[Pharm-policy] January 12, 2000 USTR, USPTO, DHHS meeting (formatting fixed)

[James Love]

Yesterday (January 12, 2000) several members of the Health Gap Coalition,
MSF and other NGO's meet with USTR, US PTO and DHHS to talk about the new
trade policy.  Others will have their own reports of what happened.  I
don't want to go into everything that was discussed, but I would say that
the meeting was pretty frank and I thought a good start.  Paul Davis and
Julie David did a nice job of getting the meeting and moving things along,
and all of the participants made useful contributions.

There were discussions of general principles, plus several country cases.  
We had decided going in to focus in particular on four country cases,
including Thailand, the Dominican Republic, the Philippines, and Kenya,
with each case illustrating a somewhat different point.

As a general matter, the Health Gap/MSF/etc coalition told the US
government that it looked forward to concrete actions following the
President and Vice President's dramatic announcements.  Julie David
chaired the meeting from our side, and USTR's Joe Papovich chaired the
government's side.

Eric Sawyer and Dr. David Hoos made introductory statements about the
concerns regarding patient access to medicines, and our expectation that
USTR would not only consider public health in new disputes, but would
pro-actively address the impact of past policies.  This was a segue into a
discussion of the Thailand case, where a decade of US pressure had led to
several changes in Thai statutes and policies, making access to medicines
more difficult.

Dr. Joelle Tanguy from MSF (Doctors without Borders) explained that the
activists in Thailand were continuing a series of protests, and that they
were asking the US government to send a signal to the Thailand government
that there would be no punitive trade pressures if the Thailand government
issued a compulsory license for ddI, and HIV/AIDS drug.  Several persons
emphasized the fact that the Thai government had been profoundly intimated
by the US government, and a positive signal was needed, to clarify that
there really had been a change in policy.  This case is seen as a test, to
see if Clinton/Gore are serious about making HIV/AIDS drugs more
available.  Toby Kasper and others asked that we receive any copies of
correspondence with the Thai government on this issue.

The next country discussion concerned the Dominican Republic (DR), which
is a new dispute over a pending bill that would authorize compulsory
licensing.  USTR had been asked to bring information to the meeting about
the DR dispute, but was not prepared to provide much information about the
trade dispute, even though the DR has been on the 301 list over this
proposed law since last spring.  However, it did seem as though the US was
objecting to the fact that the DR law would make it fairly straightforward
to get a compulsory license (CL) in the DR, after a 180 day negotiation.  
180 days (for a patent owner to say no to a voluntary license) didn't seem
very short to me.  I brought up the fact that the Dominican Republic is
very poor (about 6 percent of US per capita income), has a significant
HIV/AIDs population (about 83,000 persons, or about 1 percent of the
population in 1997) and that it doesn't have the huge legal system
infrastructure that we have in the USA, and that it was a positive thing
if the DR law was designed so that the compulsory licenses would actually
be issued.  So long as the patent owners were compensated, I didn't think
the US should object to a system that was administratively fast tracked.  
Eric Sawyer said the Caribbean was among the regions of the world were
HIV/AIDS was growing very fast.  USTR was asked to provide information
about the DR law and the US position and lobbying efforts.  "We should be
able to know what US foreign policy is," I said, "and see the basis for US
trade pressures." Julie David said that this was a test both of the
willingness of the Administration to implement the new policy, and to see
if they would make the policy process more transparent.

Julie David talked about the Philippines case, where the US government has
complained about programs on generic drugs, and mentioned the US is
engaged in similar disputes involving Mexico, Thailand, South Africa, and
elsewhere.  USTR was not willing or prepared to talk about the various
disputes over generic drug prescribing, except to say that in the past the
US has objected to proposals for mandatory prescribing by generic name and
for printing in large type the generic name, on the grounds that this
violates trademark rights.  It was mentioned (not by USTR) that the US FDA
has its own rules requiring the use of generic names on packages, and lots
was said about the hypocrisy and wrong headedness of attacks on generic
substitution.  We asked for more details on the US lobbying efforts on the
Philippines proposals.

Eric Sawyer talked about the Kenya case where Pfizer was threatening legal
action against MSF (Doctors without Borders) if they brought cheap copies
of fluconazole across the boarder.  We asked that the President issue an
executive order to prevent Pfizer from getting access to various US
taxpayer funded inventions and research, if Pfizer continued to create
barriers for access to life saving drugs.  There was discussion of
Pfizer's high prices for fluconazole.  This case was discussed to see if
the US government could use its power in a positive way, to stop companies
from making things worse.  It was mentioned that the President has already
used his executive power in the procurement and grants and contracts areas
for other policy objectives.

Paul Davis and others discussed the new public health review of trade
policy.  Joe Papovich and Dr. Tom Novotny both described the US process,
which isn't finalized yet, but seems to involve adding a new element of
review with the Administration.  The US government was told that we were
opposed to the idea that countries would face TRIPS Plus requirements for
medicines, unless they could make a special (and compelling) case to DHHS.  
Also, there was a long discussion about the infrastructure issue that I
can't do justice to here in these brief notes.  I will say that we were
opposed to the idea that the poorest countries would not qualify for
compulsory licensing, under the new policy, if DHHS didn't like the
quality of the infrastructure.  We went back and forth over complaining
about this type of colonialism, and offering suggestions on how to make it
work better -- an awkward discussion at best.

I talked briefly about how difficult it was to get governments to spend
money to treat HIV/AIDS patients, and how in many countries there is
enormous discrimination against HIV/AIDS patient, due to a variety of
social stigmas and taboos.  And how frustrating it was that our own
government would put pressure on poor countries not to solve HIV/AIDS
problems -- after they finally were willing to act.

At one point there was a discussion of having the US government issue
green papers, leading to white papers, outlining US policy on various
disputes, to make trade policy more transparent and to benefit from a more
serious policy debate.

The US government officials were serious and frank, and I thought it was a
constructive exchange.  While we were clearly expressing concern that big
public announcements were not consistent with policy on the ground, it was
also clear that this was a much different meeting than we had ever had
with the Administration, and that much progress has been made.

It's late and I have to go home.  There was much more done, and I
apologize for leaving so much out.

 Jamie


-------------------------------
James Love 
Center for Study of Responsive Law | Consumer Project on Technology 
P.O. Box 19367, Washington, DC 20036 | http://www.cptech.org
Voice 202/387-8030 | Fax 202/234-5176 | love@cptech.org