One of the key implementation priorities that we have focused on in this year's review is the implementation of Article 39.3 of the TRIPS Agreement, which requires WTO Members to protect test data submitted by drug companies to health authorities against disclosure of that data and against "unfair commercial use" of that data.

Most countries, including the United States, impose stringent regulatory testing requirements on companies seeking to market a new drug or agricultural chemical product. Many countries have recognized, however, the value of allowing abbreviated approval procedures for second-comers seeking to market an identical product to one that has already been approved. Generally, these second applicants may be required to demonstrate only the bioequivalence of their products with the product of the first company, and will not be required to repeat all of the expensive and laborious clinical tests conducted by the first company to prove the safety of the product.

However, because of the expense involved in producing the safety and efficacy data needed to obtain marketing approval, the TRIPS Agreement recognizes that the original applicant should be entitled to a period of exclusivity during which second-comers may not rely on the data that the innovative company has created to obtain approval for their copies of the product. During this period of exclusive use, the data cannot be relied upon by regulatory officials to approve similar products. This period of exclusivity is generally five years in the United States and six to ten years in the EC member States. Other countries that provide a period of exclusivity against reliance on data include Australia, China, the Czech Republic, Estonia, Japan, Jordan, Korea, Mexico, New Zealand, Slovenia, and Switzerland. We commend Bulgaria and Colombia on their recent implementation of data protection for pharmaceutical and agricultural chemical products, respectively. In addition, we commend Mexico for passage of regulations that strengthen the coordination between its health and patent agencies to protect valid patents of innovative pharmaceutical products. We urge all WTO members to swiftly complete their implementation of Article 39.3, including the rest of the Andean countries, Israel and Turkey.

As more countries fulfill their implementation obligations, we will adjust our focus to determine whether our trading partners are providing adequate and effective enforcement as required by the TRIPS enforcement provisions.

Ibid. p.4.

Reading the steady stream of U.S. complaints about failed intellectual property protections for drug registration data is a lot like reading a shortened version of PhRMA's 2004 Submission to the U.S. Trade Representative for the Special 301 Report. (See full report at http://www.phrma.org/international/resources/2004-02-12.582.pdf.) Every country on the U.S. 301 Watch List is discussed at length in the PhRMA submission except the Philippines. In each and every one of these country submissions, PhRMA expressly targets registration issues, sometime for pages at a time. This focus is no surprise because in Appendix B, PhRMA expressly states that it "urges USTR to use this year's Special 301 report to launch a global initiative on data exclusivity that will capitalize on the TRIPS clarifications that the United States has not only gained in the FTAs but also in recent WTO accessions of China and Taiwan. The United States should make it clear that the clarifications found in the FTAs on data exclusivity represent the U.S. interpretation of how the obligations contained in TRIPS Article 39.3 should be implemented and that it will allocate the necessary resource to ensure that the non-FTA countries act accordingly."

301 undermines Doha.

The USTR/PhRMA tag team is hell bent on erecting new barriers to generic competition in the form of global rules on data exclusivity and patent/registration linkage. The accomplishment of this focused campaign would undermine most, if not all, of the pro-public health flexibilities clarified in the Doha Declaration in November 2001. Even though compulsory licenses approved at Doha are ill-suited to providing a steady stream of newer medicines at affordable costs to poor people in developing countries, the availability (and threat) of compulsory licenses has pressured Big Pharma to lower drug prices. The possibility of compulsory licenses has also energized generic producers to prepare for the post-2005 Big Bang when the TRIPS' straight jacket gets imposed on countries like India which have heretofore used pre-TRIPS flexibilities to produce cheaper generics of assured quality to address health needs in developing countries.

Developing countries and activists alike must resist and raise the stakes against the registration juggernaut. Death by patent is being replaced by death by registration. Just as PhRMA and the USTR are willing to move the battle line when they have lost ground on one IPR front, we must be prepared to engage them on this new terrain.

Drug regulatory agencies in developing countries must be permitted to use previously filed proprietary data on drug safety and efficacy in order to access the bio-equivalence of more affordable generic alternatives. Without this option, poor people in the Global South will wait five years at a minimum for access to newer medicines. In many instances, they will wait much longer as drug companies unfold their cynical evergreening strategies designed to extend patent protection well beyond a single 20-year term and thereafter use patent/registration linkage to delay marketing approval for decades.

Registration is not an arcane topic? - it is now a matter of life and death. The Bush Administration must be prevailed upon by all available means to sever its allegiance to PhRMA profits and instead to recognize the human right to health. Otherwise, tens of thousands of people will continue to die unnecessarily each and every day simply because they cannot afford medicines routinely available to rich people.