Control mechanism to avoid the uncontrolled prescription of drugs, which are not approved by the European Medicines Agency (EMA), despite all this, this possibility still exists, the Ministry of Health institutes

A case of drug prescription for severe neurological illnesswhich did not finally receive marketing approval from the EMA and was withdrawn, however it was prescribed non-stop at a cost of 20 million euros for the Greek State, in 2023 until today, gave the trigger for the relevant amendment submitted by the Ministry of Health and is expected to be voted on tonight in the bill to strengthen the legal profession.

The Minister of Health, Adonis Georgiadesinformed the Plenary of the Parliament about the relevant regulation, pointing out that it is our absolute responsibility to manage the money that the Greek people have been working hard to collect from the pharmaceutical expenditure, with as much efficiency and responsibility as possible. Because – as he explained – our population is aging, the need for drugs is constantly growing, new innovative treatments are constantly (and fortunately) being found, usually extremely expensive, and if we don’t find a way to keep all these new treatments from being abused, very quickly we won’t we have to pay for any new medicine.

Note that the problems of drug shortages are to a very large extent due to the large launch of the so-called clawbackwhich leads many companies to not want to sell drugs in Greece or to completely withdraw drugs from the Greek market to avoid this heavy burden.

So, a non-remunerated drug-specific review committee is now being established, which is made up of 15 members – 11 doctors of various specialties, two EOPYY pharmacists and two Health Economists – so that when a doctor prescribes a drug, which is not approved by the EMA and prescribes it outside of indications, then this prescription goes through the specific Committee. The doctor, who makes the prescription, must prove to his colleagues why he believes that this drug really should be given to the specific patient and if the Committee judges that he has prescribed it correctly, then only he should be compensated by the EOPYY.

The case that cost 20 million euros

In order to understand the issue, as well as the reason why the regulation was required, Mr. Georgiadis explained that doctors can, through the system of electronic promotion of prescriptions, prescribe drugs without control. That is, a doctor can judge that a drug that has marketing approval from the EMA is prescribed, but he can also judge that a drug that is not approved by the EMA but is approved, for example, only by the American Medicines Agency ( FDA) or to prescribe a drug approved by the EMA that has some indications approved and the doctor decides (“because he had this idea or had read a clinical study”) that this drug can be used for some other indications, which they are not included in the marketing authorization of the drug by the EMA.

“This very great freedom is now beginning to be exercised particularly abusively” said the Minister of Health and referred to the case which ultimately cost the State 20 million euros, as follows:

“I am coming to talk about a story, which from the beginning of my tenure we have seen that there is a big problem, but an event happened a few days ago, which triggered the immediate tabling of an amendment so that we don’t waste any more time. When I took over, one of the points that I saw that is completely out of control is the expenditure on medicines, which is made through the YFET (that is, the organization that was created so that the state can procure pharmaceutical preparations for urgent needs) and the expenditure which is made through this Agency, is not subject to rebates or clawbacks like other pharmaceutical channels. Precisely because it is not guaranteed that we will find the medicine we need, at the time we need it, without at that moment, the price of the medicine being the main and basic criterion because human life comes first. A complaint was made to me by the president of the Commission, Mr. Tsivgoulis, about a certain series of drugs, which, in his opinion, are over-prescribed even though they were not approved by the EMA. One of these drugs was for a very serious disease (neuromyopathy) and which costs 100,000 euros per year for individual treatment. The previous medicine was worth 150 euros. Suddenly a year ago, when this drug got phase 2 approval from the FDA, it started to be prescribed non-stop by doctors in Greece spending about 17 million for 2023 and already about 4 million for 2024. When the president of the Society of Neurologists had publicly written that this drug is wrongly prescribed, because it has by no means been sufficiently proved to have any real therapeutic value. For this drug the company had tried to get approval from the EMA and had failed, it had received approval from the FDA, phase 2 as a promising drug with the condition that if it does not pass phase 3 it will be withdrawn. Last Friday night, the company announced that it did not pass phase 3, the drug is finally not working and is beginning the process of withdrawing it from the US market. Let me make it clear that I am the first one who would like the drug to work and save lives. Unfortunately it didn’t work, but doctors kept prescribing it and it cost the Greek taxpayer over 20 million euros already. This cannot go on. There is a series of about 20 medicines which are not approved by the European authorities but only by the American and our doctors prescribe them all the time and many times without indications”.