KEI 2007 Special 301 Submission to USTR on Pharmaceutical Test Data Protection

KEI “Special 301” Submission to USTR on Pharmaceutical Test Data Protection

12 February 2007

Knowledge Ecology International (KEI) is a non-governmental organization that searches for better outcomes, including new solutions, to the management of knowledge resources.

We welcome this opportunity to submit comments on the Special 301 Report that identifies countries that deny adequate and effective protection of intellectual property rights or deny fair and equitable market access to US persons who rely on intellectual property protection (section 182 of the Trade Act of 1974).

We would like to submit our comments on topic of the obligations under Article 39.3 of the TRIPS for WTO Members to protect pharmaceutical certain test data from unfair commercial use, particularly undisclosed test data originated from new chemical entities and that required considerable effort to generate.

We recognize that in recent years the protection of pharmaceutical test data through an exclusive rights mechanism (marketing exclusivity) has been a key issue for the US Trade Representative, at the urging of certain industry stakeholders, such as the members of the Pharmaceutical Research and Manufacturers of America (PhRMA). In addition to various bilateral and regional trade agreements and the continuing negotiations over WTO accession, the U.S. makes this issue a leading focus of its Special 301 Report, and as a condition of WTO accession.

We note that the TRIPS Agreement has detailed intellectual property provisions and dispute resolution mechanisms. Unilateral mechanisms, such as the United States Special 301 process, may have an important role in setting global norms for the protection of intellectual property, but they should be used with caution in areas concerning public health.

Upon signing the TRIPS Agreement, WTO Members have acquired some obligations. However, we disagree with the interpretation given by PhRMA regarding the nature of such obligations.

The study of the TRIPS agreement and its negotiating history establish that nothing in the TRIPS prevents a WTO member from allowing generic competitors to rely upon public information, evidence of foreign drug registrations, or non-disclosed data from another company. PhRMA is asking USTR to go considerably beyond the minimum obligations under the TRIPS.  Article 39.3 of the TRIPS agreement imposes a general obligation of protection and allows member states to decide the concrete terms of its implementation, including those that are consistent with Paragraph 4 of the 2001 the Doha Declaration on TRIPS and Public Health, a document the United States has proudly endorsed.

The US proposal for marketing exclusivity is modeled generally after an important but limited sui generis system of protection created in the United States in 1984, as part of the negotiated outcome known as the Waxman/Hatch Act.  For certain products, but not others, the Congress created a system of exclusive rights to rely upon evidence of safety and efficacy of products.  These rights are not absolute, even in the United States. For example, the US Federal Trade Commission has in some cases required licensing of such data rights to competitors, in order to protect consumers from anticompetitive practices.

We note also that in the area of agricultural chemicals, the other area covered by Article 39.3, the United States government utilizes a different approach. This includes a system of cost sharing for some uses of data.  The cost sharing approach eliminates the needs to replicate tests.

KEI is opposed to obligations on developing countries to adopt TRIPS plus provisions in the area of pharmaceutical test data.  Our primary objection concerns the exclusive rights approach, particularly if the country does not have useful mechanisms for limitations and exceptions to those rights in important cases, such as when drug prices are unaffordable, or when (as is typically the case), it would be unethical to repeat the human experiments needed for drug registration.

We therefore ask that USTR give greater latitude to developing country trading partners to consider a wider range of methods of protecting pharmaceutical test data.  In particular, we ask that USTR explicitly recognize cost sharing alternatives, similar to that used in the USA for agricultural chemicals, or as have been included in a recent FTA between Switzerland and Korea.

We have discussed these issues at length in this document:

We further ask for a meeting with USTR staff to discuss our objections to the exclusive rights approaches, when there are pricing abuses, and or when the repetition of the human use clinical trials violate well known ethical standards for experiments on humans.

James Love and Judit Rius
Knowledge Ecology International