On 22 September 2022, EuroCham Vice-Chair Minh Nguyen (Mazars), Advocacy Manager Vinh Dang, and representatives from the Pharma Group, including its Chairman Emin Turan (Sanofi), Director Thuy Nguyen and External Affairs Manager Thach Do, had a constructive meeting with Deputy Prime Minister Vu Duc Dam on the "Development of the Pharma Industry and Improving Innovative Drug Access."
Among the participants were representatives from the Ministry of Health (MOH), Vietnam Social Security, Ministry of Planning and Investment (MPI), Ministry of Finance (MOF), and business associations such as AmCham, Vietnam Pharma Association, and Vinapharm.
In response to the Prime Minister's Decision 376/QD-TTg dated 17 March 2021, Deputy Prime Minister Vu Duc Dam listened to the Ministry of Health on pharmaceutical development and gathered input from business associations.
Vice-Chair Minh Nguyen welcomed Prime Minister's Decision 1661, which simplified and eliminated several MOH administrative procedures. EuroCham's cooperation with the government, notably in the development of healthcare regulations, was also discussed.
Pharma Group Chairman Emin Turan examined the current state of the Vietnamese pharmaceutical industry and offered suggestions for accelerating access to innovative drugs. He also reported that Pharma Group members have difficulty persuading their home headquarters to invest in Vietnam because of policy volatility in the pharmaceutical industry.
EuroCham's Pharma Group made three recommendations:
- Immediately amend the Pharma Law to address drug shortages, and implement Decision No.1661/QD-TTg to simplify and reduce business regulations. Automatic registration numbers are to be extended to May 2023 in parallel with the end of marketing authorization renewable procedures, as per Decision 1661. The upcoming resolution should remove the of process renewing registration numbers to clear the backlog and harmonize with ASEAN standards;
- Review the current reference process for the approval of new drugs, invented drugs, and medicines for rare diseases, and decrease drug registration in line with Vietnam’s ASEAN neighbors;
- Make investing in Vietnam predictable and feasible. Drug registration should be accelerated along with regular updates to the National Reimbursement Drug List.
Deputy Prime Minister Vu Duc Dam said comprehensive and diligent revisions of the Pharma Law are needed, and the extension of Resolution 30 is a better way to handle immediate issues, such as extensions for MA validity.
The Deputy PM requested the MOH to:
- Provide a convincing argument for extending marketing authorization registrations to National Assembly members involved in healthcare;
- Urgently report on the mechanism for referencing innovative medicines; complete regulations for assessing the fees for evaluating drug registration dossiers;
- Amend Circular 30/2018/TT-BYT on annual rates and lists for chemical, biological, radioactive, and tracers under beneficiaries' health insurance.
Following the meeting, the Deputy Prime Minister talked briefly with EuroCham and AmCham about their contributions and the hope that EuroCham can assist with developing healthcare policies today to prevent shortages in the future.