Rare diseases in Romania – a response to ‘transposition and implementation of EU rare diseases policy in Eastern Europe’

Few days ago, searching the internet for particular information about the upcoming event (Rare Disease Day – February 28), a catchy title got me curious and made me want to read the article. I am speaking about the article entitled ‘Transposition and Implementation of EU rare disease policy in Eastern Europe’ published by your journal, volume 17, 2017 – issue 6, pages 557–566 [1]. The article contains incorrect and misleading information about Romanian National Plan/Strategy on Rare Diseases. Moreover, that information is not consistent with European official position published online by RD-Action-Data and Polices for Rare Diseases (Joint Action on Rare Diseases), an EU Health Programme (2015–2018).

While the article states that ‘…… and Romania have not yet officially adopted a national plan for rare diseases’, the Overview Report on the State of the Art of Rare Diseases Activities in Europe 2016 version included Romania among the 24 countries which have adopted a National Plan/National Strategy for Rare Diseases, pages 12–13, and is evidence to the contrary [2].

Therefore, writing a letter to the Editor is one of the best ways to share with journal readers the accurate information and facts on this matter.

For the beginning, a brief history of rare diseases (RDs) in Romania showing where we are now.

In 2007, Romania joined the European Union and harmonized its legislation with EU requirements. New strategic directions and priorities for health system reform had to be established including RDs. At that time, Romanian health-care system had the potential to positively influence the provision of integrated, comprehensive medical and social services that are sustainable and responsive to RD community needs. But a plan was needed!

Patient organizations, health-care professionals, and academics, speaking with one strong voice, Romanian National Alliance for RDs, have played an active and positive role in the establishment of a national plan/strategy for RDs. The European Council [3] and EUROPLAN project [4] recommendations for development of national plan for rare diseases were used and adapted to the national situation. It was a long way, many preliminary stages, but finally by the end of 2013 the Ministry of Health adopted the National Plan for Rare Diseases and included it within the National Public Health Strategy for 2014–2020 (‘Prosperity of Health’). The National Public Health Strategy and Action Plan for implementing it were approved by Government Decision no. 1028/2014 [5]. The strategy established a regulatory, political framework which generates a system to integrate health and social services. A dedicated budget does exist for the National Plan for RDs in Romania. The Government approved, by Decision (no.155/2017, the national programmes for rare diseases to be carried out and funded in 2017 and 2018 by Ministry of Health (dietary treatment of RDs) and National Health Insurance House (curative treatment for RDs). In addition, there is a dedicated body in place to oversee the drafting or implementation of the National Plan. At the end of 2013 the National Committee for RDs (NCRD) was created by a Public Health Ministry Decree (no.1215/2013) as an interdisciplinary scientific body without legal personality. This body plays an advisory role by providing technical expertise through both its own team and other teams specialized in different areas.

As a result of continuous activity and effort provided by health planners, policy makers, and stakeholders focused on improving the health, political, and legal framework, the Ministry of Health issued the order of Centres of Expertise for RDs (no. 540/2016). Romania has just qualified as a country having a national strategy for responding to rare diseases and a health political framework in the field. Likewise, it started to implement a few issues of its national plan such as: the national evaluation of Centres of Expertise, using the EUCERD Recommendation on Quality Criteria for Centres of Expertise [6] adapted to the national situation, and the application for ERN membership. So far in Romania there are 14 Centres of Expertise in the field of RDs and some of them are members of European Reference Networks for RDs.

Despite the political instability and economic difficulties, RDs are recognized by authorities, policy makers, and all stakeholders in the field as a priority for health care in Romania.

Declaration of interest

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Additional information

Funding

This paper was not funded.