The Problems in the Field of Clinical Research
O
ur country is at a crucial crossroad and all the productive forces of Greece face a great challenge: not only to withstand, but also to help the economy grow actively, by investing in innovation, research competence and highly specialized staff. The state, due to the lack of a clear strategic plan, has excluded the country from the production process of new and innovative drugs. There were a lot of problems in clinical research and development. Some of these problems are already known, as they relate to the overall situation in the country and others are more specific, concerning exclusively the field of medicine. Our goal should be placed between these two axes: the development of clinical research and the attraction of major international pharmaceutical companies, which will produce their medicines in production units in Greece. These products will be exported to the international market. There is a great opportunity for us, since in recent years, most big and international pharmaceutical companies are in the process of outsourcing the manufacturing of their products. It was a great pleasure for us the fact that the state legislated and put in place a serious framework for clinical research, while the Common Ministerial Decision recently issued, lays the groundwork for the development of clinical research in Greece for the first time, through simplified and unified procedures. Τhe severe lack of hospital infrastructure to support such a project has been an obstacle for clinical research for many years. For example, it is very difficult for the hospital to know at any time how many patients are taking part in clinical trials and what to “expect” from them. Therefore, it is necessary to create a secure and reliable system for monitoring clinical trials in real time. Otherwise, the lack of organization and systematic monitoring will destroy even the purest intentions for innovation and growth.
We should also highlight the fact that doctors who were taking part in clinical research all these years, had never had equivalent benefits as their colleagues abroad. The primary goal of those doctors should certainly be their participation in research, because of scientific interest and supplementation of a better CV. On the other hand, just as health units enhance their resources by carrying out clinical research, the same way should doctors participating in them enjoy corresponding benefits. In addition, the Division of Pharmaceutical Studies and Research of the National Organization of Medicines needs to increase its human resources in order to be able to cope with the new challenges. In practice, clinical research faces major problems due to the lack of an organized registration system for clinical studies taking place in Greece.
Yiannis Vlontzos President & Managing Director, Merck A.E. Hellas, SFEE Vice President, Regulatory & Scientific Issues of National Organization for Medicines, President of the Hellenic Biotech Association
Our goal should be placed between these two axes: the development of clinical research and the attraction of major international pharmaceutical companies
The creation of a database, which will be online and with easy access not only by the researchers, will be a huge step in the research field. The field of medicine is one of the most dynamic sectors of Greek industry, and as long as the state facilitates research and development, it will also enjoy its own benefit from our business initiatives.
MAY-JUNE 2013 | BUSINESS PARTNERS | 39