Parallel Importation Of Pharmaceuticals To Israel

Profession:Reinhold Cohn & Partners
 
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By a recent amendment of Israeli law, parallel importation of a pharmaceutical is now permitted in terms of the regulatory scheme applicable to pharmaceuticals.

Under the new regulatory scheme, permit may now be granted to any person or entity (and not only the manufacturer or its agent), to import a registered pharmaceutical. In addition, under the new regulatory scheme, permit may now be granted to a Pharmaceutical Trading House or any Recognized Institution to import a Compatible Preparation (a pharmaceutical identical to a registered pharmaceutical)

The Supreme Court dismissed a petition that challenged the validity of the new amendment. It held that the new amendment is neutral as regards Intellectual Property rights -- Patentees should seek remedy by way of filing infringement action against applicants for import permit.

Introduction

Parallel importation is a hot and controversial topic in the international IP arena. The State of Israel has added to the controversy when it amended its regulatory scheme and significantly amended the rules, which, until then (with few exceptions), prohibited parallel import of pharmaceuticals.

Shortly before the new legislation came into force, several pharmaceutical companies filed a petition with the Israeli Supreme court and challenged the validity of this legislation. Last month, the Supreme Court dismissed the petition and affirmed the validity of the new legislation. The Supreme Court's judgement, however, left unresolved the intellectual property law issues arising in connection with parallel import.

Importation of pharmaceuticals to Israel requires a permit from the Ministry of Health ("MOH"). Ever since the State of Israel was established (with a limited exception introduced several years ago1), pharmaceuticals were imported into Israel only by the original manufacturers of pharmaceutical preparations or the manufacturer's agent.

The legal situation changed at the end of the year 2000, when an amendment to the statutory scheme came into force2 (the "amendment"). In essence, inasmuch as the MOH regulatory scheme is concerned, parallel importation of pharmaceuticals is now permitted.

Under the new regulatory scheme, it is now allowed to import pharmaceuticals (which are registered in Israel by the manufacturer or its Israeli agent) not under appointment of the manufacturer. In addition, it is now allowed to import pharmaceutical preparations, which are not registered in Israel (if such a pharmaceutical is compatible to a registered preparation).

In this article we will briefly review the new rules applicable to importation of registered preparations by a person or entity not being the Israeli agent of the original manufacturer and the new rules applicable to importation of Compatible (non registered) preparations. We will then comment on the judgment of the Supreme Court and the interrelations of the new amendment with the Intellectual Property laws of the State of Israel.

Parallel Importation of a Registered Preparation

Until this amendment, an application for registration of a Pharmaceutical...

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