26.03.2024 We are pleased to inform you, that the European Commission published the first two methodological guidance documents on its website under “Key documents”. These guidance documents were developed within the subgroup of the methodological and procedural guidance and they were endorsed by the HTA Coordination Group on 8 March 2024.
The documents are based on guidances developed within EUnetHTA21 where they were subject to public consultations.
- Methodological Guidance for Quantitative Evidence Synthesis: Direct and Indirect Comparisons
- Practical Guidance for Quantitative Evidence Synthesis: Direct and Indirect Comparisons
The guidances are available here:
https://health.ec.europa.eu/health-technology-assessment/key-documents_en?f%5B0%5D=topic_topic%3A225&f%5B1%5D=topic_topic%3A226&f%5B2%5D=topic_topic%3A227&f%5B3%5D=topic_topic%3A228
11.03.2024 Today, the European Commission launched an online public consultation on the draft Implementing Act on Joint Clinical Assessments of Medicinal Products.
This online consultation remains open for responses until 2 April 2024.
All interested individuals and stakeholders are invited to share their views!
The draft Implementing Act provides detailed procedural rules for the Joint Clinical Assessments. It also provides the format and templates of the submission dossier and the Joint Clinical Assessment report. Your contribution can provide important information and insights on the implementation of the EU Health Technology Assessment Regulation.
A Joint Clinical Assessment is a procedure for assessing the added value of a health technology, including its relative effectiveness.
The EU Health Technology Assessment Regulation tasked the European Commission with adopting implementing acts, detailing the procedural rules for the different steps in the Regulation.
This Implementing Act is the first of six planned Acts in 2024 for which public consultations will be held.
https://ec.europa.eu/newsroom/sante/newsletter-archives/51414
On 24.11.2023, Тhe National Council took part in the forum "The National Plan to Fight Cancer - Let's Lower a Barrier to the Disease", organized by the European Cancer Patient Coalition (ECPC), the Association of Cancer Patients and the Association of medical students in Bulgaria - Sofia, with the support of the Association of the Research-based Pharmaceutical Manufacturers in Bulgaria (ARPharM) and the German-Bulgarian Chamber of Industry and Commerce.
10.11.2023 New functionality of the mobile application. The National Council has updated the mobile application (MedicinePrice) to access data on the prices of medicinal products. A new functionality has been added - when searching for a medicinal product by trade name, it is possible to search for other medicinal products with the same international non-proprietary name (INN) from the result. This functionality is available for Android and iOS operating systems.
20.09.2023 A working meeting was held today in the National Council between Prof. Ilko Getov, Deputy Minister of Health, Dr. Desislava Velkovska - Director of the Directorate "Medicine Policy" in the Ministry of Health and the new composition of the NCPR. Joint institutional topics and future regulatory changes were discussed at the meeting.
20.09.2023 An event focused on the implementation of EU HTA Regulation with participants from Greece, Bulgaria, Cyprus and Romania was held on 18th September in Athens. As a representative of the NCPR, I had the opportunity to participate in the panel discussion: "The National perspective - Expectations, opportunities and challenges ahead" where together with local experts from each country we discussed the current state of play in each national system and the challenges we still have to overcome for the successful implementation of HTAR.
31.08.2023 – By Decision No. 581 of 31.08.2023 of the Council of Ministers, Prof. Dr. Mila Vlaskovska was released as the chair of the NCPR and in her place was elected Assoc. Dr. Silvia Terezova. Prof. Dr. Lyubomir Bakalivanov was elected as a member of the NCPR.
13.07.2023 A Bulgarian government delegation represented by the National Council on Prices and Reimbursement of medicinal products and the Ministry of Health took part in the "NICE International seminar on Digital Health Technologies Assessment Frameworks" together with their colleagues from Poland and Slovakia. The seminar took place in NICE's London office and was organised by the Science and Innovation officer for Poland, British Embassy Warsaw, and Emilia Pecheva, Science and Innovation officer for Bulgaria and Romania at British Embassy Sofia.
During the seminar, NICE representatives shared valuable knowledge and experience with the participants. They presented the process of establishing and updating of the evidence standards framework (ESF) for digital health technologies and AI and the use of real-world evidence for reducing uncertainties and improving the decision-making process.
We are grateful that we had the opportunity to be part of the seminar and exchange best practices.
30.06.2023 Participation of the National Council in the XV International Scientific Conference "E-Governance and E-Communications", within the framework of "Days of Science-2023 of TU-Sofia". The National Council, represented by Ms. Galina Stoeva - General Secretary of the NCPR and Mr. Georgi Sivchev - an information technology expert, took part in the XV International Scientific Conference on the topic: "E-governance and e-communications", within the framework of "Days of Science-2023 at TU-Sofia", with the participation of Mrs. Valentina Taneva - Advisor on Education, Science and Innovation to the President of the Republic of Bulgaria and Prof. Eng. I. Kralov - Rector of Technical University-Sofia. The National Council presented a report on: SPECIALIZED WEB SERVICES FOR ACCESS TO NATIONAL DRUG PRICES AND REIMBURSEMENT COUNCIL DATA.
31.05.2023 The National Council for the third year (2021, 2022, 2023) provided an Analysis of the collected and processed statistical information (with accumulation) for the period from April 1, 2018 to December 31, 2022 for Appendix 1 of PDL regarding medicinal products paid for home treatment and for the period from July 1, 2018 to December 31, 2022 for Appendix 2 of the PDL, regarding medicinal products applicable in the treatment of malignant diseases, paid for in hospital medical care beyond the value of the provided medical services. The analyzes are provided in fulfillment of the statutory obligation on the basis of Art. 31b, para. 6 of the Ordinance, based on which the Ministry of Health and the National Health Insurance Fund can make a proposal for the purposes of the effective spending of public funds. A new data analysis method was introduced for the first time in the Report, provided in 2023, as a result of the accumulated database since the beginning of the activity. Further fitting of real population characteristics to those of the clinical trial was performed using the Iterative Proportional Fitting (IPF) algorithm. This method was used for medicinal products for which a sufficiently large patient cohort was available in real-world data.
On May 9, 2023, the National Council on Prices and Reimbursement of Medicinal Products held at the Bulgarian Academy of Sciences a Scientific conference with the main aspects: "Introduction to the implementation process of Regulation (EU) 2021/2282 on Health Technology Assessment. Readiness for implementation and strategic direction. Monitoring the effect of therapy of innovative medicinal products. Methodology and achievements". The conference was attended by representatives of government bodies, non-governmental organizations, patient organizations and the pharmaceutical industry. On the occasion of the event, congratulatory addresses were received from Dr. Asen Medzhidiev - Minister of Health, Academician Lachezar Traikov, MD - Rector of Sofia University, from the Association of Research Pharmaceutical Manufacturers in Bulgaria, the Bulgarian Generic Pharmaceutical Association and HTA.bg Evidence Matters.
On April 26, 2023, the National Council for Prices and Reimbursement of Medicinal Products, represented by Mrs. Galina Stoeva-General Secretary, together with the Executive Agency for Medicines, represented by M.Sc. Pharm. Bogdan Kirilov - executive director, took part in a forum under the motto "Anatomy of innovations in healthcare", organized by Forbes Bulgaria, in a panel "Innovations and good practices in state administration", where they presented the achievements of regulatory bodies in the field of digitization and modern technologies in drug regulation.
20.03.2023 OPTION TO MAKE ELECTRONIC PAYMENT IN THE WEB PORTAL FOR ELECTRONIC ADMINISTRATIVE SERVICES
Dear Applicants, As of March 20, 2023, a technological possibility has been provided to make electronic payments for requested electronic administrative services, for which a state fee is due. The implemented integration with the Electronic Payment Environment (ePayment) is realized through an implemented module for electronic payment - a virtual POS terminal in the Web-portal of the NSCRLP. The provided possibility for electronic payment and electronic delivery determines the level of development of the provided administrative services of the NSCRLP at the highest fourth level of electronicization.
16.01.2023 The National Council, as of January 2023, is a full member of the HTA Agencies Group (HAG). Founded in September 2021, HAG is an independent group of 32 European health agencies and institutions working together to develop strategic cooperation in the field of health technology assessment. The rapid growth of the HAG is testament to the willingness of HTA institutions across Europe to collaborate in areas of vital mutual interest. In the process of implementing Regulation 2021/2282 on HTA, the European Commission and all members remain steadfast in their commitment to work together to develop strategic cooperation in the field of HTA.
22.12.2022 On 15 December 2021, Regulation (EU) 2021/2282 of the European Parliament and of the Council on Health Technology Assessment and amending Directive 2011/24/EU (HRT Regulation) was published in the Official Journal of the European Union . The Regulation on HTA, and in particular Art. 29 of it, foresees the creation of a Stakeholder network, which will support the work of the Coordination Group for HTA and its subgroups. The Stakeholder Network will be open to both civil society organizations and stakeholder organizations, in particular patient associations, consumer organizations, non-governmental organizations in the field of health care, health technology developers, as well as health professionals, incl. representatives of scientific circles. The purpose of the Stakeholder network is to facilitate the dialogue between all interested entities and the Coordination Group. This mechanism ensures transparency and stakeholder participation in one of the most important parts of the evaluation of new health technologies, namely their clinical evaluation, which will allow the public to express their position at a very early stage of their evaluation. On 12 December 2022, the European Commission published a Call for Expressions of Interest to join the Stakeholder Network at the following internet address: https://ec.europa.eu/newsroom/sante/newsletter-archives/42515
Full information on the requirements, criteria and documents for participation are available at the following link: https://health.ec.europa.eu/consultations/call-applications-selection-members-health-technology-assessment-stakeholder-network_en.
Interested parties can submit applications until 17:00 (CET) on 17 February 2023 to the following email address: This email address is being protected from spambots. You need JavaScript enabled to view it.
14.12.2022 The National Council informs you that a mobile application ("MedicinePrice") is available on the Google Play Store to access data on medicinal products. The mobile application provides options for checking the price of a medicinal product by trade name or by International Nonproprietary Name (INN). An additional possibility has been created to scan the bar code (GTIN number) from the medicinal product packaging through the camera of the mobile device, by means of which the data for a given medicinal product is extracted. The possibility to scan the barcode from the packaging of the medicinal product is currently introduced only for medicinal products that are included in the Positive Medicines List (paid for with public funds) and for which the holders of the authorizations for use have fulfilled their obligation to enter the GTIN number for the respective medicine. The mobile application uses up-to-date data from the database in real time, enabling citizens to be informed about the state-regulated limit and maximum sales prices of medicinal products dispensed without a doctor's prescription. The mobile application is currently being tested for the Apple operating system.