Colombia's Inter-ministerial Medicines and Medical Devices Pricing Commission (CNPMD) has released for public consultation a draft resolution that introduced an exceptional methodology to set prices of medicines declared of public interest by the Colombian ministry of health.
Implications | The draft resolution targets all the potential medicines that the MoH would declare of public interest. The proposed regulation follows the Colombian MoH's instruction to the CNPMD to cut substantially the price of the oncology treatment Glivec after declaring it of public interest in June. |
Outlook | The public consultation for the CNPMD's resolution will be open until 20 September. Despite strong opposition by the Swiss producer Novartis and some international institutions, the MoH is likely to reaffirm this methodology in a final resolution after the public consultation. |
Colombia's Inter-ministerial Medicines and Medical Devices Pricing Commission (CNPMD) has released for public consultation a draft resolution that introduced an exceptional methodology to set prices of medicines declared of public interest by the Colombian ministry of health (MoH). According to CNPMD, the public consultation will be open until 20 September and the draft resolution can be accessed here, in Spanish.
The exceptional methodology proposed by the CNPMD in the draft resolution is to assess on which markets, out of the 17 countries that Colombia normally referred as part of its international reference pricing system (IRP), the specific public-interest brand medicine that competes with generics. After comparing the price according to a formula detailed in the resolution, the CNPMD proposes to apply in Colombia the lowest price found in these reference countries where generic competition exists for the specific brand medicine in question.
According to the pricing commission, this resolution aims to set a price for the Colombian market under the presumption that the public-interest medicine faces generics competition in the market.
Outlook and implications
The draft resolution targets all the potential medicines that the MoH would declare of public interest. The proposed regulation follows the MoH's instructions to the CNPMD to cut substantially the price of the oncology treatment Glivec (imatinib), as part of the dispute between the Colombian government and Novartis (Switzerland; see Colombia: 20 June 2016: Colombia's MoH publishes final resolution authorising pricing commission to cut Novartis's Glivec price).
The international opposition against this measure by the Colombian MoH has intensified with the publication of the draft methodology, and comes not only from Novartis. The Pharmaceutical Researchers and Manufacturers of America (PhRMA) industry group in a statement published yesterday (16 September) has strongly criticised the Colombian government's decision of unilaterally reducing the price of Novartis's Glivec, calling the move a "harmful global precedent".
However, some international organisations, such the United Nations, have shown support to the Colombian government's intention of controlling high prices of medicines to protect public interest in Colombia. Therefore, it remains to be seen whether, after the public consultation, the MoH ratifies the methodology proposed by the CNPMD and publishes a final resolution on this matter, which seems very likely given that the MoH ordered the CNPMD to prepare this exceptional methodology.