[A2k] IP-Watch: US Declares Opposition To WHO R&D Resolution As Proponents Raise Questions

[Thiru Balasubramaniam]

    22/5/2006


      US Declares Opposition To WHO R&D Resolution As Proponents Raise
      Questions


posted by Tove Iren S. Gerhardsen @ 10:37 pm

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The United States today made clear its opposition to a World Health
Organization (WHO) resolution that aims to promote research and
development into neglected diseases, and which is scheduled to be
discussed at this week=92s WHO annual meeting. Meanwhile proponents of the
resolution are finding it difficult to operate, according to sources.

The draft resolution
<http://www.who.int/gb/ebwha/pdf_files/EB117/B117_R13-en.pdf>, entitled,
=93[Global framework on] essential health research and development (EB117
R13),=94 was first proposed by Brazil and Kenya and was forwarded by the
WHO Executive Board meeting in January to the World Health Assembly
(/IPW/, Public Health, 28 January 2006). The assembly is being held from
22 to 27 May.

The draft resolution requests the director general to establish a
working group of interested member states to =93consider proposals to
[establish a global framework for supporting] [strengthen incentives and
mechanisms for] needs-driven research, consistent with appropriate
public interest issues.=94 The resolution also requests the director
general to =93[suggest alternative simplified systems for protection of
intellectual property, with a view to enhancing accessibility to health
innovations and building capacity for product development, uptake and
delivery in developed and developing countries.]=94

The brackets show areas of remaining disagreement. A health attach=E9 at
the US mission in Geneva told /Intellectual Property Watch /that some of
the brackets in the resolution, including those in the headline, have
been suggested by the United States.

He said the United States opposes the suggestion that R&D in this area
should be subject to intergovernmental procedures and a binding treaty,
adding that the US wants =93a different approach=94 to the same problem. He
said the US acknowledges that there is a problem but said how the
framework suggested in the resolution would work is =93utterly beyond us.=
=94
He was not able to clarify exactly what approach the United States would
suggest, however.

At a press conference of the US mission in Geneva on 22 May it also
became clear that the main focus of the US government during the
assembly is international mobilisation to fight a possible avian
influenza pandemic outbreak, as this is the objective of US Health and
Human Services Secretary Mike Leavitt.

In his remarks to the briefing, Leavitt did not mention the R&D
resolution specifically, but said that the US would continue to advocate
the position that intellectual property creates incentives.

But William Steiger, special assistant to the secretary for
international affairs, when asked about the resolution, said that the
United States is =93still studying a number of aspects=94 in the resolution
and is engaged in discussions. He said that a treaty is not the best
answer, and the United States would =93prefer not to see such a rigid
structure.=94

A related resolution
<http://www.ip-watch.org/files/WHO%20draft%20resolution.doc>based on a
recent report from the WHO Commission on Intellectual Property Rights,
Innovation and Public Health (CIPIH), which was forwarded at a
representative Executive Board meeting on 28 April, has also not been
posted on the website together with a report as was scheduled, sources
have pointed out (/IPW/, Public Health, 28 April 2006).

The resolution from the CIPIH report suggests establishment of an
intergovernmental working group to develop a global strategy and plan of
action based on the recommendations of the commission. It would
particularly address =93ways of addressing diseases that
disproportionately affect developing countries.=94

R&D Resolution Supporters Watchful for Fair Treatment

Meanwhile, supporters of the Kenya and Brazil resolution were working
before the assembly=92s start to ensure fair consideration by the assembly
of the R&D resolutions.

Some non-governmental organisations questioned the fact that the R&D
resolutions are not easily located on the WHO website under documents
for the assembly.

Questions also were circulating about the fact that CIPIH Chair Ruth
Dreifuss will not present the CIPIH report to the assembly.

In addition, Consumers International and the Consumer Project on
Technology were concerned when told that no space could be found at the
United Nations for their 24 May meeting on the R&D framework, and it had
been offered instead to hold its event at the end of the assembly. But
now the event will be held on 23 May at 6pm, with another, broader look
at the issues on 25 May. Kenya will hold a briefing on its resolution on
23 May at 12:30 to 2pm, a source said.

A WHO spokesperson told /Intellectual Property Watch /that the R&D
resolution is listed under the =93Executive Board=94 documents and not the
WHA. The spokesperson also said there is nothing unusual in the fact
that Dreifuss will not be presenting the CIPIH report as presentations
are never given at the assembly unless an issue is being presented for
the first time, the spokesperson said, adding that this is =93normal
procedure.=94

Separately, five members of the US Congress also called for a fair
debate on the resolution in a 19 May letter to Leavitt. They are: Tom
Allen (D-Maine), Dan Burton (R-Indiana), Lloyd Doggett (D-Texas),
Bernard Sanders (I-Vermont) and Dennis Kucinich (D-Ohio).

In the letter they state that, =93The WHA proposal to discuss new ways to
addressing the global sharing of R&D costs is timely and important, and
should be supported by the United States government.=94 It further states
that if the United States wants to be taken seriously by its trading
partners regarding its concerns about the global R&D burden, it should
allow for =93a full and fair debate=94 on the resolution.

Industry Event Echoes US Message

The United State=92s resistance to the R&D resolution was echoed by
panellists at an industry-sponsored event on 21 May on the impact of
intellectual property on healthcare in developing countries. But a
number of people in the audience expressed disappointment that the
presentations were not balanced.

The event was held by the International Policy Network (IPN), and the
message was that the main problem for access to medicines is poor
infrastructure in developing countries, and that organised pharmacists
may drive up the prices of drugs. IPN is seen as supportive to the
pharmaceutical industry.

The moderator of the panel and executive director of the IPN, Julian
Morris, directly stated his opposition to the R&D resolution,
questioning why new mechanisms for innovative medicines should be
developed when generics available today do not reach patients due to
distribution problems. =93What is the point of developing drugs when they
cannot be distributed?=94 he said.

Barun Mitra of the Liberty Institute in India agreed and said he does
not support government-funded R&D. He said the resolution was =93unlikely
to fly=94 and would =93not be implemented in any case.=94

Mitra said that even if these medicines were to be given for free, not
many people would receive them because if the =93extremely poor
infrastructure.=94 He also said it was =93extremely important to understand
the importance of IP for development as such,=94 referring to the
introduction of the Indian patent law for pharmaceuticals in 2005.

Jasson Urbach of Africa Fighting Malaria in South Africa said the
private healthcare sector in his country was the =93superior sector=94 and
it is no need for the government to dominate health. He said that
because of a recently decided regulation, 44 community pharmacies have
now closed down in the poorest areas of the country. A person in the
audience said that these had been community-owned pharmacies and that
new players would open new pharmacies.

Urbach also said that if the South African government is serious about
access to medicines it should remove the tax on the medicines. Also,
regulatory affairs is a problem with 25 months approval time on average
for generic medicines and 36 months for new medicines, he said.

Bibek Debroy of the Chamber of Commerce and Industry in India also
advocated the private healthcare sector. He said that in terms of
patents India had thought of short-term objectives and not ensured that
innovation takes place. He also said that while there used to be 25,000
pharmaceutical companies in India, now there are some 6,000 and they
have not closed down because of patents.

But many in the audience took issue with the presentations such as a
woman from South Africa. She said Urbach=92s talk was not balanced and
only painted a bright picture of the private healthcare sector. =93The
public sector may have problems but it provides free health services,=94
she said.

Another South African asked rhetorically how many people living with
AIDS would be able to afford drugs if everything were in the private
sector. A person in the audience echoed this, saying that in the United
Kingdom there was a price issue between private and public care.

A WHO representative said that price controls are not the problem but
taxes and mark-ups are, mentioning countries in which the price of a
generics medicine is set down from the top price instead of being
calculated up from the base. Mark ups are the price hikes pharmacies add
to medicine prices.

Dr Lee Passes Away

Separately, the WHO Director General for the past three years, Lee
Jong-wook, passed away on 22 May after having been hospitalised on 20
May for a blood clot in his brain, the WHO says. =93The sudden loss of our
leader, colleague and friend, is devastating,=94 the WHO said in a statemen=
t.

Anders Nordstr=F6m, currently assistant director general for general
management, will serve as acting director general, the WHO said. The WHO
said the assembly will proceed more or less as scheduled but the opening
reception has been cancelled.