Medicine Producers, You Must Comply with Your Public Service Obligation! But How?

The Ministry of Health has adopted a set of rules for quantifying and monitoring the fulfilment of public service obligation. However, these rules do not solve the causes of the shortage of essential medicines and pose real interpretation issues. Medicine producers have legitimate doubts as to how to appropriately apply such measures.

According to the Romanian authorities' traditional policies, medicine prices (except for non-reimbursed OTCs) were set at the European minimum level.

Furthermore, it has been decided that the price of innovative medicines that are no longer protected by a patent should be aligned with the generic/biosimilar reference price (i.e., no more than 65% / 80% of the price of the innovative medicine upon the approval of the first price of the corresponding generic/biosimilar product); this measure has already caused effects on the reimbursement price of relevant innovative medicines and, as of January 2018, it will also impact the official manufacturer, wholesale and retail prices thereof.

The logical consequence was that numerous essential medicines, in particular innovative ones, are now being massively "exported" by wholesale distributors to EU countries where considerably higher prices are charged. As a rule, this parallel trading is lawful, perfectly justified economically, and a pillar of the European Union market, but its effects on Romanian patients are deeply harmful.

The Romanian authorities have become increasingly aware of the magnitude of the parallel exports carried out by Romanian distributors and the shortage of essential medicines on the local market, and have recently adopted measures to report and control the effects of this situation, without, however, dealing with its causes.

At the end of 2016, the Ministry of Health (MoH) adopted Order No. 1345/2016 regulating the obligation to electronically report, on a daily basis, stocks and commercial operations involving medicines subject to reimbursement (i.e., included in the national price catalogue - Canamed); this obligation applies to wholesale distributors, importers and producers, as well as pharmacies, and fully came into force at the end of February 2017.

Order No. 269/2017 on the obligation to ensure appropriate and continuous medicine stocks was published on 15 March 2017, aiming to regulate the measures for quantifying and detailing the public service obligations set forth under Law No. 95/2006 on healthcare reform.

Order No. 269/2017 in Short

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