What are the challenges and the roadmap for improving health care for patients in the country, updating the positive list of drugs, problems with therapy for Oncology patients and other issues were the topic of the conversation with Dr. Natasha Azzopardi Muscat, director of health policies and systems at the Regional World Health Organization (WHO) office for Europe. Last week, she attended the high-level dialogue with the representatives of the Government in the country.

SP: Can you give some examples of EU countries and their successful practices in expanding the positive list of medicines, whose experiences Macedonia can follow as a compass for our expansion of the positive list? Progress has been made with the recent expansion of the positive list of drugs in the country, but the general impression of patients is that it is not enough.

-Many countries in the EU have successfully expanded their positive drug lists, creating valuable examples that other countries can follow. Some of them implement dynamic systems to update their positive lists, ensuring that new treatments, especially for chronic and life-threatening conditions, are more readily available. These systems typically include continuous assessment of therapeutic benefits and cost-effectiveness, allowing positive lists to be updated in a timely manner. Although each country faces unique challenges, North Macedonia has made notable progress in this area with recent enlargement. By studying and adapting best practices from other EU countries, North Macedonia can further improve its approach to ensure that more patients benefit from wider access to essential medicines. Access to medicines is a critical component of health systems around the world, and North Macedonia is no exception. The country has made progress in improving health services for citizens. Efforts continue to ensure that access to essential medicines improves in line with global health standards. It is important to keep the focus on cooperation between health facilities, authorities and international organizations to improve the system and support the needs of patients.

SP: This especially applies to the patients of the Oncology Clinic in Skopje. The number of cancer patients from the beginning of the year to date has grown by 5 thousand newly diagnosed. None of their biological or immunological therapies are on the positive drug list. Instead, the Health Fund gives the Oncology Clinic a conditional budget to purchase these extremely expensive drugs. This, in turn, creates uncertainty for patients because the budget is never sufficient for all patient needs. There are always more patients than money. Some patients are not even tested for the availability of these expensive therapies. Is it possible for our country to create a system for all cancer patients to receive the expensive therapy they need and what steps are needed towards such a system?

- I visited the Oncology Clinic during my two-day stay in Skopje and saw first-hand some of the challenges there, as well as the dedication of the healthcare workers. The challenges faced by patients at the Oncology Clinic are an important issue that we see in many health systems in the WHO European Region, not just here. And that is the need to ensure equitable access to new, expensive, life-saving treatments that are unfortunately out of reach for too many people. That is why we have set up a new WHO Europe Platform on Access to New Medicines where the public and private sectors can work together and agree on actions that improve patient access to new medicines in the region. I am happy that North Macedonia is a member of the platform. While it is encouraging that the FZOM covers these therapies to some extent, it is clear that more can be done to create a sustainable and understandable solution. This includes formalizing health technology assessment to provide evidence that guides funding decision-making in a transparent manner. Many countries have addressed similar challenges by establishing specialized funds or frameworks that specifically focus on expensive treatments for critical conditions, ensuring that all eligible patients receive the care they need. Strengthening early testing and diagnosis programs can also ensure rapid and accurate assessment of patients, maximizing the efficiency of resource allocation by following clinical protocols that ensure these high-cost drugs are used by those who may actually have benefit from them. Moving forward, collaborative efforts between health authorities, medical professionals and international partners will be key to building a system that ensures equitable access to these vital therapies.

SP: What technical support and resources does the WHO offer to Macedonia in the process of revising the positive list of drugs? From what you have seen so far as a doctor, is the Macedonian positive list similar to those in European countries, or is ours very different and outdated?

-WHO provides a set of technical support and resources to help countries strengthen their health systems, including the positive drug list review process. For North Macedonia, this includes expert guidance (guidelines) for evaluating the effectiveness and safety of medicines, health technology assessment tools and support for aligning national policies with international best practices. These collaborations are crucial in ensuring that health systems as well as the positive list of medicines are regularly updated and respond to the health needs of patients. Regarding the positive list in North Macedonia compared to that in European countries, it is important to say that each positive list reflects the unique health priorities and resources of the country. North Macedonia made important progress in revising the list and brought it closer to European standards. Although there are areas that could be further updated in terms of new therapies and treatments, the reforms taking place show a determination to improve equitable access to health care for all patients. WHO Europe is on the side of North Macedonia on this path, we are here to provide support and guidance in order to make access to medicines without financial burden a reality for everyone.

SP: Recently, WHO Europe has advanced in the field of pharmacy. Here I mean the platform for innovative medicines. Can you tell us more about this platform for innovative medicines and how it helps patients in Europe get equal access to medicines? How is this platform applicable to Macedonia?

- That's right. Recognizing the challenges of providing access to new, expensive medicines, 18 months ago we created the "Access to New Medicines" platform, where North Macedonia has been a member since day one. This platform is a safe and neutral space where all stakeholders – governments, industry and patient organizations, can discuss these issues in a safe and open way and search for solutions together. The platform is particularly relevant to smaller countries, which may have difficulty cooperating with powerful industry players on an equal footing. The platform is also an opportunity to promote dialogue with industry and other partners at national level when it comes to the process of revising the positive list. This is no small achievement and we are happy to see that the country's commitment to this initiative is unwavering. The objectives of the platform are to improve transparency to build trust and promote collaboration, to strengthen voluntary collaborations focused on solidarity to ensure access to patients. Furthermore, the goal is to develop principles for payment, pricing, health technology assessment, and reimbursement that support sustainable health systems and industry. Also, one of the goals is to identify policy options for sustainable innovation and access to new antimicrobials.

SP: WHO recently organized a workshop on financial protection in the Western Balkans region, where findings for 40 countries were presented. What are the benefits and conclusions of this workshop and how does Macedonia look in this report, what are your findings for Macedonia?

- The workshop on financial protection of the Western Balkans region is part of a multi-year project supported by the Directorate General for Neighborhood and Enlargement Negotiations of the EU (DG NEAR) and we proposed that North Macedonia lead this sub-regional event in recognition of the country's efforts to made progress for affordable access to health care, as well as the country putting financial protection for people high on the agenda. North Macedonia stands out among the countries of the Western Balkans with its monitoring of financial protection and by acting based on evidence produced jointly by the WHO Barcelona office and national experts. North Macedonia fared well compared to other Western Balkan countries as you can read in our report on the period before the pandemic. But the latest analysis shows a worsening trend (up to 2021 and data from 2023 still being processed) in relation to indicators of financial difficulties. Out-of-pocket payments are unfortunately still too high in the country. The evidence shows very clearly that the household cost of medicines is the biggest cause of hardship for people, especially for the poorest 40 percent of the population. It is therefore timely and welcome that the government is taking action, including revising the positive list of medicines covered by the Health Fund. More of the relatively inexpensive essential medicines should be on the positive list and more of the vulnerable population should be protected from the cost of getting access to the right medicines at the right time. The Regional Financial Protection Report synthesizes a wealth of experience from 40 countries in the WHO European Region, highlighting good and bad practices, along with a checklist for policymakers on what works in health financing to improve affordable access to health care. The report also makes it clear that funding alone cannot address all challenges. We need a holistic approach that also takes into account dealing with the shortage of health personnel, improving regulation, improving the capacity of institutions. These are some of the most urgent measures.

SP: The entire European region is functioning after a negative trend of circumstances that covered all the countries in the region. I mean the covid pandemic, economic pressures, inequality in access to health services. What measures for financial protection in the health system should be taken in order to change this trend?

- Throughout the region, we see that health systems rely heavily on out-of-pocket payments. This means that many people experience financial difficulties when using health care, or face barriers to access that result in unmet needs. Out-of-pocket payments push some people into poverty or make them poorer. The report I referred to in the previous question provides a synthesis of evidence to understand the relationship between financial hardship, unmet health care needs, and coverage policy. It highlights major gaps in coverage, identifies major factors that lead to out-of-pocket payments, and suggests policy changes to make health care more affordable for people. Our main message is that countries need to reduce their reliance on out-of-pocket payments for patients, as this pushes people into poverty or makes the poor poorer. Even in countries with relatively strong financial protections, there are people who face impoverishing health care costs. This can best be illustrated by the examples of dental health care. In countries where dental care is not covered by public health care, it is a factor in financial hardship for wealthier people, and poor households report an unmet need for dental care. What poorer people simply do in such a situation is - they don't go to the dentist. This results in poor oral health and, as a consequence, poor general health.

SP: What can countries do to change this trend?

– Our data shows which policies contribute to financial difficulties. What countries can do consists of the following five things. Penalizing non-contributors in a way that limits their access to part or all of public healthcare should be avoided. This leads to visible differences in coverage, especially in countries with weak tax systems, and mainly hurts people who do not have a secure job. Precarious work is a growing problem in Europe, so without action, this gap in coverage is likely to grow over time. If it is not possible to cover the entire population, it adversely affects the equality in the health system, its efficiency and resilience. Excluding people from health coverage should be avoided. This policy choice mainly harms undocumented migrants. Basing access to the publicly funded health care system on the basis of permanent residence creates administrative barriers even in countries that extend rights to persons without valid residence documents. In many countries, the rights of undocumented migrants are limited to emergency health care, which is not only unfair, but also ineffective. Another measure is to avoid charging for services without effective protection mechanisms. A large body of evidence shows that fees for services are not an effective way to direct people to use health services more efficiently. Even relatively small costs can deter people from using needed health care, can reduce adherence to treatment, can increase the use of other health services, as well as lead to financial difficulties and negatively affect health, especially among people with low incomes or chronic diseases. Despite this evidence, charging for health services is widely applied in Europe, mostly for treatment in primary care. Although many states avoid charging for primary care, all charge for drugs and medical products and dental care. Avoid not covering primary care treatment. This election takes place in several countries in Europe. It is best illustrated in prescription drug coverage gaps, a major driver of financial hardship in many states, especially for low-income people. Countries often try to protect people from paying out of pocket for primary care consultations and diagnostics by including these services in the insurance package, making them free. In contrast, most states charge for primary care treatment (prescriptions for chronic conditions, assistive products such as glasses and hearing aids, and dental treatment) and many exclude dental treatment from insurance packages. And finally, avoid thinking that voluntary health insurance is the answer. Voluntary health insurance is proposed as a solution but in practice increases inequality in access to health care and can undermine efficiency by diverting public resources away from need. In the few cases where voluntary health insurance plays a role in reducing financial hardship – covering user costs for a large part of the population in Croatia, France and Slovenia – inequality in access to insurance continues, such insurance is regressive and has high transaction costs involved in managing a complex system.