WHY IS IT DIFFICULT FOR PATIENTS TO ACCESS NEW DRUGS?

Only 42 new drugs out of 460 types circulated globally are available in Vietnam, due to long licensing procedures and time, affecting patients.

On January 21, a representative of the Ministry of Health said that generic drug prices in Vietnam are low compared to countries in the ASEAN region (for most main treatment groups). While the proportion of generic drug use at medical facilities in Vietnam is 1%, that in Asia-Pacific countries is more than 11%.

Data from the medical and pharmaceutical research organization IQVIA MIDAS, updated in the first quarter of 2022, also shows that Vietnamese patients suffer many disadvantages in accessing new drugs compared to other countries. Specifically, only 9% (equivalent to 42 new drugs) are present in Vietnam out of a total of 460 drugs introduced to the global market in the past 10 years (from 2012 to the end of 2021).

Difficulty accessing new drugs is creating a lot of burden for patients. For example, about 25% of the Vietnamese population suffers from cardiovascular disease and hypertension; More than 350.000 patients are living with cancer, but many people give up due to difficulty accessing new drugs. According to Dr. Vu Ha Thanh, Deputy Head of Internal Medicine Department 2, K Hospital, there are currently only three immunotherapy drugs for cancer treatment licensed by the Ministry of Health for circulation while the world has recognized many new therapies. These drugs are not covered by health insurance, causing many patients to abandon treatment because they do not have the finances.

The reason for this situation is that the speed of access to new drugs depends largely on the time the drug is granted a Certificate of Circulation Registration. According to the provisions of the Pharmacy Law 2016, drugs must be registered with the State management agency (Department of Drug Administration, Ministry of Health) before being circulated in the Vietnamese market, and the time for granting a Certificate of Circulation Registration (GDKLH ) for a maximum of 12 months.

However, in reality, new drugs often take 4-5 years to be granted a medical certificate because this process has many shortcomings in administrative regulations, causing difficulties for both management agencies and businesses because of limited resources. .

Recently, drug shortages have continuously occurred, partly related to the procedure for periodically renewing the medical license every 5 years after being issued a new one. Expired drugs are not allowed to be used at medical examination and treatment facilities until their validity is extended by the management agency.

To solve urgent problems, the Government issued Resolution 80 in early 2023, temporarily extending the validity of expired drugs’ GĐKLH until the end of 2024. The validity extension does not affect quality. , safety and effectiveness of drugs because these drugs have been registered for circulation for many years in Vietnam and many countries around the world.

Mr. Le Viet Dung, Deputy Director of the Drug Administration of Vietnam, Ministry of Health, said that in the 10 months of 2023, the department has had 9 announcements to extend the validity of circulation registration certificates for drugs and medicinal ingredients until 31 months of 12. ends December 2024, 2016. To continue to remove difficulties and obstacles related to ensuring drugs, medical equipment and supplies, the Ministry of Health is amending the XNUMX Pharmacy Law.

The revised Pharmacy Law project is being completed, focusing on developing the pharmaceutical industry, creating a legal corridor to prioritize research, receive technology transfer and produce invented drugs and high-tech drugs, helping people. diseases have easy access to new drugs. This is one of 5 policy groups focused on in this revised Pharmaceutical Law Project, to promote the development of the pharmaceutical industry, helping doctors and patients increase access and the right to choose treatment drugs.

In particular, the Ministry of Health proposed to simplify dossiers and procedures for extension, change, and supplementation of medical record labels and medicinal ingredients; Regulates cases of extension, change, and supplementation of the drug registration certificate that do not have to go through the Advisory Council for issuance of drug circulation registration certificates. At the same time, reduce the time to extend the renewal contract (reduced from 3 months to 1 month in case the extension does not have to go through the council).

The Ministry of Health also proposed to allow the replacement of pharmaceutical product certificates; Exemption from submitting clinical dossiers for new domestically produced drugs that meet urgent needs; Reference and recognition mechanism in drug registration, to help people quickly access advanced and new drugs.

This law project is being evaluated by the Ministry of Justice. It is expected that the Draft will be considered by the National Assembly at its 7th session (May 5), and approved at its 2024th session (October 8).

Source: VNExpress

About STELLAPHARM

Stellapharm is one of leading generics pharmaceutical companies and strong producer of anti-viral drugs in Vietnam. The company established in Vietnam in 2000; and focuses on both prescription drugs and non-prescription especially in cardiovascular diseases, antiviral drugs, anti-diabetics drugs, etc. and our products are now used by millions of patients in more than 50 countries worldwide.

The company is globally recognized for its quality through our facilities have been audited and approved by stringent authority like EMA, PMDA, Taiwan GMP, local WHO and others.

Additional information for this article: Stellapharm J.V. Co., Ltd. – Branch 1
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