The role of developing the clinical studies sector in our country through attracting investments is perhaps the biggest challenge for the health sector.
The country’s interconnection and interaction with the European environment, the need for Greece to immediately adapt to the new unified framework for regulating and operating clinical studies and, above all, highlighting the benefits of voluntary patient participation in studies are some of the turning points that must be overcome, according to the president of the HACRO Association, Evangelia Korakis.
The economic benefits of Greece
The clinical trials industry is highly competitive. Our country is compared at all levels with other European member states in terms of the criteria for attracting available investment funds. According to recent surveys carried out by PwC, IQVIA and IOBE, the main criteria for attracting investment are speed of implementation, quality criteria such as experience, know-how, consistency, infrastructure and stability, and financial incentives.
Today, in Europe, as reported by the European Medicines Agency (EMA), more than 4,000 clinical trials are approved every year, 65% of which are funded by pharmaceutical companies. By 2023, these companies are estimated to have invested a total of €50 billion in R&D in Europe. Over time, Greece’s comparative position in Europe in terms of the number of clinical studies is not satisfactory. According to ClinicalTrials.gov data for the period 2000-2020, a total of 3,101 studies were conducted in Greece, only 1.7% of all clinical trials conducted in Europe during the same period.
As HACRO Vice President Nikos Kostaras explains, over the past five years, however, the indicators have shown a clear improvement, as data from the National Organization of Medicines shows, from 2019 to 2022, approvals of requests for new clinical trials increased significantly by 70% (262 approved for drugs and medical devices in 2022 versus 154 in 2019). For 2023, a record number of requests from sponsors was observed, reaching 320 requests for approval of new clinical trials, 298 for drugs and 22 for medical devices. And for 2024, until June 201, drug studies and 20 studies for medical devices were approved.
However, Greece absorbs 120 million euros from clinical studies, when it could reach 500 million euros. With the current image of the country, if we removed the investments from clinical studies and reached 500 million euros per year, we would achieve 1.1 billion euros in GDP growth, 270 million euros in tax revenue, 23 thousand new high-level jobs such as doctors, nurses, other scientific staff and a reduction in unemployment.
The criteria are in the air
The Ministry of Health has taken the first positive steps by enacting legislative interventions such as:
- the Investment Clawback (Nos. 4712/2020 and 4965/2022), which provides for the offsetting of automatic reimbursement with percentages on research and development costs,
- the possibility for ESY hospitals (law 4.950/2022) to obtain revenue from biomedical research, which exceeds the State budget. In addition, these resources will be available to hospitals for the supply of new medical equipment or for the modernization of their infrastructures,
- the possibility of creating an independent Clinical Studies department in SNS hospitals (Law 5041/2023, Official Gazette 87/A/8-4-2023).
However, although the investment reimbursement system was introduced, which unfortunately could have provided a significant boost, in 2020 this system joined the Recovery Fund and the conditions for R&D expenditure were lost. The solution is to keep the criteria as they were for including multinationals in the investment reimbursement. If the country wants to obtain large revenues from studies, the ministry must improve the compensation conditions, implement the National Biomedical Research Register, strengthen financial incentives for pharmaceutical companies operating in Greece as well as for those that do not have a presence here, and provide the EOF and the National Ethics Committee with sufficient and properly trained staff.
Transition period ended
Europe is trying to regain its lost competitiveness in attracting global R&D investment. This is why it has established the new European Regulation 536/2014 (CTR) and a Unified Clinical Trials Information System (CTIS). The CTR came into force on 31 January 2022, but there is a 3-year transition period for clinical trials approved under the previous legislation to transition to the Regulation. After 31 January 2025, all new and ongoing clinical trials will be conducted on the basis of the Regulation.
Clinical Trials Offices
The proposal to create a Clinical Studies Office within the Ministry of Health has been tabled. Experts point out that this could be a solution to important problems in conducting a study. Greece has potential, has world-renowned scientists, has research centers and can also have competitive costs.
“We need financial incentives, tax incentives, etc.”, stresses Mr. Kostaras, so that clinical trials generate much more revenue in Greece as well. Greece cannot employ only 170 people in this sector when Bulgaria has reached 1,200 workers.”