[Ip-health] Korea Times: Patients Given No Say in AIDS Drug Dispute

[Thiru Balasubramaniam]

http://www.koreatimes.co.kr/www/news/biz/2009/06/123_47153.html

Patients Given No Say in AIDS Drug Dispute


Roche=92s AIDS drug Fuzeon
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.

thkim@koreatimes.co.kr

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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru@keionline.org


Tel: +41 22 791 6727
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