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Poland: Pharmaceutical Inspectorate to rule on direct drug sales from outside Poland

Poland
15/11/2010
Available languages: PL
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The Chief Pharmaceutical Inspector is entitled to supervise all pharmaceutical trade in Poland, including trade by companies based outside Poland, according to the Voivodship Administrative Court in Warsaw.

The case was brought because the CPI had dismissed a request by the Polish Pharmaceutical Chamber to investigate the direct sale of drugs to Polish pharmacies by AstraZeneca UK Limited.

AstraZeneca sp. z o.o. was the first to introduce a direct drug distribution system in Poland, enabling it to sell its drugs directly to pharmacies. Its activities in Poland were based on cooperation with warehouses arranging the transportation of goods to buyers.

When the PPC raised concerns whether this was permitted by the rules governing small pharmacies’ access to drugs under Polish pharmaceutical law, AstraZeneca revised its approach and used its UK company to make the sales.

When the PPC queried the lawfulness of the revised arrangement, the CPI declined to investigate on the grounds that it did not have jurisdiction over a trading company whose registered seat was outside Poland.
Now that this decision has been rejected by the Voivodship Administrative Court, the CPI will have to decide whether AstraZeneca’s direct sales system complies with the law.

The outcome may result in restrictions being imposed on direct sales, which will affect not only companies based in Poland but also foreign companies taking advantage of the EC free movement of goods to sell their products in Poland. Any developments will be reported in Law-Now.

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