May 20, 2022: International Clinical Trials Day
SFEE actively supports over time the development of Clinical Research: A great opportunity for both the patients and economy
Athens, May 20, 2022. – On the occasion of the International Clinical Trials Day (May 20), the Hellenic Association of Pharmaceutical Companies (SFEE) stresses, once again, the critical role of Clinical Research in safeguarding Public Health. Thanks to clinical research we achieved an iconic victory, the development of COVID-19 vaccines in less than a year! The year 2022, actually, signals the inception of a new era in clinical trials in Europe, through the implementation of the new European Regulation 536/2014 (EU-CTR) on clinical trials, with the parallel operational onset of its fundamental element, i.e. the Clinical Trial Information System – CTIS.
This new Regulation, which entered into force on January 31, 2022, constitutes an important change in clinical research and opens a new exciting chapter for patients and clinical trials in Europe. The important new rules implemented bring hope for more effective processes and greater benefit for the patients, since they focus on transparency enhancement and new opportunities created for the patients’ participation, especially with regard to the obligation imposed on trial sponsors to also communicate their results through specifically designed summaries /documents in laymen terms, so as for them to be accessible to anyone.
Clinical Studies constitute a great opportunity for Greece, a potential still untapped. More the €39billions are annually spent in Europe on Clinical Trials, with Greece sadly absorbing less than €100millions! Compared to Greece, Hungary attracts 5 times this much, Denmark 30 times and Belgium 70 times higher investments in pharmaceutical R & D. SFFE, being a responsible social partner, has conducted a relevant survey, in cooperation with PwC, studying the good practices of other countries in attracting clinical trials; this study has been submitted to the responsible bodies of the State.
Our country fulfills all the prerequisites so as to attract even greater number of research programs and re-double investments in a three-year horizon, reaching the sum of €250millions per year. The strategic goal of SFEE and its member companies is promoting our country as a Clinical Trials Center with international pull that will offer new breath and thrust to Public Health and National Economy, as well as patient access to new innovative therapies.
The SFEE General Manager, Mr. Michael Himonas, notes: “Important steps for attracting investments have been made, improvement margins however are huge, given that the specific sector is globally extremely competitive. The extremely productive and highly promising field of Clinical Research must be upgraded as one of the top priorities in Public Policy. Rationalization of pharmaceutical expenditure, market launching of new revolutionary treatments in the country, strengthening clinical research activities and boosting the cooperation between Greek and Foreign companies, are the necessary elements for securing a good public health policy and sustainable economic development. Parallel to that, the introduction of research orientation in the public health structures that are involved in the clinical research program activities, the seamless flow of processes and the creation of relative incentives constitute the basic elements which can improve the respective activity indices of our country’s involvement in Clinical Research, the latter leading to the attraction of important investment funds.”
Clinical research attracts direct foreign investments (DFI), imports research know-how, boosts entrepreneurship and employment with highly educated and scientifically specialized personnel, saves resources for the National Health System and substantially contributes to the growth of National Economy.
The greatest benefits, however, are primarily for the patients participating in clinical trials, since they will be offered quick access to new treatments, free medication, diagnostic and lab tests, as well as continuous and high-level medical monitoring.
Corroborating all the previous, the President of the Hellenic League Against Rheumatism (ELEANA), Ms. Athanasia Pappa, notes: “Each treatment currently available has been approved through clinical studies, which do not only offer clinical treatments but also all the information on the prevention, diagnosis and deeper understanding of the disease. In many cases, these clinical studies may well be the unique life-raft and hope, because they offer access to treatments and medications far earlier than the expected official launching of the latter. Patients miss the opportunity to participate in clinical trials because they were either not informed on this available option or were not sufficiently briefed and are afraid. Therefore, clinical studies should be first and foremost sufficiently publicized and the State, medical society and patients’ associations should offer thorough information and training, so as for patients to be better informed on the value of clinical trials and the opportunity offered to them to have access to innovative treatments.”