Comments on the draft revised and supplemented Law on Pharmacy: Proposal to have separate regulations on medical oxygen

Delegates proposed to continue clarifying the content of medical oxygen in the draft revised and supplemented Law on Pharmacy to overcome the legal gap with this type of product.

On September 19, the Ho Chi Minh City National Assembly Delegation held a workshop to provide comments on the draft Law amending and supplementing a number of articles of the Pharmacy Law. Comrade Ha Phuoc Thang, member of the City Party Committee, Deputy Head of the Ho Chi Minh City National Assembly Delegation chaired the workshop.

At the workshop, Pharmacist Le Ngoc Danh, Head of the Pharmacy Department, Ho Chi Minh City Department of Health, said that the draft revised and supplemented Pharmacy Law basically meets the changes in the development process of the pharmaceutical industry. However, there are some contents that have been removed compared to the previous draft, which may lead to discrepancies in the implementation process.

Specifically, the draft Law on Pharmacy currently no longer includes medical oxygen. Previously, medical oxygen was included in the field of medical equipment, but later regulations on equipment no longer include medical oxygen.

Pharmacist Le Ngoc Danh wondered if the draft revised and supplemented Pharmacy Law does not mention medical oxygen, how will this product be managed in the future? Currently, medical facilities are having difficulty purchasing medical oxygen because it is not within the scope of any regulations. Meanwhile, the World Health Organization considers medical oxygen to be part of the list of essential drugs. Therefore, it is proposed to clarify the above content or have a separate provision for medical oxygen in the draft Pharmacy Law.

Mr. Le Ngoc Danh, Head of Pharmaceutical Affairs Department, Ho Chi Minh City Department of Health at the workshop

Medical oxygen plays an essential role in hospitals. This draft has removed the content about medical oxygen while medical oxygen is in the list of drugs covered by health insurance. Thus, it is necessary to clarify whether medical oxygen is included in the revised and supplemented Pharmacy Law or is left out. If left out, medical oxygen is not covered by any other regulations and will not be covered by health insurance. Therefore, it is necessary to have a separate provision for medical oxygen or clarify this content.

Dr. Pham Quoc Dung, Vice Principal of Pham Ngoc Thach University of Medicine

In addition, businesses and medical facilities are facing difficulties related to the issue of renewing drug registration numbers. The Ho Chi Minh City Department of Health recommends that registration numbers should be automatically renewed for quality-assured drugs, or that one-time licensing should be applied to reduce administrative procedures.

However, this draft of the Pharmacy Law still maintains the content that drugs requiring registration renewal must submit documents and the registration number is valid for 5 years. This will put pressure on the licensing authority, risking a backlog of documents as happened during the Covid-19 pandemic.

In addition, the Head of the Pharmacy Department, Ho Chi Minh City Department of Health said that currently, the Law is issued but the Decree and Circulars are not timely, or there is a situation where the Law stipulates but the Decree and Circulars do not provide guidance. For example, Clause 1, Article 147 of the old Pharmacy Law stipulates the right of drug retail establishments, which are pharmacies, to participate in the distribution of health insurance drugs, program drugs, and project drugs when meeting specific conditions. However, this provision cannot be applied in practice because there is no detailed guidance document. The draft revised and supplemented Pharmacy Law also does not mention this content.

Another issue of concern is the regulations on traditional medicine. According to Pharmacist Le Ngoc Danh, the Ho Chi Minh City Traditional Medicine Hospital has the only GMP-certified traditional medicine factory in the country. However, because the hospital is not a business, the drugs produced cannot be sold to other hospitals in Ho Chi Minh City, nor can they be bid for. Thus, the Law provides many provisions that are in line with the requirements, but the sub-law documents do not provide sufficient guidance, causing the law to not be put into practice.

Dr. Truong Thi Ngoc Lan, Deputy Director of the Ho Chi Minh City Institute of Traditional Medicine, said that traditional medicine hospitals also face another huge barrier in the regulation that " domestically produced medicinal herbs and traditional medicines must meet good farming and harvesting practices" (stipulated in Article 7, Sections 4a and 4b) . In Vietnam, most traditional medicines are grown by farmers, so it is very difficult to meet the good practice criteria as prescribed. For example, with the medicinal herb gotu kola, the Ho Chi Minh City Institute of Traditional Medicine is having a hard time buying it because of regulations on origin, while this is just an agricultural product.

Dr. Truong Thi Ngoc Lan suggested that it should be changed to "achieving good practices in growing and harvesting medicinal herbs or achieving quality according to the pharmacopoeia", and having testing facilities to evaluate the quality of medicinal herbs.

Comrade Ha Phuoc Thang, Member of the City Party Committee, Deputy Head of the Ho Chi Minh City National Assembly Delegation

In his concluding remarks, Comrade Ha Phuoc Thang said that he would record the opinions of the delegates, summarize the report to the National Assembly Standing Committee, the reviewing and drafting unit as well as the National Assembly Deputies of Ho Chi Minh City for discussion. It is expected that the Law amending and supplementing a number of articles of the Pharmacy Law will be passed by the National Assembly at the 8th session.

Regarding drug registration numbers, Ms. Nguyen Thi Thu Hang, Deputy Director of Ho Chi Minh City Social Insurance, said that currently, there are too many licensed registration numbers and there are many duplicates. For example, paracetamol 500mg is produced by many companies and the price is very wide, from more than one hundred dong to several thousand dong per tablet. Therefore, it is recommended to have measures to limit the issuance of new registration numbers for duplicate drugs because it causes difficulties for units in the bidding process.

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Source: https://www.sggp.org.vn/gop-y-du-thao-luat-duoc-sua-doi-bo-sung-de-xuat-co-quy-dinh-rieng-ve-oxy-y-te-post759718.html