rules on the exercise of the powers of authority, with immediate, enforceable in emergency situations in public health with the aim of making possible contingency standards for epidemics and other measures considered indispensable whose effectiveness depends on the speed in your implementation. 3-measures and guidelines set out in the preceding paragraphs are coordinated, where necessary, with the Member of Government responsible for internal security and civil protection, namely reports to the mobilization and readiness of homeland security devices and protective and relief.
Article 18 public calamity situations where gravity warrants and taking into account the preventive and response mechanisms provided for in the Civil protection framework law, the Government offers, after proposal of CNSP, based on report of the EEC, the President of the Republic, PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th 21 with a view to the Declaration of a State of emergency , by public calamity, in accordance with the Constitution. Chapter V Confidentiality and processing of personal data article 19 1 databases-databases, constituted for the purpose of compliance with the provisions of this law, shall be notified to the CNPD, according to general law. 2-those responsible for processing the data referred to in the preceding paragraph shall be expressly designated by order of the DGS, within the internal organisation of the respective services, racing them to ensure compliance with the data quality, in particular the conditions of security and confidentiality. 3-the persons referred to in the preceding paragraph, as well as all those who, in the performance of their duties, are aware of personal data processed in the framework of SINAVE, are bound by the obligation of professional secrecy, even after the expiry of his or her duties.
Article 20 1-personal data treatment of the information developed under the prevention and control of communicable diseases and other risks in public health, in all that is not regulated in this law, shall be governed by the General schemes applicable to data protection PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th personal and 22 health information. 2-the information received by SINAVE, pursuant to this law, are treated in accordance with the provisions of the preceding paragraph, including analysis of results of medical examinations and health documents, in order to determine if the State of health of the person represents a potential risk to public health. 3-the data subject has the right to obtain from the information available in the DGS SINAVE on the treatment and purpose of collection of personal data, as well as to guarantee that the data is inaccurate or incomplete are erased or rectified. 4-When the internal disclosure and treatment of personal data is essential for SINAVE evaluation and risk management in public health, is guaranteed that personal data:) are necessary, essential and appropriate to the purpose of your collection; b) Are accurate and up to date, c) are not retained beyond the time required; d) are treated by health professionals, as needed for the purposes of preventive medicine, medical diagnosis, acts of care or medical treatments or health services management. CHAPTER VI sanctions Regime article 21 PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th 23 administrative offences Are very serious offenses-1, punishable, in the case of natural persons, from € 250 to € 20 000, and in the case of legal persons, with fines of € 20 000 to € 50 000: a) the failure to comply with the duty of immediate transmission of alert provided for in paragraph 1 of article 10; b) failure to comply with the duty of mandatory notification provided for in paragraph 3 of article 16 2-there is non-compliance with the duties provided for in the preceding paragraph where the thank you don't practice the Act due within 48 hours after knowledge of the underlying facts. Article 22 application and processing 1-monitoring of compliance with the rules laid down in this law is territorially competent health authority, without prejudice to the powers assigned by law to the General Inspectorate of Health Activities (IGAS). 2-the statement of offense the DGS, in the framework of its mission, the who should be sent the case raised by the health authorities.
3-The breaches of this law shall be communicated to the competent regional or local health authority, by citizens or entities, the public sector, PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/4th 24 social or private the identify. 4-the administrative claim of the application of the penalties provided for in the preceding article has no suspensory effect. 5-The breaches applied are reported to professional bodies and respective health units for the effects observed for convenient, including disciplinary proceedings. 6-the application of fines and accessory penalties the Directorate-General for health. Article 23 fines Destination the value of fines applied to administrative offences provided for in this Act reverts: 60% to the State); b) 40% to the DGS. CHAPTER VII final provisions article 24 Standard set Are repealed law No. 2036, of 9 August 1949, and the relevant regulations. Article 25° of the present law regulations Regulations should be adopted and published within 90 days after your entry into force. Article 26 PRESIDENCY of the COUNCIL of MINISTERS draft law No. 258/X/25 4 entry into force this law shall enter into force 30 days after your publication.
Seen and approved by the Council of Ministers of 11 March 2009 the Prime Minister the Minister of Parliamentary Affairs Minister Presidency
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