Indonesia Strives To Acquire Bird Flu Medicines Despite No Patent

With eight recently confirmed cases of avian influenza, Indonesia is scrambling to build up its stockpile of medicines. The preferred product to fight bird flu in humans is not under patent in Indonesia, which raises questions as to why production has been off to a slow start in the country.

Roche, the Swiss producer of the preferred treatment, Tamiflu (oseltamivir), has developed partnerships to increase worldwide supply. But none of these partnerships are in Indonesia, and although local companies have shown interest, there is only one government-owned generics company, Indo Farma, producing oseltamivir at the moment.

Roche has indicated to the Indonesian government that they are free to produce since it is unpatented, but that without a patent, it would take two to three years to develop production capabilities. But Indo Farma is beginning production this year, according to officials.

But even Indo Farma is importing oseltamivir from the company Hetero in India, with whom Roche has a license deal, showing that despite the absence of a patent in Indonesia, the country’s stockpiling may rely directly or indirectly on Roche.

Of the eight people affected in Indonesia, seven died and it is believed that it involves human-to-human transmission of the H5N1 virus, a World Health Organization (WHO) spokesperson told Intellectual Property Watch.

Such transmissions have taken place before in Hong Kong, Thailand and Vietnam, but the recent case in Indonesia is “certainly the largest cluster” of people seen so far, he said.

The spokesperson also said that considering that avian influenza is widespread in Indonesia, plus that “the control is not satisfactory,” and the number of poultry and the size of the country, one would expect that Indonesia will soon bypass Vietnam in having the highest number of human deaths from avian influenza. The likelihood of transmission is high in Indonesia, but the risk of spreading from poultry to human is still low, the spokesperson said. So far Vietnam has 42 confirmed human deaths from bird flu, according to the WHO.

Indonesia, with a population of some 220 million, needs and will continue to need medicines.

Lily Sriwahyuni, spokesperson for the Indonesian health ministry, told Intellectual Property Watch that at the moment “Indonesia and other countries may produce oseltamivir without a patent,” and that the ministry of health “has committed to prepare 12 million oseltamivir capsules in 2006,” which is well below the country’s potential needs.

The government has purchased five million capsules imported by Indo Farma produced by India’s Hetero under license from Roche, and Indo Farma expects to produce another five million by the end of 2006, Sriwahyuni said. Indonesia also is in the process of getting two million capsules from Roche directly in an “ongoing process,” she said.

In 2005, Indonesia had some 24,750 capsules of Tamiflu of which 3,800 were donated by the WHO; 500,000 by the Australian overseas development programme, AusAID/WHO; 50,000 capsules from the sales and distribution company Tempo; and 10,000 capsules donated by Taiwan. These were distributed to provincial health offices, infection hospitals and other hospitals, Sriwahyuni said.

Although she admitted that this was not a lot for 220 million people, she said that “for the time being” it is “quite enough.”

A Roche spokesperson confirmed that the company had received orders from Indonesia regarding Tamiflu and that the country is “in the process of building up” a stockpile, but could not comment further on the amount and details of the order.

She said the price of the product has not been a problem as Roche offers one price for developed and another for developing countries.

The Roche spokesperson also said that Tamiflu is not patented in Indonesia, noting that the patent in fact belongs to US company Gilead. The spokesperson said that according to the Roche patent policy, it does not take out patents on products in the “poorest countries” and there is also no patent for Tamiflu in the Philippines, for example. Gilead could not be reached for comment.

No Patent, No Problem?

The spokesperson also said that Roche had informed the Indonesian government that it is “free to produce” Tamiflu as there is no patent in that country.

But this may be easier said than done, and so far no private company in Indonesia has done so. One WHO source in Indonesia said, “There are several companies that are interested in producing oseltamivir locally. However, they have not started production yet.”

Roche argues that the absence of local production does not have anything to do with it not “handing out the recipe” for its drug.

Patents and some manufacturing processes are published, the spokesperson said, adding, “Anyone interested in oseltamivir can do a literature search and study these patents and processes.”

She said the key problem would be large-scale production. “If you start from scratch, it will take you some two to three years to be able to start producing oseltamivir,” the spokesperson said. This might be too long in the Indonesian situation.

This shows that despite the lack of patents, countries such as Indonesia apparently still encounter problems when they try to stockpile Tamiflu.

There have been no compulsory licenses issued for the production of Tamiflu, the spokesperson said. Such licenses would allow a company to manufacture the product regardless of the patent, which could increase Tamiflu’s global availability.

Instead Roche has chosen – among some 200 companies that expressed interest – 15 production partners, which participate in one or several of the steps in the production process, the spokesperson said. They are part of the production chain, and produce the product under other names than Tamiflu, the spokesperson said.

In addition, Roche has issued three sub-licenses, meaning that the companies are official partners, the spokesperson said. These are two companies in China (Shanghai Pharma Group and HEC Group) and one in India (Hetero). Roche also has a “technology transfer” deal with the pharmaceutical company, Aspen, in South Africa, the spokesperson said.

Another option for a country such as Indonesia would be to order Tamiflu from countries that have produced the product under compulsory license issued by their respective governments under the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). But so far no government has used this option for export, according to the WTO.

One IP policy source in Geneva said that the non-production of Tamiflu in Indonesia, “could very well be lack of domestic manufacturing capacity for this specific product, as I think Indonesia is behind other Asian countries such as the Philippines and Thailand in terms of that ability.”

Other Government Initiatives

But although the Indonesian government has not produced medicines, it has taken other steps to protect its people against a possible avian influenza pandemic.

It recently asked the WHO and the UN Food and Agriculture Organization to hold a conference on avian flu to bring in experts and provide recommendations for guidelines on avian flu both in humans and animals, the WHO said. The conference was held 21-23 June in Jakarta.

The government has also established the Indonesian National Committee for Avian Influenza Control and Pandemic Influenza Preparedness (Komnas FBPI) under the Coordinating Minister for People’s Welfare, the WHO in Indonesia said. This committee is above the other ministries, reflecting its importance.

“This coordinating minister is managing, among others, the minister of health, the minister of education, the state minister for women’s empowerment, the state minister for environment and other social-related ministers,” a WHO spokesperson said.

Indonesia has also received aid from the WHO. Tamiflu was given to Indonesia in the affected areas after the recent outbreaks in humans. The medicine was provided as prophylactic treatment, meaning that people who have been in contact with a contaminated person get the product to stop the virus from developing, the spokesperson said, adding that some equipment for the protection of healthcare personnel was also provided.

But these medicines were not taken from a Roche-donated WHO stock that is being held in Switzerland and the United States, which is reserved for “wrapping containment” and preventing the development of a pandemic when this can be done in a well-defined geographic area, the WHO spokesperson said.