| Summary of Facts:
• On September 19, 2002 the government of Colombia issued the Decree num. 2085 that regulates aspects of the information provided to obtain sanitary registers for new chemical entities in the drugs area. It is protecting undisclosed information (test data) presented for the attainment of the sanitary register by authorizing periods of exclusivity.
• The Decree 2085 was applied by the National Institute for the Vigilance of Drugs and Foods of Colombia (INVIMA by its initials in Spanish).
• The petitioner, ASINFAR, argues that by issuing that decree the Colombian government is regulating beyond its competence and is violating the Andean legislation (mentioned in the title of the demand). Besides this, it argues that the protection given to this information carries harmful consequences for the health of the population of the sub-region like price increases, therefore decreasing their access to the drugs. Added to this, argues it limits the competence of national laboratories over the molecules that are already in technical status and public domain.
• The Colombian government, using the argument of indispensable complement, argues that because the Decision 486 of the Commission does not detail the way to guarantee the protection of undisclosed information, by the Decree 2085 it is detailing the way to guarantee it. It argues that the principal aim of the Decree 2085 is to establish a proceeding for drugs sanitary register that is not provided by the Andean or Colombian legislation.
Issues:
- Specific Issues for Attention
• The arguments of the petitioner highlighting the consequences of the Decree on the health and access to the drugs by the low-income population of the region.
- Procedural Practice Issues
Jurisdiction: Court of Justice of the Andean Community
Standing: According to article 25 of the Treaty Creating the Court of Justice of the Andean Community, natural and legal persons affected in their rights have standing before the Court. ASINFAR has proved that the members it represents are holders, manufacturers and importers in several drugs sanitary registers over which the Decree 2085 is applied. The Court recognized there are subjective rights of the companies represented by ASINFAR that are being affected.
ASINFAR started the preliminary procedure before the General Secretariat of the Andean Community requiring its pronouncement on the issue. The General Secretariat ruled the Decree 2085 does not constitute a breach. According to the Andean Legislation, if a party has a ruling from the General Secretariat on an issue it can start an Action for Non-compliance before the Court of Justice of the Andean Community. (Articles 23, 24 and 25 of the Treaty Creating the Court of Justice of the Andean Community) (Page 23)
Evidence:
• Both parties presented several documents as evidence of their arguments.
Decision:
• Declare the demand sustained.
• Declare that the Republic of Colombia is in default of Community law by issuing the Decree 2085 in which it regulates aspects of the information supplied to obtain the register for new chemical entities in drugs sector, including its application by the INVIMA. It is establishing periods of exclusivity violating article 4 of the agreement establishing the Court of Justice of the Andean Community, articles 260 to 266, 276 and 279 of Decision 486 of the Commission of the Andean Community.
• Requires the Republic of Colombia to adopt the measures needed or reestablish the Community legislation breached.
Enforcement:
• This is the only decision issued by the Court on this case. There is no further decision on its compliance or non-compliance before the Court.
• Nevertheless, after this decision Colombia promoted a reform to the Decision 486 that was successful and after which the Commission issued the Decision 632 . The latter authorizes the members of the Andean Community the use of periods of exclusivity for test data. If the protection is harmful for national public health or food security, the members might eliminate or suspend this protection.
• Declare the demand sustained.
• Declare that the Republic of Colombia is in default of Community law by issuing the Decree 2085 in which it regulates aspects of the information supplied to obtain the register for new chemical entities in drugs areas, including its application by the INVIMA, is establishing periods of exclusivity violating article 4 of the agreement establishing the Court of Justice of the Andean Community, articles 260 to 266, 276 and 279 of Decision 486 of the Commission of the Andean Community.
• Requires the Republic of Colombia to adopt the measures needed o reestablish the Community legislation breached.
• The Court declared is proved that the Republic of Colombia in the Decree 2085 includes a term of exclusivity as a protection for test data of 3, 4 and 5 years. This protection was considered in the Decision 344, but is not in the Decision 486 (both of the Andean Commission), which came after. The Court emphasizes that despite the second paragraph of article 266 of Decision 486 authorizes to take the actions needed to guarantee the protection established in this article, it does not delegates the faculty to establish terms of exclusivity; and considers it is excessive from Colombia to protect the test data in the way established by the Decree. Therefore Colombia is violating the Community Industrial Property Legislation.
• Regarding public health and consumers of pharmaceuticals in developing countries like the members of the Andean Community, the Court reasoned that granting exclusive rights for certain periods of time might be in conflict with fundamental rights like health and life. This is because the consumption of drugs is related with their price, and a monopolic price might make impossible the access to the drug and take the potential consumers to sickness and death. Regarding test data, to protect it for a determined time has the effect of unduly extending the monopoly of the patent, postponing the free competition in the market, and therefore extending the difficulty of access to the drug. The protection granted by the Decree is not compatible with the one established in the Community legislation, nor with the limit of public health, neither with the process of integration.
• According to the structure and principles by which article 266 of the Decision 486 must be interpreted, regarding article 3 of Decree 2085 of the Republic of Colombia, the later is not compatible with Community legislation.
• This is the only decision issued by the Court on this case. There is no further decision on its compliance or non-compliance before the Court.
• Nevertheless, after this decision Colombia promoted a reform to the Decision 486 that was successful and after which the Commission issued the Decision 632 . The latter authorizes the members of the Andean Community the use of periods of exclusivity for test data. If the protection is harmful for national public health or food security, the members might eliminate or suspend this protection.
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