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THE MINISTRY OF
HEALTH
THE DRUG ADMINISTRATION OF VIETNAM -------- |
SOCIALIST
REPUBLIC OF VIET NAM
Independence – Freedom - Happiness --------------- |
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No. 13395/QLD-GT
Regarding opinions for amending and supplementing the Joint Circular No. 01/2012/TTLT-BYT-BTC and the Circular No. 11/2012/TT-BYT, on bidding for drug purchase |
Hanoi, August 19,
2013
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Respectfully to:
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- The Health Departments of provinces and central
affiliated cities;
- Hospitals/ institutes with hospital beds affiliated the Ministry of Health; - Enterprises of drug production and business. |
In order to correct the bidding work in drug
purchase in medical facilities, the Ministry of Health coordinated with
relevant Ministries and sectors in promulgating the Joint Circular No.
01/2012/TTLT-BYT-BTC, dated January 19, 2012 of the Ministry of Health, and the
Ministry of Finance, guiding the bidding of drugs procurement in the medical
facilities, and the Circular No. 11/2012/TT-BYT dated June 28, 2012 of the
Ministry of Health, guiding the preparation of bidding dossier for drug
procurement in medical facilities. After more than one year carrying out
the mentioned-above documents, it initially has presented the efficiency and
preeminence in reforming administrative procedures , assurance of justice and
transparent competition in drug bidding, and thrift in costs for drug purchase
of medical facilities, patients, state budget and medical insurance funds.
However, during implementation, the Drug
Administration of Vietnam (the Ministry of Health) has received proposals of
units regarding some difficulties and inconformity need be considered and
adjusted to be more suitable and convenient for medical facilities as well as
enterprises (proposals of units have been collected at the annex enclosed with
this document ).
Aiming to prepare for consideration, revision for
completing regulations on drug bidding in medical facilities, the Drug
Administration of Vietnam requests Units:
1. Researching and providing opinions for proposals
collected at the Annex enclosed with this document.
2. For other content, requesting the units for
providing specific opinions relating to difficulties and inconformity during
implementation of the drug bidding work and specific proposals for revision of
current regulations with the aim to remedy difficulties and inconformity.
Proposals should be sent prior to August 30, 2013
via email (Email address: quanlygiathuoc@gmail.com)
and in writing (To address: The Drug Administration of Vietnam – the Ministry
of Health, 138A Giang Vo, Ba Dinh district, Ha Noi).
Respectfully thanks for your cooperation.
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FOR THE
DIRECTOR
DEPUTY DIRECTOR Nguyen Viet Hung |
ANNEX
COLLECTION OF UNITS’
PROPOSALS RELATING TO THE REVISION OF PROVISIONS IN JOINT CIRCULAR NO.
01/2012/TTLT-BYT-BTC DATED JANUARY 19, 2012 AND CIRCULAR NO. 11/2012/TT-BYT
DATED JUNE 28, 2012
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No.
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Current
provisions
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Shortcomings,
inconformity
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Units’
proposals
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The Circular No. 01/2012/TTLT-BYT-BTC dated
January 19, 2012
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I
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Classification of drug groups in bidding package
in according to generic name
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1. Clause
1 Article 7 of the Circular No. 01/2012/TTLT-BYT-BTC dated January 19,
2012: at Drug bidding packages by generic name, each drug by
generic name is divided into groups based on technical criteria and the
licensed technology standards as follows:
- Group 1: group of drugs produced in the
countries participating in EMA, or ICH or PIC/S.
- Group 2: Group of drugs produced in the
drug-manufacturing facilities meeting principles, standards of GMP-WHO as
recommended by WHO inspected and issued certificate by the Ministry of Health
(the Drug Administration of Vietnam).
- Group 3: Group of drugs not being of the groups
mentioned in point a and b of this clause.
- Group 4: Where the drugs produced according to
franchising of drug manufacture in Vietnam under the provisions of law, based
on the facility transferring the right of drug manufacture to classify this
drug into one of the drug groups as prescribed at Points 1, 2 and 3 for
conformity.
- Group
5: of drugs have bioequivalence proof already announced by the Health
Ministry
2. Clause
2 Article 4 of the Circular No. 11/2012/TT-BYT dated June 28, 2012, only drugs produced at factories satisfying PIC/S-GMP and
EU-GMP principles and standards are eligible to join in bidding for the group
of drugs produced in member states of EMA or ICH, or PIC/S.
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1. For
drugs produced at factories satisfying PIC/S-GMP and EU- GMP principles and
standards, still remain divergent opinions, specifying:
- Classification of drug groups based on
standards of factory is correct but not sufficient, quality and efficiency of
treatment from drugs may depend on other elements: Quality of raw material
source, technology qualification and process, processing techniques …
- At present time, it had 11 announcement times
with 691 factories satisfying the PIC/S-GMP and EU-GMP principles and
standards, in which there are more 85 factories of India, 14 factories of
Indonesia, and 9 factories of Malaysia…
- Some enterprises and hospitals have reflect
that drugs produced at member countries of EMA, ICH, of which the
technology qualification in processing and management skills of pharmaceutical
products (mechanism of controlling manufacture and distribution of
pharmaceutical products) are developed higher than the remaining
countries So that, in fact, drugs produced at member countries of EMA, ICH
are appreciated regarding manufacture technology and product quality and
strict observance of EU-GMP.
- Drugs
produced at factories satisfying PIC/S-GMP and EU- GMP principles and
standards in India, Indonesia have not yet had prestige on quality resulting
that doctors do not use many these drugs.
2. For
group of drugs produced domestically There is opinion assuming that according
to provisions of the Joint Circular No. 01/2012/TTLT-BYT-BTC dated January
19, 2012 and the Circular No. 11/2012/TT-BYT dated June 28, 2012, there will
be only 01 drug produced domestically which may win bid nearby at the lowest
price, this will not encourage enterprises to invest in technology.
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1. For group 1, it is expected to classify into
02 sub-groups:
- Sub-group 1: drugs produced at manufacture
facilities located in member countries of EMA and ICH, and manufacture
facilities satisfying EU- GMP principles and standards.
- Sub-group 2: drugs produced at manufacture
facilities not located in member countries of EMA or ICH, and manufacture
facilities satisfying PIC/S-GMP or EU-GMP principles and standards.
2. Groups 2, 3, 4 and 5: unchanged
3. Some proposals for consideration to divide
these groups into smaller groups
Grounds of proposals:
- Division into 02 sub-groups applicable to group
1 will ensure the justice more for facilities complying strictly with EU-GMP
standards because there are only member countries of EMA and Japan, America.
However, for sub-group 1, it will exclude drugs produced in Australia,
Canada because these countries have not yet join in ICH and drugs which
are produced in countries with pharmacy industry develop not equal to the
remaining countries still be present in sub-group 1, such as: Cyprus, Estonia, Greece, Lithuania,
Luxembourg, Malta, Slovakia.
- The
drug groups produced domestically with addition of sub-group should be
considered to encourage the manufacture facilities in investment in
technology; and proposing technical criteria for dividing sub-groups of drugs
produced domestically but having to ensure conformity for WTO integration.
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II
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“The bidding package of oriental drugs and
drugs from medical herbs” (Clause 3 Article 7 Circular No.
01/2012/TTLT-BYT-BTC date January 19, 2012)
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At present time, establishments producing oriental
drugs and drugs from medical herbs which meet GMP-WHO are prioritized more 3
points in comparison with establishments producing oriental drugs and drugs
from medical herbs which have been granted certificate of good drug
manufacturing practice WHO-WHO. However, some opinions assume
that this provision actually is not priority for establishments producing
drugs from medical herbs which meet GMP-WHO because high prices are difficult
to able to get an acceptance of bid. At present time, there are about 10
establishments producing drugs from medical herbs which meet GMP-WHO and
ensure competition in bidding.
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Proposals regarding the bidding package of
oriental drugs and drugs from medical herbs are divided into two groups
- Group
1: Drugs from medical herbs produced from establishments producing medical
herbs meeting GMP-WHO
- Group
2: oriental drugs and drugs from medical herbs which have been granted
certificate of eligibility for trading in drugs not yet met GMP-WHO from
medical herbs.
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III
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The regulation scope of Circular No.
01/2012/TTLT-BYT-BTC dated January 19, 2012 is finished drug products.
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1. For biologicals to diagnose in vitro such as
tests for HIV, hepatitis B, diabetes… they are products in boundary between
drugs and medical equipment. Regarding conditions for establishments of
production, import, other business involving other finished drug products
(the production establishments meeting GMP or ISO or equivalent certificate,
the import and wholesale establishments satisfying conditions for trading in
equipment or trading in drugs).
2. About technical specifications, biologicals to
diagnose in vitro similar to chemicals and consumable supplies.
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Proposing for biologicals to diagnose in vitro
not belonging to scope of regulation of the Circular No. 01/2012/TTLT-BYT-BTC
dated January 19, 2012, and guide bidding similar to chemicals, consumable
supplies.
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IV
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There is no clear provision related to vaccine
used at medical establishments of vaccination service to define whether it is
required bidding or not.
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1. Vaccines
used at medical establishments of vaccination service are not presented in
contents of non-application at Clause 2 Article 2 of the Circular No.
01/2012/TTLT-BYT-BTC dated January 19, 2012 causing difficulty for medical
establishments to define whether they must organize bidding or not,
because these vaccines taken revenue source from payments of voluntary
subjects who may self select products according to their ability and
demand.
2. The
wholesale prices of these vaccines have been declared in accordance with
regulation and service charges of vaccines have been complied with the
Circular No. 232/2009/TT-BTC, prescribing the levels of, regime of
collection, remittance, management and use of the preventive medicine charges
and border quarantine charges.
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Proposing for vaccines used at medical
establishments of vaccination service to be not in scope of regulation of the
Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012.
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V
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Article 23 of the Circular No. 01/2012/TTLT-BYT-BTC
dated January 19, 2012
In special case, to prevent the drug lack
influencing specialized operations, units are allowed to apply form of
selecting other contractor for drug purchase with a limited quantity;
specified as follows:
1. Cases
of drug purchase allowed to apply form of selecting other contractor:
a) Drugs under list of rare drugs arising
irregularly according to demands of special treatment promulgated by the
Ministry of Health, and not yet been put into the bidding plan.
b) Drugs not in list of drugs of plan on bidding
for drug purchase in year approved by competent authorities, with the aim to
meet demand serving specialized operations in cases of emergency such as:
epidemics, natural disasters, serious influences to healthy of
patients.
c) Drugs stated in list of drugs of plan on
bidding for drug purchase in year approved by competent authorities, but not
yet had result of bidding or fail to select winner of bidding, while these
drugs need be purchased in a hurry to meet demand serving specialized
operations in urgent cases.
d) Drugs stated in the approved plan on bidding
for drug purchase, but in year, their use demands exceed the
quantities under plan approved by competent authorities, quantity of a drug
allowed to purchase in excess of the plan in year will not more than 20% of
quantity of that drug already won bid. Limitations of drugs of all kinds
which are allowed to purchase in excess of the plan in year at hospitals
depend on ranks of hospitals according to the ranking of the Ministry of
Health; specifying: The rank-3 and rank-4 hospitals are allowed to purchase
not exceeding VND 600 (six hundred) million; the rank-1 and rank-2
hospitals are allowed to purchase not exceeding VND 01 (one) billion;
and special-rank hospitals are allowed to purchase not exceeding VND 02
(two) billion.
2. Requirements upon procurement:
d) The drug and treatment Council of unit
considers and makes written proposals with head of unit.
b) Drugs allowed circulating in Vietnam, and
satisfying requirements on quality, use duration in accordance with current
regulations.
c) Drug prices: Unit has reference of 03 quotes
or sale invoices of supplier, wholesale prices of suppliers, wholesale prices
of declaration, re-declaration and reference of prices announced on website
of, the Drug Administration of Vietnam as basis for consideration and
entering into contracts with suppliers.
3. When purchasing drugs in above cases, head of
unit will decide on forms of procurement in conformity with current
provisions of law on bidding.
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- Provision on purchase limitation applicable to
only case of drug items allowed purchase not more than 20% of the planned
quantity in year at hospitals is not ensured the drug provision for hospitals
in respect to 03 remaining cases at sub-item a, b, c Clause 1 Article 23
because these cases must comply with provisions of the bidding Law (to ensure
that the provision must be carried out according to form of bidding
assignment not exceeding VND 100 million), is a value too less for special
hospitals in case of expensive drugs.
- At sub-item c Clause 2 Article 23 prescribing
the drug prices (unit make reference of 03 quotes/invoices, prices of
declaration/re-declaration and prices of winning bid on websites of , the
Drug Administration of Vietnam) but Clause 3 Article 23 prescribed as follows
"When purchasing drugs in above cases, head of unit will decide on forms
of procurement in conformity with current provisions of law on bidding.', so
that units have problem whether they must formulate and submit the bidding
plan or not. If units must formulate and submit the bidding plan, they will
lose much time which cause influence to the drug provision course of
hospital.
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- Proposing for application of limitation of drug
purchase to 04 cases of drug purchase allowed applying form of selecting
other contractor.
- In order to reduce procedures for procurement
and ensure the timely drug provision, propose to annul provision in Clause 3
Article 23 of "When purchasing drugs in above cases, head of unit will
decide on forms of procurement in conformity with current provisions of law
on bidding.”.
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The Circular No. 11/2012/TT-BYT dated June 28,
2012
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VI
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Section 1 Annex 3 “Standards, conditions for
production and business in drug items participating in bidding”.
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Because the bidding package of oriental drugs and
drugs from medical herbs are expected to divide into two various groups: (1)
Group 1: drugs from medical herbs produced from establishments producing drugs
from medical herbs satisfying GMP-WHO and (2) Group 2: oriental drugs and
drugs from medical herbs which have been granted certificate of eligibility
for trading in drugs but not yet met GMP-WHO and participating in bidding
into separate groups.
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Provision in point d section I Annex 3 “”Drug
items participating in bidding are oriental drugs and drugs from medical
herbs of contractors which are establishments producing this item already
been granted certificate of good drug manufacturing practice WHO-GMP” will be
adjusted from “27 points” up to “30 points".
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VII
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Point b section 5 Annex 3 - “Drug
items produced by establishments with drugs breaching quality within 1 recent
year will be deducted (- 5 points)”
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Drug quality is dependent on many subjective and
objective reasons from production, circulation, distribution and to users.
For a factory producing hundreds of drug items, if it violate quality due to
subjective or objective reason, and revoked 01 lot of 01 drug kind, it will
be lost point (15 points), in case where the remaining drug items of this
factory within 01 year after issuing decision of revocation participate in
bidding, these drugs will be difficult to have chance of winning bid, which
results the operational suspension of this factory during 01 year.
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Content of this provision is necessary to assess
assurance of drug quality. However, proposing for restructuring of the
point system in which “Drug items produced by establishments with drugs
breaching quality within 1 recent year will get 0 point, in replacement of
5-point deduction, and deduction of points will apply to the chain producing
drugs violating quality only, not deduct point for entire factory producing
drugs”.
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VII
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Point b section 7 Annex 3 - “Quality
violation situation of drug items participating in bids"
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Deduction (-10 points) for drugs violating
quality at level 2 and deduction (-5 points) for drugs violating quality at
level 3 when participating in bids are not reasonable because a violated drug
item participating in bid will be lost 15 points in comparison with drugs not
violating quality, so that, if counting section 7 for drugs violating
quality, these drugs will be lost (20 points) or (25 points), addition of the
loss (15 points) at section 5, it is sure that these drugs will be defeated
in bidding, excluding deduction of points at other criteria.
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Proposing for restructuring the point system at
point b section 7 Annex 3 by decreasing the point levels: (-5 points) for
drugs violating quality at level 2 and (0 point) for drugs violating quality
at level 3.
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VIII
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Section 10 Annex 3 – “Drug items participating in
bids by contractors with organization of drug distribution center”
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Now because there is no document prescribing for
center of drug distribution, all contractors have no points at this section.
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Proposing for clear guide about this content.
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IX
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Section 12 Annex 3 – “Drug items participating in
bids by contractors with system of distribution and provision spreading all
mountainous and difficult areas
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1. In pass time, the drafting Board of Circular
has set out provision in section 12 Annex 3 of the Circular No.
11/2012/TT-BYT dated June 28, 2012 to base on list of 20 provinces with poor
districts at the annex "Result of surveying and reviewing poor
households and near-poor households in 2012 at 62 poor rural districts under
the Resolution 30A/2008/NQ-CP" promulgated together with Decision No.
375/QD-LDTBXH dated March 28, 2012 of the Minister of Labor, Invalids and
Social Affairs, on approving result of surveying and reviewing poor
households and near-poor households in 2011. The formulation of 20 provinces
with poor rural districts is based on conditions which these districts are
located in mountainous areas with terrain divided, wide natural area but land
area for cultivation is small, weather conditions are disadvantaged,
regularly happen flash floods, pipe floods; over 90% of population is
minority ethnic people , living dispersedly, infrastructure is
lacked and bad. (The Government’s Resolution 30A/2008/NQ-CP dated December
27, 2008, on program supporting for the rapid and sustainable poverty
reduction for 61 poor rural districts).
2. In fact some localities have difficult areas
(mountainous areas, islands…) such as Quang Ninh, Kien Giang provinces…. not
stated in these 20 provinces. So that, some provincial Departments of Health
propose that application of section 12 Annex 3 of the Circular No.
11/2012/TT-BYT dated June 28, 2012 will base on the Decision No.
30/2012/QD-TTg dated July 18, 2012 of the Prime Minister, on criteria to
identify special difficult villages and communes in ethnic minority and
mountainous areas for the 2012 - 2015 period, and Circular No.
01/2012/TT-UBDT dated October 24, 2012 of the Committee for Ethnic Affairs,
guiding the Prime Minister’s Decision No. 30/2012/QD-TTg dated July 18, 2012.
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Some units propose for not specifying provinces,
as follows: Pursuant to Decision No. 30/2012/QD-TTg dated July 18, 2012 of
the Prime Minister, on criteria to identify special difficult villages and
communes in ethnic minority and mountainous areas for the 2012 - 2015 period,
and Circular No. 01/2012/TT-UBDT dated October 24, 2012 of the
Committee for Ethnic Affairs, guiding the Prime Minister’s Decision No.
30/2012/QD-TTg dated July 18, 2012, and based on provision and network of
drug provision at areas, the provincial Departments of Health where have
special difficult hamlets (as announced by the Committee for Ethnic
Affairs) will formulate criteria and define contractors which have a system
of distribution and provision spreading the mountainous and difficult areas.
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