Pharmaceuticals Policy and Law - Volume 9, issue 3-4
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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: Australia has followed a single supplier policy for the provision of blood and blood products, with an oft-declared policy of self-sufficiency. Up to 2005, the mainstay of this policy in the public domain was a provision in the Australian Therapeutic Goods Administration's (TGA – the Australian regulator of therapeutic goods) Guidelines for the Registration of Drugs. This provision stated that overseas-sourced plasma products were required to demonstrate a clinical superiority over domestically sourced and manufactured…products before they would be considered for approval on the Australian market. These domestic products have been historically supplied to the Australian community, through financial arrangements overseen by Australian governments, by CSL Ltd, a formerly government owned manufacturer of biological therapeutics which is now the world's largest private plasma products manufacturer. In 2004, a Free Trade Agreement between the United States and Australian governments included provisions, requested by the US government, which removed this requirement from the TGA's requirements. In addition, the Australian government committed to recommending an end to the current monopolistic arrangement to the other Australian jurisdictions, and to reviewing the whole area of plasma fractionation services. This review was conducted over 2006 and finalised its recommendations, which essentially advised the Australian government to maintain the current arrangements and recommended against the introduction of competition in domestic plasma fractionation services, in December 2006. Over the course of the review's work, intense public interest was evident in the issue, as shown by numerous media and other emanations. This work will review the background to Australia's blood system and, in particular, the convergent features which elicited the US FTA request and the reaction to it by the key stakeholders in the Australian blood economy. Some analysis will be offered to support an assessment of how these events can affect the status of recipients and donors in Australia's plasma product supply chain. Finally, opinion will be submitted on how these events can impact on international developments in blood safety and supply.
Abstract: The article comments on a recent ruling of the Czech Constitutional Court in the context of the public health insurance system and the way the rules of payments from this system towards various medicines are being set by the relevant ministry. The article explains the way the system has worked and it comments on the question of conformity of the national legislation with that of the EC. It also introduces the political and diplomatic circumstances that…had occurred before this ruling. By doing so, the article provides its readers not only with a legal analysis of the system (which is the main purpose of this text), but also an insight into the most obvious circumstance that must have had impact on the exact content of the courts decision.
Keywords: Czech pharmaceutical law, public health insurance, pricing of pharmaceuticals, EC – national law relationship, constitutional court, conformity with EC legislation, transparency directive, constitutional right, fair process
Abstract: The new provisions of the Deontological Code of the Pharmacist refer, first of all, to proclaiming its adherence to the Universal Charter of Human Rights and the Charter of European Pharmacy, but also to defending the patients' rights, as a primary goal of the Code. The expression of these principles brings about the obligation for the professional association to reorient its activities, mainly towards ensuring the surveillance of the observance of professional ethics, an activity that…had been marginalised in recent times, when a priority had been to defend the financial interests of pharmacists. The new Code also provides that one of the ethical standards of the pharmacist should be to supply services to the patient, something that will oblige each and every pharmacist to redefine his or her daily professional exercise. In accordance with the new code, it is possible to refuse to supply services only on grounds of serving the interest of the patient's good health, which presupposes an involvement, a decision and a responsibility of the pharmacist in the relationship with the patient. As far as emergency pharmaceutical services are concerned, the innovation of the Code consists in allowing to issue, in the absence of any medical prescription, under well defined circumstances, of certain ethical drugs. This provision has an impact both upon the exhoneration of disciplinary responsability for the infringement of some legal provisions, as well as the fact of making the pharmacist take responsibility for making a decision in the given circumstances.