NGOs, Industry Weigh Alternatives For R&D Financing, Counterfeiting At WHO

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 non-governmental 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 May.

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

Non-governmental 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 non-governmental 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.