Pharmaceuticals Policy and Law - Volume 10, issue 1-4
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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: The care of adults and children with primary immunodeficiencies is very much a multi-disciplinary and multi-professional responsibility. Amongst many of the health, and other, professionals whose input can make all the difference to the quality of life of these patients, the nurse stands out as the one person who probably has the most contact with the patients and their families. This chapter looks at the multi-dimensional role of the nurse who is working with these patients…and their families. These roles encompass the recognition of PIDs, the physical, psychosocial and emotional care of the patients and families, the prevention of complications, educational, and research. Of particular importance is the nurse's role in fostering, and working within, partnerships – partnerships with other health professionals, with families, and above all, with patients.
Keywords: Holistic care, partnership, support and care, education
Abstract: This chapter on the EU regulatory perspective of the intravenous immunoglobulins (IVIGs) encompasses the following topics: – Regulatory framework for IVIGs; – Current EMEA initiatives: revision of the core SPC/IVIG Guideline; – Paediatric Regulation: impacts/outcomes; – Patient involvement and consultation in the EMEA activities.