TOPIC: French govt announces universal HCV treatment

In France, 25 May 2016 is the national day for the fight against viral hepatitis.

The CNS (National Council for AIDS and Viral Hepatitis) has called for treatment of everyone infected with HCV.

www.cns.sante.fr/spip.php?article553

Marisol Touraine, French Minister for Social Affairs and Health, has announced universal access to treatment for all HCV patients, and wants to renegotiate the cost.

www.marisoltouraine.fr/

French President François Hollande is promising to raise the question of the cost of medicines at the next G7 meeting (26/27 May):

www.pourquoidocteur.fr/Articles/Vu-dans-...ramme-du-prochain-G7

www.ouest-france.fr/sante/hollande-pour-...aments-au-g7-4111690

Meanwhile, more and more French people are demanding access to generics:

www.metronews.fr/info/hepatite-c-pourquo.../mpex!DodSwDx8YLIEk/

www.pourquoidocteur.fr/Articles/Question...ament-des-generiques

Good news Vororo. Great to see the French government and patients responding urgently in their own ways to the need to fix the hepatitis C pandemic.

Hi Gaj, yes it looks promising.

Let's hope the G7 leaders will force Gilead to abolish their evil market segmentation and tiered pricing.

Q. What's the difference between someone infected with HCV in India and someone in France?

A. One speaks Hindi and the other speaks French. Period.

One person, one treatment, one honest price.

They say Trump is "The Deal Maker".
HCV sufferers in the U.S. may get a chance to see if that moniker is accurate...
Someone needs to force Gilead to the table here, that's for certain.
Very happy for the French!

Some here may already know this about May in US, but some may not. (Really not trying to pun may/May here).
www.cdc.gov/hepatitis/hepawarenessmonth.htm
Oh, and not to get into politics here, but, hey Mike yer joking about the Trumpster, right?

G7 working group on Global Health and Human Security sets "universal health coverage" (UHC) as a global priority:

jcie.or.jp/cross/globalhealth/2016ghwg.html

François Hollande writes editorial letter (01 May 2016) in The Lancet (how many other presidents ever did that?)

www.thelancet.com/journals/lancet/articl...6%2930393-2/abstract

More Lancet articles on France and world health (some require login/registration):

www.thelancet.com/series/france-nation-and-world

Vive la France!

Thankyou very much Vororo
I'm liking Marisol Touraine speaking up about tx for all. My french is okay for reading not so good for parlez. But I get the articles
Interesting that these all coincide with this weeks WHO Assembly
Ty for this excellent info
Alors! Tx pour tout la monde!

Haha, Matt I have to agree about Trump. I would be surprised if he did anything about this issue, but I don't think Hillary will do anything either.

They rail against prescription prices, just like they are against TPP. Whoever gets in, I bet money TPP passes either way. And nothing happens about drug prices.

The only thing happening is CUSTOMS IS BLINKING. I have lived here most of my life (Born in Canada).

What I have observed is there are laws that do not get enforced. Officially, these meds cannot be imported. But they are being allowed through. No one yet in USA has reported that their meds were seized and destroyed. Every so often, they put on a show and seize the meds and make people beg, and then relent. But officially, these meds, as FDA approved medications should NEVER be allowed in, especially in generic form!

Cough up $1000 or wait for insurance approval (F3 +)

USA!

Hello Everybody,

it seems that things are moving in France. Please find below the English translation of a news taken from a french website.
(@French speakers: in case you note any discrepancy in the translation, please let me know and I will fix it. )
the translation activity was carried out on a voluntary basis by a user registered on the platform fixhepc.com. Although the translator has made best efforts to provide a translation of high accuracy, no responsibility is assumed for it, in case of doubt or for clarification purposes, the original text in French, can be found at the source address: www.francesoir.fr/societe-sante/hepatite...rimination-subie-par

Hepatitis C: universal access to antiviral ends the discrimination experienced by some patients

Marisol Touraine decided on Wednesday to make the new direct acting antivirals treatments (NAAD) accessible to all people with hepatitis C, thus ending a great injustice. Because so far, only the "seriously ill" had access to the drugs, due to their exorbitant prices. The others had to wait until their condition worsens or to turn to generic products abroad without knowing anything of their quality.

"Today I decided universal access to treatment for hepatitis C," said the Health Minister Marisol Touraine on Wednesday 25th with the occasion of the National Day of fight against viral hepatitis. A decision that ends a "discrimination between patients which ethically is not acceptable" according to the National Council on AIDS and viral hepatitis (CNS). Because so far, the new direct acting antivirals (NAAD), available since 2014 and fully reimbursed by the health insurance, was accessible, due to their price, only to the most severely ill patients, who suffer from advanced liver fibrosis.

For example, the price of Sovaldi (sofosbuvir) can reach 41,000 euros for twelve weeks of treatment while Harvoni (sofosbuvir and ledispavir) from the Gilead laboratory costs 46,000 euros. So far from about 500,000 people with hepatitis C in France, only 30,000 could have access. The others had no choice but to wait for worsening of their disease or to turn abroad for treatment om their own expense, without knowing anything about their quality. According to the associations, cited by pourquoidocteur.fr , "many players now offer generic drugs to patients, health professionals, associations. The cost of a 12-week treatment against hepatitis C is so accessible for first price of € 550. " Thus, facing rationing, "the patients followed in France generic treatments purchased on a parallel market," and that as long as " individual drug importation is governed by legislation and poses potential infringement issues and unequal access "denounce associations, calling the state to" import or produce generic treatments in France. " Because the government has all the legal tools to do this, they assure, citing the ex officio license mechanism. Still not operated by the French state, this lever provided in the French code of intellectual property would produce a generic sofosbuvir explains pourquoidocteur.fr .

For the Huffington Post, these failures are indicative of "failure and dysfunction of our health system." "You have to understand the mechanism at work in the lobbies that organizes the fixing of the prices based on inferred resources of each country," said, on the information site, the doctor Martial Olivier-Koehret, President of the Coordinated Care Association . For him, "lobbyists are betting on the injustice of leaving aside the sick and the emotion it arouses to force health authorities to give in and accept the price imposed". "This is a pricing mechanism particularly inglorious and the least unsatisfactory. But to accept that manufacturers set the prices of their products for reimbursement by social security and adapting to the financial capacities of each country, in particular in the times of globalization, the price differences between France and other countries are also inexplicable and unacceptable" protested there. To remedy this, Marisol Touraine asked the chairman of the Economic Committee for Health Products (CEPS) to "conduct new negotiations with industry."

Here is how the G7 governments must deal with Gilead:

Compulsory licensing of pharmaceuticals and TRIPS

Here are some extracts from www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm (the underlines are mine)

What is compulsory licensing?

Compulsory licensing is when a government allows someone else to produce the patented product or process without the consent of the patent owner. It is one of the flexibilities on patent protection included in the WTO’s agreement on intellectual property — the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement.

Does there have to be an emergency?

Not necessarily. This is a common misunderstanding. The TRIPS Agreement does not specifically list the reasons that might be used to justify compulsory licensing. However, the Doha Declaration on TRIPS and Public Health confirms that countries are free to determine the grounds for granting compulsory licences.

The TRIPS Agreement does list a number of conditions for issuing compulsory licences, in Article 31. In particular:

* normally the person or company applying for a licence has to have tried to negotiate a voluntary licence with the patent holder on reasonable commercial terms. Only if that fails can a compulsory licence be issued, and

* even when a compulsory licence has been issued, the patent owner has to receive payment; the TRIPS Agreement says “the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization”, but it does not define “adequate remuneration” or “economic value”.

You said “normally” …

Yes, this is where the confusion about emergencies arises. For “national emergencies”, “other circumstances of extreme urgency” or “public non-commercial use” (or “government use”) or anti-competitive practices, there is no need to try first for a voluntary licence. It’s the only instance when the TRIPS Agreement specifically links emergencies to compulsory licensing: the purpose is to say that the first step of negotiating a voluntary licence can be bypassed in order to save time. But the patent owner still has to be paid.

Who decides whether the payment is “adequate”?

The authorities in the country concerned. The TRIPS Agreement says the patent owner must be given the right to appeal in that country as well.

The Doha Declaration

(extracts from: www.wto.org/english/tratop_e/trips_e/healthdeclexpln_e.htm)

The special declaration responds to these concerns in a number of ways.

First, it emphasizes that the TRIPS Agreement does not and should not prevent WTO members governments from taking measures to protect public health. It reaffirms the members’ rights to use fully the provisions of the TRIPS Agreement, which provide flexibility for this purpose.

Second, the declaration makes it clear that the TRIPS Agreement should be interpreted and implemented in a manner that supports WTO members’ right to protect public health and, in particular, to promote access to medicines for all.

Third, the declaration contains a number of important clarifications of some of the flexibilities contained in the TRIPS Agreement. It does this while maintaining members’ commitments under the TRIPS Agreement.

On compulsory licensing, the declaration makes it clear that each member is free to determine the grounds upon which the licences are granted. This, for example, is a useful corrective to the view sometimes expressed that some form of emergency is a pre condition for compulsory licensing.

The TRIPS Agreement does refer to national emergencies or other circumstances of extreme urgency in connection with compulsory licensing. But this is only to indicate that in these circumstances there is no need to try to obtain a voluntary licence before resorting to compulsory licensing.

The declaration makes it clear that each member has the right to determine what constitutes a national emergency or other circumstance of extreme urgency , and that public health crises can fit the bill, including HIV/AIDS, tuberculosis, malaria and other epidemics.

The declaration also refers to the “exhaustion” of intellectual property rights, and therefore a member’s right to allow parallel imports (for an explanation see fact sheet.

The TRIPS Agreement says that a member government’s practices in this area cannot be challenged under the WTO dispute settlement system.

The declaration makes it clear that the TRIPS Agreement’s provisions on exhaustion in effect leave each member free to establish its own regime without challenge — subject to the general TRIPS provisions prohibiting discrimination on the basis of a person’s nationality.

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So the TRIPS agreement leaves lot's of flexibility for member governments to deal with medical crises.

What makes Compulsory Licensing a legal power that western governments are so afraid to use, even when thousands of their citizens are dying from one of the world's most deadly diseases?

(and before anyone objects that technically hepatitis C is not an epidemic, it goes without saying that it is a pandemic, which is worse)

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But let's also not forget that Gilead's tiered pricing and nation-based market segmentation practices (see the clauses in Gilead's "Voluntary Licence" that relate to "territories") are clearly discriminatory to different nationalities.

www.gilead.com/~/media/files/pdfs/other/..._agreement.pdf?la=en

In other words, the American company called "Gilead" is violating TRIPS left, right and centre!

OK, I know its uncool to reply to my own post, but I have to put this cracking story from The Guardian (26 Jan 2016) somewhere:

Big Pharma's Worst Nightmare

www.theguardian.com/society/2016/jan/26/...rmas-worst-nightmare

Wow. What a read
Ty Vororo that was amazingly inspiring.
I will read it a couple of times and share via social media
Wow again
A

Congress would have to pass the TPP.
About all Congress can pass is hot air and gas.
No matter who is elected come November, Congressional gridlock appears to assured.
m

I completely agree about gridlock being assured.

Fitz

We in America seem to want less government until we want more when it comes to the outrageous prices we have to pay for certain medications.
m