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MINISTRY OF
HEALTH - MINISTRY OF FINANCE
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SOCIALIST REPUBLIC
OF VIETNAM
Independence - Freedom - Happiness
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No.:
01/2012/TTLT-BYT-BTC
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Hanoi,
January 19, 2012
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JOINT
CIRCULAR
GUIDING
BIDDING OF DRUGS PROCUREMENT IN THE MEDICAL FACILITIES
Pursuant to the Pharmacy Law No.34/2005/QH11
dated 14/6/2005;
Pursuant to the Procurement law
No.61/2005/QH11 dated 29/11/2005; the Law amending and supplementing some
Articles of the Law relating to investment in basic construction No.38/2009/QH12
on 19/6/2009;
Pursuant to the Decree No.79/2006/ND-CP dated
09/8/2006 of the Government detailing the implementation of some Articles of
the Pharmacy Law;
Pursuant to the Decree No.85/2009/ND-CP dated
15/10/2009 of the Government guiding the implementation of the Law on
Procurement and selection of construction contractors under the Construction
Law;
Pursuant to the Decree No.188/2007/ND-CP
dated 27/12/2007 of the Government regulating functions, duties, powers and
organizational structure of Ministry of Health;
Pursuant to the Decree No.118/2008/ND-CP
dated 27/11/2008 of the Government regulating functions, duties, powers and
organizational structure of Ministry of Finance;
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Chapter I
GENERAL
PROVISIONS
Article
1. Scope
of governing
1. This Circular
guides a number of specific contents in the implementation of the bidding of
drugs procurement of the units using funds from the state budget, health
insurance funds and other legitimate sources of revenue for demand of disease
prevention, medical examination and treatment to ensure conformity with the
specific characteristics of the drugs under the provisions of the Pharmacy Law
and documents guiding the Pharmacy Law.
2. Other contents
related to the implementation of the bidding of drugs procurement of the units
using funds from the state budget, health insurance funds and other legitimate
sources of revenue for the demand of disease prevention, medical examination
and treatment that are not be governed by this Circular shall comply with
current provisions of law on procurement.
Article
2. Subjects of application
1. This Circular
shall apply to:
a) The units using
funds from the state budget, health insurance funds, and other legitimate
sources of revenue to purchase drugs for the demand of disease prevention,
medical examination, and treatment.
b) The concerned
agencies and units engaging in the process of bidding of drugs procurement in
accordance with current regulations.
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a) Drugs ordered by
the State made payment by the state budget.
b) Medicinal herbs
and traditional medicine.
c) Blood and blood
products.
Article
3. Interpretation of terms
In this Circular, the
following terms are construed as follows:
1. Original
proprietary-name drugs: mean the drugs that are licensed for the first
circulation, on the basis of full data on quality, safety, and efficiency.
2. Generic Drugs:
mean finished drugs to replace a discovery drug manufactured without a
franchise license of Discovery Company and marketed after the patent and
monopolies have expired.
3. Bioequivalence:
Two drugs are considered as bioequivalence if they are bio-equivalent drugs
manufactured or manufactured substitutes and their bioavailability after taking
the same dose in the same test conditions as similar leading to their treatment
efficacy is considered basically to be equivalent each other.
4. Treatment
equivalence: Two drugs are considered similar treatment if they are drugs
manufactured similarly and after used the same dose, the efficacy of the drug
including effectiveness and safety is basically the same.
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Abbreviations:
- EMA (European
Medicines Agency): The European Drug Administration.
- ICH (International,
Conference on Harmonization): International conference on harmonization of
procedures for registration of pharmaceuticals for human use.
- PIC/S
(Pharmaceutical Inspection Co-operation Scheme): The system of cooperation in
the pharmaceutical inspection.
- WHO (World Health
Organization): The World Health Organization.
- VAT (Value Added
Tax): Value Added Tax.
- HI: Health
insurance.
- SI: Social
Insurance.
- PC: People's
Committee
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SPECIFIC
PROVISIONS
Section
1. Competence in bidding of drugs procurement
Article
4. Competence to approve the bidding plans of drugs procurement
1. Ministers, heads
of ministerial-level agencies, Governmental agencies (referred to as the heads
of the central agencies), Chairmen of People’s Committees of provinces and cities
under central government (referred to as Chairmen of provincial-level People's
Committees) are responsible for approving the bidding plan of drugs procurement
for the public units under their management scope.
2. Chairmen of the
Management Board (for the units with BOM) or heads of non-public units are
responsible for approving the bidding plans of drugs procurement in case of
signing contracts participating in medical examination and treatment of HI with
SI agencies.
Article
5. Competence to approve bidding documents and approve the selection results
for drugs supplier
1. Heads of the
public units are responsible for approving bidding documents and approving the
contractor selection results for drugs provision of their own units.
2. Where organizing
centralized bidding as stipulated in Point a, Clause 3, Article 26 of this
Circular, the Chairmen of provincial-level People's Committees assign the
Directors of Health Departments to perform duty of investors and to be
responsible for approving bidding documents and approving contractor selection
results for drugs provision for the units under its respective management
scope.
3. Heads of the
non-public units signing contracts of medical examination and treatment of HI
with SI agencies taking responsibility for approving bidding documents and
approving contractor selection results for drugs provision of their own units.
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Article
6. Bases for the bidding plan
1. The bidding plan
is established based on:
a) The estimate of
state budget expenditures of the plan year assigned by the State competent
agencies and other legal sources of revenue of the public units.
b) Contracts of
medical examination, treatment of HI between the units and SI agencies.
c) The actual
situation of procurement and use of drugs of the previous year.
d) The expectation of
demand for drugs of the plan year.
Where the units have
not yet been assigned estimates of state budget expenditure of plan year or not
yet signed contracts of medical examination and treatment of HI, the bases for
making the bidding plan must ensure fully 03 remaining bases as provided of in
this Article.
2. The bidding plan
is made at least 01 time/year.
Article
7. Division of bidding package
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1. Drug bidding
packages by generic name.
Drug bidding packages
by generic name may have one or more drugs under generic names. Each drug by
generic name which is divided into groups based on technical criteria and
technology standards is licensed as follows:
a) Group of drugs
produced in the countries participating in EMA, or ICH or PIC/S.
b) Group of drugs
produced in the drug-manufacturing facilities meeting principles, standards of
GMP-WHO as recommended by WHO inspected and issued certificate by the Ministry
of Health of Vietnam (Drug Administration).
c) Group of drugs not
being of the groups mentioned in point a and b of this clause.
d) Where the drugs
produced according to franchising of drug manufacture in Vietnam under the
provisions of law, based on the basis of transferring the right of drug
production to divide this drug into one of the groups of drugs as prescribed at
Point a, b and c, this clause accordingly.
đ) Group of drugs
demonstrated bioequivalence announced by the Health Ministry.
2. Drugs bidding
package by of proprietary- name
If in a year, it
needs to use proprietary-name drugs to serve the needs of special treatment of
the units, based on the consent of the Council of Drug and Treatment of the
units, the units shall make bidding package by proprietary- name drugs. The
drugs that are included in drugs bidding packages by proprietary- name include:
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b) Drugs on the list
of rare drugs issued by the Health Ministry.
3. Oriental drugs
bidding packages or drugs from medicinal herbs.
Article
8. The contents of each bidding package in the bidding plan
1. Name and contents
of bidding package:
a) For the drugs
bidding packages by generic name, contents of the bidding package include names
of active substances, the concentration or content, dosage form, unit, quantity
and planned price including VAT. If the drug is a mixture of many components,
it must inscribe fully the ingredients of drug by generic name.
b) For the bidding
packages by proprietary-name, contents of the package include drug name, names
of active substances, the concentration or content, dosage form, unit, quantity
and planned price including VAT and must be accompanied by the phrase "or
equivalent treatment".
c) For packages of
oriental medicines or drugs from medicinal herbs, the contents of bidding
package include drug name, dosage form, unit, quantity and planned price
included VAT.
2. Price of bidding
packages
a) The bidding
package price is the total value of drugs in the package.
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c) Where maximum
price has not yet been announced, when the bidding plan of drugs procurement,
the units must:
- Refer drug prices
which were won bidding within 12 previous months of the units updated and
published on the website of the Drug Administration by the Ministry of Health
(Drug Administration) (address: http:// www.dav.gov.vn) for used as a basis for
setting up plan of each drug.
- For the drugs that
have not got price won the bidding or planned price higher than drug price won
the bidding announced by the Ministry of Health within the previous 12 months,
the unit must refer the quotation, or sale invoices of at least 03 drugs suppliers
on the market at the time of setting up the bidding plans; at the same time
ensure the planned price of drugs in the bidding plan does not exceed the
wholesale price declared, re-declared that is still valid of the drugs being
referred.
- The drug items
having few suppliers, having inadequate 03 quotations, or sale invoices, heads
of the units based on the quotations, or sale invoices of the suppliers of
those drugs, explanation on the planned prices of drugs proposed by the units
that were consistent with prices of those drugs on the market at the time of
setting up bidding plan.
3. Capital.
The units must
specify funds used to pay for drugs in the bidding plan.
4. Contractor
selection forms
The bidding for drugs
as prescribed in this Circular is applied the form of open bidding in the
country, in terms of goods. In case of using other forms of bidding, it should
clearly explain for the competent persons to consider and decide.
5. Method of bidding
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6. Time for
organizing selection of contractors for each bidding package shall comply with
the provisions of the law on procurement.
7. Form of contract
shall comply with the provisions of the law on procurement and economic
contract.
Article
9. Submission for approving the bidding plans
1. Responsibility for
submission for approval:
Units’ heads shall
submit 01 set of dossier for approving bidding plans (the original) to
competent person as defined in Article 4 of this Circular for consideration and
approval of bidding plans of drugs procurement and send 01 set of dossier for
approving bidding plans of drugs procurement (original) to the agencies or
organizations in charge of appraisal as prescribed in Clause 1, Article 10 of
this Circular. Dossier may be sent by mail or sent directly through archives of
the agencies to manage under the current regulations.
2. Dossier submitted
for approving bidding plan includes:
a) Documents
submitted for approval
- An application for
approval of bidding plan of drugs procurement with full contents specified in
Article 8 of this Circular and the total value of the bidding packages in the
bidding plan submitted for approval by the unit.
- The brief report on
results of implementing drug procurement bidding plan of the preceding year and
briefly explaining the drug procurement bidding plan which is being submitted
for approval. When the number and value of drugs have changed compared to the
preceding year, the unit needs an explanation.
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- The documents used
as a basis for planning drug procurement bidding provided for in Article 6 of
this Circular.
- Minutes of meetings
of the Council of drugs and treatment of the units on the bidding plan of
proprietary-name drugs procurement within year as prescribed in Clause 2,
Article 7 of this Circular.
- The decision to
approve the list, quantity, and planned price of each drug item in each bidding
package of the unit head.
Article
10. Appraisal of the bidding plans
Drug procurement
bidding plans must be evaluated before submitted to the competent persons for
consideration and approval.
1. Agencies,
organizations of appraisal
a) For the central
public units: the heads of the central agencies shall decide the agencies,
organizations to evaluate the drugs procurement bidding plans.
b) For the local
public units (including the case of centralized bidding organization in the
Departments of Health under the provisions at Point a, Clause
3, Article 26 of this
Circular): Chairmen of the PPC decide to assign the Departments of Health to
preside over and coordinate with the concerned agencies in the localities for
evaluating the drugs procurement bidding plans.
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2. The duties of the
appraisal agencies, organizations
a) The appraisal
agencies or organizations are responsible for inspection and evaluation of the
contents specified in Article 6, Article 7, Article 8 and Article 9 of this
Circular within a period of not exceeding 10 working days from the date of
receiving all the concerned documents. In case of insufficient documentation in
accordance with provisions, the appraisal agencies or organizations are
responsible for guiding the supplementation of documents and returning dossier
for the unit within 5 working days from the date of receiving the documents.
b) Agencies or
organizations appraising the drug procurement bidding plan must make report on
the appraisal results on the basis of compliance with the provisions in Article
65 of the Procurement law, together with 01 set of the dossier submitted for
approval of bidding plan of the appraised unit (copies) to the competent
persons defined in Article 4 of this Circular for consideration and approval of
drugs procurement bidding plan within 03 working days from the date of
completion of the inspection and evaluation prescribed at Point a, Clause 2 of
this Article. Documents submitted for approval are sent by mail or sent
directly through the archives of agency of the competent persons to approve
bidding plan for management under current regulations.
Article
11. Approval of the bidding plans
Competent persons to
approve drugs procurement bidding plans provided for in Article 4 of this
Circular shall have approved the drugs procurement bidding plans for a period
of not exceeding 05 working days after receiving complete appraisal reports of
the agencies and organizations in charge of appraisal.
Section
3. The bidding documents
Article
12. Establishment of bidding documents.
Dossier for invitation
for drugs bid is built under the provisions of the Procurement law, the written
guidance of the current Law and guidance of the Ministry of Health on the
establishment of dossier for invitation for drugs bid in the health facilities.
1. Responsibility for
submission for approval
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2. Contents of
bidding documents
To comply with
current regulations and guidance on bidding documents for procurement of goods,
the provisions in Article 7 and Article 8 of this Circular and guidance of the
Ministry of Health; to comply with the provisions of Clause 72, Section I, Part
I of plan to simplify the administrative procedures under the management functions
of the Health Ministry issued together with the Resolution No.62/NQ-CP dated
17/12/2010 of the Government, specifically bidding documents may not be
required or forced the contractors to submit the papers, or meet conditions as
follows:
a) Certificate of
Pharmaceutical Product (CPP);
b) Certificate of
Good Manufacture Practice (GMP);
c) Certificate of
origin of raw materials, materials standards, notarized license for
distribution of products in Vietnam;
d) The quality
standards and methods of testing of finished drugs;
đ) Drugs’
registration number is required to be valid for more than 06 months.
Article
13. Appraisal of bidding documents
1. Dossier for
invitation for drugs procurement bid must be evaluated before submitted to the
competent persons for consideration and approval.
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3. The obligations of
the appraisal agencies, organizations
a) The appraisal
agencies, organizations are responsible for inspecting and evaluating the
contents of bidding documents in accordance with the Procurement Law, the
current guidelines on procurement and other regulations in this Circular for a
period of not more than 10 working days from receipt of all concerned
documents.
b) Agency,
organization evaluating bidding documents shall prepare a report of the result
of appraising bidding documents as prescribed by current law on procurement,
together with 01 set of bidding documents (copy) to submit to the unit head for
review and approval of bidding documents within 03 working days from the date
of completion of the inspection and evaluation as prescribed at Point a, Clause
3 of this Article. Documents submitted for approval are sent by mail or sent
directly through the agency achieves of persons competent to approve bidding
plan for management under current regulations.
Article
14. Approval of bidding documents
The unit heads are
responsible for approving bidding documents for a period of not more than 05
working days after receiving the full evaluation reports of the agencies or
organizations presiding over the evaluation of bidding documents.
Section
4. Contractor selection results
Article
15. Evaluation of bids
The bidders submit 03
sets of bids (01 original and 02 copies) to invite tendering party. Method of
submitting documents and period of validity of the documents shall be specified
by the invite tendering party on the basis of the provisions of Procurement
Law. The invite tendering party evaluates the bids by each item in each
package, in compliance with the provisions of the Procurement law, the law
guiding documents, and guidelines of the Ministry of Health.
Article
16. Review and approval for winning bid
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2. For drugs bidding
packages by generic name: Each group of drugs under generic name specified in
clause 1 of Article 7 of this Circular is considered for bid winning only 01
type of drug meeting the technical requirements and quality specified in the
bidding documents and with bid price evaluated as lowest in the group of drugs.
3. For drugs bidding
packages under the proprietary name and oriental-drug bidding packages or drugs
from the pharmaceutical herbs: Each drug shall be considered bid winning only
01 type of drug with bid price evaluated as lowest in the items meeting the
technical requirements and quality specified in the bidding documents
4. Giving priority
winning selection of drugs produced domestically with similar quality and price
not higher than drugs imported at the time of bidding.
Article
17. Submission for approval of contractor selection results
1. Responsibility for
submission for approval
Agencies,
organizations assigned by heads of the units the task of bidding organization
shall review and approve the bid winning and report the results of selection of
contractors to unit heads, and send to the agencies and organizations in charge
of evaluating the results of selection of contractor stipulated in Clause 1,
Article 18 of this Circular 01 set of dossier submitted for approval of
contractor selection result within 45 days after bid opening is made.
2. Dossier submitted
for approval of contractor selection results
a) 01 original of
report on the evaluation of bids and proposals for bid winning
b) 01 set of bidding
documents (copies) that has been evaluated and approved as prescribed in
Articles 12, 13, 14, 15 and 16 of this Circular and the current provisions of
law on procurement.
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Article
18. Appraisal of results of contractor selection
1. Agencies,
organizations appraising the contractor selection results shall be decided by
the unit head.
2. The tasks of the
appraisal agencies, organizations
The appraisal agency
or organization is responsible for the inspection, evaluation, and compilation
of report of contractors selection results under the provisions of this
Circular and the current provisions of law on procurement within a period of
not exceeding 15 working days from the date of receipt of all relevant
documents to submit to the unit head for review and approval of contractor
selection result.
3. Dossiers submitted
for approval of contractor selection results includes:
a) 01 original of
report on contractor selection result.
b) 01 set of dossier
submitted for approval of contractor selection result (copy) of the agency or
organization assigned the task of organizing the bidding prescribed in Clause
2, Article 17 of this Circular.
Dossiers submitted
for approval of contractor selection results is sent by mail or sent directly
through achieves of agencies and organizations in charge of evaluating results
of selection of contractors for management under the current regulations.
Article
19. Approval and notification of results of contractor selection
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2. Unit head shall
notify the contractor selection results under the current provisions of law on
procurement.
Article
20. Bid winning drug prices
1. Bid winning price
of each drug item is not be higher than price of such drug item in the
bidding plan that has been approved by competent authority.
2. When there is any
drug item in the drug bidding package that bid prices of all bidders are higher
than the planned price of the drug item that has been approved by competent
authority, head of unit shall notify in writing that there is no winning bidder
and cancel the bidding of such drug item to make a re-selection of contractor
under the current provisions of law on procurement.
Where necessary, it
must ensure adequate drugs to meet the needs of medical examination and
treatment of units, the unit heads (or the Directors of Health Departments in
case the Departments of Health organize the centralized bidding) are considered
and decided the selection of drugs won bidding on the basis of the written
requests of the Council of Drug and Treatment of the units (or agencies or
organizations presiding over the evaluation of the bidding results in the case
Departments of Health organize the centralized bidding) if it satisfies
sufficiently the following conditions:
a) Prices of drugs
approved for bid winning do not exceed the maximum prices of those drugs
published by the Ministry of Health at the nearest time. In the case of maximum
prices have not yet been announced, the prices of drugs approved for bid
winning shall not exceed the wholesale price declared, re-declared which are
still valid of those drugs.
b) The total value of
drugs won biding shall not exceed the price of drugs bidding package approved
by the competent authority in the bidding plan.
Section
5. Other provisions
Article
21. Report on the results of contractor selection
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2. The hospitals,
institutes with hospital beds under the Ministry of Health, provincial-level
hospitals and non-public units contracted medical examination, treatment of HI
send the reports on contractor selection results by form in the annex enclosed
with this Circular to the Ministry of Health (Drug Administration) to be posted
on the website of the Drug Administration for used as a basis for reference to
make the planned price. Report sending forms: Written or electronic mail
(address: [email protected]).
Article
22. Costs in bidding
To comply with the
current provisions of the Procurement law and documents guiding the current
law.
Article
23. In case of the application of other forms of contractor selection
In special cases, to
avoid drug shortages affecting professional activities, the units may apply
other method of selecting contractors to purchase limited amount of drug,
specifically as follows:
1. The cases of drugs
procurement are applied another form of the contractor selection
a) Drugs on the list
of rare drugs arising unexpectedly according to demand of special treatment
issued by the Health Ministry not been yet included in the bidding plans.
b) The drugs which
have not included in the list of drugs under the bidding plan of drugs
procurement in year approved by the competent authorities to meet the need of
professional activities in case of emergency, such as epidemics, natural
disasters, and serious affect on damage the health of patients.
c) The drugs which
have included in the list of drugs under the bidding plan of drugs procurement
in year approved by the competent authorities, but have not yet got the bidding
results or it fails to select the bid winners, and needed to buy urgently to
meet demand of professional activities in case of urgency.
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2. Requirements as
procurement
a) Councils of Drug
and Treatment of the units consider and recommend in writing to the heads of
the units.
b) The drugs that are
permitted for circulation in Vietnam and meeting the requirements of quality,
expiry under the current regulations.
c) On the purchase
price of drugs: The units must refer 03 quotations, or sale invoices of
suppliers, wholesale price declared, re-declared and refer the prices published
on the website of the Drug Administration as basis for consideration and
signing contracts with suppliers.
3. When buying drugs
in the above cases, the unit heads decide the form of procurement in accordance
with the current provisions of law on procurement.
Article
24. Examination, inspection and handling of violations
The examination,
inspection and handling of violations shall comply with current regulations of
the Procurement law.
During the
examination, inspection, if detecting violations of the law, depending on the
nature and extent of violations, it shall handle according to the current
provisions of the Procurement law and the provisions of the Law on Inspection.
Chapter
III
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Article
25. Effect
1. This Circular
takes effect as from June 01, 2012.
2. To annul the Joint
Circular No.10/2007/TTLT-BYT-BTC dated 10/08/2007 of joint Ministries of Health
- Finance guiding the implementation of drug procurement in the public health
facilities.
Article
26. Organization of implementation
1. The Health
Ministry is responsible for announcing the list of countries participating in
EMA, ICH, PIC/S, the drug manufacturing facilities meeting the principles,
standards of GMP-WHO as recommended by the WHO and inspected, issued
certificates by the Ministry of Health of Vietnam (Drug Administration); the
list of original proprietary-name drugs, drug with equivalent treatment with
original proprietary-name drugs; the list of drugs documented bioequivalence.
2. The heads of the
central agencies direct the subordinate units to perform drug procurement in
accordance with provisions on this Circular and the current provisions of law
on procurement.
3. Chairmen of
provincial-level People's Committees shall decide on the bidding of drugs
procurement at the subordinate units under one of the following specific forms:
a) To assign the
Department of Health to organize the centralized bidding for the subordinate
units. The units based on the notification of winning result from the Health
Department to negotiate and conclude contracts for the drugs supply under
current provisions.
b) To direct the
subordinate units and non-public units contracted medical examination,
treatment of HI with the SI agencies in the province to apply the results of
contractor selection of provincial-level general hospitals that were approved
by the competent authorities to buy drugs in the form of direct procurement in
accordance with current provisions of legislation on procurement.
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4. The SI agencies
participate in the Councils appraising the bidding plans, bid evaluation team
and in the evaluation of the results of the contractor selection of the bidding
units of drugs procurement from health insurance funds as designated by the
General Director of Social Insurance Vietnam.
5. For the bidding
packages submitted for approval of the bidding plan before the effective date
of this Circular, shall comply with the provisions of the Procurement Law, the
Law amending and supplementing some Articles of the Law relating to investment
in basic construction, Decree No.85/2009/ND-CP dated 15/10/2009 of the
Government; Pharmacy Law dated 14/6/2005 and Decree No.79/2006/ND - CP dated
09/8/2006 of Government; the provisions of Circular No.10/2007/TTLT-BYT-BTC
dated 08/10/2007 of the joint Ministries of Health - Finance guiding the
implementation of drug procurement in the public health facilities to ensure
compliance with the provisions of the Procurement law and documents guiding the
Law on Procurement.
During the
implementation, if any problem arises, the concerned units should reflect to
the Ministry of Health - Ministry of Finance for study and settlement./.
FOR MINISTER OF
FINANCE
DEPUTY MINISTER
Nguyen Thi Minh
FOR MINISTER OF
HEALTH
DEPUTY MINISTER
Nguyen Thi Xuyen
APPENDIX
1
FORM
OF REPORT ON SELECTION RESULT OF DRUGS SUPPLIER
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No.: ........
- Address:
- Tel:
- Fax:
SOCIALIST REPUBLIC
OF VIETNAM
Independence - Freedom - Happiness
---------------------------------------
Hanoi,
date month 20...
REPORT ON
DRUG PRICES WON BID OF YEAR ...
To: Drug
Administration – Ministry of Health.
138A - Giang Vo, Ba Dinh, Ha Noi.
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No.
Name of
active stubstances
(only
record Name
of active stubstances)
Concentration,
content
Drugs’
names
Registration
number or number of import license
Names
of manufaturers
Manufacturing
countries
Packing
standard
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Quantity
Unit
price (included VAT)
(in the
smallest unit)
Amount
Bider
won the bid
1
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(Signature, stamp)