[Ip-health] KEI Submission: Special 301 Review

[Judit Rius Sanjuan]

Today, Knowledge Ecology International (KEI) submitted comments to the
US Trade Representative on the Special 301 Review.

Submission available here:
http://www.keionline.org/misc-docs/KEI_301SubmissionFeb2007.pdf

KEI =93Special 301=94 Submission
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 areas
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 that developing countries adopt TRIPS plus
obligations in the area of data, but our primary objection concerns the
exclusive rights approach, particularly if the country does not have
useful mechanism to provide limitations and exceptions to those rights
in important cases, such as when drug prices are unaffordable, or when
(as if typically the case), it would be unethical to repeat the human
experiments needed for drug registration.

We therefore ask that USTR allow developing country trading partners to
consider a wider range of methods of protecting test data. In
particular, we ask that USTR explicitly
allow for 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:
http://www.cptech.org/ip/health/data/CPTech-Test-Data.pdf

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
+1.202.332.2670
james.love@keionline.org
judit.rius@keionline.org

--
Judit Rius Sanjuan
Attorney
judit.rius@keionline.org

Knowledge Ecology International (KEI)
www.cptech.org
1621 Connecticut Ave, NW, Suite 500 Washington, DC 20009 USA
Tel.: +1.202.332.2670, Ext 18  Fax: +1.202.332.2673