Pharmaceuticals Policy and Law - Volume 13, 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: HTA is an interdisciplinary assessment of evidence and knowledge about the intended and unintended effects of using a health technology. Patients with rare diseases have valuable knowledge about the illness in the real-life setting, but too often their views are seen as anecdotal or biased. So, more needs to be done to elicit patients' perspectives to add value to HTA through effective participation of patients throughout the HTA process and collection of evidence about patients' perspectives…through robust qualitative research. Traditionally HTA has been a broad assessment to move evidence into practice, but in recent years a more limited view of clinical and cost effectiveness has been the focus. For HTAs in rare diseases, this is not enough. Consideration of ethical, organizational and social issues are vital and here patients' perspectives could be particularly valuable to bring a real-life understanding of the potential impact of the health technology. As countries around the world put more emphasis on creating clear plans to manage rare diseases, we need to ensure that all stakeholders work together to ensure that HTAs are being used flexibly to ensure that there is equity of access to therapies for rare diseases that provide real added value.