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A selective survey of national legislation on foods for infants and young children.

Food legislation and food control infrastructures play a substantial part in determining the quality and quantity of the diet. However, in many countries they are not sufficiently developed in enable adequate protection. As an aid in formulating and improving legislation on foods for infants and small children, a study of existing laws was undertaken for FAO's Legislation Branch, Legal Department. The following is a synopsis of the main findings, supported by a review of international codes.

Advertising↗

[Informed consent in health legislation of Mexico].

This paper deals with informed consent in Mexican Health Legislation in the context of a contract regulated by the Mexican Civil Code, in which a patient capable of making a thoughtful decision agrees to a specific plan of medical management and has received sufficient information, in a clear and explicit manner so that he/she can make a decision and in consequence agrees, or does not agree, to a course of action and to its consequences, under the Nuremberg Code. In Mexico, informed consent has recently been incorporated into health care legislation, and is basically oriented toward the field of medical research, while in other medical procedures, a legal authorization, and not an informed consent form is required, as with surgical procedures such as definitive fertility control (e.g. vasectomy or fallopian tube ligation). We emphasize the necessity of the adding of informed consent to Mexican health legislation in general, substituting it for other terms to legalize medical action, such as authorization, permission, dispositioned compliance, acceptance or approval-all of which have an essentially different and limited connotation, and are not Patient's Rights legal protector mechanisms, from our point of view.

Informed Consent↗

Better health care legislation.

Health care legislation is of key interest to many citizens of Michigan today. State Senator Dianne Byrum (D-Lansing) has worked diligently as an advocate in health care legislation over the past three years, and continues to develop safe-guards for patients in the managed care and insurance systems. Sen. Byrum hopes to create legislation that will "engage Michigan in dialogue on public policy aspects of health care and how it's changing in terms of providers and consumers." She currently serves as the Democratic Vice-Chair of the Senate Health Policy Committee and recently worked at the committee level on the Patient Bill of Rights-which was signed into law on December 31, 1996.

Delivery of Health Care↗

[A review of the European community directives relating to materials and articles intended to come into contact with food products in the light of Polish legislation].

The integration of Poland with the European Community makes the harmonization of Polish legislation necessary. Among numerous Directives, which provisions should be introduced into domestic legislation before Poland enters the European Union, the Directives related to materials and articles intended to contact with food consist a large group. The review and analysis of 17 Directives that appeared up to the end of year 1997 have been done. The list of these Directives is shown in the Table I. The framework Directive 89/109/EEC on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs have been comprehensively discussed together with the specific Directives concerning the following matters: symbol which should accompany the materials and articles intendet to contact with food: Directive 80/590/EEC; plastics materials: Directive 90/128/EEC with later ammendments provided by the Directives: 90/128/EEC, 93/9/EEC, 95/3/EC and 96/11/EC; vinyl chloride monomer (acceptable limit and analytical method): Directives: 78/142/EEC, 80/766/EEC and 81/432/EEC, regenerated cellulose film-Directives: 93/10/ECC i 93/111/EEC; ceramic articles: Directive 84/500/EEC; testing migration of constituents of plastic materials-Directives: 85/572/EEC and 82/711/EEC with later ammendments: Directives: 93/8/EEC, 97/48/EC, The relevant Polish regulatory provisions concerning the matters related to materials and articles intendet to contact with foodstuffs have also been discussed. The need for harmonization of Polish regulations with the relevant legislation adopted by the Member States of the European Community was emphasized.

Humans↗

Fair use versus fair return: copyright legislation and its consequences.

The purpose of this article is to examine the ramifications of legislative recognition of the concept of fair use in the Copyright Act of 1976. The fair use concept, while of small consequence in its normative origins, has turned out to be the foundation of the most perplexing and divisive issues in the new legislative guidelines governing copyright. Legislative recognition of the concept of fair use, coupled with enormous growth of a new technology--extending from xerography to on-line database systems--creates de facto exemptions to both the intent and content of new copyright guidelines. The issue is not one of limiting use or suppressing information, but of mechanisms for safeguarding the rights of copyright holders, be they authors or publishers, and insuring the free flow of information by providing a proper return on both intellectual creativity and capital expenditures. The authors argue that the elimination, or at least curtailment of fair use doctrine, coupled with an increase in technological approaches to reporting of secondary use of copyrighted material, will benefit all sections of the knowledge industry. Authors will receive proper royalties on use; publishers will be able to sell more books and journals at lower prices; and librarians will be liberated from extensive chores such as monitoring usage or determining fee schedules and transferences. The issue is one of fair return--an issue obscured and ultimately subverted by fair use.

Copyright↗

Pack-size legislation reduces severity of paracetamol overdoses in Ireland.

BACKGROUND: Legislation was introduced in Ireland in October 2001 to control the sale of paracetamol in non-pharmacy outlets. Preparations are now limited to 12 tablets per pack and only one pack can be sold per transaction. AIM: To assess the impact of this legislation on acute deliberate paracetamol overdoses. METHODS: We reviewed acute deliberate paracetamol overdoses reported during two 24-months periods before and after October 2001. We grouped cases according to the number of tablets taken and compared the periods using chi-square and Mann-Whitney tests. RESULTS: The number of tablets taken in acute deliberate paracetamol overdose fell significantly after October 2001 (chi2 = 11.663, P = 0.0029). Fewer cases involved 12-24 tablets (U = 74, P < 0.001) and fewer cases involved more than 24 tablets (U = 131.5, P = 0.0006). CONCLUSION: Legislation controlling sale and packaging of paracetamol preparations appears to be associated with a significant fall in the number of tablets taken in acute deliberate paracetamol overdoses.

Acetaminophen↗

Can legislation provide a better match between demand and supply in psychotherapy?

BACKGROUND: There is evidence showing that psychotherapy very often does not reach the persons most in need of it. A change in patterns of "consumer behaviour" is difficult to achieve on the basis of individual behavioural change. Can it be achieved by changes in legislation? METHODS: By comparing socio-demographic criteria of patients seen at the University Clinic of Psychoanalysis and Psychotherapy between 1990 and 1996, we are able to give some evidence that changes in legislation, concerning psychotherapy, which took place in the years 1991, 1994 and 1995, had a significant effect on the socio-demographic composition of our patient population, showing a convergence of patient population towards the socio-demographic criteria of the population of Vienna. CONCLUSION: We argue that the changes in legislation in Austria, concerning funding of psychotherapy, and introducing a new profession "psychotherapist", have a measurable effect which works in two ways: 1) direct effect: decreased financial charge of patients; 2) indirect effect: increased motivation of patients, resulting from a reduction in stigmas attached to the role of "psychiatric patient".

Adult↗

The impact of vendorship legislation and interprofessional competition in the market for social workers' services.

The results of this article suggest that, in the short run, vendorship legislation will not result in a large shift of social workers from organized settings into private practice. However, vendorship legislation appears to increase the number of social workers in private practice in areas that have not attracted as many psychiatrists. Thus, vendorship may have a favorable impact on the geographic distribution of mental health providers. Vendorship legislation may result in increases in private practice social workers in underserved areas. The results also suggest that social workers and psychiatrists compete in the market for mental health services. In counties with higher psychiatrist-to-population ratios, fees for social workers' services are lower. Further, in counties with higher psychiatrist-to-population ratios, the number of social workers in private practice decreased after vendorship. Finally, there is a large range of optimal practice size for social workers. Social workers with 20 or more clients per month can provide mental health services at the lowest average cost per client. Thus social workers operating either full-time or part-time practices with more than 20 clients per month can provide mental health services efficiently.

Cost Control↗

A review of legal and policy issues in legislating compensation for victims of toxic substance pollution.

Despite the actual and potential effects of toxic substance pollution upon human health, the United States Congress has never enacted a comprehensive victim compensation system. The approach of the Congress, to date, has been limited by a concern about legislating on a topic fraught with scientific uncertainty--the actual causation of injury or death by toxic substance pollution. Individuals who believe they have been injured by toxic substances often bring their claims in state courts, where they face the difficult task of proving causation. Industry is principally concerned with the high cost of a compensation system, not the public health issue of scientific causation. From a policy standpoint, legislation is needed that produces information and standards on causation which assist both victims and industry. Congress has the opportunity to craft legislation that will deal rationally with an epic problem. To do so, however, the Congress must recognize scientific uncertainty as an omnipresent element of causation in cases of toxic substance pollution. This starting point, a comprehensive system of compensating victims of toxic substance pollution, can be drafted to address the values of data collection, data interpretation, prevention, conservation of economic resources, and fairness.

Disability Evaluation↗

Ethical conflict in long-term care: is legislation the answer?

The Omnibus Budget Reconciliation Act of 1987 radically redefined the relationship between nursing facilities and their residents. To explore the impact of this autonomy-enhancing but controversial legislation on nursing operations in skilled nursing facilities, two focus groups were convened. Nurse administrators identified ways in which the recently implemented legislation facilitates or inhibits resolution of the ethical conflicts they face. Participants concluded that legislation alone was insufficient to create needed reform in long-term care and recommended a multifaceted approach. A model is presented for creating a community of caring that identifies regulatory reform, professional empowerment, and organizational redesign as catalysts for a change.

Adult↗

Trends in helmet use and head injuries in San Diego County: the effect of bicycle helmet legislation.

The purpose of this study is to evaluate the effect of California's bicycle helmet law on bicycle-related head injuries in San Diego County with a year 2000 population of approximately 3 million people. The study design is an ecological trend design based on observational data from a Trauma Registry. Outcome measures include helmet use compliance, site/severity of injury and abbreviated injury scale (AIS). There were 1116 bicycle trauma patients recorded in the San Diego County Trauma Registry between 1992 and 1996. The percentages of pre-law and post-law helmet use were 13.2 and 31.7%, respectively. Over the whole study period, the overall helmet use increased by an average of 43% per year with an averaged 84% rate increase in helmet use among children. Only 16.1% of patients with serious head injury used helmets, compared to 28.2% in those who did not have serious head injury. The odds ratio of helmet use against serious head injuries is 0.43 (95% CI 0.28-0.66) after adjusting for age, ethnicity and time. The p-values for comparing pre- and post-legislation serious head injury rates are p=0.764, 0.4 and 0.194 for the overall, adult and child populations, respectively. Helmet legislation increased helmet use in the targeted child population and the effect was carried over to the adult population. Helmet use has a protective effect against serious head injury. Probably due to several of its limitations, the current study did not confirm that helmet legislation alone significantly reduced head injury rates in San Diego County during the study period.

Adolescent↗

The evolution of legislation to regulate pediatric clinical trials: Present and continuing challenges.

Children suffer from many of the same diseases as adults and are often treated with the same agents. However, it was not until 1997 that legislation mandating studies in children was introduced in the United States. A 2000 International Conference on Harmonisation (ICH) Guidance on the Clinical Investigation of Medicinal Products in the Pediatric Population intended to encourage and facilitate timely pediatric clinical trials detailed critical issues in pediatric drug development and ways to ethically study the safety and efficacy of drugs in the unique and vulnerable pediatric population. In 2005, there is draft legislation in Europe. In Japan, pediatric data are not currently required although studies in pediatric populations are encouraged. This chapter describes the history of legislation on the study of drugs in the pediatric population and details present and continuing challenges for the child, parent/guardian, manufacturer and health authority.

Child↗

Guidelines and legislation for dye house effluents.

Increasing attention has been paid over the years to the environmental problems related to industrial activities. Environmental standards have been established and control organisms have been created with a view to applying restrictive legislation. In the dyeing industry, ennoblers discharge in the environment large volumes of strongly coloured effluents that are heavily loaded with pollutants and highly concentrated in salts. This chemical load is generated during the different steps of textile preparation. After reviewing the characteristics of these effluents, this paper gives a comparative review of the current legislations on the dyeing industry emissions. It examines more closely the discharge legislation, first in France and then in other countries around the world. A comparison of the six most representative parameters shows how different the applied constraints are in different countries.

Coloring Agents↗

The effectiveness of the 'ride-bright' legislation for motorcycles in Singapore.

This paper examines the effectiveness of the 'ride-bright' legislation implemented in Singapore in November 1995. The odds ratio test is used to investigate if there is any significant difference in the number of daytime motorcycle accidents by severity before and after the implementation of the legislation. The findings indicate that although there is insignificant change in the number of slight injury accidents, the legislation is effective in reducing the number of fatal and serious injury accidents.

Accidents, Traffic↗

Effect of state legislation prohibiting denial of emergency department patient claims.

STUDY OBJECTIVE: On July 1, 1996, two Florida state laws were implemented to prevent denial of legitimate patient claims. Our objective was to determine whether the laws have been effective in reducing inappropriate denials as measured by the proportion of claims and charges denied. METHODS: A comprehensive set of claims for in-state emergency physician services from a physician billing company were analyzed for the period January 1996 through June 1997, covering 6 months before and 12 months after the effective date of state legislation. The number of facilities included in the data varied from 55 to 67 (mean 63). Denials were classified into 6 categories by payer type. Gross denials were those claims that were completely not paid by the payer, net denials represented the amount denied after patient payments. Downcoding was not examined in this study. Main outcome measures were the proportion of claims and charges denied before and after July 1, 1996. RESULTS: The classification of relative proportions of primary payers did not change appreciably over the study period. The proportion of denied claims decreased significantly (Kruskal-Wallis P <.001), starting 2 months after implementation. CONCLUSION: After initiation of state legislation, payers continue to inappropriately deny claims, although the number of claims and total charges denied has decreased. In response to this legislation, payers are denying larger claims and patient copayments have increased.

Emergency Service, Hospital↗

Health care for handicapped adolescents: international legislative and policy trends.

Between 1970-1976, 45 countries enacted or made adjustments to laws on health care for the handicapped. This article explores some of the legal arrangements made to address the issue of health care for the handicapped adolescent. It reviews the legal definition of "handicapped" and analyzes the legislative support created for health care programs. Most programs are comprehensive. They focus on prevention, detection and reporting, as well as treatment and rehabilitation. Better care for disabled adolescents is one of the more important intended results of recent legislation directed to the handicapped. Rehabilitation has been increasingly recognized as a right. Prevention is an increasing focus. Legislation, however important, is only a beginning; it expresses the political will be create programs to address the issue. The challenge is to implement the law.

Adolescent↗

From retreat to health centre: legislation, commercial opportunity and the repositioning of a Victorian private asylum.

This paper examines the interplay of commercial imperatives and health care legislation in the survival of a privately owned psychiatric hospital in Guelph, Ontario, Canada. Using documentary and archival evidence, we show how the Homewood Retreat (later Sanitarium, and eventually Health Centre) was able to respond to and anticipate legislative developments through the agency of successive medical superintendents and the structural positioning of the institution as an inextricably integrated element in local and provincial mental health provision. Our case study is used to draw out wider lessons concerning agency, legislative context and treatment modality in the determination of organizational histories. We conclude by noting the important role of the private sector in ensuring the continued provision of an asylum form of mental health care.

Facility Regulation and Control↗

The revision of the air quality legislation in the european union related to ground-level ozone.

Complying with the obligation in the current ozone directive, the European Commission came forward in 1999 with a strategy to combat tropospheric ozone together with a proposed revision of the air quality legislation for this pollutant. As a daughter legislation under the 1996 Framework Directive on Air Quality, the proposed ozone daughter directive defines for the first time (interim) air quality targets for ozone to be attained by 2010, complemented by long-term objectives for ozone based on the guideline values of the World Health Organisation. It also sets out enhanced requirements for monitoring and assessment of ozone concentrations, as well as minimum criteria for appropriate information of the public about the measured air pollution. In the past, abatement strategies against air pollution consisted of concrete obligations for controlling emissions derived solely on the basis of technical and economic aspects, covering specific types of installations or activities, thus with no direct quantitative relationship to the level of air pollution let alone to its effects. In compensating this deficit, the Commission presented, as a complement to the existing sectoral legislation, a proposal for a directive on national emission ceilings (NEC) which quantifies emission targets for every Member State to bring its total precursor emissions by 2010 down to levels being considered as necessary to achieve everywhere on a regional scale the air quality targets set in the ozone daughter directive. As the core element of the ozone abatement strategy, the national ceilings for emissions of sulfur dioxide (SO(2)), nitrogen oxides (NO(x)), ammonia (NH(3)) and volatile organic compounds (VOC) were derived from a cost-effectiveness analysis integrating information on economic, technical, physical and biological aspects of ozone pollution and abatement. This integrated assessment considers the potential and costs for further emission control in the various economic sectors in the Member States and combines this with information on ozone formation and transport processes in the atmosphere and with indicators for the impact of ozone on human health and environmental. Reflecting the discussions with Member States and stakeholders, a number of decisive steps in the process of deriving the national emission ceilings are presented here: the way of framing interim objectives, how to choose an appropriate ambition level, aspects of how to cope with uncertainties in the model and the input data and how to treat extreme meteorological situations and resolve problems in the spatial distribution of the interim objectives given the different size of countries. Finally, the paper explains the scenario underpinning the proposed national emission ceilings, its environmental gains and the distribution of cost incurring for emission control measures in Member States.

Air Pollution↗