中国医药产业CRO的发展前景

通过介绍现代医药科技的迅猛发展医药新产品开发带来的挑战以及国外医药界通过ＣＲＯ的形 效利用资源,形成合力,迎接挑战的先进经验,进而对中国医药产业目前进行新药研究与开发的现状和资源分布情况进行了客观分析,对医药ＣＲＯ在中国的发展前景进行了探讨和预测。     

Medicine and pharmacy — facts and myths about the development of an innovative pharmaceutical industry in Poland

Innovation is fundamental to the pharmaceutical industry and a key to improvements in healthcare. Its effectiveness depends on huge, constant investments in research. This innovative industry directly affects the course of studies in healthcare and medicine. Its efforts translate directly into the length and quality of our lives. For several years now, the progress underway in pharmaceutical industry has produced measurable benefits. Doctors have new pharmaceuticals at their disposal, including many types of antibiotics and anti-viral drugs, vaccines and a wide range of drugs which save lives or make them more comfortable. In the near future, ever more efficient cures for neoplastic, rheumatic, neurological, psychic, metabolic, circulatory or respiratory diseases can be expected. Innovation is necessary. The human population is ageing, and the task of an innovative pharmaceutical industry is to keep it in a good condition. The use of innovative drugs can translate directly into lowering the costs of illness. A continuous reduction in spending on healthcare has been observed. The costs of inventing an innovative drug are enormous though (US$ 800 million), and studies on a new drug last between 10 and 13 years. An essential element in recovering the incurred costs and ensuring funds needed for new research is protection by patent. Innovative pharmaceutical companies in Poland are committed to increasing the competitiveness and sustaining the development of not only the market, but also the entire pharmaceutical sector. It is a group of companies of crucial importance to the Polish healthcare system, as it influences improvement in the quality of medical services. Through their investments and spending on research and development, innovative companies accelerate economic growth. In Poland, the innovative pharmaceutical industry is represented by the Association of Pharmaceutical Companies Representatives in Poland (SPFFwP). An earlier version of this paper was presented at an international conference, “The Ethics of Intellectual Property Rights and Patents,” held in Warsaw, Poland on 23–24 April, 2004.     

L’accès aux médicaments : quelles contributions des règles sur les brevets de l’Accord de partenariat transpacifique global et progressiste ?

Enhanced protection for patents in free trade agreements would undermine access to medicines and show difficulties for developing countries with respect to public health issue. In the context of the Comprehensive and Progressive Trans-Pacific Partnership Agreement, however, after the withdrawal of the United States, the legal regime applicable to patents seems less rigid and, therefore, more favorable to access to medicines. This results, on the one hand, from certain flexibilities contained in this agreement itself; and on the other hand, the suspension of some material and procedural obligations. This article aims to analyze these two sides to justify the contribution of this agreement to ensure access to medicines.     

La « préparation magistrale » en droit français : un lot exclusif par patient ?

Outpatient pharmaceutical needs are not always met by industrial products and do not necessarily justify hospitals activation. Preparing in advance and storing a batch of compounded drugs for one or more patients with identical/recurrent needs – as part of compound outsourcing in ambulatory sector – raises issues. While the french law does not expressly provide (and according to prevailing interpretations excludes) this hypothesis, it seems to us to be possible – in contrast to the prominent french judicial and administrative courts, as well as to the European Court of justice. We here propose to reset the debate within both the existing laws and a systemic perspective, and call for a normative clarification.