Filenews 29 December 2024 - by Marilena Panayi
Cyprus intervenes in the European Union and proposes solutions that will help, especially states small in population, and reduce the inequalities observed so far between the Member States of the Union and concern both the speed of securing new and innovative treatments, as well as the prices at which manufacturers sell their medicines. depending on the size of the orders submitted to them.
The Health Ministry's effort to find a legally correct method for a common purchase of medicines in the EU began several months ago with the response of member states being such as to justify promotion for the implementation of what Cyprus proposed last summer.
A big issue, especially for small countries, is the prices at which medicines are secured for their citizens, since inevitably small markets are not considered advantageous by manufacturers.
According to the Ministry of Health, the implementation of Cyprus' proposal will help ensure more favorable prices for medicines and, by extension, lower reimbursement by health systems (including the GHS), since the negotiation with pharmaceutical companies will concern a larger patient population.
In early December, Health Minister Michalis Damianos made an official presentation of the Cyprus proposal to the EU, while last week he was briefed on developments around this issue and the Council of Ministers.
In general, Cyprus' proposal provides for the voluntary participation of Member States in joint tendering procedures to be launched immediately after the evaluation process for new medicines.
Croatia, Denmark, Greece, Latvia, Malta and Slovenia have already signed Cyprus' initiative, while Estonia, Lithuania, Portugal and the Czech Republic have verbally expressed their intention to support it.
During the presentation of his proposal to the Council of Ministers, the Minister of Health informed the Government on the way in which it is promoted in the other EU member states, stressing the fact that the purpose of the initiative is the cooperation between countries that will express interest in the joint procurement, in particular, of innovative medicines.
In fact, Cyprus aims to complete the procedures as soon as possible in order to make the beginning and enable the first joint offer for innovative pharmaceutical products that will undergo Health Technology Assessment (HTA), for which a relevant European Regulation enters into force as of January 1, 2025.
Linking supply to the evaluation of medicines
The proposal of the Minister of Health initially concerned the participation of small states in the joint bidding process, since the more populous states can, from a position of strength, secure better prices when negotiating with pharmaceutical manufacturers. In the course of promoting the proposal of the Cypriot Minister of Health, it became apparent that there is also interest in participating in this procedure for a joint tender for the purchase of medicines, on the part of larger countries, and therefore, it was decided that the voluntary participation of states in the joint offer will be proposed, so as not to exclude any state.
The proposal, which is being prepared at the initiative of the Minister of Health Michalis Damianos, provides for the announcement of a joint offer to secure new specialized medicines immediately after the completion of the evaluation process of these drugs through the Health Technology Assessment Program.
The connection of the proposal with the Health Technology Assessment (HTA) process is certainly not accidental, since all new and innovative treatments will be passed, evaluated and then approved through this European program.
This program, which has been in place since January, aims to evaluate medicines and medical equipment by Member States and organized patient groups in the EU for their effectiveness and suitability compared to existing corresponding treatments/equipment. In practice and in accordance with the terms of implementation of the program, upon initiation of the licensing process for a pharmaceutical preparation or medical device, the competent national authorities, in the case of Cyprus, the Pharmaceutical Services, for medicines and the Medical Services for medical equipment, will receive from the European Commission all the necessary data on the characteristics of each product as well as a questionnaire which they will be asked to answer and patients.
If the characteristics of a formulation/medical device are such that they will not substantially help the health or quality of life of patients, then again the relevant answers will be recorded in the questionnaire. The answers given in each case by patients and professionals will be sent by the competent national authorities to the European Commission, which in turn will prepare the "joint clinical assessment" in which a summary of the positions recorded by all Member States will be made. The joint clinical assessment, according to the timetable set, will be ready within 30 days of the authorisation of the medicine or medical device by the European Medicines Agency (EMA) and therefore, the health systems of the Member States will have at their disposal earlier and in more detail everything they need to proceed with the procedures for making these products available to citizens.
