Deyan Denev, Director of Association of Research-based Pharmaceutical Manufacturers in Bulgaria (ARPharM)
In recent years, the pharmaceutical industry has provided significant assistance to the healthcare system. What are the dimensions of this assistance?
The main contribution of the research-based pharmaceutical industry to Bulgarian healthcare is the provision of new classes of medicines that bring more clinical benefits, improved overall survival and more years of quality life. According to an analysis of health outcomes, the total number of quality-adjusted life-years added for the 126 000 patients treated with innovative drug therapies paid for by the NHIF reached 1 241 000, or nearly 10 years on average per patient. There are increasing numbers of patients receiving treatment for cancer with targeted or immunotherapy; for psoriasis, rheumatoid arthritis, psoriatic and entheopathic arthropathies with biologics from the interleukin inhibitor group; for diabetes mellitus with incretin-based therapy, SGLT-2 inhibitors, GLP-1 receptor agonists and fixed combination therapy with long-acting analogue insulins; with enzymes for drug therapy of patients with rare diseases, for spinal muscular atrophy and related syndromes, for the treatment of Duchenne-type muscular dystrophy; with innovative therapies for atrial fibrillation and flutter, for stroke prevention and systemic embolism, for routine prevention of recurrent attacks of hereditary angioedema; for cystic fibrosis; for macular degeneration and for diabetic retinopathy, and many others.
What should be done so that the Health Insurance Fund's rebate system does not limit the timely entry of innovative medicines in Bulgaria?
In 2025, the NHIF will pay for medicines worth nearly BGN 3.3 billion, but the budget for this is only BGN 2.3 billion. The NHIF will ask the pharmaceutical companies to pay it back. This "hole" in the budget is getting bigger every year and generates a significant financial risk for the pharmaceutical companies, which may lead to difficulties and delays in the payment of medicines by the NHIF, as well as withdrawal from reimbursement of some products due to the complete withdrawal by the NHIF of the revenue from the sale of the respective quantities that formed the growth, the imposition of an obligation for free supply and even the imposition of a negative price.
It is obvious that the mechanism to control the cost of medicines needs to be optimised. Do you have any specific suggestions?
Currently, the NHIF transfers the risk of annual budget deficits for health insurance payments for medicines to private entities such as pharmaceutical companies, which is unacceptable. There is a need for optimisation in the direction of sharing (rather than full transfer) of insurance risk and placing the compensation mechanism within the limits and scope established by the Constitution.
Are the financial resources of the Health Insurance Fund for medicines allocated fairly?
Until 2024, the financial resources of the NHIF for medicines were divided into 3 groups, and from 2025 the groups became five. Through selective grouping and preferential budgeting, ways are being sought to reduce the burden of the mechanism on certain drug suppliers. However, this is at the expense of increasing this burden for other suppliers. In this sense, the increase in the number of groups runs counter to the basic principles of equality of treatment for the marketing authorisation holders - the partners of the NHIF.
What is your opinion on reducing VAT on medicines?
Bulgaria, along with Denmark and Germany, are the three EU Member States where the full VAT rate is also imposed on reimbursed medicinal products. In all other countries the rate is differentiated. Reducing VAT on medicines is guaranteed to free up resources for the NHIF and households, as long as all elements of the price of a medicine are regulated.
Do you support the practice of the NHIF or the Ministry of Health to make a single tender and to negotiate the most favourable prices, volumes, terms of delivery of oncology drugs on the basis of preliminary orders of hospitals? They should receive and report them according to the relevant rules and controls, and the NHIF or the MoH should pay for them at the prices they themselves have agreed?
We support framework contracting of medicines by a centralised body to maximise value for money. However, hospitals themselves should determine the quantities of medicines according to the needs of their patients.
