Eeva Ollila

International Actors and Population Policies in India, with Special Reference to Contraceptive Policies

The international population policy agenda has traditionally been dominated by demographically driven population control policies. However, in the population policy development that preceded the International Conference on Population and Development in 1994, peoples reproductive needs and rights received more emphasis. The aim of this study was to analyze how the new emphasis in population policies has been interpreted at the country level. In analyzing population policy rhetoric and its practical interpretations in India in 1994, the authors found that the rhetoric was broadening to encompass womens empowerment and reproductive health and that the use of direct method-specific monetary incentives and disincentives for accepting family planning methods was disapproved. However, population policy options were still considered mainly in terms of their ability to reduce fertility. Furthermore, the increased emphasis on the general market agenda was more important than that on reproductive needs and rights in molding population policies, as was evident in the greater stress on cost-recovery systems and nongovernmental actors. The findings suggest that the broader agenda for population policies and reproductive rights has been interpreted so that it can serve the aims of population-growth control and be implemented in the context of more market-oriented social policies and trade liberalization.

Experience of Finnish women with Norplant insertions and removals

Objective Norplant® and Norplant‐2® have been available for use by Finnish women since 1984 and 1986, respectively. The objective of this study was to explore Norplant users’ experiences of insertions, removals and medical treatments.

Secrecy in drug regulation

The objective of this paper is to describe secrecy in drug regulation in Finland, by recording and reporting our experience in obtaining Norplant® licensing documentation. The materials used are the documents, phone calls and other contacts recorded in a research diary that were produced while relevant authorities considered our application to obtain the documents and the publication of our manuscript. The application process was complicated, and it took three years to obtain the licensing documentation and two years to try, unsuccessfully, to get permission to publish the manuscript. In the course of these procedures we made 188 active contacts, and the authorities wrote several memoranda. The drug regulatory authority and the manufacturer wanted to categorise the whole licensing process as a trade secret, and to have the manufacturer define what a trade secret is and when trade secrets could be released, while the Ministry for Social Affairs and Health valued more open regulation. The process is still not complete because the manufacturer has sued the ministry in court about their decision to grant dispensation. It can be concluded that to enable independent research on drugs and drug regulation, the publicity status of documents must be clear, and trade secrecy must be defined narrowly. Decisions on dispensation to give access to classified documents should consider the interests of public health and should be made by authorities other than the drug regulatory authority.

Does licensing of drugs in industrialized countries guarantee drug quality and safety for Third World countries? The case of norplant licensing in Finland.

Norplant® implantable contraceptives were developed mainly for use in Third World countries, but first were approved for marketing in Finland in 1983 and in Sweden in 1985. Since then Norplant has been approved in more than 40 countries, most of them in the Third World. The authors analyzed the clinical documentation submitted to the Finnish and Swedish drug control authorities, and the assessments made of the data. The Finnish review process lasted for three years, and the number of data increased substantially during that time. The authors have not been allowed to publish the clinical data submitted in Finland, but a reconstruction from the Swedish data showed that the clinical data were of poor quality and were mainly focused on assessing efficacy. Side effects, acceptability, and requirements of the health care system for proper use of Norplant were poorly studied. This example of Norplant licensing in Finland shows that licensing of drugs in industrialized countries is insufficient for guaranteeing their safety in Third World countries.

Sales Licensing Documentation and Trade Secrecy: the case of NorplantR Contraceptives

National drug regulation aims at protecting and improving the health of the population by ensuring that the drugs in use are effective, safe, of good quality and rationally used. Vital drugs should be available and accessible at a reasonable cost for the individual and for the society. Rational use of drugs implies that, in addition to the properties of the drugs, there is adequate information to select the most appropriate drug or no drug at all. The functions of drug regulation include regulation both before and after sales approval, but in practice, licensing for sales has been the most important form of public regulation on drugs. Based on the information provided by the product license holder, the drug regulatory authorities evaluate the risks and benefits of the drug during the sales licensing process to determine whether the drug should be allowed to enter the markets of that country.

Impact of Induced Abortions and Statistical Definitions on Perinatal Mortality Figures

Two problems originating from the advanced use of medical technology in screening for malformations and in the care of preterm and low birthweight infants are presented: the impact of the increasing number of induced medical abortions and the differences in statistical definitions on perinatal mortality (PNM) figures. Data on 186,562 births registered in the Finnish Medical Birth Registry between 1987 and 1989 were studied, and 65,554 medical abortions (of which 1647 were performed after the sixteenth week of gestation) registered in the Abortion Registry between 1985 and 1990. A 115% increase in abortions for medical reasons in the period 1985-1990 was found. It was estimated that the trend accounted for up to one-third of the decline in PNM rate during that time. The perinatal mortality rate was strongly influenced by very small infants. The application of the Finnish version of the International Classification of Diseases, Ninth Revision (ICD-9) (including all livebirths and using both birthweight of 500 g and gestational age of 22 weeks as the criteria) resulted in PNM rates which were about 5% higher than according to ICD-9. We suggest that the impact of medical abortions on perinatal statistics has reduced the value of the perinatal mortality rate as an indicator of the standard of care.