EC’s two medicines in transit exceptions
At the WIPO SCP coffee break, one attendee explained to KEI that the EU has in two places, (1) the regulations on tiered pricing, and (2) the implementation of the WTO’s 30 August 2003 decision on compulsory licensing, created an exception for goods in transit to developing countries.
Unfortunately, these carve-outs do not apply to the more common instances of medicines in transit that fall outside of these rarely used mechanisms. The language, however, may be a useful model that could be usefully extended to cover the situations that lead to the Dutch Seizures of legitimate generic medicines in transit to developing countries.
Here is some text from two regulations:
Council Regulation (EC) No 953/2003 of 26 May 2003 to avoid trade diversion into the European Union of certain key medicines
Council Regulation (EC) No 953/2003
of 26 May 2003
to avoid trade diversion into the European Union of certain key medicines
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 133 thereof,
1. It shall be prohibited to import into the Community tiered priced products for the purposes of release for free circulation, re-export, placing under suspensive procedures or placing in a free zone or free warehouse.
2. The following shall be exempted from the prohibition regarding tiered priced products as set out in paragraph 1:
(a) re-export to countries of destination;
(b) placing under a transit or customs warehouse procedure or in a free zone or free warehouse for the purpose of re-export to a country of destination.
Here is the language from EC Regulation No 816/2006.
REGULATION (EC) No 816/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 17 May 2006
on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems
(6) As the compulsory licensing system set up by this Regulation is intended to address public health problems, it should be used in good faith. This system should not be used by countries to pursue industrial or commercial policy objectives. This Regulation is designed to create a secure legal framework and to discourage litigation.
(9) Provision should be made for customs action at external borders to deal with products manufactured and sold for export under a compulsory licence which a person attempts to reimport into the territory of the Community.
Prohibition of importation
1. The import into the Community of products manufactured under a compulsory licence granted pursuant to the Decision and/or this Regulation for the purposes of release for free circulation, re-export, placing under suspensive procedures or placing in a free zone or free warehouse shall be prohibited.
2. Paragraph 1 shall not apply in the case of re-export to the importing country cited in the application and identified in the packaging and documentation associated with the product, or placing under a transit or customs warehouse procedure or in a free zone or free warehouse for the purpose of re-export to that importing country.