Need for vaccines in Iran in terms of the current health conditions
Vaccines needed for immunization programs in Iran (EPI) include BCG, DTP, HepB, polio, and MCV (see Table1). The influenza, rabies and HPV vaccines (all imported from other countries) are available on the market but not in the EPI and there is still a clear lack of availability of Haemophilus influenza type B (Hib) and rotavirus vaccines in EPI. According to an internal study, the prevalence of Hib carriers is 7.6%, similar to other developing countries, yet this vaccine is still not part of the program[5]. The government intends to include these two vaccines in the program; this is dependent both on adding them to the Iranian drug list and the ability of vaccine producers to produce them, which has not been the case so far. It should be emphasized that Iran has already adopted a National Drug List (NDL), which is selected by the Iran Drug Selecting Committee (IDSC). All drug supply management process, including registration, procurement, inspection, quality control, and post marketing control, can be handled by the IDSC for a drug that is accepted for inclusion on the NDL[6].
Table 1 Immunization schedule of expanded program of immunization program in Iran, 2010 The vaccine supply in Iran, the effect of international relationships, and the vaccine production capacity in Iran in case of crises
It seems there is no clear vision in Iran regarding the vaccine supply in the future. The world’s approach toward combo vaccines and changes in the type of vaccines, such as the expanded use of inactivated polio vaccine (IPV) instead of oral polio vaccine (OPV) and the probable eradication of some diseases within the country in the coming years, could significantly affect Iran's vaccine industry.
With the advent of new diseases and phenomena like bioterrorism, the capacity for vaccine production has become increasingly important. Some developed countries, such as the United Kingdom[7] and the United States[8] have invested in this sector to assure their ability to control such threats. The Iranian vaccine industry has illustrated its abilities to supply domestic need in crises; the main example of this is its performance during the imposed war with Iraq. As most key opinion leaders stated, they are not concerned about crises, however, the country must continually increase its capacity.
The introduction of model countries and the importance of international cooperation in the vaccine industry
There was general agreement among those interviewed regarding international cooperation for growth in this industry. Today, the importance of collaboration by vaccine makers in developing countries has become clear. The LG Company in Korea, which has obtained WHO prequalification, is establishing strategic cooperation in the field of R&D with large vaccine companies[9]. According to reports published by the local government, such cooperation by the Institute Pasteur for production of pentavalent vaccine and other biotechnology products with countries such as Cuba, India, Malaysia, and France has already been enacted[10], although most of the interviewees found these partnerships to be very limited, especially in the case of the Razi Institute.
The current situation of Irans vaccine industry regarding technology, human resources, and R&D
According to the interviewees, there are lesser problems in access to technology for traditional and well-established vaccines; however, because of the current and upcoming changes in the methods of producing these vaccines, Iran’s vaccine industry needs to be updated by acquiring new technologies for surviving international competition. In the field of newer vaccines, access to equipment and devices, especially access to technology, is influenced dramatically by political issues.
It seems that despite highly educated professionals in this industry, the human resources situation in Iran is far from ideal because of the lack of regular targeted training and the need for updated knowledge and information, which could be because of governmental structure and political problems and challenges.
The best source for R&D work on the diseases of developing countries is the countries where the diseases are endemic. The Commission on Health Research for Development in 1990 showed that only 10% of investment in health research is allocated to 90% of the diseases and health problems of the world. This is called the 10/90 gap. Children in developing countries do not benefit from advances in the field of vaccines in richer countries[11]. Iran could recognize the vaccine market in developing and less developed countries and manage research and development investments toward their needs to be able to use these opportunities in the future. By following the current approach in the management of R&D in Iran, the vaccine industry will not be able to participate in global markets or even cover domestic needs. According to an internal report by the Razi Institute[12], the rate of capital invested by the Razi Institute in R&D in the annual budget is only 2%; in light of the large areas of activity in this institute in the field of vaccines and serums (human and animal), this seems to be a very limited amount.
Public and private sector partnerships
The Ministry of Health is responsible for supplying the needed vaccines and planning the vaccination programs. In Iran, the government is involved in both producing and supplying vaccines. The Institute Pasteur is under supervision of the Ministry of Health and the Razi Institute operates under the Ministry of Agriculture. However, because of being regarded as a strategic industry for Iran in the area of national security, the possible privatization of these two vaccine makers is not imminent. As previously stated, it seems that the presence of the private sector along with the public sector would help the vaccine industry to overcome many problems, such as efficiently maintaining and strengthening human resources, managing and optimizing targeted areas of R&D capacities, and the provision on opportunities to establish a presence in international markets. Several factors impede the private sector from becoming involved in vaccine production. The only purchaser for the EPI vaccine is the government and because both vaccine manufacturers belong to the government, there is not an opportunity for the private sector to become involved in such a market. The government prefers to have complete authority in vaccine production and supply so that it can assure a consistent supply regardless of gain or loss (which is the main incentive for the private sector) at different times and in different situations.
Irans ability to compete in international markets, the probable challenges to WTO accession, and suggested solutions
Most expert interviewees feel that the first step in moving toward international market status is obtaining WHO prequalification for the country’s vaccines. Today, many countries are faced with several problems in supplying essential vaccines. Concerns in this regard increased after the implementation of IP rules and discussions related to world trade[13]. But some vaccine-related agencies, such as the United Nations Children's Fund (UNICEF) and the Pan American Health Organization (PAHO), and government–private cooperatives, like the Global Alliance for Vaccines and Immunization (the GAVI Alliance), are working to help these countries. GAVI, for example, aims to increase the economic attractiveness of the market by stimulating vaccine demand in developing countries, as well as strengthening infrastructure and ensuring their ability to procure such products[14]. UNICEF also purchases about 55% of the world’s vaccines[15]. The World Health Organization grants prequalification to ensure that UN agencies buy quality, safe, and efficacious vaccines. According to internal news, Iran’s National Regulatory Authority (NRA) recently gained WHO prequalification, but many problems concerning cGMP compliance still require resolution. Unfortunately, due to lack of sufficient investment, it is not possible to upgrade the facilities and equipment at the Razi Institute to comply with the principles of cGMP. However, most interviewees believed that it will be easier to obtain these standards by the Institute Pasteur’s new facility (where the Hep B vaccine is manufactured).
The future of the vaccine industry after accession is very important because it is directly related to the country’s public health. Therefore, it is necessary to understand the WTO rules affecting this industry. Three agreements— “Trade Related Aspects of Intellectual Property Rights (TRIPs),” “Subsidies and Compensatory Measures,” and “Government Procurement Agreement (GPA)”—could be associated with this industry and must be carefully considered. Here, we review one of the most important agreements: TRIPS.TRIPs: Intellectual property right is considered as an asset by companies which could be seen as patents, distinctive signs, copyright, industrial designs and trade secrets[16]. In pharmaceuticals, patent rights cause a monopoly for patent holders by preventing others from using a particular invention for a specified period of time[17]. Nevertheless, to resolve the concerns of developing countries[18], the TRIPs agreement offers some flexibility for governments in providing their social goals. Transition periods, compulsory licenses, and parallel importation are from such flexibilities[19]. But in terms of being influenced by TRIPs, there are some differences between vaccines and other pharmaceutical products. The most important difference is the complexity of the processes used to manufacture biological products like vaccines. There are considerable scientific techniques and secrets (know-how) in the manufacturing processes of such products that companies prefer to maintain in-house as trade secrets and which will not be disclosed; therefore, compulsory licenses would not be all that useful[20]. Another issue is that it has become usual to patent one or more of the vaccine components, such as adjutants[21]. In a study conducted in 2005, the World Health Organization showed that most suppliers of vaccines in developing countries have not considered that IP plays an important role in vaccine R&D[22]. Iranian drug policy makers should also ensure efficacy, quality, and safety measures by full adherence to Iranian national drug policy rules[23]. These issues should be paid adequate attention before proceeding to WTO accession.