Thông tư 05/2010/TT-BYT hướng dẫn bảo mật dữ liệu thử nghiệm trong đăng ký thuốc do Bộ Y tế ban hành

CIRCULAR

GUIDING THE KEEPING OF CONFIDENTIALITY OF TRIAL DATA IN MEDICINE REGISTRATION

THE MINISTRY OF HEALTH

Pursuant to June 14, 2005 Law No. 34/2005/ QH11 on Pharmacy;
Pursuant to November 29, 2005 Law No. 50/2005/QH11 on Intellectual Property, which was amended and supplemented by June 19, 2009 Law No. 36/2009/QH12 Amending and Supplementing a Number of Articles of the Law on Intellectual Property;
Pursuant to the Government's Decree No. 188/2007/ND-CP of December 27, 2007, defining the functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to the Government's Decree No. 103/2006/ND-CP of September 22, 2006, detailing and guiding the implementation of a number of articles of the Law on Intellectual Property on industrial property;
The Ministry of Health guides the keeping of confidentiality of trial data in medicine registration as follows:

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

1. This Circular guides the request and procedures for keeping confidentiality of trial data in medicine registration.

2. This Circular applies only to finished medicine products containing new active ingredients and does not apply to medicine materials.

Article 2. Subjects of application

This Circular is applicable to Vietnamese and foreign organizations and individuals that conduct medicine registration related activities in Vietnam.

Article 3. Interpretation of terms

In this Circular, the following terms and expressions are construed as follows:

1. Medicine means a substance or mixture of substances for human use for disease prevention, treatment or diagnosis or adjustment of physiological functions of human body, including finished medicine products, medicine materials, vaccines and medical biologicals other than functional foods.

2. Active ingredient (also pharmaceutical active ingredient or pharmakon) means a substance or mixture of substance of substances having a therapeutic activity and used in medicine manufacture.

3. New active ingredient means an active ingredient which has never been permitted for circulation in Vietnam and not yet permitted for circulation in anywhere else in the world for 12 months counting back from the date of filing the application for registration of a medicine containing such ingredient in Vietnam.

4. Keeping confidentiality of data and trial data (below collectively referred to as keeping data confidentiality) means keeping confidentiality of pharmaceutical trial data in the process of medicine registration specified in Article 128 of the Law on Intellectual Property and Article 20 of the Government's Decree No. 103/2006/ND-CP of September 22, 2006, detailing and guiding the implementation of a number of articles of the Law on Intellectual Property on industrial property.

5. Circular on medicine registration means the Minister of Health's Circular No. 22/2009/ TT-BYT of November 24, 2009, on medicine registration.

Article 4. Responsibility to keep data confidentiality

The Vietnam Drug Administration is the agency responsible for keeping data confidentiality in medicine registration under this Circular.

Chapter II

CONDITIONS ON KEEPING DATA CONFIDENTIALITY

Article 5. Data to be kept confidential

Data to be kept confidential include data of clinical trials of medicines containing new active ingredients provided by medicine-registering establishments in medicine registration dossiers (for use in proving the safety and desired effects of medicines under the Circular on medicine registration) and satisfying the conditions specified in Article 6 of this Circular.

Article 6. Conditions for data to be kept confidential

Data will be kept confidential when fully satisfying the following conditions:

1. 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.

2. They are an outcome of a substantial investment of labor;

3. There is a request for confidentiality keeping specified in Clause 1, Article 7 of this Circular.

Chapter III

CONDITIONS FOR AND ORDER OF RECEIVING MEDICINE REGISTRATION DOSSIERS SUBJECT TO DATA CONFIDENTIALITY KEEPING REQUESTS

Article 7. Conditions for receiving medicine registration dossiers subject to data confidentiality keeping requests

1. Apart from satisfying the general requirements on dossiers specified in the Circular on medicine registration, a medicine registration dossier subject to a data confidentiality keeping request must also contain at least the following documents:

a/ An application for medicine registration, made according to a set form provided in the Circular on medicine registration (not printed herein), in which the medicine-registering establishment shall express its data confidentiality keeping request by ticking in an appropriate box for such request and enumerate documents showing data requested to be kept confidential;

b/ Documents showing data requested to be kept confidential, which must be presented as clinical reports as prescribed in the Circular on medicine registration.

2. All the above documents must be appended with a "confidential" stamp, enveloped in a separate package, which is sealed and appended with a "confidential" stamp.

Article 8. Order of receiving medicine registration dossiers subject to data confidentiality keeping requests

A medicine registration dossier subject to a data confidentiality keeping request shall be received by the Vietnam Drug Administration in the following order:

1. Identifying contents of data requested to be kept confidential indicated in the medicine registration dossier under Clause 1, Article 7 of this Circular.

2. Checking the appearance of the confidential document package before breaking the seal and checking the format of documents contained therein under Point b. Clause 1, Article 7 of this Circular.

3. Comparing documents contained in the confidential document package against documents listed in the data confidentiality keeping request.

4. Recording the data confidentiality keeping request in the register of received dossiers and dossier receipts, and at the same time re-sealing the confidential document package, for dossiers satisfying the conditions specified in Article 7 of this Circular. If medicine registration dossiers subject to data confidentiality keeping requests fail to satisfy the conditions specified in Article 7 of this Circular, the Vietnam Drug Administration shall receive only medicine registration dossiers of registering establishments that withdraw their data confidentiality keeping requests.

Chapter IV

KEEPING OF DATA CONFIDENTIALITY

Article 9. Acceptance of data confidentiality keeping requests

1. For accepted medicine registration dossiers subject to data confidentiality keeping requests (except for those specified in Article 10 of this Circular), the Vietnam Drug Administration shall also accept data confidentiality keeping requests and take confidentiality-keeping measures specified in Article 12 of this Circular.

2. Decisions on acceptance of data confidentiality keeping requests shall be notified by the Vietnam Drug Administration to medicine-registering establishments and published on the Vietnam Drug Administration's website together with notices of decisions on grant of medicine circulation registration numbers.

Article 10. Refusal to keep data confidentiality

1. In the following cases, the Vietnam Drug Administration shall refuse to keep data confidentiality:

a/ Data requested to be kept confidential are not those specified in Article 5 of this Circular;

b/ Medicine in the medicine registration dossier subject to data confidentiality keeping request is not permitted for circulation in Vietnam:

c/ There is a ground to believe that the data requested to be kept confidential fail to satisfy at least one of the confidentiality keeping conditions specified in Article 6 of this Circular;

d/ Keeping data confidentiality might cause serious impacts on human health.

2. Notices of refusal to keep data confidentiality shall be sent by the Vietnam Drug Administration to medicine-registering establishments together with notices of decisions to grant or on refusal to grant medicine circulation registration numbers, clearly stating the reasons for refusal.

Article 11. Opinions of a third party on keeping data confidentiality

1. From the date a decision on acceptance of a data confidentiality keeping request is announced, all organizations and individuals may request the Vietnam Drug Administration to terminate the keeping of data confidentiality under Article 14 of this Circular.

2. A request for termination of the keeping of data confidentiality must be made in writing, according to a set form provided in this Circular (not printed herein), and enclosed with documents or quotations of information sources to support the request.

3. Within 15 working days after receiving a request for termination of the keeping of data confidentiality, the Vietnam Drug Administration shall notify such in writing to the medicine-registering establishment whose data are kept confidential. Within 3 working months after the Vietnam Drug Administration signs a written notice, the medicine-registering establishment shall send a written reply to explain the reason(s) for keeping, and supply necessary documents and evidence as requested in the notice.

4. Based on results of consideration of a request for termination of the keeping of data confidentiality and opinions of concerned parties, if finding such a request well-grounded, the Vietnam Drug Administration shall issue a decision to terminate the keeping of data confidentiality and post such decision on its website; or issue a decision on refusal to terminate the keeping of data confidentiality and notify such to organizations/individuals that request the termination if finding the such request groundless.

Article 12. Data confidentiality keeping measures

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.

Article 13. Duration of keeping data confidentiality

1. The data confidentiality keeping measures specified in Clauses 1,2 and 3 of Article 12 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.

2. The data confidentiality keeping measure specified in Clause 4, Article 12 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.

Article 14. Termination of keeping of data confidentiality

The keeping of data confidentiality shall be partially or wholly terminated in the following cases:

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

2. 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.

3. 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.

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

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

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

Chapter V

RIGHTS AND OBLIGATIONS OF ESTABLISHMENTS HAVING CONFIDENTIAL DATA

Article 15. Rights of establishments having confidential data

A medicine-registering establishment having confidential data has the following rights:

1. To prevent other medicine-registering establishments from using confidential data for unhealthy commercial purposes, including illegal use of data for filing medicine registration applications.

2. To lodge a complaint with the Vietnam Drug Administration on suspicion of a disclosure or illegal use of confidential data for filing a medicine registration application.

Article 16. Obligations of medicine-registering establishments having confidential data

A medicine-registering establishment having confidential data has the following obligations:

1. To prove its holding of the right to the data and that the data fully satisfy the conditions to be kept confidential at the request of the Vietnam Drug Administration in the case specified in Clause 3. Article 11 of this Circular.

2. To evidence the disclosure and/or illegal use of confidential data for unhealthy commercial purposes in case it exercises its rights provided in Article 15 of this Circular.

Chapter VI

ORGANIZATION OF IMPLEMENTATION

Article 17. Effect

1. This Circular takes effect 45 days from the date of its signing.

2. This Circular replaces the Minister of Health's Decision No. 30/2006/QD-BYT of September 30, 2006, promulgating the Regulation on keeping confidentiality of data in medicine registration dossiers. Dossiers subject to data confidentiality keeping requests filed with the Vietnam Drug Administration before the effective date of this Circular shall be examined and examination results shall be notified under the said Regulation.

3. Any problems arising in the course of implementation should be promptly reported to the Ministry of Health (the Vietnam Drug Administration) for consideration and settlement.-