TWN Info Service on Health Issues (May09/02)
13 May 2009
Third World Network

Noting that the Pandemic Influenza Preparedness Intergovernmental Meeting will take place in Geneva on 15 -16 May 2009, I thought it may interest you to see what has been coming out in the mainstream media on the issue of swine flu, IPRs, and availability of anti-virals or vaccines for developing countries.

Below is a compilation of the news stories.

Sangeeta Shashikant
Third World Network

Critics: WHO Slow on Generics for Swine Flu May 11, 2009

By The Associated Press, Filed at 6:29 a.m. ET

LONDON (AP) -- As poor countries face a possible swine flu pandemic with only enough Tamiflu to treat a tiny fraction of their populations, some experts are calling for a simple but contentious solution: massive production of generics.

Antivirals such as Tamiflu are believed to be effective against swine flu if administered early, and cheap generics can easily be made in countries like India. Many rich nations sit on stockpiles of expensive Tamiflu bought from Swiss drugmaker, Roche.

Tamiflu is patent protected but World Trade Organization rules allow poor countries to override such rights in a health crisis. Indian pharmaceuticals giant Cipla said it would charge about $12 per course of a generic Tamiflu. One course of Roche Tamiflu can sell for up to $100.

That has led critics to question why the World Health Organization hasn't ordered up batches of generic Tamiflu or encouraged poor countries to do so as it raised its pandemic alert level to phase 5 -- signaling it believes a global flu outbreak to be ''imminent.''

Some suspect WHO is reluctant to anger drug companies, which supply the agency with stockpiles of drugs, by encouraging the use of generics. Despite WTO rules, Western pharmaceuticals have long fought to keep generics out of the market in all circumstances.

''There needs to be a better system in place so that WHO does not have to rely on the goodwill and charity of drugmakers to get medicines for poor countries,'' said Sangeeta Shashikant of Third World Network, a nonprofit development organization.

WHO insists it's doing its best to secure antivirals for poor countries.

''WHO will work on behalf of its member states to secure further antivirals as needed, either through donations or purchase at the lowest possible price, to support developing countries in need,'' said Elil Renganathan, a WHO official working on antivirals.

Two flu medicines, Tamiflu and Relenza, are mainly used to treat flu, but they only work if started within 48 hours of first symptoms. Studies show they cut the duration of illness by about one day, compared with no treatment.

Little is known about whether these medicines cut the chances of serious flu complications, like pneumonia, and few studies have tested them in children.

Experts say vaccines would offer the best protection against a swine flu pandemic but they won't be available for months.

And even when they are, rich countries are first in line: Britain, Canada, Denmark, France, the United States and others have all signed deals with vaccine makers to ensure they get the first batches of pandemic vaccine off the production line.

WHO is appealing to vaccine makers to save some of their vaccines for poor countries, but it's doubtful they will get enough to treat a significant portion of the population.

On Monday, Cipla announced it could produce 1.5 million treatments of a generic version of Tamiflu in the next few weeks. But Yusuf Hamied, the company's chairman, said it is ready to make millions more courses as soon as poor countries and agencies like WHO place orders.

''We could make a lot more, but there needs to be firm commitment from countries and international agencies like WHO,'' he said. ''The ball is in their court.''

So far, WHO has not recommended that countries with production capacity start making their own generic supplies of antivirals.

WHO has a stockpile of about 5 million Tamiflu treatment courses donated by Roche, and earlier this week, the agency began sending 2.4 million treatments to 72 poor countries. But such numbers pale in comparison to hundreds of millions of people in the developing world who would be vulnerable in a flu pandemic.

The agency says it is exploring generic production, but no decisions have been made. WHO says it is unsure how much massive generic production could increase the global supply and would not estimate a cost.

Renganathan said WHO wants to ensure any generic medicines meet drug safety standards. He said they are investigating the possibility of generic production with companies wherever they are located.

Still, critics say WHO has been slowfooted on generics.

''I don't know why WHO hasn't pursued generics,'' said Tido von Schoen-Angerer, director of Medecins Sans Frontieres' Access to Essential Medicines Campaign.

''A big role for WHO is to increase the world's generics supply of antivirals and make sure all countries have access,'' von Schoen-Angerer said. ''It's not clear why WHO hasn't prioritized this.''

With a large supply of generics, developing countries that could afford them, like Thailand and Brazil, could reinforce their own supplies. For poorer nations, agencies like UNICEF might buy the antivirals and distribute them to countries in need.

High rates of HIV, malaria, tuberculosis, malnutrition and other health problems greatly deepen the vulnerability of the world's poorest countries to a flu pandemic.

So far, critics say there's no indication from WHO that generic options will be prioritized for poor countries that can't afford Roche's Tamiflu.

''Countries are going to scramble to get as many medicines as they can in this situation,'' said Martin Khor, executive director of the South Centre, a think tank focused on developing countries.

''WHO should be helping countries to get stockpiles of antivirals as cheaply as possible.''

Copyright 2009 The Associated Press Privacy Policy

Vaccine shortfall leaves poorer countries at risk

By Andrew Jack in London

Financial Times Published: April 29 2009 22:04 | Last updated: April 29 2009 22:40

Manufacturers warned on Wednesday that limited stocks of a future swine flu vaccine could be distributed on a “first come, first served” basis, leaving hundreds of millions of people in poorer countries without protection.

Andrin Oswald from Novartis, one of the world’s top flu vaccine producers, told the Financial Times his company had already allocated more than a fifth of its total capacity for making a future pandemic vaccine to governments, including the US and the UK.

His comments came as representatives of the vaccine industry met European health officials to prepare for an EU meeting on Thursday in Brussels to discuss their response to a pandemic, including how to allocate and pay for supplies.

With several months required to produce new vaccines, and total global manufacturing capacity far below the world’s population, scarce supplies could be the source for political tensions between richer, well-prepared countries and the rest.

Planners have also raised concerns that a handful of European countries that dominate vaccine production – including France and Germany – could close their borders to restrict the export of vaccines until their own populations are covered.

“We are expecting the Commission to develop a strategy for allocation between countries,” said Luc Hessel from Sanofi-Pasteur, the vaccines arm of Sanofi-Aventis of France and a board member of the European Vaccine Manufacturers’ Association.

He said that about 15 countries – including Canada and the US, many in Europe, and Japan and Australia – had placed “advance contracts” for about 200m pandemic flu doses, representing half of current total annual production for seasonal flu vaccines of 400m.

However, he stressed that a range of new techniques could substantially boost productivity.

In the past few years, the vaccine industry has been working with the World Health Organisation and policymakers to devise ways to expand vaccine capacity.

By switching to a single “monovalent” dose rather than trivalent vaccines that protect against three different seasonal flu strains each year, productivity could be substantially enhanced.

Further gains could come from injecting just into the skin, which appears to boost efficacy, as well as the use of a chemical adjuvant to boost the body’s immune response and allow “cross-protection” for strains other than the one for which the vaccine was specifically engineered.

Manufacturers and health officials are also wary of switching immediately from producing vaccines for the next seasonal flu outbreak while data on the impact of the H1N1 virus are limited.

However, these production cycles should be finished within a few weeks, giving time for them to consider whether to replace one of the three antigens in the next seasonal vaccine with the H1N1 strain identified in Mexico.

Vaccine makers have long argued that the best way to prepare for pandemic production is to boost seasonal vaccination, which allows capacity to be strengthened and switched to pandemic production when necessary.

Novartis said it would shortly release the results of tests showing the efficacy of its existing adjuvanted flu vaccine against H1N1.

Copyright The Financial Times Limited 2009

Poor may lose out in swine flu vaccine production

Katherine Nightingale and T. V. Padma 30 April 2009 | Sci dev net

Almost all of the world's vaccine production capacity is located in just nine developed countries.

The ability of developing countries to combat a swine flu pandemic could be undermined by the fact that most major vaccine producers are based in developed countries and likely to have commitments to meet the needs of the populations in those countries, a leading development organisation has warned.

Sangeeta Shashikant, a researcher at the Third World Network, points out that almost all of the world's vaccine production capacity is located in just nine developed countries and that the governments of these countries will have entered into advance purchase agreements with their vaccine producers, giving them priority in the event of a pandemic.

"If [developing countries] don't have capacity [to produce vaccines] then they'll have to rely on the goodwill of developed countries, as well as companies," Shashikant told SciDev.Net.

UN secretary general Ban Ki-moon said at a press conference this week (27 April) that developing countries are especially vulnerable to the swine flu outbreak and need protection against it. "They have been hit hard by other crises this year: food, energy, the global economy, climate change," he said. "We must ensure that they are not also hit disproportionately hard by a potential health crisis."

Strains of the swine flu virus taken from infected people are already being used in a handful of labs in developed countries to create a vaccine virus a version of the virus that contains the correct antigens against the swine flu strain but is not dangerous to humans. The disabled virus will be sent to manufacturers to grow the vaccine in eggs.

But the process is time-consuming. Even if the WHO requests manufacturers to switch from seasonal to pandemic vaccine production < a step it has not yet taken < it could be up to six months before a vaccine is available.

Vaccine manufacturers have already been donating their H5N1 pandemic flu vaccines to a WHO stockpile. According to Tachi Yamada executive director of the global health programme at the Bill and Melinda Gates Foundation GlaxoSmithKline has donated 50 million doses and Sanofi 60 million doses, while Novartis has also indicated that it would take part in the scheme.

But Yamada told SciDev.Net that "this is a whole new ballgame" because H5N1 was not the main concern in the current pandemic.

"The vaccine manufacturers are all quite aware of their role and responsibilities in reacting to this kind of crisis, and they're all very interested in doing the right thing," he said. "They're just waiting for instructions on what to do."

The utmost importance

Ravini Thenabadu, a spokesperson for the WHO, told SciDev.Net that the organisation is currently in talks with vaccine manufacturers to assess their production capacity and the percentage of their vaccine output that could go to developing countries.

She described developing country access as being of "the utmost importance" to the WHO, and said that the organisation would fight to ensure that developing countries received sufficient supplies of the vaccine.

When a new virus emerges the WHO coordinates a set of procedures under which virus samples are sent to WHO collaborating centres, and may then be sent on to companies to make vaccines and drugs that the companies are permitted to patent.

In recent years, however, critics have claimed that this provides an unfair opportunity to such companies to profit financially from vaccine sales. Indonesia caused controversy in 2007 when it stopped sharing bird flu samples until a benefit-sharing mechanism had been set up (see Indonesia stops sharing bird flu samples).

Developing countries have already been in negotiations with the WHO about a benefit-sharing procedure to ensure that when a pandemic virus originates in a developing country, poorer countries are guaranteed access to any vaccine developed against the virus in question.

Suggested mechanisms include setting aside a percentage of the vaccine for developing countries to purchase at a reduced price, creating an emergency WHO stockpile of the vaccine and placing a portion of vaccine manufacturers' profits into a fund for developing countries.

Until a mechanism has been established poorer countries will be exposed to the danger of inadequate or unaffordable supplies of vaccine Flickr/sarihuella

But no mechanism has yet been agreed upon  leaving poorer countries exposed to the danger of inadequate or unaffordable supplies of vaccine, says Shashikant.

Nandula Raghuram, reader in biotechnology at the Indraprastha University in Delhi, points out that although the avian flu case offers a good example of international research collaboration, "that cooperation does not extend to a more liberal policy on sharing of drugs and vaccines that emerge from such research".

"The licenses for production and mass manufacture are given to companies which prefer to have exclusive manufacturing rights at such times," Raghuram told SciDev.Net.

Graham Dutfield, professor of international governance at the University of Leeds, United Kingdom, suggests that there is a need to plan for such situations in advance. "The private sector will almost certainly need to be involved but [the challenge is] how to reconcile the profit motivation of firms, and the likelihood of heavy patenting activity, with the need to get vaccines where they are most needed," he says.

To many observers, the debate over the need to secure access to vaccines in the case of a pandemic has highlighted the lack of research and vaccine production facilities in the developing world.

Raghuram, for example, points out that the uneven capacity for vaccine production between developed and developing countries is particularly noticeable in the case of newly-emerged infections, such as avian or swine flu.

"In such cases, research on new vaccines involves international collaborative efforts with the WHO, where often scientists from developing countries do not participate," he says.

Shashikant blames the lack of participation on the lack of research capacity in developing countries. "The aim should be to build [developing country] capacity for them to be able to S analyse the virus sample and give information," she says.

"Each region should have some capacity to produce drugs or vaccines when there is a situation such as this."

As Flu Spreads, Generic Drugmakers Wait for Call

By Brandon Keim Email Author May 11, 2009, 3:26 pm

Even as the World Health Organization acknowledges that swine flu will spread worldwide and could evolve in unpredictable ways, it hasn’t ordered generic versions of Tamiflu, the most effective anti-flu drug.

Indian generic drug maker Cipla says it could make 1.5 million courses of oseltamavir, as the drug is non-commercially known, before the end of June. They would cost about $12 per course, or a fifth of what’s charged by Roche, the pharmaceutical company who owns the marketing rights to Tamiflu.

The Associated Press reports the WHO has about 5 million Tamiflu courses donated by Roche. Last week the organization started distributing 2.4 million courses to poor countries.

But that stockpile is dwarfed by the possible spread of the virus, which has officially infected 4,7000 people worldwide, and registered its first case in mainland China. The WHO says a pandemic — the multi- continent, community-level establishment of the swine flu — is imminent. Their assessment is backed by a paper just published in Science by researchers who say swine flu’s transmission rates appear similar to pandemic strains that swept the world in 1918, 1957 and 1968.

Even if the virus stays in its apparently mild present form, the toll could be massive. But that mildness can’t be taken for granted. The outbreak is still in its early stages, as the WHO told the United Nations last week, “The only thing that can be said with certainty about influenza viruses is that they are entirely unpredictable.”

Given all this, and the WHO’s admission that global drug manufacturing capacity is “still not sufficient to produce enough antiviral medication and pandemic vaccines to protect the entire world population in time,” it would make sense for the WHO to push for immediate generic Tamiflu production. But two weeks after calling the outbreak “a public health emergency of international concern,” and with flu season starting in the southern hemisphere, the WHO continues to rely on Roche.

“A big role for WHO is to increase the world’s generics supply of antivirals and make sure all countries have access,” said Tido von Schoen-Angerer, director of Doctors Without Border’s Access to Essential Medicines Campaign, to the AP. “It’s not clear why WHO hasn’t prioritized this.”

The delay raises the specter of countries who can afford Tamiflu keeping the drugs for themselves, and leaving poor countries at the mercies of the virus.

Columbia University epidemiologist Ian Lipkin warned that the swine flu could ravage South America before vaccines can be made. “We’ve talked about how we’re willing to share with people in the developing world. But already people are talking about hoarding,” he said. “This is morally wrong. We said, ‘We’re going to share with you, when push comes to shove.’ Now’s the time to put up, because these countries are at serious risk. If we hoard these drugs, it’s just wrong.”

Science, published online, May 11, 2009.