[Pharm-policy] Dr. Thomas Novotny's response regarding WHA Executive Board meeting

[James Love]

Subject: Response to email
   Date: Thu, 27 Jan 2000 17:54:01 -0500
  From: TNovotny@osophs.dhhs.gov (Thomas Novotny)
    To: love@cptech.org, JWright@osophs.dhhs.gov (Jason Wright)
     
     Jason: please distribute to Stu, USTR, David Hohman, Ken Bernard, etc.

Jamie: I trust that when you distribute this email, you will not edit 
it in any way.  

I feel that I need to clarify a few things noted in your recent email 
traffic (Jan 27) that without clarification might constitute 
misrepresentation.

I am the head of the US Delegate to the WHO Executive Board, and I led 
a five-person delegation, including Stuart Nightingale, to the ongoing 
meeting of the Board.  In preparation for this meeting, the USG had 
developed carefully worded interventions in response to the WHO paper 
on HIV/AIDS.  These interventions were vetted around DHHS and other 
agencies, but our corrections to the WHO draft resolution are subject 
to a fairly intense consensus process based on vigorous, 
straightforward exchange with our fellow board members.  Although I, 
as the head of delegation, encouraged the other members of my team to 
get input from all interested parties, including NGOS and 
pharmaceutical representatives, I had no contact with any of these 
groups outside of the meeting I attended with USTR and the invited 
NGOS earlier this month.  

1. You stated that the Clinton/Gore administration "is apparently 
working with the International Federation of Pharmaceutical 
Manufacturers, etc." to remove language from the resolution that you 
described as "similar to the language that passed the World Health 
Assembly in 1999."
   This is completely erroneous on two counts: 1) we are not working 
with anyone but the USG to contribute to the drafting of the 
resolutions; this is what we get paid for, and as stated above, our 
contributions are based on cleared language from the Department and 
other agencies.  2) We fought hard (and succeeded) to get IDENTICAL 
language to the Revised Drug Strategy that was the product of intense 
negotiations at the last World Health Assembly.  This language is now 
included in preamble of the resolution and later with wording that 
replaces the flawed clause 2(7) that you quoted in your email.  The 
language was agreed on by consensus among a drafting group that 
included African nations, India, European countries, and Chile, among 
others.  I think there was little dissention to the following language 
(which we insisted recall the Revised Drug Strategy).

In preamble: "Recalling resolution WHA52.19 as approved by the 52nd 
World Health Assembly, which inter alia requests the Director-General 
to cooperate with Member States at their request, and with 
international organizations in monitoring and analysing the 
pharmaceutical and public health implications of relevant 
international agreements, including trade agreements, so that Member 
States can effectively assess and subsequently develop pharmaceutical 
and health policies and regulatory measures that address their 
concerns and priorities, and are able to maximize the positive and 
mitigate the negative impact of those agreements;"

As for removing the IPR-related language, we opposed this because it 
went beyond what was agreed to in the Revised Drug Strategy; following 
is Clause 2(12) replacing 2(7):

TO COOPERATE WITH GOVERNMENTS AT THEIR REQUEST AND OTHER INTERNATIONAL 
ORGANIZATIONS REGARDING POSSIBLE OPTIONS UNDER RELEVANT INTERNATIONAL 
AGREEMENTS, INCLUDING TRADE AGREEMENTS TO IMPROVE ACCESS TO 
HIV/AIDS-RELATED DRUGS;

We believe this covers WHO responsibilities and opportunities to work 
with WTO and WIPO on trade agreements to improve access to drugs (just 
as USDHHS now cooperates with USTR to insure the flexibility of US 
Trade Policy in health crises).


2. You suggested that we were trying to include language from the 
IPFMA.  That is completely wrong.  The language we support is based on 
our conversations with the WHO Secretariat and which was also 
published as a result of the first IPFMA-WHO Roundtable on 
Pharmaceuticals.  I believe this product is a result of the pursuit of 
"dialogue with the pharmaceutical industry" referred to above.  WHO 
agreed to it, and we think it makes perfect sense.  

We developed as new clause 2(9): "to pursue dialogue with the 
pharmaceutical industry with a view to making HIV/AIDS-related drugs 
increasingly accessible to Member States and their populations through 
drug development, cost reduction, and strengthening reliable 
distribution;"

and new clause 2(10): "to reinforce, promote, and explore partnerships 
in order to make HIV/AIDS-related drugs accessible through affordable 
prices, adequate financing, and effective health-care systems, and to 
ensure that drugs are safely and effectively used;"

We believe this wording represents a comprehensive approach to drug 
accessibility and care.  I believe that the EB will think so too, as 
we have had frank, open, and productive discussions to reach 
agreement. I think that what we have said here is perfectly consistent 
with what the VP spoke about at the UN Security Council; what it does 
not do, and we feel strongly that it must not do, is refer solely to 
price as the answer to accessibility.  

Please feel free to let me know how "drug development, cost reduction, 
and strengthening reliable distribution" or "affordable prices, 
adequate financing, and effective health-care systems" do not lead to 
improved accessibility.  Again, we worked hard not to let only the 
price issue drive accessibility concerns.  To limit accessibility 
concerns only to price would be terribly mistaken.  Your position on 
this is far to narrow.  Price reduction is only one tool to improve 
access.  Drugs could be free and still not be effective without 
effective health care systems.  In fact, they would rapidly become 
ineffective.

Finally, you must now realize the dialogue that continues between DHHS 
and USTR is already showing results.  Today, USTR released a paper in 
which they stated, "If the Thai government determines that issuing a 
compulsory license is required to address its health care crisis, the 
United States will raise no objection, provided the compulsory license 
is issued in a manner fully consistent with the WTO Agreement on Trade 
Related Aspects of Intellectual Property RIghts (TRIPS)."

We are still working on the details of our collaboration, and during 
my visits here to WHO and UNAIDS, we obtained important input on just 
how we might work with USTR to follow through on the President's 
directives.  We still need more time to work this out, but we consider 
it a major priority for our Global Health Strategy on HIV/AIDS.

On a personal note, Jamie, this is the second time you have 
disseminated factually incorrect information around the world 
regarding our work with USTR, and now about our work with the WHO 
Executive Board.  This only damages our relationship with the NGOS and 
undermines our work with WHO.  I am sure that is not your objective, 
and I hope you will try harder to represent our actions with more 
balance and accuracy.





-- 
James Love, Consumer Project on Technology
P.O. Box 19367        | http://www.cptech.org
Washington, DC 20036  | mailto:love@cptech.org
Voice 1.202.387.8030  | fax 1.202.387.8030