Công văn 13395/QLD-GT

THE MINISTRY OF HEALTH
THE DRUG ADMINISTRATION OF VIETNAM
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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

Respectfully to:

- 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.

FOR THE DIRECTOR
DEPUTY DIRECTOR




Nguyen Viet Hung

No.

Current provisions

Shortcomings, inconformity

Units’ proposals

The Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012

I

Classification of drug groups in bidding package in according to generic name

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.

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.

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.

II

 “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)

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.

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.

III

The regulation scope of Circular No. 01/2012/TTLT-BYT-BTC dated January 19, 2012 is finished drug products.

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.

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.

IV

There is no clear provision related to vaccine used at medical establishments of vaccination service to define whether it is required bidding or not.

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. 

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. 

V

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.

- 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.

- 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.”.

The Circular No. 11/2012/TT-BYT dated June 28, 2012

VI

Section 1 Annex 3 “Standards, conditions for production and business in drug items participating in bidding”.

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.

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".

VII

Point b section 5 Annex 3 -   “Drug items produced by establishments with drugs breaching quality within 1 recent year will be deducted (- 5 points)”

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.

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”.

VII

Point b section 7 Annex 3 -  “Quality violation situation of drug items participating in bids"

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.

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.

VIII

Section 10 Annex 3 – “Drug items participating in bids by contractors with organization of drug distribution center”

Now because there is no document prescribing for center of drug distribution, all contractors have no points at this section.

Proposing for clear guide about this content.

IX

Section 12 Annex 3 – “Drug items participating in bids by contractors with system of distribution and provision spreading all mountainous and difficult areas

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.

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.