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Let me begin by thanking the Drug Administration of Viet Nam and, the Office of the National Regulatory Authority for organizing this event to launch this important benchmarking exercise.
Although work to strengthen the regulatory system can feel demanding, everyone here today can feel confident that their work is having a very real impact on people’s health and lives.
Just last week, a colleague shared with me that three members of her extended family had cancer. Her family was worried though, because they had heard about substandard or falsified medications on the market. She told me about her family’s stress, heartbreak and loss of trust – because they didn’t know if the cancer medications were effective or safe for their loved ones to use.
It is for people like my colleague and her family that we do the work you are all here to help us with this week: to ensure people have access to the medicines they need, and to ensure they are safe, high quality, and effective.
Viet Nam is not alone in facing the challenge of substandard and falsified medical products, as well as related challenges such as ensuring that local manufacturers maintain good practices.
These are significant global health problems, impacting millions of people and compromising health systems worldwide. In 2017, WHO estimated that 1 in 10 medicines in low- and middle-income countries failed quality control tests, suggesting the product is substandard or falsified. As we know, this can lead to serious health risks, treatment failures and even death.
The economic burden is also substantial, with billions of dollars lost annually due to ineffective treatments, increased health-care costs and loss of productivity. And it can contribute to drug resistance, making diseases harder to treat.
So, it is commendable that this National Benchmarking exercise will cover not just vaccines, but – for the first time – it will also include medicines.
Viet Nam can be proud of the work it has done so far to strengthen its regulatory system, and WHO is honoured to have accompanied the country in this work.
And, we have celebrated together too, for example, in 2020 when Viet Nam’s vaccines regulatory system reached the second highest level of maturity – level 3 of WHO’s Global Benchmarking Tool. This is a solid accomplishment that deserves recognition. The process is rigorous and demanding. It is not easy to achieve, and perhaps even harder to maintain. So, we applaud Viet Nam’s perseverance and commitment to excellence.
For the past five years, the National Regulatory Authority has been preparing for the benchmarking exercise that begins today. I would like to particularly recognize the efforts of Dr Vu Tuan Cuong and Dr Le Viet Dung and their team at the Drug Administration of Viet Nam and other National Regulatory Authority agencies. You have continually worked to build capacity and address any gaps. And over the past few months, you have completed the demanding self-benchmarking exercise as a prerequisite to this week’s work.
Looking to the future, Viet Nam can continue to rely on our technical support as you draft and agree a new Institutional Development Plan with key areas for improvement. Your continued efforts on training, strengthening vaccine and medicine regulations, enhancing your procurement system, and developing the new law on medical devices will all contribute to accelerating progress.
This week will surely be intense. But it will also provide the National Regulatory Authority with the assessment it needs to steer the way forward for continued strengthening of the regulatory system in Viet Nam into the future.
WHO is proud to support you in this work. I am particularly grateful for the range of international experts from nearly every region of the world that we have brought together to support Viet Nam’s benchmarking exercise – and also grateful to my own team in our office here for the huge amount of hard work that has gone into preparing for this week.
In closing, I would like to congratulate Viet Nam once again on reaching this point. You have again demonstrated your commitment to a strong regulatory system that helps to ensure the safety and wellbeing of all people in Viet Nam.
I wish you an excellent week, as we collectively strive for a healthier, safer Viet Nam.
Xin cảm ơn!