Interview with the Health Care Committee President Mr. Icevic


Interview with the Health Care Committee President Mr. Icevic

Miloš Ičević, MD
Head of Integrated Product Strategy, Hoffman-La Roche


AmCham: How would you estimate the current situation in the areas of pharmaceutical and health care policies in Montenegro?

Mr. Icevic:  It will be quite some time before we understand the full impact of the COVID-19 pandemic. However, the history of such crises tells us two things. First of all, the importance of prioritizing health and health care, being bases for prosperity. Second, it is a reminder that health care systems are facing unprecedented challenges with an aging population, an increased prevalence of chronic diseases, and that new communicable diseases and pandemics can emerge unexpectedly. This is imposing an increased demand for health care services and health interventions, including medicines, and a consistent need for innovation. To meet the upcoming demand, and to make the health care system more resilient in the future, it is necessary to create prerequisites for strengthening legislation and strategic investments.  

When it comes to the regulatory framework in Montenegro over the past two years, we witnessed the adoption of significant amendments to the Law on Obligatory Health Insurance and Law on Health Care, and the latest, fully aligned with EU regulations, Law on Medicines.

Healthcare expenditure (HCE) in the 2020 state budget was the highest in our history, which certainly represents the valorization of ‘health-as-priority’. However, HCE in Montenegro is still at the level of around 5% of GDP, whereas the EU average that we need to strive for is at 9.6%.

By reinforcing the value of innovation in medicine, patients' access to innovative medicines and diagnostics improved significantly over the past two years. Having in mind the fact that data from developed countries show that innovative medicines contributed to prolongation of life expectancy at 75%, I cannot find a better way to emphasize how important this is for our patients and citizens. However, availability of those medicines is still not at the level of  the EU, i.e. Croatia and Slovenia, but we are definitely on a progressive path and a leap ahead of most Western Balkans countries.

Speaking of innovation in digital health, progress has been made by introducing an increased number of e-services being available to the citizens, including telemedicine and teleradiology in the Main Referral Hospital i.e. Clinical Center and three General Hospitals. It is important to mention an ongoing implementation of an interoperable information system in the Clinical Center of Montenegro. This is a great basis for a future-proof health care system, but at the same time, there is a lot of important work ahead of us, which requires both speed and continuity.


AmCham: Which activities have been undertaken by the AmCham Health Care Committee in the past two years in order to improve situation in this area? 

Mr. Icevic:  These two years have been really fruitful for the Health Care Committee with many activities and intense dialogue with decision-makers. We defined our strategic priorities under two pillars: Value and Access to Innovative Medicines and Digital Transformation of the Health Care System in Montenegro. Bold vision, assessment of the current situation in Montenegro, region and worldwide best practice examples with proposed actions are captured in two Position papers of this Committee for both pillars. With reference to the first pillar, Value and Access to Innovative Medicines, the relevant Position Document was adopted by the end of 2019 with five activity areas: approval, pricing, the process of listing the medicines with the Republic Fund for Health Insurance (reimbursement), funding and importance of data digitizing and networking. We discussed this with all decision-makers, with focus on reimbursement and financing models. Importantly, we have also organized an educational workshop on novel pricing and payments models by using special Managed Entry Agreements, with the global director of the International Society of Pharmacoeconomic Research as trainer. The second Position Paper on Digital Transformation of Health Care System is under review, and it will bring a proposal of four activity areas, however it had been preceded by significant activities. We shall use it to propose key activity areas, starting from the National Strategy development, through curricula development for the employees in the  health care system and students up to better data usage.   

We have invested a lot of time into preparation of an international policy conference related to those two topics, but it has been postponed twice during this year due to COVID-19 pandemic. Nevertheless, huge work was not wasted and opportunity wasn’t missed as some activities were  undertaken anyway. We are also about to launch a portal in the beginning of next year with credible content and speakers, education and dialogue with experts and general public. Importantly, we have created a great network with international opinion leaders and policy makers in these fields, which we will leverage for the future. The essence of all activities is continuous policy dialogue with all decision-makers based on evidence and meaningful experience exchange with other countries.


AmCham: Do citizens of Montenegro have an access to innovative medicines and health care technologies?

Mr. Icevic: As already mentioned, there has been significant progress in access to innovative medicines and technologies both for patients and citizens. With regards to medicines, after years of stagnation, in the past three and especially past two years, during 2018 and 2019 there were a few Reimbursement List updates that significantly improved patients' access in Montenegro. This is of particular importance for patients with diseases such as cancer and chronic conditions, as well as communicable diseases, that once were the main cause of high mortality rate and disabilities, whereby today they are successfully treated by innovative medicines. Here we do not only have in mind improvement in the results of medical treatments, but also enabling improved family and socio-economic productivity.

It seems to me that those efforts are not recognized well enough by public, and therefore we have to do our best in order to understand added value both for patients and the society. Implementation of Managed Entry Agreements enabled increased accessibility and discount schemes for almost all new medicines compared with the legally defined maximum prices, which resulted in important savings for the system.

With regard to access to innovative medicines, there is one important segment that we discussed with decision-makers, which, however we didn’t succeed to solve in 2020 – legal amendments regarding enabling reimbursement of medicines that are not on the Reimbursement List and funding of medicines for rare diseases. This is an urgent priority for 2021, as this was raised by patients’ representatives, patients and caregivers as well. Since Reimbursement List’s update in February, there were no discussions about new medicines, therefore we need to reestablish the continuity of the process which is both in the interest of citizens and the system itself. The pace of adoption is extremely important, even of vital importance, whether we're talking about the medicines or other technologies (such as digital technologies, diagnostics and therapies), because the pace of innovation is enormous. We cannot allow ourselves to lag behind the developed world, because at one point the gap could be so big that it cannot be easily bridged, which is in fact the scenario that happens to some countries.

I will mention two examples, being a result of this. The World Economic Forum reported in its Annual report that the biggest gap in life expectancy between two countries was 33 years, while Swedish Karolinska Institute Pan-European research showed that 5-year-survival-rate from cancer varied from 40% to 64% in different European countries.


AmCham: Which areas or issues do you still deem important to be resolved in order to improve business climate in the area of health care in Montenegro?

Mr. Icevic: It is of utmost importance to prioritize health and health care, not only amid the current pandemic, but as a fundamental right of patients and citizens. In order to do this, we need a broad coalition of those willing to align on shared bold vision, and to commit to it by developing solid and modern long-term national strategies. This year was marked by the activities aimed at solving COVID-19 crisis. While these are still an ongoing vital priority, we cannot neglect other health care policies, but we need to apply the lessons learned from the pandemic and prioritize work on other health policies in order to ensure a resilient health care system and continuity of providing quality care for all patients. The basis of these lessons learned and needs are prevention, access to innovative medicines and vaccines, digital transformation and increased efficiency of health care systems.

The European Commission paved the way for it with its Work Programs for 2020 and 2021 with: Europe’s Beating Cancer Plan, Europe’s Data Strategy (and European Health Data in particular) and Europe’s Pharmaceutical Strategy which have been adopted this year. These documents address some of the key public health concerns that require immediate action (i.e. cancer) or the need to generate, collect and use large amounts of digitized health data in order to measure and improve treatment outcomes and achieve better health care efficiency. Europe’s Pharmaceutical Strategy adopted at the end of November, following public hearing which had taken several months, positioned pharmaceutical industry, pharmaceutical innovation and affordable and accessible medicines for all Europeans, as the key priority in the forthcoming period. I would like to emphasize that these strategies were developed in collaboration between public authorities and regulators with industry, civil society, health care stakeholders, researchers, academia and many others. We need to use the same approach and principles to facilitate intense national dialogue, and an international experts’ network for development of the national strategies for fighting cancer, rare diseases and digital transformation of the system. As part of these initiatives, but also reflecting on Europe’s Pharmaceutical Strategy, we will continue dialogue on reestablishing continuity of the reimbursement process. 

I recently attended one global virtual symposium and the key message which I often quote is the following: the current public health crisis demands a remarkable level of cooperation across sectors and disciplines to prioritize health as a basis of prosperity. This is exactly what the AmCham Health Care Committee will try to leverage in order to use the momentum to achieve our bold vision. Within this broad coalition we need to understand and look at health and healthcare not as a cost, but as an important investment. ‘’Health is an investment, not an expense, although it will become an expense if we don’t invest in it.’’


This interview is part of the AmCham Business Climate Report, for 2019-2020.