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EU cannot give effect to a compulsory licence for HCV generics 6 years 9 months ago #24975

  • rohcvfighter
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Hi Everybody,

I just found this article that was published at the end of June 2017 and which offers several relevant information explaining why EU countries may not (currently) give effect to compulsory licenses for HCV drugs.


The case of Romania who contemplated last year to issue a compulsory license for sofosbuvir is also mentioned:

Case of Romania

In 2016, the government of Romania contemplated issuing a compulsory licence for the hepatitis C medicine sofosbuvir, which, in Europe, was only available from the originator company at a price of around 50.000 euro for a 12-week treatment [28]. Since the registration of a generic version of sofosbuvir is not possible before the expiry of the data exclusivity in 2022 [29],7 Romania, like any other EU Member State, cannot give effect to a compulsory licence. Further, the EU market exclusivity for sofosbuvir expires at the earliest in 2024. The case of Romania reveals the obstacles to the effective use of compulsory licensing created by EU data exclusivity.

The end of the article, recommending a greater legislative coherence in EU, sounds in my ears as more and more waiting..... as politics usually require a lot of time in order to reach a conclusion.

What a strange world .... until last year, people were in doubt whether generic HCV drugs work. Now it is more and more known that HCV generic drugs do work effectively (even governments see the HCV generics as a good solution to treat patients), yet the mass treatment of HCV patients is being stopped by .... politics.....

As mentioned in other places on this forum, the HCV patients face 3 choices:
1) get treated with the expensive subsidized treatment (if they are "lucky" enough to access it)
2) wait (= stay untreated and feel further sick)
3) get treated with generics imported legally (thank you FixHepC )

In fiecare an HCV ucide peste 500000 oameni.Medicamentele generice pentru hepatita C functioneaza. Nu deveni statistica! Cauta pe Google “medicamente generice pentru hepatita C”.
HCV kills more than 500000 people every year. HCV generic drugs work. Don't become a statistic.
By sharing this Youtube video you might save someone’s life!
My TX: HEPCVIR-L[generic Harvoni]-India
SVR52 achieved
The following user(s) said Thank You: Hazel, Donna, Iain, Mnem

EU cannot give effect to a compulsory licence for HCV generics 6 years 9 months ago #24976

  • Hazel
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Interesting Rohcvfighter! I have a cartoon being done of those 3 choices exactly! I will post here next week. :)
Genotype 3 30 years, 2x treatment interferon/ribavirin non responder. Cirrhosis 17 years. Fibroscan, decompensating, 40 down to 22 by 29/3/16- now down to 6.5, normal, no cirrhosis. Started Buyers Club Sof/Dac 14 Nov 15. SVR 12 29/0716
The following user(s) said Thank You: Iain

EU cannot give effect to a compulsory licence for HCV generics 6 years 9 months ago #24977

  • DrJames
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We should spend less time worrying about what is legal, and more about what is right
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