[Ip-health] Colombian citizens paid US $ 412 million EXTRA due to data exclusivity

Francisco Rossi francisco_rossi at hotmail.com
Sun Apr 29 19:58:04 PDT 2012

Dear friends:

Ifarma and Mision Salud, two Colombian NGOs members of the Lac Global Alliance for access to medicines, finalsed an assesment of the impact of almost ten years of data exclusivity.  

A spanish version is available at www.ifarma.org

This is an abstract in english.




Completed almost 10 years of the issuance of Decree 2085 of 2002, which
introduced data exclusivity for medicines in Colombia, the LAC-Global Alliance for
Access to Medicines and Colombian foundations Misión Salud and IFARMA developed
an evaluation of the different impacts related to its implementation. Data
exclusivity was introduced in Colombia in exchange to trade preferences –
ATPDEA – and sustained during the negotiations of the Free Trade Agreement FTA.

This evaluation had two purposes: to contribute to the national
discussion on data exclusivity and to propose alternatives to improve the
existing system, and secondly, to serve as input for other countries pressed, negotiating
or implementing similar measures.

Colombian citizens have paid US $412 million “Extra” as a direct
consequence of data exclusivity. This figure was calculated from the total
spending on protected new Chemical entities during the period, compared with
“theoretical” spending at competitive prices. There was estimated a
“differential price” by observing price reductions once the data exclusivity
protection period expired.

This figure corresponds to the value of the medical insurance of around
146.000 people, in a country that had made enormous efforts to expand the
coverage of the Health System in the last 15 years. Considering that the total
pharmaceutical market of the country is estimated in US $ 3,3 billion, it
corresponds to a non-depreciable percentage of 15%. It also corresponds to the annual
per capita consumption (US $ 67 - 2010) on medicines of almost 6,2 million
Colombian citizens.

Governmental decision to protect data exclusivity transferred this
amount of resources to Big Pharma in one of the most unequal countries of the
American continent with poverty rate around 50%.

Since developing countries have been victims of different pressure mechanisms
to incorporate data exclusivity in its legislation, they should keep in mind
the findings of this review and impact estimates when negotiating such measures
in trade agreements. Data exclusivity will have an economic impact on the
health system and pocket spending by citizens and families, which will affect
the country according with how to distribute the funding of the sector. Since
the impact focuses on innovative products, their effects will be felt mainly in
the expensive drugs, according to the funding model that country has
established for these products. 


During the period, 122 new chemical entities entered in the Colombian
market, of a total of 10,873 registrations granted, representing about 1% of
the total. The innovation capability of this industry is not very impressing, especially
considering that many of these new entities are “me too” products or
modifications of known products.

100% of the new Chemical entities applications requested data
exclusivity. Of these, 81% were granted and only 5, (4.1%) were
rejected, mainly considering that the information was widely disclosed previously. 

Looking at the country of origin of holders of protected products, it became
clear that all of them were foreigners. Data exclusivity is not encouraging
local innovation. Furthermore, this measure did not promote the rapid entry of generic
versions once the protection expired.

It has been argued that data protection would stimulate the rapid entry
of novel products to the market. However, a comparison of the experience of
Colombia Venezuela and Argentina, countries where there is no data exclusivity,
suggested that it obeys more to market considerations and not to the existence
of data exclusivity.

In reviewing the type of protected products, a significant proportion
corresponded to a high cost anti-cancer and anti-infective (including antiretroviral)
drugs, two types of products involved in a social emergency on health
declaration in 2009. Undoubtedly, these are products of public health interest.
Although the public interest was considered an exception for data exclusivity,
it was never applied, despite an explicit request by the organizations of the
alliance. We Also must call the attention that it was granted exclusivity to a
second use of a product and to a minor modifications of a known chemical
entity, despite both of them were explicit exceptions in the 2085 Decree.

Francisco Rossi


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