Dr. Evgeni Tassovski, Executive Director of the Bulgarian Generic Pharmaceutical Association (BGPharma)
In recent years, the pharmaceutical industry has provided significant assistance to the healthcare system. What are the dimensions of this assistance?
In the civilized world, it is not possible to have healthcare systems without medicines produced by the pharmaceutical industry. Innovative - to create life-saving and life-extending medicines, and generic - to produce proven life-sustaining medicines for mass ailments at affordable prices. Innovative drugs are very expensive (especially modern targeted therapy) and place a heavy burden on health insurance funds, which pay for them in full, while generics, which are regulator-guaranteed exact copies of the innovative ones, are much more affordable once their patent protection is removed, but most are co-payable from family budgets. This is the reality of the health insurance system in our country. The budget for oncology medicines for 2025 has reached the colossal sum of BGN 1.61 billion for 35 000 patients, and BGN 380 million for home treatment medicines for nearly 2 million Bulgarian citizens, more than half of whom are of working age. The large expenditure on medicines necessitated the creation of a Sustainability Mechanism and the reimbursement of overpayments to the NHIF by drug manufacturers.
What should be done so that the Health Insurance Fund's rebate system does not limit the timely entry of innovative medicines in Bulgaria?
The rebate system and the Reimbursement Mechanism cannot at all prevent the rapid penetration of innovative medicines in our country. Bulgaria is one of the leading EU countries in the introduction of innovative medicines. Even the reimbursement of 100% of the cost for the first year of entry into reimbursement is not an obstacle. The profit margin for these medicines is very significant and such restrictions do not affect them. The difficulties are with generic medicines, which have a relatively very small profit margin and these so-called additional financial burdens force them to leave the Bulgarian market. This is currently the reality for antineoplastic drugs, the first-line chemotherapeutics for the treatment of cancer. The first stage of treatment is lacking and not provided, especially for children with oncohematological diseases. This must not be allowed!
It is obvious that the mechanism to control the cost of medicines needs to be optimised. Do you have any specific suggestions?
The rebate system and the so-called mechanism require a new examination and the creation of more flexible differentiated rules so that important low-priced medicines do not leave the Bulgarian market and the rule "who overspends more, reimburses more" is applied. An extremely important element is the control of the implementation of contracts between the manufacturing companies and the NHIF regarding the compliance with the commitments made on the size of the costs, according to the Health Technology Assessment. Ineffective controls lead to increased overspending without serious consequences. Spending growth for oncology and other expensive innovative therapies over the past 5 years has hovered above 15% and reached as high as 24%. A tipping point is being reached where the NHIF budget is unable to cover the rising costs of innovative medicines, mainly in oncology.
Are the financial resources of the Health Insurance Fund for medicines allocated fairly?
Since the beginning of the establishment of the NHIF, the philosophy of the rules for payment of medicines was to reimburse expensive innovative medicines that were inaccessible to citizens due to their high cost. Gradually, the scope of reimbursed medicines increased, but to this day, the most disadvantaged citizens are those suffering from massive, mostly cardiovascular diseases such as arterial hypertension, vascular heart disease and central nervous system diseases, leading to the highest mortality. The last three EC reports on the state of health care in Bulgaria concluded that Bulgarian citizens pay the most for medicines for home treatment - over 45%. This led to the positive social measure of the previous government to increase to 100% the reimbursement of 409 medicinal products of 53 INN /molecules/ for the treatment of the diseases cited above. What is needed is, first, a thorough analysis of the imbalances in the allocation of NHIF funds for medicines, identification of specific reasons that have led to this, and measures and reforms to address them.
One direction is to expand the scope of medicines for other diseases for home treatment, which should be reimbursed at 100% (respiratory system, neurology, etc.), but with financial resources provided by the NHIF. Generic manufacturers cannot bear this additional financial and social burden.
The other direction is the search for additional sources of financial resources, and there has long been the idea of creating a mixed-source fund for the treatment of citizens with high-cost rare diseases. This could lead to a relative easing of the NHIF budget.
What is your opinion on reducing VAT on medicines?
Reducing the VAT on medicines can have a positive effect by reducing the final cost of medicines in a pharmacy for citizens. The prices of medicines are strictly regulated and controlled, and VAT is added to the final price. When it is less, the price will certainly be more advantageous for citizens. It should be borne in mind that this applies only to prescription medicines. For food supplements and so-called OTC products there is no regulation and price control. They are on the free market, and there is no guarantee that lowering VAT will lead to a reduction in price.
Regarding the medicines paid by the NHIF, the fall in VAT will deprive the state budget of significant revenues. The only useful consequence will be to show objectively the amount of money spent on medicines from the NHIF budget. Currently, 26.5% of the NHIF budget is spent on medicines, which is above the EU average.
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 MoH should pay for them at the prices they themselves have agreed?
An attempt to pass such a reform concerning the NHIF was made two years ago, but the complaints reached the EC and it was found that the legal basis does not allow the NHIF to conduct tenders.
The actual practice in EU countries is to conduct common broad tendering procedures for all medicines paid for by public funds. These tenders are managed by the respective Ministries of Health. In this country, the so-called Single Electronic Tender was launched several years ago, but it was not operational for more than a year and, due to accumulated complaints from wholesalers, it was blocked. It is now moving towards the possibility of a positive court decision and the restoration of the electronic centralised auction.
It's always the little pebbles that tip the car over. It is high time to draw up precise tendering rules according to a European model and to do away with the not infrequent opportunities for legal challenges and suspension of the tendering procedure. Problems are often created by ignorance and lack of professionalism, but sometimes also by astonishing silence.
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