Subject: Re: RIA Reports (ORGANS, TISSUES and CELLS)
From: Natia Nogaideli <[email-masked]>
To: Mirela Busic <[email-masked]>
Cc: Achi Zangurashvili <[email-masked]>, Vakhtang Chkheidze <[email-masked]>, "[email-masked]" <[email-masked]>, Tamar Gabunia <[email-masked]>, Anzor tchavtchavadze <[email-masked]>, Laura Carrasco Macia <[email-masked]>, "KOCHISHVILI Nika (EEAS-TBILISI)" <[email-masked]>
Date: Thu, 08 Apr 2021 20:09:19 +0000

Dear Mirela,

Happy Easter to you and your family!

Thank
you for your support,

The development of deceased donation
is really important in Georgia. Accordingly, I share your opinion about
defining of death criteria in the current legislation; Though, the practice of
regulating such issues doesn’t exist at the legislative level in Georgia. I
don’t have the competence of a lawyer, probably Archil will give you detailed
information about this issue.

Concurrently, I have sent you
the draft law On the Use of Human Tissue and Cell, where I have corrected
several articles. However, I have not received any feedback from you. Please
send me updates about this draft law.

I prepared comments /
amendments about the MAR bill, which was discussed with Vanja at an online meeting
held on the 18th of March. Although she hasn’t sent the final
version of the bill up to this point.

If possible, please, provide
us with the final versions of the bills.

Nowadays, I am working on
bylaws. I will have presented my opinions about them by the end of next week.

Once again thank you very
much for your kind support.

Looking forward to your
response.

Kind regards,

Natia

On Friday, April 2, 2021, 03:22:43 PM GMT+4, Mirela Busic wrote:

Dear Natia,
thank you for your comments and suggestions that have been all  taken into consideration.

I would like just  to point out a few key messages; our common goal is to address the major gaps and barriers in the current regulation (such as BDD and the level of protection of living donors) that should be overcomed with new regulation, otherwise there will be no progress in the field. The solution to leave current regulations (no changes) would not be in the best interest of patients and therefore (I assume) not a preferred option of your Government.

As the issue of determination of death is the paramount  (the key prerequisite)  for development of deceased organ donation, I strongly disagree with your opinion regarding brain death determination to be left on the level of secondary legislation. There are many reasons why criteria for determination of death must be regulated by the primary  legislation (Law) and I really don't see any reasons (according to Georgian normative techniques) why it cannot be part of the Law.  However, I'm happy to elaborate more on this and other open issues and discuss it with Arci and a targeted group of experts in the normative and medicine fields, during the consultation process.

We plan to organise a meeting with you and the Ministry so we can present the outputs and open issues and agree on the consultation process.

I wish you a nice weekend

Mirela

On Sun, Mar 21, 2021 at 8:36 PM Natia Nogaideli <[email-masked]> wrote:

Dear Mirela,

I hope you are doing well.

Unfortunately, the law sent in
February is quite different from the version prepared in August 2020. Consequently,
the law needed to be re-drafted. Although, I had written to you on 4-th March about
our disagreement over certain articles, in the version, sent by you on 6th
of March, our opinions haven’t been taken into account.

We believe, the draft law
presented in the Ministry should be in full compliance with Euro Directives. Moreover,
during the preparation of the draft law Georgian Legislation, the structure of the healthcare system, functions, and responsibilities of the Ministry of Health,
redistribution of responsibilities between state agencies, funding system for
medical services, social, cultural, and economic characteristics of the country
should be taken into account.

In the attached file you can find a corrected version of the draft law with our opinions in track-change format. I
want to clarify some issues, which I did not agree with and have corrected in
the text:

a)      Some
definitions, that have no need to be in the law, have been taken out. For
example All institutions that will become a ‘Procurement Center’ - nowadays has
permission, there will be no new permit/license for the Procurement Center, beside
some additional requirements must be met within the existing permits; As for
ICU Departments - ICU departments in all multi-profile clinics will have an
obligation to participate in determining the death of a potential donor and in
all appropriate procedures (Which will be regulated by amending the existing permit
requirements); Also, Death, Death declaration, Brain death, ........ have been
removed from the definitions, according to the Georgian normative technique the
National diagnostic protocol for determination of death cannot be a part of the
law;

b)      At
this point live donation is a well-regulated area in Georgia. While kinship
donation and cross-donation, the transplantation is approved by the
Transplantation Council, and for emotional connection - the court approval is
needed. Cross-donation does not involve the exchange of organs during an
emotional connection. Consequently, the existing system of live donation should
remain, as long as it is based on altruistic donation and the risks are
minimized;

c)       National
Protocol for Determination of Death has been removed from the law, because
according to the legislation of Georgia, as well as the established practice,
such issues cannot be regulated by the
law; At the same time, the issues of national protocols’ recognition are
regulated by the Law of Georgia on Health Care; The protocol will be approved
after discussion with the medical associations according to the current
legislation;

d)      Issues
for granting the right to operate are regulated by the Law of Georgia on
Licenses and Permits; Permit and license is permanent; That is the reason why
we are introducing the concept of a certificate, which needs to be updated
every 4 years. It gives the opportunity to inspect transplant centers once every 4
years. Procurement Centers will be all multi-profile hospitals that operate
within the permit. Amendments will be made in permit conditions to ensure procurement
of organs in these clinics. Legislation in Georgia does not provide for the
suspension of a permit/license.

I think the naming of chapters and articles should be revised
with Archil.

Some
issues need to be discussed with the ministry, primarily the establishment of
the National Center for Substances of Human Origin.

It
is important to review the final agreed version of the law during March 22-27. Open
issues will be discussed with the ministry in later periods.

I
sent you a revised version of the Tissues Law
on March 4th  (I do not agree with certain articles in the bill you submitted).
Timely completion of the Tissue Law
is also very important. Maybe we will go through this law together on March 28-29.

Looking forward to your feedback.

Kind regards,

Natia

On Wednesday, March 17, 2021, 07:26:06 PM GMT+4, Mirela Busic <[email-masked]> wrote:

Thank you, confirmed.

sri, 17. ožu 2021. 12:39 Vakhtang Chkheidze <[email-masked]> je napisao:

Dear Mirela,
Thank you for your email.

I am also available tomorrow at 4 PM your time (7 PM my time).

Talk to you tomorrow.

Kind regards.

Vakhtang

On Wed, 17 Mar 2021, 14:26 Mirela Busic, <[email-masked]> wrote:

Dear  Vakhtang,
happy to do that, I'm available tomorrow at 4 pm my time, 7 pm your time, if convenient  for you?

Mirela

On Wed, Mar 17, 2021 at 10:07 AM Vakhtang Chkheidze <[email-masked]> wrote:

Dear Mirela,

Thank you for sending the draft versions of the RIA documents.

I would like to have an online meeting with you concerning these new documents - just briefly to have a discussion about this matter.

Please inform me - when we can have an online meeting at any convenience for you time? By Zoom or Whatsapp.

Looking forward to hearing from you.

Thank you in advance.

Kind regards.

Vakhtang

On Tue, Mar 16, 2021 at 5:01 PM Mirela Busic <[email-masked]> wrote:

Dear colleagues,
in continuation to our online meetings held to agree on the last version of the laws, please find the draft versions of the RIA documents accompanying the law proposals.

In this stage of finalisations of the Law proposals and RIAs, I suggest a meeting with the beneficiary ( Mrs Tamar, and Mr Anzor)  for consultation on the next steps that entails;

- public consultations (we should agree on date for the launch of public consultation and its operative management)

- organisation and date of the online one-day  workshops to present and discuss the proposed policy with all stakeholders

Meanwhile, I would appreciate your inputs for improvements and completion of the RIA documents (written in a separate documents).

Thank you for your, so far, contribution in the process of finalisation of the new law proposals and initial input for the RIA (Tissues and cells) kindly provided by Vakhtang.

Looking forward to your feedback

Mirela

--

Vakhtang Chkheidze MD, PhD

Mobile: +995 599 57 66 03

E-mail: [email-masked]