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MINISTRY OF HEALTH
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SOCIAL REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 15/2019/TT-BYT
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Hanoi, July 11, 2019
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CIRCULAR
ON BIDDING FOR SUPPLY OF DRUGS FOR PUBLIC
HEALTH FACILITIES
Pursuant to Law
on Bidding dated November 26, 2013;
Pursuant to Law
on Pharmacy dated April 06, 2016;
Pursuant to
Decree No. 63/2014/ND-CP dated June 26, 2014 on guidelines for some articles on
contractor selection of Law on Bidding;
Pursuant to
Decree No. 54/2017/ND-CP dated May 8, 2017 on guidelines for some articles and
implementation of Law on Pharmacy;
Pursuant to
Decree No. 75/2017/ND-CP dated June 20, 2017 on functions, tasks, powers and
organizational structure of the Ministry of Health;
At the request
of Director of the Drug Administration, Director of the Planning and Finance
Department;
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Chapter I
GENERAL PROVISIONS
Article 1. Scope
1. This Circular provides guidance on bidding for supply of drugs
(modern medicines, herbal medicines, traditional medicines, vaccines and
biological medical products) and herbal ingredients for public health
facilities, including: the division of contract packages and drug groups; prepares
plans, forms, methods and organizes selection of drug suppliers; provides
guidance on centralized procurement and price negotiation using state capital,
health insurance fund, proceeds from medical examination and treatment services
and other lawful sources of income of public health facilities.
2. The procurement of drugs by drug retailers within the premises of
public health facilities shall comply with the provisions specified in Clause
76, Article 5 of Decree No. 155/2018/ND-CP dated November 12, 2018 amending a
number of provisions on business investment conditions under the state
management scope of the Ministry of Health. In case the health facility
organizes the bidding for supply of drugs for the drug retailers within their
premises, the guidance in this Circular shall be applied.
3. The procurement of medicines under orders and plans of the State
shall follow the Decree No. 32/2019/ND-CP dated April 10, 2019 on task
assignment, ordering or bidding for supplying products and public services
using state budget sources.
4. The procurement of medicines for use in military health facilities
shall comply with the guidance of the Ministry of Defense and the Ministry of
Public Security.
5. The procurement of medical oxygen, nitrite oxide (NO) and in vitro
diagnostic reagents shall comply with the Circular No. 58/2016/TT-BTC dated
March 29, 2016 of the Minister of Finance on using state capital to procure and
maintain regular operation of regulatory authorities, units of the people's
armed forces, public service providers, political organizations,
socio-political organizations, socio-political-professional organizations,
social organizations, socio-professional organizations.
6. The procurement of whole blood, qualified blood preparations shall
comply with Circular No. 05/2017/TT-BYT of April 14, 2017 of the Minister of
Health on maximum prices and cost of pricing a unit of whole blood or blood
qualified preparation, and Circular No. 20/2018/TT-BYT dated August 30, 2018 of
the Minister of Health amending some articles of the Ministry's Circular No.
05/2017/TT-BYT dated April 14, 2017 on maximum prices and cost of pricing a
unit of whole blood or blood qualified preparation.
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Other contents
relating to preparation of demand plans; signing contract with suppliers;
management of use, advance, payment for ARVs; regulations, funding sources and
methods of cost support as well as payment for ARVs to HIV-infected people with
health insurance cards shall comply with Circular No. 28/2017/TT-BYT dated June
28, 2017 of the Ministry of Health on management of ARVs funded by health
insurance fund and cost support as well as payment for ARVs to HIV-infected
people with health insurance cards and Circular No. 08/2018/TT-BYT dated April
18, 2018 amending a number of articles of Circular No. 28/2017/TT-BYT dated
June 28, 2017 on management of ARVs funded by health insurance fund and cost
support as well as payment for ARVs to HIV-infected people with health
insurance cards.
Article 2. Regulated entities
1. This Circular applies to organizations and individuals participating
or involved in bidding for supply of drugs.
2. State-invested health facilities operated under Law on Enterprises
shall follow the provisions of this Circular.
3. Private health facilities participating in provision of medical
examination and treatment services covered by health insurance shall follow
Article 52 of Law on Bidding and the provisions of Clause 7, Article 50 of this
Circular.
Article 3. Definitions
For the purposes
of this Circular; the terms below shall be construed as follows:
1. SRA (Stringent Regulatory Authorities) refers to drug administration
specified in Clause 10 Article 2 of Circular No. 32/2018/TT-BYT dated November
12, 2018 on marketing authorization of drugs and medicinal ingredients.
2. Reference authority refers to drug administration specified in
Clause 9 Article 2 of Circular No. 32/2018/TT-BYT dated November 12, 2018 on
marketing authorization of drugs and medicinal ingredients.
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4. PIC/s (Pharmaceutical Inspection Co-operation Scheme) stands for
Pharmaceutical Inspection Co-operation Scheme.
5. GMP requirements refer to good manufacturing practices for
pharmaceutical products.
6. GACP requirements refer to good agricultural and collection
practices for herbal ingredients.
7. A drug manufacturing line fulfilling EU-GMP requirements refers to a
drug manufacturing line granted EU-GMP certificate by a competent authority of
a country that is a member state of EMA (European Medicines Agency).
8. A drug manufacturing line fulfilling the requirements equivalent to
EU-GMP refers to a drug manufacturing line granted GMP certificate by a
competent authority of a country that is considered SRA.
9. A drug manufacturing line satisfying PIC/s-GMP requirements refers
to a drug manufacturing line granted PIC/s-GMP certificate by a competent
authority of a country that is a participant in PIC/s.
10. CIF price is an import price that includes the cost, insurance and
freight from the exporting country to the Vietnamese port.
11. Reference biological means a biological granted certificates of
marketing authorization in Vietnam on the basis of sufficient data about its
quality, safety and efficacy.
12. Pharmaceutical equivalence means drugs containing the same active
ingredient and concentration in the same dosage form, having the same route of
administration and reaching the same quality standards.
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Article 4. Responsibility for planning and organizing selection of
drug supplier (hereinafter referred to as “contractor”)
1. Heads of health facilities shall organize and develop the contractor
selection plan specified in Article 14 of this Circular and the following
provisions:
a) For drugs on
the national list of drugs for centralized bidding procurement, list of drugs
for procurement by price negotiation: National centralized drug procurement
center shall develop the contractor selection plan.
The plan shall be
based on the demand for drugs of health facilities according to the
notification of the national centralized drug procurement center. The
implementation time is up to 36 months, categorized by drug category and supply
interval (quarterly, annually);
a) For drugs on
the local lists of drugs for centralized bidding procurement: the local
centralized drug procurement units shall develop the contractor selection plan.
The plan is based on the demand for drugs of health facilities according to the
notification of the local centralized drug procurement units. The
implementation time is up to 36 months, categorized by drug category and supply
interval (quarterly, annually);
c) For contractor
selection carried out by health facilities, the health facilities shall develop
their own contractor selection plans. The plan is made periodically or on
request. The implementation time is up to 12 months or on request, categorized
by drug category.
2. Heads of health facilities shall organize the contractor selection
plan and ensure the following regulations:
a) For drugs on
the national list of drugs for centralized bidding procurement, list of drugs
for procurement by price negotiation: national centralized drug procurement
center shall organize the contractor selection plan specified in Chapter IV and
Chapter V of this Circular;
a) For drugs on
the Local lists of drugs for centralized bidding procurement: the local
centralized drug procurement units shall organize the contractor selection plan
specified in Chapter IV of this Circular;
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Article 5. Reporting bidding results
1. Within 10 days from the day on which the contractor selection result
is approved, Heads of health facilities shall report the contractor selection
result as below:
a) Hospitals and
institutions providing inpatient treatment affiliated to the Ministry of Health
shall send their contractor selection results to the Ministry of Health.
b) Local centralized
drug procurement units, health facilities offering bidding for supply of drugs
under management of People's Committees of provinces and central-affiliated
cities (hereinafter refer to as “provinces”) shall send contractor selection
results to Provincial Departments of Health of provinces.
c) Health
facilities of other sectors and other health facilities shall send contractor
selection results to competent authorities for approval.
2. Within up to 10 days from the day on which the contractor selection
results are received from the units specified in Point b Clause 1 of this
Article, Provincial Departments of Health of provinces shall send a
consolidated report to the Ministry of Health.
3. Forms of report submission:
a) Report forms
shall comply with Appendix 1 and Appendix 2 enclosed herewith;
b) Reports shall
be sent by post and email to the Ministry of Health as follows:
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- 01 copy shall be sent to Drug Administration (Ministry of Health)
at: [email protected] for procurements of generic drugs, proprietary
drugs or equivalent drugs.
- 01 copy shall be sent to Traditional Medicine Administration
(Ministry of Health) at: [email protected] for procurements of
traditional drugs, herbal drugs, herbal ingredients and traditional
ingredients.
4. Before the 31st of October every year, health
authorities, hospitals and institutions providing inpatient treatment affiliated
to the Ministry of Health and; Provincial Departments of Health of provinces
and central-affiliated cities shall prepare and send reports on violations
committed by contractors during bidding for supply of drugs by local health
facilities in the previous period as specified in Appendix 3 enclosed herewith
to the Ministry of Health (Department of Planning - Finance for all contract
packages; Drug Administration for contract packages of generic drugs,
proprietary drugs or equivalent drugs; Traditional Medicine Administration for
contract packages of herbal drugs, traditional drugs, herbal ingredients and
traditional ingredients). The reports shall be the basis for contractor
evaluation in the next period.
Article 6. Expenses and document retention during contractor
selection
1. Expenses incurred during the process of contractor selection shall
comply with Article 9 of Decree No. 63/2014/ND-CP dated June 26, 2014 on
detailed guidelines for some articles on contractor selection of Law on Bidding
(hereinafter referred to as Decree No. 63/2014/ND-CP).
2. Retention of documents during the process of contractor selection
shall comply with Article 10 of Decree No. 63/2014/ND-CP .
Chapter II
DIVISION OF CONTRACT PACKAGES AND DRUGS
Article 7. Generic drug contract package
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1. Category 1 includes drugs satisfying one of the three following
criteria:
a) Drugs
manufactured entirely by a manufacturing line satisfying EU-GMP requirements or
equivalent requirements in a country that is considered SRA;
b) Drugs on the
list of proprietary drugs or reference biological announced by Ministry of
Health, except for proprietary drugs on the list of drugs eligible for price
negotiation issued by Ministry of Health and with announced price negotiation
results;
c) Drugs
manufactured entirely in Vietnam and satisfy all following requirements:
- Drugs manufactured by a manufacturing line satisfying EU-GMP
requirements or equivalent requirements and certified by drug authority of Vietnam
to satisfy EU-GMP requirements or equivalent requirements;
- Drugs granted certificates of free sale by the national drug
authority of a country that is considered SRA as specified in Clause 8 Article
50 of this Circular;
- Drugs sold in Vietnam and drugs granted certificates of free sale by
a country that is considered SRA shall have the same dosage form, production
process, quality criterion, verification method; active ingredients, excipients
shall have the same quality criterion, production facility and production place
as specified in Clause 8 Article 50 of this Circular.
2. Category 2 includes drugs satisfying one of the two following
criteria:
a) Drugs
manufactured entirely by a manufacturing line satisfying EU-GMP requirements or
equivalent requirements and granted certificates by the drug authority of
Vietnam.
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3. Category 3 includes drugs manufactured by a manufacturing line
satisfying GMP requirements and granted certificates by the drug authority of
Vietnam and having evidence of bioequivalence announced by the drug authority
of Vietnam.
4. Category 4 includes drugs manufactured entirely by a manufacturing
line in Vietnam satisfying WHO-GMP requirements and granted certificates by the
drug authority of Vietnam.
5. Category 5 includes drugs manufactured by a manufacturing line
satisfying WHO-GMP requirements and granted certificates by the drug authority
of Vietnam and not included in provisions specified in Clauses 1, 2, 3 and 4 of
this Article.
Article 8. Contract package of proprietary drugs or equivalent drugs
1. Heads of health facilities shall make decision on procurement of
proprietary drugs or equivalent drugs or reference biological on the basis of
suggestions of Drug and Treatment Council.
2. A contract package of proprietary drugs or equivalent drugs may
contain one or several proprietary drugs or equivalent drugs or reference
biological, each drug is one part of the contract package. Drugs bidding for a
contract package of proprietary drugs or equivalent drugs shall include drugs
satisfying the two following criteria:
a) Drugs on the
list of proprietary drugs or equivalent drugs and reference biological
announced by Ministry of Health, except for proprietary drugs on the list of
drugs eligible for price negotiation issued by Ministry of Health and with
announced price negotiation results;
b) Drugs
manufactured entirely in countries considered SRA, unless the health facility
requests for evidence of proprietary drugs or reference biological marketing
for the first time in countries not considered SRA or having at least one
manufacturing stage in Vietnam
Article 9. Contract package of herbal drugs and traditional drugs
(excluding traditional ingredients)
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1. Category 1 includes drugs satisfying the two following criteria:
a) Drugs
manufactured entirely from herbal ingredients planted and collected or
naturally farmed satisfying GACP requirements and granted certificates by
Ministry of Health of Vietnam;
b) Drugs
manufactured entirely by a manufacturing line in Vietnam satisfying GMP
requirements of herbal drugs and traditional drugs and granted certificates by
Ministry of Health of Vietnam.
2. Category 2 includes herbal drugs and traditional drugs manufactured
entirely by a manufacturing line in Vietnam satisfying GMP requirements of
herbal drugs and traditional drugs and granted certificates by Ministry of
Health of Vietnam.
3. Category 3 includes herbal drugs and traditional drugs not
satisfying criteria specified in Clauses 1 and 2 of this Article.
Article 10. Contract package of traditional ingredients
A contract package
of traditional ingredients may contain one or several traditional ingredients;
each list of ingredient must be sorted by category; each ingredient in each
category is one part of the contract package. The contract package of
traditional ingredients is divided into 3 categories and based on technical
criteria as follows:
1. Category 1 includes traditional ingredients satisfying the following
two criteria:
a) Drugs
manufactured from herbal ingredients planted and collected or naturally farmed
satisfying GACP requirements and granted certificates by Ministry of Health of
Vietnam;
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2. Category 2 includes traditional ingredients manufactured entirely by
a manufacturing line in Vietnam satisfying GMP requirements of traditional
ingredients (including glue, granule, extract, essential oil, resin, gum,
jelly) and granted certificates by Ministry of Health of Vietnam.
3. Category 3 includes traditional ingredients not satisfying criteria
specified in Clauses 1 and 2 of this Article.
Article 11. Contract package of herbal ingredients
A contract package
of herbal ingredients may contain one or several herbal ingredients, each list
of herbal ingredients shall be sorted by category; each ingredient in each
category is one part of the contract package. The contract package of herbal
ingredients is divided into 3 categories and based on technical criteria as
follows:
1. Category 1 includes herbal ingredients planted and collected or
naturally farmed satisfying GACP requirements and granted certificates by
Ministry of Health of Vietnam.
2. Category 2 includes semi-finished herbal ingredients: glue, granule,
extract, essential oil, resin, gum, jelly manufactured by a manufacturing line
in Vietnam satisfying GMP requirements of herbal ingredients and granted
certificates by Ministry of Health of Vietnam.
3. Category 3 includes herbal ingredients not satisfying criteria
specified in Clauses 1 and 2 of this Article.
Article 12. Provisions on submission of bids of drug categories
1. Bidding principles of drug categories in a contract package.
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b) If an offered
drug manufactured by several facilities, these facilities participated in
production process shall satisfy technical criteria of the offered drug
category.
2. Contract package of generic:
a) Drugs
satisfying criteria of Category 1 may be sorted into Category 1, Category 2,
Category 5;
b) Drugs
satisfying criteria of Category 2 may be sorted into Category 2, Category 5;
c) Drugs
satisfying criteria of Category 3 may be sorted into Category 3, Category 5;
d) Drugs
satisfying criteria of Category 4 may be sorted into Category 4, Category 5;
dd) Drugs not
satisfying criteria of Category 1, Category 2, Category 3 and Category 4 shall
only be sorted into Category 5.
3. Contract package of herbal drugs and traditional drugs:
a) Drugs
satisfying criteria of Category 1 may be sorted into Category 1, Category 2 and
Category 3;
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c) Drugs not
satisfying criteria of Category 1, Category 2 shall only be sorted into
Category 3.
4. Contract package of traditional ingredients:
a) Traditional
ingredients satisfying criteria of Category 1 may be sorted into Category 1,
Category 2, Category 3;
b) Traditional
ingredients satisfying criteria of Category 2 may be sorted into Category 2,
Category 3;
c) Traditional
ingredients not satisfying criteria of Category 1, Category 2 shall only be
sorted into Category 3.
5. Contract package of herbal ingredients:
a) Herbal
ingredients satisfying criteria of Category 1 may be sorted into Category 1 and
Category 3;
b) Herbal
ingredients satisfying criteria of Category 2 shall only be sorted into
Category 2;
c) Herbal
ingredients not satisfying criteria of Category 1, Category 2 shall only be
sorted into Category 3.
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a) Foreign drugs
manufactured under a processing contract or technology transfer contract in
Vietnam may be sorted into the drug categories specified in Point b of this
Clause if satisfying the following criteria:
- There's a technology transfer contract with specific comprehensive
technology transfer roadmap for the processor or technology transferee to
prepare to manufacture finished drugs in Vietnam within 5 years from the date
of certificate of marketing authorization is granted.
- Drugs manufactured under a processing contract or technology
transfer contract and drugs manufactured without under a processing contract or
technology transfer contract shall have the same dosage form, production
process, quality criteria of ingredients and finished drugs;
- Drugs not on the List of domestically-manufactured drugs satisfying
treatment, pricing and supply requirements issued by the Ministry of Health
according to technique criteria (except for all manufacturing stages in Vietnam
when the certificate of marketing authorization is granted in Vietnam).
b) The submission
of bids for foreign drugs manufactured under a processing contract or
technology transfer contract in Vietnam satisfying the provisions specified in
Point a of this Clause if:
- Foreign drugs manufactured under a processing contract or technology
transfer contract in Vietnam on the List of proprietary drugs or the List of
reference bioequivalence and satisfying the provisions specified in Point b
Clause 2 Article 8 of this Circular may be sorted into the contract package of
proprietary drugs or equivalent drugs. Drugs on the List of drugs for
procurement through price negotiation issued by Ministry of Health, procurement
of these drugs shall be under price negotiation form;
- Foreign drugs specified in Point a Clause 1 Article 7 of this
Circular manufactured under a processing contract or technology transfer
contract in Vietnam by a manufacturing line satisfying EU-GMP requirements or
equivalent requirements and granted certificates by the drug authority of
Vietnam may be sorted into Category 1, Category 2, Category 4 and Category 5;
- Foreign drugs specified in Clause 2 Article7 of this Circular
manufactured under a processing contract or technology transfer contract in
Vietnam by a manufacturing line satisfying EU-GMP requirements or equivalent
requirements and granted certificates by the drug authority of Vietnam may be
sorted into Category 2, Category 4 and Category 5;
- Other drugs manufactured under a processing contract or technology
transfer contract in Vietnam may be sorted into Category 4 and Category 5.
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Chapter III
DRUG PROCUREMENT FOR PUBLIC HEALTH
FACILITIES
Section 1. MAKING CONTRACTOR SELECTION PLAN
Article 13. Basis for making contractor selection plan
1. The contractor selection plan is made annually or whenever necessary
on the following bases:
a) State budget:
Funding of drug
procurement from state budget shall be annually provided by a competent
authority. If funding has not been provided, the plan shall be made according
to the procurement and use of drugs funded by state budget in the preceding
year and the anticipated demand for drugs in the current year;
b) Proceeds from
provision of medical examination and treatment services and payments from
social insurance agencies:
- Contract for medical examination and treatment covered by health
insurance between the health facility and the social insurance agency;
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c) For drugs
covered by other sources of income of the health facility: the plan shall be
made according to the procurement and use of drugs covered by other sources of
income in the preceding year and anticipated demand for drugs in the planning
year of the health facility.
2. If the health facility has selected a contractor and signed a
contract but the demand for a drug exceeds the contractual quantity by 20%,
such health facility shall make a plan for selection of additional contractor
to satisfy its demand.
Article 14. Contents of contractor selection plan
1. Name of contract package:
Categorization of
contract packages and drug categories shall follow the provisions from Article
7 to Article 12 of this Circular.
If a contract
package is categorized into several parts, each of them shall have a suitable
name. Specific information in contractor selection plan are as follows:
a) Each part in a
contract package of generic drugs shall include: name of the active ingredient;
content/concentration; route of administration, dosage form; category;
measuring unit, quantity; unit price and total value;
b) Each part in a
contract package of original branded name drugs or equivalent drugs shall
include: name of the drug and the phrase “or equivalent drugs”; content/concentration;
route of administration, dosage form; category; measuring unit, quantity; unit
price and total value. If an active ingredient has several names of proprietary
drug or equivalent drug or reference bioequivalence on the List of proprietary drug
or equivalent drug or reference bioequivalence published by Ministry of Health,
name of the drug shall include names of proprietary drug or equivalent drug or
reference bioequivalence;
c) Each part in a
contract package of herbal drugs or traditional drugs shall include: name of
the drug; route of administration, dosage form; measuring unit; category;
quantity; unit price and total value; Names of drugs shall be written complying
with the provisions in Article 3 of this Decree.
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2. Dosage form of a contract package of generic drugs/herbal
drugs/traditional drugs under contractor selection plan shall be written
complying with the provisions in Appendix 4 enclosed herewith. The dosage forms
(with asterisks) shall be written separately under the condition that:
a) Having the same
dosage form as proprietary drugs or reference bioequivalence with the same
active ingredients, route of administration, or drugs with the same active
ingredients, route of administration granted certificates of free sale in SRA
countries.
b) If the drug is
not specified in Point a Clause 2 of this Article, the health facility shall
state clearly the demand for using this dosage form in terms of necessity,
estimated quantity and it’s only used in case use of another dosage form is
impossible;
3. Names in a contract package of herbal drugs or traditional drugs
shall be written as follows:
a) Only specify
the drug ingredients; do not write trade names;
b) For drugs
having the same ingredients or dosage form: only specify the concentrations of
the ingredients if the difference in concentrations leads to difference in dose
and indications of treatment according to opinions of Drug and Treatment
Council.
4. Value of contract package:
a) Value of a
contract package means total value of the contract package, including all
expenses;
b) If a contract
package is divided into smaller parts, each part shall specify unit price and
total value of that part as prescribed in Clause 1 of this Article, except for
total value of the contract package. The unit price in the contractor selection
plan shall be proposed by the planning health facility, which is responsible
for such proposed price;
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- The estimated price of each drug/ingredient shall not exceed the
highest successful bid for that drug/ingredient in each published technical
category;
- For
drugs/ingredients whose successful bids are unpublished or estimated prices are
higher than successful bids published by the Ministry of Health (Drug
Administration of Vietnam, Traditional Medicine Administration of Vietnam)
within the previous 12 months, the health facility shall check quotations or
invoices of at least 03 suppliers during the contractor selection plan and
ensure that the price estimated by the health facility shall not exceed the
effective wholesale price of such drugs (except for herbal ingredients and
traditional ingredients).
For drugs having
fewer than 03 suppliers (fewer than 03 quotations or invoices), the head of the
health facility shall propose the price according to such quotations and
invoices, provide explanation, and take responsibility for the appropriateness
of the estimated price when the contractor selection plan is made.
d) Estimated price
of items with the same active ingredients, concentrations/contents, dosage form
in the contract package of generic drugs shall comply with the following
principles:
- The estimated price of Category 1 shall not be higher than that of
proprietary drugs or reference bioequivalence;
- The estimated price of Category 2 and Category 3 shall not be higher
than that of proprietary drugs or reference bioequivalence and Category 1;
- The estimated price of Category 4 shall not be higher than the that
of proprietary drugs or reference bioequivalence; Category 1 and Category 2
manufactured in Vietnam and Category 3;
- The estimated price of Category 5 shall not be higher than that of
proprietary drugs or reference bioequivalence; Category 1; Category 2; Category
3 and Category 4.
5. Funding sources: the health facility must specify the sources of
funding for drug procurement; if the funding source is ODA or concessional
loan, the name of sponsor and fund composition must be specified, including the
aid and counterpart fund (if any).
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a) Contractor
selection methods:
Depending on the
value and nature of each contract package, the health facility shall select one
of the methods specified in Article 20 through 25 of the Law on Bidding and
detailed guidance in this Circular.
b) Contractor
selection procedures:
Depending on the
contractor selection method and value of the contract package, the health
facility shall propose contractor selection procedures as prescribed in Article
28 and Article 29 of the Law on Bidding and Decree No. 63/2014/ND-CP , and
guidance in this Circular. For a small contract package requiring quality and
good prices, the single-stage two-envelop bidding procedures shall be applied.
7. Starting time of contractor selection:
The month or
quarter in which bidding documents or request for proposals are issued shall be
specified.
8. Type of contract shall depend on the value and nature of the
contract package and supply method as prescribed in Article 62 of the Law on
Bidding.
9. Time limit for contract execution shall be specified in the
contractor selection plan which must not exceed 12 months from the effective
date of the contract.
Article 15. Submission of contractor selection plan for approval
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a) The head of the
health facility shall be responsible for preparing the plan for selection of
drug supply contractor in order to ensure adequate supply of drugs serving
treatment at the health facility.
b) At least 03
months before the expiry of the previous drug supply contract, the head of the
health facility shall submit the contractor selection plan to a competent
person or a person authorized to approve contractor selection plan according to
Clause 1 Article 17 of this Circular.
2. A proposal of contractor selection plan shall contain:
a) Basis for
making the contractor selection plan as specified in Article 13 of this
Circular;
b) Contents of the
contractor selection plan as specified in Article 14 of this Circular to be
specific:
- Names of contract packages, value of each part and total value of
contract packages in the contractor selection plan and the basis for dividing
the contract packages. If the contract package of drug is funded by state
budget, the total value of contract packages in the contractor selection plan
must not exceed the approved cost estimate;
- The contractor selection method and procedures applied to each
contract package shall be one of those specified in Articles 19, 20, 21, 22,
23, 24, 25, 26 of this Circular. If competitive bidding is not applied, the
proposal shall explain the reason for choosing other methods.
- Explanation for increase in using drugs manufactured in Vietnam in
accordance with guidance of Ministry of Health.
3. Documents enclosed with the proposal:
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b) Documents as
the basis for making the contractor selection plan as specified in Article 13
of this Circular;
Minutes of the
meeting with the Drug and Treatment Council and its comments on the list,
quantity of drugs, the need for proprietary drugs or equivalent drugs or
reference bioequivalence, the need for dosage form separately written in the
contractor selection plan specified in Clause 2 Article 14 of this Circular,
specification of names and concentrations in the content package of traditional
drugs or herbal drugs.
d) Investors shall
make decision on approval for funding source, list, quantity and estimated
price in the contractor selection plan.
4. The proposal of the contractor selection plan shall be sent by post
or directly or electronically to the unit appointed to appraise contractor
selection plans. The proposal of contractor selection plan shall comply with
Form No. 5 in Appendix enclosed herewith.
Article 16. Appraisal of contractor selection plan
The contractor
selection plan shall be appraised before it is submitted to the competent
person for approval as specified in Clause 1 Article 17 of this Circular.
1. Organization of appraisal:
a) For public
health facilities under the management of Ministries, ministerial authorities,
Governmental authorities: Ministers, Heads of ministerial authorities and
Governmental authorities shall decide the unit in charge of appraising their
contractor selection plans (hereinafter referred to as appraising unit);
b) For public
health facilities under the management of local governments:
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- The person authorized by the Chairperson of People's Committee of
province (if any) to approve the contractor selection plan shall appoint a
qualified unit to appraise the plan before approving it.
c) The legally
responsible person or the person authorized by the legally responsible person
of health facilities not specified in Point a and Point b Clause 1 of this
Article shall appoint a unit in charge of organizing the appraisal of
contractor selection plan.
2. Duties of appraising unit:
a) Appraise the
contents specified in Articles 7, 8, 9, 10, 11, 12, 13, 14, 15 of this Circular
within 20 days from the day on which adequate documents are received. If
documents are inadequate, the appraising unit shall request addition of
documents or return the documents to the health facility within 05 working days
from the receipt of such documents;
b) Make an
appraisal report according to Form No. 6 enclosed herewith. The report shall be
enclosed with one set of the application for approval for appraised contractor
selection plan (original) and submitted to the competent person specified in
Clause 1 Article 17 of this Circular for approval.
Article 17. Approval for contractor selection plan
1. The power to approve contractor selection plans:
a) Ministers,
Heads of ministerial authorities and Governmental authorities shall consider
approving contractor selection plans for health facilities under their
management; Ministers, Heads of ministerial authorities and Governmental
authorities shall appoint a unit to approve contractor selection plans for
heads of health facilities under their management In this case, the authorized
person shall appoint a qualified unit to appraise the plan before approving it.
b) Chairpersons of
People's Committee of province shall consider approving contractor selection
plans of health facilities under their management. Chairpersons of People's
Committee of province may appoint a unit to approve contractor selection plans
for heads of health facilities within their management. In this case, the
authorized person shall appoint a qualified unit to appraise the plan before
approving it.
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d) Task assignment
of approval for contractor selection plans of military health facilities shall
comply with the guidance of the Ministry of Defense and the Ministry of Public
Security.
2. Within 05 working days from the receipt of the appraisal report and
the proposal, the competent person specified in Clause 1 of this Article shall
consider approving the plan.
3. The contractor selection plan shall be posted on national bidding
network as prescribed in Article 8 of the Law on Bidding and its instructional
documents.
Article 18. Regulations on contractor selection self-organization
for drugs on the list of drugs for centralized bidding procurement and the list
of drugs for procurement by price negotiation
1. Health facilities may carry out contractor selection themselves for
drugs on the list of drugs for centralized bidding procurement and the list of
drugs for procurement by price negotiation, ensure that time limit and quantity
must not exceed demand for use within 12 months (from the receipt of written
notification from centralized drug procurement units) if:
a) The health
facility needs to use a drug on the List of drugs for centralized bidding
procurement or the list of drugs for procurement by price negotiation but the
results of centralized contractor selection or price negotiation have not been
published;
b) The health
facility needs to use a drug on the list of drugs for centralized bidding
procurement or the list of drugs for procurement through price negotiation with
a concluded supply contract but the selected contractor is unable to supply
drugs and the receipt of notification from the centralized drug procurement
unit of contractor selection self-organization.
c) The health
facility has used up the quantity of drugs specified in the framework agreement
and exceeds the capacity specified in Clause 5 Article 37, Clause 13 Article 40
and Clause 12 Article 41 of this Circular;
d) The health
facility is established after the demand for drugs has been determined, and the
increased demand exceeds the capability of the national centralized drug
procurement center and the local centralized drug procurement unit.
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Section 2. CONTRACTOR SELECTION METHODS
Article 19. Competitive bidding
Competitive bidding
shall be applied to every contract package regulated by this Circular, except
for the cases in Article 20 through 24 hereof.
Article 20. Selective bidding
1. Selective bidding shall be applied to any procurement under special
control of the Ministry of Health or any procurement of special drugs that can
be supplied by few suppliers.
2. Drug manufacturers and drug suppliers included by the Ministry of
Health on the list of capable, experienced, reputable manufacturers specified
in Point dd Clause 1 Article 77 of Decree No. 63/2014/ND-CP shall be invited to
participate in selective bidding if their drugs are suitable for the
procurements.
Article 21. Direct contracting
1. Usual direct contracting and simplified direct contracting:
a) Usual direct
contracting applies to contract packages worth VND1 billion at most specified
in Point e, Clause 1, Article 22 of Law on Bidding;
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2. Procedures of usual direct contracting and simplified direct
contracting:
a) The usual
direct contracting procedures are specified in Article 55 of Decree No.
63/2014/ND-CP .
b) The simplified
direct contracting procedures are specified in Article 56 of Decree No.
63/2014/ND-CP after the contractor selection plan is approved.
In case of direct
contracting specified in Point a Clause 1 Article 22 of Law on Bidding (except
for contract packages that are state secrets), the provisions specified in
Clause 8 Article 6 of Circular No. 10/2015/TT-BKHDT dated October 26, 2015 of
Minister of Planning and Investment on contractor selection plans.
Article 22. Competitive offering
1. Competitive offering shall be applied when all of the conditions
below are satisfied:
a) The contract
package value does not exceed VND5 billion;
b) The drug on the
list of essential medicines promulgated by the Ministry of Health or a commonly
available drug whose technical characteristics and quality have been
standardized and equivalent;
c) There is a
contractor selection plan approved by the competent person;
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2. The competitive offering procedures are specified in Article 58 and
Article 59 of Decree No. 63/2014/ND-CP .
Article 23. Direct procurement
1. Direct procurement shall be applied when all of the conditions below
are satisfied:
a) The contractor
has won the contract through competitive bidding or selective bidding and has
signed a contract earlier;
b) The current
procurement includes similar drugs and the value is smaller than 130% of the
earlier contract. If the drug of the direct procurement is one of the drugs of
a similar contract signed earlier, the value of the direct procurement must be
smaller than 130% of that of the same kind of drug of the earlier contract;
c) Unit prices of
drugs of the direct procurement do not exceed those of corresponding drugs in
the earlier contract and suitable for the successful bids announced at the time
of approval for contractor selection plan;
d) The period of
time from the signing date of the earlier contract to the date on which the
direct procurement result is approved must not exceed 12 months. In a 12-month
period, a health facility may make only one procurement of each product in the
earlier contract. In special cases, the health facility shall submit a document
to the competent person specified in Clause 1 Article 17 of this Circular for
consideration.
2. If the previous contractor is no longer capable of executing the
direct procurement contract, another contractor who satisfies the requirements
(in terms of capacity, experience, technology and prices) in the bidding
documents and the previous contractor selection result may be selected.
3. The direct procurement procedures are specified in Article 60 of
Decree No. 63/2014/ND-CP .
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1. Self-supply shall be applied to the procurements specified in
Article 25 of Law on Bidding after all provisions specified in Article 61 of
Decree No. 63/2014/ND-CP are satisfied.
2. The self-supply procedures are specified in Article 62 of Decree No.
63/2014/ND-CP .
Section 3. CONTRACTOR SELECTION PROCEDURES
Article 25. Single-stage one-envelop procedures
Single-stage
one-envelop procedures shall be applied to:
1. Small-value contract packages through competitive bidding or
selective bidding specified in Article 63 Decree No. 63/2014/ND-CP ;
2. Contract packages through competitive offering;
3. Contract packages through direct procurement;
4. Contract packages through usual direct contracting.
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Single-stage
two-envelop procedures shall be applied to:
1. Contract packages worth more than VND10 billion through competitive
bidding or selective bidding.
2. Contract packages worth less than VND10 billion through competitive
bidding or selective bidding but both quality and prices have to be taken into
account.
Section 4. BIDDING DOCUMENTS AND REQUEST FOR PROPOSALS
Section 27. Preparing bidding documents amd request for proposals
1. Bidding documents or request for drug procurement shall be prepared
in accordance with Law on Bidding and the following instructional documents and
provisions:
a) The bidding
documents and request for drug procurements of proprietary drugs or equivalent
drugs, generic drugs, herbal drugs and traditional drugs shall comply with the
bidding documents applying one-stage one-envelop procedures specified in
Appendix 7 or bidding documents applying one-stage two-envelop procedures
specified in Appendix 8 enclosed herewith.
b) The bidding
documents and request for contract packages of traditional ingredients and
herbal ingredients shall comply with the guidance of Ministry of Health on
detailed bidding documents for procurement of herbal and traditional
ingredients for health facilities.
2. According to the contractor selection plan approved by a competent
authority, the procuring entity shall prepare the bidding documents or request
for drug procurement and submit an application for approval to the appraising
unit.
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a) Drugs on the
list enclosed with Circular No. 03/2019/TT-BYT satisfying WHO-GMP technical
criteria may not offer imported drugs satisfying technical criteria of category
5 specified in Clause 5 Article 7 of this Circular.
b) Drugs on the
list enclosed with Circular No. 03/2019/TT-BYT satisfying EU-GMP technical
criteria may not offer imported drugs satisfying technical criteria of category
2 specified in Clause 2 Article 7 of this Circular.
4. The bidding documents or request for herbs procurement must specify
that contractors shall not offer imported herbs in the same categories as herbs
on the list of domestically planted and collected herbs satisfying treatment,
pricing and supply requirements published by the Ministry of Health.
5. Due to unexpected increase in demand, drugs on the list of
domestically manufactured drugs satisfying treatment, pricing and supply
capacity or herbs on the list of domestically planted and collected drugs
satisfying treatment, pricing and supply capacity exceed supply capacity of
domestic manufacturing facilities or health facilities, Ministry of Health
shall decide the imported drug/herbs offering in the same technical criteria
categories as drugs/herbs on the list of domestically manufactured
drugs/domestically planted and collected herbs satisfying treatment, pricing
and supply requirements in a certain time to ensure sufficient supply of
drugs/herbs.
Section 28. Appraising bidding documents and request for proposals
1. Bidding documents and request for proposals shall be appraised
before it is submitted to heads of health facilities for approval.
2. Appraising units shall be decided by heads of health facilities.
3. Duties of appraising unit:
Inspect the
contents of bidding documents or request for proposals in accordance with Law
on Bidding as well as its instructional documents and provisions of this
Circular;
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Article 29. Approving bidding documents, request for proposals
Heads of health
facilities shall consider approving bidding documents or request for proposals
within 10 days from the day on which the appraisal report and sufficient
documents are received from appraising units.
Section 5. CONTRACTOR SELECTION ORGANIZATION
Article 30. Bid security, submission of bids/proposals
1. The head of the health facility (or the procuring entity) shall
specify the value of bid security in the bidding documents/request for
proposals in accordance with the following principles:
a) The bid
security value shall equal 1% - 3% of the contract package value (1% - 1.5% for
small contract packages).
b) If the contract
package is divided into smaller parts, the bid security value for each part
shall equal 1% - 3% of the value of such part (1% - 1.5% for small contract
packages).
2. A contractor may participate in one, some, or all parts of a
procurement. If the contractor participates in more than one part, the bid
security value shall be the total value of bid security for each part.
3. A contractor may choose one of the following bid security methods:
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b) Pay security;
c) A letter of
guarantee issued by a bank or credit institution lawfully operating in Vietnam.
Investors shall
not request contractors to follow any specific method of the three above
methods.
4. The procuring entity shall specify the validity period of request
for proposals or bids which shall not exceed 180 days from the bid closing
time.
Where necessary, the validity period of bids/proposals may be
extended as long as the drug supply schedule is met. Each contractor shall
submit 02 sets of the bid/proposal (01 original and 01 copy) to the procuring
entity before the bid closing time.
Article 31. Evaluating bids/request for proposals
1. Depending on the nature and value of the contract package, the
method and procedure for contractor selection, the head of the health facility
shall select one of the method for evaluating bids/proposals specified in
Article 39 and Article 41 of Law on Bidding. The evaluation method must be
specified in bids/request for proposals.
2. The procuring entity shall evaluate bids/proposals for each part of
the procurement in accordance with the Law on Bidding and regulations of the
Ministry of Health on preparing bids/proposals for supply of drugs.
The evaluation of
ability and experience of contractors shall be based on the total parts of the
contract package that the contractors participated.
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4. Procedures for evaluating bids/proposals shall depend on the
contractor selection procedures approved by a competent authority, to be
specific:
Single-stage
one-envelop procedure: Article 15 through 18 of Decree No. 63/2014/ND-CP shall
be applied ;
Single-stage
two-envelop procedure: Article 27 through 30 of Decree No. 63/2014/ND-CP shall
be applied ;
5. Time limit for evaluating proposals is up to 30 days; time limit for
evaluating bids is 45 days (25 days for small procurements) from the bid
closing to the day on which the procuring entity submits the contractor
selection result to the head of the health facility for approval. In case of
competitive bidding and selective bidding under single-stage two-envelop
procedures, the time limit for evaluating bids shall be the total time for
evaluating technical proposals (from the bid closing date to the day on which
the head of the health facility approves the list of bidders satisfying
technical requirements) plus (+) the time for evaluating financial proposals
(from the day on which financial proposals are opened to the day on which the
procuring entity submits the contractor selection result to the head of the
health facility for approval). Where necessary, the time limit for evaluating
bids/proposals may be extended for up to 20 more days as long as the drug
supply schedule is met.
Article 32. Contract negotiation and proposal for successful
contractor
1. Contract negotiation shall comply with the provisions specified in
Article 19 of Decree No. 63/2014/ND-CP and shall be implemented before the
procuring entity proposes successful contractor.
The contractor
whose bid after correction of errors and adjustment of deviation minus (-)
discount is lowest (if lowest price method is applied); whose evaluated price
is lowest (if evaluated price method is applied); or whose total score is
highest (if combined method is applied) shall be ranked first and invited to
contract negotiation.
If the selected
contractor is invited to contract negotiation but he/she is absent, such
contractor shall not receive bid security.
2. Conditions for being proposed for successful contractors are
specified in Article 43 of Law on Bidding and the bidding documents specified
in Appendix 7 or Appendix 8 enclosed herewith.
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3. If the bid after correction of errors and adjustment of deviation
minus (-) discount (if any) of every contractor satisfying technical
requirements and on the list of ranked contractors exceeds the price for the
approved part in the contract package, there are the following options:
a) If the drug
price in the approved contractor selection plan is considered reasonable,
contractors shall be requested to submit new price offering as specified in
Clause 8 Article 117 of Decree No. 63/2014/ND-CP
b) If the drug
price is not reasonable, the procuring entity shall prepare a report and
propose adjustment to the contract package value and send it to the competent
person for consideration;
c) If sufficient
supply of drugs is necessary to serve demand for medical examination and
treatment, the procuring entity may consider deciding to select the drug
according to contractors’ rankings when all of the following conditions are
satisfied:
- The successful bid shall not exceed the effective declared or
re-declared wholesale price of the drug;
- The total value of proposed drugs offered by bidders shall not
exceed the total value of those parts in the contractor selection plan approved
by a competent authority.
Article 33. Reporting on submission of contractor selection result
appraisal
1. The procuring entity shall send 01 set of the contractor selection
result appraisal to the appraising unit, including:
a) 01 original of
the report on evaluation of bids/request for proposals
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2. Procedures for reporting, appraising, approving, and publishing
contractor selection results are specified in Article 20 of Decree No.
63/2014/ND-CP .
Article 34. Appraising and submitting contractor selection results
for approval
1. The head of the health facility shall appoint a unit to appraise the
contractor selection result.
2. Duties of appraising unit:
a) Within 20 days
(10 days for small contract packages) from the date on which sufficient
documents are received, the appraising unit shall inspect and evaluate the
contractor selection procedures specified in Article 30, 31 and Article 32 of
this Circular;
b) Prepare an
appraisal report and submit it to the head of the health facility for
consideration for approval in accordance with provisions of this Circular and
regulations of law on bidding.
3. An application for approval for contractor selection result shall
include:
a) 01 original of
the report on contractor selection result appraisal;
b) A set of the
application for approval for contractor selection result (original) of the
procuring entity.
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1. Within 10 working days (up to 05 working days for small contract
packages) from the receipt of the sufficient application for approval for
contractor selection result of the appraising unit specified in Clause 3
Article 34 of this Circular, the head of the health facility shall consider
approving the result.
2. When the contractor selection result is approved, the procuring
entity shall send a written notification of the contractor selection result to
contractors in accordance with regulations of law on bidding.
3. The notifications sent to unsuccessful contractors shall provide
explanation for their failure.
4. If the contract package is divided into smaller parts and the time
for bid evaluation might affect the drug supply schedule of the health
facility, the head of the health facility may consider approving the contractor
selection result of one or some parts in several stages to keep the drug supply
schedule unchanged.
5. If any drug in a contract package does not receive any bids or no
bidders for which are successful or none of the options specified in Clause 1
of this Article is viable, the head of the health facility or the procuring
entity shall cancel the procurement and submit an adjusted contractor selection
plan to a competent authority for approval. The time for appraisal and approval
for adjusted plan shall comply with Article 16 and Article 17 of this Circular.
If drug information of the contract package including name of the active
ingredient; contents/concentrations; route of administration, dosage form;
category; measuring unit; quantity; unit price and total value of those drugs
are unchanged comparing to the approved plan, the competent authority shall
select the qualified contractor without reappraisal of the contractor selection
plan.
Article 36. Successful bids
The successful bid
for each drug shall not exceed its price in the contractor selection plan
approved by the competent person and shall not exceed the effective wholesale
price of such drug, except for the cases specified in Clause 3 Article 32 of
this Circular.
Article 37. Contract conclusion and guarantee for contract execution
and use of drugs
1. Before signing the contract, the procuring entity may increase or
decrease the maximum quantity of drugs by less than 10% comparing to the
quantity of drugs in the bidding plan under the condition that there is no
change on unit price or other provisions of bids and bidding documents.
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3. The head of the health facility and the successful contractor shall
implement the drug supply contract in accordance with law on business contracts
and ensure that at least 80% of the value of each part in the concluded
contract shall be implemented. For emergency treatment, antidotes, and rare
drugs, specially controlled drugs, fluids for intravenous infusion and other
cases after reporting to the competent authority, the health facility shall
ensure that at least 50% of the value of each part in the concluded contract
shall be implemented.
If the health
facility does not complete at least 80% of the value of each part in the
concluded contract, the head of the health facility shall explain to the
competent person.
4. The health facility must not buy more drug in a category than the
quantity specified in the contractor selection result if the quantity of drugs
in other categories of the same selected active ingredient is not completely
bought under concluded contracts.
5. In the following cases, it is allowed to buy in excess to the limit
by up to 20% of the quantity of drug in such category specified in the concluded
contract without having to submit the additional contractor selection plan:
a) Drugs of other
categories with the same active ingredient or concentration or content are
depleted and only drugs of a contract package of proprietary drugs or equivalent
drugs remain;
b) Other drug
categories with the same selected active ingredient or concentration or content
has to be suspended from supply or suspended from sale or removed from the list
of drugs having evidence of bioequivalence after they are selected;
c) The contractor
is unable to supply a sufficient quantity of drugs in a category as specified
in the concluded contract due to force majeure events. In this case, a written
notification and relevant documents shall be presented.
6. If an offered drug is changed during the contractor selection
process, or the drug is supplied but the substitute drug is not offered in the
bid, the investor may consider allowing the contractor to supply the substitute
drug, to be specific:
a) The name of the
drug or the factory or package content is changed during its sale but the
number of marketing authorization certificate or number of import license
remains unchanged;
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When using the
substitute drug, the contractor must provide every information necessary for
the procuring entity to evaluate the replacement, including: copies (certified
by the contractor) of the marketing authorization or certificate of
pharmaceutical product, written permissions from regulatory authorities (if
any) and explanation for the unchanged quality standards of the offered drug
and substitute drug.
c) The selected
proprietary drug or reference bioequivalence (or offered in the bid) whose the
number of marketing authorization certificate or other information and the
alternative drug on the list of orginal branded drugs or the list of reference
bioequivalence published by Ministry of Health;
d) Changes in name
specification of herbal ingredients do not change components of the drug and
allowed by the competent authority.
Chapter IV
CENTRALIZED DRUG PROCUREMENT
Article 38. General provisions on centralized drug procurement
1. Centralized drug procurement units shall:
a) Survey demand
for drugs, prepare and submit a contractor selection plan, organize the
contractor selection, complete and conclude contracts or framework agreements
with selected contractors, publish contractor selection results and framework
agreements on the websites of the Ministry of Health and Provincial Departments
of Health as the basis for them to complete and sign contracts with selected
contractors.
b) Supervise the
progress of execution of framework agreements and contracts with selected
contractors.
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3. When surveying demand for drugs on the national list of drugs for
centralized bidding procurement list or the price negotiation list, the health
facility shall exclude the remaining quantity of drugs under contracts with
selected contractors according to previous contractor selection results.
4. Contractor selection method: nationwide competitive bidding;
5. Contractor selection procedure: single-stage two-envelop;
6. Bid evaluation shall be carried out according to the method that
evaluates both quality and price of each drug, which is one part of the
contract package (combined method).
7. The centralized drug procurement shall be carried out by signing a
framework agreement, except for the following cases in which a contract shall
be signed directly:
a) Procurement of
medicines and vaccines serving open vaccination programs/projects funded by
state budget under decisions of the Minister of Health or Presidents of the
People’s Committees of provinces;
b) Procurement of
drugs of programs and projects funded by ODA, aid, sponsorship from domestic
and overseas sponsors who require direct contract conclusion;
8. Organizing appraisal of contractor selection plan:
a) Planning –
Finance Department shall organize appraisal of national centralized drug
procurement plans.
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c) Centralized
drug procurement plans shall be appraised in accordance with Clause 1 Article
37 of Law on Bidding and Article 16 of this Circular.
9. Contract negotiation:
Contract
negotiation shall be in accordance with Clause 1 Article 32 of this Circular,
During centralized contractor selection, contract negotiation shall comply with
the provisions of Clause 3 Article 19 of Decree 63/2014/ND-CP and these
following cases shall be considered:
a) If a large
quantity of a drug is divided into smaller contract packages specified in point
a Clause 4 Article 40 of this Circular and has the same item proposed for contract awarding in several contract packages
with the price difference, the contractor may be requested to analyse
components of the bid price and explain about the price difference of the same
item supplied at different places. These analyses shall be used as a basis for
contract negotiation towards the price of the drug under the contract package
whose the proposed successful bid is low in order to bring economic efficiency
of the contract package.
b) If a drug in a
category only has 01 certificate of marketing authorization, 01 contractor and
the proposed successful bid in this drug category is higher than that of the
drug having the same active ingredient, content/concentration, route of
administration and dosage form in another category with more advanced technical
standards and competitive price thanks to the participation of many
contractors, the contract negotiation on the proposed successful bid shall
follow these principles:
- The successful bid of Category 1 shall not be higher than the
successful bid of proprietary drugs or reference bioequivalence;
- The successful bid of Category 2 or Category 3 shall not be higher
than the successful bid of proprietary drugs or reference bioequivalence and
Category 1;
- The successful bid of Category 4 shall not be higher than the
successful bid of proprietary drugs or reference bioequivalence; Category 1 and
Category 2 manufactured in Vietnam and Category 3;
- The successful bid of Category 5 shall not be higher than the
successful bid of proprietary drugs or reference bioequivalence; Category 1;
Category 2; Category 3 and Category 4.
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11. Duties, functions, organization and operation of the national
centralized drug procurement center shall be decided by Minister of Health.
Duties, functions, organization and operation of the local centralized drug
procurement units shall be decided by Presidents of the People’s Committees of
provinces at the request of Ministry of Health.
Article 39. Responsibilities of relevant parties and effect of
framework agreement
1. A health facility wishing to purchase drugs on the list of drugs for
centralized drug procurement shall prepare and sign a contract with the selected
contractor according to the contractor selection result and the contractual
unit price does not exceed the framework agreement published. The contractor
shall provide guarantee for contract execution in accordance with Article 66 of
Law on Bidding and Clause 2 Article 37 of this Circular with the health
facility before the effective time of the contract.
2. The unit specified in Clause 1 Article 40 and Clause 2 Article 41 of
this Circular shall survey demand for drugs on the lists of each health facility
under its management and regulate the plan procedures to ensure that at least
80% of the quantity of drugs reported are used. For emergency treatment,
antidotes, and rare drugs, specially controlled drugs, fluids for intravenous
infusion and drugs used in other emergency cases after reporting to the
competent authority, the health facility shall ensure that at least 50% of the
value of each part in the concluded contract shall be implemented.
3. The contractor selected by centralized procurement shall supply
drugs with the quantity and schedule agreed in the contract with each health
facility. During the contract implementation, the health facility and the
contractor may negotiate changes to the quantity according to stipulations of
the bidding documents issued by the unit in charge of centralized drug
procurement. The centralized drug procurement unit shall cooperate with units
in charge and selected contractors in regulating plan implementation to ensure
adequate supply of drugs for the health facility.
4. Time limit for the centralized drug procurement contract (national
and local) shall comply with provisions of the contractor selection plan
approved by the competent authority but shall not exceed 36 months from the
effective date of the centralized drug procurement results and framework
agreements.
Article 40. Organizing national-level centralized drug procurement
1. The survey on demand for drug use shall follow these principles:
a) The health
facilities affiliated to Ministry of Health shall survey the demand for drugs
with specified names, detailed quantities, categories, supply schedules and
submit the result enclosed with the documents specified in Clause 2 of this
Article to the national centralized drug procurement center.
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d) The local
centralized drug procurement units surveys demand for drug use, reports to
Provincial Departments of Health and send the drug use plan enclosed with the
documents specified in Clause 2 of this Article to the national centralized
drug procurement center.
c) The survey
shall be annually sent to the national centralized drug procurement center
before June 15th or another deadline specified by this center.
2. Documents enclosed with the application for centralized drug
procurement demand:
a) Summary of the
result of contractor selection and drug use of the preceding year, the drug
inventory and the quantity of drugs that are planned but have not been used at
the time of making summary of the health facilities;
b) A brief
explanation for the proposed drug procurement plan shall be given, and a
detailed explanation shall also be given in case of fluctuations in 30% of the
quantity of the used drugs of the preceding year.
b) Documents as
the basis for making the drug procurement plan specified in Article 13 of this
Circular;
d) The minutes of
the meeting with Drug and Treatment Council of the health facility affiliated
to Ministry of Health or the minutes of review of Provincial Departments of
Health and its comments on the list, quantity of drugs and demand for drugs of
the health facilities under the management of ministries and regulatory
authorities and local health authorities.
3. The national centralized drug procurement center shall review the
demand for list and quantity of drugs of each health facility under the
management of Ministry of Health and survey the demand for list, quantity,
supply schedule of each drug in order to develop contractor selection plan.
4. Contractor selection plan shall be developed as follows:
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Example: Drug A is
on the national list of drugs for centralized bidding procurement and the
demand for drug A is 100 million tablets per year. No supplier is able to
supply this drug with such quantity so it may be divided into smaller contract
packages:
- + It may be divided into 03 smaller contract packages for 03 regions:
contract package 1 for health facilities in the North with 40 million tablets;
contract package 2 for health facilities in the Central Coast with 20 million
tablets; contract package 3 for health facilities in the South with 40 million
tablets;
- + It may be divided into several smaller contract packages for 07
socio-economic areas: Red River Delta, the Northeast, the Northwest; the North
Central Coast, the South Central Coast, the Southeast and Mekong Delta.
b) Drug category
division in contract packages and contents of contractor selection plans shall
comply with Article 7 through Article 14 of this Circular. Time limit for
contract execution shall comply with Clause 4 Article 39 of this Circular.
5. Organizing appraisal of contractor selection plan:
a) The national
centralized drug procurement center shall submit the proposal of the contractor
selection plan to Department of Planning - Finance, Ministry of Health.
b) The appraisal
of contractor selection plan under the national list of drugs for centralized
bidding procurement shall comply with Clause 2 Article 16 of this Circular.
Planning – Finance Department shall organize the appraisal of lists, quantity
of contract packages, estimated unit prices and quantity of drugs as well as
contractor selection plans. In case of necessity, Planning – Finance Department
shall ask for advice from Drug Procurement Consultancy Council before
submitting the contractor selection plan to Minister of Health for approval.
6. Approving contractor selection plan:
Minister of Health
shall consider approving contractor selection plans at the request of Planning
– Finance Department.
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According to the
contractor selection plan approved by Minister of Health, the national
centralized drug procurement center shall prepare the bidding documents and
organize bid evaluation in accordance with Article 27 through 29 of this
Circular.
8. Organizing contractor selection:
The national
centralized drug procurement center shall organize the contractor selection,
bid evaluation, negotiation of contracts, propose successful contractors; and
report the contractor selection result in accordance with Article 30 through 33
of this Circular.
9. Appraising, approving and publishing contractor selection result:
The national
centralized drug procurement center shall organize the contractor selection,
bid evaluation, negotiation of contracts, propose successful contractors and
report the contractor selection result in accordance with Article 30 through 33
of this Circular. It may be necessary to consult with Drug Procurement
Consultancy Council before approving the contractor selection result;
b) The national
centralized drug procurement center shall announce and publish contractor
selection result according to Law on bidding.
10. Completing and concluding contracts or framework agreements:
a) The national
centralized drug procurement center shall complete and conclude contracts or
framework agreements with selected contractors in accordance with Law on bidding;
publish framework agreements on the Ministry of Health's website and send
written notifications to health facilities under the management of the Ministry
of Health, other regulatory authorities, and Provincial Provincial Departments
of Health;
b) The units
surveying and proposing demand for drugs specified in Clause 1 of this Article
shall notify the contractor selection result and the framework agreement to the
health facilities regulated by the framework agreement.
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In consideration
of the contractor selection result, the framework agreement, the demand for
drug and drug use plans of health facilities, the national centralized drug
procurement center (for direct contract conclusion) and health facilities shall
complete and conclude contracts with contractors ensuring:
a) Conformity with
the framework agreement;
b) The price of
each drug in the contract does not exceed the successful bid announced by the
national centralized drug procurement center.
c) Time limit for
contract execution shall be specified in the contractor selection plan approved
by competent authority but may not exceed 36 months from the effective date of
the centralized procurement results and framework agreements until the date
parties fulfill obligations in accordance with the provisions of the contract.
12. Report on contractor selection results of national centralized drug
procurement:
a) Before 10th of
each month and the first 10th of each quarter or on request, contractors shall
submit reports on supply of drugs on the national list of drugs for centralized
drug procurement to the national centralized drug procurement center in
accordance with Appendix 9 and Appendix 10 enclosed herewith.
b) Before the
first 10th of each quarter or on request, the health facilities under the
management of local governments and the health facilities under the management
of ministries and branches shall submit reports on supply of drugs to the local
centralized drug procurement units in accordance with Appendix 11 enclosed
herewith.
c) Before the
first 15th of each quarter or on request, the local centralized drug
procurement units and the health facilities affiliated to Ministry of Health
shall submit reports on supply of drugs on the national list of drugs for
centralized drug procurement to the national centralized drug procurement
center in accordance with Appendix 11 enclosed herewith.
13. Supervising the progress of execution of framework agreements:
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a) If the demand
for drugs of a health facility under the management of local governments or a
health facility under the management of ministries and branches exceeds the
quantity of drugs specified in the framework agreement by 20%, the local
centralized drug procurement unit shall be notified to regulate drug quantities
between local health facilities.
Within 10 days
from the receipt of the written request for regulation of the health facility,
the local centralized drug procurement unit shall send a written reply to the
health facility.
b) If the demand
for drugs of the health facility affiliated to Ministry of Health exceeds the
quantity of drugs specified in the framework agreement; or the demand for drugs
of health facilities under the management of local governments or ministries
and branches exceeds the capacity of the local centralized drug procurement
unit; or the health facility's unexpected demand for a drug has not been
mentioned in the contractor selection plan, the national centralized drug
procurement center shall be notified to regulate drug quantities between health
facilities. Within 05 days from the receipt of the request for regulation of
the local health facility, the local centralized drug procurement unit shall submit
a report to the national centralized drug procurement center in accordance with
Appendix 12 enclosed herewith.
Within 10 days
from the receipt of the written request for regulation of the health facility,
the national centralized drug procurement center shall send a written reply to
the health facility.
The regulated drug
quantities of the national centralized drug procurement center shall not exceed
the quantity of drugs approved in the contractor selection plan and on the
national list of drugs for centralized bidding procurement. The regulation
shall comply with the regulation process of drugs on the national list of drugs
for centralized bidding procurement published by the national centralized drug
procurement center.
14. Payments for drug supply contracts:
The national
centralized drug procurement center (for direct contract conclusion); health
facilities (for framework agreement conclusion) shall pay the contractors in
accordance with regulations of law and terms of the concluded contracts.
The written
approval for drug regulation between centralized drug procurement units is a
part of Drug Purchase Contract and also a basis for the health facility and the
contractor to sign appendix of contract (for regulated items in the framework
agreement) or sign contract (for regulated items not in the framework
agreement).
Article 41. Organizing local centralized drug procurement
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a) The local lists
of drugs for centralized bidding procurement apply to the health facilities
located in localities including local health facilities, central health
facilities, health facilities under the management of ministries and branches
and health authorities in localities. Central health facilities, health
facilities under the management of ministries and branches and internal health
departments shall have the same responsibility as health facilities under the
management of local authorities for preparing drug use plans in accordance with
regulations on the local centralized contractor selection in their provinces.
Local centralized
drug procurement units shall have the same responsibility as health facilities
under the management of local authorities for surveying demand for drugs and
selecting contractors for local health facilities, central health facilities,
health facilities under the management of ministries and branches and internal
health departments in their provinces.
b) According to
the local lists of drugs for centralized bidding procurement, health facilities
of provincial governments (including local health facilities, central health
facilities, health facilities under the management of ministries and branches
and internal health departments) shall survey demand for drugs and submit it to
the local centralized drug procurement units.
c) The lists and
quantities of drugs shall be sent to the local centralized drug procurement
units before July 15th or another deadline specified by the local
centralized drug procurement units;
2. The local centralized drug procurement center shall review the
demand for list and quantity of drugs of local health facilities and survey the
demand for list, quantity, supply schedule of each drug in order to develop
contractor selection plan.
3. Making contractor selection plan: Local centralized drug procurement
units shall be responsible for division of drug categories in contract packages
and contents of contractor selection plans shall comply with Article 7 through
Article 14 of this Circular. Time limit for contract execution shall comply
with Clause 4 Article 39 of this Circular.
4. Organizing appraisal of contractor selection plan:
a) Local
centralized drug procurement units shall submit proposals of contractor
selection plans to Provincial Departments of Health.
b) The appraisal
of contractor selection plan for drugs on the local lists of drugs for
centralized bidding procurement shall comply with Clause 2 Article 16 of this
Circular. Provincial Departments of Health shall organize the appraisal of
contractor selection plans and submit them to Chairpersons of the People’s
Committees of provinces for approval;
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Chairpersons of
the People’s Committees of provinces shall consider approving the local
contractor selection plans at the request of Provincial Departments of Health.
6. Preparation for contractor selection:
According to the
contractor selection plans approved by Minister of Health, the local
centralized drug procurement units shall prepare the bidding documents and
submit them to Provincial Departments of Health for approval in accordance with
Article 27 through 29 of this Circular.
7. Organizing contractor selection:
The local
centralized drug procurement units shall implement the contractor selection,
bid evaluation, negotiation of contracts; propose successful contractors and
report on appraisal submission in accordance with Article 30 through 33 of this
Circular.
8. Appraising, approving and publishing contractor selection results:
a) The local
centralized drug procurement units shall prepare and submit the contractor
selection results to Provincial Departments of Health for appraisal and
approval;
b) Provincial
Departments of Health shall appraise and approve the contractor selection
results in accordance with Article 34 and Article 35 of this Circular;
c) The local
centralized drug procurement units shall announce and publish the contractor
selection results in accordance with Law on bidding.
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a) According to
the approved contractor selection results, the local centralized drug
procurement units shall complete and conclude framework agreements with
contractors in accordance with Law on Bidding;
b) The local
centralized drug procurement units shall publish the concluded framework
agreements in accordance with Law on bidding on the websites of People's
Committee of provinces and Provincial Departments of Health and send written
notifications to health facilities regulated by such framework agreements;
10. Completing and concluding drug supply contracts:
According to the
contractor selection results, the framework agreement, the demand for drug and
drug use plans of health facilities, the local centralized drug procurement
units (for direct contract conclusion) and health facilities shall complete and
conclude contracts with contractors ensuring:
a) Conformity with
conditions in framework agreements;
b) The price of
each drug in the contract does not exceed the successful bid announced by the
local centralized drug procurement units.
c) Time limit for
contract execution shall be specified in the contractor selection plans
approved by competent authorities but may not exceed 36 months from the
effective date of the centralized procurement results and framework agreements
until the parties fulfill obligations in accordance with the provisions of the
contract.
11. Reporting local centralized contractor selection results:
c) Before the
first 10th of each quarter or on request, contractors shall submit reports on
supply contract of drugs on the local lists of drugs for centralized bidding
procurement to the local centralized drug procurement units in accordance with
Appendix 10 enclosed herewith.
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12. Supervising progress of execution of framework agreements:
The local
centralized drug procurement units shall supervise and regulate drug supply for
the health facilities regulated by the framework agreement on the basis of
these principles:
a) If the demand
for drugs of a health facility exceeds the quantity of drugs specified in the
framework agreement by 20%; or the health facility's unexpected demand for a
drug has not been mentioned in the contractor selection plan, the local
centralized drug procurement unit shall be notified in accordance with Appendix
12 enclosed herewith to regulate drug quantities between local health
facilities. Within 10 days from the receipt of the written request for
regulation of the health facility, the local centralized drug procurement unit
shall send a written reply to the health facility.
The regulated drug
quantities of the local centralized drug procurement units shall not exceed the
quantity of drugs approved in the contractor selection plan for supply of drugs
on the local lists of drugs for centralized bidding procurement by 30%. The
regulation shall comply with the regulation process of drugs on the local lists
of drugs for centralized bidding procurement published by the local centralized
drug procurement units.
13. Payment: Health facilities shall pay contractors in accordance with
regulations of law and terms of the concluded contracts. The written approval
for drug regulation between centralized drug procurement units is a part of
Drug Purchase Contract and also a basis for health facilities and contractors
to sign appendix of contract (for regulated items in framework agreements) or
sign contract (for regulated items not in framework agreements).
Chapter V
PRICE NEGOTIATION
Article 42. General provisions on price negotiation
1. Drug Price Negotiation Council (hereinafter referred to as Council):
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b) Council shall
include:
- A Chairperson is Minister of Health;
- 02 Deputy Chairpersons is Head of Social Insurance of Vietnam and
Director of National Centralized Drug Procurement Center.
- Members who are representatives of relevant agencies affiliated to
Ministry of Health, Ministry of Finance, Social Insurance Office, and
independent experts in relevant fields.
c) Council shall:
- Consider price negotiation plans developed by the national centralized
drug procurement center.
- Implement drug price negotiation under the approved plans;
2. The national centralized drug procurement center, a standing unit of
Council, shall:
a) Develop
detailed price negotiation plans;
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c) Evaluate
proposals;
d) Develop
estimated price negotiation plans;
dd) Publish price
negotiation results;
e) Supervise and
regulate the supply and use of drugs selected by price negotiation;
g) Participate in
all stages of drug price negotiation process; aggregate and provide relevant
information during price negotiation process;
h) Carry out other
tasks at the request of Chairperson of Council.
3. Drug Procurement Consultancy Council shall advise the Minister of
Health in all stages of the drug price negotiation process on request.
4. If an offered drug is changed during the contractor selection
process, or the drug is supplied but the substitute drug is not offered in the
bid, the unit in charge specified in Clause 1 Article 37 of this Circular shall
consider approving for drug substitution specified in Clause 6 Article 37 of
this Circular.
Article 43. Prepare, appraise and approve price negotiation plans
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The national
centralized drug procurement center shall aggregate demand for drug use
specified in Clause 1 Article 40 of this Circular.
2. Making drug price negotiation plan:
The national
centralized drug procurement center shall prepare drug price negotiation plans.
Contents of drug price negotiation plan shall be specified in Article 14 of
this Circular with the following information:
a) Names and
prices of contract packages, total value of contract packages and value of each
part of contract packages in contractor selection plans;
b) The estimated
price of each drug through price negotiation shall be specified in Clause 4
Article 14 of this Circular;
c) Requirements in
terms of quality standards and delivery time, specific purchase conditions of
each drug under price negotiation;
d) The expected
time for price negotiation for each drug on the list of drugs under price
negotiation;
dd) In case of
necessity, the national centralized drug procurement center shall consult with
Council on the price negotiation plan before submitting to the appraising unit.
3. Appraising drug price negotiation plan:
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Planning – Finance
Department shall appraise the lists, contract package quantities, estimated
unit prices and drug quantities. The appraisal of price negotiation plan shall
comply with Clause 2 and Article 16 of this Circular.
4. The Minister of Health shall consider approving the price
negotiation plan on the basis of the report submitted by Planning – Finance
Department. In case of necessity, Minister of Health shall consult with Drug
Procurement Consultancy Council on drug bidding before approving.
Article 44. Prepare, appraise and approve proposals
According to the
contractor selection through price negotiation plan approved by Minister of
Health, the national centralized drug procurement center shall prepare the
bidding documents, appraise and approve the proposals.
1. Preparing the request for proposals:
a) The request for
proposals for drugs through price negotiation shall comply with Law on bidding,
detailed documents on Law on bidding and the national centralized drug
procurement center;
b) A proposal
shall contain sufficient information about the contract package; instructions
on preparation and submission of approvals; required capacity and experience of
contractors; criteria for technical and financial evaluation. Capacity,
experience and technical criteria shall be marked by “pass” or “fail”;
c) A proposal for
instructions shall contain information about prices, specific
economic-technical criteria to be applied during the price negotiation process
that has to be provided by contractors in their quotations, such as:
- EX works, CIF, selling prices for health facilities in manufacturing
countries and ASEAN countries provided by contractors;
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- Indications and clinical effectiveness evaluation of drugs in
treatment; The report on clinical effectiveness evaluation in treatment in
comparison with other standard drugs (if any);
- Data for pharmaceutical economic analysis of drugs including: cost –
efficacy, cost – benefits and cost – effects provided by the contractor.
- The contractor’s commitments to quantity and quality of drugs
supplied as well as supply schedule if awarded the contract;
2. Appraising request for proposals:
a) The request for
proposals under price negotiation shall be appraised before submitting to
Director of the National Centralized Drug Procurement Center for approval.
b) The appraising
unit shall be decided by the Director of the National Centralized Drug
Procurement Center.
3. Approving request for proposals:
The Director of
the National Centralized Drug Procurement Center shall approve the request for
proposals according to the appraising unit’s report.
Article 45. Organizing drug price negotiation
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2. Contractors prepare and submit proposals according to request for
proposals.
a) Bid security
and submission of proposals shall be specified in Article 30 of this Circular;
b) According to
the notification of bidding for drug supply and request for proposals under
price negotiation in order to prepare and submit the proposal by post or
directly to the national centralized drug procurement center.
3. Evaluating proposals and preparing price negotiation plans
a) The national
centralized drug procurement center shall evaluate proposals in accordance with
regulations of request for proposals. Proposals shall be publicly opened. In
the process of evaluation, the procuring entity may invite the contractor to
negotiation and amendments to some necessary information of proposals in order
to prove the contractor's qualification in terms of capacity, experience,
schedule, quantity, quality, technical solutions and measures of implementing the
contract package.
b) According to
the contractor’s proposal and the experts’ proposal evaluation report, the
national centralized drug procurement center shall prepare price negotiation
plans. In case of necessity, the center shall invite clinical and
pharmaceutical economic experts to participate in developing price negotiation
plan for each drug.
The price
negotiation plan shall summarize the information on pharmacological effect, the
estimated price and successful bid of the drug under price negotiation; drugs
having the same active ingredient, content/concentration, dosage form but not
in the same group of offered drugs; drugs in the same group of replaceable
pharmacological effect (if any), the factors relating to the price negotiation
plan and terms of the framework agreement that will be negotiated.
c) Chairperson of
Council shall approve the price negotiation plan before price negotiation.
4. Price negotiation and decision:
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b) A contractor
shall be invited to price negotiation if having lawful qualification,
satisfying requirements of capacity, experience and technical proposal of the
request for proposals and providing the estimated price that does not exceed
the estimate for the approved contract package;
c) The Council
shall decide whether to choose carry out the negotiations directly or by
correspondence. The Council's contents shall be based on the contractor’
proposal, the proposal evaluation report, relevant information and the approved
price negotiation plan;
d) If more than
one contractors participate in the price negotiation of the drugs having the
same active ingredient, content/concentration, dosage form, the Council shall
request them to submit new quotations which specify the time and location for
receiving such quotations and time for opening them, and invite them to attend
the opening session. The prices in the new quotations must not exceed the
negotiated prices. The contractor whose new bid is lowest shall be awarded the
contract.
dd) If the first
price negotiation is unsuccessful, the Council shall decide to invite or not to
invite the contractor to the second negotiation. The national centralized drug
procurement center shall notify the Council's official conclusion to each
contractor after the first negotiation;
e) If the
contractor is invited to the second price negotiation, the contractor shall
submit the new proposal and quotation in accordance with the negotiation letter
of the national centralized drug procurement center.
g) Successful bids
through price negotiation shall be decided by the Council and contractors. The
Council and the contractor shall conclude a framework agreement and other
conditions after reaching agreement on price;
h) After the
Council and the contractor’s representative conclude price nogotiation
contracts, the national centralized drug procurement center shall send a
written request for concluded price confirmation within 7 days to the
contractor.
Article 46. Appraising, approving and implementing drug price
negotiation results
1. Appraising and approving drug price negotiation results:
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- If the Council and the contractor are unable to reach agreement on
price after negotiation sessions, the national centralized drug procurement
center shall submit a report to Planning – Finance Department and notify the
result to the contractor and health facilities nationwide.
2. Publish price negotiation results:
a) The national
centralized drug procurement center shall publish contractor selection results
through price negotiation and provide guidance on implementation of price
negotiation results to health facilities in accordance with law.
b) For drugs on
the unsuccessful list of drugs for procurement by price negotiation, according
to the Council's opinions, the national centralized drug procurement center
shall propose alternative procurement plans and submit them to Minister of
Health for consideration and approval. For the proprietary drugs granted many
certificates of marketing authorization of Category 1 specified in Article 7 of
this Circular promulgated by Ministry of Health, health facilities may carry
out contractor selection by themselves through competitive bidding of generic
contract packages according to the Ministry of Health’s notice.
3. Payments for drug supply contracts:
a) The national
centralized drug procurement center shall complete and conclude framework
agreements with successful contractors; publish price negotiation results and
framework agreements on the Ministry of Health's website. Responsibility of
relevant parties and effect of framework agreements shall comply with Article
39 of this Circular. Selected contractors shall provide guarantee for contract
execution specified in Clause 1 Article 39 of this Circular;
b) According to
price negotiation results, framework agreements, distributed drug quantities
and plan of drug use budget approved by the competent authority, health
facilities shall conclude contracts with contractors under the condition that
prices in contracts do not exceed successful bids and framework agreements
published by the national centralized drug procurement center;
For effective drug
supply contracts, health facilities shall regulate drug prices to ensure that
they do not exceed published negotiation prices or the effective time of
framework agreements.
c) The contractor
selected through price negotiation shall supply drugs with the quantity,
schedule and other conditions agreed in the framework agreement and the
concluded contract with each health facility;
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e) The health
insurance authority shall make unanimous payment for all public health
facilities according to price negotiation results published by the national
centralized drug procurement center.
4. Report on drug price negotiation results:
Contractors
through price negotiation and health facilities shall submit reports on drug
supply results through price negotiation to the national centralized drug
procurement center specified in Clause 12 Article 40 of this Circular.
5. Supervising progress of execution of framework agreements:
The national
centralized drug procurement center shall supervise and regulate the supply and
use of drugs selected by price negotiation in the concluded framework agreement
specified in Clause 13 Article 40 of this Circular.
Chapter VI
IMPLEMENTATION
Article 47. Effect
1. This Circular comes into force from October 1, 2019.
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Article 48. Transitional provisions
1. The contract packages whose contractor selection plans are approved
before the effective date of this Circular shall comply with the provisions of
Circular No. 11/2016/TT-BYT dated May 11, 2016 of Minister of Health providing
guidance on bidding for supply of drugs for public health facilities, unless
the facilities specified in Article 2 of this Circular volunteer to follow this
Circular's provisions from the issuance date.
2. For drug manufacturing facilities satisfying EU-GMP requirements or
equivalent requirements and manufacturing facilities satisfying PIC/s-GMP
requirements of the national drug authority of the country considered a member
of PIC/s and ICH published by Drug Administration of Vietnam on its website
before the effective date of this Circular; these manufacturing facilities
shall not need to undergo evaluation of satisfying EU-GMP requirements or
equivalent requirements or PIC/s-GMP requirements organized by the drug authority
of Vietnam within months from the effective date of this Circular.
Article 49. Reference clause
In case any of the
documents referred to in this Circular is replaced or amended, the newest
document shall be applied.
Article 50. Organization and implementation
1. Heads of central authorities shall instruct affiliated health
facilities to select contractors in accordance with this Circular and
regulations of law on contractor selection.
2. Ministers, Heads of ministrial authorities shall assign tasks and
inspect the assignment applied to some contract packages of health facilities
under their management.
3. Chairperson of People’s Committee of each province shall:
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a) Instruct health
facilities to organize selection of suppliers of drugs on such list in
accordance with this Circular;
c) Decide addition
of other drugs to the local lists of drugs for centralized drug procurement
(except for drugs on the list of drugs for price negotiation and for national
centralized bidding) for use at local health facilities at the request of the
Director of the Provincial Department of Health. Time limit for contract
execution shall comply with Clause 4 Article 39 of this Circular.
If central health
facilities, internal health departments and health facilities under the
management of ministries and branches use the local lists of additional drugs
(except for the local lists of drugs for centralized bidding procurement issued
by Ministry of Health), health authorities of other sectors and internal health
departments and supervisory authorities of health facilities under the
management of ministries and branches shall sign agreement with Provincial
Departments of Health to submit reports to People's Committees of provinces for
contractor selection organization.
d) Decide and
inspect task assignments to some contract packages of health facilities under
their management at the request of the Director of the Provincial Department of
Health.
4. Drug administration of Vietnam, Traditional Medicine Administration
of Vietnam shall update the following information on their websites:
a) Lists serving
contractor selection, including:
- The list of reference authorities;
- The list of drug authorities of SRA countries;
- The list of drug authorities of countries that are state members of
PIC/s and ICH;
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- The list of drug manufacturing facilities satisfying EU-GMP
requirements or equivalent requirements ;
- The list of drug manufacturing facilities satisfying PIC/s-GMP
requirements in a country that is a member state of PIC/s and ICH and granted
certificates by drug authority of Vietnam.
- The list of drug manufacturing facilities that have herbal and
traditional drugs satisfying GMP requirements granted certificates by Ministry
of Health of Vietnam;
- The list of drug manufacturing facilities in Vietnam that have
traditional ingredients satisfying GMP requirements granted certificates by
Ministry of Health of Vietnam;
- The list of drug manufacturing facilities in Vietnam that have
herbal ingredients satisfying GMP requirements granted certificates by Ministry
of Health of Vietnam;
b) Lists of drugs
serving contractor selection, including:
- List of drugs granted certificates of marketing authorization or
import licences;
- List of proprietary drugs;
- List of reference bioequivalence;
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- List of drugs manufactured under a processing contract or technology
transfer contract in Vietnam;
- List of proprietary drugs and reference bioequivalence manufactured
under a processing contract or technology transfer contract in Vietnam;
- List of drugs having documents proving bioequivalence;
- List of drugs granted certificates of marketing authorization by one
of reference authority;
- List of drugs granted certificates of marketing authorization by one
of drug authority of SRA countries;
- List of drugs manufactured entirely in Vietnam satisfying criteria
of Category 1 specified in point c Clause 1 Article 7 of this Circular;
- List of ingredients in dosage form of glue, granule, extract,
essential oil, resin, gum, jelly in accordance with regulations of Ministry of
Health on quality management of herbal ingredients and traditional drugs;
- List of semi-finished herbal ingredients: glue, granule, extract,
essential oil, resin, gum, jelly in accordance with regulations of Ministry of
Health on quality management of medicinal ingredients;
- List of drugs on the list of national products;
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- List of herbal ingredients planted and collected or naturally farmed
satisfying GACP requirements and granted certificates by Ministry of of Health
of Vietnam;
- List of drugs manufactured in Vietnam satisfying requirements for
treatment, price and supply capacity;
- List of herbal ingredients domestically planted and collected
satisfying requirements for treatment, price and supply capacity;
- List of drugs manufactured from active ingredients in SRA countries
or active ingredients granted CEP certificates;
- List of drugs and manufacturing facilities, suppliers failing to
satisfy quality requirements or complying with regulations on bidding and drug
supply;
c) Information on
declared/re-declared drug price;
d) Information on
drug price and successful bids of herbal ingredients for health facilities;
dd) List of
capable, experienced and reputable drug manufacturers and suppliers to be
invited to selective bidding.
5. When purchasing drugs funded by health insurance, the social
insurance shall send officials to participate in:
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b) Making,
appraising the bidding documents;
c) Evaluating the
bid and appraising the contractor selection result.
6. During the contractor selection process, the health facility or
organizing unit shall send documents (except for confidential documents in
accordance with Law on bidding) to members participating in the Council or
Expert group specified in points a b c Clause 5 of this Article before meeting
within 5 days (except for urgent drug procurement for treatment). After the
above deadline, the health facility or organizing unit shall follow the steps in
the process of contractor selection to hold meeting of Council or Expert Group.
The members participating in the above-mentioned Councils or Expert Groups
shall comply with regulations of these Councils or Expert Groups according to
the Heads of Councils or Expert Groups.
Participants’
opinions shall be raised at the meeting. Any participant's opinion that is
different from that of the others shall be specified in the report.
7. Procurement of health insurance drugs of private health facilities
shall be based on the following principles:
a) Private health
facilities may participate in centralized drug procurements (national
procurements, local procurements, price negotiations) in their provinces. Such
private health facilities shall formulate drug use plans and comply with
regulations on local centralized bidding as if they are health facilities under
the management of local authorities. Provincial Departments of Health and local
centralized drug procurement units shall organize biddings for supply of drugs
for private health facilities as if they are health facilities under the
management of local authorities.
b) Private health
facilities not participating in centralized drug procurements (national
procurements, local procurements, price negotiations) may carry out contractor
selection themselves in accordance with law on bidding, instructional documents
and this Circular.
c) If a private
health facility does not organize contractor selection as prescribed in points
a and b of this Circular, the social insurance authority shall only pay
according to the published result of local or national contractor selection or
price negotiation result if the information such as trade name, number of
marketing authorization certificate or number of import license, dosage form,
content/concentration, route of administration, package contents, manufacturer,
manufacturing country are correct.
If the drug is not
included in the local or national-level concentrated procurement plan or price
negotiation plan, it shall be paid for according to successful bids of public
health facilities of the same districts which are published by Social Insurance
Office in accordance with Point b Clause 3 Article 77 of Decree No.
63/2014/ND-CP .
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a) Certificates of
free sale granted by drug authority of SRA countries and consular legalization
(original copies or certified true copies).
b) List of
information proving drugs sold in Vietnam and drugs granted certificates of
free sale by SRA countries having the same dosage form, manufacturing process,
quality standard, verifying method; active ingredient and excipient having the same quality standard, manufacturing
facility and manufacturing place specified in Appendix 13 enclosed herewith.
9. Health facilities requesting for evidence of proprietary drugs or
reference bioequivalence sold for the first time in countries not on the SRA
list specified in point b Clause 2 Article 8 of this Circular shall provide the
following documents and be legally responsible for their precision:
a) Patents for
modern medicines granted by one of competent intellectual property authority. A
patent for the active ingredient (if the drug has only one active ingredient)
or the mixture of active ingredients (if the drug has more than one active
ingredients) enclosed with the request for protection of the corresponding drug
(original copy or certified true copy).
b) International
birth date of drugs shall be expressed in periodic safety update reports;
c) Other evidence
(if any).
Article 51. Responsibility for implementation
Director of Drug
administration of Vietnam, Director of Traditional Medicine Administration of
Vietnam, Director of Planning – Finance Department, Chief of the Ministry
Office, Ministrial Chief Inspector, Director of the National Centralized Drug
Procurement Center, Heads of units affiliated to Ministry of Health, Director
of Departments of Health of provinces, drug business facilities and other
relevant organizations/individuals/authorities shall implement this Circular.
Difficulties that
arise during the implementation of this Circular should be reported to the Ministry
of Health for consideration./.
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PP. PRIME MINISTER
DEPUTY MINISTER
Truong Quoc Cuong