Dear Daumantas,

I would like to share some opinions about the project you have sent:

1. According to Article 42, paragraph 1, sub-paragraph "d" of the draft, "The Government of Georgia shall before 1 July 2021... adopt resolution on transitional regulations of the law of Georgia on the quality and safety of human blood components, during two months after the adoption of this law".

With regard to this norm, I would like to say that we cannot determine the transitional provisions of the law by a government decree. According to Article 16, Paragraph 4 of the Law of Georgia "On Normative Acts", transitional provisions shall be defined by a normative act when norms different from basic norms are determined for a specific period of time or when certain conditions and period of time is required for the normative act to take full effect.

Thus, I do not consider it expedient to write such a general norm (article 42.1."d" of the draft of law) in the law (in the transitional provisions). We need to write the specific issues (different the basics) in the transitional provisions of the law which is necessary to temporarily regulated and then we can impose obligation on government to temporarily regulate some issues. At the same time, the law may require the government to take certain measures to enforce the law.

2. I think it is possible to remove Articles 35 and 36 from the draft law and regulate the relevant issues under Articles 361, 442 and 445 of the Code of Administrative Offenses of Georgia.

(Article 361 - Administrative liability for violation of licence or permit conditions

1. Failure of a licence or permit holder to fulfil licence or permit conditions within the period fixed after the imposition of an administrative penalty shall result in tripling the imposed fine according to the rule laid down by the Law of Georgia on Licences and Permits.

2. If a licence or permit holder fails to fulfil the licence or permit conditions after the expiry of the period fixed after the imposition of a tripled fine, the imposed fine shall be tripled according to the rule laid down by the Law of Georgia on Licences and Permits.

Article 442 - Unlawful medical practice

1. Medical activities conducted without a permit –

shall carry a fine of not more than GEL 10 000.

2. Medical care activities conducted without a licence –

shall carry a fine of not more than GEL 5 000.

3. Medical practice without a state certificate –

shall carry a fine of not more than GEL 1 000.

4. An act indicated in paragraph 1 or 2 of this article committed repeatedly –

shall carry a fine double the amount of the fine imposed for the administrative offence committed for the first time.

 

Article 445 - Non-compliance with a medical care licence and permit conditions

1. Non-fulfilment of medical care licence conditions –

shall carry a fine according to the violation of the licence conditions, but not more than GEL 5 000.

2. Non-fulfilment of medical care permit conditions –

shall carry a fine according to the violation of the permit conditions, but not more than GEL 10 000.)

3. Paragraph 9 of Article 13 of the draft law needs legal refinement. In particular, the reference norm about the Law on Licenses and Permits is not correct in this case, as this article establishes the grounds for refusing to issue a license to operate and not for revoking an already issued license basics. Issues related to license revocation are established in other articles of Georgian law "On licenses and permits" (chapter V).

I will review all the articles in the coming days and provide you with additional opinions in case of need.

With regards,