[Ip-health] Article: NAFTA and the battle for more access to health

Dolores Cullen dcullen at mfjint.com
Wed Aug 22 07:27:25 PDT 2018

Mexican newspaper El Economista just published an article raising concerns
about the potential impact of the ongoing NAFTA negotiations on access to
medicines.  The article, in Spanish, may be accessed at:

Here is a basic translation:

NAFTA and the battle for more access to health
Be careful Dr Alcocer, the battle could be lost before starting August 21,
2018, 19:53 
A question for Dr. Jorge Alcocer - appointed to be the next Secretary of
Health - and the team that will take the reins of the health sector in the
next government that will take office in Mexico: are they aware of the
probable negative impact on drug prices of the renegotiation of the North
America Free Trade Agreement (NAFTA)? What is agreed in the intellectual
property chapter of NAFTA can put at risk the health plans of the incoming
government if they accept provisions that extend the monopoly power of
companies producing original or innovative medicines, thus affecting
expenditures in health, which are already insufficient. In a conversation
with María Fabiana Jorge, an intellectual property consultant based in
Washington, she made us see the above and the importance of achieving a good
balance. The development of new medicines should be promoted but unnecessary
delays in the entry of generic and biosimilar (biocomparable) drugs into the
market at more affordable prices should also be prevented. It is important
that Jesus Seade, who leads the technical team of the incoming government in
the renegotiation of NAFTA, have a clear picture: If the terms that are
accepted further extend the power of ³big pharma", Mexico would be taking a
pathway that is irreconcilable with the goal of strengthening access to
medicines. In order to ensure that the terms of the intellectual property
chapter do not tie the hands of Mexico, there are five issues that must be
taken into account:

1.No patent term extensions: Mexico does not grant them and must prevent the
evergreening of patents that unnecessarily delays the entry of competing
therapies and therefore the reduction of prices. 2. No data protection
beyond existing standards: Mexico grants 5 years of protection to the test
data of medicines containing new chemical entities. This in itself goes
beyond the obligations adopted under the global intellectual property
agreement of the World Trade Organization (TRIPS Agreement); if it extends
such protection, it would be another factor that would contribute to
delaying competition. And speaking of the TRIPS Agreement, Mexico should not
accept any limitations to the flexibilities provided in the Agreement
(reaffirmed in the Doha Declaration) which gives WTO members the right to
protect public health and promote access to medicines for all. 3. No
protection of data for biologics: Mexico does not grant it and it would be a
mistake to do so. The Federal Trade Commission (FTC) of the U.S. has
concluded that it is not necessary to grant such protection because biologic
medicines are the most expensive in the market, costing hundreds of
thousands of dollars per person per year. 4. Linkage. It is the informative
link between the health authority (COFEPRIS) and the intellectual property
institute (IMPI) and one of the most regressive clauses regarding access to
medicines. The linkage mechanism is already in force in Mexico, and it is
already a factor that raises the prices of therapies. As of today, it is in
a regulation. Incorporating it in NAFTA would mean leaving it out of
control: the legislature would have no way of debating and defining what is
best for the Mexican society in this regard. 5. Regulatory review exception
or Bolar clause. The agreement must include a regulatory review exception to
ensure that generic and biosimilar companies can conduct the necessary tests
and register a drug during the term of a patent in order to be able to enter
the market immediately after its expiration. Otherwise there would be a de
facto extension of the patents. President-elect Andrés Manuel López Obrador
has proposed improving access to health for the Mexican people. To achieve
this, he will have to make sure that he does not give his approval to
obligations under NAFTA that will tie his hands during his Presidency. The
battle could be lost before it has even begun.

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