National Assembly Delegate: Drugs have been circulating in the US and Europe for 5-6 years, but when entering Vietnam, they still 'have to wait for a visa'

Representative Nguyen Lan Hieu - Photo: National Assembly Media

On October 22nd, during a discussion on amending the Law on Pharmaceuticals in the National Assembly, Representative Nguyen Lan Hieu (Binh Dinh) raised the issue of the current situation where obtaining visas for medicines still requires "queuing for a whole year".

"Therefore, the people may still be disadvantaged and not benefit from the new achievements of science ," Mr. Hieu stated.

There is a need for clear regulations regarding the importation of medicines that have been approved by other countries.

According to Mr. Hieu, many countries are much stricter than Vietnam, such as Japan, the US, and Europe, where "drugs have been in circulation for 5-6 years, but we still have to wait for visa approval."

Therefore, he emphasized the need for clear regulations regarding the import of drugs that have been recognized by countries around the world through large-scale application studies.

Just as the FDA in the US, Japan, and Europe grant licenses and the products are covered by health insurance in those countries, a streamlined procedure for obtaining marketing authorization in Vietnam could be implemented.

"For example, if we have a visa to the US or Europe in our passport, we can apply for a visa to Taiwan online, without an interview, which saves a lot of time and is free. This method should also be implemented."

"Or, some developing countries have already used those drugs, so we can help bring them to Vietnam sooner, as well as new treatment methods that can be applied in Vietnam," Mr. Hieu added.

In addition, according to Mr. Hieu, regarding rare drugs that have not yet been registered for circulation in Vietnam, which were mentioned in the previous session, the draft law has not yet emphasized this issue.

He cited examples such as specific treatments, antidotes, and allergens for desensitization... These drugs are very important and can save patients' lives, but their use is very low.

While waiting for importation, the registration process is very time-consuming, and companies are reluctant to import small quantities without profit, so people often have to buy them through unofficial channels.

Therefore, he suggested that regulations on this matter were needed and that the bill should include a definition of specialized drugs for specific treatment cases.

This allows hospitals to purchase directly from foreign manufacturers, or the Ministry of Health can implement a centralized purchasing plan in advance, with hospitals receiving supplies from the Ministry of Health when needed.

Representative Pham Khanh Phong Lan - Photo: National Assembly Media

Lack of management in the distribution and retail pharmacy sector.

Meanwhile, delegate Pham Khanh Phong Lan (Ho Chi Minh City) argued that there is still a significant lack of guidance on managing the intermediate levels and tiers, including tens of thousands of pharmaceutical distribution companies and retail pharmacies.

While retail pharmacies are now concentrated in densely populated areas, they remain scarce in remote and rural regions, as was the case before.

"The number of these companies and pharmacies is increasing, while we have no method, no solution to strengthen management."

We want to regulate drug prices, but we can't set limits on how many intermediaries a single pill can pass through or what the permissible profit margin is; we can only rely on self-declaration by the drug manufacturers.

That price is impossible to determine, so the old order will repeat itself here, and it will be very difficult.

"Until we have a proper management system for this distribution network, the practice of circular buying and selling, the unrestricted sale of prescription drugs, or the mixing of counterfeit and substandard drugs can still occur," Ms. Lan added.

Regarding the number of registered drugs, according to Ms. Lan, Vietnam currently has over 800 active ingredients and 22,000 drug registration numbers, a figure far exceeding that of other countries. The duplication of drug registration numbers domestically is very common, leading to management difficulties.

She suggested limiting the number of drug registrations to make the registration process more transparent and rigorous, and requested that this provision be added to the draft law.

"Regarding the registration process, I would like to reiterate once again that I am extremely frustrated that registration numbers are still only issued on paper, and this poses many risks."

"We must learn from other countries on how to restrict production processes through technical barriers so that we can inspect them on-site," Ms. Lan said.

Source: https://tuoitre.vn/dai-bieu-quoc-hoi-thuoc-luu-hanh-o-my-chau-au-5-6-nam-nhung-vao-viet-nam-van-phai-cho-cap-visa-2024102215054374.htm