E-DRUG: Dr. Thomas Novotny's response regarding WHA Executive Board meeting
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[We distributed an earlier Pharm-Policy message about the WHA debate; as this
replies to our earlier E-drug message, I am circulating also Dr Novotny's response
and Jamie Love's 2nd response below. For further discussion, please see
Pharm-Policy at: http://lists.essential.org/mailman/listinfo/pharm-policy
WB]
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.
Thomas Novotny
Email: TNovotny@OSOPHS.DHHS.GOV
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2nd Response by Jamie Love:
I appreciate Dr. Thomas Novotny's willingness to provide
information about the US government's positions at the WHO
Executive Board (EB) meetings in Geneva this week, and welcome a
continued dialogue on these matters, so that US policy is truly
transparent.
One can draw different conclusions as to how and why US policy
evolved as it did over the past week in Geneva and at USTR, and I
will not address these issues in detail in this note.
I remain somewhat puzzled over the US government (USG) policy
with respect to the WHO and trade policy, including trade policy
as it relates to intellectual property rights on pharmaceuticals.
I would appreciate a clarification from Dr. Novotny on a few
points. And since Dr. Novotny is concerned about the US
government position being misrepresented, I would encourage him
to respond directly, once again.
Several persons in Geneva have reported that Dr. Novotny
expressed opposition to the WHO playing a role in policy making
on intellectual property right (IPR) issues, and Dr. Novotny
acknowledges that the USG did ask that the EB remove the
following language from the original EB AIDS resolution:
The Executive Board . . . REQUESTS the
Director-General:
7) on their request, to advise governments
on their options under the Agreement on
Trade-Related Aspects of Intellectual Property
Rights (TRIPS) to increase their capacity to
negotiate for more affordable HIV/AIDS-related
drugs;
According to Dr. Novotny, "we [the USG] opposed this because it
went beyond what was agreed to in the Revised Drug Strategy."
I would point out that "going beyond" the RDS isn't bad, from our
point of view, and in any case, it is a stretch to say this is
"going beyond." It looks to me like an effort to implement the
RDS, and to give some plain language support for WHO doing
something useful on IPR issues.
In any event, the language Dr. Novotny did not like was later
replaced, by the EB, which this language:
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;
Dr. Novotny says: "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)." Which is true, but it is certainly less specific with
regarding the IPR than was the language it replaced.
I had predicted earlier and Dr. Novotny points out now, language
was added to make reference to the RDS. However, again the words
intellectual property rights don't appear in the AIDS resolution.
The new "sanitized" version of the AIDS resolution doesn't
mention patents or intellectual property rights anywhere anymore,
as if this isn't a matter of controversy the should be addressed
by the WHO.
Dr. Novotny's interventions as to how WIPO and the WTO should be
the lead players on this issue, and his efforts to remove
reference to intellectual property rights from the document, have
given us a new more industry friendly resolution.
Dr. Novotny also takes credit for inserting more of the familiar
"industry partnership" language into the resolution, specifically
on the issue of pricing problems. So, while Vice President Gore
on the campaign trail is concerned about price gouging by the
drug companies, WHO is to told to "reinforce, promote, and
explore partnerships" with the drug companies, to make drugs more
affordable.
Addressing a red herring, Dr. Novotny says "what it [the AIDS
resolution] does not do, and we feel strongly that it must not
do, is refer solely to price as the answer to accessibility." To
drive the point home and make it personal, Dr. Novotny says:
"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 too 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."
Now I don't recall ever saying that accessibility concerns are
limited to issues of price, and I don't know any serious people
who would say this. Perhaps Dr. Novotny will issue a similar
statement lambasting those who advocate investments
infrastructuring saying:
"Again, we worked hard not to let only the
infrastructure issue drive accessibility concerns. To
limit accessibility concerns only to infrastructure
would be terribly mistaken. Your position on this is
far to narrow. Infrastructure investment is only one
tool to improve access. The infrastructure could be
world class, and if drugs were unaffordable, people
would still die."
Of course, it would be a taboo for a public health official to
issue such a statement, because it would undermine funding for
health care infrastructure, which we all agree is important. And
more importantly, it should be obvious to most people that both
issues (and many others) are important.
Of course, intellectual property issues are more controversial
than spending on public health professionals. This is because
the drug companies care about this issue a lot.
Dr. Novotny then says:
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 Rigths (TRIPS)."
Now, with all due respect to Dr. Novotny, I find it amazing that
he would pick this example, because as far as I know (and I know
a lot on this one), DHHS had nothing to do with the USTR/Thailand
letter. The NGO lobbying on this issue could not have been more
intense, and no one was talking with (or about) DHHS at all. I
wouldn't mind Dr. Novotny claiming credit for future Act UP!,
MSF, CPT campaign efforts, if he plays a role of some type, and
we look forward to the day when he does.
Here are questions for Dr. Novotny:
1. Will the US government support or oppose WHO playing an
active and indeed a pro-active role providing poor countries
with information on IPR disputes as they related to trade
policy and public health?
2. Would you oppose or not oppose the publication of a paper by
the WHO that would call for "fast track" compulsory
licensing of essential medicines in poor countries?
3. Will DHHS intervene with USTR on the dispute over the
Dominican Republic's proposed patent law, which includes
fast track compulsory licensing?
4. Will you support or oppose our request that the USTR provide
a communication to the WTO on the issue of patent exceptions
(under Article 30) for production for export? (Needed for
poor countries to benefit from compulsory licensing.)
PUBLIC CONSULTATION
I would also like to comment on consultation with the public.
When Dr. Novotny met with about a dozen HIV/AIDS, public health
and consumer groups on January 12, to discuss trade policy as it
relates to IPR and pharmacueticals, he never mentioned that the
USG had a problem with the December 22, 1999 draft of the WHO
AIDS resolution. None of the many groups that I work with was
given a heads up that the US would ask that the language on
intellectual property rights be removed. I think it should be
clear that it is possible to consult with interested parties in
advance, and it should be obvious who the interested parties are.
As Dr. Novotny notes, the USG solicited input from pharmaceutical
companies. My advice is pick upon the phone and raise these
issues before, to see how it is going to be received by consumer
interests and public health groups (including ones not funded by
drug companies).
Final comments
We are facing a big crisis in access to medicines, and the
issues will become even more explosive with the next generation
of medicines, which should include products that will be better
for use in developing countries. (For example, from a compliance
point of view, or products that actually cure conditions).
We want our government, the USG, to be strong for the poor.
We want the USG to say things in international forums that make
us proud.
For decades, the USG has been strong for the rich and
powerful. In the WHO, the USG has a well deserved reputation for
being very strong for the drug companies. We want to see a
change. The drug companies have plenty of power already. They
don't need our government to act as their guardian angel or
global apologist.
There are many good points you can make for the drug
companies. You can repeat the IFPMA talking points endlessly,
including the ones that even we would agree with. You can talk
about the virtues of protecting intellectual property, the need
to develop new medicines, and you can explain how it isn't all
their fault. And even after you remove all the exaggeration and
eliminate patently false claims, they will still have some good
points. We recognize this as well as anyone. And by repeating
these points endlessly, you will make them even stronger.
But there are another set of talking points that are not on
the IFPMA web page. The IFPMA doesn't point out that compulsory
licensing is part of the TRIPS, or that it permits governments
rather than companies to determine how much money the poor should
pay for patents. The IFPMA has its favorite parts of the TRIPS,
but it leaves out the parts that give rights to the poor. The
IFPMA doesn't provide accurate information about the costs of
drug development or the role of taxpayer supported research in
the development of essential medicines. The IFPMA doesn't
discuss the high pricing of government funded pharmacuetical
inventions.
The IFPMA doesn't talk about the pricing of fluconazole, and
how this medication can help AIDS patients right now, for a tiny
fraction of the Pfizer price. The IFPMA doesn't talk about how
the industry uses the legal system to block the introduction of
generic drugs, or how costly and difficult it is for poor
countries to litigate against the best law firms in world. The
IFPMA doesn't talk about how it can get patents in developing
countries that would not pass the examination process in the USA.
The IFPMA doesn't talk about the importance of domestic
industries in providing generic competition. The IFPMA doesn't
talk about abuses of the US orphan drug marketing exclusivity,
the abuses of health registration data exclusivity, or the
countless other regulatory barriers they lobby for.
There are lots of things the IFPMA doesn't talk about. So
by using your position to advance the IFPMA agenda, you leave out
other agendas, and other talking points. The world for the poor
is the same world for the rich, but it is perceived differently.
Try to see things from the point of view of the poor. Make the
poor more powerful. This is what we are asking.
Jamie Love <love@cptech.org>
--
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