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TOPIC: EU - who has the competence to authorize the generic HCV drugs?

EU - who has the competence to authorize the generic HCV drugs? 5 years 2 weeks ago #21801

  • rohcvfighter
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Hello Everybody,

this topic is addressed mainly to those living in the European Union.

In 2015 there existed a petition addressed to the European Parliament demanding a plan to eradicate HCV from Europe and which included also the request that EU should implement some legislation changes in order to allow the usage/entrance on the market of HCV generic drugs: www.europarl.europa.eu/sides/getDoc.do?t...uage=EN&secondRef=01

Although the document is full of political (i.e. unclear) statements, on page 3/4 it is mentioned that:
Regarding the proposal to change EU legislation on intellectual property rights so as to allow easier and more rapid access of generic drugs against hepatitis C, in the context described by the petitioner, national measures for the issuance of a compulsory license for a patented medicinal product on general interest grounds are foreseen in national laws of certain Member States (in the case of the country of the petitioner, the Spanish patent law (Ley 11/1986) specifically by articles 73 and 86, article 90.1 being also relevant). There have not, to date, been calls to harmonise such compulsory licensing at EU level and the Commission does not have sufficient information to indicate the need for such harmonization in the interest of the Single Market for generic medicines and the protection of public health.

I guess this means that the citizens of EU should not expect (at least not in the near/middle future) that EU will do something to allow the usage of generic drugs in all countries belonging to EU, rather it is up to each country to decide this. This might mean that one European country has the power to decide at its national level the usage of generic HCV drugs, while other country may decide not to. At least in theory .... Am I having a wrong understanding?

As such politics means wasting a lot of time .... what option does an HCV patient have in the real life?
Not many:
1. getting the life into own hands and take the generic HCV drugs via personal importation
or
2. wait....as much as one can until either a miracle will happen (perhaps Santa Clause or Tooth Fairy will deliver the treatment :silly: :woohoo: ) or the liver will be bad enough in order to access the treatment through the courtesy of the healthcare system :sick: .

Cheers,
RHF
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
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EU - who has the competence to authorize the generic HCV drugs? 5 years 2 weeks ago #21821

  • LondonGirl
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Bureaucracy to the max and corruption over patient care, sadly.

As far as England is concerned, we don't even know if we're in Europe any more :huh: and with current Gvt who have their fingers in big pies, well ......

It seems, it's down to individual hospitals whether they 'break the rules' to even monitor treatment on generics, and this has come a long, long way within a year thanks to Dr Freeman, Dr Andrew Hill and Greg Jeffereys at EASL , MonkMed, who do things properly and tirelessly and patient advocates like the people on here, having faith and getting cured. At least Drs are listening now, a giant step in the right direction and mainly down to medics, certainly not the powers that be and highly paid management.

I can't see Europe going for this in the near future, although I can imagine there are some in the Eu that would like to implement it, so I think there may be hope for the distant future. It would save the health authorities a fortune, improve the lives of patients enormously, as well as actually saving lives but no doubt big pharma & business types would put pay to that currently.

But to all of the above, I salute you, you started something and it's awesome :+1:

A vision for future, maybe ? Ridding Europe and the world of Hepatitis C, Quite frankly, it's disgusting and immoral not to.
GT1a Dec14 F2/8.7 VL 900000-2.5M
Jan16 Hepcivir-L MonkMed/Redemption
Baseline: VL 913575 Alt 76 Platelets low
Wk2 VL1157 Alt 23
DET Wk 8 VL 32 Alt19 'In the slow lane'
June16 Fibro 5.7 F0/1 LIF 1.5
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Thank-you Tim, Dr Debasis @ MonkMed & Dr Freeman @ Fix HepC
Last Edit: 5 years 2 weeks ago by LondonGirl.
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EU - who has the competence to authorize the generic HCV drugs? 5 years 2 weeks ago #21824

  • rohcvfighter
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Hi LG,

Thank you for this view, I see it in the same way.
Even more, looking at the answer from the EU parliament, I would say that in order for EU to initiate something, it would be required that on a lower level (national level) the countries should initiate an action favorable to HCV generic drugs. But on the national level there exist other systems (healthcare system, governments, pharma companies and distributors, etc) which are very complex and have many rules that perhaps are forbidding them to talk so easy about generics. What these systems might require is that on an even lower level, the citizens, will talk and demand that something has to be done about the HCV generics.
As a funny thing, the systems have the power to authorize the generics, but not so much freedom to talk about these generics, while the citizens have the freedom (human right) as well as the legitimacy to talk about generics, but less power in accessing the treatment.

I guess the key is for people to talk fearless about the HCV generic medication.

Cheers,

RHF
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
Last Edit: 5 years 2 weeks ago by rohcvfighter. Reason: Typing error corrections
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