The future of tobacco product regulation and labelling in Europe: implications for the forthcoming European Union directive.
The European Commission has announced that it is considering legislation concerning further restrictions on cigarette tar and nicotine yields, as well as new provisions to regulate additives and the labelling of tobacco products. This report considers these issues and their relation to public health. In particular, we argue that further reductions in tar and nicotine yields as measured by the International Standards Organisation/Federal Trade Commission (ISO/FTC) method will be largely cosmetic and certainly misleading to consumers. If a new directive uses the ISO/FTC methodology as a basis for regulation, it risks lending further official support to the concept of "low tar" cigarettes, which may be used by smokers as an alternative to smoking cessation. Although new regulations based on the ISO/FTC methodology may appear to offer health gains, these will be illusory and there may even be negative health consequences, as has been the case with these tests up to the present. We therefore make the following recommendations for the way forward. (+info)
Epidemiological data of treated end-stage renal failure in the European Union (EU) during the year 1995: report of the European Renal Association Registry and the National Registries.
BACKGROUND: The new Centre Questionnaire, mainly based on the collection of epidemiological data, was launched in 1996 and the overall response rate of centres for the 15 countries constituting the European Union (EU) reached 82.2% (66-100%) for 1995. RESULTS: We could derive the following information for a general population of 372.6 million. In 1995, the incidence of new end-stage renal failure (ESRF) patients (Ni/P) was 120 p.m.p. (per million population) with a clear north to south/west gradient (69 in Ireland, 131 in Italy and 163 in Germany). The incidence of ESRF deaths (No/P) was 67 p.m.p. (from 35 in Ireland to 89 in Germany). The net increase of patients was therefore 53 p.m.p. (from 13 in Greece to 74 in Germany). The point prevalence of treated ESRF patients (Ns/P) alive on 31 December 1995 was 644 p.m.p. (from 444 in Finland to 773 in Italy). The mean increase in the stock of ESRF patients was +8.2% (4.6 to 13.0) as a linear rate and +0.085 as a fractional rate (exponential). The first treatment of new patients (Ni) was haemodialysis (HD; 81%), peritoneal dialysis (PD; 18%) and pre-emptive renal transplantation (Tx; 1%). The latest treatment for patients still alive was HD (58.5%), PD (9%) or functional Tx (32.5%). The number of Tx was 30 p.m.p. (from 14 in Greece to 45 in Spain). The death rate was 10.4% for all those with ESRF, with 14.4% for those dialysed and 2.2% for transplanted patients. In 1995, 6.5% of dialysed patients received a graft and 4.0% of transplant patients returned to dialysis. The linear expansion rate of the dialysis pool and the transplant pool was respectively 8.3% and 7.9%. CONCLUSIONS: This data shows considerable disparities among countries of the EU which merit further evaluation. Also this analysis by the ERA Registry provides data of value for health and economic purposes. (+info)
Genetically modified organisms: an analysis of the regulatory framework currently employed within the European Union.
BACKGROUND: Genetic engineering technology is starting to bring many commercial products to the market. These genetically modified organisms (GMOs) and their derived products are subject to topical debate as to their benefits and risks. The strengths and weaknesses of the regulatory framework that controls their development and application is central to the question of whether this technology poses significant risk to the public health during this critical phase of its evolution. METHODS: A critical review was carried out of the legal framework regulating the contained use, deliberate release and some aspects of consumer protection relevant to the control of GMOs in Europe and the United Kingdom. RESULTS: The current legal framework is failing to provide a speed of adaptation commensurate with the development of the science of genetic engineering; failing to properly respond to democratic control; failing to resolve significant conflict between the protection of free markets and protection of public health and the environment; and failing to implement obligations on biodiversity. CONCLUSION: The present legal framework must be replaced. Current European Union proposals for new standards of regulation are welcome, but provide only for further incremental change, and do not address some significant fundamental flaws in our current laws. (+info)
A new questionnaire for the repeat of the first stage of the European Community Respiratory Health Survey: a pilot study.
In the early 1990s a multicentre survey on asthma was performed on the young adult population (European Community Respiratory Health Survey - ECRHS). This study is to be repeated in order to estimate changes in the prevalence of asthma-like symptoms during the last decade and to assess the social and economic costs of the disease and their variations among countries. The self-administered questionnaire devised for this purpose is a two-page questionnaire. The first page contains the same items as those used in the first survey with four additional questions related to: 1) the frequency and severity of asthma attacks; 2) the presence of chronic bronchitis; 3) smoking habits; and 4) a visual analogue scale assessing perception of outdoor pollution. The second page aims to collect information regarding the direct and indirect costs of asthma. The influence of the length of the questionnaire on the response rate was assessed in a pilot study in Italy. Two random samples of 150 subjects received either the one-page questionnaire (first page) or the two-page questionnaire. The response rate was compared with that obtained from the first postal wave in the 1991-1992 survey. Although the response rate was unchanged when using the one-page questionnaire (45% versus 45%), it decreased by 7% when the two-page questionnaire was used (38% versus 45%). On the basis of these results, no problem should arise if four more questions are added to the one-page questionnaire. The slight reduction in the response rate of the two-page questionnaire is worrying but could be corrected by the use of telephone interviews. (+info)
Development of orphan vaccines: an industry perspective.
The development of vaccines against rare emerging infectious diseases is hampered by many disincentives. In the face of growing in-house expenditures associated with research and development projects in a complex legal and regulatory environment, most pharmaceutical companies prioritize their projects and streamline their product portfolio. Nevertheless, for humanitarian reasons, there is a need to develop niche vaccines for rare diseases not preventable or curable by other means. The U.S. Orphan Drug Act of 1983 and a similar proposal from the European Commission (currently under legislative approval) provide financial and practical incentives for the research and development of drugs to treat rare diseases. In addition, updated epidemiologic information from experts in the field of emerging diseases; increased disease awareness among health professionals, patients, and the general public; a list of priority vaccines; emergence of a dedicated organization with strong leadership; and the long-term pharmacoeconomic viability of orphan products will be key factors in overcoming the complexity of orphan status and the limited need for vaccine. (+info)
Possibilities for regulatory actions in the prevention of musculoskeletal disorders.
This review argues that there is a need for regulatory action against work-related musculoskeletal disorders. Designing such regulation is fraught with problems, such as insufficient knowledge about mechanisms and exposure-dose-response relationships, and lack of consensus on definitions. The multifactorial character of the disorders, especially risks involving work organization, further increases the problems. Nevertheless, regulation is necessary because of the poor results of voluntary prevention and the large costs of these disorders. Some major regulations are reviewed, and it is argued that there is insufficient scientific support for quantitative regulations proposed for some European norms. The recent Nordic ergonomic regulations for the prevention of work-related musculoskeletal disorders is a step forward, since they succeed in providing guidance, including some on work organizational issues, with only few quantitative measures. Researchers should become more involved in these activities, and priorities in future research that would benefit a more scientific approach to ergonomic regulation are indicated. (+info)
Occupational exposure to carcinogens in the European Union.
OBJECTIVES: To construct a computer assisted information system for the estimation of the numbers of workers exposed to established and suspected human carcinogens in the member states of the European Union (EU). METHODS: A database called CAREX (carcinogen exposure) was designed to provide selected exposure data and documented estimates of the number of workers exposed to carcinogens by country, carcinogen, and industry. CAREX includes data on agents evaluated by the International Agency for Research on Cancer (IARC) (all agents in groups 1 and 2A as of February 1995, and selected agents in group 2B) and on ionising radiation, displayed across the 55 industrial classes. The 1990-3 occupational exposure was estimated in two phases. Firstly, estimates were generated by the CAREX system on the basis of national labour force data and exposure prevalence estimates from two reference countries (Finland and the United States) which had the most comprehensive data available on exposures to these agents. For selected countries, these estimates were then refined by national experts in view of the perceived exposure patterns in their own countries compared with those of the reference countries. RESULTS: About 32 million workers (23% of those employed) in the EU were exposed to agents covered by CAREX. At least 22 million workers were exposed to IARC group 1 carcinogens. The exposed workers had altogether 42 million exposures (1.3 mean exposures for each exposed worker). The most common exposures were solar radiation (9.1 million workers exposed at least 75% of working time), environmental tobacco smoke (7.5 million workers exposed at least 75% of working time), crystalline silica (3.2 million exposed), diesel exhaust (3.0 million), radon (2.7 million), and wood dust (2.6 million). CONCLUSION: These preliminary estimates indicate that in the early 1990s, a substantial proportion of workers in the EU were exposed to carcinogens. (+info)
A survey of undergraduate orthodontic education in 23 European countries.
This paper reports on a survey of teaching contents and time allocation within the undergraduate orthodontic curriculum in European countries in 1997, and on whether or not these countries set a formal undergraduate examination in orthodontics. A questionnaire and an explanatory letter were mailed to all members of the EURO-QUAL BIOMED II project. Answers were validated during a meeting of project participants and by fax when necessary. Completed questionnaires, which were subsequently validated, were returned by orthodontists from 23 countries. They indicated that orthodontics was taught in all undergraduate curriculums of the countries surveyed. The number of hours in the undergraduate curriculum devoted to orthodontics was reported as varying from 135 to 500 hours with a mean of 245 hours. The time reported as allocated to theory, clinical practice, laboratory work, diagnosis, and treatment planning varied widely. In general, clinical practice and theory were reported as being allocated most curriculum hours, whilst diagnosis, laboratory work, and treatment planing were reported as receiving relatively less time. Removable appliances were reported to be taught in 22 of the 23 countries, functional appliances in 21 countries and fixed appliances in 17 countries. An undergraduate examination in orthodontics was reported by 20 countries. It was concluded that orthodontics occupies a small proportion of the undergraduate curriculum in dentistry in most countries, the emphasis is on theory and clinical work, and that removable appliances, functional appliances, and certain aspects of fixed appliances are taught in the majority of countries that responded to the questionnaire (+info)