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Background: The relevance and quantity of clinical research has caused concern and regulation is claimed to hinder clinical research. This paper compares clinical research regulations in Finland to those of England, Canada, and the USA around 2010-2011. Methods: Several approaches and data sources were used, including semi-or unstructured interviews of experts. For the analysis, a theoretical framework was made, data from various sources was synthesized, and features of the systems were simplified and classified. The various specific names and terms used in the data were changed into general ones. Results: Common structures for the regulation existed in all four countries, but the details and scope varied. The research regulated within the main system was determined by research type (Finland), the financer of the health system (England), or research site (Canada, USA). Only Finland had specific legislation on medical research. The overriding impression of the regulatory systems was one of complexity. All countries had extra regulation for drug research. The types of drug research covered varied from trials with unlicensed (new) products or new indications (USA and Canada), to all types of interventional drug research (England), where 'interventional' was interpreted broadly (Finland). The complexity of regulations had led to the creation of various big and small businesses to help researchers and sponsors. There was notable variation in the role played by the public research funder. The role played by health care was difficult to study and seemed to involve varying interests as researchers were also health care employees. Research ethics committees were important and their tasks also included aspects other than ethics. Conclusions: This study revealed that a comparison between countries can provide useful insights into the distinctive aspects of each country's system, as well as identifying common features that require international action. ; Peer reviewed

Physicians' drug prescribing habits are not adequate. This paper gives examples from Finland suggesting that information given by drug industry is likely to create and reinforce poor prescribing. Results from four different studies looking at the content of the Finnish commercial drug catalogues suggest that physicians relying on them may be led astray. Studies on drug representatives' presentations in 1975 and 1986 showed that negative aspects of drugs were often omitted. The confusion created by the double name system (trade names and generic names) is illustrated by a survey, showing that physicians did not often know the generic equivalents of the trade names and vice versa. At the end, predictions of possible changes in commercial drug information are presented.

<i>Objectives:</i> To report on Finnish physicians' opinions on the possible future use of genetic screening and their interest in knowing their own risk for diseases. <i>Methods:</i> A questionnaire survey mailed to gynaecologists, paediatricians, general practitioners and clinical geneticists. Both leading physicians and a sample of other practitioners were included (response rate 74%, n = 571). <i>Results: </i>Physicians preferred genetic testing of people at risk over population-wide screening. Breast and colon cancer, familial hypercholesterolaemia and juvenile diabetes were diseases for which screening was most often considered useful. The most popular target group was the whole population. Opinions on the suitability of genetic screening were not uniform, and physicians did not take a stand on genetic screening as a whole but differentiated by disease and target group. Those wanting to know their own risk for diseases supported screening procedures in general more than did other physicians. <i>Conclusions:</i> Physicians were not enthusiastic about genetic screening. Nevertheless, testing of individuals with a family history of certain diseases is likely to become more widespread.

SummaryMenopause (cessation of menstruction) and the period surrounding it (climacterium) are often defined retrospectively by asking a woman the date of her last menstrual period (LMP). Based on a survey of 2000 women aged 45–64 in 1989 in Finland, this study examines (1) the relation between these definitions and women's own definitions of their climacteric status and of the cessation of menstruction and (2) the effect of menopausal and postmeno pausal hormone therapy and hysterectomy on the definition of menopause and climacterium. Agreement of the woman's own definition of her climacteric status and interval since LMP was 25% among current hormone users, 41% among hysterectomised women and 64% among those who were neither currently using hormones nor had been hysterectomised. Current hormone users defined the climacteric phase as longer than their LMP suggested. Current hormone use and hysterectomy had little effect on reported final cessation of menstrual periods. It is concluded that hysterectomy and hormone therapy shape women's thinking about the end of reproductive life, blur the concepts of menopause and postmenopause and confuse the measurement of age at menopause.

The introduction of new drugs is often characterized as an important cause of increased use of psychotropic drugs. Major new drugs were introduced in the 1950s. The purpose of this paper is to examine whether the introduction of these new drugs affected consumption levels in several European countries in the 1950s. New data were collected and analysed from two pharmacies in Finland and previously published data from Denmark, England, Wales, and Sweden were reanalysed. The trends as well as the level of the psychotropic drug consumption varied greatly between these countries. In Finland and Sweden consumption increased greatly. No trend information was available in Denmark; the consumption level, however, was apparently much higher than in Finland or Sweden. In England and WAles consumption was steady. The data from Finland showed that increased consumption was due to the use of traditional sedatives rather than to the new drugs. Our results suggest that the increase in the consumption of psychotropic drugs in the 1950s was not due to the introduction of new drugs as such.

Review by research ethics committees (RECs) is the key in medical research regulation. Data from meeting notes and project summaries were abstracted from all projects submitted in 2002 ( n = 1,004) and 2007 ( n = 1,045) to the official medical RECs in Finland. Data from consecutive submissions were combined per project. When comparing RECs, logistic regression was used to adjust for application characteristics. The number of projects handled varied notably by REC. In the first handling, 85% of applications in 2002 and 77% in 2007 were approved, while 13% and 20% were tabled. For 61% of the projects, the review time was <30 days, 16% had >89 days, and 6% had 6 months or longer. The variation by REC in approval rates, number of handlings, or long review times was not explained by project characteristics. In the last handling, 94% of the projects in both years were approved or concluded not to need a statement from that REC. The most common reason for tabling or not approving an application was patient autonomy, usually centered on the patient leaflet. The next most common reasons were requests for further information and dissatisfaction with the scientific aspects of the project. The reasons classified as "ethics" in the narrow sense were rare. The REC focus was to assure that researchers follow the various rules on medical research and to improve the quality of research and project documents. REC considerations could be divided into decisions based on ethics and recommendations covering other aspects.

Abstract Background Studies on prenatal care in China have focused on the timing and frequency of prenatal care and relatively little information can be found on how maternal care has been organized and funded or on the actual content of the visits, especially in the less developed rural areas. This study explored maternal care in a rural county from Anhui province in terms of care organization, provision and utilization. Methods A total of 699 mothers of infants under one year of age were interviewed with structured questionnaires; the county health bureau officials and managers of township hospitals (n = 10) and county level hospitals (n = 2) were interviewed; the process of the maternal care services was observed by the researchers. In addition, statistics from the local government were used. Results The county level hospitals were well staffed and equipped and served as a referral centre for women with a high-risk pregnancy. Township hospitals had, on average, 1.7 midwives serving an average population of 15,000 people. Only 10–20% of the current costs in county level hospitals and township hospitals were funded by the local government, and women paid for delivery care. There was no systematic organized prenatal care and referrals were not mandatory. About half of the women had their first prenatal visit before the 13th gestational week, 36% had fewer than 5 prenatal visits, and about 9% had no prenatal visits. A major reason for not having prenatal care visits was that women considered it unnecessary. Most women (87%) gave birth in public health facilities, and the rest in a private clinic or at home. A total of 8% of births were delivered by caesarean section. Very few women had any postnatal visits. About half of the women received the recommended number of prenatal blood pressure and haemoglobin measurements. Conclusion Delivery care was better provided than both prenatal and postnatal care in the study area. Reliance on user fees gave the hospitals an incentive to put more emphasis on revenue generating activities such as delivery care instead of prenatal and postnatal care.

Objective: To study the current legislation and trends in terminations of pregnancy in the European Union (EU). Design: Data were collected on legislation and statistics for terminations of pregnancy. Setting: Population-based statistics from the EU member states. Population: Women in reproductive age in the 27 EU member states. Methods: Information on legislation was collected for all 27 EU member states. Statistical information until 2008 was compiled from international (n = 24) and national sources (n = 17). Statistical data were not available for Austria, Cyprus and Luxembourg. Main outcomes measures: Terminations of pregnancy per 1000 women aged 15-49 years. Results: Ireland, Malta and Poland have restrictive legislation. Luxembourg permits termination of pregnancy on physical and mental health indications; Cyprus, Finland, and the UK further include socio-economic indications. In all other EU member states termination of pregnancy can be performed in early pregnancy on a women's request. In general, the rates of termination of pregnancy have declined in recent years. In total, 10.3 terminations were reported per 1000 women aged 15-49 years in the EU in 2008. The rate was 12.3/1000 for countries requiring a legal indication for termination, and 11.0/1000 for countries allowing termination on request. Northern Europe (10.9/1000) and Central and Eastern Europe (10.8/1000) had higher rates than Southern Europe (8.9/1000). Northern Europe, however, had substantially higher rates of termination of pregnancy among teenagers. Conclusion: A more consistent and coherent reporting of terminations of pregnancy is needed in the EU. The large variation of termination rates between countries suggests that termination of pregnancy rates may be reduced in some countries without restricting women's access to termination. Sexual education and provision of access to reliable and affordable contraception are essential to achieve low rates of termination of pregnancy. ; The REPROSTAT 3 (The State of Reproductive Health and Fertility in the European Union) project has been funded by the Health Programme of DG Health and Consumers at the European Commission and High Commissariat of Health, Ministry of Health, Portugal. ; peer-reviewed