Dear Tamar,

Following our recent meeting and discussions, I am forwarding you the revised draft of the Law of Georgia on Medicinal Products.

The revision was done by our regional Office staff and an external consultant from UK.

There were significant challenges for them in the process of revision, and namely:

1. Our staff and consultant do not know the structure of legal system/documents in Georgia.
   That’s why they have insisted many times on the presence of MoH lawyers but that did not happen.
   However they had with them an expert from the Ministry of Justice who will be involved in the translation of the draft.
2. Many chapters are too detailed and contain norms of the Law and under-law acts.
   These were reportingly commented by the consultant during his talks with the Agency representatives
3. At that stage the local Georgian experts did not want to name the Agency in the Law.
   Our understanding was the Agency is being organized under the other Law.
   Still, our experts considered the full name and not just generic “Agency” should be mentioned in the Law.
4. In the opinion of our experts the Agency will not be able to timely perform all assessments, evaluations, etc.
   Hence, there will be a need to establish councils and committees. It still remains to be decided who and how will establish/create those and how they will be governed.
5. Independence of the Agency was not clearly defined. Probably at this stage this is not so crucial as the agency will be merged with the National Regulatory Agency.
   Still our experts suggested the following statement to be used, in case possible:
   e.g. ”Employees of the Agency, members of councils, committees and commissions appointed pursuant to this Act and other persons giving advice to the Agency participating in the processing of decisions on authorization, control and monitoring of adverse reactions of medicinal products are not permitted to have any financial or other interest in the pharmaceutical industry that may influence their impartiality.
   The persons specified above must each year make a statement of their financial interests in the pharmaceutical industry.”
6. The sources of funding of the Agency were not clear at that stage.
   Again, this might be a provision in the other Law. However, financial flexibility and sustainability are vitally needed.

They provided also a couple of general comments:

• To use definitions in EU Acquis and/or WHO not extending them to the technical details
• To analyze comments to the law made by WHO staff and consultant with lawyers of the MoH and Ministry of Justice

This being said, we are ready to provide further support in finalizing the law or adapting it to current realities, if needed.

With best regards

Silviu