[Pharm-policy] January 12, 2000 meeting with USTR, DHHS, and USPTO

[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
http://www.cptech.org
mailto:love@cptech.org
voice 1.202.387.8030