The recent measures taken by the Greek government regarding compensation of new innovative medicines has plunged the pharmaceutical market into uncertainty and disappointment. All professionals of the sector anxiously await to see how the new provisions will affect Greek patients’ access to new treatments as well as employment in the pharmaceutical sector and investments on clinical studies.
At the same time, the government maintains that its main objective is to stop Greek scientists from going abroad to find work and attract foreign investors so as to boost healthy entrepreneurship. However, the clinical research sector remains stagnant, despite the fact that it could significantly enhance job opportunities for young scientists and attract substantial investments.
Despite promises for promotion of clinical research, Greece is lagging behind other European countries. Each year more than 30 billion euro is invested in this sector in Europe, out of which Greece hardly absorbs 80 million – when it could easily utilize thrice that! The main cause of this situation is the delay due to bureaucracy within Regional Health Authorities and hospitals.
Main Discussion topics
- Trends, prospects and hurdles in the development of clinical studies
- New European Regulation on clinical trials
- How do new technologies influence clinical research?
- What are the benefits from the promotion of clinical trials?
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International Clinical Research: trends, prospects, strategies
On a global scale, 130 billion dollars are invested every year in Research and Development by international biopharmaceutical companies. About 70 billion dollars of the above are spent on clinical research, corresponding to approximately 10,000 randomized clinical trials annually, while the estimated total number of trials currently underway is more than 350,000.
On May 2014 a new E.U. Regulation on clinical trials was published, which will come into force in 2018. Its main goal is to accelerate the development of pharmaceutical research.
Among other provisions, national notification and approval systems are replaced by a pan-European licensing procedure which is accessible through a new Clinical Trial Data Portal Gateway, a single entry point for submission of data and information pertaining to clinical trials. This option is aimed at making the E.U. an attractive destination for clinical trials.
This new approval framework ensures a satisfactory level of transparency in clinical trials as well as the public’s access to the E.U. data base. Moreover, it provides that the member-states shall appoint inspectors for the supervision of clinical trials. Finally, it is worth noting that the Committee may conduct inspections in order to check whether the member-states comply with the Regulation or not.
Emerging new technologies as well as the rapid development of informatics and the use of smart devices (smartphones-tablets), which have influenced our everyday lives, also have a great impact on clinical research. The management and processing of huge bulks of patients’ data and their easy and fast sharing is a crucial factor in reducing cost and accelerating relevant procedures. For instance, on a global level various Cloud services have been developed and are already being promoted for easier storage, management and exchange of clinical trial data.
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Patients’ participation in decision-making
The development of clinical research may have many advantages not only for a country’s economy but also for patients, who benefit from:
- Better health care
- Better medical services without additional cost for insurance institutions and hospitals
- Early access to medicines that are not out in the Greek market yet
- Access to innovative drugs and “orphan” medicinal products (for rare diseases)
- More intensive observation of symptoms and the patient’s overall health condition during clinical trials
- Free medical consultations, procedures, tests and medicines within the framework of the clinical trial
- Increase of life expectancy
- Upgrading of quality of life
Undoubtedly, in Greece the public is inadequately informed on the value of clinical trials. At the same time, patients do not have access to data on clinical studies already underway or which will be conducted in the future.
Main discussion topics
- What information do Greek people have on clinical trials and what are their opinions on the subject?
- How will the new measures affect innovative medicinal products?
- Patients’ information on clinical trials
- Patients’ participation in the designing of a research protocol
- Patients’ inclusion in clinical studies
- Clinical trials register
Main discussion topics
- Benefits of clinical trials for hospitals
- Hurdles and counter-incentives in conducting clinical trials in hospitals
- Measures and incentives necessary for the promotion of clinical research
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Clinical trials in hospitals: the management’s viewpoint
Many global studies have proven that conducting clinical trials in hospitals may potentially yield great benefits, such as:
- More profits: the hospital receives 15-20% on the total budget of a clinical trial.
- Upgrade of health care services: many studies have confirmed that hospitals where clinical trials are conducted offer better treatment results to their patients.
- Patients’ access to new, innovative treatments: clinical trials enable patients suffering from serious incurable diseases to have access to new, more effective treatments.
Despite all the above and numerous promises regarding the promotion of clinical trials, the latter have not yet become a priority for most regional health authorities or hospitals’ administrative bodies. Therefore, decision-making procedures are slow and there are delays of many weeks or even months in launching clinical trials.
In addition, a serious counter-incentive discourages potential investors from taking an interest in financing clinical trials in public Greek hospitals. Big companies usually invest in specific scientists and Centers of Excellence. However, the legal framework in force in Greece has set a ceiling on NHS doctors’ income, which means that there are those who do not feel motivated to organize clinical trials.
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Development of clinical trials in Greece: hurdles – prospects
In the last years, the Greek state seems to have started to realize that the promotion of clinical research could function as a lever for economic growth, offering multiple benefits not only to patients but also to the national health system and the Greek economy. At the same time, it could be the catalyst that will stem the tide of migration of young Greek scientists.
It is characteristic that an increase of 100 million euro in clinical trials means 220 million euro for the Greek economy and 4,300 new jobs for Greek scientists (according to studies by the Greek Institute of Economic and Industrial Research – IOBE). Unfortunately, Greece is lagging behind in the clinical research sector and it is estimated that at least 200 million euro are lost annually due to bureaucracy.
Despite the fact that great progress has been noted on an institutional level, in practice there are still serious bureaucratic obstacles and administrative distortions. Furthermore, nobody seems to be able to predict how clinical trials will be affected by the new measures regarding compensation for new, innovative drugs by EOPYY (the Greek Organization for Health Services).
Another untapped source of profit is the sector of bio-equivalence studies. Greek pharmaceutical industries conduct more than 100 such studies each year abroad and many experts estimate that Greece could be transformed into a hub of bio-equivalence research. However, our country lacks the necessary supporting framework.
What Greece is in need of is a Strategic Plan on Clinical Research, which would help launch the necessary actions. At the same time, new challenges are emerging due to the application of the new European Regulation on clinical trials, which aims to accelerate the development rate of pharmaceutical research through the conduction of clinical trials in the E.U.
Main discussion topics
- How will the new measures affect the sector of innovative medicinal products?
- What are the main causes of delay in the realization of clinical trials today?
- Measures for the development of bio-equivalence studies
- Incentives for the development of clinical research
- How ready are we to apply the new Regulation on clinical trials? What are the challenges and risks for Greece?