In December 2010, the Romanian Government announced a significant restructuring plan for the national healthcare system for 2011.
Pharmacy law amendments
On 30 December 2010, the Government Emergency Ordinance 130/2010 on the amendment of the Pharmacy Law was enacted. The amendments concern the maintenance of the demographic criterion for the establishment of pharmacies until 31 December 2012. Following the amendment, one pharmacy may be set up: (i)for every 3,000 inhabitants in Bucharest; (ii)for every 3,500 in county capitals; and (iii) for every 4,000in other locations in Romania. There is no exemption for setting up pharmacies in malls, airports and railway stations, as initially proposed. The pharma business community considers this change a restriction on competition, which prevents new players entering the market.
In addition to these amendments, the Romanian Ministry of Health announced the preparation of a new draft law on pharmacies, to be finalised in early 2011, which will include, among other provisions, the express interdiction of online sales of both OTC and prescription drugs in Romania. This topic promises to spark debate at the national level, as, following the ECJ DocMorris case in 2003, online sales of OTCs are allowed in Community territory and do not constitute an exception to the free movement of goods in the EU.
New rules for marketing drugs
The Romanian Government approved a new classification for the release of drugs intended for human use (Order no. 1602 dated 31 December 2010). The new classification system establishes the following classes of drugs: (i) PRF: prescription drugs, for which the prescription is retained by the pharmacy; (ii) P6L: prescription drugs, for which the prescription may be renewed within a period of 6 months; (iii) PS: drugs with a special prescription (e.g. psychotropic products and drugs); and (iv) PR: drugs with restrictive prescription, used in specialised fields (e.g. hereditary angioedema disease). Any other drug which does not fit to the above definitions shall be deemed an OTC drug. For drugs authorised before Order no. 1602/2010 enters into force, the new classification will apply once the renewal of the marketing authorisation is requested.
New regulations have been approved regarding marketing authorisation and the supervision of drugs for human use (Order no. 1448/2010 on the amendment of the schedule to the Health Minister Order no. 895/2006 for the approval of the Regulations regarding the marketing authorisation and the supervision of human drugs). The amendments provide for new forms of market authorisation requests.
The National Agency for Drugs and Medical Equipment reclassified all drugs containing Metamizol (e.g. analgesics) as prescription drugs and not OTCs. This reclassification shall lead to material amendments relating to the labeling, prospectus and marketing of such drugs.
At the beginning of December 2010, the Ministry of Health adopted, Order no. 1483/2010 on the approval of the Norms regarding the administrative procedure of the National Agency for Drugs and Medical Equipment for the management of variations (the “Order”), replacing Order no. 874/2006. The Order follows EC Regulation no. 1234/2008 concerning the examination of variations to the terms of marketing authorisation for medicinal products for human use and veterinary medicinal products. The Order sets out the documentation and the timeframes applicable to each type of variation to the marketing authorisation.
New draft regulation on Food Supplements
A new draft law on food supplements entered the public debate on 11 January 2011 and will be discussed until 11 February 2011. The draft law contains provisions regarding the production, the importation and the trade of food supplements on the Romanian market. The draft law seeks to transpose Directive 2002/46/EC, as subsequently amended, on the approximation of the laws of Member States relating to food supplements, into national law.
New rules for the provision of medical services to the national healthcare system
The Framework Agreement regarding the conditions in which medical assistance is provided within the social health insurance system in 2011 – 2012 (the “New Framework Agreement”) was adopted at the end of 2010 and shall enter into force on 1 of April 2011. The New Framework Agreement establishes a two–year validity period for service agreements concluded between health insurance houses and providers of medical services, replacing the one-year validity period under the former framework agreement. Other amendments relate to the procedure for the provision of hospital services, transportation services and supply of pharmaceutical products.
e - Romania Strategy
In view of implementing the e-Romania Strategy, the Government has adopted a set of rules for IT operating system standards relevant to all players in the pharmaceutical sector (including pharmacies, distributors, manufacturers).