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.
Abstract: There is growing concern about a decline in the total fertility rate worldwide, but nowhere is the concern greater than in OECD countries, some of which already face the prospect of population decline as well. While the trend is largely the result of structural economic and social changes, our paper indicates that it is partly influenced by the scale of the defined-benefits, pay-as-you-go (PAYG) social security systems operating in most countries. Through a dynamic, overlapping-generations model…where the generations are linked by parental altruism, we show analytically that social security tax and benefit rates generate incentives for individuals to reduce not just the fertility rate within families, but also the incentive to form families, which we capture empirically by the fraction of adults married. We conduct calibrated simulations as well as regression analyses that measure the quantitative importance of social security tax rates in lowering both net marriage and total fertility rates. Our results show that the impact of social security on these variables has been non-trivial. We also offer policy implications concerning the desirable way to reform the current social security system in order to mitigate its unintended effects on family formation and fertility and improve its financial solvency.
Abstract: While some are proponents of restrictive legislation, others have argued that there is too much legislation for ART and cite existing legal choices for women in relation to human reproduction which respect individual autonomy. It has been argued that where genuine, informed decision-making occurs and there is a process for legitimate ethical review, that restrictive laws make little sense. In some cases restrictive legislation denies access to appropriate treatment for couples that have no other means…of forming their families. History reveals that governments can make ill informed, expedient decisions, which are not necessarily in the best interests of their citizens. Italy provides a sobering example. Legislation is difficult to repeal and in a high-tech, rapidly evolving area such as ART, even the most well intended legislation could quickly prove obsolete. In Australia, crucial to achieving good outcomes in the regulation of ART has been the involvement of patients in legislation, accreditation and policy, working in partnership with health care providers, the media and members of parliament. This has ensured transparency and quality in service delivery. It is also appropriate, as it recognises that ultimately it is patients who must live with the consequences of policy and treatment decisions.
Abstract: Technological advances during the past decade have dramatically increased the success rates of ART. Unlike the leaps that technology has taken, the law and public policy have been slower to advance. The legal regulation of the techniques that help to overcome infertility problems are based on the fundamental rights of the persons. The freedom to procreate, as a premise to the right to form a family, is the realisation of the free development of personality and, inserts…itself in the scope of freedoms and not in that of rights, in a strict sense. We need to consider the meaning of human procreation in all its aspects and entailments. The law must address transcendent ethical worries. However, there must not be confusion between the ethical and legal dimensions. The article identifies and defines, the main problems which face the legislator and which the legal system must respond to. The areas which need regulation are the foundational value of human, the protection of human dignity, the health of the human subjects, human freedom, the intrinsic value of new knowledge, the promotion of justice and equality, privacy, without forgetting, the relief of the suffering of those afflicted with infertility. The regulation of informed consent is another essential element of the exercise of the assisted reproduction techniques. Legal systems must provide an adequate response to all of the above issues. Although there are some discrepancies between the legislation of different countries, there are also some significant similarities. The response in each country was conditioned by its cultural, religious and social traditions.
Abstract: The major complication of assisted reproductive technologies is the increased incidence of multiple pregnancies. Multiple pregnancies are associated with higher morbidity and mortality rates related to a higher incidence of prematurity and (very) low-birth-weight babies. The epidemic of iatrogenic multiple births has increased the incidence of maternal, perinatal and childhood morbidity and mortality. Healthcare cost of infertility treatment did increase significantly and this may lead to social and political concern. For in…vitro fertilization, reducing the number of embryos transferred and the use of natural cycle IVF will decrease the number of multiple gestations. For non-IVF ovarian stimulation, a strict ovarian stimulation protocol aiming at mono-ovulation should be followed. The Belgian project to prevent multiple pregnancies was started in July 2003. A reimbursement of ART-related laboratory activities was linked to a transfer policy aiming at substantial multiple pregnancy reduction. It's a nice example of efficient forward looking health economics through responsabilisation. The first results indicate an increase of the number of IVF cycles by more than 30% and a more than 50% reduction of twin pregnancies. The next step will be the prevention of multiple pregnancies associated with non-IVF ovarian stimulation.
Keywords: Access to treatment, infertility treatment, IVF, multiple pregnancies, policy
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.
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.