REVIEW 6-YEAR IMPLEMENTATION OF PHARMACEUTICAL LAW
Trần Thị Mai Oanh, Nguyễn Khánh Phương, Hoàng Thị Phượng, Nguyễn Thị Thủy, Đỗ Trà My et al.
Place of publication: Ministry of Health
Year of publication: 2012
The Pharmaceutical Law enacted on June 14, 2005 provides a major legal framework for public governance in pharmaceutical sector. Six years after implementation, the Pharmaceutical Law has proved up to par in meeting existing needs, strengthening the effectiveness and efficiency of pharmaceutical governance, and safeguarding the legitimate rights and interests of the population for access to quality, rational and safe drugs. The introduction of the Pharmaceutical Law enables the pharmaceutical sector in Vietnam to develop and play a better part in the region and the world. The implementing process of the Pharmaceutical Law and its sub-law documents, however, reveals various gaps and challenges. There is a real need for changes and updates of the 2005 Pharmaceutical Law to help negotiate with emerging social relations in the field of pharmacy, as well as revision and replacement of any regulatory schemes that are no longer relevant to the current needs and international treaties that Vietnam is a party to. The amendment of the law needs to base on objective and comprehensive review of the enforcement process and impacts of the Pharmaceutical Law 6 years after it was first introduced.
(1) review the implementation process of the Pharmaceutical Law; (2) evaluate the results of the Pharmaceutical Law implementation for 2005-2011; (3) recommend adjustments and revisions to the Pharmaceutical Law.
Methodology: A cross-sectional design was used, combining with site survey and desk study. Rapid assessment activities took place in the four provinces of Hanoi, Nghe An, Ho Chi Minh City and Kien Giang. Questionnaire-based quantitative surveys were conducted with 63 Health Departments and 180 pharmaceutical firms nationwide. Qualitative study, incorporating focus group and in-depth interviews, applied to various stakeholders concerning enactment, monitoring and enforcement of the Pharmaceutical Law at both national and sub-national levels. The review relies itself on indicators reflecting different parts of the Pharmaceutical Law, while also revolving around emerging issues that need refinement and updates in the upcoming Pharmaceutical Law.
1. The Pharmaceutical Law No. 34/QH11 released on June 14, 2005 provided a regulatory framework for the development of a relatively full-fledged normative system and accommodated public administration in the field of pharmacy. A few regulatory instruments, however, seem to lack consistency or reveal limitations on feasibility .
2. When the Pharmaceutical Law was in place, inspection and supervision in pharmaceutical area has been enhanced and strengthened. But these activities still face certain challenges due to organizational and staffing constraints, especially at locality level.
3. The organizational structure, operational system and human resources of pharmacy-related regulators at all tiers appear not completely well-prepared for the job of rolling out pharmacy-related laws and regulations in an adequate and timely manner.
4. The adoption of the Pharmaceutical Law and related legislation has helped improve governance, while enabling the local pharmaceutical sector to play a more active role in the region and the world. The results are impressive positive changes in almost all parts of the system, from production, trade, supply to consumption of drugs. The gross turnover of locally-made medicines has been on a year-on-year upward trend, reaching over $1 billion in value, meeting 46.88% of consumers’ needs (2011). The public governance apparatus in the pharmaceutical sector has been streamlined and consolidated. Commercial activities, including stages from production, wholesale and retails, are closely supervised in line with existing laws and regulations. Drug prices have generally been maintained at a relatively stable level. Introduction of GPs in production, distribution, storage, testing and retails has created a facelift in the pharmaceutical sector, promoting international integration in various areas. The price index for pharmaceutical products invariably remains lower than CPI.
5. The implementing process of the Pharmaceutical Law and related legislation, however, face challenges, given drawbacks in both policy enactment and implementation.
6. Recommended changes and updates to the current Pharmaceutical Law are quite broad-based and involve almost every part of the law.
1. The 2005 Pharmaceutical Law needs to be revised and updated building on the recommendations of this review to allow further improvement of the pharmacy-related legislative system in a holistic, consistent and highly effective way.
2. Clearer definition of roles, allocation of jobs and mandates in drug price control between different ministries, line agencies and coordinating mechanisms is needed.
3. Production and consumption of locally made drugs should be encouraged.
4. A collaborative and overseeing scheme involving pharmacy-related authorities and relevant ministries and agencies should be established for areas under overlapping jurisdiction such as drug price control, priorities of investment in the pharmaceutical sector to develop the local industry, advertisement of drugs and other products that may be confused as drugs, intellectual property and so on.
5. Drug and vaccine testing capacity should be upgraded to meet the requirements of drug quality control, especially the need to determine bioequivalence and detect counterfeit, poor quality pharmaceutical products. Research and proposal for establishment of 5-6 regional drug testing centers affiliated to the Ministry of Health should be conducted, building the current approach in other countries in the region.
6. The national pharmacovigilance system should be optimized and strengthened, while health workers receive capacity building in relation to pharmacovigilance work, to help promote rational and safe use of drugs.