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: To this day, more than three million children worldwide have been born after the treatment with extracorporal assisted reproductive techniques (ART). This makes ART a "tool" in combatting negative population growth in countries with declining birth rates. Germany today shows the lowest reproductive rate since World War II yet legislation closes its eye to the role of reproductive medicine and instead issues counterproductive laws: while vast economic resources are activated to trigger changes in reproductive behavior,…couples wanting to bear children by means of assisted reproduction techniques are discouraged by a 50% co-payment towards their treatment. By pointing out the relationship of demographic development, economic value of children and current legislation the article shows the contradiction between legislation and social need.
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Keywords: Assisted reproduction techniques, demographic development, IVF, ICSI, German legislation, reproductive medicine, health care, economic value of children
Abstract: Low fertility can be divided into two types; moderately low fertility where the fertility rate is above 1.5 births per woman but below the replacement level of 2.1 and very low fertility where the fertility rate is below 1.5. The paper describes the negative effects of very low fertility in relation to demographic, economic and social sustainability. While countries can never be absolutely certain about the efficacy of pronatalist policy, the paper argues that the risks…of doing nothing for very low fertility countries substantially outweigh the risks that policies will not be effective. A comprehensive approach to very low fertility would simultaneously address the financial impact of having children, child care and early childhood education and workplace arrangements. Depending upon the country, it may also involve a higher level of security of tenure of jobs for young people and changes in values regarding the timing of the first birth. The actual policy mix will vary from country to country depending upon each county's particular circumstances. For countries with very low fertility rates, it is time for comprehensive action. For those with moderately low fertility, it is time to consolidate levels of support for families with children.
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