August 2017 - The Romanian Ministry of Health has recently issued an order on the obligation to provide adequate and continuous stocks of pharmaceuticals (the “Order”), which aims to clarify the implementation of this obligation and to provide certain limitations on the export of drugs from Romania when the demand in Romania for such drugs is not fulfilled.
Prior to the issuance of the Order, the general obligation to provide adequate and continuous stocks of drugs was defined in the legislation regulating the pharmaceutical industry, such that both (a) marketing authorisation holders (or their representatives) and (b) distributors of drugs are obliged to provide adequate and continuous stocks of medications to ensure that the needs of patients in Romania are covered. The Order does not detail the implementation of this obligation or limiting exports in case this obligation is not fulfilled.
Obligation to maintain an adequate stock of pharmaceuticals
In order to ensure the coverage of requests in Romania for certain medications, the holders of marketing authorisations and wholesale distributors of pharmaceuticals must comply with the public service obligation for each drug on the list of prescription drugs for which they hold the marketing authorisation and which they distribute on the Romanian market.
The holders of marketing authorisations should ensure a minimum monthly stock of drugs at least at the level of the average monthly turnover of the drugs (calculated as the average monthly turnover for the last three months).
Wholesale distributors should maintain, between receipt of two successive deliveries of a specific medication, a sufficient quantity of this medication in their stock that represents the minimum level of adequate and continuous stock of such medication that can respond to any justified order received by that wholesale distributor.
Delivery of drugs upon receipt of justified requests
Upon a justified request (e.g. drug prescription) from a pharmacy or a healthcare institution (e.g. a hospital), the holders of marketing authorisations and wholesale distributors are to follow the procedure set out in the Order (including by liaising with each other or with other wholesale distributors with whom they have contractual relations) in order to ensure delivery of the requested drug within 24 hours from receiving the justified request (except for occurrence of exceptional situations provided expressly in the Order – e.g. quality/security issues, the impossibility to obtain the active substance, temporary ceasing of production).
Triggers for imposing limitations on the export of a drug
A national alert is triggered when the stock at the national level of a particular medication drops below the average monthly turnover for seven consecutive days for the category of drugs with the same non-proprietary name, pharmaceutical form and concentration (the “National Alert Drug”). Such alerts are publicly reported and submitted to the Ministry of Health through the electronic system set in place for reporting stocks.
The Ministry of Health includes the National Alert Drug in the temporary list of drugs under observation (the “Temporary List”) at the latest within three days of the occurrence of a national alert.
Limitations to exporting drugs
The Order sets out limitations on the export of drugs included in the Temporary List. The enforcement of such limitations relates to the obligation of marketing authorisation holders, wholesale distributors of drugs and pharmacies to notify the authorities of the export of drugs from Romania 10 days prior to such an export occurring and to warrant that such an export is in compliance with their obligation to provide adequate and continuous stocks of drugs.
Further, the Ministry of Health, together with the National Agency for Drugs and Medical Devices, performs additional checks and inspections in relation to the reasons for the occurrence of the national alert level (e.g. if exceptional situations apply).