By Kim Tong-hyung
Staff Reporter
The country's patent authority decided not to permit local pharmaceuticals to produce the generic versions of Fuzeon, an HIV drug designed for people who are resistant to other treatments, despite strong protests by patients and human rights advocates.
The decision came just hours after the National Human Rights Commission called for the government to seize the patents from Swiss-based Roche, Fuzeon's maker, to allow Korean patients to purchase cheaper generics made by local companies.
The Korean government wants to put Fuzeon in the National Health Insurance system, but had failed to reach an agreement with Roche on price. The Ministry of Health, Welfare and Family Affairs wants to provide Fuzeon at 25,000 won per pill, but Roche isn't willing to go below 30,000 won.
So despite being cleared by authorities for domestic sales in 2004, Roche hasn't been distributing Fuzeon to Korea for more than four years, although an international aid organization has been providing the pills to Korean patients for free since last year.
Pressured by criticism, Roche also announced in February that it will provide Fuzeon free to Korean AIDS patients under a ``compassionate program,'' which it explained as a temporary measure before the company strikes a deal with the government over drug prices.
In rejecting the request by civic groups, including the Korean HIV/AIDS Network of Solidarity and IPleft, to issue compulsory licenses for Fuzeon, the Korean Intellectual Property Office (KIPO) said that allowing local drug makers to produce generic Fuzeon couldn't be regarded as a necessity.
KIPO pointed out that the pills are already being provided to AIDS patients for free, and that it's unclear if local pharmaceuticals will have the ability to produce copy drugs even if they are allowed to. The patent authority also said that other alternatives to Fuzeon are about to be cleared for sale in Korea, which weakens the ground for issuing compulsory licenses.
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).
This allows the country's domestic firms to produce generic versions of drugs, although the import of generic drugs from other nations is limited under the TRIPS provision.
``It's really difficult to say that we are facing a threat grave enough to public interest that requires the issuing of compulsory licensing,'' said Kim Jong-taek, an official from KIPO's industrial property division.
Civic groups have been claiming that Roche's withdrawing its distribution of Fuzeon here has been compromising the rights of Korean patients to access effective treatment, and has been calling for the government to allow generic production.
However, the government seems reluctant to risk a trade dispute with the Swiss drug giant as it considers that the country's AIDS problem is not as severe as in countries such as Thailand or Brazil, which issued compulsory licenses for Fuzeon.
There are about 5,000 surviving AIDS patients in Korea, according to government figures, with around 100 of them in the terminal phase that requires Fuzeon prescriptions. However, only two of these patients have applied for the pills to Roche after it announced its intentions to give them out for free.
An official from the human rights commission criticized the KIPO decision, saying it will be hard for a terminal AIDS patients to pay nearly 2 million won per month for Fuzeon when their earning abilities are limited.
``No terminal AIDS patients will be able to buy the drugs individually without help. And since Roche will be compensated after the sales of generic drugs are allowed, compulsory licensing is certainly an option to consider,'' he said.
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 drug 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.
There are also calls for the government to issue compulsory licenses for Tamiflu, Roche's antiviral drug that is considered the best bet against H1N1 influenza A, although the Health Ministry said that possibility has never been discussed.