Romania

Romania is the second largest country in Central Europe and has been a member of the European union since 2007. It is one of the fastest economically developing countries in the CEE region. Romania is described as a semi-presidential republic with the governmental legislative power being represented through an elected Parliament. The official language is Romanian. The healthcare system in Romania is centralized, governed by the Ministry of Health and National Health Insurance Fund. It is based on the principals of equal access to healthcare for all citizens. The quality of services is below EU average and is financed by general mandatory taxes.

Healthcare budget

$4.8 billion

Inhabitants

19.4 million

GDP per capita

$14.903

Currency

RON (1 RON = 0,21 euro)

World Ranking

GDP 44th

Statistics as April 21st 2021

Romanian healthcare

In 2017 Romania allocated 5.2% of GDP for healthcare spending which was well below the EU average, (9.8% in 2018).

Romania has a program of universal health insurance with a mandatory payroll tax which is used to provide coverage for the entire population. In addition to health insurance, the government also manages most of the hospitals in the country, many of which are aging and chronically underfunded. There is a significant difference in the quality of healthcare and medical facilities between major urban and rural areas.

The tax-funded universal healthcare system is organized by the state-owned National Health Insurance Fund, with health insurance being free for children (all under 18), parents of newborn babies, students, pensioners (over 62) and handicapped people.

In the major urban areas, medical facilities are generally well-equipped, with world-class private healthcare also available.

Pharmaceutical environment

Romania is one of the largest pharmaceutical markets in Eastern Europe with a significant increase in recent years. The total pharmaceutical market in 2019 was 4.14 million EUR which included Rx products of 3.33 million EUR.

International price comparisons and reference pricing are present in Romania and new drugs need to be submitted against the lowest European price.

However, since 2016 there has been positive changes in the reimbursement approval process for innovative medicines, orphan Drugs and unmet medical needs.

The claw back tax, a percentage paid quarterly by manufacturers from sales, in the case of innovative medicines, was capped at 25%. For conditionally reimbursed products, the claw back tax is no longer paid, but a discount is in place and relates to the negotiated Cost-Volume Contract.

Todays challenges

Romania has the lowest medical expenses per capita within the EU. Expected life at birth is 5 year less then EU average (2017).

The cost of medicines is increasing due to the aging population and the introduction of new treatments. Obesity and smoking are also a general issue within the population.

Following Romania’s entry into the EU the big challenge has been the migration of young, qualified people, including HCP’s (more than 15,000 physicians) to leave the country for better paid jobs in other EU member states. Consequently, there is an acute shortage of healthcare professionals with around 30% of positions unfilled. Salaries of doctors and nurses were increased in 2018 and are approaching those of Western Europe and efforts are being made to improve conditions in hospitals.

Services

Sales and Marketing

Entering the European market is not easy. 44 countries with different healthcare systems. What is your strategy? Apart from the Big-5, what do you do with the other 25 countries? We offer a solution for 25 countries. Sales and marketing is our core business.

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Distribution

We manage, through our logistic partners with their regional warehouses, the distribution to our region (25 countries). They have the capability to handle the most demanding of specialized product order management, storage, handling and distribution requirements.

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Early Market Research

You know that market research is critical. It provides customer insights, competitive intelligence, behavioural tendencies, and product positioning. And market research increasingly is becoming an important component for linking R&D and marketing teams.

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Market Access

Achieving reimbursement and getting the right price are the 2 most important drivers for a successful launch of an innovative pharmaceuticals in our part of Europe. Health Authorities in any European country decide individually based on their local regulations, policies, framework, social values and available health care budget.

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Market Authorisation

Unlike other regions, in the EU a number of options is available to obtain a marketing authorisation. Centralised at the European Medicines Agency in Amsterdam or decentralised with the individual competent authorities of the member states, each marketing authorisation application procedure has its pros and cons.

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Pharmacovigilance

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

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