Law 1/2009 Of 23 January, Amending The General Law Of Health

Original Language Title: Llei 1/2009, del 23 de gener, de modificació de la Llei general de sanitat

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Law 1/2009 of 23 January, amending the general law of health since the General Council in its session of 23 January 2009 has approved the following: Law 1/2009 of 23 January, amending the general law of health preamble The general health Law, which was approved by the General Council on March 20, 1989 , was intended to be "the proper support for the development of a health policy consistent with the principles of health included in most of the United States of Europe", as well as a "common framework" to group a series of internal regulations in the field of health.

This law had issues evident in the care, with regard to the performance of the CASS and the development of the functions of the Andorran Health Care Service, which had been created only three years earlier.

As recognized by the preamble, the axes were essential to the recognition of the right to health, the structure of the health system and the distribution of powers between the Government of Andorra.

For nearly twenty years, the application of this general law of health has allowed us to achieve the objectives satisfactorily that the legislature had been set initially.

However, in the course of the last few years, there have been significant changes in the field of health that make it necessary to adapt the law to the current situation.

It seems appropriate to highlight some kind of performances of the Ministry of health in the area of public health that had not been taken into account in the legal text above.

It is, in particular, highlight and specify legally the fundamental role of the Administration in the development of programs and campaigns of prevention, education and information in the field of health as well as the sanitary control, in order to achieve a better state of health of the population in general and, therefore, containment of costs in the matter.

It is also to highlight and to regulate the performance of the Government in case of emergency or risk to public health, such as epidemiological threats or outbreaks outbreaks. In these cases, the Administration must be prepared in the best possible way and to coordinate the performance of all healthcare providers when this is necessary.

If you want to preserve and enhance the powers of the Administration in health matters, it makes clear the need to offer a greater flexibility in the relations between the same Administration and institutions in the field of health (Caixa Andorrana de Seguretat Social, the Andorran Health Care Service and the professional associations), and also in the relationships between these same institutions.

As occurs in many European countries of our environment, it is clear that the legal figure that best enables this flexibility is the contract, adaptable, evolving instrument, which can easily be the subject of review and thanks to which they can take into account, at any time, the real situation of the parties and the level of achievement of the objectives set.

Therefore, it seems appropriate to adapt the legal text above, and reflect this evolution towards contractual relations based on negotiation and consensus, that allow to establish the objectives and the means needed to achieve them.

Adopting the same evolution that in the neighboring countries, it is advisable to insert and set in the legal notion of innovative "portfolio of products and services of health" available in Andorra or abroad. The content of this portfolio is to set up the Government with the collaboration of health providers, the professional associations involved and of the Caixa Andorrana de Seguretat Social, taking into account criteria of quality, safety, effectiveness and efficiency.

With this modification, the aim is to get the optimization of the use of existing resources in the country and, therefore, the rationalization of health care spending.

On the other hand, and preserving the freedom of exercise of health professionals as one of the pillars structure law, you need to enter basic obligations of professional practice and recognise the importance and representativeness that have acquired the schools that are health professionals.

The professional bodies will claim as privileged interlocutors of the public administration, and the law has expressly recognized.

Although so very subsidiary, also is used to update the law to adapt the vocabulary used in the writing of 1989, which has been in some cases clearly outdated, in a comprehensive health insurance terminology, used currently more running on an international scale.

Article 1 amendment to article 4 modifies the article 4, which is worded as follows: "Article 4 in the context of this definition of the health system, the functions related to health care and hygiene and public health, the general administration and supervised bodies are distributed as follows: a) correspond to the Government planning and programming in all areas related to health , and execution in matters of hygiene and public health.

The latter is carried out normally through the Ministry responsible for health, respecting the powers recognized the common.

b) corresponds to the Caixa Andorrana de Seguretat Social fundraising contributions of its policyholders, the financing of health services received by beneficiaries and the social security regulations in regard to the contributions and benefits, in the terms established by the regulations in force.

c) corresponds to the Andorran Health Care Service for the management of publicly funded health services, in addition to the functions defined in the law of creation of this service. The Andorran Health Care Service assumes that management, while respecting the objectives and the priorities of public health, defined by the Government. "

Article 2 modifying article 6 modifies article 6, which is worded as follows: "Article 6 coordination between public health and private activities should respect, at all times, the major bases and the principles of the free professional practice of health professionals, in accordance with the provisions of this law."

Article 3 amendment to article 8 modifies the article 8, which is worded as follows: "Article 8 health care within the framework of the health system is guaranteed in Andorra

by the Government's own health care services through the Andorran health care Service, and of the people and private entities, as follows: a) to the groups protected by the social security system, they should reimburse the cost of the health services according to the provisions of the regulations of the Caixa Andorrana de Seguretat Social.

b) for citizens with sufficient resources and not protected by social security or who explicitly give up the benefits of this protection, the assistance provided involves the full payment of the services received.

c) within the framework of the health and social assistance, the Government defines the conditions under which funds the necessary benefits to patients as locals and residents in the country, legally and effectively, that demonstrate does not have economic resources or other possibilities of social protection as well as to patients who are not nationals and non-residents in individual health situation of extreme urgency and that demonstrate to be insolvent and without social cover. The Government delegates the production of the corresponding benefits in the Andorran Health Care Service, which assumes, as an exception, the costs caused, while respecting the legal provisions and the criteria and conditions determined by the Government. "

Article 4 addition of the article 12 bis creates the article 12 bis, which is worded as follows: "Article 12 bis 1. The application and implementation of health policy is carried out, among others, through the granting of contracts framework between, on the one hand, the Government, and on the other hand, the CASS or the SAAS or professional associations involved or the organisations representing health professionals, without prejudice to the transversal contracts that these institutions established between them.

2. health institutions cross contracts signed between them and the other specific contracts that they sign on the matter must respect the provisions of the framework contract.

3. In any case, the contracts have to define at least the rights and obligations of the parties, and also the means and the objectives pursued.

4. To grant the contracts mentioned, recognizes enough representativeness to professional associations. "

Article 5. Modification of the name of the title IV modifies the name of the title IV, which happens to be what follows: "title IV. Health services "Article 6 Chapter Renumbering only of title IV Will renumera the chapter only of title IV, which is as follows:" chapter. Health services programming "Article 7 Modification of article 13 modifies the letter a) and added a second paragraph to article 13, which is worded as follows:" Article 13 1. The Government, in addition to regulate professional practice, health care services are the following: a free program) In primary care, the Ministry responsible for health promotion and health prevention activities program through incentive formulas agreed by the parties concerned. It also stimulates the coordinated performance of health professionals and of the social sphere, with the aim of introducing a multidisciplinary dimension in health care.

b) specialized healthcare, in consultation, hospitalisation and also through other alternatives: domiciliary, day hospitalisation, etc.

c) The specific care of rehabilitation in the hospital and extrahospital.

d) the practice of explorations and of diagnostic and therapeutic procedures, outpatient treatment and detention.

e) pharmaceutical assistance.

f) proper assistance in urgent cases, the basic welfare regulation in hours and holidays.

g) on normal and emergency medical transport.

2. The Government plan the services mentioned in this article, and for its quality, safety and efficiency. "

Article 8 amendment of article 15 modifies article 15, which is worded as follows: "Article 15 1. The health programs must prioritize the high risk population groups and should set up specific measures for the protection of maternal and perinatal health: a) for children.

b) mental health.

c) caring for the elderly.

d) attention to the disabled.

2. Through the creation of appropriate management devices, the Government undertook the implementation of health programs in preferred areas of interest defined in terms of the health needs detected. "

Article 9 addition of the second chapter of title IV is added to title IV Chapter second, of a new article 15 bis, which is as follows: "second chapter. Portfolio of services and products of health "Article 10 Addition article 15 bis is added in article 15 bis, which is worded as follows:" Article 15 bis 1. It is understood by "portfolio of services and products of health" the set of acts, of the products and services offered to the population in terms of health and produced by means of techniques, technologies and processes based on experimentation, studies and scientific knowledge.

2. The Government should establish regulatory for the contents of the portfolio of services and health products as well as the instruments and mechanisms necessary for effecting the collaboration of health care providers, professional associations involved and of the Caixa Andorrana de Seguretat Social.

3. The portfolio of services and health products includes, among others, the programs of public health, primary care and specialized, the emergencies, sanitary transport, medicines, medical devices and food products intended for a special diet.

4. The preparation, application and updating of the portfolio of services and health products take place while respecting duly rated criteria and based on: a) the effectiveness, quality and proven security, in accordance with the most current scientific data.

b) The responsibility of the health institutions and health professionals to produce these events, benefits and health products for the benefit of the population.

5. The portfolio of services and products of health determines services and health products produced and available in Andorra, which may occur in the future and those who can only offer abroad, and establish the conditions of implementation, production and financing.

6. In all cases, the decision of public funding of services and health products take into account criteria of efficacy and efficiency. "

Article 11 Amendment of the designation of the title V

Modifies the name of the title V, which happens to be what follows: "title V. public health programming" Article 12 amendment of article 16 modifies article 16, which is worded as follows: "Article 16 the Government should schedule, within the scope of its powers, specific actions in the areas of hygiene and public health of the following : a) environmental health.

b) occupational health.

c) veterinary Health oriented towards the fight against zoonosis.

d) food safety.

e) sanitary Control of the drugs and other health products.

f) health education and health promotion.

g) health information and surveillance of public health.

h) prevention and control of the disease. "

Article 13. Modification of article 40 modifies the first section and added a fourth paragraph in article 40, which is worded as follows: "Article 40 1. Corresponds to the Government to evaluate the suitability of medications and other health products marketed in the country both to authorize its circulation and use as to control its quality. The Government can also recognize directly the marketing authorisations medicines and sanitary products which the competent authorities of the countries references in the material have delivered.

2. only you can authorize the drugs and other health products safe and effective, with the quality and purity due, and made to a natural or legal person with sufficient capacity.

3. For the distribution of the products mentioned may be required prior authorization in accordance with conditions of approval or individual.

4. The Government may set specific terms of prescribing, dispensing and use of these products. "

Article 14 Amendment of article 41 paragraph 3 is added to article 41, which is worded as follows: "Article 41 1. The Government establishes the cases in which the authorisations of medicines and other health products should be subject to revalidation.

2. The authorisation of medicines and other health products may be suspended or revoked for serious reasons of public health.

3. When a drug or a medical device presents or may present a risk to health, the Government may decide to temporarily suspend the marketing or remove it permanently from the market. "

Article 15 addition of the seventh chapter of title V is added to title V, chapter seventh, consisting of articles 47 bis and ter, 47 with the following name: "Chapter seven. Public health surveillance "Article 16 Addition of article 47 bis is added in article 47 bis, which is worded as follows:" Article 47 bis 1. The Government is developing a health information system and public health surveillance that allows: a) the observation and the permanent monitoring of the State of health of the population.

b) observing and monitoring health risks permanent may involve a danger to the population.

c) to deal with threats to the health of the population and enable the processes used to manage the situation that will arise.

2. In case of emergency or public health risk, the Government takes all the measures it has at its disposal and coordinates actions and media services and the departments involved.

3. public health surveillance includes all fields and, in particular, infectious diseases, chronic diseases, illnesses, trauma, and also the occupational and environmental risks that have or may have consequences on health.

4. The Government establishes programs for the promotion of health and prevention of disease. "

Article 17 of the article 47 ter is added the article 47 ter, which is worded as follows: "Article 47 ter 1. The health professionals develop a fundamental role in the collection and transmission of data relating to the State of health of the population in Andorra, which allows you to keep informed about the health information system and public health surveillance.

2. Is, therefore, to health professionals the compulsory communication to the Government of the nominatives data concerning notifiable diseases, as well as the programs and health records, according to the rules established by the Government. The Government ensures the confidential character of the transmission, the treatment and conservation of such data in accordance with the provisions of law 15/2003, of 18 December, of protection of personal data.

3. It corresponds also to the health professionals communicate compulsorily to the Government information concerning the other diseases for which the Government has established a system of surveillance and monitoring.

4. The Government makes available to health professionals involved in the collection of the relevant health information data that results from the processing of these data.

5. In case of emergency or risk to public health or disaster, or any other threat to public health, the Government may require health professionals to provide their services in accordance with established protocols and participating in crisis management plans defined by the same Government. "

Article 18 Amendment 51 article deleted the letters c), d) and (e)) of article 51, which is worded as follows: "Article 51 The Central Laboratory has, in addition to the functions set out in the previous article and the additional may be established under other legal provisions, the following: a) Prepare new analytical techniques, set quality standards and to elaborate proposals for regulations.

b) give technical information about all matters relating to their activity. "

Article 19 Amendment of article 54 modifies the article 54, which is worded as follows: "Article 54 a) the development and implementation of health policy, thanks to, among other means, to the signing of the contracts referred to in article 12 bis of this law.

b) the management, the control and supervision of the Andorran Health Care Service, through the Ministry responsible for health.

c) opening and authorization of modification of health centres, services and establishments, and the determination of the corresponding technical requirements.

d) determination of the requirements that have to present the professionals who want to exercise, and the elaboration of a register of Health Professions.

e) the preparation of guidelines and stimulus measures relating to the training of health human resources, with the aim of ensuring the presence of suitable professionals in number and qualification.

f) the design of health information systems and epidemiological surveillance.

g) activities related to the foreign health, resulting from the transit of people and goods, in accordance with international regulations.

h) international relations in the field of health cooperation and signing of agreements and agreements with other countries, in accordance with the institutional system.

I) inspection of centres, services and establishments of health use.

j) the elaboration of general norms in the area of sanitary control of the environment, food, medications, medical products and all other products intended for direct human consumption or used in manufacturing processes to the food industry.

k) the preparation and the management of specific records of companies and products related to the objectives of the present law.

the) control of advertising and propaganda relating to medicines, healthcare products and services. "

Article 20 modification of the name of the title VIII modifies the name of title VIII, which is as follows: "title VIII. Administrative organisation of the Ministry responsible for health "Article 21 Amendment 56 article modifies the article 56, which is worded as follows:" Article 56 the Government, through the Ministry responsible for health, exercise the powers set out in article 54 and coordinates its activities with the rest of Government. "

Article 22 Amendment of the article 57 modifies the article 57, which is worded as follows: "Article 57 1. The Government oversees compliance with the applicable regulations on health matters in all sectors related to health, whether it is public or private institutions, health professionals or other persons concerned.

2. The Government ensures that the Ministry responsible for health has the structure, the Organization, the human and economic resources necessary to exercise the powers that are found in the areas of planning, management, monitoring and evaluation in the field of health.

3. For the purposes of making inspections, found violations and proposed penalties, the staff of the Ministry responsible for health that has assigned these powers have the quality of health authority agent. "

Article 23 Amendment 58 article modifies the article 58, which is worded as follows: "Article 58 the Government acts through the adoption of appropriate measures to preserve the public health, in the following cases: a) hazardous materials and traffic are products for public health.

b) activities in phase of execution or exploitation which caused a serious danger or immediate threat to the health of citizens or for the health of the environment.

c) situations of emergency, disaster or risk to public health. "

Article 24 Amendment of article 61 is deleted the paragraph 1 of article 61, which is worded as follows: "Article 61 When the infractions may be constitutive of the crime, the Administration that instructed the record sanctioning has to account to the public prosecutor and suspend the processing of the file until the judicial authority issued a firm ruling."

Article 25 Amendment 65 article modifies the article 65, which is worded as follows: "Article 65 1. The offences referred to in the previous article will be penalize with fine, according to the following ranking: a) slight offences up to 1,000 euros.

b) serious offences from 1,001 EUR up to 20,000 euros.

c) The very serious offences from € 20,001 to 100,000 euros.

2. The imposition of sanctions does not absolve the offender to compensate for damages it has caused.

3. Periodically, the Government should review and adapt the amounts of the fines set out in paragraph 1 of this article. "

Article 26 Amendment of article 69 modifies the article 69, which is worded as follows: "Article 69 1. The health professionals who wish to exercise in the Principality of Andorra have to comply with the obligations set by the legislation.

2. The authorisation to exercise given by the Government to a health professional has no effect in the absence of professional registration in the corresponding professional association interested, when it exists. "

Article 27 adding article 69 bis creates the article 69 bis, which is worded as follows: "Article 69 bis 1. The professional associations that bring together health professionals collaborate with the Administration on the authorization of professional practice of its members, in the control of this exercise, in the continuing education of its members, and sign the contracts referred to in this law.

2. When necessary, the professional bodies confirmed infringements of its members to the provisions of the Association and professionals, and impose corresponding sanctions to violators. "

Article 28 Addition of article 69 ter Will create the article 69 ter, which is worded as follows: "Article 69 ter 1. All health professionals authorized to exercise in the Principality of Andorra shall: a) to exercise their profession according to the rules of art, through the use of the most current data and the application of referential regularly updated a good professional practice and the criterion of efficiency.

b) have professional insurance in force.

c) respecting the professional secrecy and ensure the confidentiality of all personal and nominative information received in the context of their professional practice, without prejudice to the obligations that correspond in virtue of the provisions of article 47 ter of this law.

d) participate in the health service to remain in the conditions set by the Government, with the understanding that this service is paid.

2. All authorized health professionals working in the Andorran health care Service must sign a specific agreement with this entity and commit to respect in all cases your internal rules. "

Sole transitory provision Are health professionals who currently enjoy an authorisation to exercise but who are not registered are within one year from the entry into force of this law to show the corresponding professional association, when it exists.

Single repealing provision Is repealed the law on Declaration of infectious diseases-notifiable infectious, on 14 October 1983, and all the other rules of rank less than or equal to this law in all matters that contradict.

First final provision

It entrusts to the Government the drafting of the revised text of all the articles of the general law of health, of March 20, 1989, with the addition of all the modifications, additions and clarifications provided by this law, within a maximum period of three months from the date of entry into force.

Second final provision this law enters into force on the same day to be published in the official bulletin of the Principality of Andorra.

Casa de la Vall, January 23, 2009 Joan Gabriel i Estany Syndic General Us the co-princes the sancionem and promulguem and let's get the publication in the official bulletin of the Principality of Andorra.

Nicolas Sarkozy Joan Enric Vives Sicília and President of the French Republic and the Bishop of Urgell Co-prince of Andorra Co-prince of Andorra