Should Korea Seize Roche Patents?
Kim, a 34-year-old office worker in Seoul, visited his doctor for a prescription for Tamiflu, the antiviral drug that is considered the best bet against swine flu, recently renamed H1N1 influenza A.
Not that he was suffering from a high fever, coughs or any other symptoms to suspect infection, but the response to the latest flu outbreak had him feeling uneasy ahead of a business trip to California.
``The doctor wrote me the prescription, but he also said he had no idea whether the medicine will work if I come down with swine flu,'' Kim said.
``He also wondered whether I would be able to find Tamiflu anywhere.''
After returning empty from five to six drug stores around his neighborhood, Kim took a cross-city bus trip and finally found a pharmacy with stock near Seoul National University Hospital in Hyehwa-dong. But the complications didn't stop there.
``It took me like 30 minutes to get the drug ― my doctor had prescribed seven pills for me as precaution, but the pharmacy people said regulations required Tamiflu to be sold 10 pills at a time. There was a lot of confusion and phone calls were made back and forth,'' he said.
``I ended up paying more than 38,000 won for those 10 pills. For an expensive medicine that is clearly so valuable in these times and in such a short supply, the control of distribution seems pretty lax.''
At least, Kim is one of the lucky few who managed to get his hands on the drug, let alone get a prescription. Searching for Tamiflu has become somewhat of an urban adventure for travelers in a country where the fears over swine flu continue to take hold.
The number of South Korean infections has now reached over 40, according to the influenza taskforce of the Ministry for Health, Welfare and Family Affairs, and the patients include a 32-year-old woman who is three-months pregnant.
There are also fears that the summer holiday season might fuel the spread of the virus, with an increased number of leisure travelers moving in and out of the country and students coming home from their schools overseas.
Although health authorities downplay the worries, stressing that the virus presently remains in a mild form, the continuing spread of influenza A, still in the early stages of the outbreak, has critics concerned about the country's readiness to combat a possible epidemic.
Korea has so far stockpiled 2.5 million doses of Tamiflu and plans to spend another 63 billion won (about $51 million) to double the supply by the end of the year.
However, a course for 5 million accounts for just 5 percent of Korea's population, which is far below the standards of the World Health Organization (WHO), which recommends countries secure enough drugs for at least 20 percent of their population.
The shortage of Tamiflu supplies has medical experts and civic groups questioning why the government is refusing to consider allowing local pharmaceuticals to push for generic Tamiflu production.
This would require that the government to seize the patent rights from Roche, the Swiss drug maker that is licensed as the exclusive manufacturer of Tamiflu, and declare a ``compulsory license,'' which enables a third-party to use the patented invention without the authorization of the patent holder.
An important question is whether the country and companies have the ability to produce sufficient amounts of ``copy drugs'' for emergency pandemic use.
But according to industry watchers, about 10 or more Korean pharmaceutical companies, including Yuhan, which provides materials to Roche for Tamiflu production, are merely waiting for the call.
Taiwan issued compulsory licenses to local companies to produce generic versions of Tamiflu during the bird flu outbreak of 2005. Indian drug maker, Cipla, recently said it could make 1.5 million doses of the antiviral drugs by the end of June, benefiting from being based in a country where Tamiflu is not patented.
Korea's last, serious debate over compulsory licensing was in 2005, when the county was hit by the avian flu. At that time, the Korea Food and Drug Administration (KFDA) asked a number of drug makers whether would be able to manufacture oseltamivir, or Tamiflu's non-commercial name.
Responding to the call were 16 companies, including Yuhan, Green Cross, Chong Kun Dang, Daewoong and Idong Pharmaceutical, who submitted to health authorities reports on the raw materials, manufacturing methods and testing data regarding the production of the antiviral drug.
Some of the companies even presented prototypes, according to industry sources, but the Health Ministry eventually chose not to make the reports public.
A Roche official said it would take the Korean companies up to a year for them to put the generic versions of Tamiflu on shelves, even should the government issue the compulsory licenses. The Korean companies refute that, saying they can do it in less than six months.
``We have already made it clear to the KFDA that we can make drugs that have the same effect as Tamiflu. The companies that gained the experience of making prototypes will be faster in reaching the market,'' said an official from Green Cross.
``The claims that it would take us eight to 12 months to market the generic drugs are clearly off the mark,'' he said.
All countries can issue compulsory licenses under their national patent acts, but are also required to incorporate the related provisions of the World Trade Organization Trade-Related Aspects of Intellectual Property Rights (TRIPS). And since the articles of TRIPS states that the use of generic drugs produced under compulsory licenses must be ``predominantly'' for domestic use, importing the drugs from Cipla and other companies seems out of the question.
A Health Ministry official said that the questions over whether the government should explore options for compulsory licensing have never been debated seriously.
``The government has never considered the possibility of compulsory licensing to this day,'' he said.
``Our study on Korea pharmaceutical firms was more about looking for companies capable of producing some of the materials for Tamiflu, not about reviewing their ability to produce a generic versions of the drug.''
The Korean government had often been at odds with multinational drug giants who own exclusive rights to market drugs for difficult medical conditions.
Swiss-based Novartis halted the Korean supplies of its leukemia drug, Glivec, in 2002, after the Korean government set the prices of the drugs at 17,800 won with insurance, lower than the 25,000 won the company had demanded. Glivec is now sold at around 23,000 won.
A similar dispute had Roche pull its anti-HIV drug, Fuzeon, from Korea in 2004. An international aid organization has been providing Korean HIV and AIDS patients with Fuzeon since last year.
Woo Seok-gyun, a doctor and policy director of the Korean Federation of Medical Groups for Health Rights (KFHR), criticizes that the government have been too casual over the debate on compulsory licensing.
It's debatable whether the current situation is dire enough for the government to seize Roche's patent rights. But Woo claims that being prepared is the key, considering that the flu is still in its early stages, with even the WHO acknowledging that the virus will eventually spread worldwide, and has the possibility of mutating in South American and Asian countries.
``Whether it would take six months or up to a year for the generic drugs to reach the market, it would be reasonable for us to be prepared, as we will be already late when the trouble actually comes,'' said Woo.
``The United States issued compulsory licenses for anti-anthrax drugs to domestic companies during the anthrax scare of 2002, which ended with two casualties. Korean government officials, on the other hand, seem reluctant to put public health issues ahead of business interests.''
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