Filenews 12 January 2024 - by Marilena Panayi
Patients will have a say and a role in the process of evaluating new medicines and medical devices in the European Union, since they will now be able, through the procedures that the competent national authorities will be obliged to follow, to express their opinion on the suitability, effectiveness and effects of medicines and consumables on their health and quality of life.
The whole process, as explained to "F" by the Director of Pharmaceutical Services, Elena Panagiotopoulou, "falls within the framework of the "Health Technology Assessment" (HTA) program, which will start to be implemented from 2025 for medicines and from 2026 for medical equipment. The HTA includes a series of procedures, "and among them is the involvement of organized bodies representing patients in each country and bodies representing health professionals."
At the same time, with the start of the licensing process for a pharmaceutical product 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, material with the characteristics of each product as well as a questionnaire which patients will be asked to answer.
The overall goal is "to investigate whether a new treatment or equipment is worth the cost needed to reach the patient."
For example, "let's say that a drug is now being manufactured that can cover the patient, who without this drug would have to undergo some surgery or other operation or receive daily injections of another treatment. Patients and doctors will answer whether these characteristics will actually help the patient and the benefit to his health and quality of life will be greater than the value of the formulation."
If the characteristics of a preparation 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 same procedure will be followed for medical equipment. Let's say that now an effusion pump is being manufactured, which prevents the daily delivery of drugs by injections into the patient's body. Again, the question will be whether this product improves health and quality of life and is worth the money."
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 "must be ready within 30 days of the authorisation of the medicinal product or medical device by the European Medicines Agency (EMA) and as a result, Member States' health systems 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."
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