Subject: Re: RIA Reports (ORGANS, TISSUES and CELLS)
From: Mirela Busic <[email-masked]>
To: Achi Zangurashvili <[email-masked]>
Cc: Anzor tchavtchavadze <[email-masked]>, "KOCHISHVILI Nika (EEAS-TBILISI)" <[email-masked]>, Laura Carrasco Macia <[email-masked]>, Natia Nogaideli <[email-masked]>, Tamar Gabunia <[email-masked]>, Vakhtang Chkheidze <[email-masked]>, "[email-masked]" <[email-masked]>
Date: Tue, 06 Apr 2021 10:00:34 +0000

Dear Archi,
thank you for your expert opinion. I would like just to clarify what chapters in the TISSUE Bill (Law) you are referring to.

I assume that you are referring to the provisions of the licensing and the Competent Authority(ies) .  Yes,  we have discussed and generally agreed on the provisions on the competent authority (es) and licencing criteria to be upgraded taking into account requirements of your existing legal/normative practise.

Kind regards

Mirela

On Mon, Apr 5, 2021 at 6:55 AM Achi Zangurashvili <[email-masked]> wrote:

Dear Mirela,

I would like to comment on your opinion on chapters V and VI of the tissues draft law. During our last meeting I did not deliberately talk about this issue because Natia had a principled opinion on this issue which she was going to share for you.

One thing I can say unequivocally is that these chapters and the articles included in them should be refined in terms of legal technique.

As for the existence of these chapters at the legislative level. According to Georgian legislation, we do not have a system of annexes, such as those in EU acts, that could regulate such issues. An alternative to annexes with us practically are by-laws. Such issues, as defined in Chapters V and VI of the draft law, are usually defined in our by-laws (And that does not completely diminish the importance of these issues).

However, this is not a requirement of any law of Georgia, it is a practical system of legislation established in Georgia. Our legislation defines only those issues that must be defined by law, in other cases a dispositional approach is provided and must be resolved as a result of the evaluation of each specific issue.

I think that in terms of flexibility in enforcing the normative act, it would be better if the above issues will be resolved by by-laws, however, as you mentioned, we can discuss about this issue as well as with the Ministry and experts of medicine as to whether it is appropriate to regulate such issues at the law level.

With regards,

Achi

On Fri, Apr 2, 2021 at 3:22 PM Mirela Busic <[email-masked]> 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]

--

Archil Zangurashvili

Lawyer. Legal Expert

M: 577-12-77-71

20% of Georgia is occupied by Russia.

--

Archil Zangurashvili

Lawyer. Legal Expert

M: 577-12-77-71

20% of Georgia is occupied by Russia.