[Ip-health] IP-Watch: NGOs, Industry Weigh Alternatives For R&D Financing, Counterfeiting At WHO

Thiru Balasubramaniam 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  
development software.

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  
settlement case.

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  
Wednesday afternoon.

“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.


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru at keionline.org

Tel: +41 22 791 6727
Mobile: +41 76 508 0997

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