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SFEE’s Press Release

Athens, May 19^th, 2021. – On the occasion of the International Clinical Trials Day (May 20^th), the Hellenic Association of Pharmaceutical Companies (SfEE) stresses, once again, the most important role of Clinical Trials in the protection of Public Health. It is thanks to clinical research that we have vaccines against COVID-19 in less than a year since its outbreak. More than 4,800 clinical studies are conducted worldwide for the discovery of the appropriate COVID-19 treatment, while more than 1,000 candidate drugs are being tested, with 100 of them being candidate vaccines. SfEE, having fully assimilated the added value of clinical research, has always been a strong and dynamic advocate for its development in Greece, given that our country is lagging behind in the number of clinical trials, compared with European countries of similar size. More than €36b. are invested annually in Europe in clinical trials, of which Greece sadly absorbs a mere €100mil. In contrast to Greece, Hungary attracts 5 times more, Denmark 30 times more and Belgium 70 times more investments in pharmaceutical Research & Development.

In the last two years, the State proceeded in offering incentives to this end, such as the possibility to offset investments in clinical trials with the clawback each company is obliged to pay back and the tripling of the tax exemption rate for investments in Research & Development. The ensuing result was a small rise in the number of clinical trials effected in our country recently, from 134 clinical trials in 2018, to 154 in 2019 and 175 in 2020. The country’s potential, nevertheless, is much higher.

SfEE has been steadily pursuing over the last years the goal to have Greece established as the investment “hub” for research and development in clinical trials in Southeastern Europe. It acknowledges that we have a world class highly trained scientific personnel and dispose all the necessary infrastructure in the National Health System (high number of hospitals and physicians, favorable tax regime), yet Greece is still falling short in clinical research activity. Being a social partner with acute sense of responsibility, SfEE, in cooperation with PwC, has recently completed a relative study on good practices of other countries in attracting clinical trials, which was submitted to competent agencies of the State.

As seen from the results of the study, we need to focus on a national strategic plan, in order to claim the position we deserve in the conduct of clinical trials, which will be based on the:

1. Facilitation of patients’ participation
2. Simplification of processes, curtailing of red-tape and shortening of time necessary for approvals
3. Introduction of incentives for research and development and
4. Training of the hospitals administrative staff.

SfEE proposes the creation of a Staff Structure in the Ministry, as well as all big hospitals in the country, which will be operating as an one-stop-shop coordinator. Denmark, for instance, established a National Clinical Trials Bureau in 2012 with respective responsibilities, so as to deal with relative problems, and currently ranks 3rd at Pan-European level in the clinical trial investments per capita.

This way the participation of our country in clinical trials will be maximized.

There will be multiple benefits, primarily for the patients participating in them, for involved scientists, researchers and health structures, as well as national economy.

• For the patients: Fast and free access to new therapies, medicines, lab and diagnostic tests free of charge, continuous and high-class medical monitoring.
• For the researchers: Physicians and other staff participating in clinical trials strongly improve their skills and knowledge on every disease, hence improving the quality of services offered to all patients. Clinical trials is also a way to effect the brain gain desired, following the brain drain of the previous decade.
• For entrepreneurship and employment. An opportunity for life-long training of scientists.
• Attraction of Direct Foreign Investments (FDI), resources saving for the National Health System. For each investment effected in clinical trials in our country, more than 70% of its budget is allocated to researchers’ fees and hospital revenues, thus strongly boosting the budgets of the country’s public hospitals.

In a moderate scenario, i.e., if we manage to reach the European average, on the basis of our country’s size, we can attract investments of €500 mil. on an annual basis, starting with €100 mil. in 2020, and thus attain important GDP growth and the creation of thousands, new, quality jobs.

SfEE President, Mr. Olympios Papadimitriou, noted, on the subject: “Important steps have been made for the attraction of new investments, nevertheless there are still great margins for improvement, since the specific industry is extremely competitive, at a global scale. The highly promising and productive Clinical Research sector should be promoted as one of the paramount priorities of the Ministry for Health Political Leadership. The introduction of a research orientation in the health structures involved in clinical research trials, the smooth functioning in the processes and the creation of relative incentives, constitute key points that may improve the respective indices of our country’s activity in Clinical Trial, an element that will lead to attracting important investment capital in our country.”