The New Therapies: Will They Be Available Here?

You have been the chairman of the Management Board of ARPharM for almost a year: How do you assess the past period and what conclusions have you drawn about the state of the sector in Bulgaria?

The year has been very dynamic – with a lot of work and a clear goal: to establish the sector as a reliable partner to institutions and society. My conclusion is that Bulgaria has real potential – we have exceptional specialists and expert centers, with good experience and a stable foundation in clinical trials, as well as evidence that when there is dialogue, workable solutions can be achieved. At the same time, the system remains vulnerable: Bulgaria is among the countries with some of the lowest net public spending on medicinal treatment per person in Europe, funding is highly unpredictable, and the rules often hinder the introduction of innovations. If we want sustainable healthcare, we must view medicines and innovations as an investment, not as an expense.

How would you describe access to innovative therapies in Bulgaria today and do Bulgarian patients have timely access to the latest therapies? Where does Bulgaria stand compared to Europe in terms of access to modern treatments?

There has been progress – in some therapeutic areas, patients are already receiving modern treatments that were previously unattainable. But “timely access” is still not a standard. On average, the time from European approval to actual access for Bulgarian patients is longer than the EU average – we are talking about approximately 768 days in Bulgaria compared to about 578 days on average in Europe and 445 days for EU4 (Germany, France, Italy, and Spain). This means nearly two years and more waiting for treatment, and for some diseases, patients simply do not have that chance - the cost of that time is measured in human life.

There is also a second aspect – not only how quickly, but also whether new therapies become available at all. Data from international comparisons such as Patients W.A.I.T. Indicator show that in countries like Bulgaria, only about half of the newly approved therapies in the EU actually reach patients for the periods analyzed, while some of the rest arrive later or with prescribing restrictions or never reach Bulgarian patients.

My position is clear: patients in Bulgaria must have a chance for treatment according to European standards – not later and not “when resources are left”.

What are the main barriers that delay the introduction of innovative medicines in our country? Is there a risk that Bulgaria will remain at “second speed” regarding new therapies?

There are several barriers, and they accumulate on top of each other.

First – pricing policy: here, the price is referenced to the lowest in a group of 10 reference countries, i.e. in practice, the lowest price from the manufacturer in Europe, and Bulgarian prices are visible and used as a benchmark for other countries. This makes small markets like ours sensitive and sometimes leads to delays in the introduction of new therapies.

Second – the budget framework and mechanisms for compensating deficits: when financial risk is disproportionately transferred onto companies through unlimited payback obligations, the system becomes unpredictable for the payer (the state), for suppliers, and ultimately – for the patient.

There are also many specific numbers behind this: in 2024, the NHIF paid pharmacies and hospitals for medicinal products worth approximately 2.760 billion BGN (including VAT), with budget funds for medicines around 2.015 billion BGN – i.e. a difference of approximately 745 million BGN, which has been covered through discounts and compensations from pharmaceutical companies. Only in 2024, the additional discounts and compensations to the NHIF exceed 800 million BGN – approximately 29% of expected payments. For 2025, this burden approaches 1 billion BGN, i.e. over 30% on average. To illustrate it another way – the NHIF reimburses the medicines that physicians have prescribed and patients received in pharmacies and hospitals until mid-August ... After that, the treatment of Bulgarian patients is “subsidized” by the industry until the end of the year ... this is not the best example of sustainability, right?

The problem is not in the principle of negotiation, but in the lack of reasonable boundaries and predictability – because due to the way the mechanism for sustainability and predictability of the NHIF budget works, in individual cases, it can lead to economic absurdity: obligations to the NHIF that exceed revenues from sales of the respective therapies. This is a direct risk to the sustainable presence of innovations in our market.

Third – the administrative deadlines and processes that remain long and difficult to plan. This is a “Bulgarian syndrome” that we all see in every administrative process we have to face daily.

Fourth – the highest VAT in Europe on reimbursed medicines (20%), which “eats up” resources from already limited budgets.

Yes, there is a risk that Bulgaria will remain at “second speed” or even “out of the calculations” if we do not make the system more predictable and if we do not treat innovation as a strategic investment in health, productivity, and the economy. This means therapies reaching first “predictable” markets and considering their launch here as a second, third, or as a whole next stage or never.

What are the real consequences for patients when access to innovations is delayed? What choice does Bulgaria face today when we talk about access to innovations in healthcare?

When access is delayed, these are missed opportunities for a longer and better quality of life and this is not abstract statistics. In many diseases, an early start of the right therapy means fewer complications, fewer hospitalizations, fewer disabilities, and a greater chance for a person to remain active – in his family and at work. And when patients do not receive the best available treatment on time, the system often pays “later” – with more hospital costs, social payments, and lost productivity. The choice for Bulgaria is whether we will continue to “patch” with short-term measures and risk transfer, or we will create predictable rules and sustainable financing so that innovation reaches people on time.

There is also strong data on the benefits when access is expanded: according to analyses of health outcomes, for about 126,000 patients treated with innovative therapies funded by the NHIF, the total number of added years of life in good quality reaches approximately 1,241,000 – nearly 10 years on average per patient. These are real human years of life in better health, not “paper expenditure”.

An interesting statistic is that innovative therapy is responsible for 73% of the increase in life expectancy, achieved during the period 2016–2023 in member countries of the Organisation for Economic Co-operation and Development (OECD). Do we want to allow ourselves to miss this opportunity here?

What is the role of the state in accelerating this process and where do you see the biggest deficits?

The role of the state is key, because it sets the rules and ensures predictability. The biggest deficits I see are: lack of sufficient transparency and a medium-term framework in health budget planning; frequent changes and “firefighting” solutions; and models that do not link costs with clear health priorities and outcomes. Where is the Health Strategy of Bulgaria actually implemented? Nshould this be prioritized in the health budget?

When there is no predictability, everyone loses – institutions, businesses, and patients.

The solution lies in partnership: the state, NHIF, medical organizations, patient groups, and industry must work towards a common goal for better health outcomes for patients with sustainable financing.

Is a change in the regulatory framework necessary and which specific reforms are most urgent?

The short answer is: Yes! If we want faster access and sustainability, change is necessary.

The most urgent reforms in my opinion are:

(1) a predictable and balanced model for sharing financial risk, including a clear cap on total payback obligations and mechanisms that do not disproportionately penalize innovations;

(2) more transparent and shorter timelines for assessment and reimbursement, aligned with European requirements;

(3) better protection of the confidentiality of net prices – for example, by separating discounts from publicly visible list prices to reduce negative effects from external reference pricing;

(4) a review of VAT on reimbursed medicines, because high tax directly reduces the resource for treatment;

(5) strict implementation of the new European regulation on health technology assessment and accelerating access to Bulgaria, so that our country does not become a “last stop” for innovation.

What is the role of clinical trials and how can Bulgaria attract more of them? What do patients and the health system gain from more active participation in clinical studies?

Clinical trials are one of the most direct ways for patients to gain early access to the latest therapies under strict medical supervision. They bring solid investments, training, and experience for medical teams, as well as data that improve real clinical practice.

To attract more trials, Bulgaria needs faster and digitized administrative procedures, clear deadlines, predictability, support for research centers, and an active national policy to attract R &D investments, such as tax incentives. This is beneficial for everyone: patients get a chance for therapy, the system – knowledge and resources, and the country – reputation and economic effect.

Is the Bulgarian system ready to implement high-tech and “expensive” therapies?

Directly – while they are considered “expensive” they will simply be an expense ... the moment their potential contribution to health in good quality and benefits for the economy is assessed, they will turn into an investment.

The system can be ready – but readiness is not just a matter of price, but of organization. High-tech therapies require clear pathways for diagnosis and monitoring, centers with capacity, quality data, and payment models that account for patient outcomes.

If the framework is unpredictable and the budget is chronically under pressure, implementation becomes difficult. Therefore, the key is to have long-term planning and transparent rules, so we can introduce modern therapies sustainably, focusing on the effect: fewer disabilities, fewer hospitalizations, and a better life.

What needs to change for Bulgaria to become more attractive for investments in the sector?

Investments follow predictability. If we want Bulgaria to be more attractive, we need to reduce regulatory and financial unpredictability: a stable budget framework, predictable rules for payback with a reasonable cap, faster and clearer procedures for assessment and reimbursement, and policies that do not “push” resources from treatment to taxes and administrative burdens. At the same time, it is important to build on our strengths: good medical specialists, potential for clinical trials, digitization, and working with data. These are the conditions under which the sector can invest more in research, training, partnerships, and real solutions for patients.

If you had to summarize in one sentence what your vision for the future of access to innovative therapies in Bulgaria would be, what would it be?

The goal is clear: innovations must reach Bulgarian patients on time, predictably, and sustainably – to European standards, with rules that encourage medical progress, not hinder it.