EC closes infringement against Romania over parallel trade of medicines

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The European Commission (EC) decided to close its infringement procedures and the treatment of complaints in the area of parallel trade of medicines for human use against Romania, together with Polan, and Slovakia, as a a press release informs.

From the start, the Juncker Commission has been focusing on its political priorities and pursuing them vigorously. This political approach is also reflected in the Commission’s handling of infringement cases.

The Communication “EU law: Better results through better application” sets out the Commission’s approach to prioritising cases in a strategic manner, carefully weighing the various public and private interests involved.

Parallel imports and exports of medicinal products is a lawful form of trade within the Single Market. Member States may, however, in certain cases restrict parallel trade, as long as the measures are justified, reasonable and proportionate to ensure a legitimate public interest. For example, to ensure an adequate and continuous supply of pharmaceuticals to the population. The lack of appropriate and continued supplies of human medicinal products to pharmacies is a serious and growing problem that has occurred in recent years in a number of Member States and can gravely impact the treatment of patients.

EC acknowledges that parallel trade in medicines may be one of the reasons for the occurrence of shortages of a number of medicinal products for human use. Reconciling the respect to the free movement of goods with the right of access to healthcare to patients is a fine balancing act.

”After careful assessment, the Commission has concluded on the need to look for other ways than infringements to adequately solve this complex situation in order to swiftly and efficiently deal with an issue that might have negative impact on the health of European citizens. The Commission considers that a structured dialogue including all relevant parties should rapidly take place. The Commission remains committed to supporting Member States in their efforts to ensure that citizens have timely access to affordable, preventive and curative healthcare of good quality. To do so, it will gather more information from the Member States and other stakeholders to discuss the implementation of the public service obligation and export restrictions within the Commission Working Group on Pharmaceuticals (Human Pharmaceutical Committee),” the release reads.

Parallel trade allows wholesalers to buy medicinal products in one Member State (typically where prices of medicines are lower too), and sell into other Member States (where prices are higher). Parallel imports and exports of medicinal products are compatible with the free movement of goods.



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