Hi Tamar,

 

I’m sorry to hear about the political challenges!  We will do whatever we can to support you.  Graeme would be the best person to speak to the media and I’m confident we can arrange a video conference for him as soon as needed.

 

As for supply, the first 4,003 bottles is ready to ship.  We are only waiting for the import permit.  We will get you the information needed for the import permit within a couple days.

 

Best,

 

Ben

 

 

Dear Ben

 

I hope this email finds you both doing well. I am writing to ask if clarification (provided by Eka Adamia in her e-mail below)  on required documents for granting the importation waiver is sufficient. Could you please also let me know the date when the first order of 4003 units reaches us. For the moment, we have all newly detected patients in the waiting list. Supplies are extremely low for patients currently on treatment-we can somehow handle this within the next 7-10 days maximum.

What complicates this situation even further is a new wave of criticism about the Hep C program from the political opponents.  On Friday, January 10^th the State Auditor published the financial audit report of the Social Service Agency. This covers 2018 and indicates that the SSA did not manage to make adequate Hep C drug projections that resulted in expiration of drugs with a monetary value over 0.5 billion (this is based on estimated amount established by the revenue service at the program initiation). You may have heard that in 2018 drugs for around 2000 patients remained unused (this was explained by lower enrolment compared to previous years-overall enrollment per month  in previous years varied from 2500 to 3500, then it reduced to 1000-1200), and the program was not able to utilize them before the expiry date. This fact was investigated by relevant state agencies-no deviation or leakage found. However, since the report was published on Friday, the opposition took this as an opportunity to attack the program again. To respond to this criticism and clarify all kind of misleading statements about the program failure Dr. Amiran, myself , experts, members of the Parliament, patients who benefited are making public announcements/speeches. Here is the link to one of the announcements for easy reference https://1tv.ge/en/news/head-of-national-center-of-diseases-control-georgia-has-best-indicators-for-hepatitis-c-medication/

Would it be possible for you or other Gilead colleagues to make a brief public announcement (video or a written post) for Geo media to explain what 2018 supply management issues meant for you, how this compares with other countries supply chain management experience and also say a few words about Gilead’s commitment and prospects for future collaboration within the agreement. With your concurrence, we could also arrange a video call with you for media at an earliest convenience. We will also be approaching other international partners with a similar request.

Given these circumstances I am really concerned that any delay in drug supply will be interpreted as another sign of the program failure. It is a critical moment now to protect the great achievements of the Hep C Elimination program and its future progress from improper political interference. Hopefully all will be successfully resolved soon.

Many thanks for your understanding and cooperation.

I look forward to hearing from you.

With kindest regards

 

პატივისცემით,

თამარ გაბუნია

მინისტრის პირველი მოადგილე

 

Sincerely,

Tamar Gabunia, MD, MPH

First Deputy Minister

 

 

 

 

 

Dear Ben,

 

On behalf of Dr. Tamar Gabunia, I would like to clarify that application and distribution timetable will be provided by the LEPL Social Service Agency.

 

Hereby, kindly ask you to send a letter (preferably by e-mail for quick response) with indication of the amount and series of the medications.

 

In addition, please, be informed that the list of documents should include a document confirming the registration issued by the producer country (that means that registration by DCGI in India (their FDA) will be sufficient).

 

Please, kindly let me know if any clarification is required.

 

Sincerely,

 

Ekaterine Adamia

 

 

 

Ministry of IDPs from the Occupied Territories,

Labour, Health and Social Affairs of Georgia

 

Address: 144, Ak. Tsereteli Ave. Tbilisi 0119

Phone: (032) 5100381110

Mob: (+995) 577282825

 

 

 

 

 

Hi Tamar,

 

Thanks!  To clarify:

 

1. Application. What is this?  Is this a form?  A letter?
2. Accompany:
   1. Request letter: This is from you? Will you supply this?
   2. Confirmation assessment: Would registration by DCGI in India (their FDA) be sufficient?
   3. Distribution timetable and legal basis: Will you provide this?
   4. Patient leaflet.  Done.
   5. Quality certificate:  Would registration by DCGI in India be sufficient?

 

The product is ready to ship right now so only pending the import permit and Mylan can ship.

Ben

 

-----Original Message-----
From: Tamar Gabunia <tgabunia@moh.gov.ge>
Sent: Thursday, January 9, 2020 1:11 AM
To: Ben Kamarck <Ben.Kamarck@gilead.com>
Cc: Graeme Robertson <Graeme.Robertson@gilead.com>; Ekaterine Adamia <eadamia@moh.gov.ge>
Subject: [EXTERNAL] RE: SOF/VEL

 

Dear Ben,

 

Please find the list of documents needed for granting the registration waiver.

According to the Georgian legislation unregistered medicinal products may be imported, for non-commercial purposes in the following case:

Under particular circumstances (a natural disaster, mass injury of the population, epidemic, rare disease) for humanitarian purposes, as well as in the case of a special state interest, with the consent of the Ministry. In such cases, the purpose of the import should be clearly stated in the shipping documents.

In order to obtain the consent of the Ministry the following documents should be submitted to the Department of health and LEPL Regulatory Agency:

1. Application.

2. The application should be accompanied with:

a) A request from the donor's representative organization (if the donor organization is importer) and the electronic version of the list of medicines (on CD)

b) A preliminary confirmation assessment document of medicines issued by World Health Organization and/or a document confirming the registration of medicines issued by the country or interstate pharmaceutical product state regulatory authority, which are recognized by the Georgian Government and/or a document confirming the registration of medicines in the country of manufacture;

c) Distribution timetable of medicines and legal basis of importation of medicines for humanitarian purposes (an agreement, a contract or an official letter, etc.);

d) Patient leaflet of medicine;

e) A copy of the certificate of quality of medicines and/or a document certifying the medicines were manufactured in accordance with international standards, issued by the competent authority (relevant governmental body, recognized international organizations, special regulatory bodies).

 

On the bases of intermediate decisions by the Regulatory Agency and Department of Health policy the consent or refusal for importing unregistered medicines into Georgia will be issued by the Minister.  

 

Please kindly let me know if any clarification is required.

 

პატივისცემით,

თამარ გაბუნია

მინისტრის მოადგილე

 

Sincerely,

Tamar Gabunia, MD, MPH

Deputy Minister

 

 

 

 

 

-----Original Message-----

From: Ben Kamarck <Ben.Kamarck@gilead.com>

Sent: Monday, January 6, 2020 4:35 AM

To: Tamar Gabunia <tgabunia@moh.gov.ge>

Cc: Graeme Robertson <Graeme.Robertson@gilead.com>

Subject: SOF/VEL

 

Hi Tamar,

 

We have decided to source from Mylan, at least initially, as they can deliver fastest and because they have a pending application for WHO prequalification and expect it in Q2.  They have the first 4,003 units ready to go and are planning for 20k March as discussed.

 

What do they need to submit for the registration waiver / import permit for this first shipment?  We can coordinate any documents they may need.

 

Of course, they will also begin the registration process but they will likely take longer than this order and the March order.

 

Thanks!

 

Ben