More than 320 new innovative medicines also came to Greece in a four-year period

After an important period marked by the economic crisis and the dramatic reduction of health spending, Greece, through the Committee for the Evaluation and Reimbursement of Medicines for Human Use (EAAFAX), has managed to approve the introduction into the country of over 320 new treatments.

Many of them concern the treatment of cancer, rare diseases, but also more common diseases such as cardiovascular and diabetes. In fact, more than 50 new innovative preparations are “orphan drugs”, that is, they concern rare diseases.

In particular, based on the data presented by the chair of the Committee, Associate Professor of Pediatrics – Adolescent Medicine EKPA, Flora Bakopoulou at a conference on Health Technology Assessment, from January 2020 until today, EAAFACH evaluated 1,289 applications, of which the 24 received a negative opinion. The applications received by the Commission in total were 1,216 plus 85 pending ones received from its previous composition.

Of these, 257 (about 20%) related to original substances, 68 to hybrid drugs, 54 to orphans, 33 to originals with a known active ingredient, 32 to biosimilars and 12 to vaccines. Today, only 12 drug applications with complete dossiers are pending for evaluation.

During the same period, approximately 1,289 applications were evaluated, of which 270 (approximately 20%) related to original substances, 63 to hybrid drugs, 54 to orphans, 27 to originals with a known active substance, 35 to biosimilars and 11 in vaccines.

Out of all the applications, 39 were not accepted and 24 files received a negative opinion and were withdrawn.

According to the data, the Commission’s productivity is constantly increasing. In particular, 125 drugs were evaluated in 2020, 213 in 2021 and 219 in 2022. In 2023, 116 drugs were evaluated, however, this decrease reflects the decrease in applications submitted by the pharmaceutical industry. As for the current year, during the first two months 30 evaluations were carried out. The average evaluation days has been reduced drastically, from 160 days in 2020, to 31 days in 2023.

Regarding the requests in the Electronic Pre-Approval System (EPS), the Commission has received 14,970 requests in 3 years, of which 12,225 had a positive recommendation and 2,745 negative.

Central assessment from 2025

As Mrs. Bakopoulou pointed out, in December 2021 the European Regulation on Health Technology Assessment was adopted, which concerns both of the above categories.

The European Regulation provides for the clinical evaluation of new active substances and indications at the European level. That is, the added clinical value of the innovative drugs will be evaluated in relation to the existing ones. As for the non-clinical evaluation (financial, ethical aspects) it will remain at the national level. Central assessments will be able to be used by Member States as a basis for their own further actions needed to make pricing and reimbursement decisions for new products.

The European Regulation is expected to come into force in January 2025, starting with medicines. The first products to be evaluated in 2025 will be oncology and advanced therapies (estimated not to exceed 10). From 2028, orphan drugs will be added to the evaluation and from 2030 it is expected that all pharmaceutical products (original active and new indications) will enter the central evaluation process.

From 2026, the first clinical evaluations for medical technological products are expected and will concern high-risk medical devices and in vitro diagnostic medical devices, which are expected to have a very large impact on the health of patients as well as on health systems. And in this case, the clinical assessment will be done centrally and the non-clinical assessment at the national level.

“In Greece we are a little behind. The first implementing act on joint clinical evaluations for medicines was expected to have already been issued. However, it is under consultation and it is expected to be issued next week”, said the president of the Commission. As regards the implementing acts on the conflict of interest (Conflict of interest), the exchange of information with the European Medicines Agency (EMA), the methodology of joint scientific consultations on medicines are expected to be adopted around the summer, given that by January 2025 should have been issued and Member States should be able to implement them.

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