E-DRUG: generic drugs in Mexico (7)
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Larry Sasich from Public Citizen and Professor Steve Schondelmeyer from
the University of Minnesota are far more expert about the US experience
in generic drugs than I. I can recall working on legislation to promote
generic drug substitution during the 1970's, in the state of Alaska, and
at that time, many many states had enacted legislation which were
designed to require pharmacists to notify patients of less expensive
generic substitutions, and to make such substitution legal, in the
absence of a doctor specifically checking a no-substitution box printed
on the prescription form. Now I live in Virginia, and my HMO requires
the use of substitution from an HMO formulary, which is a broader
substitution than a generic drug. My pharmacist makes the substitution,
without consulting the doctor.
Apparently PhrMA has persuaded the US trade negotiators to apply
pressure to many countries who are seeking to promote generics, under
absurd theories that laws which require generic name prescriptions, or
use of generic names on packaging, violate GATT or NAFTA trademark
rights. Since you are writing about Mexico, it is a good idea to review
the NAFTA provisions on trademarks.
The intellectual property provisions of NAFTA are on the Web at:
http://the-tech.mit.edu/Bulletins/Nafta/17.intellect
The term "party" refers to a country. Here are a couple of sections
worth reading:
Article 1704: Control of Abusive or Anticompetitive Practices or
Conditions
Nothing in this Chapter shall prevent a Party
from specifying in its domestic law licensing
practices or conditions that may in particular
cases constitute an abuse of intellectual property
rights having an adverse effect on competition in the
relevant market. A Party may adopt or maintain,
consistent with the other provisions of this Agreement,
appropriate measures to prevent or control such practices
or conditions.
You should also look at Article 1708: Trademarks, and read: sections 2,
10 and 12, which say:
Article 1708: Trademarks
2. Each Party shall provide to the owner of a registered
trademark the right to prevent all persons not having
the owner's consent from using in commerce identical or
similar signs for goods or services that are identical
or similar to those goods or services in respect of which
the owner's trademark is registered, where such use would
result in a likelihood of confusion. In the case of the
use of an identical sign for identical goods or
services, a likelihood of confusion shall be presumed.
The rights described above shall not prejudice any prior
rights, nor shall they affect the possibility of a Party
making rights available on the basis of use.
[This is the main "right" of a trademark owner, the right to prevent
others from using the trademark.]
10. No Party shall encumber the use of a trademark
in commerce by special requirements, such as a
use that reduces the trademark's function as an
indication of source or a use with another trademark.
[This *may* be a section the drug companies will use to claim they are
harmed by generic labeling laws].
12. A Party may provide limited exceptions to the
rights conferred by a trademark, such as fair
use of descriptive terms, provided that such
exceptions take into account the legitimate
interests of the trademark owner and of other
persons.
[This section gives governments broad rights to limit trademark rights
for public purposes].
Nothing in NAFTA specifically deals with trademarks and generic drugs,
but the general provisions for trademarks are focused on the traditional
issue of infringing use of a companies trademark. For example, only
CocaCola can use its trademark for Coke, and only Levi can use its
trademark jeans. Requiring disclosures of the scientific (generic) name
on the label of a for drugs is a common policy initiative that should
not be affected by NAFTA or GATT. If specific claims are made regarding
international law, please advise the list of the precise terms under
which general laws are being attacked.
I am not a lawyer, and I welcome comments by those who are lawyers.
Jamie
--
James Packard Love
Consumer Project on Technology
P.O. Box 19367 | Washington, DC 20036
voice 202.387.8030 | fax 202.234.5176
love@cptech.org | http://www.cptech.org
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