In last twenty years, the average drug consumption / capita in Vietnam grew rapidly. In 1990, drug consumption is only U.S. $ 0.5 / person / year largely based on former Soviet Union and SEV economic block aid (30 million rubles / year). At that time, Vietnam groups lowered drug consuming countries in the world.
Up to November 2011, Vietnam has 108 pharmaceutical factories compliant to GMP-WHO, a few plants to European GMP, Japanese GMP standards to make a turnover of U.S. $ 919 million of pharmaceutical products (as of December 12, 2010) in which 39 FDI projects account for 28% of total turnover.
There are approximately 22,000 pharmaceutical products being allowed to circulate in the market and prepared from about 1,500 active pharmaceutical ingredients (API), and enough to meet the requirements for treatment of disease patterns in Vietnam during the period of industrialization - modernization. The list of local drugs covers all pharmacological groups classified by the World Health Organization (WHO). During the subsidy period Vietnamese pharmaceutical industry can only produces about 500 essential drugs. New drugs, proprietary medicines must enter into Vietnam drug market by un-official way (family gift from overseas Vietnamese). Nowadays, within one to two years new innovated drugs could be imported under various forms ( under import license, for clinical evaluation ...) and followed the quality control and usage monitoring (in hospital, under prescription and monitored by a physician ...) by the Drug Administration and the Department of Health. The active pharmaceutical ingredient (API) circulate in the market at different dosage forms with different brands from different sources (domestic, industrialized countries, countries with the same levels of development to Vietnam ...), controlled through the registration numbers, with different prices, which offers patients the appropriate choices dependent to their income and ability to pay.
Counterfeit and substandard medicines have been basically controlled. In the early 90' decade of last century, the proportion of fake drugs and substandard medicines was around 8-9% (due to uncontrolled sources of family gift and donation drugs...). In Mid 90', the rate of fake and substandard medicines is equivalent to the rate of countries from the region as reported in an independent surveys conducted by WHO in Vietnam in 1995. This result has been improved in recent years. In 2010, the rate of substandard drugs was less than 3% and the rate of counterfeit drugs was less than 0.1% similar to Indochina and ASEAN countries one. This significant result above is due to the policy of the Ministry of Health strengthening and improving staff capacity, science and technological level ... for the National Institutes and Provincial Centers of Drug Quality Control.
The growth rate of Vietnamese pharmaceutical industry in the decade 2000-2010 was 15-20% annually, considered highest in the region while the growth rate of the global pharmaceutical industry is only at one digit number (9 %, 2009). Growth rate forecast for the pharmaceutical industry in the period 2010-2015 is around 17-19%, although the growth rate of the national economy during this period may be only one digit.
1. In the world every year there are about 1,000 innovated APIs protected by intellectual property monopoly. With the legal system of international and national intellectual property protection, no pharmaceutical company is licensed to produce the active ingredients and finished products from these APIs except for the company that invented them.
2. API industry, one among six leading of hi-tech industries (aerospace, petrochemical, automobile, electronic, information and pharmaceutical industry), is a sophisticated industry with the enormous financial and science-technology. The API industry cannot self-develop that should be developed sustainably together with the development of national science - technology and other supportive industries (petrochemical industry, industrial automatic technology, biotechnology, information technology, new materials industry, automation ...). In summary, API industry is able only to develop on the basis of an effective and efficient industry and national economy, the scientific infrastructure, high-technology and creative capacity of the country.
Therefore, a country must only decide to invest in those areas where the pharmaceutical industry has a competitive advantage. Currently about 20 countries only on the world are able to research and discover and produce new active API. These countries are in the group of industrial developed countries in Europe and North America (Appendix 2). Other countries, especially developing countries, have focused on the finished products manufacturing industry. The international experts noted that in a pharmaceutical field, a country with income per capita below U.S. $ 10,000 / year cannot be a candidate to join the group of APIs manufacturers.
After more than 15 years of GMP application, now Vietnamese finished products manufacturing industry is proved to be relatively competitive in the region. Many multinational corporation aim at the pharmaceutical factories in Vietnam to seek possibilities of cooperation in pharmaceutical production in accordance with their out-sourcing strategies to Asia with many advantages (absorption ability of technology, infrastructure and technology investment with lower costs than in the West, human resources with appropriate qualifications and skill but relative lower cost than the West's ...). Pharmaceutical production in Asia will reduce production costs in order to have a competitive price and possibility to expand markets to multinational companies, and at the same time consumers in developing countries also benefit drugs with high quality and affordable price, decreasing the "transfer pricing manoeuvre " in importation of drug. The drug quality and prices are under control of national drug administration agency and Ministry of Health.
1. To expand pharmaceutical products export-import business to private sectors, not being assigned the exclusive importer for the state pharmaceutical enterprises only, and to allow private pharmaceutical company to be involved in import and export of medicines (if eligible capital, manpower, facilities, technology and customer relationship).
2. To equity the state-owned pharmaceutical enterprises.
3. To encourage foreign direct investment and private investment in pharmaceutical production industry.
In the new context of Vietnam, the Ministry of Health has changed the "Department of Pharmacy" into the "Drug Administration" directly administrating drugs instead of only advising as before , which is similar to the common administration models in the world. After 15 years since the formation, Vietnamese Drug Administration has been enhanced in such aspects (human resources, professionalism, technology infrastructure, international relations ...), which significantly contributed to the restoration and maintain discipline in the Vietnamese pharmaceutical market.
2.1. The domestic pharmaceutical industry developed rapidly, but lack of planning. It should had paid much attention to high-tech industry for good quality products, instead of a focus on prices competition only. The quality of medicines now faces the risk of losing a confidence of physicians and consumers.
Some domestic manufacturers produced "me-too" drugs, which resulted in a market chaos and a "confusion" for physicians' and consumers' usage. Pharmaceutical Administration Agency has not issued the proper barriers to limit the registration of overlapping products and effectively managed drugs circulation on the market. The local pharmaceutical manufacturers did not concern in patent and industrial property protection (Appendix 1, 2). The National protection agency of intellectual property and industrial property (NOIT: National Office of Intellectual Property) could not effectively limit unfair competition by "copy" drug manufacturing.
The Vietnamese pharmaceutical companies are currently manufacturing common or generic drugs, and very little focused investment in research and development for producing products with high knowledge content, technology and know-how in order to enhance value, quality and effectiveness of drug. The manufacturers usually pay much attention to improving the packaging forms, labels ... but not focus enough to the quality of packaging material, while the climate is quite harsh in Vietnam (Vietnam's climate is classified by the World Health Organization to the Region IV - extreme climates in the world in terms of adverse effects to the stability of the drug). So far in Vietnam do not have any manufacturer of pharmaceutical packaging that meet WHO GMP standards.
Ready for regional and global integration and to catch up the outsourcing strategy of multinational corporations, step by step bring the Vietnamese pharmaceuticals to regional and global market, the domestic pharmaceutical industry must reach modern standards internationally recognized. If not, Vietnam would be less competitive investment environment than China and the other ASEAN countries, where have more favorable conditions and investment environment and huge market (China). As a result, in the future, Vietnam may have to import drugs from Asian countries.
After nearly 20 years of pharmaceutical industry transition to a market mechanism, there is not unified view of the mechanism for drug prices management. A tendency to consider drugs as other consumer goods have not seen the dual character of pharmaceuticals both the economic and the social facet. Thus, it appears two extremities: or the full liberalization of the management of drug prices under the competitive and market mechanism, or return to the subsidy mechanism.
Since 2003, after consultation with drug price management experience from former socialist countries with the level of economic social development similar to Vietnam, the author of this article has proposed the application "margin" system in the management of drug prices. Recently Drug Administration of Vietnam (DAV) has issued regulations for the experimental application of "wholesale margin" in the distribution system. This is a step forwards in the management of medicine prices in Vietnam.
In an open drug market, it has appeared more and more tendency to use the "new medicine" of expensive brand-name drugs, imported drugs ... .This results in an increase of drug abuse, ignorance of adverse drug reaction. The procedure of drug purchase for the public health system needs to be improved. Health insurance has no clear and important role to control proper use of medicines in hospitals and bidding process for a more effective selection of drugs used in treatment.
Department of Health has not issued a full standard treatment regimen as a basis for a selection and use of drugs in the hospitals and therapy facility. The treatment regimens and drug list for the treatment facility may be "influenced" by the drug suppliers and other factors.
According to "The directions for speed- up of industrial development, upgrading quality and enhancing competitiveness" from "Economic social strategy for period 2011-2020" passed at the XI Congress of the Communist Party, the pharmaceutical industry of Vietnam is determined to be one of the industry with competitive advantages, and able to participate in global production and supply networks chain: "To prioritize the development of products with competitive advantage offering the ability to participate in production networks and global value chain of the high-tech industry, mechanical engineering, information technology and communications, pharmaceutical industry ...".
For more competitive advantages, the domestic pharmaceutical industry should be able to produce high quality products in compliance with international standards with low production costs and reasonable price and in order to lower the price of pharmaceuticals. In context that majority of pharmaceutical raw materials must be imported according to international prices (account about 30-40% factory price of finished products), the production factor costs (direct and indirect) of local pharmaceuticals plays an extreme important role for the competitiveness capacity building. To be aware that competitiveness cannot rely on cheap labor force because the pharmaceutical industry is a high-tech industry, pharmaceutical quality must be built by the research - development activity, by technology, modern manufacturing processes, manufacturing process automation and by the total quality management system ... In pharmaceutical industry, low-cost labor force does not make an important sense.
1. To lower production costs, increasing price competiveness to expand market share of their products especially in developing countries with large population but limited purchasing power.
2. To export back to the markets of the developed countries with very strict control of quality standards and production conditions to reduce healthcare costs.
3. To concentrate financial, scientific, technical and high quality human resources to research and to invent new drugs, new dosage forms, the "blockbuster" APIs with a huge profit.
1. Partial or total acquisition of local factories in the developing countries to improve and upgrade the standards in compliance with advanced standards of pharmaceutical industry in developed countries (North America, Europe ...). To close existing pharmaceutical plants in the industrialized countries with high production cost, requiring more expenditure on environmental protection and labor forces; to relocate of the pollution to other countries where environmental laws is less restrictive.
2. Outsourcing of production and/or production under contract enable factories in developing countries to absorb advanced technology and to apply global quality management systems of multinational pharmaceutical corporations.
3. Implementation of the franchise agreement, marketing authorization transfer agreement of potential domestic products from companies in developing countries, upgrading quality standards and production technology process in conformance with the global quality standards of the corporation for distribution in the domestic market and/or export.
It's evident that, first of all the strategies of "outsourcing" aims to maximize profits and minimize risks for multinational pharmaceutical corporates. However, this is also an opportunity as well as the first step for local pharmaceutical companies of developing countries, including Vietnam to involve in "global value chain" of medicines.
To build and strengthen competitiveness in order to participate in the global value chain of pharmaceutical products is a prerequisite for modernization of Vietnam's pharmaceutical industry in next decade, especially pharmaceutical dosage forms industry to transform from a pharmaceutical industry developed by the width (quantity) to the modern pharmaceutical industry developed in depth (quality).
3.2. Avoid "middle income trap" and overcome "glass ceiling"
The concept of "middle income trap" for developing countries is mentioned by Indermitt Gill and Homi Kharas in the report "East Asia Renaissance" (World Bank, 2007). These authors commented: Although many developing countries, particularly in Asia, have succeeded in achieving high economic growth for a long time, but not all countries that have avoided "middle income trap " when the labor costs tend to be much higher than production costs and the modest skills and creative capacity level of country are unable to be driving force for transforming country into high-income group.
To avoid "middle income trap", the national industry as well as a specific industrial branch must overcome a certain "glass ceiling" to move from the level of simple production, lack of supporting industries to a higher technology and management level, which are able to produce high quality goods, to design, improve and innovate new products as the global leading manufacturers did. In other words, to transform a low productivity industry to an industry based on productive capacity, a creation and use of financial and human resources should be more effectively and higher productivity.
Clearly, to achieve the goal of Vietnam becoming an "industrialized country" in 2020, the country's economy as well as the pharmaceutical industry has to overcome "glass ceiling" and avoid a fall into the "middle income trap" as many local and foreign economists mentioned, especially when the pharmaceutical industry has been identified as one among areas with fierce competiveness in the period from 2011 to 2020.
1. Active pharmaceutical ingredient (API) industry or chemico-pharmaceutical industry focusing on research, discovery, development and production of APIs. This is a high-tech and sophisticated industry related to the chemical industry.
2. Pharmaceutical dosage forms industry focusing on research and production of pharmaceutical dosage forms from raw materials/APIs. This is a specific industry related to special technology and production equipment.
At present the assessment and classification of the pharmaceutical industry development level of a country is based on criteria of international organizations such as UNIDO (Industrial Development Organization United Nations), UNCTAD (The Annual Meeting on Trade and Development United Nations) and WHO (World Health Organization).
WHO and UNCTAD unanimously agreed to classify the development level of the national pharmaceutical industry in four levels from low to high: fully importation (Level 1), produced some generic, mostly imported (level 2), domestic pharmaceutical production, generic production, exportation of pharmaceuticals (level 3), API production and new drug discovery (Level 4).
UNIDO divide the nations of the world into five groups: group 1 (59 countries) with no pharmaceutical industry, full importation of drugs; group 2 (123 countries) with only semi-finished products packing/bulk products packing, processing; group 3 (86 countries) with domestic pharmaceutical industry able to produce finished products from imported raw materials; group 4 (13 countries) to produce raw materials/API, intermediate materials and finally the group 5 (17 countries) able to invent and produce new innovated APIs and new innovated pharmaceutical dosage forms.
According to local and international experts in the pharmaceutical industry, the Vietnamese pharmaceutical industry can rank as 2.5 to 3 following both the above classifications.
The above classifications of the international organizations are only in order to determine the level of development of a national pharmaceutical industry based on capacity of production. These criteria cannot be used to determine the modern level of pharmaceutical industry. Obviously, it is difficult to compare the modern status of pharmaceutical industry in India, China, Europe with the United States pharmaceutical industry even though India and China are ranked as fourth group following UNIDO classification and India, China - the two most populous countries in the world - have supplied the world a huge amount of pharmaceutical raw materials even though that the quality of these raw materials should be a matter of debate.
Unfortunately, until now, there are no criteria to rank the modern level of national pharmaceutical industry, particularly the pharmaceutical dosage forms industry. Even so, the author of this article proposes following aspects to be considered about the development level ranking of pharmaceutical dosage forms industry.
1. The quality management system: The application of Good Manufacturing Practices in the management of production (c GMP, FDA - GMP, EU - GMP, JAPAN GMP, WHO - GMP ...) and application of advanced standards for drug quality, drug-testing methods specified in the latest version of the Pharmacopoeia of the United States, Britain, Japan, European Community ... internationally recognized.
4. The ability of research, invention and production of new dosage forms (innovated dosage forms) based on scientific achievements: the new drug delivery system, targeted drug system, the modified release drugs, nano-drugs and biotechnical products ...).
5. The level of investment in research - development activities in finance, human resources and research facilities for transformation of the pharmaceutical manufacturers to research - based company / knowledge - based company. In order to do that, the budget for research - development of the corporate multinational pharmaceuticals should be accounted for 20% of sales, while in developing countries this rate is often 1 - 2% only.
The approach and the implementation of the above elements ensure the capacity for production of high quality pharmaceutical products and step by step to participate in new drug production and discovery process. By this way, the national pharmaceutical industry overcomes the "glass ceiling" to join the group of industrial countries. Some Asian countries including Korea have successfully avoided "middle income trap" and overcame the "glass ceiling" to join the group of industrialized countries after just two generations (about 40 years). Regarding the development level of the pharmaceutical industry, South Korea has been classified as fourth group by UNIDO classification and recently it becomes a new member of the group 5.
Until early years of this decade, Vietnam Government has promulgated a series of policy documents guiding the development of Vietnam pharmaceutical industry for the period with a vision toward 2030 (Resolution 46-NQ / TW, Decision 43/2007/QD-TTg on the pharmaceutical industry development and building models of drug supply systems, Decision 81/2009/QD-TTg on development planning of pharmaceutical industry...). On the other hand, Drug Administration recently also plans to review and evaluate 15 years of "National Drug Policy of Vietnam" (CSQGT) implementation and develop a draft of "National Drug Policy" suitable to the new economic - social context.
But so far, Vietnam has not yet a master plan dedicated for the development of pharmaceutical industry in this decade. The detailed master plan is an extreme important document to guide investors, especially the domestic private investors, foreign investors as well as for local existing pharmaceutical companies in planning new development, expansion and upgrading of production facilities and enhancing their competitiveness.
The plan should define the direction and priority for development areas, the modern level and status the pharmaceutical industry needs to reach at the end of this decade, the dispose of reasonable investment on geographic area, level of quality requirement for local pharmaceutical products. In brief, the plan needs special focus on priority areas to develop and modernize in this decade. The identification of the priority areas is extremely important to successfully implement master plans. It is necessary to understand that too many priorities mean no real preference at all.
Need to develop and promulgate national policies to encourage enterprises to focus investment in priority areas for modernization of the Vietnamese pharmaceutical industry. In the context of the country economy on market mechanisms and integrating into the world economy, the national policies are effective tools to guide the operation of the business where a direct interference of the government authority to manage the business is going down. The policy should encourage the development of pharmaceutical industry in depth (quality, research - development, innovation...), limit the development in width (quantity, medium quality...) and stimulate the manufacturers to transform diversified product portfolio to specialized one. When the pharmaceutical manufacturers have reached a "technological frontier" the policies need to encourage and stimulate the emergence of new businesses with modern technology. This requires a mindset change from policy, legislation, regulation makers to business managers. Drug authorities should promulgate effective measures to restrict unfair competition by "low quality, low cost," ,which discourage serious investors.
It's needed to increase the feasibility and effectiveness of the pharmaceutical legislation system in order to ensure effective management for drug administration agencies. In the context of global integration, drug administration agency should pay attention to harmony the regulations with pharmaceutical regulations of other countries in the region and the target markets of the Vietnamese pharmaceutical industry, to harmony with the general guidelines of the World Health Organization (WHO), with Pharmaceutical Inspection Convention (PIC), Pharmaceutical Inspection Co-operation Scheme (PIC/S) or agreements related to the pharmaceutical sector e.g. Trade Related Intellectual Property Agreement (TRIP), the International Conference of Harmonization (ICH).
As indicated above, to jump through "middle income trap" and "glass ceiling", the decisive factors is to build creative capacity and high productivity of the industry, two factors determined by the quality of human resources.
First of all, it should be clear that the human resources for Vietnam's pharmaceutical industry is not entirely comprised pharmacists. Modern pharmaceutical industry requires the participation of elite professionals from many branches of science and various technologies including medical professionals and economists. Therefore, the development of the pharmaceutical industry cannot be separated from that, and cannot depend mainly on the quality of the scientific - technical professionals and country scientific-technological resources. This is especially more evident in chemico-pharmaceutical industry. It should be considered that chemico-pharmaceutical industry is a part of the national chemical/petrochemical industry. It should have policies to attract and create mechanisms for experts and leading scientists in related fields to contribute to improving the creativity and productivity of the pharmaceutical industry of Vietnam.
As a country just crossed the low income threshold, the investment in scientific research institutions not only relies on public investment, but the Government should have policies that encourage and promote private sector investment. However, the current business scale of the Vietnamese pharmaceutical enterprises is small with limited financial resources. A significant financial investment in research facilities is needed to make the public - private matching models and to encourage collaboration between different businesses forms for improving the potential of scientific facilities in the pharmaceutical sector.
For pharmaceutical human resources of high quality, it's needed to reform and modernize the training program and curriculum of the Vietnamese pharmacy colleges according the common trend in the world. There should be a training program and curriculum for 2 different types of pharmacists: pharmacists working in pharmaceutical industry (product - oriented pharmacist) and pharmacists working in healthcare facilities and community healthcare (patient - oriented pharmacist). These two types of pharmacist need to be educated with different background and skills.
Decade 2011 - 2020 will be a landmark period for the economy in general and the pharmaceutical industry of Vietnam in particular with the objectives defined: "to become an industrial modern country in 2020". The vital importance is needed soon to make development master plans and enforce specific strategies and measures to setup the objectives of Vietnam pharmaceutical industry in the context of fierce competition of the current globalization process.
From 1988-2000: 18 countries (Switzerland, Germany, USA, Japan, Netherlands, Canada, Britain, France, Israel, Austria, Finland, Denmark, Belgium, Norway, Australia, Italy and New Zealand). After 2000, a further six countries (Taiwan, Iceland, Ireland, Singapore, South Korea, Hong Kong).