Compulsory licensing sought for hepatitis C medication

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MEDICINE
Compulsory licensing sought for hepatitis C medication
PRATCH RUJIVANAROM
THE NATION


Aids patient-rights activists and Rural Pharmacists Association representatives yesterday rally |outside the Public Health Ministry in Nonthaburi

BANGKOK: -- ACTIVISTS yesterday called on the Public Health Ministry to use compulsory licensing to ensure wide access of the medicine for hepatitis C and to control its price.

The Aids Access Foundation, together with the Ozone Foundation, the Foundation for Aids Rights, the Thai Aids Treatment Action Group and the Rural Pharmacists Association expressed their concern in writing to the ministry about the excessively expensive hepatitis C medicine sofosbuvir, and urged it to take action.

"Up to 1.3 million hepatitis C patients will be affected by the overly expensive cost of a US firm's hepatitis C medicine, which costs US$1,000 (around Bt32,000) per pill. An overall treatment course requires a patient to use 90 pills of this medicine, which would cost more than Bt2.5 million," said Nimit Tien-udom, director of the Aids Access Foundation.

According to his investigation, a pharmaceutical company in India manufactures sofosbuvir at just Bt71 per pill.

Nimit said his objective was to ask the Public Health Ministry to implement compulsory licensing for sofosbuvir in case Gilead Sciences Inc successfully registers a patent for this drug in Thailand.

"This drug is very important to hepatitis C patients, so the government should use its power over patents to ensure all patients can access the hepatitis C medicine," he said.

Late last December, his group asked the Intellectual Property Department to reconsider letting Gilead Sciences register a patent for sofosbuvir in Thailand, as the chemical ingredients of the drug were already known and the medicine is very important for hepatitis C patients.

However, there was no reaction from the department.

"I suggest that there should be many firms competing in selling this medicine, not only one firm monopolising the market," Nimit said.

Explaining the importance of |sofosbuvir, he said the current medicine used for hepatitis C was less effective and had too many side effects compared with the new medicine, which can cure the disease within three months.

Dr Surachet Satitramai, deputy permanent secretary of the Public Health Ministry, said it had accepted the group's plea to take up the issue with the Commerce Ministry and the Food and Drug Administration.

Surachet later said there would be a careful consideration of this matter, as this is a new drug.

He also assured fairness to the people and the pharmaceutical company, as per the law.

Source: http://www.nationmultimedia.com/national/Compulsory-licensing-sought-for-hepatitis-C-medica-30260550.html


-- The Nation 2015-05-21

[NickJ]

I have a friend that is undergoing this drug protocol in the U.S. at the moment and I can say that the cost is indeed 1000$ a pill.

India has it for 71b????? Is it the same medication? Or would it be like there dangerous version of viagra, kamagra?

[oxo1947]

I get a little confused with the different strains of hep........isn't Hep C covered if you have the 3 injections ?

[rametindallas]

I have a friend that is undergoing this drug protocol in the U.S. at the moment and I can say that the cost is indeed 1000$ a pill.

India has it for 71b????? Is it the same medication? Or would it be like there dangerous version of viagra, kamagra?

Is it the same medication?

Yes, it is identical to the patented version; some people refer to these copies as 'generic'.

The manufacturing costs of medications is not why they are priced so high. It is extremely difficult and very expensive to get a new drug approved by the Federal Drug Administration. First there is expensive research and many failed drugs before a drug is found that is both safe and efficacious. Then expensive doctors and lawyers need to make a case for an application to conduct animal testing and trials which, if successful, will lead to possible human testing for safety and trials for effectiveness. The insurance costs are huge. There are very strict protocols for every step in this process. $1,000.00 per tablet times 90 tablets is killing insurance company profits and they are losing money on these treatments but the pharmaceutical company that took all the financial risks, without knowing they would eventually get approved, deserve to make their investment back, profit for their shareholders, and also enough money to develop even newer drugs to stay in business.

The reason India can sell the same drug so cheaply is because they didn't spend anything for research or development and they don't pay royalties to the patent holder. They analyzed the drug, made a copy of it, and their government licenses them to do that. Thailand does this with some AIDS drugs and this is what the health activists want Thailand to do with this new drug. When a wonder drug comes out that cures the previously incurable, it is almost a sin to deprive the poor of access. It's hard to strike a balance between the need of Hep C sufferers and the needs of the developers of the drug to continue in business. I see both sides and hope a compromise can be reached; at least for the poor.

[rametindallas]

I get a little confused with the different strains of hep........isn't Hep C covered if you have the 3 injections ?

Go to Google, or your favorite search engine, and type in "treatments for Hepatitis C". All will be revealed.

Google is you friend.

[jollyhangmon]

I get a little confused with the different strains of hep........isn't Hep C covered if you have the 3 injections ?

Nope!

To my knowledge there still isn't any preemtive vaccine against Hep.C (and above), just covers A & B so far and as it were. Of course several companies/scientists are pursuing that goal so wish 'em luck.

After all once it works out fat buck is pouring in as we can read - a grand for one tab oh boy, they certainly know how to milk loaded patients & insurances but mainly public health systems i'd guess at these costs.

[ICECOOL]

I have a friend who is trying to access this drug in India at the moment. Has been getting the run around. He was told it was likely he would be given it free in Australia on compassionate grounds because he is too well for a liver transplant, Travelled back to Oz over Xmas only to be told..no..because there had been a slight improvement in his condition. Research in respect of the Indian drug is that there are strict conditions on its use. It MUST be administered by an Indian doctor and only a with 4 week course of drugs at any one time (my friend needs 3 treatments)

[ricklev]

http://en.wikipedia.org/wiki/Doha_Declaration

Compulsory licensing of this drug by Thailand is clearly legal under the Doha Declaration.

However, the USA will retaliate by finding other trade violations.

[maidee]

$1000 dollar a pill that costs 2.5$ to make

now that is what is wrong with healthcare

[FangFerang]

Medicines for life-threatening illnesses should not be granted patents--and the R&D cost should simply be reimbursed to the company with tax breaks and offsets--oops, I forgot. They already get tax breaks, offsets and subsidies, especially subsidized free university researchers...

Ah, screw it. Drugs for life threatening illnesses should not be patented.

[Maestro]

I have a friend that is undergoing this drug protocol in the U.S. at the moment and I can say that the cost is indeed 1000$ a pill.

India has it for 71b????? Is it the same medication? Or would it be like there dangerous version of viagra, kamagra?

The systematic (IUPAC) name of the active substance is Isopropyl (2S)-2-[[[(2R,3R,4R,5R)-5-(2,4-dioxopyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyl-tetrahydrofuran-2-yl]methoxy-phenoxy-phosphoryl]amino]propanoate

The molecular formula is C₂₂H₂₉FN₃O₉P

The generic name is sofosbuvir.

The trade name of the sofosbuvir product approved by the US FDA is Sovaldi, manufactured by Gilead Sciences.

The trade names of some other products containing the active ingredient sofosbuvir, so-called generic equivalents, are Hepcinat, Resof, Hepcvir, SoviHep.

Unless evidenced by the results of scientific studies, the quality, efficacy, safety (side effects, therapeutic index, LD₅₀), shelf life, etc of the generic copies may not be the same as those of the original product. The quality and quantity of inactive ingredients, also known as excipients, may also not be the same.