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TOPIC: Legally Importing Generics to France - Official Guidelines

Legally Importing Generics to France - Official Guidelines 5 years 4 months ago #17770

  • Vororo
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Bonjour à tous,

According to recent guidelines issued by the French ANSM (Agence Nationale de Sécurité du Médicament et des produits de Santé), it is permitted to import by mail a personal supply of medication provided it is accompanied by a prescription from the country of origin.

Here is a link to the "Fiche Pratique" published by the ANSM (March 2016):

ansm.sante.fr/var/ansm_site/storage/orig...56a18d619d8c839b.pdf

(see also ansm.sante.fr/Mediatheque/Publications/F...emarches-Medicaments)

Here is my English translation:

Individual importation of medications

Individuals may only import a medication in a quantity that is consistent with a personal therapeutic use for a duration that does not normally exceed three months or for a duration of treatment indicated by the prescription.

No authorisation is necessary to import medicine into French territories for an individual who personally transports the medication.

When an individual imports a medication other than by personal transportation (that is to say by express carrier or by mail), prior authorisation is not required subject to the following cases:

* the medication has been authorised for sale in France (French "AMM") or has been registered (e.g. for certain homeopathic or traditional medicines) in a member state of the European Economic Area;

OR

* the medication is authorised in the country of origin (outside the EEA) and the individual presents to the customs service a prescription confirming that the medication is for a treatment prescribed by an established doctor in that country.

On the other hand, and always in the case of express or postal delivery, an authorisation from the ANSM for the importation is still necessary if the medication does not have an AMM or a registration in a state of origin belonging to the EEA;

OR

the medication is not authorised in the country of origin;

OR

the medication is authorised in the country of origin but the individual cannot present a prescription from an established doctor in that country.

Attention: these provisions do not apply to medications classed as narcotics...


In short (my interpretation):

If medications such as Sofosbuvir, Daclatasvir, and Ledipasvir are authorised medications in country X, then it is allowed to import these medications from country X by mail or express courier if the importation is accompanied by a prescription from an established doctor in country X.

Acknowledgement: This information was first highlighted by our friends from the Collectif Hépatites Virales (CHV):

collectif-hepatites-virales.com/index.ph...cite-et-en-tolerance

Vive la France!!
Diagnosed Jan 2015: GT3, A0+F0/F1. Fatigue + Brain-Fog.
Started Sof+Dac from fixHepC 10-Nov-2015. NO sides.
Pre-Tx: AST 82, ALT 133, Viral Load 1 900 000.
Week4: AST 47, ALT 58. VL < 15 (unquantifiable).
Week12 (EOT): AST 30, ALT 26, VL UND
Week16 (EOT+4): AST 32, ALT 28, GGT 24, VL UND
Week28 (EOT+16): AST 26, ALT 22, GGT 24, VL UND
Ever grateful to Dr James.

Relapsed somewhere after all that... Bummer!

Jan 2018: VL 63 000 (still GT3).
Last Edit: 5 years 4 months ago by Vororo. Reason: fixed crap colors
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Legally Importing Generics to France - Official Guidelines 5 years 4 months ago #17771

  • rohcvfighter
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Do I understand correctly that France and Fixhepc just became brothers? :)

As long as France wants to renegotiate HCV drug prices, what France just did is a great strategic move. :+1:
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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Legally Importing Generics to France - Official Guidelines 5 years 4 months ago #17772

  • Vororo
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rohcvfighter wrote:
Do I understand correctly that France and Fixhepc just became brothers? :)

As long as France wants to renegotiate HCV drug prices, what France just did is a great strategic move. :+1:

Yeah, this should add a lot to the negotiations ;)

More generally, it certainly looks like a big step forward from the previous situation in France:

fixhepc.com/forum/questions-and-answers/...egulations.html#2926

Still, for anyone importing to France by mail or courier service it might be a good idea to ask the doctor/supplier to include a print-out of the ANSM advice along with the prescription, if only to keep Fedex and DHL, etc., on the straight and narrow.

Here it is again:

ansm.sante.fr/var/ansm_site/storage/orig...56a18d619d8c839b.pdf
Diagnosed Jan 2015: GT3, A0+F0/F1. Fatigue + Brain-Fog.
Started Sof+Dac from fixHepC 10-Nov-2015. NO sides.
Pre-Tx: AST 82, ALT 133, Viral Load 1 900 000.
Week4: AST 47, ALT 58. VL < 15 (unquantifiable).
Week12 (EOT): AST 30, ALT 26, VL UND
Week16 (EOT+4): AST 32, ALT 28, GGT 24, VL UND
Week28 (EOT+16): AST 26, ALT 22, GGT 24, VL UND
Ever grateful to Dr James.

Relapsed somewhere after all that... Bummer!

Jan 2018: VL 63 000 (still GT3).
Last Edit: 5 years 4 months ago by Vororo.
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Legally Importing Generics to France - Official Guidelines 5 years 4 months ago #17844

  • mgalbrai
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FedEx and DHL have a fast learning curve. They will be become "proactive" in short order, I imagine, making sure that all documentation is in order for a successful delivery to the destination country (France) before sending the package on its way. That has been my experience in dealing with them as far as US shipments go.
m
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G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
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Legally Importing Generics to France - Official Guidelines 5 years 4 months ago #18185

  • Vororo
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a recent post from hepatoweb.com (19/06/2016)

Mai 2016 – Hépatite C: les génériques indiens des AAD aussi efficaces que les princeps

Patients français, allez à l’étranger pour vous faire soigner !

En France, les nouveaux AAD sont remboursés chez les adultes chroniquement infectés par le VHC à partir du stade "F2 sévère" et, quel que soit le stade de fibrose hépatique, chez les personnes co-infectées par le VIH , ainsi que celles présentant une cryoglobulinémie mixte ou un lymphome B associé au VHC.

Interrogé par Medscape édition française, le secrétaire général de l'Association française pour l'étude du foie (AFEF), le Pr Victor de Lédinghen, s'est dit "ravi" des résultats présentés par le Dr Freeman. « Désormais, nous allons pouvoir dire à nos patients, n'ayant pas accès au traitement, qu'ils peuvent envisager un séjour thérapeutique à l'étranger ».

Si la France ne permet pas d'importer des médicaments, elle autorise le transport de médicaments à usage personnel en provenance d'un pays étranger. Selon la douane française, « la quantité transportée correspond à la durée du traitement prescrit sur l'ordonnance ou, à défaut, à trois mois de traitement ».

La loi étant en faveur du transport de médicament, « cela ouvre la porte au séjour thérapeutique », souligne le Pr De Lédinghen. « Il faudra toutefois veiller à bien choisir le pays de destination, en privilégiant les fabricants ayant pu obtenir la licence du princeps ».


Read the full article (also in French): hepatoweb.com/espace_actualites.php
Diagnosed Jan 2015: GT3, A0+F0/F1. Fatigue + Brain-Fog.
Started Sof+Dac from fixHepC 10-Nov-2015. NO sides.
Pre-Tx: AST 82, ALT 133, Viral Load 1 900 000.
Week4: AST 47, ALT 58. VL < 15 (unquantifiable).
Week12 (EOT): AST 30, ALT 26, VL UND
Week16 (EOT+4): AST 32, ALT 28, GGT 24, VL UND
Week28 (EOT+16): AST 26, ALT 22, GGT 24, VL UND
Ever grateful to Dr James.

Relapsed somewhere after all that... Bummer!

Jan 2018: VL 63 000 (still GT3).
Last Edit: 5 years 4 months ago by Vororo.
The administrator has disabled public write access.
The following user(s) said Thank You: pat1, Gaj

Legally Importing Generics to France - Official Guidelines 5 years 4 months ago #18198

  • Gaj
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Thanks Vororo. :cheer:

For those who can't read French here is a translation of the full article courtesy of Mr Google who is much better at it than me. ;)

May 2016 - Hepatitis C: Indian generic AAD as effective as the originator 
Vincent Richeux - Medscape - 2016




Generic AAD, imported from India by patients with hepatitis C (HCV) through a dedicated website, have proven as safe and effective as the originator molecule, reported Dr. James Freeman (Hobart, Australia), at the International Congress Liver (ILC), 2016, Barcelona [1].A new step towards widespread access to ADF? 

Excessive Price AAD originator treatments are regularly criticized because they represent the brake to access therapy to cure the infection with HCV. For 12 weeks of treatment with sofosbuvir, leader of the AAD produced by Gilead, the price ranges from 900 euros in Egypt to 84 000 in the United States. In France, it takes 46,000 euros. 

Several countries, such as China and India, were able to obtain the licenses of originator, following agreement with manufacturers to produce their own generic AAD at a price of around 1,000 euros per treatment. 

Import for personal use via a "buyer's club" 

"When the first patient asked council to import generic drugs from Chinese manufacturers in order to treat his hepatitis C, I decided to buy myself and test them to make sure of their quality" , explained Dr. Freeman. 
It thus began the FIXhepc Australian initiative, which assists patients HCV + who wish to obtain generic AAD, inaccessible in their country. Drugs are now ordered from Indian manufacturers, who obtained the license of the originator. 
"The process is legal," says Dr Freeman. "It is based on the authorization granted in some countries, such as Australia and the United Kingdom to import drugs for personal use not exceeding three months of treatment. " 
On the dedicated website, patients are encouraged to incorporate a "buyer's club", with $ 1,600 for a 12-week treatment of sofosbuvir + ledipasvir or $ 1,500 for the combination sofosbuvir + Daclatasvir. 

Sustained response rate of 95%

FIXhepc proposes to import generic Australia, test and deliver them to patients in countries allowing personal importation. According to the site, the United Kingdom, but also Italy, Switzerland, Poland or Romania are the countries of Europe, where delivery is possible.
From January 2016, Dr. Freeman included patients wishing to import generic, through the buyer's club, in an observational study, named REDEMPTION (DAA Reviewing efficacity Managing Patient Treatment in Online Neighbourhoods).The results presented at the ILC concern a total of 448 patients, 54 years on average in Australia, mostly, but also in Asia and South America. At the time of inclusion, they were naive to treatment half and 30% had cirrhosis. Imported generic were analyzed by chromatography and mass spectrometry. The sofosbuvir / ledipasvir combination was a majority (45%), followed by sofosbuvir / Daclatasvir (42%). In other cases, these combinations were associated with ribavirin.

No more side effects

Of all the tested generic, the virologic response rate (SVR) amounted to 95%. It reached 97% for the combination sofosbuvir / Daclatasvir. "The response rates appeared similar to those reported for the originator in Phase 3 clinical trials," said Dr. Freeman.
Patients were followed remotely via telemedicine. The most frequently reported adverse events were insomnia, fatigue and headaches. According to the doctor, "there were no more adverse effects compared with AAD."
Three patients had cirrhosis temporarily switch to a decompensated stage, but the treatment was maintained. Four died due to hepatocellular carcinoma.
"These results show that we have there an effective treatment to cure patients with hepatitis C for less than 1000 dollars. Millions of people could benefit. So it is now time to use them, "concluded Dr. Freeman before being greeted by long applause.

French patients go abroad to treat you!

In France, the new ADF are reimbursed in adults chronically infected with HCV from the stage "F2 severe" and, whatever the stage of liver fibrosis in people co-infected with HIV and those with a mixed cryoglobulinemia or a B lymphoma associated with HCV.
Asked by Medscape French edition, the general secretary of the French Association for the Study of Liver (AFEF), Prof. Victor Lédinghen, said he was "delighted" the results presented by Dr. Freeman. "Now we can tell our patients, without access to treatment, they may consider a therapeutic stay abroad."
If France does not import drugs, she allows the transportation of personal medicines from a foreign country. According to French customs, "the quantity transported corresponds to the duration of treatment prescribed on the order or, failing that, three months of treatment."
The law is in favor of transport medicine, "this opens the door to therapeutic stay," says Prof. De Lédinghen. "It will ensure, however, choose the destination country, focusing on manufacturers who have obtained the license of originator." "Never generic only appeared so soon after the arrival of a new treatment on the market.Results regarding their effectiveness once again raises the issue of widespread access to ADF. The situation became absurd. "
The secretary hopes an announcement in the sense of the Health Minister, Marisol Touraine, during the National Day against hepatitis B and C, to be held on 25 May.

REFERENCE:
[1] - Freeman J, High sustained virological response rates using Direct acting generic antiviral treatment for hepatitis C, imported into Australia, April 16, 2016, ILC 2016, Barcelona.
fixhepc.com/getting-treated/how-to-do-it...ort-regulations.html
G3a since '78 - Dx '12 - F4 (2xHCC)
24wk Tx - PEG/Riba/Dac 2013 relapsed
24wk Tx - Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx - 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 - 22/06/17 UND
SRV12 - 27/07/17 UND
SVR24 - 26/10/17 UND
:cheer: :cheer: :cheer:
Last Edit: 5 years 4 months ago by Gaj.
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