[Random-bits] What civil society can do to ensure governments can respond to a public health emergency (such as, but not limited to, an avian flu pandemic)?

[James Love]

*In terms of patent issues,* what civil society can do to ensure
governments can respond to a public health emergency (such as, but
not limited to, an avian flu pandemic)?

1.  Find out if your government has opted-out of the WTO's 30 August
2003 decision as an importing country.  In other words, is your
country eligible to import medicines produced in a foreign country
under a compulsory license?  This is important, as is almost
certainly the case, your country would benefit from importing generic
medicines produced under a compulsory license, in order to build up
adequate stockpiles or to obtain needed medicines in the event of a
crisis.

The list of which countries *cannot* import under this WTO decision
because their trade representatives have *opted-out* of the limited
TRIPS waiver are listed here:

-------------------
http://www.wto.org/english/tratop_e/trips_e/factsheet_pharm02_e.htm
FACT SHEET: TRIPS AND PHARMACEUTICAL PATENTS
Obligations and exceptions

   [snip]

      A.  Never:

"All WTO member countries are eligible to import under this decision,
but 23 developed countries are listed in the decision as announcing
voluntarily that they will not use the system to import: Australia,
Austria, Belgium, Canada, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Japan, Luxembourg, Netherlands, New Zealand,
Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom and the
US."

      B.   When they join the EU: Never:

"Another 10 countries about to join the EU said they would only use
the system to import in national emergencies or other circumstances
of extreme urgency, and would not import once they had joined the EU:
Czech Republic, Cyprus, Estonia, Hungary, Latvia, Lithuania, Malta,
Poland, Slovak Republic and Slovenia."

      C.   Only for national emergencies:

"And 11 more said they would only do so in national emergencies or
other circumstances of extreme urgency: Hong Kong China, Israel,
Korea, Kuwait, Macao China, Mexico, Qatar, Singapore, Chinese Taipei,
Turkey, United Arab Emirates."

      D.   Everyone else.  No restrictions on gravity of health problem.


2.    If you country has opted-out as an importer, write a letter and
ask for a meeting with your government officials.  Ask them to
explain why they have opted out, and this will affect the ability of
your government to protect the public health of its citizens.  Make
sure you get people on record, including the names of people you deal
with and their positions in the government or parliament.   This will
make policy makers more accountable and responsive to consumer
interests.

3.    If your government is an opt-out country, a government
officials (and legislators) to reverse the decision and opt-in as an
importing country.   Tell them that this issue will be discussed in
Hong Kong at the WTO ministerial meeting in December 2005.

4.    Find out what type of compulsory licensing statute your country
has, including provisions for government (or crown) use, or ex
officio licenses.

5.    Tell legislators that your compulsory licensing (or government
use) law should contain the following provisions:

a.    A no hassle authority to determine when to invoke the
compulsory licensing or government use provisions.  The US and many
other countries can do this automatically, without having to make an
extensive factual finding of abuse of rights.  Other countries have
much more complex procedures.

b.    An elimination of injunctive relief for these type of
compulsory licenses, as is the case in the USA and some other
countries, and as is permitted under Article 44. of the TRIPS, which
reads in part:  "Notwithstanding the other provisions of this Part
and provided that the provisions of Part II specifically addressing
use by governments, or by third parties authorized by a government,
without the authorization of the right holder are complied with,
Members may limit the remedies available against such use to payment
of remuneration in accordance with subparagraph (h) of Article 31."

c.    Insist on a good mechanism for setting remuneration to the
patent owners.  Avoid the mechanisms in the US or Singapore statutes
for government use that raises the possibility that a country may be
saddled very high royalty payments (a problem that Tommy Thompson
complained about in the 2001 CIRPO patent dispute).   Instead,
suggest a more general provision that remuneration will be adequate
(the TRIPS standard), and consistent with transparent administrative
remuneration guidelines, that can be modified from time to time.

6.    For extra credit, provide standby and ongoing authority for the
country to seek affordable supplies of medicine in order to ensure
that stockpiles of medicine are adequate to address significant
threats to the public health.   The authorization to buy from generic
suppliers should be automatic if stockpiles are significantly below
levels recommended by public health medical experts, and if the size
of the stockpiles are constrained by high prices and/or limited
capacity of patent owners to provide the needed medicines.

7.  Insist that your country notify the WTO that your country also
has the authority to export medicines to another country under the 30
August 2003 WTO decision (even better, under Article 30 of the
TRIPS), including but not limited to cases where it is useful to
share domestic stockpiles with another country that is facing an
immediate crisis.

8. Let others know what you are doing, so they can learn from your
experiences.

FMI:  http://www.cptech.org/ip/health/tamiflu/index.html

---------------------------------
James Love, CPTech / www.cptech.org / mailto:james.love@cptech.org /
tel. +1.202.332.2670 / mobile +1.202.361.3040