New drugs available in Vietnam are still low.
Data from the IQVIA MIDAS Pharmaceutical Research Organization updated in the first quarter of 2022 shows that only 42 new drugs (equivalent to 9%) are available in Vietnam out of a total of 460 types launched globally in the past 10 years (from 2012 to the end of 2021). This is a relatively low rate compared to the average of 20% in the Asia-Pacific region.
The slow availability of new and advanced drugs in Vietnam limits treatment opportunities for patients, especially for serious illnesses.
When they cannot access domestic medicine, many patients seek treatment abroad. Dr. Duong Huy Luong, Deputy Director of the Ministry of Health, said that Vietnamese people spend about 2 billion USD each year to go abroad for medical treatment, a figure that could increase to 3-4 billion USD in the near future. In addition, some medicines that are not covered by health insurance are barriers that force many patients to give up treatment because they cannot afford the financial burden.
For example, cancer drugs are also a major economic burden for the whole society. Spending on cancer drugs in 2023 is 7,521 billion VND, ranking first in total drug payments from the Health Insurance Fund.
According to statistics from hospitals, the average cost of treatment for a cancer patient is over 176 million VND/year, of which the patient must pay up to 70%.
According to statistics from the Ministry of Health, there are currently 69 cancer treatment drugs in the drug list out of a total of 1,037 drugs in the list of chemical and biological drugs covered by health insurance within the scope of benefits for health insurance participants.
However, there are currently many new generation advanced treatment drugs that are highly effective in treating cancer, meeting the requirements of clinical experts as well as the expectations of patients, but are not yet on the list of drugs covered by health insurance.
According to the provisions of the 2016 Pharmacy Law, drugs must be registered with the state management agency (Department of Drug Administration, Ministry of Health) before being circulated in the Vietnamese market, the maximum time for granting a circulation registration certificate is 12 months.
Although the Drug Administration of Vietnam has recently made many announcements to extend the validity of drug and pharmaceutical ingredient registration certificates, it has not yet solved the drug shortage problem at medical facilities.
Opportunity for patients to access new drugs
The draft amendments and supplements to a number of articles of the 2016 Pharmacy Law have many preferential policies and incentives for the development of the pharmaceutical industry with the goal of helping people have more access to new drugs with high treatment efficiency and reasonable prices. This draft amendment is expected to be submitted to the National Assembly for approval at the ongoing session (Session VIII, October - November 2024).
Mr. Chu Dang Trung, Head of Legal Division - Integration, Ministry of Health said that there are 5 new points in the Draft amending and supplementing a number of articles of the 2016 Pharmacy Law, including simplifying administrative procedures on the order and procedures for granting drug circulation registration certificates; increasing references, recognition, and accreditation to create favorable conditions and increase proactiveness for businesses.
According to Mr. Trung, the draft revised Law on Pharmacy also expands the business rights for foreign-invested pharmaceutical businesses (FIEs) in Vietnam. This will allow FIEs to participate more deeply in Vietnam's drug supply chain. At the same time, these businesses will be allowed to directly distribute drugs produced by the businesses themselves, to order processing, and to transfer technology in Vietnam. Attract FIEs to invest in this field to improve domestic production capacity. Along with that, the bill creates conditions for domestic drug manufacturing facilities to access advanced drug manufacturing technology. Moving towards proactively ensuring drug supply and drug security for people's health care.
Amending and supplementing a number of regulations to promote the development of the pharmaceutical industry in order to supplement more appropriate and innovative policies compared to the 2016 Pharmacy Law to attract investment and further promote research and development of pharmaceutical raw material production; research and receive technology transfer for the production of high-tech drugs, biotech drugs, and special-treatment drugs; simplifying the procedures for granting drug circulation registration certificates, increasing the ability to access drugs early for people while still ensuring quality control, safety and effectiveness as well as compliance with international practices.
