Report:F7c09ac7-5a3e-4c7a-b473-3d9d8205fecf

Facts & Figures

Bulgaria

Where

• Bulgaria

Research infrastructure

In 2019, there were 16,940 full-time researchers in Bulgaria (1). Bulgaria has 37 public and 14 private higher education institutions (2). There are 7 research institutes (3) and 14 centres of excellence and centres of competence (4). Bulgarian Academy of Sciences with 42 autonomous scientific units (5) and Agricultural academy with 24 research institutes, 4 scientific centres, 13 DS Research and production centres (6).

Research funding

In 2017, the gross expenditures on research and development were€389 million, which comprises 0.75% of the country’s GDP (7). Most funding was spent in the business sector (70.3%), government (23.2%), higher education (5.7%) and non-profit institutions (0.8%) (7,8). Bulgaria had 591 signed grants and 881 participations in H2020 projects receiving €143,6 million funding from H2020 (9) and 3 ERC grants receiving €2,42 million (9).

Research strategy

Bulgarian Ministry of Education and Science launched the National strategy for development of scientific research in the Republic of Bulgaria 2017-2030 (Better Science for better Bulgaria). One of the Strategy’s objectives is to transform Bulgaria into center for advanced research and development of new technologies, recover and raise its international status and prestige in science in order to keep talented scientists in the country. It also aims to achieve long-term economic growth and improve the quality of life in Bulgaria (10).

Research governance, compliance and integrity

The Ministry of Education and Science is an overseeing body for education and research in Bulgaria while the Parliament is the decision making a body for the higher education institutions. There is the Academic Ethics Committee under the Ministry of Education and Science (11). Bulgaria has Ethics Committee for Multi-Centre Trials (12) and around 150 local ethics committees, registered by the Bulgarian Drug Agency (12). These committees are established across different institutions (universities, hospitals etc.). Each committee has from 7 to 12 members from different fields of medicine and at least two non-medical members. Moreover, at least one member has to be financially independent of the institution. The work of local ethics committees and the Ethics Committee for Multi-Centre trials is supervised by the Central Ethics Committee which is responsible to the Council of Ministers. The Central Ethics Committee serves as an appeal body for cases that have been rejected by local ethics committees and Ethics Committee for Multi-Centre Trials, providing guidance to those committees (12,13).

Institutions have their codes or standard operating procedures that serve as a guide for ethics committees. For example, major universities have standard operating procedures for their ethics committees (12).

There are no research integrity officers in Bulgarian research institutions. With regard to investigation of alleged misconduct, this role is usually taken by ethics committees situated at universities, hospitals and research institutions. Academic Ethics Committee, established by Ministry of Education and Science, is responsible for handling cases of misconduct in academia (14,15).

Bulgaria has no legislation regarding whistleblower protection or legal definition of whistleblowing. The Administrative Procedure Code (applied only in the public sector) allows reporting corruption, mismanagement and other illegal or inappropriate acts that affect state or public interests. Moreover, the Law on Conflict of Interests states that anyone can report an alleged conflict of interest if he or she has information about violations in public office (16).

Bodies for RE+RI	Scope
Ethics Committee for Multi-Centre Trials	Deals with application assessment for the research that will be conducted in more than one institution in Bulgaria.
Central Ethics Committee	Gives opinions on deontological and ethical issues in clinical trials when approached by the ethics committees, Bulgarian Drug Agency or by the contracting authority.
Academic Ethics Committee	Deals with cases of misconduct in academia regarding award system, conflict of interest among science teams and detecting cases of plagiarism.

Laws and regulations

A number of laws regarding RE and RI are officially instated in Bulgaria (17).

Law	Scope
Law on Drugs and Pharmacies in Human Medicine (1995)	Regulates clinical trial activity in Bulgaria.
Health Law (2005)	Organizes and finances healthcare, patients’ rights, accessibility and quality of health care, mental health, alternative medical services, medical education, medical profession and medical science as well as administrative-punitive measures.
Medicinal Products in Human Medicine Act	Governs the procedures for placing pharmaceutical products on the market, clinical trials, manufacture and import of pharmaceutical products as well as active substances, their packing, classification, safety, sale, retail trade and export, advertisement and state control.
Medical Devices Act (2007)	Regulates advertising medicines and medical devices.
Law on the professional organizations of physicians and dentists (2007)	Regulates the structure, organization and activities of the professional organizations of physicians and dentists, the conditions for practicing the medical and dental professions and the liability for breaching professional ethics.
Ordinance No. 31 of August 12th, 2007 establishing rules for good clinical practice	Governs the principles and guidance for good clinical practice with regard to pharmaceutical products for human use intended for research.
Ordinance on the essential requirements and the procedures for conformity assessment to the essential requirements for medical devices referred to in article 2, paragraph 1 (3) of the law on medical devices	Defines essential requirements for the medical devices; the procedures for conformity assessment to the essential requirements and the technical documentation; the requirements for the notified bodies and for a risk analysis and risk management procedures for medical devices containing animal tissue which is rendered non-viable. It also defines the rules for classification of medical devices.
Ordinance No. 2 of February 5th, 2008 on the requirements for collection, validation and provision of information on unwanted side effects and on the content and format of emergency reports for adverse drug reactions and periodic safety reports	Specifies the procedures for collecting, verifying and reporting adverse drug reactions.
Code of professional ethics of doctors in Bulgaria (2000)	Defines the rules of professional medical ethics binding on every physician.
Ordinance No. 27 of June 15th, 2007 on the data requirements and the documentation for the authorization and the registration of medicinal products.	Determines the requirements for the data and documentation submitted for authorization or registration, extension, modification and renewal of the marketing authorization or registration under a national procedure, under mutual recognition procedure and decentralized procedure for all kinds of medical products. Medicinal products that fall within the scope of Regulation (EC) are not subject to this Ordinance.
Rules and Regulations of the Central Ethics Commission to the Council of Ministers on the Law of Medicinal Products in Human Medicine (2007)	Determine the conditions and the order for work of the Central Ethics Commission to the Council of Ministers under the Law on Medical Products in Human Medicine.
Rules for the procedure of the commission for professional ethics of Bulgarian Medical Association (2015)	Provides rules on the observance of professional-medical, moral and deontological issues related to the exercise of the profession.
Law for the Development of the Academic Staff in the Republic of Bulgaria	Regulates development of academic staff from the acquisition of degrees “doctor” and “doctor of sciences” to academic positions.
Rules for the Application of the Act for the Development of the Academic Staff in the Republic of Bulgaria	Regulates the public relations related to the acquisition of scientific digress and for holding academic positions in the republic of Bulgaria.
Rules for the Activity of the Commission for Academic Ethics	Examines cases of violations in the procedures for the award of academic degrees or academic positions, signals of plagiarism in doctoral dissertations, unreliability of scientific data or conflicts of interest in the formation of the scientific jury under the terms of Development of the Academic Staff in the Republic of Bulgaria.

Measures to promote good scientific practices and open science

RI training

To become members of a local ethics committee, candidates must finish training course and obtain the certificate. Moreover, members of the Multi-Centre Ethics Committee have to complete basic training regarding legal provisions (12). There are also annual training courses organised by Bulgarian Drug Agency (11). Ethics committees organise seminars and training but there is no information regarding their frequency.

RI dialogue and communication

Bulgarian Academy of Sciences promotes open access policy through conferences and meetings (18).

European Researcher’s Night is organised annually in different Bulgarian cities and aims to bring science closer to the general public. The event is composed of workshops and presentations to engage the general public in science by presenting scientific results and knowledge (19).

From its very first year (2011), Sofia Science Festival has attracted a large number of supporters. It is a space where there is no dividing line between culture and science. The Festival is a founding member of the Bulgarian Festivals Association (20). Apart from that, online journal Nauka.bg presents science results, policies and instruments in cooperation between the Ministry of Education and Science and Science Forum Association (21).

Although some interest in academic integrity and plagiarism was apparent in Bulgaria, the low teacher and management response rates demonstrate a reluctance to discuss this topic. No evidence of specific research was found within the country about academic integrity or of people actively trying to bring about changes to improve practices nationally or locally (22).

There is a small group of social scientists in the field of Science and Technology Studies (Bulgarian academy of science) who started working on Science ethics, Responsible research and innovation; Research integrity in 2002. At present there is training for young researchers: “Ethics in Science and technology”, which has been implemented in universities and research institutes.

The public perception of the role of RI in Bulgaria is low. This appears in many ways a more general problem in many European countries. However, interesting examples exist in which an all-party parliamentary consensus can be developed with both academia and business to secure widespread support for a major national effort on RI (23). Occasionally research integrity is discussed in the press.

RI incentives

The National Evaluation and Accreditation Agency is responsible for evaluation, accreditation and monitoring of the quality in higher education institutions and research organizations with aim of assuring high academic standards (24). There are also several annual rewards for researchers in different scientific disciplines.

Guidelines

Bulgaria

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Ana Marusic, Andrijana Perković Paloš, Elsa Amin contributed to this report. Latest contribution was Oct 24, 2021