Overview of Pharmaceutical Businesses in Hanoi

Chapter 2

IMPLEMENTATION OF LAW ON PHARMACEUTICAL BUSINESS REGISTRATION FROM PRACTICE IN HANOI CITY

2.1. Overview of pharmaceutical businesses in Hanoi

Hanoi is the capital of the Socialist Republic of Vietnam, the political - economic - social center of the whole country. After the merger, Hanoi is the largest city in Vietnam in terms of natural area with 3,345 km2 , second in terms of urban area, after Ho Chi Minh City. Hanoi also ranks second in population with 7,200,000 people (2014). Located in the fertile Red River Delta, this place soon became a political, cultural and economic center from the beginning of Vietnam's history. Along with Ho Chi Minh City, Hai Phong, Da Nang, Hanoi is one of the four leading economic centers of the whole country. In 2009, after expansion, Hanoi's GDP increased by about 6.67%, total budget revenue was about 70,054 billion VND.

According to Resolution 15/2008/QH12 of the National Assembly on adjusting the administrative boundaries of Hanoi capital and provinces, effective from August 1, 2008, the entire Ha Tay province, Me Linh district of Vinh Phuc province and 4 communes of Luong Son district, Hoa Binh province were merged into Hanoi. Hanoi currently consists of 29 district-level administrative units (including 10 districts, 18 districts, 1 town). Including new districts and counties such as Ha Dong, Son Tay town and 13 districts: Dan Phuong, Ba Vi, Chuong My, Hoai Duc, Me Linh, My Duc, Thuong Tin, Phu Xuyen, Phuc Tho, Quoc Oai, Thach That, Thanh Oai, Ung Hoa.

In recent years, despite facing many difficulties and challenges due to the impact of the global economic crisis, Hanoi's economy has recovered and grown quite well. Gross regional domestic product (GRDP) increased by 9.24%. Regarding business performance , the number of newly registered businesses in 2015 was estimated at 18,340, an increase of 33.7% compared to 2014. 10 months

In early 2015, 14,102 enterprises ceased operations (an increase of 14.2% over the same period in 2014), of which: 927 enterprises dissolved, 10,115 enterprises abandoned their business addresses, and 3,060 enterprises temporarily ceased operations.[30]

In the pharmaceutical sector, Hanoi is one of the major pharmaceutical production and distribution centers in the country. Hanoi is home to a large number of pharmaceutical production, trading and distribution enterprises, including domestic pharmaceutical production enterprises, foreign-invested enterprises, representative offices of major international pharmaceutical companies... The pharmaceutical market is always bustling because it is an important pharmaceutical circulation and distribution hub to most provinces, cities, mountainous areas, islands, remote areas in the country. In recent years, the number of pharmaceutical businesses in the city has increased rapidly and diversified in business scale. The pharmaceutical distribution system has developed widely with 3 major pharmaceutical distribution centers: Lang Ha, Ngoc Khanh, Hapulico (Vu Trong Phung): of which Hapulico is the largest distribution center today with 5 floors and a scale of more than 200 pharmacies to meet the wholesale and retail needs of pharmaceuticals. Currently in Hanoi, in addition to local enterprises, there are many pharmaceutical production and trading enterprises under the Central Government, ministries, branches, and provincial enterprise branches.

2.2 Current status of law enforcement on pharmaceutical business registration in Hanoi city

The pharmaceutical industry always plays an important role in our country's economy. The Party and the State always pay attention to the development of the pharmaceutical industry. The attention is expressed through Resolution No. 46-NQ/TW dated February 23, 2005 on the protection, care and improvement of people's health. The Resolution identifies the pharmaceutical industry as a key economic sector, prioritizes the development of the pharmaceutical industry, improves domestic drug production capacity, prioritizes the production of high-tech dosage forms, plans the development of medicinal material areas,

production of chemical and pharmaceutical raw materials; strengthening and developing the circulation and distribution network to stabilize the drug market... providing drug support for policy beneficiaries. In order to realize that policy, the National Assembly, the Government and ministries and branches have issued legal documents to regulate issues related to the pharmaceutical industry in general and the pharmaceutical business sector in particular. Decree 78/2015/ND-CP also clearly stipulates in Article 7 as follows: “ Enterprises are entitled to conduct business in conditional investment and business sectors from the time they have met the conditions prescribed by law and must ensure that they meet those conditions throughout their operation. State management of conditional investment and business sectors and inspection of enterprises' compliance with business conditions are under the authority of specialized agencies according to the provisions of specialized laws.” .Thus, legal documents regulating business conditions such as pharmaceutical business outside the Pharmacy Law and specialized Decrees and Circulars on Pharmacy are not effective. The business conditions of enterprises here are the Certificate of eligibility for business issued by the Department of Health and the Ministry of Health. To be granted a Certificate of eligibility for pharmaceutical business, a pharmaceutical business establishment must meet the following conditions:[22, Article 11]

- Facilities, technology and qualified personnel necessary for each form of business.

- The professional pharmacy manager has been granted a pharmacy practice certificate appropriate to the business form.

2.2.1 Registration for pharmaceutical wholesale business:

In the current pharmaceutical market, wholesale distribution plays an important role in the link between manufacturers, importers and retailers. In recent years, the number of enterprises registering to trade in pharmaceuticals has increased rapidly. According to the summary report of 5 years of pharmaceutical practice in the period 2011-2015 of the Hanoi Department of Health, by 2015, the city had about 1,400

Enterprises registered to do wholesale distribution of pharmaceuticals, in which the number of applications for certificates of eligibility to do pharmaceutical business increases every year:[25]

Year

2011	2012	2013	2014	2015
Business Registration Certificate Number	567	668	623	868	953

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With the number of registered businesses increasing each year, both in terms of re-issuance and new issuance, the management agency must anticipate the regulations for this type of business to be suitable and follow the WHO's procedures and standards. The regulations on granting Certificates of eligibility for business in pharmaceutical wholesale business include regulations on professional managers and good distribution practice standards (GDP).

2.2.1.1. Pharmaceutical professional manager:

Professional managers in pharmacy are those who are trained in appropriate knowledge and expertise and meet the requirements of work experience, practice time, and work in accordance with the requirements of the business sector. For the health sector, ethics is the top priority in practicing. Therefore, professional managers are not allowed to commit illegal acts, for example: committing illegal acts while practicing, during the learning process as well as internships are not subject to administrative or criminal sanctions. With that requirement, the Law on Pharmacy has stipulated that people who are not granted a pharmacy practice certificate include:

Being banned from practicing pharmacy according to a criminal judgment or decision of the Court; being prosecuted for criminal liability; being in the process of serving a criminal judgment or decision of the Court, or a decision to apply administrative measures to be sent to an educational institution; being in the process of being disciplined from the form of warning or higher related to medical or pharmaceutical expertise. Having lost civil act capacity or having limited civil act capacity.

The professional manager of a pharmaceutical wholesale establishment must have the following qualifications and time:[13, Article 15]

- The pharmaceutical professional manager of a pharmaceutical wholesale enterprise must have a university degree in Pharmacy and at least 3 years of practice at a legal pharmaceutical facility.

- The professional manager of pharmaceuticals of a vaccine and medical biological products wholesale enterprise must have a university degree in Pharmacy or Medicine (or a university degree in biology and at least 3 years of practice at a legal pharmaceutical facility).

- The professional pharmacy manager of an enterprise, cooperative, or individual household trading in medicinal herbs, oriental medicine, or medicine from medicinal herbs must have one of the following documents: a university degree in Pharmacy, a high school degree in Pharmacy, a university or high school degree in traditional medicine; various types of diplomas in traditional medicine, traditional medicine, a certificate of traditional medicine, a professional qualification in traditional medicine and pharmacy, and at least 02 years of practice at a legal pharmaceutical facility.

- The professional pharmacy manager of a vaccine and medical biological products sales agency must have at least one of the following degrees: a university degree in Pharmacy, a high school degree in Pharmacy, a high school degree in Medicine, a university degree in Medicine or a university degree in Biology and at least 02 years of practice at a legal pharmaceutical facility.

In order to ensure fairness as well as preserve the identity of Vietnamese traditional medicine, the Ministry of Health also issued Circular 02/2007/TT-BYT regulating and explaining more clearly the conditions for accepting related diplomas such as:

- University or vocational high school diploma in traditional medicine.

- Certificate of traditional medicine practitioner and traditional medicine practitioner issued by a training facility designated by the Ministry of Health to train and issue a certificate.

- Certificate of traditional medicine issued by the Ministry of Health or the Department of Health before Circular 01/2004/TT-BYT dated January 6, 2004 of the Ministry of Health guiding private medical practice took effect.

- Certificate of traditional medicine practitioner or traditional medicine pharmacist issued by the Ministry of Health or the Department of Health before the effective date of Circular 01/2004 of the Ministry of Health guiding the private practice of medicine and pharmacy.

- Certificate of traditional medicine qualification issued by the Ministry of Health or Department of Health.

*Application for issuance, change, extension, re-issuance of Pharmacy Practice Certificate:

For those who have met the requirements for professional qualifications, Article 16 of Decree 79 stipulates the application for a pharmacy practice certificate as follows:

- Application for Certificate of Pharmacy Practice

- Legal copies of professional qualifications

- A CV certified by the Chairman of the People's Committee of the commune, ward or town where the applicant for a Certificate of Practice resides or by the Head of the agency where the applicant is working, if he/she is a civil servant.

- Certificate of good health to practice issued by a medical facility as prescribed by the Ministry of Health within 06 months from the date of issue.

- Certificate of practice time at a legal pharmacy issued by the head of that facility. A legal pharmacy here is understood as an establishment operating in the pharmaceutical field established in accordance with the provisions of law, including: drug business establishments, pharmaceutical departments of medical examination and treatment establishments, institutes and drug testing centers, state pharmaceutical management agencies, public and private schools training pharmaceutical staff.

Commitment to comply with the provisions of relevant legal documents on pharmaceuticals.

- Notarized or certified copy of ID card.

- 02 portrait photos size 4cm x 6cm.

* The application for changing the Pharmacy Practice Certificate due to damage, tearing, change of permanent address of the individual registering to practice pharmacy, extension of Pharmacy Practice Certificate, re-issuance of Pharmacy Practice Certificate in general must have the following requirements:

- Application

- Certificate of practice has been issued

- Health certificate (for extension application)

- 02 photos 4cm x 6cm.

* Procedures and authority for granting, re-granting, changing and extending Practice Certificates

medicine:

The Ministry of Health has issued guidelines on granting pharmaceutical practice certificates.According to

The Law on Pharmacy, the Department of Health issues a pharmacy practice certificate to an individual who registers to practice pharmacy. The Department-level management agency here is the Pharmacy Practice Management Office of the Department of Health that receives applications for a pharmacy practice certificate. Within 30 days from the date of receipt of a valid application for re-issuance, change, or extension of a pharmacy practice certificate, the agency receiving the application must organize an appraisal to issue, change, or extend the pharmacy practice certificate: if it is not issued, re-issued, changed, or extended, the agency receiving the application must have a written response stating the reason. However, here, according to Article 18 of Decree 79/2006/ND-CP and Circular 02/2007/TT-BYT, the deadline for notification of the application is still only within 30 days. This will cause individuals to waste time waiting while this period can be shortened. Enterprises always consider time as gold in business. Any opportunity will pass by if not grasped, it is clear that this procedure not only affects individuals but also affects the process of establishing a business. For the Ministry of Health, as a management agency and an advisory body to the government on issues related to the industry, although

However, it was not until 2012 when Decree 89/2012/ND-CP was issued that this issue was resolved. Section 4 of Decree 89/2012/ND-CP amends and supplements Article 18 of Decree 79/2006/ND-CP; clearly stipulates the time limit for handling invalid dossiers: “ Within 03 working days from the date of receipt of the dossier requesting the issuance or re-issuance of a pharmacy practice certificate, the dossier receiving agency shall return the dossier to the individual submitting the dossier.”

Previously, according to the Law on Pharmacy and Decree 79/2006/ND-CP, the issued practice certificate was only valid for 05 years from the date of issue and had to be renewed 03 months before expiration. The certificate issued by the Department of Health, renewed, is valid within the province or centrally-run city where the certificate was issued. This has caused difficulties for individuals when moving their workplace, especially for retired officials. To overcome this, Decree 89/2012/ND-CP amended and supplemented Article 17 of Decree 79/2006/ND-CP as follows: “ A pharmacy practice certificate is issued once and is valid nationwide. For a pharmacy practice certificate that has been issued for a period of 5 years, when it expires, the individual must apply for a re-issuance of the pharmacy practice certificate at a competent State agency.” This problem has solved the situation where individuals only focus on making certificates and doing business in Hanoi. Meanwhile, some provinces, cities, and a large number of districts do not have pharmacists and a wide distribution system.

2.2.1.2.Conditions on facilities, materials and techniques:

In addition to the requirements for pharmaceutical professional managers, the indispensable conditions for the issuance of a Certificate of Eligibility for Pharmaceutical Business stated in the Law on Pharmacy are the material facilities, techniques and personnel with the necessary professional qualifications for pharmaceutical wholesale business. Article 22 of Decree 79/2006/ND-CP also clearly stipulates that the material facilities, techniques and personnel of pharmaceutical wholesale establishments must meet the standards of good distribution practice (GDP) to be eligible for the issuance of a Certificate of Eligibility for Pharmaceutical Business for wholesale establishments. Article

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