How can people best access generic drugs?

(Chinhphu.vn) – Mr. Nguyen Thanh Lam, Deputy Director of the Department of Drug Administration, Ministry of Health, said that in 2024, the time for drug appraisal and licensing has been reduced to 11.6 months, and is expected to be only 10.3 months this year.

Drug registration time is just over 10 months away

Priority registration and licensing procedures for generic drugs

According to Mr. Nguyen Thanh Lam, to develop a new drug, pharmaceutical companies often have to spend decades of research at a cost of tens, even billions of dollars. Therefore, if only relying on invented drugs, no country can have enough financial resources to meet the treatment needs of its people.

From this reality, generic drugs were born. These are drugs developed after the original drug's protection period has expired, with similar ingredients, uses and treatment effects but at a much cheaper price.

Mr. Nguyen Thanh Lam also said that from a management and policy perspective, most countries, including Vietnam, consider encouraging research, production and use of high-quality generic drugs an important priority of the pharmaceutical industry.

Since 2014, Decision No. 68/NQ-CP approving the National Strategy for the Development of the Vietnamese Pharmaceutical Industry to 2020 and Vision to 2030 has focused on promoting research and production of domestic generic drugs. Decision No. 376/QD-TTg approving the National Strategy for the Development of the Vietnamese Pharmaceutical Industry to 2030, with a vision to 2045, also clearly stated the goal that by 2030, 75% of generic drugs will be produced domestically and used in the health system.

Also since 2016, the Pharmacy Law has clearly stipulated the policy of prioritizing the use of generic drugs in drug procurement using the state budget and health insurance.

In the latest amended Law on Pharmacy, this policy continues to be expanded, including prioritizing administrative procedures, registration and licensing for generic drugs.

The leader of the Drug Administration Department also shared that, according to statistics from the Health Insurance, about 80% of the drugs used in public health facilities are currently generic drugs. This shows that the policy of prioritizing the development and use of generic drugs has been fully institutionalized in the Party's policies and the State's laws and is gradually being put into practice through the public health system.

Mr. Nguyen Thanh Lam, Deputy Director of the Department of Drug Administration, Ministry of Health, spoke at the seminar - Photo: VGP/DT

Drug registration time is just over 10 months away

Responding to a report by the auditing company KPMG stating that the time for drug registration in Vietnam lasts 24 - 36 months, significantly longer than in some countries in the region, Mr. Nguyen Thanh Lam said that this was a problem from the previous period, and that this problem has now been resolved.

"Since 2013, the 100% online drug registration system has been in operation, at which time the average time to complete a dossier was 15.7 months. By 2024, this time has reduced to 11.6 months, and is expected to be only about 10.3 months in 2025," Mr. Lam informed.

According to the Drug Administration, the current appraisal and licensing process has been completely digitized, all records of businesses and research centers are processed online. The problem is no longer a petition, but how to develop this system to become increasingly intelligent and effective.

The Ministry of Health has now clearly stipulated that the average time to license a drug is 12 months, and at the same time, added an international reference mechanism to shorten the time for specific groups of drugs. Specifically, generic drugs manufactured under technology transfer contracts only take about 3 months to be evaluated and licensed, while other drugs can be resolved in about 9 months.

Recently, the Ministry of Health has added 4 pharmaceutical universities to the appraisal system, after being trained according to ASEAN regional standards, to increase objectivity and professional capacity in the process of evaluating dossiers.

At the same time, the Drug Administration of Vietnam also promotes international cooperation, invites foreign experts to train and share experiences with domestic experts and appraisers, aiming to build a transparent, professional licensing system compatible with regional standards.

How can people access the best quality generic drugs? - Photo: VGP/HM

What to do to help people access the best quality generic drugs ?

From the perspective of treatment facilities, Associate Professor, Dr. Nguyen Cong Hoang, Director of Thai Nguyen Central Hospital, National Assembly Delegate of Thai Nguyen Province, said that there are three key factors that need to be resolved, including tax policy, public-private partnership mechanism and regulations for foreign enterprises. If we can "untie" these bottlenecks, create an open and stable investment environment, we can completely form large-scale pharmaceutical production projects, contributing to reducing costs and improving access to medicine for people.

Approaching the aspect of high-quality generic drugs not only serving domestic needs but also serving exports, Dr. Tran Hong Nguyen, Vice Chairman of the Law and Justice Committee, said that it is necessary to design practical policies to promote the development of this field. Accordingly, there should be mechanisms on finance, land, tax, encouraging the application of science and technology, selecting qualified enterprises to invest in Vietnam, such as we attract Samsung to invest in Thai Nguyen, Bac Ninh...

Emphasizing that "the most important thing is how to make it possible for people to access quality generic drugs in the best way", Mr. Duong Tuan Duc, Head of the Health Insurance Policy Implementation Department, Vietnam Social Security, said that the Ministry of Health needs to determine the need for drug procurement based on the need for illness; must amend and adjust bidding regulations, determine the need for procurement based on the level of illness of the patient. Along with that, it is necessary to focus on expanding national centralized bidding for generic drugs, especially group 1 drugs.

According to delegates, Vietnam has shown positive signs by attracting more than 1.8 billion USD in foreign investment capital into the pharmaceutical sector, but this number could increase even more if the policy environment is improved towards transparency, predictability and encouragement of innovation.

Hien Minh

Source: https://baochinhphu.vn/lam-the-nao-de-nguoi-dan-tiep-can-duoc-thuoc-genenic-mot-cach-tot-nhat-102251105174738029.htm