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PubMed1996

Relationships between the academic community and the pharmaceutical industry: the legislative background and its effect on spending on medical research and development.

Patent legislation governing drugs has evolved through a series of amendments to the Patent Act. From 1923 until 1993, Canada operated a system of "compulsory licensing," allowing generic copies of patented medicines to be manufactured within Canada and, by 1969, to be imported. In 1987, the act was amended (Bill C-22) to provide patented medicines with a fixed period of market protection before a compulsory license could be issued and to create a price review board to monitor and control prices charged. In return for patent protection, brand-name drug companies promised to invest a growing percentage of sales revenue in research and development in Canada. A 1993 amendment to the Patent Act (Bill C-91) brought a fundamental change to the legislation by abolishing the system of compulsory licensing and applying general patent regulations to medicines, thereby bringing Canadian law into line with that of its trading partners. It is now illegal to sell a copy of a drug until the patent expires (20 years after the patent is filed). This means that marketed drugs are protected for 8 to 13 years, since drug development takes a large proportion of the life of the patent. Since this amendment was passed, the brand-name drug companies have made major contributions to research and development in Canada, increasing from 6.5% of sales revenue in 1987 to 11.6% in 1994. Major irritants in the legislation remain. Generic drug companies have complained about "linkage regulations" that allow brand-name drug companies to legally challenge generic drug production on the basis of alleged infringements of linked patents, delaying the marketing of the generic drug. The act also prohibits Canadian manufacturers from exporting a generic drug to a country where it is not protected if it still protected in Canada. Brand-name manufacturers want some means of patent term restoration if regulatory authorities prolong the time taken before marketing a drug. This legislation is being reviewed by parliament beginning in 1997.

Canada↗
PubMed2003

Newborn length of stay, health care utilization, and the effect of Minnesota legislation.

OBJECTIVE: To describe newborn length of stay, postdischarge follow-up, and health care utilization in the context of Minnesota's early discharge legislation. DESIGN AND SETTING: Retrospective study using claims data from a large managed care organization. PARTICIPANTS: Term newborns born from January 1995 through February 1999 (N = 22 944). OUTCOME MEASURES: Newborn length of stay, home or clinic visits within 1 week of discharge (early follow-up), immunizations completed by age 3 months, readmissions within 1 month of discharge, and urgent care or emergency department visits within 2 months of discharge. RESULTS: After enactment of Minnesota's early discharge legislation in 1996, the percentage of newborns with short stays (0-1 days after vaginal birth or 2-3 days after cesarean birth) decreased from 52% to 16% for vaginally born infants and from 87% to 63% for cesarean-born infants (P =.001). Although the legislation mandated coverage for home visits after short stays, only 12.4% of short-stay newborns had early home visits. Overall, 50% of infants had early home or clinic follow-up; compared with those who did not receive early follow-up, these infants were more likely to have complete immunizations (adjusted odds ratio [OR], 1.09; 95% confidence interval [CI], 1.03-1.14), urgent care or emergency department visits (adjusted OR, 1.22; 95% CI, 1.07-1.39), and readmissions (adjusted OR, 2.49; 95% CI, 2.02-3.08). CONCLUSIONS: Although implementation of Minnesota's early discharge legislation corresponded with significantly increased lengths of stay, very few short-stay infants received the postdischarge care for which coverage was mandated. Our findings indicate, however, that infants at higher risk for adverse outcomes were appropriately identified to receive early follow-up.

Health Services Research↗
PubMed1994

Low blood alcohol concentrations and driving impairment. A review of experimental studies and international legislation.

While noting that there is no international scientific or legislative uniformity in blood alcohol concentration (BAC) levels admissible for driving motor vehicles, the authors analyse problems concerning the effects of low levels of ethyl alcohol on driving ability. A summary of the international literature on this subject reveals: the existence of contrasting assumptions, with scientific evidence clearly demonstrating altered psychomotor functions; the need to adopt sufficiently complex psychometric tests to reveal the effects of low BACs; the need to improve standardization of experimental studies on man-machine interaction; the need to investigate the following areas: tolerance to alcohol; low BACs with inexperienced, infrequent drinkers and chronic, heavy drinkers; hangover effects; alcohol-gender-age interactions, and specific effects on young drivers; alcohol-drug combinations. The analysis of legislation and enforcement policies also reveals the need for: re-evaluation of the international legal BAC threshold and standardization of procedures for ascertaining the degree of driving disability; further scientific research to compare and evaluate selected legislative initiatives currently in place in most states; to identify the best strategies and procedures to detect and arrest impaired drivers; to determine the optimum random testing rate to maximize deterrent effects in the workplace at minimal cost; to design innovative and comprehensive approaches to rehabilitation programs needed for subgroups of offenders and of workers; to study the effectiveness of new legislations and policies.

Alcohol Drinking↗
PubMed1997

The legislative structuring of insanity acquittee policies.

Using Missouri's insanity acquittee system as a case study, this analysis explores the extent to which legislation can structure the implementation of mental health policy. It found that Missouri's insanity acquittee legislation substantially structured policy implementation toward its primary goal of public safety. It did so (a) by including actors from both the criminal justice and mental health systems in the insanity acquittee release process, (b) by specifying procedures and criteria for the commitment and release of insanity acquittees, and (c) by requiring monthly monitoring of insanity acquittees released into the community and funding the staff positions to conduct the monitoring. The ability of legislation to structure policy implementation highlights the need for active involvement by mental health policy makers in the legislative process to shape policy goals and to structure implementation to support the interests of the mental health community. Without this involvement, implementation options available to mental health administrators may be severely limited.

Criminal Law↗
PubMed2005

[Status of rendering an expert opinion following the changes in the German traffic legislation].

The new traffic legislation in Germany ("FeVAndV") solves at least the most urgent problems for the ophthalmological driver's license assessment which were present in the old, preceding regulations ("FeV"). Many suggestions of the traffic committee of the German Ophthalmological Society ("DOG") were taken into consideration. As expected, the recommendations of the traffic committee concerning an obligatory test of mesopic vision were not adopted into the new legislation. We still have the unacceptable situation that on the one hand the European legislation demands an obligatory test of mesopic vision in suspected candidates and the German legislation even has the necessary key note for a ban on night driving ("05.01"). On the other hand, testing of mesopic vision is not considered on a regular basis in the new German regulations. This is not acceptable from an ophthalmological point of view.

Automobile Driver Examination↗
PubMed2005

Immediate impact of 'penalty points legislation' on acute hospital trauma services.

Road traffic accident (RTA) related mortality and injury may be reduced by up to 40% with the introduction of 'road safety' legislation. Little is known regarding changes in pattern of injury and overall resource impact on acute trauma services. This prospective study examines RTA related admissions, injuries sustained and resultant sub-speciality operative workload in a Level 1 Trauma Centre during the 12 months immediately prior to and following the introduction of 'penalty points' legislation. Eight hundred and twenty RTA related admissions were identified over the 24-month period from 01/11/2001 to 31/10/2003. There was a 36.7% decrease in RTA related admissions subsequent to the introduction of new legislation. Bed occupancy was almost halved. However, the relative Orthopaedic workload increased from 34% to 41% with a 10% increase in relative bed occupancy. The pattern of orthopaedic injury was significantly altered with a >50% absolute reduction in high velocity injuries. Curiously, there was no change in the absolute number of spinal fractures seen. This favourable early Irish experience of 'penalty points' legislation mirrors that of worldwide published literature. Our findings demonstrate that the injury reduction effects were primarily enjoyed by non-orthopaedic sub-specialities. Such findings mandate consideration when allocating vital resources to sub-specialities within busy trauma units.

Accidents, Traffic↗
PubMed2006

The impact of legislation on the usage and environmental concentrations of Irgarol 1051 in UK coastal waters.

In 2001, legislative measures were introduced in the UK to restrict usage of antifouling agents in small (<25 m) vessel paints to dichlofluanid, zinc pyrithione and zineb. This removed the previously popular booster biocides diuron and Irgarol 1051 from the market. To investigate the impact of this legislation, water samples were taken from locations where previous biocide levels were well documented. Results from analyses demonstrate a clear reduction in water concentrations of Irgarol 1051 (between 10% and 55% of that found during pre-restriction studies), indicating that legislation appears to have been effective. Although other booster biocides were screened for (chlorothalonil, dichlofluanid and Sea-Nine 211), they were below the limits of detection (<1 ng/l) in all samples. A survey of chandlers and discussions with legislative authorities supports these results and concurs the removal of Irgarol 1051 based paints from the market using simple regulations at a manufacturer level with little regulation at a retailer level.

Disinfectants↗
PubMed2004

Evaluation of effectiveness of safety seatbelt legislation in the United Arab Emirates.

Seatbelt legalisation was implemented in the United Arab Emirates (UAE) in January 1999. This provided the opportunity to evaluate the effectiveness of the legislation in the Eastern District of Abu Dhabi Emirate in the UAE by establishing levels of injury severity from motor vehicle crashes (MVC) before and after the legislation and the rate of compliance with the legislation. Data were obtained from a major hospital in the Eastern District of Abu Dhabi Emirate, UAE. Subjects were a systematic sample of MVC victims who arrived alive at hospital in either the pre-implementation period (January-June 1998) or the post-implementation period (February-August 2000). The main measures of outcome were injury severity codes, numbers of hospital bed days and rates of admission and discharge at hospital. The analysis of injury severity from MVCs, from the pre- to the post-implementation period, revealed a significant declining trend (chi-square = 77.68, P < 0.001). While the proportion of minor injuries increased from 42% (95% CI: 36-48%) in the pre-implementation period to 77% (95% CI: 71-83%) in the post-implementation period, the proportion of "moderate to fatal injuries" declined from 54% (95% CI: 48-60%) to 17% (P = 0.001) and the median number of hospital bed days declined from 5 days (25% = 2; 75% = 8 ) to 3 days (25% = 1; 75% = 4 ). The rate of seatbelt compliance reported by occupants involved in MVCs in the post-implementation period was 59% (95% CI: 52-67%). The implementation of the seatbelt legislation in the Eastern District of Abu Dhabi Emirate was associated with statistically significant reduction in morbidity in those arriving alive at hospital following MVC, including reduced severity of injury, admission rate to hospital and the duration of hospital stay. More active implementation of seatbelt law would most likely further reduce severity of MVC injuries and fatalities in the Eastern District of Abu Dhabi Emirate, UAE.

Accidents, Traffic↗
PubMed1993

An observational study of car occupant restraint in Fife: impact of recent legislation.

During August 1992 an observational study of car occupant restraint use was carried out at 14 sites throughout Fife (representing traffic-signal-controlled junctions in rural and non-rural sites and observations made outside primary schools). This study replicated another completed in April 1991 before the most recent legislation on rear seat restraints. The overall restraint use found at the traffic signal sites (excluding taxis) was 87% (drivers 94%, front seat passengers 93% and rear seat passengers 59%). There was lower restraint use (68%) in cars taking children to and from primary schools (drivers 87%, front seat passengers 77% and rear seat passengers 50%). Passengers seated in rear centre seats were least likely to be restrained (40%) especially where they were an older child or adult (only 14% of this latter group being restrained). Restraint use in taxi cabs was low (drivers 11%, passengers 41%). Since rear seat legislation was introduced in July 1991 there has been a 77% increase in rear seat restraint use, especially in older children and adults (233% increase) and in 1-4-year-old children (119% increase); it is likely that these improvements are largely as a result of the legislation. However, approximately 40% of rear seat passengers still travel without rear seat belt restraint. There is therefore a continuing need to emphasise both public education and the enforcement of current legislation. Educational measures should be targeted at groups known to be low users such as drivers and passengers in taxis, children carried on school 'delivery trips' and adults in rear seats.

Adolescent↗
PubMed2003

The influence of change of legislation concerning sickness absence on physicians' performance as certifiers. A population-based study.

In Sweden, a change of the legislation for sickness absence became effective on 1st October, 1995. The purpose of the change was to reduce costs for sickness absence by exclusion of non-medical criteria for sick-listing, more part-time sick-listing and faster rehabilitation. This study was conducted in order to describe and analyse certification practice of various physician categories, before and after the change in legislation. Thirty-one thousand seven hundred and thirty certificates for sickness absence, collected by the local offices of the National Social Insurance Board in eight Swedish counties, fulfilled the inclusion criteria. The number of certificates decreased temporarily. The number of certified net days, i.e. crude days multiplied by degree, tended to increase and there was no shift from full to partial sick-listing during the period. There were small changes regarding case mix, i.e. patient characteristics, and sick-listing physician category. The results were almost unchanged when these small changes were taken into account. General practitioners issued significantly shorter periods of sick-leave than the other categories both years. The goals of the legislative change were thus not met. The result of the study indicates that other factors than the legislation may be more important for physicians' practice.

Adult↗
PubMed2001

A review of state legislation related to immunization registries.

BACKGROUND: Since the early 1990s, a concerted effort has been made to develop community- and state-based immunization registries. A 1995 survey showed that nine states had laws specifically authorizing immunization registries. This survey was conducted to describe the current status of legislation and policies addressing immunization registries and the sharing of immunization information. METHODS: A telephone survey was administered from September 1997 to February 1998 to immunization program managers and/or their designees within the state health department of each of the 50 states and the District of Columbia. Some of the survey items were later updated through follow-up interviews and informal communications. Copies of legislation, administrative rules and regulations, and immunization registry policies were collected for review. RESULTS: As of October 2000, 24 of 51 states (47%) had laws (21) or rules (3) specifically authorizing an immunization registry. Nine additional states (18%) have laws specifically addressing the sharing of immunization information. CONCLUSIONS: Over half of the states have enacted legislation or rules addressing registries or the sharing of immunization information. Further research should be conducted to assess the impact of this legislation on immunization registries.

Adolescent↗
PubMed1998

A review of midwifery legislation in Australia--history, current state & future directions.

The legislative regulation of midwifery in Australia, as elsewhere, governs the practice of midwives in the profession and controls the entry of new practitioners. Legislation exists in all states of Australia, and since 1992 there have been marked changes in the nature and scope of legislated control. This paper explores the origins of midwifery regulation, the recent changes in legislation and reviews the current Acts, Ordinances & Rules governing midwifery. In doing so, it examines common themes and areas of discrepancy across the country. The implications of both are discussed in terms of present implementation and future development.

Australia↗
PubMed1999

Normativity, guardianship, and the elderly. Some lessons from Canadian legislation.

The concept of guardianship, its associated principles, distinctions, and articulation of the legal needs of the elderly are introduced via a review of well-canvassed criticisms of Canadian guardianship legislation. Claims that the reformed legislation of Alberta, Quebec, and British Columbia represent models of adequate adult guardianship compared with traditional (archaic lunacy) law are examined. This paper argues that these renovated models exhibit a dubious normative advance over traditional legislation. Specifically, the normative presuppositions of the reformed legislation, such as, restriction to an autonomy-paternalism framework, and the norms of the liberal individual and state, obscure important issues in at least two key areas which challenge the models' assumptions; namely, assessment and legal competence and assessment and need. The development of guardianship laws and of social arrangements that are more responsive to the life experiences of the elderly requires critical re-articulation of the nature of individuals and their communities.

Adult↗
PubMed2001

Transplant legislation: ethical and practical issues in liver allocation--The case of Switzerland.

Ethical and practical issues relating to liver allocation have been discussed in many countries. Several governments, including the United States, have attempted over the past few years to impose new legislation, which has resulted in virulent debates among individual centers, organ procurement agencies, states, and various groups of interest. This report discusses the current ongoing legislative process in Switzerland. In 1999, the people of Switzerland voted to develop transplant legislation. This reflected the need to regulate poorly defined practices to adapt to the rapid progress within the field of transplantation. The main issue facing the Swiss transplant community is whether new legislation will allow medical evolution in organ allocation criteria without creating regulations that may become outdated with time. In addition, public debate has been shown to have a negative impact on organ donation, thus emphasizing an ever-present penury in cadaveric allografts. This article discusses these issues within the context of liver transplantation in Switzerland and also raises the uniform ethical and practical constraints placed on the medical transplant community in the face of an organ shortage.

Ethics, Medical↗
PubMed2000

[Penetrating and perforating eye injuries in 343 patients due to auto accidents before and after compulsory seat belt legislation resulting in fines (1966-1998)].

BACKGROUND: Constructional improvements of passengers safety in cars alone did not result in a significant decline of open globe injuries in traffic accidents. Only after compulsory seat belt legislation was introduced in Germany and Great Britain, a 60%-75% reduction in ocular injuries was observed. We examined, how the characteristics of severe eye injuries in car accidents changed during the last 28 years. PATIENTS AND METHODS: The case records of 343 patients, who suffered from open globe injuries during car accidents between 1966 and 1993 and were primarily admitted in the University Eye Hospitals of Freiburg and Würzburg, have been analyzed retrospectively. Injuries were evaluated for their extent, time of injury (hour and season), age, sex and outcome of visual acuity after surgery. RESULTS: Between 1966 and 1984 wind-screen injuries declined slowly from 25/year to 16/year. Since the introduction of compulsory seat belt legislation in Germany in 1984 we observed a sudden reduction to 4 injuries/year, followed by an additional slow decline to 2.5 injuries/year. Male/female ratio changed from 2.1/1 before to 9/1 after 1984. Due to the seat belt legislation, injuries declined during summer season (april through september) by factor 7.6, during winter season (october through march) by factor 3.8. Injuries during daylight (6 a.m. to 6 p.m.) decreased more rapidly (by factor 14) than during nighttime (6 p.m. to 6 a.m.: factor 4). The decline of eye injuries was most pronounced among those with an age of less than 23 years (by factor 10.8) and those who were 31-50 years old (by factor 6.8), but least among those between 23 and 30 years of age (2.2). Since 1984, open globe injuries combined with mid-facial and cranial fractures increased resulting in a poorer visual outcome: 29% of eyes became blind before 1984 and 40% since then due to the higher survival probability of very severe accidents. A majority of injured persons still had not fastened their seat belt and about 50% were drunk. CONCLUSION: Compulsory seat belt legislation introduced in Germany in 1984 was most effective in preventing eye injuries among female passengers, during daytime or among persons younger than 23 years. However, 23-30 year old male drivers who had not fastened their seat belt, drove in darkness or during winter and had drunk alcohol, were still at highest risk for an open globe injury. The increase of victims with a combination of open globe injuries and midfacial injuries, polytrauma or cerebral trauma may be related to the airbag and other improved safety measures.

Accidents, Traffic↗
PubMed2002

The impact of legislation and secular trends on newborn length of stay for Medicaid infants in Ohio.

OBJECTIVES: To examine the impact of state legislation mandating minimum maternal and newborn length of stay (LOS). STUDY DESIGN: By using Medicaid claims data linked to vital statistics files, LOS, and "short stay" (</=1 day after vaginal delivery, </=2 days after cesarean delivery) were determined for 151,464 term newborns born to mothers receiving Medicaid in Ohio from July 1, 1991 to June 30, 1998. Changes in LOS and "short stay" were examined for 4 periods that reflected events occurring in Ohio at the time. RESULTS: The proportion of newborns discharged after a "short stay" increased dramatically before legislation (7/1/91-8/31/95) but decreased after the introduction of legislation (9/1/95-6/30/96). In the 4 months after passage of the law, but before its effective date (Period III), the odds of a "short stay" decreased. This decrease continued in the 20 months after the law went into effect (Period IV). White, young, married mothers without a high school degree or with poor prenatal care and lower birth weight infants were more likely to be discharged early. CONCLUSIONS: LOS and "short stay" returned to near-1991 levels for Medicaid newborns in Ohio after legislative activity.

Delivery, Obstetric↗
PubMed2002

International legislation on trace elements as contaminants in food: a review.

Environmental contaminants such as trace elements may be present in all foods. Foods, raw materials and ingredients for food production are to an increasing extent traded across borders. Hence, there is a need for international legislation on trace elements as contaminants in food. In 1961, the FAO and WHO established the Codex Alimentarius to elaborate international food legislation. Contaminants in food are handled by the Codex Committee for Food Additives and Contaminants (CCFAC). The Codex Alimentarius system for developing legislation concerning trace elements as contaminants in food is based upon the Codex General Standard for Contaminants and Toxins in Food (GSCTF). By October 2001, the principles for setting maximum limits (MLs) for contaminants in food are agreed, and work is in progress on MLs for trace elements such as lead and cadmium in the various food categories. The status for the proposals is presented and discussed. The EU Regulation 466/2001 of 8 March 2001 sets MLs for lead and cadmium in various foods. This regulation will apply from 5 April 2002. The EU regulation is more detailed but similar to the Codex draft standards for lead and cadmium in food. In future, legislators and administrators in the Codex and EU and analytical chemists will discuss how to use more and better analytical data as risk-management tools to protect public health. Trace elements' speciation is an important aspect of this discussion.

European Union↗
PubMedDate not supplied

Characteristics of state legislation governing medical care at mass gatherings.

UNLABELLED: Organized mass gathering medical care (MGMC) has existed in the United States for 30 years, but there is little evidence to support any standard of care or uniformity in its delivery. OBJECTIVE: To determine whether MGMC regulations exist within state EMS legislation and to describe the characteristics of any such regulations. METHODS: The authors conducted a cross-sectional survey of U.S. state EMS directors in fall 1998 to determine the prevalence of formal legislation governing MGMC. The lead author received copies of legislation from every state EMS office that indicated such legislation existed. RESULTS: Responses were obtained from all 50 state EMS offices and that of the District of Columbia (n = 51). Only six (12%) states provide regulatory guidance for MGMC. These regulations reside within departments of health in all six states and within the divisions of EMS in three of these six. Only one state requires physician oversight of a medical action plan and minimum staffing by EMS personnel, respectively. No state addresses early defibrillation capability or EMS scope of practice. There is no agreement on the definition of either a mass gathering or minimum resource deployment. Public health and hygiene practices at mass gatherings also lack uniformity. CONCLUSION: Few states regulate MGMC. Existing regulations are poorly developed and lack both standardized terminology and content.

Cross-Sectional Studies↗