Lifesciences Romania Update - January 2014

The Romanian healthcare system is currently undergoing a comprehensive reform aimed at making the system financially sustainable and more efficient.

This below outlines some recent developments (from December 2013) relating to the ongoing reform of the healthcare system (see Section 1) and to new legislation passed by the Ministry of Health (MoH) (see Section 2).

1. Draft Government Decisions

A number of draft government decisions and laws are currently awaiting approval – all of which aim to further improve the Romanian healthcare system as part of the reform mentioned above.

At the end of December 2013, the following draft government decisions have been published on the MoH’s website in view of final consultations before the drafts are submitted to the Government for approval:

• draft Government Decision for the approval of the National Health System Strategy for 2014 – 2020
• draft Government Decision for the approval of the national health programs
• draft Government Decision for the approval of the minimum package and of the basic package of health services
• draft Government Decision for the amendment of the Government Decision 720/2008 regarding the list of reimbursed medicinal products

Note: In addition to the draft government decisions listed above, the healthcare system in Romania is set to be reformed via the laws listed below. These draft laws have been the object of public debates during 2013 and are now subject to approval by the Government and then by the Parliament.

• draft Law regarding malpractice
• draft Law for the implementation of a pilot project regarding the amendment of hospitals’ status
• draft Law for the implementation of a pilot project regarding the increase of the income of doctors working in hospitals
• draft Law for the amendment of Law 95/2006 regarding the healthcare system reform (now, back in public debate as of 15 January 2014)

2. New Orders of MoH

On December 2013, a number of orders issued by MoH have been published in the Official Gazette, including:

• Order of MoH 1531/2013 for the amendment of Order of MoH 245/2012 regarding the approval of the prices of medicinal products. The amendments came into effect on 1 January 2014 and concern the prices of products that were approved / re-approved between 13 September 2013 and 5 December 2013. The amended catalogue of prices is valid until 31 March 2014.
• Order of MoH 1538/2013 for the extension of the application of Order 423/191/2013 approving the methodological norms on the enforcement of the framework contract for 2013 regarding the supply of medical assistance within the 2013-2014 national social health insurance system. The amendments came into effect on 1 January 2014 and are aimed at extending the application of said methodological norms until 31 March 2014.
• Order of MoH 1553/2013 for the amendment of the Guide on good practice for the wholesale distribution of medicinal products, as approved by Oder of MoH 1963/2008. The amendments came into effect on 24 December 2013 and concern the new requirement of including the medicinal product identification code (so-called “CIM code”) in the records for the purposes of tracking the distribution of products.
• Order of MoH 1554/2013 for the extension of the term provided by Order of MoH 456/2013 on the approval of the List of medicinal products that present a high risk of discontinuity on the market. The amendments came into effect on 24 December 2013 and concern the extension of the term regarding the prohibition of export of the medicinal products in question, from 31 December 2013 to 30 June 2014 (note, the list of such products has been last amended on December 2013).
• Order of MoH 1579/2013 for the amendment of Order of MoH 1275/2011 regarding the approval of the lists and of the reimbursement prices of the medicinal products granted within the national health programs and regarding the methodology of calculation of such prices. The amendments were effective 1 January 2014.

For further information on any of the above, or more details on the impact they might have on your business, please do not hesitate to contact our Lifesciences team in Bucharest, who would be pleased to provide you with additional information and discuss these developments with you further.