Relevant regulations

Relevant Regulations

 Legal Framework for Compulsory Licensing

• Decreto 2153 de 1992
  This decree establishes the framework for the nature, functions, and structure of the Superintendency of Industry and Commerce. Article 4.6 provides the Superintendent with the authority to grant compulsory licenses: “Art. 4.6. Otorgar licencias obligatorias de patentes, en los casos previstos en la Ley.

• Decision 486 of 2000 Common Intellectual Property Regime, Andean Community
  This decision regulates patents and intellectual property in the Andean Community. Chapter VII provides a framework for compulsory licensing.
   
• Resolución 17585 de 2001, Diario Oficial 44.443, Superintendency of Industry and Commerce
  This resolution is a specific regulation on the process for compulsory licensing. Chapter II establishes the procedure to be followed in the case of public interest, emergency, or national security.
   
• Decreto 4302 de 2008, Ministry of Commerce, Industry and Tourism
  The decree clarifies the process for issuing a declaration of public interest. For this particular case, the Superintendent of Industry and Commerce identified the Ministry of Social Protection as the competent authority for issuing a declaration of public interest.
   
• Resolución 005283 de 2008
  Technical committee denies the existence of public interest in access to Kaletra
   
• Resolución 001444 de 2009, Ministry of Health and Social Protection
  The ministry adopts the recommendation of the technical committee and denies public interest in access to Kaletra

  Pricing regulation

  • Comisión Nacional de Precios de Medicamentos, Circular No.04 2006, Comision Nacional de Precios de Medicamentos
  • Colombia’s National Commission on Medicines Prices’ Circular 002 de 2008

    The circular places lopinavir+ritonavir on the “régimen de libertad regulada”, a list of drugs that have special implications for public health, whose price if regulated by the government.

  • Comisión Nacional de Precios de Medicamentos, Circular No.06 de 2013
     

  Declaration of a Social Emergency

• Decreto 126 de 2010, Diario Oficial No. 47.599
  The decree issues a declaration of social emergency to avert the financial crisis threatening the viability of the Social Security and Health System
   

  HIV/AIDS policies

• Decreto 1543 de 1997
   

• Ley 972 de 2005
  The law declares HIV/AIDS to be in the interest of and a national priority for the Colombian government. The law provides the Colombian government with the authority to use regulatory mechanisms to ensure access to medicines for people in need.
   

  Drug registration policies

• Decreto 677 de 1995
  The decree includes relevant provisions on parallel importation of drugs.

• Decreto 2085 de 2002
  The decree provides data exclusivity for undisclosed information. Exceptions include public health, among others.

• INVIMA, Colombia’s drug regulatory body, suspends registration process for Ranbaxy Laboratories’ drug application for generic lopinavir+ritonavir (August, 2008)
   

• Decreto 1313 de 2010
  The decree reinstates parallel importation
   

       Health Reform Bill

• Ley 1438 de 2001. Reforma del Sistema General de Seguridad Social en Salud
   

      National Pharmaceutical Policy

• Consejo Nacional de Politica Economica y Social (2012), “Politica Farmaceutica Nacional” (National Pharmaceutical Policy)
   

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