Mr Omar Obeidat
Al Tamimi & Company
Dubai World Trade Centre
P O Box 9275
Dubai
United Arab Emirates

When the Agreement on Trade Related Aspects of Intellectual Property Rights ("TRIPS Agreement") was drafted nearly a decade ago, pharmaceutical protection was guaranteed effective data protection and further schemes were introduced to safeguard the interests of the pharmaceutical companies in countries making use of the transition periods contained in the TRIPS Agreement. Therefore, so called "mailbox" applications for pharmaceutical patents were introduced and the exclusive marketing rights scheme was put in place. These schemes were introduced to make a balance between the capabilities and interests of developing countries and least developed countries on the one hand and between the interests of right holders on the other.

However, the Doha World Trade Organisation ("WTO") Ministerial Conference in November 2001 witnessed a revolution over the flexibilities provided by the TRIPS Agreement where the least developed countries attacked the TRIPS Agreement and portrayed it as being anti public health and requested more flexibility to allow governments of least developed countries leeway in accessing pharmaceutical products. The result was the Doha Declaration on the TRIPS Agreement and Public Health which emphasised that the TRIPS Agreement may not be used to prevent governments from acting to protect public health. The Doha Declaration on the TRIPS Agreement and Public Health extended the deadline for least developed countries to implement provisions regulating pharmaceutical patents until 1 January 2016. The Declaration entrusted the TRIPS Council to find a solution to countries that face difficulties in making use of the necessary licensing scheme. Although WTO members were to agree on differential treatment for developing countries and access to essential medicines for poor countries that do not enjoy the capacity to manufacture drugs themselves before the end of the year 2002, it was not until August 2003 that an agreement was reached. The WTO Council also approved a waiver for least developed countries from providing exclusive marketing rights for new drugs.

On 30 August 2003, the negotiations between WTO member governments finally progressed to an agreement that allows poor countries to import cheaper generic drugs made under compulsory licensing. The decision on implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health was a win for the least developed countries where a member country importing patented pharmaceutical products from an exporting member was granted compulsory licence for the patented drug. Despite the conditions and restrictions stated in this decision requiring a compulsory licence to be limited to the amount necessary to meet the needs of the importing country in addition to the restrictions related to notification and publication and the obligation placed upon importing countries to employ administrative procedures capable of preventing re-exportation of the products, there are no guarantees that drugs licensed and imported under this system will not be re-exported at least until working with this system proves otherwise.

The decision which offers a waiver to Article 31 of the TRIPS Agreement will be terminated upon the WTO members completing amendments to the relevant provisions in the TRIPS Agreement. The TRIPS Council is expected to work at the end of this year on the amendments of these provisions. It is expected that the amendments in the TRIPS Agreement, although required to be based on the Declaration, however, will be tightened to ensure non-abuse of this licensing system.

Pharmaceutical patents will remain an area of challenge and struggle between poor and rich members while the pharmaceutical industry is the remaining victim of these international negotiations since their rights and interests have been narrowed yet another time. For the pharmaceutical industry, their weakness operates as any other industry, yet they are expected in their international treaties and trade arrangements to weigh their humanitarian image more than their corporate side. It is only fair that governments in the developed world share the humanitarian costs alongside their industries.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.