Restrictions on the import of expensive drugs – New criteria for the health ministry

Costs for imported through IFT have been launched and that is why he decided to put a ‘cuter’. The Ministry of Health goes on to set up the non-paid Electronic Pre-Approval Control Committee (S.U. Control Committee), which will belong to the National Health Services Agency (EOPY) through an amendment tabled on Tuesday night (12.03.2024) and included in a Ministry of Justice bill. The work of the new Commission will be the previous audit, of all requests for the import of expensive medicinal products from abroad through the Institute for Pharmaceutical Research and Technology (IFET). These preparations should be noted that EOPY fully compensates them. The amendment was quickly tabled, following the Health Ministry’s finding that 15m euros were spent introducing to the country a very expensive treatment that was early approved by the US FDA and which ultimately proved ineffective in phase III studies, resulting in the manufacturing company announcing its withdrawal. Referring to the issue at the recent conference of Economist Impact, the Minister of Health, Adonis Georgiades, also blamed doctors for subscribing the medicine for neuromyopathy Relyvrio, which had not even been approved by the European Medicines Agency (EMA). Please note that the cost of the EEAY for all these preparations for 2023 reached 168.7 million euros. The composition of the Commission and its work The SAA Audit Committee will consist of 15 members: 11 qualified doctors of various disciplines, 2 pharmacists of E.O.P.Y. and 2 health economists. It will check the import requests for medicines and either set conditions and restrictions for their approval, or recommend their non-remuneration until their inclusion in the List of Remunerated Medicines. In particular, as mentioned in that amendment, the Commission will be doing its utmost to check individual requests falling under c. (b) and (c) paragraph 1 of Article 265 relating to a medicinal product with a new active substance or a combination of substances introduced for the first time after the entry into force of this or to a medicinal product with an active substance to be granted in an unapproved indication for which a request appears in the S.U. for the first time after the entry into force of this. Pharmaceutical preparations for which they have been accepted through the U.S. individual requests submitted before the publication of this may be checked by the Commission upon a new request submitted after publication. IFT: What are the approval criteria for the import of medicinal products? The Commission will check individual requests for the identification of a highly uncovered medical need, in accordance with the following criteria: life-threatening condition, a condition causing serious disability and a condition for which there are compensated treatments in the country. Since, at the Commission’s discretion, a high undisclosed medical need for the particular condition concerned by the request is established, the Commission will further check the criteria: identification of a large therapeutic effect on a specific indication, direct therapeutic interconnection with the majority of the population with the particular condition clinical data of high certainty. According to the explanatory statement of the amendment, the E.O.P. expenditure. P.Y. for the administration of these medicinal products traded by the Agency’s pharmacies, from EUR 94 million in 2022, amounted to EUR 168.7 million in 2023. As stated, ‘this increase makes it necessary to thoroughly check requests in order to identify cases where the imported preparation concerns a highly uncovered medical need’.