“Bulgarian Alliance for Precision and Personalized Medicine“/BAPPM/, is a non-profit legal entity, which unites medical and other specialists with experience and professional interest in the field of molecular, genome, precision, and personalized medicine.
Although there is a constantly growing interest towards the principals and methods of precision and personalized medicine from the medical community as well as from the healthcare institutions, no clear mechanism for its implementation in Bulgaria has been developed yet. The entire process of precision diagnostics, personalized treatment choice, monitoring of the effect, and assessing the outcomes (medical, financial and societal) is not provided and secured. Implementation of personalized medicine is still limited in oncology, hematology and certain conditions in cardiology.
However, there is still no commitment by the authorities for undertaking actual steps for development and implementation of sustained mechanism, securing the correct application of personalized medicine and its future development, and integration in the healthcare system. Currently, there is no algorithm for ensuring the entire process of precision diagnostics and personalized therapy, despite the adoption of some new regulations, directed towards the early introduction of innovative therapies, such as HTA /without acknowledgment of specifics of target therapies for the time being/, updating the procedures for clinical trials, raising awareness and respectively patient’s access etc. There were a number of separate, but sporadic and fragmented steps in this direction by ArPharm, scientific medical societies, national consultants, patients’ organizations etc. Unfortunately, they were not coordinated and as a result, even some of the updated regulations duplicate are missing and some are in contradiction to each other. Most of them are not generally accepted, often brought to court, lagged behind, and are still undergoing constant changes. This situation definitely hampers the consensus on key elements of the further development of personalized medicine in Bulgaria.
Taking into account the need for introducing specific, logically connected and complying with respective legal frame regulatory requirements and procedures, such as:
- Adoption of updated medical standards in medical genetics, clinical pathology, molecular pathology, and other medical specialties;
- Development of new clinical pathways/DRGs, based on the new standards;
- Update of therapeutic guidelines in the context of implementation of precision and personalized medicine;
- Adoption of clear criteria for diagnostic structures, performing molecular and genetic testing, incl. accreditation, certification, and external audit;
- Introduction of strict criteria for quality, compliance, relevance etc. of companion diagnostic tests, financed with public resources;
- Development and implementation of a HTA methodology, respecting specifics of target therapies, and personalized medicine;
- Introduction of HTA for IVDs and companion diagnostics in particular;
- Creation of registry and database for precision medicine and personalized treatment in Bulgaria;
- International research, clinical and real-world data collection and sharing;
- Continuous education and further qualification in the field of personalized diagnostics and treatment of medical professionals, resident doctors, and medical students;
and many more…
We have created a structure, which unites expertize and efforts of highly qualified specialists with proven record in different medical fields and specializations. Personalized and precision medicine is a multi-disciplinary approach in medicine, which crosses the lines of the current definitions for medical specializations and therapeutic areas. Their further development and implementation require joined actions and specific steps by various medical specialists and areas in medicine, pharmacy, healthcare management and health policy.
The founder-members of BAPPM are persons with highest qualification and unquestionable achievements – national consultants, chairs of scientific societies and leading specialists with proven record in the fields of implementation and further development of precision and personalized medicine.
For achievement for its objectives and in the scope of its activities, the Alliance:
- Develops and offers expert opinions and specialized programs in the field of precision and personalized medicine;
- Organizes public discussions, meetings, seminars and various education activities in the area of precision and personalized medicine, genomics, molecular biology and pathology;
- Develops and offers concepts and projects, relied to sustained development and complying with all international guidelines and requirements implementation of precision and personalized medicine;
- Initiates various activities for facilitating the timely access of Bulgarian patients to innovations in precision and personalized medicine;
- Cooperates with people and other national and international partner organizations with similar goals and scope of activities.
In its efforts for implementation and further development of precision and personalized medicine in Bulgaria, BAPPM works in cooperation and collaboration with EAPM, professional organizations, BMA, BPHU, research and academic societies, industry, institutions patients’ and other NGOs.