Nations Closer To Pandemic Vaccine Framework, Key Negotiator Says

There could be some good news in 2011 for poor populations concerned about the impact of devastating pandemic diseases. Nations last week reached some breakthroughs behind closed doors in the sensitive international negotiations on finding a way to ensure all global citizens can obtain vaccines in the face of pandemics, according to a leading official in the talks. But some observers said problems remain in establishing clear rules for fair access and benefit-sharing of viruses and vaccines.

The second meeting of the Open-Ended Working Group on Pandemic Influenza Preparedness was held from 13-17 December at the World Health Organization. This open-ended working group is part of a longstanding effort to agree on a framework on pandemic influenza preparedness. The group will resume on 11-15 April to finalise the framework.

According to a draft final report on the meeting, available here, there was discussion of technical studies (IPW, WHO, 6 December 2010), focusing on four areas related to building capacity in surveillance and vaccine production, increasing access and affordability, and sustainable funding mechanisms.

A key sticking point in the past has been a standard material transfer agreement (SMTA), including intellectual property rights provisions, for the sharing of viruses and other pandemic-related materials and for sharing related benefits.

This time, the emphasis by some countries on an SMTA appeared to be put into a larger context as one part of the solution, rather than the only solution. The report mentioned “constructive” discussions on an SMTA for countries inside the existing WHO global influenza surveillance network and another for those outside it. It also said there “seems to be an emerging consensus that the WHO should play a leading role” in the pandemic benefit sharing system.

A midweek, 14 December draft from the co-chairs on the SMTA agreement, available here, shows disagreement over intellectual property rights.

The draft report lists agreements reached, such as the need to: finalise the framework including annexes; have multiple tools including the SMTA; open consultations with stakeholders; and have information about other agreements and about related patents in consultation with the World Intellectual Property Organization.

The working group will report on its progress to the 17-25 January WHO Executive Board meeting, and the target for completion of the framework is the May 2011 World Health Assembly.

The swine flu, H1N1, pandemic originated in Mexico and was declared over by the WHO in August 2010, amid concerns that its danger had been exaggerated. An external review of the WHO’s response to the pandemic is ongoing, with a final report on its findings expected at the WHA next May.

Ambassador Camacho: ‘Very Sensitive Work’

Juan José Gomez Camacho, Mexican Ambassador to the UN in Geneva, has been a leader of the negotiating process over the past year. In an interview with Intellectual Property Watch, he described the work on pandemic virus sharing as “very sensitive.” This echoed comments made last week by US Ambassador Betty King (IPW, US Policy, 17 December 2010).

“What we are doing is building and strengthening an effective global system to react to pandemics, because pandemics kill people and are a challenge to health security,” Camacho said. “After H1N1 [so-called swine flu], we realised the system is [not] prepared to react.”

The outcome of last week’s meeting is “very positive,” he added. “This is the first time we managed to put aside politics, ideology and emotion – this is a highly complex, highly sensitive issue. We managed to have real negotiations based on technical issues, on data, all focused on the same objective: an effective, transparent, efficient and fairer system.”

A big contributing factor has been that over the past year Norway and Mexico led a process that “did a lot of good work at the ambassador level – getting ambassadors of key countries involved,” he said. “We engaged everyone including ambassadors in a very strong learning process on how pandemics take place, how vaccines are found, and what is needed.

A key result from last week’s meeting on framework was that “we decided that the challenges are so big and complex that we are going to need [a mixture of solutions], he said. “We are not going to solve this through one single tool, but rather, with multiple tools.”

Camacho characterised last week’s agreement as:

– Increasing vaccine manufacturing capacity throughout the world

– Strengthening and increasing surveillance and lab capacity around the world

– Strengthening and ensuring access to vaccines, especially for least developed countries

– Strengthening … the capacity for countries to receive vaccines

– Devising financing mechanisms for these (he called this “very important. We need a lot of funding.”)

– Negotiating a legal instrument that will govern the exchange of viruses and benefits of viruses (“we need legal certainty,” he said).

There is a growing consensus that the beneficiary of viruses has to be the pandemic preparedness system, he said.

Doubts about Fair Play

In the recent pandemics, poorer countries particularly struggled to obtain treatment for the disease. And there were some continuing doubts about the process from observers after last week.

One concern is that developed countries are not increasing efforts to ensure access and benefit sharing despite the new agreement – the Nagoya Protocol – at the UN Convention on Biological Diversity (IPW, Biodiversity/Genetic Resources/Biotech, 29 October 2010).

A midweek draft text of the annex encompassing principles and objectives, available here, showed an effort by some member state to include a line declaring that “influenza pathogens do not fall within the scope” of the CBD or Nagoya Protocol. It is unclear whether this line remained in the text by week’s end.

“Despite having legal obligations under the CBD, developed countries continue to be reluctant to ensure fair and equitable benefit sharing by recipients of influenza biological materials on a mandatory basis,” said Sangeeta Shashikant of Third World Network.

“Moreover,” she added, “instead of collaborating collectively under the auspices of WHO to develop an ambitious framework that delivers sharing of viruses as well as equitable benefits to facilitate pandemic preparedness, the positions taken by developed countries on a range of issues including on benefit sharing by recipients of influenza biological materials, on intellectual property, on issues of transparency indicate an interest not towards protecting global public health but towards protecting the profits of their industries and the interests of their institutions and safeguarding their – developed countries’ – access to vaccines and other treatments in the event of a pandemic.”

Camacho explained the existing problems that need to be addressed. There are limits to the current system, as the world population is close to 7 billion and manufacturing capacity currently is about 1 billion, Camacho said. In addition, there is a limited amount of vaccines distributed, based on commercial reasons, so there is a need to build a system where they are distributed based on health reasons, he said. Thirdly, vaccines are very expensive, so many countries will not be able to afford them.

“We have been engaging stakeholders in this,” he said, and while there is “still a lot of work to do,” they are now “all on the same page.”

Asked whether he expected an agreement to be reached by the annual World Health Assembly in May, Camacho said, “Absolutely, there is no other option.” It is too critical, he said.