[Ip-health] IP-Watch: NGOs, Industry Weigh Alternatives For R&D Financing, Counterfeiting At WHO
thiru at keionline.org
Sat May 22 01:06:58 PDT 2010
Intellectual Property Watch
21 May 2010
NGOs, Industry Weigh Alternatives For R&D Financing, Counterfeiting At
By Catherine Saez, William New and Kaitlin Mara @ 3:20 pm
The past year’s expert working group process at the World Health
Organization on solutions for financing of research and development
into diseases afflicting poor nations was flawed and led to an
unsatisfactory result, representatives of nongovernmental
organisations said this week. But innovation and access can both be
provided, and the issue of IP protection can be de-linked from the way
innovation is done, speakers at a side event to this week’s World
Health Assembly said. Meanwhile, NGOs and industry also offered their
views on WHO counterfeiting efforts this week.
Amit Sengupta of People’s Health Movement said there is evidence that
the IP-based system is broken. “We are starting to see in many sectors
open technology initiatives,” and much of the innovation today is done
in a collaborative manner, he said at a 19 May event organised by
Knowledge Ecology International. The Health Assembly runs from 17-21
There is clear evidence that there has been influence, especially by
the pharmaceutical industry, in the process of the expert working
group, asserted Rohit Malpani of Oxfam International. WHO is meant to
go beyond the status quo, to seek more balanced, transparent
solutions, with clear feedback and input from the public and the
governments, and a system to prevent outside influence, he said. In
whatever form the WHA decides to take the process forward, it needs to
be open and transparent, inviting all stakeholders into the process,
said Sophie Bloemen of Health Action International Europe.
A research and development treaty is one possible way to remedy the
problematic of R&D financing of essential health research in
developing countries, participants said. The mention of such a treaty
appears in the 2008 WHA global strategy and plan of action on public
health, innovation and intellectual property, in paragraph 2.3(c).
The R&D treaty needs to look at innovation as a whole, and to look at
public funding. Sengupta gave the example of the Open Source Drug
Discovery initiative in India, which follows the pattern of open
Bangladesh, Barbados, Bolivia and Suriname submitted a proposal to the
WHO for discussions on a biomedical R&D treaty in April 2009 [pdf].
The R&D treaty would be a global norm-setting instrument to provide
sustainable funding for priority medical R&D. The treaty could also
apply to results of medical trials, ethical standards, sharing the
cost of clinical trials in some cases, and management of publicly
funded research, James Love, KEI director, told Intellectual Property
Watch. He added that there is no set definition of the treaty but
numerous proposals that have to be taken into consideration.
Also in the same global strategy was the mention of the possibility to
de-link the cost of R&D from the price of health products [5.3(a)].
However, this notion seems to have been lost by the expert working
group, said Bloemen.
De-linkage should be one of the norms of the R&D treaty, said Tido von
Schoen-Angerer, director of the MSF Campaign for Access to Essential
Medicines. “It is already there,” he said, it just needs to be taken
forward. The WHO should review the current and proposed R&D incentive
mechanisms to comply with the de-linkage principal.
“The de-linkage idea is that you don’t use high prices of products” to
finance R&D, Love said. Although “deeply embedded in our way of
thinking,” the preconception of having a temporary monopoly allowing
high prices for a long time has harmful consequences on poor population.
Separately, the Latin America & Caribbean Global Alliance for Access
to Medicines published a declaration on 18 May to reaffirm their
commitment to universal access to medicines. They said the failures of
the expert working group “are evident and unfortunate.” In the
declaration, the alliance supports the Ecuadorian decision to issue
compulsory licences, and the Colombian government, which authorised
parallel imports. The declaration also rejects attempts to enact the
Anti-Counterfeiting Trade Agreement (ACTA).
The declaration, available here [pdf], was co-signed by 12 parties,
including HAI International, Federación Médica de Colombia, KEI,
Public Citizen (US), and FarmaMundi in Spain.
NGOs on Counterfeiting
Nongovernmental organisations at a separate side event this week
concurred with developing country claims this week that the WHO anti-
counterfeiting efforts appear to be influenced by brand-name
pharmaceutical producers who benefit from interfering with legitimate
trade in generics.
“It’s cynical and deliberate,” Amit Sengupta told the event. He said
this detracts from what governments are seeking to do through the UN
health agency, and that WHO should not be party to such activity but
rather should have a role in helping develop capacity and health
monitoring in developing countries. Intellectual property rights are
increasingly being used in different sectors to inhibit fair
competition, he charged, adding, “the bogie of counterfeit is being
used to interfere with access to medicines.”
NGOs said WHO should dissociate itself with the International Medical
Products Anti-Counterfeiting Taskforce (IMPACT) and instead look at
the “root causes” of the health problem.
WHO’s partnership with industry “makes it not part of the solution but
part of the problem,” said Oxfam’s Malpani. He and others on the panel
raised concern about European Union customs rules that are being
blamed for delayed shipments of generics from India to the developing
world, now the subject of a World Trade Organization dispute
Malpani said Europe’s rules are being exported to other countries via
the Anti-Counterfeiting Trade Agreement and free trade agreements, and
may lead to widespread confusion between counterfeit medicines – a
trademark issue – and lawful generic medicines.
As to why no further cases of mistaken delays of generics shipments
have occurred in the past year, KEI’s Love said if nothing changed, it
could happen again in the future. “They’re just cooling it for a bit
because they got bad press,” he suggested.
Industry on Counterfeiting
Also commenting Wednesday were the International Alliance of Patients’
Organizations, the International Federation of Pharmaceutical
Manufacturers and Associations (IFPMA) and the International
Pharmaceutical Federation (FIP).
“Counterfeit medical products are a serious and growing threat to
public health worldwide,” said IFPMA, adding that counterfeiters make
fake versions of both generic and branded medicines. They said the
only conflicts of interest were between those who work to protect
patient health and those who work to harm it, and said the assembled
delegates all belonged to the first group. FIP said they were against
adopting an “overly broad definition” as it could limit access, but
said the main victims of counterfeit were patients.
IFPMA external relations manager Mario Ottiglio told Intellectual
Property Watch IFPMA hopes the outcome “will reinforce the WHO’s
leadership role” on the issue takes into account the need for
“collaboration which includes all stakeholders across the
pharmaceutical supply chain.”
“IMPACT is part of a global IP enforcement agenda that can be seen
across national and international levels,” said an undelivered
statement from Health Action International, adding that WHO should
“avoid association with initiatives that pose a threat to generic
competition, divert resources away from quality control and regulation.”
WHO requires nongovernmental groups to submit statements for review 24
hours prior to delivery, which can make it hard to deliver statements
relevant to the current state of negotiation, especially at the WHA
when schedules change rapidly. Counterfeit was originally scheduled
for Thursday but on Wednesday morning the discussion was moved to
“An intellectual property approach serves the commercial interests of
multinational pharmaceutical companies, and not the public health
interests of WHO member states,” Oxfam said in an undelivered
statement. The statement says pursuing IP goals will “neither protect
against the profitable global trade in fraudulent products, nor
safeguard patients from the many other categories of poor quality
medicines that pollute the worlds supply chains.”
The statement calls for the WHO to focus on the regulatory capacity of
its members, as half lack fully effective systems and 30 percent have
no regulation at all.
Knowledge Ecology International (KEI)
thiru at keionline.org
Tel: +41 22 791 6727
Mobile: +41 76 508 0997
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