• October 2, 2015

    Doctors specializing in Medicine will have a right to a contract with the NHIF was decided by the MPs yesterday, when they accepted the amendments to the Law on Medical Institutions. This way they made the promise of the Health Minister Petar Moskov, which he made to the doctors in the campaign “Young Medic”, become a fact.

    Specializing doctors currently do not have the right to work with the Fund and this is the reason why hospitals find it difficult to provide the necessary funds to ensure they have good salaries. However, this will change with the changes and clinics will want to recruit young physicians on staff. Furthermore, the MPs adopted the opportunity for emergency doctors to work more flexible shifts, and in the areas where there are no clinics, physicians are required be on duty at least 10 hours a week.

  • The Health Insurance Fund will finance hospitals only according to the needs of the population

    The Health Insurance Fund will not finance all newfound hospitals and will base its decisions on the National Health Card, which will have an obligatory nature. It will list the needs of the regional population. This was the bottom-line decision of the Parliament when adopting the amendments to the Law on Medical Institutions.

    GERB listened to the promise of Prime Minister Borisov to provide support for the health reform of Minister Petar Moskov. The most important changes which concern the funding of hospitals will be solved with the regulations and methodologies of the Health Ministry. It will depend on the Health Minister whether the NHIF will refuse hospital contracts and which hospitals will that be, and whether the government and private hospitals will be forced to unite and for what. Currently Bulgaria has twice as many hospital beds as the EU, and according to the statistics, every fourth Bulgarian is hospitalized once a year, and in practice such people are subjected to treatment not necessarily or even needlessly.

    The National Health Card will have an obligatory nature. It will describe by districts the population medical attention needs. How treatment needs in specialties and hospitals will be determined will be recorded in the methodology of the Health Ministry. The Fund will not finance all institutions in the regions where there are more hospitals than population needs. The criteria by which the NHIF will decide with whom to form a contract and who will remain without funding, will be described in an ordinance. Minister Moscow claims that hospitals that provide comprehensive treatment and do not focus only on well-funded activities by the NHIF will receive priority funding.

    The law provides that the treatment which paid by the NHIF is divided into two packages – Basic and Additional. For the diseases of the Basic package, a comprehensive treatment of which will be provided, the Health Fund will only enter into contracts with hospitals or groups of hospitals that can provide this. Minister Moskov explained that his idea of comprehensive care will be enacted into an ordinance for cancer, the most common cardiovascular diseases and for some rare diseases starting next year. The aim is to have comprehensive care provide for the whole Basic package within the next 3 years.

    The proposal of the Health Minister was the care in question to be provided in one place, i.e. either in a hospital or a group of hospitals. But the majority adopted a softer text according to which hospitals will able to enter into contracts with each other to receive funding from the NHIF for complex care, without merging.

    The idea is, for example, in cancer patient treatment to have at any stage a guarantee for surgery, chemotherapy and radiotherapy, and not to receive surgical treatment in one hospital, and infusions – in another, where the person arranges the stay by himself. The NHIF would not pay all hospitals for the reported treatment covering 3 clinical pathways, and would enter into a single contract for all the treatment needed in one. That is, either all pathways would be paid for, or none. Hospitals would have to arrive at an understanding whether to group into holding companies or unions under the Trade Act, or to enter into contracts among themselves and decide who would receive how much funding.

    The opposition is concerned that if the state, municipal and private hospitals begin to make associations this would lead to siphoning money. But according to Moskov, the idea is that hospitals, dealing only with chemotherapy, for example, would not be able to receive money directly from the Fund, as well as that consolidating would help downsize the administration.

    The idea which caused protests in the summer – that oncology, psychiatric and skin outpatient facilities should merge with the other hospitals – was dropped once and for all. Hospital accreditation will be required in order to land a contract with the NHIF, as it is now, and directors of hospitals are still required to have a qualification in Health Management.

    What will the packages contain?

    By the 15th of September it should become clear what the Basic package would contain and what the Additional one would contain, said Deputy Health Minister Vanyo Sharkov. The diseases from the Basic package would be the main priority and, according to the promises of Moskov, there would be 100% guaranteed funding for them, while those from the Additional will receive less money than now and the treatment would have to wait. The Basic package would include child and maternal health, strokes, cardiology, cardiac surgery and interventional cardiology, traumatology and neurosurgery. Regarding the Additional package what is clear for the time being is that it would contain the “pimples” in the words of Sharkov – i.e. the non-essential diseases. Most one-day eye surgery would be transferred from hospital to outpatient care. The Basic package was also not defined in a law, and the determining of its contents was left entirely to the Ministry of Health.

  • September 1, 2015

    For the first time the Republic of Bulgaria, as a Member State of the EU, will be the reference country in the decentralized procedure (DCP) for Marketing Authorisation for a medicinal products with applicant Tchaikapharma High Quality Medicines Inc., Bulgaria. The concerned parties in the procedure are Austria, Greece, Portugal, Romania, Slovakia and the Czech Republic.

    As a reference party to the procedure the BDA will assess the dossier for Marketing Authorisation for medicinal products (fixed combination) with active ingredients ramipril and amlodipine. A team of the BDA will prepare evaluation reports, including questions to the applicant at any stage of the procedure. The evaluation will be consistent with the requirements of current Pharmacopoeia (Ph.Eur.), the Guidelines of the International Committee on Harmonization (ICH) and European guidelines on quality, safety and efficacy of medicinal products.

  • July 14, 2015

    Bulgarian Drug Agency issued a new Marketing Authorisation to Tchaikapharma High Quality Medicines Inc. for the medicinal product for treatment of diabetes mellitus Aroba 100 mg tablets.

    Aroba contains the active substance acarbose, and belongs to the group of medicines called alpha-glucosidase inhibitors. It is used as supplement treatment concomitantly with diet in patients with diabetes and for the prevention of type 2 diabetes in patients with demonstrated impaired glucose tolerance. The dosage should be individualized for each patient by the doctor as the efficacy and tolerability vary from individual to individual.

    ATC code: A10BF 01

    More information about Aroba can be found here.

  • July 13, 2015

    The Guardian wrote that the Scientists had found that two licensed drugs stopped the degeneration of the brain in mice. The discovery gives hope of success in the search for drugs for the therapy of Alzheimer’s disease.
    The results, presented at the annual conference of scientists researching Alzheimer’s disease, were defined as “promising” because the drugs used were already proven safe and well accepted by the human body. This can save years in the process of development and approval of new drugs.
    Giovanna Maluchi of Cambridge University said: “This is really exciting. Medicines are licensed. This means that we go directly to the underlying clinical tests on a small group of patients, since no new ingredients, these are known drugs.” The scientists have decided not to disclose the names of the two drugs that are not currently used for the treatment of dementia in order not to cause testing from patients before the clinical trials prove their effectiveness.
    The discovery is based on key study conducted two years ago, which proves that the death of brain cells can be stopped in mice by switching off the wrong signal in the brain, stopping the production of new proteins. However, the study had used a composition that causes serious side effects and was not suitable for humans. Both drugs had been identified after Maluchi’s team had examined hundreds of licensed drugs in search of a safe drug with the same protective effect on the brain.
    The researchers point out that before the clinical trials a research would be conducted that would confirm that the same error signal, which was treated in mice, caused degeneration and memory loss in Alzheimer’s disease. Maluchi said that if the study would be conducted as soon as possible and would confirm that connection, the clinical trials could begin within a few years.