Supplementing the national reserve of "orphan drugs" for emergency use

From practical work, Deputy Nguyen Tri Thuc (HCMC), Director of Cho Ray Hospital, spoke at the parliament on the afternoon of June 26 about rare drugs used in emergency.

Delegate Nguyen Tri Thuc (HCMC), Director of Cho Ray Hospital. Photo: QUANG PHUC

Stating that the health sector is having difficulty purchasing and stockpiling rare drugs used in emergency situations, such as Botulinum antitoxin, Deputy Tri Thuc said that in the world, drugs with only one manufacturer - possibly due to the selling price not ensuring the profit cost of pharmaceutical companies - to treat rare diseases are called orphan medicines. The Ministry of Health has issued a list of rare drugs according to Circular 26/2019/TT-BYT, including 214 lists of drugs to treat rare diseases and 229 lists of unavailable drugs. However, this list is no longer relevant because it is not regularly updated.

“Currently, there is no list of orphan drugs used in emergency care. Therefore, the Ministry of Health needs to establish an appraisal council and issue this list of drugs instead of granting a circulation registration certificate like other common drugs,” Deputy Thuc suggested. He also proposed adding regulations on national reserves of rare drugs (orphan drugs) used in emergency care to Article 3 of the Pharmacy Law and assigning the Ministry of Health to organize procurement and storage; ensuring availability for immediate use when needed.

National Assembly delegates attending the meeting. Photo: QUANG PHUC

According to Deputy Nguyen Tri Thuc, the recent shortage of radioactive drugs used to diagnose cancer patients on PET/CT machines has occurred in most hospitals that do not have reactors to produce radioactive drugs. The draft law stipulates that medical examination and treatment facilities are allowed to provide radioactive drugs to other medical examination and treatment facilities according to regulations of the Ministry of Health, but in reality there is no guiding circular and the 2023 Bidding Law has not yet regulated.

According to the delegate, the Ministry of Health needs to have a circular guiding units to be able to buy radioactive drugs from each other, to avoid shortages of radioactive drugs used for patient diagnosis, and waste of investment resources.

Sharing concerns about patients' access to drugs, especially those with malignant diseases, Deputy Nguyen Anh Tri (Hanoi) stated that the list of drugs covered by health insurance is issued by circulars, but from 2011 to now, it has only been issued four times.

Delegate Nguyen Anh Tri (Hanoi)

“Thus, every 3 to 4 years, the Ministry of Health issues a circular regulating the new drug list. In each circular, the number of drugs added is also very small. Meanwhile, science and technology are increasingly advancing, new drugs are being introduced quickly and in large numbers, new treatment regimens are constantly appearing, fundamentally changing the quality of disease treatment, especially for difficult diseases and malignant diseases...”, Mr. Nguyen Anh Tri analyzed.

This delay has a significant impact on the quality of treatment for patients. Deputy Nguyen Anh Tri proposed that the draft law add the content that the Ministry of Health is responsible for updating the list of complementary medicines annually. In addition, the Ministry of Health needs to coordinate with the Vietnam Social Security to develop provisions on adjusting the annual payment rate, thereby maximally protecting the legitimate rights and interests of the people, especially patients with malignant diseases requiring long-term treatment.

MR. PHUONG

Source: https://www.sggp.org.vn/bo-sung-du-tru-quoc-gia-thuoc-mo-coi-dung-trong-cap-cuu-post746404.html