Access to medicines | Brussels, 29 July 2016

The EU is part of a pharmaceutical arrangement process which was agreed between several participants (EU, US, Japan, Canada, Switzerland, Norway and Macao) under the auspices of the World Trade Organisation (WTO, former GATT) in 1994.

The pharmaceutical arrangement provides duty-free treatment to pharmaceutical products and to their ingredients from its members. The product scope includes finished products as well as a closed list of inputs (pharmaceutical ingredients).

The original agreement published by the WTO is available online.

This agreement foresees periodical reviews to incorporate new active pharmaceutical ingredients, called International Non-Proprietary Names (INNs) which are published every year by the World Health Organisation (WHO). So far, four reviews to the agreement have been concluded. The launch of a new review should start soon. Some industry associations already requested the start of the review and submitted a list of INNs to be added into the product scope of the agreement. The European Union as the biggest pharmaceutical products exporter is coordinating the pharma reviews and organising relevant meetings in that purpose.

The lists of INNs provided for pharmaceutical substances, and of pharmaceutical products, which are free of duty are determined respectively in the annexes 3 and 6 of the EU Combined Nomenclature.

Companies that would like to propose products which qualify to become part of the review of the pharma agreement are invited to provide relevant information by contacting the DG TRADE services in the EU Commission at the latest on 15 September at the following address:

TRADE-PHARMA@ec.europa.eu