Greece is a middling performer in terms of clinical trial numbers on the European stage, nestled next to Finland and Romania on total trial numbers between 2002 and 2020 but ahead of Germany and Italy on trials per capita. However, the pharmaceutical industry does see opportunities for establishing greater trial footprints in the country, as is borne out by AbbVie’s creation of a clinical trials hub in Athens with oversight for 13 countries and Bayer’s move to form a clinical trials academy along with local player Elpen back in 2020.
This is backed up by solid fundamentals. George Mitropoulos of EY, which held the country’s first clinical trials workshop earlier in 2023 in collaboration with the Ministry of Health and Pfizer, notes that “Greece has a significant presence in global clinical trials and is one of the top 25 or 30 countries globally for clinical trial investments. This is thanks to the quality of our services, infrastructure, investigators, R&D centres, and regulatory environment, as well as the diverse population of patients who tend to be willing to participate in trials, and the country’s reasonable cost levels.”
[Greece] is the second and third largest patient enroller globally for two of GSK’s clinical trials in lung cancer and multiple myeloma respectively, drawing on the high level of healthcare professionals that exist here
Antonino Biroccio, GSK
Several pharma country managers based in Greece tend to agree. GSK’s Antonino Biroccio notes that “Greece is a key hub for our clinical trial operations and real-world evidence (RWE) generation. The country is the second and third largest patient enroller globally for two of GSK’s clinical trials in lung cancer and multiple myeloma respectively, drawing on the high level of healthcare professionals that exist here.”
For Takeda’s Cornelia Zanetti, “Greece is usually a high recruiter of clinical trial participants for the company. Furthermore, the high expertise of healthcare professionals and level of care also makes Greece competitive in attracting trials.” Yvoni Papastelatou of Sanofi, Sanofi, which currently invests EUR three million on clinical trials in Greece every year and has 26 ongoing studies across over 100 research centres, adds that “Greece has the potential to become a clinical trials hub for the region, leveraging its great wealth of highly qualified clinical centres, internationally recognized health care professionals and experienced scientific staff.”
Clawback Offset – Underwhelming Impact
However, governmental initiatives to draw greater numbers of clinical trials to Greece – most notably by offsetting the amount of clawback that companies investing in trials need to pay back to the state – are thus far yet to bear fruit.
“In 2020, the Greek government introduced initiatives to invest in clinical trials and offset part of the clawback,” explains Agata Jakoncic of MSD, which currently engages in 42 clinical trials in the country, ten of which are scientifically demanding Phase I or II studies. “In the first year, it was a great initiative that motivated us to invest in more clinical trials. However, it has significantly deteriorated and the offset for investment in innovative R&D and clinical trials has been minuscule.”
Merck’s Susan King-Barnardo addends that “the offsetting of mandatory returns for those companies engaged in clinical trials was a positive initiative from the Greek government. However, the eligibility criteria for allowable expenses need to be broadened before this initiative can materially support international R&D investments.”
“A few years ago, Ipsen started focusing more on clinical studies in Greece in the hope that part of the clawback would be offset by the cost of these studies,” continues the company’s GM for Greece, Cyprus and Israel George Carystinos. “Unfortunately, this only partly materialised before disappearing for global companies.” Carystinos does however note that “this did lead us to realise some of Greece’s clinical trial advantages. It is relatively straightforward to recruit patients here, we have terrific academic centres, and our experts look at getting their patients onto clinical studies as a way of trying new medicines more quickly.”
Other key challenges include the red tape involved in establishing clinical trials in Greece. “The main challenge today is bureaucracy,” states Zanetti. “Sometimes Takeda Greece is unable to participate in a global trial because it takes too long to set up the trial site or get the approvals necessary to begin. Otherwise, we might be able to attract many Phase II and III trials as well as global trials.”
The main challenge today is bureaucracy. Sometimes Takeda Greece is unable to participate in a global trial because it takes too long to set up the trial site or get the approvals necessary to begin
Cornelia Zanetti, Takeda
“The Ministry of Health is eager to grow Greece’s clinical trial footprint even further, but there are challenges, mostly in the sense of clarity of process, how things are approved, and how some regulations are being interpreted by different stakeholders,” continues Jakoncic.
Sanofi’s Papastelatou finishes, “To further uplift the country’s positioning, administrative procedures should be decomplexified to create a more promising environment for collaboration among stakeholders.”
Moves in the Right Direction
Despite all the challenges, clinical trial numbers in Greece did grow from 134 in 2017 to 175 in 2020, with the process for conducting clinical trials made less complex and more transparent, and several initiatives between public and private stakeholders are underway to further bolster these numbers.
“The SFEE has a working team with the Ministry of Health on how to attract more clinical trials to Greece,” expounds Michael Himonas, general manager of the innovators’ association. “Together with PwC, we even conducted a study on this topic, taking lessons learned from other markets and trying to bring them to Greece. Creating more homogeneity of practices between hospitals and reducing bureaucracy is a key barrier that we are working on as we look to leverage the 30-40 of Greece’s 128 public hospitals that are capable of conducting clinical trials.” He finishes, “Taking ideas from other countries, Denmark has moved to set up a private company, ‘Trial Nation’, in charge of all the networking for clinical trials which is something we could also emulate.”
We are now working on the specifics of the future roadmap, towards our ambition to attract even more trials, in line with a country like Belgium, which although roughly comparable to Greece in size, way outperforms Greece on trial numbers
George Mitropoulos, EY
Mitropoulos adds that “EY has worked with the Ministry of Health and has documented the process and clearly identified the bottlenecks preventing the country from attracting more clinical trials today. We are now working on the specifics of the future roadmap, towards our ambition to attract even more trials, in line with a country like Belgium, which although roughly comparable to Greece in size, way outperforms Greece on trial numbers.”
For Papastelatou, “the development of a data-oriented & digital-oriented culture can also support this push.” She continues, “There are significant opportunities in Greece to leverage RWE and boost digitalization. In this field, we see a significant intention on the part of the authorities to push this forward and potentially even to ‘leap-frog’ other countries.”
However, as IQVIA’s Nikos Kostaras warns, “There is still a long road to travel and annual investments into clinical trials stand at less than EUR 100 million. As IQVIA and as part of the national CRO association (HACRO), we have participated in many discussions and helped draft a set of proposals about improving the situation for clinical trial investments which was delivered to the Prime Minister. The government knows what needs to be done but is understaffed and has not yet taken the right decisions quickly enough.”