COVID-19: Extension of Market Access to Life-Saving and Life-Extending Drugs - Issues Impacting the Life Sciences
Vietnam, a country of 97 million people, has been widely recognized for its successful handling of the novel coronavirus outbreak. On January 27, as the country celebrated the Lunar New Year holiday, Prime Minister Nguyen Xuan Phuc declared war on the coronavirus, having said "fighting this epidemic is like fighting the enemy". The Prime Minister and his cabinet acted expediently in controlling the spread of the virus. After implementing early preventative methods such as contact tracing and quarantining by area and apartment buildings, culminating in a three-week nationwide lockdown, Vietnam lifted various social distancing and restrictive rules in late April. Businesses and schools have reopened, and life is gradually returning to normal.
However, after defeating this “enemy”, Vietnamese people are facing another challenge, which will place the lives of thousands of Vietnamese in great danger. Currently, Marketing Authorizations (“MAs”)—that permit foreign manufactured drugs access to the Vietnamese market and to the Vietnamese patient—for a large number of medicines, which are for the treatment of acute, chronic illnesses will expire on July 1, 2020. If the MAs of medicines are not re-certified, the medicines cannot, as a matter of law, be imported into Vietnam.
In this Newsletter, we provide a broad picture of the situation and make certain recommendations. including: (i) the background; (ii) the reasons for this problem; (iii) what happened in the past; (iv) available legislative options for current situation; (v) recommendations; and (vi) conclusion.
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