CLINICAL TRIALS: JUSTICE IS SERVED
The clinical trials environment is generally considered quite attractive in Austria. While capital invested in clinical trials
only amounts to between EUR 200-400 million (USD 271-542 million), and the number of trials performed annually has declined
in recent years, the reason it is generally attractive is its efficiency. As PHARMIG's Jan Huber states, "Physicians, ethics
commissions and legal bodies here work in a very professional and timely manner." If a company needs to perform clinical trials
in a setting that allows the company to get a product on the market faster without compromising on quality, then Austria is
a shining example in comparison to its fellow European counterparts.
János Filakovszky, Vice President, Quintiles Eastern Holdings GmbH
János Filakovszky, vice president of Quintiles Eastern Holdings, noted that this is also due to "the very favorable regulatory
environment and a well-regulated clinical research industry. Austria usually obtains regulatory approvals before most European
countries." This is beneficial not only to clinical research organizations but also major pharmaceutical companies that invest
in this kind of research, such as Bayer, which conducts a number of Phase II-IV trials in Austria. Bayer Austria managing
director and senior Bayer representative for South East Europe, Martin Hagenlocher, notes that "the country has high quality
research institutes, university clinics, and the hospitals outside of universities have very high standards and qualified
personnel to run clinical studies. There is a good base for clinical research in Austria combined with reasonable support
Martin Hagenlocher, Managing Director, and Senior Bayer Representative South East Europe, Bayer Austria GmbH
There are some minor limitations. Austria's population consists of approximately eight and a half million people, and thus
obtaining a high number of patients for a clinical trial for one disease can be quite difficult in comparison to countries
with larger populations. As Klaus Fischer, CEO of Austrian contract research organization Assign Group, points out, sometimes
only a dozen patients will have a certain disease in Austria's largest hospital. "If you want to demonstrate efficacy, safety
and quality, you need 400-1000 patients and this would take an extremely long time in Austria. In China there are hospitals
with thousands of patients with such conditions. If you want to have those diseases treated, you have to go to those hospitals
where treatment is offered."
Klaus Fischer, CEO, Assign Clinical Research GmbH
While there may be a number of hospitals in Austria that offer treatment, these hospitals may be spread across the country,
thus making Austria a rather decentralized environment for conducting such trials. "In order to obtain patients," Fischer
continues, "you have to talk to many smaller potential study centers and this is an additional cost factor in clinical studies.
This is also recognized by pharmaceutical companies. If you know the right study centers, then you can compete against larger
recruiting countries with larger populations."
The pharmaceutical industry in Austria, while growing slowly, is still ahead of many of its European counterparts simply because
of this growth. The quality of healthcare, innovation, and drugs themselves are extremely high, and there is certainly a positive
feeling and direction within the Austrian pharmaceutical community. While not the biggest market in Europe, the collaboration
between the industry and academia, as well as private and public partnerships, makes Austria a particularly favorable and
exciting place to work. As Papanikolaou notes, "Personal relations tend to be very important in Austria. Even if what you
are offering does not match entirely with customer expectations, they will be satisfied at the end of the day because of the
relationship management involved. Austrians are a little bit more flexible in both thinking and working. There is usually
only one way to cross a river — but Austrians can find several!"