Pharmaceuticals Policy and Law - Volume 9, issue 1-2
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The new international review,
Pharmaceuticals Policy and Law, appears with the aim of studying and evaluating the
legal status of medicinal products in the European Union, and its implications in other markets such as the USA and Japan, without neglecting the specific problems of developing countries.
Pharmaceuticals Policy and Law intends to participate in the process of world convergence of pharmaceutical legislation helped by a network of academic centers specializing in pharmaceutical law, without omitting a scientific, economic and social approach to medicinal products.
The specificity of medicinal products conditions their legal status. Legislation regulating other goods cannot be applied to them. To begin with, they are the result of scientific and technical innovation. Research policies determine their progress. The pharmaceutical industry is, by nature, multinational. But, next to these global trends, different traditions still remain at a national level. Within the EU, barriers to free trade in medicinal products still remain despite more than thirty years of harmonisation. The social dimension of medicinal products is complex and very significant in the preoccupations of our societies. Patenting is essential but not sufficient. The life-cycle of medicinal products is protected by professional responsibility, required in the general concept of health safety. It is important to remember their ethical dimension, including research and innovation in new fields such as genetic manipulation and biotechnology, which requires social consent to preserve human dignity and fundamental rights.
Abstract: The extremely low fertility levels observed in some countries are the culmination of the process of social change that started with the demographic transition a few hundred years ago. This article argues that, as in the transition itself, the behavior of fertility today is closely related to changes in mortality. We briefly discuss the history of human population, and analyze the recent behavior of mortality and fertility across countries, in order to show that these two…variables have remained intimately linked throughout the recent demographic history. We then argue that both economic and evolutionary theories suggest that this should indeed be the case: individuals should respond to reductions in mortality rates by reducing the optimal size of families. Only by understanding the determinants of the current behavior of fertility researchers and policy makers will be able to forecast its future trend and design adequate policies to deal with the problems at hand.
Abstract: Concern for very low fertility and its consequences is spreading in the Southern European Union countries. Population ageing is already a fact and these countries are rapidly ageing and expected to become the oldest populations in the EU-15 by 2050, with an increasing proportion of the very old (over 80), more subject to loss or reduction of their personal autonomy. Actions to face population changes should be embedded in social policies in a threefold strategy: implementing…adaptive measures to population ageing, acting on the work family relationship to favour fertility and dealing with specific situations of very low fertility. All changes described by the second transition theory are at work in the Southern EU countries but the presence of some specific obstacles, among which the extreme situation of youths and working mothers, prevent the developments that have already occurred in other countries. In addition, public resources for supporting the family are much lower than in other parts of the EU-15.
Abstract: More than 70 000 children are born annually in Europe as a result of assisted reproduction (ART). Concerning individual European countries, there is a large variation in the uptake if ART. In Denmark and Finland the number of ART treatment cycles is well above 1500 cycles per million inhabitants, while countries like Portugal, Spain, Ireland and the UK have only one third to one fourth as many ART cycles annually. Denmark is the country with the highest…uptake of ART in Europe and currently about 6% of all children born in has been conceived by ART. If the rest of the European countries managed to increase their uptake of ART to the same level as Denmark, nearly 400 000 children would be born annually as a result of ART. The total fertility rate in all European countries has fallen below replacement levels and the old age dependency ratio will in many countries increase to a level which is not economically sustainable. It is obvious that Europeans need to address the demographic issue. Health economic studies indicate that increased spending on ART might be a very cost effective measure to increase the total fertility rate of a population.