EDITORIAL NOTE No. 7
10 April, 2017
In light of the confusion created by a statement issued by the Ministry of Health on April 6,
2017, AFIDRO is forced to clarify point by point the statements expressed by that office, in the
following terms:
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The Ministry’s press release begins by stating that: “The resolution that declared the existence
of public interest grounds against the drug Imatinib (Glivec, by its trade name) remains in
force and will not be revoked, the Ministry of Health and Social Protection reported in
response to a letter presented by Afidro in which it insinuates that the Government would be
contemplating the possibility of reversing the measure”.
To this regard, the following needs to be remembered:
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For those affected by it, the resolution containing the Declaration of Existence of Public
Interest Grounds against Imatinib entered into force in September 2016, when the
administrative process that resolved the respective appeals was completed.
AFIDRO has never “insinuated” that the Government is contemplating the possibility of
reversing the measure. AFIDRO, and all persons interested in Colombia being perceived as
a State which is respectful of intellectual property, wish that this unjustified Declaration of
Public Interest Grounds be revoked, and presented said request at the time.
The Ministry’s press release continues: “Similarly, the National Pricing Commission for Drugs and
Medical Devices has not considered revoking Circular 03 of 2016, which established a methodology
to regulate drug prices under exceptional situations, when a public interest has been declared”.
The following considerations are worth mentioning:
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The National Pricing Commission for Drugs and Medical Devices (CNPMDM for its
acronym in Spanish) has the legal duty to consider the possibility of revoking Circular 03,
because it has in its hands an official request to this regard, presented by AFIDRO.
The CNPMDM could, of course, refrain from revoking Circular 03 of 2016, provided that it
argues its position in due manner, but what it cannot refrain from is considering the request.
It is surprising that a deliberate decision to violate the law is so emphatically announced, in
an official communication, and the decision to not even consider a duly presented and
reasoned request is celebrated.
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Teléfono: (57) (1) 486 7575
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On March 24, 2017, the CNPMDM allowed for the expiration of the period to resolve
AFIDRO’s request to revoke the Circular. To this date, this situation remains unresolved.
The reasons for which there has been no response are not difficult to infer: it is highly
probable that none of the three senior officials who comprise the CNPMDM could have come
up with an argument that would refute the legal grounds included in our request; legal
grounds which would immediately call for a reversal, if the matter was objectively analyzed.
Later, the press release stated that: “The statement by the Ministry of Health was made as a result of
the expressions used ambiguously by Afidro in its letter, according to which, following a meeting
held last 25 January with the General Secretary for the Office of the President, the Government agreed
to never again adopt measures such as the above, and that as a “correction” or “rectification”, the
Government would repeal Resolution 2475 (Declaration of Public Interest) and Circular 03.”
We would like to share the following considerations:
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It is false that AFIDRO has stated that the Government has committed, “by way of
‘correction’ or ‘rectification’” to repeal Resolution 2475 of 2016, which refers to the
Declaration of Existence of Public Interest Grounds. It is true that AFIDRO has asked for this
to happen. Those are two very different things.
It is also true that in all public or private forums, various government spokesmen have said
that the Glivec case was the result of exceptional circumstances, and that they see no future
scenarios where this may happen again.
What Afidro said in the above-mentioned communication dated January 25, 2017 is the
opposite of ambiguous. [1] The letter makes reference to verifiable facts: that Resolution
2475 is still in force and that the request to revoke Circular 03 of 2016 has not yet been
resolved.
The Ministry's statement concludes: “Contrary to what was suggested by the research and
development pharmaceutical trade association, the two decisions adopted by the Government remain
in force: both the Resolution which declares the public interest grounds and requests that the
CNPMDM set a new price for Glivec, as well as the Circular that establishes the methodology for
setting prices when public interest grounds have been declared.”
Thereon:
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Why does the Ministry of Health publicly announce the meaning of a decision that should be
taken by another organization, the CNPMDM? Why does it announce the meaning of the
decision without informing the public of the arguments which, in its opinion, lead to the
dismissal of the grounds on which the request to revoke was based? Can the government
make non-motivated decisions in these cases? What is the opinion of the other members of
Dirección: Carrera 14 No. 99-33 Piso 6, oficina 602, Bogotá, Colombia
Teléfono: (57) (1) 486 7575

the Price Commission, or did they act as silent partners, serving as passive observers
regarding the decisions already taken by one of its members?
It is not true that the two decisions were adopted by the Government: the Declaration of
Public Interest was adopted by ministerial resolution, and the Price Circular, by the
CNPMDM. It is well known that, in constitutional terms, the President and the corresponding
minister or department director, for each particular office, constitute the Government. It
would therefore seem that there was a subtle attempt to link the President of the Republic to
decisions where he did not participate.
Gustavo Morales Cobo
Executive President
[1] The paragraph that addresses the matter in Afidro's letter expressly states the following: “…during
the meeting, we had the opportunity to directly address, not only the huge damage to the confidence
perceived by all economic agents in the Colombian intellectual property regime, caused by last year’s
issue by the Ministry of Health of a Declaration of Public Interest (DPI) on a specific product, without
providing any of the internationally accepted conditions for the application of said figure, which is
intended to exempt the ordinary protections of a patent, but also the more serious damage
caused by the National Pricing Commission for Drugs and Medical Devices which issued, illegally
based on said Declaration, a general pricing regime applicable to products subject to a DPI, which,
because it is more severe than the current ordinary regulation in force, stripped away any value arising
from the innovative effort of a patent.
The Government's statements that such a chain of mistakes will not happen again absolutely lacks
credibility, since the Minister of Health has indicated, after our meeting, that he would consider this
possibility regarding new categories of medicines and, in any case, the unnecessary permanence of
this precedent is an objective and tangible fact that cannot be considered a mere threat, or the result
of an exaggerated negative predisposition from our sector.
The truth is that, in the weeks since the meeting, nothing has happened to suggest a correction or
rectification by the Government. The Declaration of Public Interest remains in force, although a
unilateral decision to revoke it would suffice; and Circular 03 of 2016, regarding prices to products
subject to a DPI, which was issued without legal basis, has not yet been revoked, despite the formal
requests presented, and whose deadline for response by the authorities expires on March 24 ...”.
Dirección: Carrera 14 No. 99-33 Piso 6, oficina 602, Bogotá, Colombia
Teléfono: (57) (1) 486 7575