Pharmaceuticals Policy and Law - Volume 7, issue 0
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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 analysis of Blood Transfusion operating modes in the European Union is meant to bring up an inventory enabling each country to shape up its development. This statement shows up huge differences between countries as much for donations as for blood usage. Differences are both qualitative and quantitative: 92% of blood donations are indeed carried out as mobile units in the UK vs 0% in Norway or Belgium. Considering the number of inhabitants, blood donation figures (whole…blood) in Finland are nearly twice (1,6) higher than in France. Also, numbers of donors and new donors are quite different: 29.6% in Spain and 9.8% in Austria. The discard rate for RBC's varies from 2.4% (in Sweden) to 9.5% (in Luxemburg). Age distribution for donations ranges from 17 to 69. Man/woman ratio is of 60/40 in Austria and Germany, 45/55 in the UK. Blood donation is non remunerated in most EU countries, except in Austria, Germany, Sweden… There is a great disparity re the use of Labile Blood Products in such countries as Germany (33% more than Italy) and Finland (50% more than France). The European Directive 2002/98/EC implementation will progressively improve the logical operating mode of Blood Transfusion in Europe. Other directives such as 2004/33/EC, 2005/61/EC and 2005/62/EC are expected to impact the technical aspects of donations, traceability, quality assurance and h�movigilance.
Abstract: Albumin, IVIG and clotting factors are among the most familiar products that are developed from human plasma. But there are many others that are of importance and that often go unnoticed. This article takes a detailed look at the lesser-known products and proteins so vital to thousands of people worldwide.
Abstract: The term 'immunoglobulin' describes the structure and function of a class of proteins present in the body, and particularly in the blood: they are globular proteins which have a role in providing immunity, and are also known as 'antibodies'. Immunoglobulins can be classified both according to their content and to their mode of administration. Standard pooled immunoglobulin is derived from the plasma of unselected normal donors. It may be given intravenously (IV), in which case it…is known as IVIG (Ig being an abbreviation for immunoglobulin), or by the subcutaneous (SC) or intramuscular (IM) route: SCIg or IMIg. Hyperimmune immunoglobulins contain a high level of antibodies against specific pathogens. Donors have to be selected for, or inoculated to produce, high levels of reactivity. Their plasma is used to manufacture specific immunoglobulins to prevent or treat diseases such as hepatitis B, tetanus or haemolytic disease of the newborn in which rhesus incompatibility between the mother and her foetus can lead to the death of the baby. This article focuses on standard pooled preparations. The body responds to infections with a succession of steps. Firstly the large, broad acting IgM antibody is produced. Meanwhile white blood cells start producing the smaller, more specific IgG molecule in high quantities. It is this type of antibody which is the most prevalent in the blood, accounting for 70–75% of the total immunoglobulin pool. The other classes of antibodies are IgA, IgE and IgD. Antibodies are Y-shaped proteins that bind to antigens with both upper arms of the Y. Under normal conditions an antibody binds to an antigen (a bacterium, virus, or other pathogen) and "tags" it for destruction.
Abstract: Haemophilia is an inherited genetic disorder causing bleeding mainly into the joints and muscles. It is carried through the mother to the son; however, one in three cases is a mutation with no previous history of haemophilia in the family. A misconception is if a person with haemophilia cuts themselves they will bleed to death. Whilst there is now good treatment available with clotting concentrates mainly in developed countries, the majority of people with haemophilia receive…little or no treatment, due largely to cost, in the rest of the world.