Measures to keep trial data in medicine registration confidentiality in Vietnam

Measures to keep trial data in medicine registration confidentiality in Vietnam (Internet image)

Regarding this issue, LawNet would like to answer as follows:

1. Conditions for trial data in medicine registration to be kept confidential in Vietnam

According to Article 6 of Circular 05/2010/TT-BYT, data will be kept confidential when fully satisfying the following conditions:

- They constitute a business secret which satisfies the protection conditions specified in Clause 23. Article 4, and Article 84 of the Law on Intellectual Property.

- They are an outcome of a substantial investment of labor;

- There is a request for confidentiality keeping specified in Clause 1, Article 7 of Circular 05/2010/TT-BYT.

2. Data confidentiality keeping measures in Vietnam

According to  Article 12 of Circular 05/2010/TT-BYT, in case a request for data confidentiality is accepted, the Vietnam Drug Administration shall take the following measures:

(1) Archiving and managing documents showing data requested to be kept confidential under regulations on management of secret documents.

(2) Preventing any third party from accessing confidential data unless the access to these data by a competent management agency aims to verify results of a clinical trial, safety and effect of a medicine or to meet requirements of public health care.

(3) Abstaining from disclosing data, unless the disclosure is necessary to protect the public.

(4) Temporarily refusing to consider and grant permits to medicine-registering establishments that file their registration dossiers later than a dossier with confidential data, in case dossiers of establishments with later application dates refer to data currently kept confidential without the consent of the medicine-registering establishment whose data is kept confidential and establishments with later application dates cannot prove that data referred to in their dossiers are created independently from confidential data.

3. Duration of keeping trial data in medicine registration confidentiality in Vietnam

Specifically, in Article 13 of Circular 05/2010/TT-BYT, the duration of keeping trial data in medicine registration confidentiality is as follows:

- The data confidentiality keeping measures specified in (1), (2) and (3) shall be applied from the date the data are filed to the date the data are disclosed. However, the duration of keeping data confidentiality must not exceed the duration of management of secret documents prescribed in current regulations.

- The data confidentiality keeping measure specified in (4) shall be applied from the date the data are filed to the date of expiration of the 5-year validity of a medicine circulation permit granted to a medicine-registering establishment having confidential data.

4. Cases of termination of keeping of data confidentiality in Vietnam

According to Article 14 of Circular 05/2010/TT-BYT, the keeping of data confidentiality shall be partially or wholly terminated in the following cases:

- Data no longer satisfy the confidentiality keeping conditions specified in Article 6 of this Circular.

- A competent agency has grounds to believe that the medicine-registering establishment having data currently kept confidential has no lawful right to use these data.

- A decision to grant a circulation permit for a medicine with confidential data is no longer valid or the medicine registration number is revoked or the medicine-registering establishment voluntarily requests revocation of the registration number.

- A competent agency issues a decision to compel the licensing of a patent on the medicine with confidential data.

- An agency competent to settle complaints issues a decision to invalidate a decision on acceptance of a data confidentiality keeping request.

- Termination of the keeping of data confidentiality is needed to protect public health and meet the society's urgent needs.

Tran Thanh Rin

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