Continuing from Roche Will Provide Fuzeon (HIV/AIDS drug) For Free.
As far as I heard from a source,
- Fuzeon is for patients in the terminal phase.
- There are 155 HIV/AIDS patients in Korea. The Korean government is maintaining a list of HIV/AIDS patients. The number 155 is from the government’s list.
- Patients get Fuzeon for free under Roche’s Expanded Access Program (EAP) (also called the Compassionate Program by the patients’ group)
- Fuzeon therapy costs $25,000 per year in the U.S.
- It is said that the Korea Orphan Drug Center
has not received a single request for Fuzeon. is giving Fuzeon to two HIV-resistant patients. (as of April 22, 2009)
According to press, the patientts group was planning to request for compulsory license in March 2009 on the basis of failure to work a patent. Article 107(1)(2) of the Patent Act of Korea provides that non-working of a patent for 3 years can be a ground for requesting for a compulsory license.
1. How many patients in Korea need to have Fuzeon?
It might be that there is no single HIV/AIDS patient in the terminal phase in Korea, judging from the fact that the Korea Orphan Drug Center (KODC) has not received a single request. The HIV/AIDS patients is said to form a community and if a patient is in need of Fuzeon, which means the patient is in terminal condition, other patients will surely tell the patient to get Fuzeon from the KODC.
But, as we don’t seem to have a drug that stops the progression of HIV/AIDS, a number of patients will reach the terminal phase sooner or later.
2. National Health Insurance system
The Ministry of Health wants put Fuzeon in the National Health Insurance system just as in the Glivec case. But it couldn’t strike a deal with Roche on the price. The Ministory of Health wants 25,000 KRW per pill, while Roche’s bottom line is 30,000 KRW.
Under the National Health Insurance system, the insurance will cover 80 – 90% of the drug price. The remaining 10 – 20% will be borne by patients. In Glivec case, Novartis compensates CML patients for the 10% share in the drug price that is not covered by the insurance.
The problem of patients is that there is no guarantee that Roche will compensate patients for the deductible-equivalent portion of the drug price (10%) as Novartis is doing in the Glivec situation. 10% of 25,000 USD is not egregiously much but is still burdensome for patients who are in most cases without a regular job.
So, the patients are requesting a permanent Expanded Access Program so that they can access the drug at no cost.
3. How likely is it that KIPO will grant a compulsory license?
The patients’ groups are using the compulsory license as a negotiation leverage. But how likely is the Korean Intellectual Property Office going to grant a compulsory license? As far as my note says, there is a single case KIPO granted a compulsory license. It was 29 years ago. KIPO has not granted a compulsory license ever since.