Pharmaceuticals Policy and Law - Volume 19, 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: Electronic Health involves the integration of all information and knowledge sources involved in the delivery of healthcare. E-Health systems include: a) Electronic Health Records (EHRs). b) Health Identifier number. c) e-Prescribing. d) Telemedicine Systems. e) Automated Pricing. There are major disparities between countries on the deployment of EHRs part of an interoperable infrastructure. The idea of Electronic Health Records and e-Prescriptions is embedded in the concept of an “Electronic Health Card”. The European Health Insurance Card gives access to medically necessary, state-provided healthcare during a temporary stay in any of the EU countries. EU Member States have different national laws…on electronic health records (EHRs). Others challenges are: Different legal approaches on the content of EHRs, patient consent, list of health data, the terminology and Liability. Despite the many benefits that result from the use of smart cards, haven several limitations. One of the main limitations is the cost of replacing the existing infrastructure. Additionally, the current standardization regarding medical records and health data is not sufficient and this problem must be resolved.
Keywords: Electronic Health Records (EHRs), infrastructure, healthcare system