Resumen de WTO “Paragraph 6” system for affordable access to medicines: Relief or regulatory ritualism?

Muhammad Z. Abbas, Shamreeza Riaz

• Regulatory Ritualismmeans acceptance of regulatory goals while losing focus in achieving them. In other words, it means ignoring of goals or objectives of a process or mechanism and focusing too much on regulations, rules, and formalities. Advanced countries and developing countries have been in a continuous negotiation over access to drugs ever since coming into effect of TRIPS Agreement. The Doha Declaration was a rare negotiation win for third world countries. This paper endeavors to apply the notion of Regulatory Ritualismto Paragraph 6 of the Doha Declaration 2001 and to subsequent WTO General Council's Waiver Decision 2003 which aimed at giving effect to Paragraph 6 flexibility. The first part of the paper discusses the historical background of the Doha Declaration and 2003 Decision. The second part of this paper analyses Paragraph 6 of the Doha Declaration and subsequent Waiver Decision in the light of the notion of Regulatory Ritualismand Rule Complexity, with a special focus on Apotex‐Rwandacase study, the case of India and the case of Australia. The final part of this paper sums up the discussion on the issue and provides suggestions.