TWN Info Service on Health Issues No.12

25 October 2005

Dear Friends,

Avian Flu Threat

As you know, a major health issue worldwide now is the potential evolution of the bird flu into a human-transmitted pandemic.  Governments around the world are trying to stock up Tamiflu, the drug that can treat the severity of the flu.  Due to the increased demand, the drug manufacturer Roche is unable to meet the supply.
This has highlighted again the problem caused by patents on medicines.
Sangeeta Shashikant has compiled some interesting articles on this issue, and has also written a note to introduce the issue and the articles.  Below please find her note and the articles.
With best wishes
Evelyne Hong

Dear All,

At the recent 2nd Conference of the African Health Ministers (10 - 14 October) held in Botswana, the AU Commissioner of Social Affairs Ms Bience Gawanas expressed concern and questioned whether the African continent was ready to manage the challenge of avian flu. One of the outcomes of the meetings, the Gaborone Declaration expressed alarm by the imminent threat that an avian influenza pandemic poses for Africa and in the Declaration, the African Ministers mandated the AU Commission to alert the Heads of State of the imminent threat of an avian influenza pandemic and to seek technical guidance and assistance for member states on strengthening their integrated disease surveillance and response strategies, community education, and procurement.

On the subject of the Avian flu, please find several short articles on actions the different countries are contemplating and an update on debates taking place on patents and compulsory licenses.

Currently, Swiss drugmaker Roche holds the patents to manufacture Tamiflu, the anti-viral drug used to treat bird flu. A treatment of 10 pills costs about US$ 60. Roche does not have the capacity to provide supply for all orders around the world. It is estimated that even if Roche produced for 7% of the world population that would be considered a lot. Roche initially maintained that only it could manufacture the product and refused to license to any other company the right to manufacture. However following pronouncement by many countries that they would proceed to issue compulsory licenses (i.e. a license that allows the manufacturing, import and export of a patented product without the consent of the patent holder), and civil society pressure, Roche has changed its position. Now it has agreed to sublicense production of Tamiflu to four generic drug makers and other companies that are capable of mass producing the drug to help prevent an avian flu pandemic in humans.

Some countries that are thinking of manufacturing generic versions of Tamiflu, for their own domestic purpose as well as for export are Cipla (India), GPO (Thailand), Argentina, Taiwan, South Korea and Philippines. Where there are patents on Tamiflu, compulsory licenses may be issued following certain procedures. For more information on the procedures relating to compulsory license please refer to the TWN Manual at

The issuing of compulsory licenses to override the exclusive rights of the patent holder is common, especially in the developed countries. For example in 2001, during the anthrax attacks in US following the Sept. 11 terrorist attacks, the German drug firm Bayer was told that if it did not ramp up production and sell its anti-infective Cipro at a reasonable cost, a compulsory license would be issued. In the end Bayer cut its prices by 55% and boosted production. Canada busted Bayer's patent and licensed a domestic firm to make generic copies.

Over the years Malaysia, Zambia, Zimbabwe, Indonesia, Mozambique are among some the countries that have issued compulsory licenses for AIDSs medicines. These compulsory licenses can be found at

An organization called CP Tech is running a page on Tamiflu at

For further information, please do not hesitate to contact us.

Best Wishes
Sangeeta Shashikant
Third World Network
Tel (O) : 41 22 908 3550
Fax: 41 22 908 3551

AIDS activists calls for generic Tamiflu in Africa
Fri Oct 21, 2005 4:47 PM BST

ZURICH (Reuters) - Activists who put pressure on drugs companies to make AIDS treatments accessible in Africa called on Friday on the maker of antiviral Tamiflu to renounce its rights on the drug in the developing world.

As concerns mount over how countries would deal with a potential flu pandemic stemming from bird flu virus H5N1, the Act Up-Paris lobby group and the African Essential Drug Network (RAME) said that Roche Holding AG should allow generic companies to make the drug for Africans.

"Africa cannot afford to wait until Roche is done 'talking': Act-Up Paris and African Essential Drug Network demand that Roche ... renounce all its exclusive rights on Tamiflu in developing countries," the groups said in a joint statement.

The groups called on Roche to grant manufacturers access to their know-how and commit to launching generic versions of Tamiflu in the developing world.

Under pressure from generic drug companies and politicians in developing nations and the United States, Roche agreed this week to discuss granting licenses to others to make versions of Tamiflu.

"We will talk to anybody -- people who can manufacture the drug, and are able to manufacture it faster than us, and complement our manufacturing," Roche's Chief Executive Franz Humer told Reuters earlier this week.

Indian generic drug companies, Asian governments and U.S. Senators have approached Roche over granting sub-licenses to farm out production of the drug. However, it is still unclear how sub-licensing will work in practice.

A spokeswoman for Roche confirmed that the company had received many requests about producing the drug, but was unable to give details.

The H5N1 avian flu virus has killed more than 60 people in four Asian countries -- Indonesia, Thailand, Vietnam and Cambodia.

Stocks of Tamiflu and another antiviral drugs recommended by the World Health Organization (WHO) and made by GlaxoSmithKline Relenza are very limited, experts say.

For Immediate Release - October 21 2005 - Act Up-Paris/RAME
Generic Tamiflu : no time left for "talk", Roche must take action now

Act Up-Paris and the Burkina Faso Network for Essential Drugs (1) call on Roche to unblock generic production for Africa

Roche CEO Franz Humer said Wednesday in an interview to Reuters that "Roche will discuss possible licenses with anybody able to manufacture the drug." For African countries, who have been unable to make stockpiles of Tamiflu, and who are already seeing migrating birds arrive from contaminated regions, there is no time left for talk: Roche must immediately authorize and facilitate the launch of a generic production of Tamiflu.

Faced with a pandemic, Roche is not free to dictate its terms

- Roche is not the inventor of Tamiflu: the Swiss company has merely come to reap the fruit of others' research by buying the rights to oseltamivir from Gilead in 1996. The 50 million dollars Roche paid Gilead for Tamiflu (2) have long since been recouped: total cumulated orders are now well in excess of 1 billion dollars.

- Roche claims to be willing to grant licenses to other manufacturers, but refuses to specify its terms: criteria for grant, royalty level, pricing freedom vs imposition of anti-competitive fixed prices, or even timeframe and transparency of the licensure "talks".

- With HIV medications, Roche's track record on voluntary licensing is to systematically foil efforts to launch generic production, and to refuse to issue licenses, for example to the Brazilian government (3).

Taking account of the opacity of Roche's voluntary licensing offer, one cannot take the company's intent to facilitate a generic response to the needs (amounts, prices) and the urgency (timeframe) seriously.

Thus, considering the huge profits already reaped over Tamiflu, as well as the terrible vulnerability of  Africa to an avian flu epidemic, it is inacceptable that Roche should dictate it terms and slow down the launch of massive generic Tamiflu production for poor countries.

People with AIDS at special risk from avian flu

- people with AIDS and other people with impaired immunity (the elderly, children below 12 months) are at highest risk of lethal avian flu complications like pneumonia (4) ; in France the government recommends that PWAs should receive priority access to Tamiflu, but what will happen to the millions of PWAs who live in Africa and other Tamiflu-less regions ?

- Africa will likely be hit by the avian epizootic well before Europe, since in winter birds migrate from North to South ;

- Even without the avian flu, Africa is already the region with the highest rate of respiratory infection mortality ; moreover, nearly 30 million Africans are infected with the AIDS virus ;

- launching a generic production of Tamiflu will take between 4 and 15 months, depending on whether Roche keeps its manufacturing know-how secret or not, according to experts from the generic drug industry.

In this context, Africa cannot afford to wait until Roche is done "talking". Act Up-Paris and African Essential Drug Network (RAME) demand that Roche:

- renounce all its exclusive rights on Tamiflu in developing countries ;

- grant generic manufacturers complete access to Tamiflu manufacturing and quality assurance know-how ;

- commit to taking all measures necessary to facilitate the soonest possible launch of mass production of generic Tamiflu, especially for Africa and other impoverished regions.

Contacts :
Act Up : Khalil Elouardighi  + 33 6 63 15 38 82 ; RAME : Simon Kaboré
+226 7024 4455.


(1) RAME = Network for Access to Essential Drugs (Réseau Accès pour les Médicaments Essentiels), Ouagadougou, Burkina Faso, .
RAME is a member of est Panafrican AIDS Treatment Access Movement
(3) "Brazil to Break Roche's Patent on AIDS Medication", Wall Street Journal, August 23 2001 ; "Roche Reaches Accord on Drug with Brazil", New York Times, September 9 2001.
(4) Colds and Influenza (the Flu), a report by the Well Connected Project of Harvard Medical School,

Asia nations agree to stockpile anti-bird flu drugs
11 Aug 2005 09:00:53 GMT
Source: Reuters

By Darren Schuettler

BANGKOK, Aug 11 (Reuters) - A dozen Asian nations agreed on Thursday to build a regional stockpile of anti-bird flu drugs and some governments demanded production of cheaper generic versions of the Tamiflu antiviral drug.

Details of the plan, which aims to race drugs to the site of a human outbreak within 24 hours to prevent a wider global pandemic, had still to be worked out, health ministers and U.N. officials said after a meeting in Bangkok.

"It would be the first time in the history of mankind that a pandemic has been stamped out before it happened," William Aldis, the World Health Organization (WHO) representative in Thailand, told reporters.

Several Asian countries, including those hard hit by the H5N1 virus which has killed 62 people since late 2003, have begun stockpiling Tamiflu, made by Switzerland's Roche AG <ROG.VX> and also known as oseltamivir. But the WHO will now work with 12 Asian countries -- including Thailand, Vietnam, China, Japan and South Korea -- to decide how best to deliver the drugs to "burn out" a human outbreak, or at least blunt it enough so it can be contained.

The Bangkok meeting did not decide where the regional stockpile would be, nor did the ministers agree on a timeframe for when it would be up and running.

Those details would be worked out in consultations between the WHO and the countries involved, which also include Cambodia, Laos, Brunei, Bhutan, Philippines, Myanmar and Malaysia.

"What we are doing here is pushing it forward in terms of the management and logistics," Aldis said.

Scientists fear the virus, which does not pass easily between humans, could mutate to become easily transmittable and unleash a global pandemic which could kill millions.


The threat has become more acute with the spread of bird flu to Russian Siberia and Kazakhstan. It has killed only waterfowl and poultry there, but raised fears it could spread to Europe.

"We are all very much aware of the potential of this pandemic and yet the reality is we only have one drug company that manufactures this antiviral drug," said Philippine Health Secretary Francisco Duque.

"I think its incumbent on us to exert pressure to open this up for more manufacturers to increase production," said Duque, whose country does not have a stockpile of the drug.

Tamiflu costs about $3 per capsule in the Philippines and a course of treatment requires 10 doses. Aldis said the cost per dose can drop to $1.70 if bought in bulk, and further if bought in powder form.

Developing countries with pharmaceutical factors can issue a compulsory licence to make generic copies of patented drugs in the event of a medical emergency.

Thailand, which has stockpiled enough Tamiflu to treat 22,000 patients and another 20,000 doses of influenza vaccine, said in March it may consider producing a generic version of the drug.

The meeting did not take a decision on compulsory licensing, which Aldis called a "premature" option while the WHO was negotiating with Roche.

"We're well aware of the issue of oseltamivir supply and production and it's being worked out," he said.

Annan says UN will ensure access to medication in case of flu pandemic
Bradley Klapper
Canadian Press
Thursday, October 06, 2005

GENEVA (AP) - UN Secretary-General Kofi Annan said Thursday the United Nations will not let intellectual property rights stand in the way of access to flu treatments and vaccines in case of a pandemic.

"We should be clear in this situation: We will take the measures to make sure poor and rich have access to the medications and the vaccines required," Annan said, calling on rich nations and pharmaceutical companies to help impoverished countries prepare themselves.

Annan said he will be "encouraging pharmaceutical companies and others to be helpful and making sure we do not allow intellectual property rights to get in the way of access of the poor to medication."

Patents allow the developer of a drug an exclusive right to make and sell the drug for several years. But sometimes countries are allowed to create generic versions of patented drugs, if the medicine is considered essential.

Annan met the global body's top health officials to discuss the bird flu virus, which has affected parts of Asia.

"Some countries are not prepared," Annan told reporters at World Health Organization headquarters.

"Some are obviously complacent. Others do not have the capacity and need help to be able to do it and we need to identify those countries and offer them help."

Annan's comments were a "very interesting political statement", according to humanitarian organization Medecins Sans Frontieres, or Doctors without Borders.

"The UN has no legal power over patents, but national governments can set them aside, on a variety of grounds, including public health," said Ellen 't Hoen, director of policy advocacy at MSF's campaign for essential medicines.

Annan did not specify whether he was referring to the patented drug Tamiflu, which governments are scrambling to stockpile. Tamiflu, made by the Swiss pharmaceutical company Roche, is considered the only drug that can treat human cases of bird flu and is thought to be the best protection in the early days of a human flu pandemic.

Once a pandemic emerges, a vaccine, as well as possibly more drugs, are expected to be created or identified, and the UN wants to ensure everyone will be able to get some, regardless of cost or availability.

Countries would be able to create their own generic versions of such drugs.

"We need to be able to organize this ahead of time so that we don't have to quibble about these things when a crisis and critical moment arrives," Annan said.

"I wouldn't want to hear that same kind of debate we got into with antiretrovirals and HIV/AIDS."

Some countries, such as Brazil and India, have already broken patents under global trade laws to produce generic versions of patented AIDS medication, but they faced protests from intellectual property rights advocates and industry groups.

Annan was briefed by Margaret Chan, WHO's top official in charge of monitoring avian influenza. Chan said over 140 million chickens have been culled or died in the fight to prevent more bird-to-human transmissions of the virus.

The slaughtering of the poultry has cost some $12 billion US.

The latest bird flu epidemic has infected 110 people, over half of whom have died, Chan said.

"We have never seen this kind of mortality rate."

Last week, Annan appointed Dr. David Nabarro to lead the coordination of a global response to the bird flu and a possible human pandemic.

Nabarro warned that such a pandemic could kill anywhere between 5 million and 150 million people. The WHO later moved to dampen fears over Nabarro's predictions, saying that a maximum death toll of 7.4 million was a better forecast.

WHO, governments weigh patent override for Tamiflu

Last Updated Tue,
18 Oct 2005 22:13:33 EDT
CBC News <>

The threat of a global flu pandemic has led to calls for governments to override the patent on the drug Tamiflu.

Roche Pharmaceuticals of Switzerland owns the exclusive patent rights to Tamiflu for the next 10 years. The company originally developed the drug to prevent and treat typical flu strains that appear every year.

"In the event of an outbreak of pandemic flu, vaccine may not be available in which case then our Tamiflu would be our next weapon," said Ryan Melnychuk, a virologist at Dalhousie University in Halifax.

Officials at the World Health Organization have advised governments that can afford Tamiflu to stockpile it. Canada was one of the first countries to do so, buying 23 million doses to treat the sick and prevent infection among essential workers. Other Canadians will be on their own.

Health Minister Ujjal Dosanjh doesn't think he'll need to break the patent. "If you ask the Public Health Agency, they will tell you that this is a reasonable number," said Dosanjh. "If we need more, hopefully we would be able to get more."

The federal government has tried to get around a drug patent before.
After the anthrax scares in 2001, then Health Minister Allan Rock bought stockpiles of the antibiotic Cipro from a generic company because he couldn't get enough from the patent holder.

Most developing countries, including those that have seen cases of avian flu in humans, can't afford to stockpile Tamiflu.

Roche won't disclose how much Tamiflu it can make every year, but governments like the U.S. have been told it could take 10 years to fill all the orders.

*Generic option*

UN Secretary General Kofi Annan was among the first to raise the idea of governments stepping in to override the patent on Tamiflu, to allow generic drug companies to help meet demand.

Governments override patents regularly for everything from computer software to sheet music, agreed economist James Love of the Consumer Project on Technology in Washington.

"It's no big stretch to do it for a medicine, particularly in a case like this, where a patent owner cannot supply the stockpiles of medicines that the WHO says are necessary," said Love, who specializes in intellectual property rights.

A generic drug maker in India has announced it will ignore the patent on Tamiflu and produce a generic version that could be sold to developing countries. Roche is now signalling a willingness to allow other companies to make Tamiflu without giving up its patents.

"In support of the global effort to fight a potential pandemic, we would be prepared to discuss such sub-licences to increase the manufacturing of Tamflu, provided such groups can realistically produce substantial amounts of the medicine for emergency pandemic use," company CEO William Burns said in a release.

In the U.S., Democratic Senator Charles Schumer of New York said he wants Roche to commit to the idea quickly.

Phillipines Government asked to make drugs' prices affordable

Monday, October 10, 2005

LOCAL pharmaceutical companies have urged the government to make the international patent system more adaptable to the Philippine market.

Mike dela Cruz, president of the Philippine Chamber of Pharmaceutical Industry Incorporated (PCPI), said there is a need to study how the World Trade Organization's (WTO) Trade-Related Aspect of Intellectual Property Rights (Trips) agreement would work in favor of the Philippines by lowering the prices of medicines.

"Multinational pharmaceutical companies need to protect their patent rights and profits. This is upheld in international agreements and as WTO member, we have to abide by, but the government should also ensure that medicines are accessible and affordable to those who need them," he said.

Dela Cruz said it is the time for the Department of Health (DOH) to employ ways on how it could make the drugs available and within the Filipinos' means, particularly the anti-retroviral drugs, to the victims of human immunodeficiency virus/acquired immune deficiency syndrome (HIV/Aids).

With the Philippines facing a possible pandemic should the dreaded avian influenza or bird flu enter the country, dela Cruz said it is not enough that "we are complete with protective gears because virus should be treated with medicines."

"The anti-bird flu strategies may include planning and mobilizing human and financial resources, public information and obtaining medical equipment and protective gear; but what are we going to do about the lack of bird flu vaccines?," he asked.

He said the issues involving the intellectual property rights (IPRs) should be addressed soon "if we don't want multiple virus infection threats hit us." Among the key factors which should be resolved, he said, include the patent infringement and challenges of bringing in the medicines that could treat avian influenza and HIV/Aids.

As of the moment, dela Cruz said there is no available vaccine yet that could cure those who fall ill of avian influenza because what is available in the market is the Tamiflu, which is said to be not very effective in treating the disease.

"There is a relationship between IPRs and public health. More specifically, the patent regime affects people's access to essential medicines because it has power over issues like importation, licensing, pricing and availability of patented medicines," he said.

Dela Cruz said PCPI and the Intellectual Property Office of the country will hold an international forum wherein they would discuss IPR in the context of public health.

The forum will be held on October 20 to 21 at the Intercontinental Hotel in Makati City to be attended by stake holders and officials from the government. (MSN/Sunnex)

Indian Company to Make Generic Version of Flu Drug Tamiflu

Published: October 14, 2005

A major Indian drug company announced yesterday that it would start making a generic version of Tamiflu, the anti-influenza drug that is in critically short supply in the face of a possible epidemic of avian flu.

"Right or wrong, we're going to commercialize and make oseltamivir," said Dr. Yusuf K. Hamied, chairman of Cipla of Bombay, using the drug's generic name and acknowledging that he might face a fight in the Indian courts with Roche, the Swiss pharmaceutical giant that holds the patent.

Although generic manufacturers cannot legally sell the patented drug in the West, all national patent laws, including those of the United States, allow governments to cancel patents during emergencies and either buy generics or force patent holders to license their formulas to rivals.

A spokeswoman for the Department of Health and Human Services, which has recently ordered 12.3 million doses of Tamiflu from Roche, said she could not comment on the effect of Cipla's announcement. "Preparing the world for a pandemic flu outbreak is a top priority, and we're looking at various options in stockpiling drugs and vaccine," said the spokeswoman, Christina Pearson. "But there are a lot of issues, and it's too early to speculate about this right now."

Roche has been under growing pressure from several countries and the United Nations secretary general, Kofi Annan, to license generic versions of the drug, which eases flu's worst symptoms.

The company, which sells Tamiflu for $60 per treatment in the United States, has repeatedly refused to license the generic version, or even to disclose how much it makes, other than saying it plans to increase production "eightfold." A Roche spokesman, Terry Hurley, said yesterday that the company "fully intends to remain the sole manufacturer of Tamiflu."

Making the drug involves 10 complex steps, he said, and the company believes that it will take another company "two to three years, starting from scratch," to produce it.

Dr. Hamied dismissed that claim, saying that he initially thought it would be too hard but that his scientists had finished reverse- engineering the drug in his laboratories two weeks ago. He said he could have small commercial quantities available as early as January.

Asked if he thought Dr. Hamied was making an idle boast, Mr. Hurley declined to comment.

Cipla, India's third-largest drug maker, has copied dozens of Western drugs, including Lipitor and Viagra, and produces raw ingredients for Western drug companies. Its inexpensive H.I.V. drugs, approved by the World Health Organization, are used by 400,000 people worldwide.

Dr. Hamied said he would sell generic Tamiflu "at a humanitarian price" in developing nations and not aim at the American or European market. "God forbid the avian flu should strike India," he said. "There is no line of defense."

Under Indian patent laws, which were tightened in March, he believes that he can sell the drug in India and in 49 other countries rated "least developed" by the United Nations.

The new law recognizes patents filed by Western companies after Jan. 1, 1995, and the Tamiflu patent in India was filed with a "priority date" of Feb. 26, 1995. Dr. Hamied said he thought the Indian government would be unlikely to fight over a 10-year-old difference of two months, especially if the lives of millions of Indians were at stake.

Scientists in Taiwan and other countries have said they, too, can produce generic Tamiflu, if patent issues are resolved.

Mr. Hurley declined to say whether Roche would fight Cipla in court, but said, "If we determine that there has been an infringement, we'd move to protect our rights and interests."

Argentina says plans to produce own bird flu drug

19 Oct 2005 01:34:00 GMT
Source: Reuters
By Hilary Burke

BUENOS AIRES, Argentina, Oct 18 (Reuters) - Argentina plans to produce a generic version of the patented drug Tamiflu to protect against bird flu, which scientists warn could turn into a deadly human pandemic, officials said on Tuesday.

Tamiflu, developed by Swiss drugmaker Roche Holding AG <ROG.VX>, is one of the drugs the World Health Organization recommends stockpiling in case the virus mutates to spread rapidly among humans. More than 60 people have died in Asia after contracting the flu from birds.

"Many countries, Argentina among them, have built up reserves of these antivirals. We have bought them, but this laboratory's production is not sufficient to meet world demand," Health Minister Gines Gonzalez Garcia told Reuters.

"We don't have to wait until the virus appears to say we are going to do this and produce the drug. We must have it in case the virus appears."

Under pressure to boost Tamiflu supplies, Roche said it might let rival firms and governments make it under license.

Argentina said it would exercise its right, enshrined in international accords, to issue a compulsory license to produce generic copies of patented drugs in a medical emergency.

"This is being discussed in Geneva, in the World Trade Organization. This is not just an issue for Argentina," Gonzalez Garcia said.

Last week, Indian drugmaker Cipla <CIPL.BO> announced it had already begun making a copycat version of the Roche flu treatment. Roche said Cipla had not yet contacted the company to discuss a production license but one government in Asia, which it would not name, did get in touch.

The especially virulent H5N1 strain of bird flu has been found in flocks from Japan to Indonesia, and has moved west into Turkey and Romania.

In Latin America, the virus appeared in Chile in 2002, and Colombia announced last week it had discovered a mild strain.

Argentine officials said the country was at low risk for avian flu. The majority of Argentina's highly industrialized poultry production is consumed locally and its few imports come mainly from neighboring Brazil. Researchers have warned the virus is showing signs it can evade the effects of Tamiflu, illustrating the need to find and use other treatments and work quickly to develop a vaccine. (Additional reporting by Karina Grazina)

S. Korea Seeks to Manufacture Bird Flu Drug Wednesday,

October 19, 2005

The Korean Food and Drug Administration is seeking to independently manufacture the avian influenza antiviral drug, Tamiflu.

The move comes as Tamiflu's manufacturer, Swiss pharmaceutical company Roche Holding AG, is facing increasing international pressure to cede its patent rights to the prescription drug amid global concerns of a potential bird flu pandemic.

The food and drug regulatory agency had requested the Korea Pharmaceutical Manufacturers Association, Korean Research-based Pharmaceutical Industry Association and the Korea Venture Business Association to learn whether any local companies have the necessary technology to manufacture the drug.

The agency is also trying to determine whether it can issue a compulsory license for Tamiflu. A compulsory license is an exception to patent law that allows for use of a copyrighted work without the explicit permission of its owner.

Tamiflu is designed to be active against all clinically relevant influenza viruses and is considered to be effective against the avian
H-5-N-1 strain circulating in the Far East.

The manufacturing process for Tamiflu is regarded to be a complex and lengthy one.

Reported by KBS World Radio
Contact the KBS News:

HeeSeob Nam
Intellectual Property Left (

GPO to make Thai version of Tamiflu

Bangkok Post
October 18,  2005

The first Thai-made generic version of the anti-viral drug Oseltamivir, better known as Tamiflu, will be manufactured by the Government Pharmaceutical Organisation and be available to the public from October of next year, chief of the Disease Control Department Thawat Sundarachan said yesterday. Thailand plans to start production of Oseltamivir, and expects to have up to 50,000 capsules by next October. It is now in the laboratory testing stage.

``We have ordered the active pharmaceutical ingredient of Oseltamivir from India.

``We expect clinical tests to be completed before October. But in case of a [bird flu] epidemic spreading [among humans], we will speed up production of the medicine.

``There is no need to wait for the clinical trials,'' he said.

Thailand has so far stocked up 660,000 capsules of imported Oseltamivir, or Tamiflu, which is one of the few medicines known to be effective in combating bird flu in humans, and ordered another 340,000 capsules from Switzerland.

The medicine's shelf-life is about five years.

Pharmaceutical giant Roche, which is based in Switzerland, has the sole patent to produce Oseltamivir under the Tamiflu brand name.

Dr Thawat downplayed concerns over intellectual property rights, saying that the government would introduce a compulsory license allowing the country to produce the drug on the grounds of urgent public health needs.

Meanwhile in Kanchanaburi, public health and livestock officials have destroyed 364 free-range chickens raised by villagers in Phanom Thuan district after many were found to have died of bird flu.

The action was taken after samples of dead chickens were collected from 14 areas in tambon Phang Tru and sent to the research and animal health development centre in Ratchaburi for testing. The centre confirmed the chickens died of the lethal H5N1 avian flu virus.

More than 10 officials were dispatched to the area to spray disinfectant and they declared the area an outbreak zone.

Ratchaburi governor Wongsawat Sawasdipanich and public health and livestock office chiefs also went to Ban Khao Ngaem in Muang district where sparrows have succumbed to bird flu.

Samples of fowl were taken at random from about 18,000 chickens being raised in 26 villages within a 5km radius from where the outbreak was detected and sent to Mahidol University for laboratory testing.

Disinfectants were sprayed in a wide area to prevent any possible spread of the disease.

DOH requests license from Roche to manufacture drug Tamiflu (Updated 12:50 a.m.)

By Stephen Che
The China Post

Health authorities have requested that the Swiss drug company Roche Holding AG, maker of the only known drug to effectively fight bird flu, engage in negotiations with the Taiwan government over releasing the right to manufacture the drug Tamiflu.

Department of Health (DOH) minister Hou Sheng-mou said that he has written to the CEO of Roche Holding AG Dr. Franz B. Humer to invite him to negotiate the matter of allowing Taiwan drug manufactures to produce Tamiflu, of which Roche holds the patent.

As it takes twelve months to make Tamiflu, there has been a worldwide shortage of the drug as the World Health Organization recommends governments to keep in reserve enough Tamiflu to accommodate 10 percent of their population in case of an outbreak among humans.

Taiwan has already ordered Tamiflu from Roche Holding AG to provide for only 4 percent of the population by the middle of next year, according to Hou.

Director of Center for Disease Control Steve Kuo has said that the nation's National Health Research Institutes has already made small portions of the drug and he is confident local manufacturers could mass-produce Tamiflu within a few months, according to the Financial Times.

Hou said that current laws allow for the nullification of drug patents in case of a disease outbreak, and that the Taiwan government will not hesitate to start local manufacturing of Tamiflu if the worst does occur.

But Hou said that he hopes to negotiate with Roche Holding AG before the disease does spread between humans in order to increase Taiwan's reserve of Tamiflu as quick as possible.

Schumer, Roche Statements
On Tamiflu-Licensing Pact
October 20, 2005 3:07 p.m.

U.S. Senators Chuck Schumer and Lindsey Graham today announced that Roche Pharmaceuticals was committed to meeting with four generic drug companies starting immediately to redouble their efforts to vastly increase supply of their Avian flu treatment by licensing production to more drug companies.

Schumer has repeatedly called for Roche, the maker of Tamiflu, to immediately license the Avian Flu treatment to other drug companies in order to dramatically increase production. Schumer and Graham announced this deal after meeting with George Abercrombie, CEO of Roche Pharmaceuticals North America.

Schumer stated, "Roche has graciously stepped up to the plate, and has essentially agreed to share its technology and the rights to manufacture this drug with other companies who are willing to help out."

The tenets of the deal that Schumer and Graham announced with Roche are:

  • Schumer provided the names of four companies to Mr. George Abercrombie, the CEO of Roche in the United States. These companies -- Teva Pharmaceuticals, Barr Laboratories, Mylan Laboratories, and Ranbaxy Laboratories -- each believe they can produce more Tamiflu if given the chance, and want to step up to serve the global public health need by working in cooperation with Roche.
  • Roche has agreed to meet with each of these companies as soon as possible
    -- and indeed will begin meeting with additional companies immediately, also in cooperation with HHS, which may have additional companies in mind as well.
  • Roche has agreed to sublicense the production of Tamiflu to any of these companies that can produce it in quantities large enough to help meet the anticipated demand in case of a flu outbreak, and the determination as to who gets licensed will be made in cooperation with the U.S. Government and other governments around the world.
  • Roche will make reasonable efforts to work with companies who demonstrate appropriate capabilities to manufacture Tamiflu in order to accelerate product supply.
  • For companies eligible for a sublicense, Roche agrees to negotiate equitable terms.

Tamiflu is the only known effective treatment for avian flu, and Roche holds the exclusive rights to manufacturing it. One company simply cannot handle all the demand when tens and hundreds of millions of doses are being ordered.
Schumer expects Roche to continue working with these companies until the bottleneck of supply for government stockpiling purposes has been relieved, at which point they may regain their status as sole manufacturer. The purpose here is not to break the patent on Tamiflu, but rather to meet an emergency need for quantities of this drug that Roche itself simply cannot do alone.

"Roche has come a great distance in the best interests of the global public health, truly dedicating their efforts to protecting human life rather than focusing on their bottom line," Schumer concluded.

Following is the text of a statement released by George Abercrombie, president and CEO of Roche North America, after meeting with Sens. Schumer and Graham:

We appreciate the leadership that Senator Schumer and Senator Graham have shown in helping the U.S. be more prepared for a possible avian flu pandemic.

We discussed with them today our previously announced intention to meet with companies that may be able to assist in manufacturing additional supplies of Tamiflu.
I reiterated to the senators Roche's commitment to do whatever is needed to prepare for a pandemic. We at Roche recognize the global health emergency posed by the threat of an avian flu pandemic, and we understand that as the manufacturer of Tamiflu we play a central role in preparedness.

We continue to take the steps necessary to protect the health of people on a world-wide basis, and to make Tamiflu available wherever it is needed for both seasonal influenza and pandemic stockpiling. We already have expanded dramatically our own production capability and continue to make significant investments both internally and with partner companies.

Roche has an internal high-level team in place that is dedicated to assessing the ability of other companies and partners to either produce or provide capabilities in Tamiflu production. We want to be sure that they can produce substantial amounts of Tamiflu for pandemic use in a timely manner in accordance with appropriate quality specifications, safety and regulatory guidelines.

Sources: Sen. Schumer's office, Roche