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PubMed2004

The new European legislation on traditional herbal medicines: main features and perspectives.

Under the Italian Presidency of the Council of the European Union (July 2003-December 2003) an agreement has been reached by the European Parliament and the Council on the approval of the proposal of Directive of the European Parliament and the Council amending the Directive 2001/83/EC as regards traditional herbal medicinal products. Once implemented in the E.U. Member States, this new Directive will remove the constraints that have made it difficult granting marketing authorisations of herbal substances and preparations as traditional medicinal products under the pre-existing Community legislation. The main features (i.e. traditional herbal medicine definition, simplified registration procedure, provisions for Community herbal monographs and Community list of herbal substances and preparations and establishment of the Committee for Herbal Medicinal Products) of this new Community legislation are analysed and discussed in the present paper together with some expected positive public health impacts.

Europe↗
PubMed2006

Legislation relating to nutraceuticals in the European Union with a particular focus on botanical-sourced products.

Nutraceuticals are food or food ingredients that have defined physiological effects. They do not easily fall into the legal categories of food or drug and often inhabit a grey area between the two. These products in general terms cover health promotion, "optimal nutrition" the concept of enhanced performance--both physically and mentally--and reduction of disease risk factors. In this paper the focus is mainly on legislation governing botanical-sourced nutraceuticals in the European Union (EU). Nutraceutical concept in general has been defined. Different pieces of legislation influencing botanical nutraceuticals are described. The issue of the borderline between food and drug is discussed. The regulatory status of botanical nutraceuticals as food supplement, food ingredient, functional and fortified food, novel foods and foods for particular nutritional use in the diversified, complex and ever-changing European regulatory environment is described. Botanical nutraceuticals present additional problems because of their complex nature and composition particularly with respect to the quality aspects, which in turn affect safety parameters and overall efficacy of the products. Quality issues relating to botanical sources, growth conditions, end products, their specifications and other technical criteria are highlighted. Guiding principles to be observed for conducting in vitro, in vivo studies in animals and their impact on clinical safety data are discussed. Finally, health claims, their types and criteria of substantiation in light of ongoing discussions with regard to the EU frame work of regulation on nutrition and health claims and role of process for the assessment of scientific support for claims (PASSCLAIM) initiative is discussed. The concept of grading of evidence to substantiate different claims and to establish standards, which should not be revoked or reversed by emerging science at a later stage has been considered. These issues are crucial and are being discussed at EU Parliament and Commission level during the development of the health claim regulations.

Animals↗
PubMed1998

Obstetrician-gynecologists as primary care physicians: the Oregon experience--early perceptions regarding the effects of legislative action.

OBJECTIVE: Our purpose was to assess whether legislative action influenced the role of obstetrician-gynecologists as primary care physicians. STUDY DESIGN: An observational study was performed on the basis of a questionnaire sent to 410 obstetrician-gynecologists and 27 medical directors of managed-care organizations. RESULTS: Of 67% of obstetrician-gynecologists and 96% of medical directors who responded, there was agreement as to the content of primary care, but a minority (38%) of obstetrician-gynecologists identified themselves as primary care providers. A minority of medical directors (35%) felt that obstetrician-gynecologists should serve in that role. Both obstetrician-gynecologists and medical directors felt that legislation had little impact. CONCLUSION: The reticence of obstetrician-gynecologists to assume a major role in primary care appears to be the result of an uneasiness with accepting a more comprehensive role in patient management and gatekeeping. They appear comfortable with the more traditional roles but feel that training and experience has not prepared them well for the management of more complex medical problems.

Female↗
PubMed2000

Health policy and legislation: impact on cancer nursing and care.

OBJECTIVES: To review policy and legislative initiatives in which nursing has played roles and to provide insight into trends and issues that characterize the policy and political agendas in which oncology nurses can play advocacy roles in the new millennium. DATA SOURCES: Professional journals, books, newspapers, news magazines, and internet web sites. CONCLUSIONS: Oncology nurses can offer solutions to the dilemmas posed by fiscal realities, unique American values and expectations, and the complexities of cancer care in the United State's market-based health care system. Oncology nurses must assume roles as health policy specialists. IMPLICATIONS FOR NURSING PRACTICE: For nurses to gain acceptance in health policy arenas, individual nurses and groups of nurses must become expert in assessing the environment, the interpretation of cues, and the development and implementation of realistic strategies targeting priority health policy and legislative issues.

Delivery of Health Care↗
PubMed1998

An update on the impact of gun control legislation on suicide.

OBJECTIVE: The authors review recent literature examining the impact of gun control legislation on suicide rates. METHOD: MEDLINE and PsychLIT searches on gun ownership, gun control, and psychiatric firearm-related topics from 1982 through March 1997 were examined for reports focusing on gun control legislation and suicide. RESULTS: Suicide rates typically decreased following implementation of a variety of firearm control laws. Suicide-prone individuals seldom substitute other means or go outside legal channels for suicide weapons. Firearm restrictions may decrease the ready accessibility of firearms enough to allow the peak period of suicidality to pass. CONCLUSION: The findings support gun control measures as a strategy for reducing suicide rates.

Aged↗
PubMed2001

Legislative and preventive measures related to contact dermatitis.

Legislation can be a useful tool in the prevention of contact dermatitis. This is particularly true for dermatitis due to exposure to the many contact allergens that are chemical substances in products. A brief review is given of the most important European legislation--the EU Nickel Directive, the Cosmetics Directive, the Hazardous Substances Directive and the Hazardous Preparations Directive--and of some national regulations and standardization projects. It is concluded that it is essential that experts on contact dermatitis support, with their expert knowledge, national and European authorities.

Allergens↗
PubMed1975

The congress and health manpower: a legislative morass.

To correct deficiencies in physicians' services, chiefly related to geographic maldistribution and overspecialization, numerous bills have been introduced in both the House and the Senate. These bills would increase the annual number of medical graduates, would mandate service in areas defined as lacking in physicians, and would promote the training of primary-care physicians as opposed to more specialized training. The number of foreign medical graduates would also be restricted. Almost all this legislation potentially may diminish the quality of medical education without substantially affecting the provision of health service. Recently introduced legislation (HR 3279), however, seems to deal more rationally with the problems of health manpower.

Education, Medical↗
PubMed2005

Iodine content of salt 2 years after the introduction of the universal salt iodisation legislation in Lesotho.

The aim of the present study was to assess the impact of the universal salt iodisation legislation on I levels of salt at household, retail and entry level in Lesotho. We used a multistage proportion to population size method to select thirty-one clusters from all the districts and ecological zones of Lesotho. In each cluster, thirty households were randomly selected and salt samples were collected. Six salt samples from two randomly selected retailers in each cluster, and a total of 107 salt samples from all the commercial entry points in the country were also collected. Lesotho does not produce salt and it imports almost all its salt from South Africa. The salt samples were analysed using the iodometric titration method. The median I concentration of salt was 36.2 ppm at entry point, 37.3 ppm at retail level and 38.5 ppm at household level. At household level only 1.6 % used non-iodised salt and 86.9 % used adequately iodised salt. Of all salt collected at household level, 20.4 % was coarse salt, which was significantly less well iodised than fine salt. The study demonstrates a major achievement in the availability of iodised salt as well as household use of adequately iodised salt. Under-iodisation of coarse salt and non-uniformity of salt iodisation at the production site were observed. Therefore, there is a need for enforcement of the salt iodisation legislation especially at entry-point level to ensure that only iodised salt enters the country. During enforcement more emphasis should be given to iodisation of coarse salt.

Commerce↗
PubMedDate not supplied

A review of the research requirements for Europe to support legislation in the area of food contact materials and articles.

A strong science base is required to underpin the planning and decision making process involved in determining future European Community legislation in the area of food contact materials and articles. The generation of this science base should be undertaken on a Europe-wide basis and needs to be coordinated to avoid duplication of effort and to secure agreement on the underlying science being used to determine future strategy. This review considers possible work that might be required in the future to support legislation on food contact materials and classifies it in terms of short-term problem-solving and longer-term strategic research.

Europe↗
PubMed1980

Legislative aspects of pesticide regulations.

This paper reviews the development of pesticides as an agricultural and health tool and discusses the national and international implications of pesticide regulation. The need for scientific input to the legislative and regulative processes is explained. Appropriate legislation and regulatory structures are presented. Finally, the need for international cooperation in the use and control of pesticides is analyzed.

International Cooperation↗
PubMed1980

Statute and legislative history of the Federal Insecticide, Fungicide, and Rodenticide Act and its impact on agriculture.

This report discusses the responsibilities of government for the legislation of pesticides, and describes the impact of various statutes on the use of pesticides in agriculture. Governmental responsibilities for management of the economy, education, and enactment of laws and regulations are discussed, and the history of U.S. legislation of pesticides and related substances is presented. Finally, the impact of pesticide regulation on international trade is considered.

History, 20th Century↗
PubMed1980

Legislative aspects of pesticide regulations in Egypt.

The problems of pesticide exposure and intoxication in Egypt are discussed. Data is presented on the incidence of pesticides poisoning and on the concentration of various pesticides in several types of environmental samples. Finally, present legislation and proposed legislative changes are presented.

Egypt↗
PubMed2000

Disclosure of donor insemination to the child: the impact of Swedish legislation on couples' attitudes.

The question whether or not parents of children conceived after donor insemination (DI) tell their offspring about its biological background was addressed. Swedish legislation from 1985 gives the child born after DI the right, when grown up, to receive identifying information about the sperm donor. Until now no information about compliance with the law has been available. All parents who gave birth to a child by DI after the new legislation in two major Swedish fertility centres (Stockholm and Umeâ) received a questionnaire containing questions about the issue of informing the child. The response rate was 80%. The majority of parents (89%) had not informed their children, whereas 59% had told someone else. As a response to an open question, 105/132 parents chose to comment on their answer about not having informed their child. Of these families, 61 intended to tell their child later, 16 were not sure and 28 were not going to inform the child. Compliance with the law must be regarded as low since only 52% of the parents had told or intended to tell their child. In addition, concern is raised about the children who run the risk of being informed by someone other than their parents.

Adolescent↗
PubMed1997

Firearm fatalities in Eastern Saudi Arabia: impact of culture and legislation.

A study of all firearm fatalities in the Eastern Province of Saudi Arabia during the 10-year period from 1985 to 1994 is presented. The overall number of cases was 71 (0.35 per 100,000 population), of which 48% were homicides, 28% were suicides, and 24% were accidental. Most victims were young male Saudis; most were shot in the chest (41%) or the head (34%). Hand guns were responsible for all suicides, 56% of homicides, and 71% of accidental deaths. The study shows some resemblance between the homicide and suicide groups with regard to the age of victim, type of weapon used, and site of entrance wound. The findings in the present study are comparable to reports from other Middle East countries, but different from those in communities with different cultural and legislative backgrounds. Our findings may support the argument that more strict firearm legislation is helpful in limiting the number of firearm fatalities in the community.

Accidents↗
PubMed1987

Seat belt legislation in Britain.

The background to the passage of the seat belt usage law in Britain is described. Voluntary belt use rates in the 1970's were approximately 30%, with educational campaigns having a minimal effect. The political process and the factors influencing the seat belt legislation are described, particularly the role of the media. The provisions and the consequences of the law are outlined with belt use in the general traffic stream rising to 90%. Deaths and serious injury to front seat car occupant casualties declined by 25% in comparing the year after with the year before the introduction of the law. Changes in other categories of casualties were within normal statistical limits and were uninfluenced by the seat belt legislation.

Accidents, Traffic↗
PubMed2001

New reproductive technologies, ethics and legislation in Brazil: a delayed debate.

This paper focuses on the debate about the utilization of new reproductive technologies in Brazil, and the paths taken in the Brazilian National Congress in an attempt to draw up legislation to regulate the clinical practice of human assisted reproduction. British documents, such as the Warnock Report and Human Fertilization and Embriology [sic] Authority (HFEA) are used for thorough reference. The analysis of the Law Projects in the National Congress, the Resolution by the Federal Medicine Council, Resolution 196/96 and documents by the the Ministerio Publico (Public Prosecution Office), supplied the bases for the discussion. The principal question involved is the observation of different technical and moral prientations [sic] that influence the conduct of the issue in the legislative process. It is possible to observe that the main focus of the projects relates to the rights and interests of the children, to those possibly benefited by the technique and to embryo reduction. Very little attention has been directed to the issues of sexual and reproductive rights and to the health of the women submitted to the new reproductive techologies [sic].

Bioethics↗
PubMed2006

Legislation restricting paracetamol sales and patterns of self-harm and death from paracetamol-containing preparations in Scotland.

AIMS: To describe how changes in legislation to restrict paracetamol sales have affected overdose discharges and death associated with the drug in Scotland. METHODS: A descriptive analysis of routine death and hospital discharge data for the entire Scottish population between 1995 and 2004. Patients in Scotland participated who were discharged from hospital with a diagnosis of poisoning; deaths in Scotland from diagnosis of poisoning 1995-2003 were also analysed. Outcome measures were changes in mortality and overdose due to poisoning involving paracetamol. A comparison was made of in-hospital and out-of-hospital mortality in fatalities involving paracetamol. RESULTS: The majority of paracetamol-associated deaths were due to co-proxamol. Deaths associated with paracetamol alone or with ethanol occurred principally in hospital and were a minority of deaths overall. The proportion of in-hospital deaths attributed to paracetamol increased (post/pre ratio 1.347; 95% confidence interval 1.076, 1.639; P = 0.013). Overall numbers of cases discharged with poisoning fell. The proportion of these involving paracetamol in any form increased significantly in all groups except young men aged 10 to <20 years. CONCLUSIONS: Legislation has not reduced mortality or proportional use of paracetamol in overdose, both of which appear to have increased in Scotland since pack-size limitations. Other approaches are necessary to reduce the death rate from overdoses involving paracetamol.

Acetaminophen↗
PubMed2007

Managing scientific uncertainty in health legislation.

Legislation and regulation of biomedical research is seldom a one-off process since biomedical science evolves rapidly, dynamically and often unpredictably. This paper discusses the challenges faced by regulators who need to produce legislation and policy in rapidly changing fields and outlines some practical suggestions for managing law reform and policy-making under these circumstances.

Animals↗