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Greece attracts clinical trials: SFEE presents PwC study focused on our country

Halandri, 13 July 2021.- “Clinical trials can serve as a key driver of scientific knowledge and as oxygen for the economy”, stated Mr. Olympios Papadimitriou, President of the Hellenic Association of Pharmaceutical Companies (SFEE) at a press conference held to present a PwC study on how to attract clinical trials to Greece. “Still, Greece lags behind its European peers in the number of clinical trials. More than €36 billion are invested annually in Europe, of which our country, unfortunately, absorbs only about €100 million!

Over the last two years, it is true that steps have been taken in the right direction, such as the exclusion of vaccines from pharmaceutical expenditure, the possibility to offset investment against claw-back for an amount of €100 million, as well as the tripling of the rate of super-deduction for research and development (R&D) expenses. The result has been a small increase in the number of clinical trials during the past couple of years, from 134 in 2018 to 154 in 2019 and 175 in 2020. The measure enabling to offset investment against claw-back has been extended for the next three years, which will further encourage investment. However, a more simplified, harmonised and less bureaucratic framework for clinical trials would be much more effective in strengthening this activity”, stated SFEE President Mr. Papadimitriou.

Addressing the event, Mr. Dimitris Filippou, President of the National Organisation for Medicines (EOF), noted: “The recent SARS-CoV-2 pandemic continues to affect all aspects of human activity, in particular the healthcare sector. It is well known to all of us that health systems have come under tremendous pressure from the pandemic, and structural and operational changes have inevitably taken place in order to tackle this emergency. Every year some 4,000 clinical trials are approved in Europe, and 65% of them are funded by pharmaceutical companies. So it is a way of indirectly but substantially financing health systems. And this is exactly the opportunity we must seize as a country: to use clinical trials, on the one hand, to offer high-quality services to our patients and, on the other, to utilise the resources for rationalising expenditure and upgrading the health system. We at EOF, starting from the pandemic, have managed to catch up with the European average in terms of speed and reliability of the approval process, which creates a favourable environment for attracting clinical trials. The realistic goal for 2021 is for the number of approvals to exceed 200 trials, compared with 130-150 in previous years. At the same time, we have worked on the legislative framework and there are legislative interventions aimed to change the way the State treats clinical trials and companies. We consider important and decisive the provision of information to patients, the education of scientists and investment on the part of the State with legislative interventions and actions, such as the establishment of a clinical trials office at each hospital”.

Prof. Dr Meletios-Athanasios Dimopoulos, Rector of the National and Kapodistrian University of Athens, discussed the present and future of clinical trials in Greece and their potential to become a tool for economic growth at a difficult time. “The beginning and the end of every clinical trial is our effort to ensure new innovative treatments for our patients. The patient is and must be at the heart of every procedure and every effort. The conduct of clinical trials requires the cooperation of authorities, scientific staff, patients, sponsors, CROs and patient associations. It is a human chain of trust and cooperation that leads to desired results. Clinical research, at both the domestic and the international level, has faced great challenges over the last two years. During the pandemic, there have been disruptions in various procedures, such as postponement of patients’ visits to research centres, as well as reduced patient participation in clinical trials, suspension or discontinuation of several studies, with adverse scientific, economic and social consequences. Gradually, however, the implementation of new procedures, these problems have been smoothed out and resolved. New technologies and telemedicine have played a crucial role in this direction, ensuring rapid approval processes, and making a decisive contribution to the return to scientific and research normality. This was particularly evident from the speed with which clinical trials have been conducted for the development of COVID-19 vaccines. Conducting clinical trials tailored to patients’ needs will make clinical trials much more accessible to patients in the future. Improvements in the regulatory framework will eliminate red tape and delays and will strengthen the competitiveness of our country in this area as well”.

Ms. Katerina Koutsogianni, President of the Greek Patients’ Association, highlighted the importance of clinical trials for patients and noted: “Clinical trials are the only path to innovation: without trials, we cannot have new, more effective and safe treatments. The benefits are multiple for patients, who are given the opportunity of fast and free access to innovative medicines and diagnostic tests and, at the same time, continuous and high-quality medical care. By participating in clinical trials, patients are empowered and play an active role in managing their health. However, the role of patients should not be limited to their participation, but should be more active across all stages of a clinical trial, from design to implementation.”

The study “How will Greece attract clinical trials?,” presented by Ms. Andriana Skyfta, Senior Manager – PwC Greece, provides an overview of structural problems and a number of proposals based on good practices and relevant incentive policies implemented in other European countries. As shown by the results of the study, we need to focus on a national strategic plan based on:

1) facilitating patient participation;

2) simplifying procedures, cutting red tape and improving times;

3) providing incentives for research and development; and

4) training the administrative staff of hospitals.

SFEE’s proposal refers to creating a clinical trials structure at the Ministry of Health, as well as at all major hospitals across the country, which will operate as a one-stop shop. Denmark, for instance, which in 2012 set up a National Office for Clinical Trials to deal with similar problems, now ranks third in Europe in per capita investment in clinical trials.

In this way, Greece’s presence on the international clinical research scene will be maximised.

The benefits are multiple, primarily for the patients who participate in clinical trials, but also for the national economy:

• For patients: rapid and free-of-charge access to new treatments, medicines and laboratory and diagnostic tests, continuous and high-quality medical care.
• Research know-how: Doctors involved in clinical trials significantly improve their skills and knowledge about disease, thereby also significantly improving the quality of services they offer to all patients.
• Enhancing entrepreneurship and employment, with highly qualified scientific human resources.
• Attracting foreign direct investment (FDI), saving resources for the National Health System. For every investment in clinical trials in our country, 20% accrues, mandatorily under the law, to the host hospital and the supervising Healthcare Region, strengthening the budgets of public hospitals in the country.

In a not-too-ambitious scenario, i.e. if we manage to reach the European average, based on the size of our country, we can attract investments of €500 million annually, up from €100 million in 2020, and achieve significant GDP growth and of course the creation of thousands of new jobs.

In closing, Mr. Dimitris Anagnostakis, SFEE Vice-President, responsible for Scientific-related Matters and Clinical Trials, called for the cooperation of all stakeholders. As he characteristically said: “What is needed is the close cooperation of all the parties involved, in order to find consensus solutions that will promote the country’s potential and make it a reliable European partner. The goal of SFEE and all its member pharmaceutical companies is to make our country a hub for the conduct of clinical trials with an international impact, which will give fresh life and impetus to both Public Health and the National Economy. But this also means that we need to become more competitive!”

Mr. Spyros Panagiotopoulos, President of the Hellenic Pulmonary Fibrosis Association, shared his personal experience: “I participated in a clinical trial on the first PF medicine fibrosis in 2012, which lasted for two years. I am grateful to Professor Dr. Demosthenes Bourοs for including me in this clinical trial, enabling me to outlive the life expectancy for PF patients which was 3-5 years”.

See the presentation