Bojana Mirosavljevic is a prominent rare disease patient advocate from Serbia, and the founder and president of Život/Life, a patient association for children with rare diseases. She is also the mother of Zoya, who lost her battle against Batten disease in 2013 at the age of nine. Out of that loss, and drawing on her unique perspective as both a scientist and a mother of a rare disease patient, Bojana turned personal tragedy into sustained advocacy for change in Serbia and beyond.
Bojana’s personal journey has shaped her long-standing advocacy work, which ultimately prompted Serbia to led to enact of Zoya’s Law in Serbia in 2015. Named after her daughter, the law was introduced to improve the prevention and diagnosis of genetic and rare diseases, including access to genetic testing, carrier testing within affected families and prenatal diagnosis.
ERDERA spoke with Bojana about why patient voices must be embedded in research and policy from the very start, and what systemic changes are still urgently needed, particularly around diagnosis and national rare disease registries.
Zoya’s Law is the first legislation piece in Serbia that mentions rare diseases. It establishes a clear diagnostic pathway and implements prevention measures.
If a doctor in Serbia is unable to diagnose a patient within six months, they are now required to send blood or tissue samples—depending on the suspected condition—to an international or global laboratory for further analysis.
The law also introduces prenatal diagnostic testing for families with affected members, carrier testing to identify the presence and transmission of pathogenic genes within families, and pre implantation genetic testing. Together, these measures support both earlier diagnosis and informed family planning.
And most importantly, Zoya’s Law removes the financial burden from patients. Before its adoption, families had to cover the cost for diagnostic tests themselves, often making diagnosis inaccessible. They are now paid through the government health insurance.
You have been a very active voice for rare disease advocacy across Europe. What would you say is biggest challenges in rare diseases?
Globally, diagnosis remains the biggest challenge. Patients do not have time. We need to act faster.
Around 30% of rare disease patients die before their fifth birthday, which means they cannot wait ten years to receive a correct diagnosis. Any delay in diagnosis directly affects outcomes, often critically.
If a diagnosis is made earlier, then treatment is more effective. That is why time and diagnosis are the most defining factors in rare diseases.
Why would you say it is so important to involve patient representatives in research initiatives?
Including the patient voice is absolutely crucial. Patients are the experts in their disease because they live with it every day. If researchers, policymakers, or industry partners do not speak with patients, many problems will appear later on.
Whether you are a researcher or an industry sponsor, you need to speak and ask the patients.
What would you say is the unique role of patients and patient representatives in making progress in the field of rare diseases?
Education is essential, there is never enough education. Patients need to educate themselves in order to sit at the same table as other stakeholders and participate as equals. Patients are not passive recipients of care.
Patients are a crucial stakeholder. They are the glue that keeps all other stakeholders together. Without patients, the system does not exist.
What is the importance of national rare disease registries? Why are they so critical?
From the perspective of patients and the organizations that represent them, the absence of functional rare disease registries creates a significant “invisible space” within the healthcare system.
First, patients become statistically invisible. If we do not know how many people are living with a specific rare disease, where they are located, and what their needs are, it becomes extremely difficult to plan healthcare services, ensure access to appropriate therapies, and establish specialized centres.
Second, the healthcare system loses visibility into the real patient journey.
Registries make it possible to monitor how long it takes to reach a diagnosis, understand disease progression, identify complications, and assess treatment outcomes.
They also facilitate the implementation of clinical research and studies while providing access to a larger pool of patients, and enable more efficient long-term outcome monitoring, which is often a significant challenge in rare disease research due to the limited number of affected individuals. Patients simply do not have time to wait for long approval and marketing authorisation processes. Without a functioning registry, patients cannot be identified and therefore included in clinical research.
And how do these registries connect with national plans?
Registries enable health authorities and healthcare providers to better plan the resources and services required for people living with rare diseases. Based on the data collected, national strategies and action plans can be developed to improve the quality and organization of healthcare. Effective planning is not possible without reliable data and robust statistics.
Without an accurate registry, governments cannot plan or budget for diagnostic procedures or therapies, and therefore patients continue to be treated on an ad hoc, case-by-case basis.
We do not need registries that exist only as a checkbox. We need solid, sound and functional registries that actually work.
Looking ahead, what do you hope ERDERA can help achieve at national level?
As patient advocates and representatives, we also need concrete tools to translate this momentum into action within our own countries. Therefore, we need to ensure that these achievements can be implemented at national level.
Personally, I can already see significant improvements. I remain optimistic; I truly hope these achievements are possible in the future.