The common technical document as basis of the authorization of marketing of medicinal products in the European Union

Abstract

The drug is currently considered as a product of human consumption of necessities and instrument that helps to ensure public health, combining a triple health, economic and social dimension. Around the drug builds a peculiar market, due to the special nature of the product, which aims to restore health, cure, prevent, treat or diagnose disease, but that if put on the market without meeting the health requirements may be harmful to health. For this reason the public sector intervention is justified and the health administration intervenes the pharmaceutical market at all levels. Firstly, at the level of establishing the conditions for the marketing and product by subjecting it to an authorization and registration prior to putting them into circulation. Secondly, at the level of officials or individuals involved in marketing; manufacturer, distributor and sanitary establishments responsible for their delivery to the public. The drug is a product of industrial manufacturing, fruit of an activity of research and innovation that is protected by a patent, according to the traditional system of protection of inventions through patent which is based on the concept of monopoly and privilege in order to encourage inventive activity for the benefit of progress in positive case. In the industrial sector, the patent is an exception in the General rules of competition-based market economy, since it allows holders of inventions to prevent third making, using, or selling your product during a time in which the State granted exclusive monopoly so that individuals can recover investment and sufficient for new research benefits. This approach takes a more social dimension when it comes to a pharmaceutical invention. Pharmaceutical patent is the legal instrument which contributes most to encourage research and development of new drugs. Without this privilege pharmaceutical laboratories could not deal with the long and expensive process of developing a new drug and therapeutic progress would stop.