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THE
MINISTRY OF HEALTH
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SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
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No.
05/2010/TT-BYT
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Hanoi,
March 01, 2010
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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.
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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.
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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;
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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:
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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
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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.
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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.
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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
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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
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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.-
FOR
THE MINISTER OF HEALTH
DEPUTY MINISTER
Cao Minh Quang