Decision 632
Clarification of the second paragraph of
Article 266 of Decision 486 (year 2000)
THE ANDEAN COMMUNITY COMMISSION,
HAVING SEEN: Articles 22 and 55 of
the Cartagena Agreement and Article 266 of
Decision 486; and
WHEREAS: On September 14, 2000, the
Andean Community Commission approved
Decision 486 containing the Common
Industrial Property System;
The Agreement on Trade-Related
Aspects of Intellectual Property Rights
(TRIPS) signed by all of the Member States
of the World Trade Organization establishes
the obligation to protect “against unfair
commercial use” any test data that may
be submitted to health authorities as
backing for applications to register
pharmaceutical products or agricultural
chemical products;
The second paragraph of Article 266
of Decision 486 stipulates that Member
Countries make take the necessary measures
to guarantee the protection of test data;
One of the means adopted by the
international community to effectively
protect such test data is to impede, for a
given period of time, their use by third
parties to obtain licenses for marketing
pharmaceutical or agricultural chemical
products;
It is necessary to define the scope
of application of the second paragraph of
Article 266 of Decision 486, so that any
Member Country wishing to do so may
establish time periods during which it shall
not authorize a third party, without the
consent of the person who originally
presented the data in question, to market a
product based on that information;
As jurisprudence for Community law,
Article 79 of Decision 344 also made it
possible, in this case explicitly, for
Member Countries to establish a period of
exclusivity to protect test data;
As stipulated in the Judgment handed
down in Proceeding 7-AI-99, “only the
Commission, as the legislative body from
which the clarified, explained or
interpreted Decision emanated, is authorized
to make what is known in legal doctrine as
an “authentic interpretation,” by issuing
another legal norm at the same level or with
the same hierarchy. This interpretation, by
virtue of being set out in a law, shares the
characteristics of that law, including that
of its general applicability, among other
things;”
In this same judgment, the Court went
on to state that “on occasion,
legislators, as part of their legislative
responsibilities, enact laws or regulations
that because of their subsequency, supersede
in their application, amend, annul or
interpret previously enacted laws. This
later legislative effort is intended to
clarify the material content of a law that
in the legislators’ opinion was unclear or
that had been subject to differing
interpretations, with the result that the
legal certainty and ends sought by that law
were occasionally undermined. The
legislators consider these ends to be
unchanging, so that, for all legal purposes,
the enactor of the previous law and the
person interpreting it at a later time are
considered to be one and the same, thereby
respecting the underlying basis for the
sovereignty that is expressed in the
exercise of legislative functions;”
It is necessary to interpret the
second paragraph of Article 266 of Decision
486 authoritatively, in the sense that it
permits the Member Countries to select,
adopt and implement the measures they deem
advisable to guarantee the protection of the
test data referred to in the first paragraph
of Article 266;
By virtue of this interpretation, the
Andean Community Commission clarifies the
intent of the legislators, as embodied in
the second paragraph of Article 266 of
Decision 486, by establishing that each
Member Country shall have the authority to
choose the means for protecting test data,
including the possibility of establishing
time periods during which a Member Country
shall not authorize a third party, without
the consent of the person who had originally
presented such test data, to market a
product based on that information;
By virtue of this Decision, Member
Countries may establish the conditions under
which they shall require the presentation of
information about test data and other
undisclosed data;
The countries have the independence
to determine the conditions they will
require to approve the marketing of
pharmaceutical products or agricultural
chemical products that incorporate new
chemical formulas. They may therefore
approve such marketing, based on the
existence of prior evidence of the approval
of the marketing of such products in other
countries;
In the event that the protection of
test data through the establishment of data
exclusivity periods proves to be harmful to
the public health or food security of any
Member Country, that Country may eliminate
or suspend the said protection;
In order to guarantee Community
transparency in the application of the legal
provisions contained in this Decision, the
Member Countries commit to informing the
General Secretariat about any action they
may take in reliance on this Decision;
DECIDES:
Article 1.-
Any Member Country wishing to do so may
include, among the measures referred to in
the second paragraph of Article 266 of
Decision 486, the establishment of time
periods during which it shall not authorize
a third party, without the consent of the
person who originally submitted the test
data, to market a product based on such
information.
Article 2.-
Member Countries may establish the
conditions under which they shall require
the presentation of information about the
test data or other undisclosed data, for
purposes of the procedures for approval of
the protective measures.
Article 3.-
If a Member Country deems that the
protection of test data granted in its
territory pursuant to Article 1 of this
Decision is damaging to domestic public
health or food security, its competent
national authority may eliminate or suspend
that protection.
Article 4.-
Member Countries shall inform the General
Secretariat about their use of the authority
provided for in Article 1 of this Decision
and the General Secretariat shall pass on
that information to the other Member
Countries.
Signed in the city of Lima, Peru, on
the sixth of April of two thousand and six.
