Preparing The World For Influenza Pandemic, Industry Role Key, Says WHO

An influenza pandemic is like the sword of Damocles over the world, and the recent H1N1 pandemic showed that the global response was inadequate, said the co-chairs of a World Health Organization group working on pandemic influenza preparedness meeting this week.

Negotiations that were described as delicate by the co-chairs are being done behind closed doors and unadvertised consultations with industry might draw some criticism about the lack of transparency.

The Open-Ended Working Group of Member States on Pandemic Influenza Preparedness: sharing of influenza viruses and access to vaccines and other benefits (OEWG/PIP) is meeting from 11-15 April.

During a press briefing today, co-chairs Bente Angell-Hansen of Norway and Juan Jose Gomez-Camacho of Mexico said the world was not prepared to face a pandemic in an efficient manner. The goal of the working group is to present to next month’s World Health Assembly (WHA) a framework for a global system that is effective, efficient, coherent, transparent, and fair, Gomez-Camacho said.

The previous meeting of the group, in December, ended on a positive note and hopes for the group to reach consensus at the April meeting (IPW, WHO, 24 December 2010).

Several challenges will have to be tackled this week, he said, among which are: increasing vaccine manufacturing capacity, which will require the development of new production capacity in particular in developing countries; ensuring that vaccines are both affordable and accessible; ensuring that vaccines can be deployed and distributed in a timely fashion, Gomez-Camacho said. This is a challenge because many countries do not have the infrastructure required to receive and distribute vaccines, he added.

Among the challenges, he said, are: the strengthening of the global surveillance capacity so that pandemic viruses can be identified early on; ensuring coherent and coordinated global response, as countries should not respond to a pandemic solely on the basis of their domestic requirements;and ensuring that “we have a legally binding instrument” that will regulate the exchange, the virus access, and the benefit sharing, he said. Also, the system that allows viruses to go through the WHO system so that they are shared with industry for vaccine production has to be regulated in a legally binding manner, he added.

Finally, funding is an important part of the challenge, Gomez-Camacho said.

WHO released on 12 January the report of the previous meeting [pdf] which took place in December. The report includes the proposed framework with brackets in the text reflecting parts difficult to agree on, and a number of paragraphs on which countries found consensus.

The co-chairs have been conducting consultations with governments and industry, he said. According to sources, on 6 April a consultation was held with industry at WHO, open to member states and regional economic integration organisations. About 30 industries participated in the meeting, they said.

Industry has a major role to play, the co-chairs said. To a question challenging the transparency of the process, Gomez-Camacho said those meeting were taking place in the context of “complex negotiations” that were not “meant to be open.”

Many developed and developing countries would like to “wrap up the whole package,” he said. At the end of the week, a framework should be provided, laying out a set of procedures to prepare for a potential future pandemic, and to be able to react and respond should it occur.

According to Angell-Hansen, the co-chairs have been trying to discuss possible solutions with industry, to build a system that would not be based on donations, but on key commitments from the pharmaceutical industry. Handling those discussions is a difficult exercise, she said, because there are many sensitive issues such as intellectual property rights, and pricing, and industry is “giving positive signal back to us,” she said.

Intellectual property rights have been a key sticking point in the past, with member countries unable to agree on a standard material transfer agreement (SMTA) including an IP rights provision, for the sharing of viruses and other pandemic-related materials and for sharing related benefits.

Over the last two pandemics, H5N1 (avian flu) and H1N1 (so-called swine flu), the countries where the viruses originated said that they did not benefit from the fact that they had shared the virus.

In 2007, Indonesia decided to stop sharing the H5N1 virus to WHO because it said the “resulting vaccines produced by commercial companies are likely to be unavailable to developing countries such as Indonesia,” before resuming the sharing later that year, according to a WHO press release.

Mexico, which swiftly shared the H1N1 virus in 2009, found that they did not receive the benefits from the sharing, with access to vaccines being restricted in Mexico due to limited stocks. (IPW, WHO, 20 January 2010).

IP rights making the vaccines unaffordable and unavailable in those countries, as well as in a number of other developing countries, raised concern in developing countries.

Gomez-Camacho said the co-chairs also met with civil society. Four civil society organisations submitted statements on the negotiations and the future framework to address influenza pandemic. In particular, the Bern Declaration asked that countries comply with the United Nations Convention on Biological Diversity and the Nagoya Protocol on access and benefit sharing.

The Third World Network (TWN) recommended that WHO network laboratories, or entities outside the network should not be allowed to claim IP rights over the influenza biological material. TWN also said that SMTAs were a key instrument for governing virus sharing, and should be matched with a dispute settlement mechanism.

Seasonal flu vaccine production is extremely important, said Angell-Hansen, as a sustained seasonal vaccine production would be a base to rapidly increase production of a pandemic vaccine through the use of adjuvant, in particular new types of adjuvant (a pharmacological agent added to a vaccine, in order to boost the action of the vaccine).

The industry’s estimate for pandemic vaccine production capacity is 1.1 billion vaccine doses but the co-chairs admitted, in answer to a question, that no independent audit had been carried out on the industry’s assessment.