Mexico
- Compulsory Licensing & Pricing
The
alliance between Institutional Revolutionary Party (PRI) and the
new Green Ecologist Party of Mexico (PVEM) led to mess in the work
of the Chambers of Deputies who had as a consequence forwarded various
decrees related to pricing and compulsory licensing to the Senate
for discussion. One of these decrees affects Mexican General
Law on Health and the Mexican Industrial Property Law directly related
to the subject and attempts to strengthen the position of law-quality
pharmaceutical chains, in a move that not even generic companies
support.
Background:
The Trade-Related
Intellectual Property Rights (TRIPs) clearly establishes certain
conditions that member countries mu7st comply with, in order to
grant compulsory licences for patents. However, regarding
the countries considered as least-developed and those that do not
have the required capacity for production of medicaments, the Doha
Declaration on TRIPs and Public Health specified the need to clarify
the criteria for compulsory licensing. Since Mexico is not
considered in any of these categories, therefore any additional
conditions to those permitted by TRIPs for the granting of licences
of public utility should be considered as a breach of TRIPs's Article
31, which prompted modifications to the Industrial Property Law
(Artcle 77) that are discussed below:
Previous/Linkage
Reforms to Article 77:
Former Article
77 already contemplated public utility licences as a mechanism to
prevent the use of a patent to impede the solution of a national
emergency or elimination of a risk to national security. However,
a modification to this Article after intense discussion by both
generic and research-based companies and the government was published
which specified that those diseases declared as priority attention
diseases are to be considered to be causes of national emergency.
It also set forth a procedure to grant compulsory licences that
to some extent did not comply with the procedures and conditions
mandated by TRIPs.
Since this
reform brought some criticisms regarding the IP system in general
in Mexico under the US Rule 301, the so-called linkage system was
enacted to reinforce patent protection by relating the grant of
health registration approvals for medicines to the patent system,
similar to the Federal Drug Administration of the US.
The linkage system mandates that health approvals will not be granted
to third parties that are not authorized by the assignee of a patent
or its authorized licensee, thus linking health authorities with
industrial property offices This system further provides for
permission to submit applications for approval of generic drugs
three years before the expiry date of the corresponding patent,
among other provisions.
Reforms
to Article 376:
With the
aim of assuring the quality of medicaments, the Ministry of Health
enacted a report to Article 376 which specifies requirement to renew
health approvals every five years, otherwise the approval would
be revoked. The reform was considered a setback and a step
to ensure that the necessary conditions of quality are maintained
regarding medicaments.
Reforms
approved by the Chamber of Deputies:
With regard
to the Mexican General Law of Health (GLH), the proposed reforms
conceptually promote a preference for generic medicaments in government
purchasing over other kinds of drugs, which is not acceptable in
commercial terms, and that serves as a preamble to the reforms regarding
pricing. The proposed additions state that one of the purposes
of the General Health System is ensuring people accessibility to
medicaments through accessible pricing and costs and includes promotion
of interchangeable generic medicaments in governmental health institutions.
Another
reforms in Article 31 includes provisions for the authorization
of importation of a patented medicaments which is illegal without
the authorization of its owner under the Mexican Patent Act.
So the proposal contravenes the rights determined by the Article
25 of the IPL.
Article
74 was modified to incorporate interchangeable generic medicaments
as something the Ministry of Health should handle in order to be
used in hospitals specializing in mental illness, in a modification
which has well-known antidepressants as the target.
It is expected
that the modifications approved by the Chamber of Deputies in the
Congress must lead to a broad revision of the modifications that
were previously made to the involved laws and rules so they are
not inconsistent with each other. The Senate must study the reforms
proposed by the Deputies and may modify, reject or approve them.
IPR
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