Gergana Aneva - Managing Director of Rud Pedersen Bulgaria: Transformation in the Pharmaceutical Sector, New EU Regulations, and Bulgaria's Place on Europe's Health Map

In the dynamic context of new European regulations and increasing pressure for modernization, the strategic role of public policy consulting firms is becoming increasingly pivotal.

Rud Pedersen Public Affairs – Bulgaria is part of a leading independent European strategic consultancy group. With 20 offices in 19 countries and an active client base of 300–500 companies and organizations, Rud Pedersen’s mission is to assist in the successful navigation of the rapidly changing regulatory environment and to turn complexity into opportunity.

We speak with Gergana Aneva, Managing Director of the company in Bulgaria, about the transformation in the pharmaceutical sector, new EU regulations, and Bulgaria’s place in the future European health architecture.

I. THE EUROPEAN TRANSFORMATION – THE NEW RULES OF THE GAME

The European healthcare system is on the threshold of a major change. New regulations, digitalization, and the pursuit of more sustainable policies are changing the way pharmaceutical markets develop and how access to innovation is managed.

Ms. Aneva, how would you describe the main changes occurring in the pharmaceutical sector – both here and in Europe?

Gergana Aneva: As early as 2023, the EU launched the first comprehensive review of pharmaceutical legislation in 20 years. The goal is to ensure that Europe remains a competitive hub for pharmaceutical innovation, sustainable supply chains, and timely patient access to therapies.

The main changes are moving in three directions:

First, regulations are being modernized with stricter standards for safety, transparency, and health technology assessment. The good news is that Bulgaria is gradually synchronizing with these European practices, especially regarding access to and reimbursement of new therapies.

Second, accelerated digitalization. It is changing the way health data is collected and treatment outcomes are tracked. In Europe, this is a key driver of personalized medicine; in our country, it is also progressing, albeit step by step.

Third, sustainability and economic efficiency are becoming central. Assessing the value of medicines and rational budget management are directing the industry toward innovations that are both clinically effective and economically justified.

What are the leading topics at the European level at the moment?

Gergana Aneva: I would emphasize three topics that stand out most clearly to me: the digitalization of health data, the responsible implementation of artificial intelligence, and unified European standards for Health Technology Assessment (HTA).

The European Health Data Space (EHDS) is sector-specific legislation regarding health data that came into effect on March 26, 2025. Its goal is to create a new and decentralized EU infrastructure for the secondary use of health data and to integrate and standardize access to health data across the EU. This promotes the creation of a true single market for digital health products and services and represents a massive opportunity for research and innovation, but it also imposes serious requirements for data protection and cybersecurity – factors that businesses must manage strategically.

The EHDS will allow individuals to control their health data, whether in their home country or another member state, but simultaneously, the cross-border sharing of data for secondary use provided for in the regulation will require all 27 member states to more closely synchronize their national interpretations of the General Data Protection Regulation (GDPR).

The Artificial Intelligence Act (AI Act) introduces a clear framework for the safe and responsible use of AI in healthcare. It requires transparent algorithms, safety guarantees, and strong human oversight, especially in decisions related to diagnosis and treatment. Penalties for non-compliance are significant – up to €35 million or 7% of a company’s global turnover. For companies, this is an opportunity to integrate AI into their processes, but also a signal that unregulated solutions will no longer be acceptable, necessitating careful planning of technological solutions.

And last but not least, the Health Technology Assessment Regulation (HTA Regulation) establishes a pan-European methodology for assessing the clinical and economic value of new therapies. The regulation provides predictability in the assessment of new therapies and should form clearer criteria for businesses when planning portfolios and investments. It also facilitates patient access to innovation.

Collectively, these initiatives shape a new framework for innovation. For business, this is a period of adaptation – it must be simultaneously fast, digitally competent, and ready to prove the value of its products. For patients, the result is safer and faster access to new, effective therapies.

What will the EHDS change specifically for our region?

Gergana Aneva: In the EU, the conditions for access to data for secondary use are currently highly fragmented.

Most countries lack national legislation regulating the use of health data, quality varies, and interoperability remains a universal challenge.

Up to two-thirds of EU member states have a strong regional component in the distribution of competencies for planning and providing public health services, which means that a single model of centralized national EHDS management will not be suitable for all countries.

Awareness of the EHDS is low among both institutions and medical professionals. Many national structures are not yet undertaking the necessary preparations for their future role as data holders. It is necessary to build culture, trust, and technological capacity.

Bulgaria is no exception. The EHDS will lead to a significant transformation – gradual, but inevitable. The way health data is managed and used in our country will change. We will have to ensure that electronic prescriptions, images, laboratory results, and discharge reports are issued and accepted in a common European format. Under strict conditions, researchers, innovators, public institutions, and industry will have access to large amounts of high-quality health data for research, innovation, and the optimization of health services. For business, this brings both data protection and security requirements, as well as opportunities for faster development and collaboration at the European level. And patients will feel the effect through better coordination of treatment, more accessible personalized therapies, and more efficient use of resources.

In essence, the EHDS places Bulgaria at the center of the European digital transition in healthcare.

II. DIGITALIZATION, DATA, AND ARTIFICIAL INTELLIGENCE – A BALANCE BETWEEN ETHICS AND INNOVATION

How will the AI Act affect the healthcare sector?

Gergana Aneva: One year after the AI Act came into force, the European Union has a unique opportunity to take a leading role in the responsible use of AI in healthcare, but for the health sector, there are practically some challenges along the way.

The regulation applies horizontally to all sectors. In this way, it covers systems used in healthcare but does not establish separate sectoral rules. The AI Act adopts a risk-based approach: the higher the risk, the stricter the requirements.

According to the Regulation, AI systems are classified into four risk categories: minimal, limited, high, and unacceptable, with corresponding obligations increasing with the level of risk. In the healthcare sector, high-risk systems include: AI systems for biometric categorization, determining eligibility for healthcare, and emergency patient triage.

Compliance requirements for high-risk systems include: establishing a comprehensive risk management framework; ensuring data quality, integrity, and security; maintaining detailed records of the AI system’s functionality and compliance; providing clear information on the AI system’s capabilities and limitations; and implementing measures to ensure appropriate human oversight and intervention.

If the AI Act is implemented without sufficient coordination with existing medical-technological regulations, it could lead to delays in patient access to safe and effective technologies.

For example, professional organizations represented at the European level are working toward having the EC and member states extend the full application date for AI systems falling under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) to August 2, 2029, to ensure sufficient time for finalizing guidance, homogeneous standards, designating competent national authorities, and preparing the entire health-tech ecosystem.

Time is also needed to confirm that Notified Bodies under the MDR/IVDR can perform conformity assessments and to introduce AI-specific technological codes to facilitate the process.

In conclusion, it can be said that the AI Act is an important regulatory step – an ambition deserving of admiration, but it requires a focus on the healthcare sector to address its specificities. It is necessary for the regulatory approach to be coordinated, predictable, and tailored to the specific needs of the sector, ensuring compatibility with existing regulations.

The challenge lies in balancing strict safety and ethics provisions with the speed of global innovation. The EU is a leader in regulation and ethics but lacks market flexibility.

Can we accelerate access to new therapies through EHDS and real-world data from practice?

Gergana Aneva: Yes, that is precisely one of the greatest opportunities that the European Health Data Space will open up – the use of Real World Data and Real World Evidence for faster decision-making regarding access to new therapies.

This means that information collected in daily clinical practice – for example, on the effectiveness, safety, or economic impact of a given treatment – can be used in health technology assessments and regulatory processes. Decisions will no longer be based solely on clinical trials, but also on results from the actual healthcare system.

For Bulgaria, this is a chance to take a step toward a smarter, data-driven policy for access to treatment. If we manage to build a reliable data system and trust between institutions, industry, and society, Bulgaria can realistically accelerate the path from scientific discovery to the patient.

How does Bulgaria fit into this digital transformation?

Gergana Aneva: Bulgaria is increasingly positioning itself as part of the European digital transformation in healthcare, albeit with some delay. In recent years, we have seen progress – the introduction of the electronic health record, electronic prescriptions, and directing efforts toward better connectivity between medical facilities and institutions are important steps.

The real challenge, however, is not just the introduction of technology, but the building of an ecosystem where data is collected, analyzed, and used effectively. To fully benefit from initiatives like EHDS, Bulgaria must invest in data standardization, cybersecurity, and the training of specialists who can work with these new tools.

From a business perspective, digital transformation opens a field for innovation – companies developing solutions based on real-world data, telemedicine, or artificial intelligence will have the opportunity to integrate into the European market.

In this sense, Bulgaria is in a process of catching up, but also of gaining ground – with real potential to accelerate the pace if it unites the efforts of the state, industry, and the scientific community.

Digitalization is no longer just a technological project, but a strategic priority for the future of the healthcare system.

III. THE BULGARIAN PERSPECTIVE – PREPAREDNESS, CHALLENGES, AND VISION

While Europe seeks a balance between regulations and innovation, the question is how ready Bulgaria is to fit into this dynamic. This means not only adaptation but also an active position in European debates.

Where does Bulgaria stand compared to other EU countries?

Gergana Aneva: While countries like Denmark, Finland, or Estonia are already using real-world health data to support scientific research and health policies, in our country, systems are still being built and connected.

But this does not mean we are outside the dynamic. Bulgaria has a real chance to participate actively – precisely because European regulations, such as the EHDS and the AI Act, place all countries on a starting line where the key will be not so much scale as the readiness to adapt quickly.

How can we be not just catching up, but active participants in European policy?

Gergana Aneva: The challenge before us is twofold – to build infrastructure and capacity and simultaneously to take a more active position in the European discussions that shape future rules.

The truth is that a key factor in the process is the experts in the field, and it is in them that we must invest. Specialists who understand regulations, digital technologies, and innovation, and who can present Bulgaria’s position in EU discussions and working groups in a reasoned manner, will be the most valuable resource. Rud Pedersen does exactly this for its clients – we combine our European practice and understanding of regulations in a broad context with expertise and knowledge of the specifics of the local environment, thereby building successful proactive advocacy strategies.

Ultimately, active participation requires synchronization between the state, the academic community, and business – not only to fulfill European requirements but also to have the opportunity to influence them, to make them economically and technologically feasible, balanced between ambition and reality, to share our experience, and to derive maximum benefit for Bulgarian patients and the healthcare system as a whole.

The question is not whether we can fit into the European transformation, but whether we will do so proactively – with vision and ambition, rather than simply through adaptation to decisions already made.

What are the challenges facing pharma companies in our country in the context of the new regulations, and what is your vision for the future of the sector?

Gergana Aneva: The new regulations in Europe present pharmaceutical companies with a number of challenges in our country. First, there is regulatory complexity – companies must comply simultaneously with national rules, European directives, and requirements for health technology assessment, which increases the administrative burden.

Second, digitalization and the use of real-world data require investments in infrastructure and competencies – both technical and expert.

Third, the new regulations change market dynamics – expectations for transparency, proof of value, and product safety are higher than ever.

In today’s increasingly digitalized and connected global world, Europe is struggling to maintain its competitiveness. The EU is redefining healthcare and technology as core pillars of strategic sovereignty, seeking control over critical value chains.

Medical technologies and biotechnologies are of fundamental importance, and through the new Life Sciences Strategy (2025), the EU sets an ambitious goal: to become a global leader in the field by 2030. Life sciences encompass a wide range of fields related to living organisms – including biology, medicine, biotechnology, pharmacy, genomics, neurosciences, and medical technologies. This is the sector at the heart of developing new drugs, therapies, diagnostic tools, and innovative medical solutions, and Europe aims to build a strong and sustainable ecosystem where innovation can flourish freely.

The phrase “If I had asked people what they wanted, they would have said faster horses“, often – though inaccurately – attributed to the father of modern car manufacturing, Henry Ford, illustrates an important truth: people usually think within the framework of the familiar and find it difficult to imagine radically new solutions. However, mere improvements to the existing will not be enough to achieve Europe’s desired leading position in innovation.

True progress requires an innovative, visionary, and avant-garde approach. Such an approach, however, can only become a reality when the regulatory approach is also coordinated, predictable, practical, and tailored to the specific needs of the sector. Only then will Europe be able to foster innovation and position itself as a global leader in the next wave of scientific and technological breakthroughs.