The development and production of new generation antibiotics can be a promising direction. According to the World Health Organization (WHO), new bacteria become resistant to all existing antibiotics. WHO published a list of the main bacteria with which to fight: Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacteriaceae (critical urgency);
Enterococcus faecium, Staphylococcus aureus, Helicobacter pylori, Campylobacter spp., Salmonellae, Neisseria gonorrhoeae (high urgency);
Streptococcus pneumoniae, Haemophilus influenzae, Shigella spp. (medium urgency). These types of bacteria are resistant to treatment, which can lead to death. The list shows the scientific community the sphere where it is necessary to concentrate. Over the past 10 years, only few new antibiotics have appeared on the pharmaceutical market due to the fact that antibiotics do not bring big profits, because antibiotics are taken for a short time.
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Another promising area of pharmaceuticals is the biotechnology industry.
However, the development and production of biotech products poses a greater risk than the production of generic drugs. For this reason, it is necessary to take measures to reduce costs and risks through public funding for clinical research and the creation of industrial consortia. Accelerated development of biotechnological services implies changes in the regulatory framework based on the analysis of international experience of other countries, where the biotechnological segment developed over a long period of time.
The possibility of creating an innovative base of pharmaceutical enterprises can be a gradual transition from the production of simple generic drugs to more complex ones. At the moment, the CIS countries have their own generic productions. For this reason, further expansion of Kazakhstani exports to the CIS countries will be conditioned by the capabilities of domestic producers to offer competitive innovative products or analogs of unique complex drugs.
The innovative potential of domestic pharmaceutical enterprises directly depends on the provision of state support and the creation of an innovative climate. In order to further obtain technological and personnel competencies in the production of innovative drugs, it is necessary to attract leaders of the pharmaceutical market. The interest of foreign investors is due to the availability of storage facilities at the Kazakh side, as well as the infrastructure. Through their of Kazakh partners, foreign companies get opportunities to promote products in the Kazakhstan market, established sales channels, and administrative resources. From such an alliance, domestic companies benefit from investments, advanced technologies and innovations.
Implementation of international standards GXP (system of good practices) provides quality in the production of drugs and provides access to international markets. According to the proper practices, quality standards are established at all stages of drug production. A very important standard is the GVP (the standard of post-registration observations), which allows recording cases of side effects or inaction of drugs.
To introduce new qualifications for the pharmaceutical industry, cooperation between higher education institutions and pharmaceutical enterprises should be strengthened. In this regard, it is necessary to create a platform for discussing topical issues and problems in the field of education, which can reduce the existing gap between the education received and the real needs of pharmaceutical enterprises.
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The creation of centers for the development of new drugs on the basis of higher education institutions will allow to unite the stakeholders in the pharmaceutical industry. At the same time, in higher educational institutions in the field of pharmaceuticals, it is necessary to update educational programs, considering international experience and standards. Thus, educational programs should be taught in accordance with GMP standards, which would further facilitate the work of the pharmaceutical complex after the introduction of the international standard of GMP and in the future would allow the creation of competitive production. In addition, the creation of a training center for pharmacists should be envisaged for the international standard of GMP, involving domestic and foreign specialists.
To achieve high production of pharmaceutical products, it is necessary to increase the level of state support for the industry. Measures should be envisaged for producers of domestic pharmaceutical products:
- receiving loans guaranteed by the government with a deferred payment and partial reimbursement of the loan from the republican budget;
- financial support from the state when registering domestic drugs abroad, buying licenses and raw materials;
- exemption from payment of import customs duties on equipment necessary for the investment project;
- development of mechanisms for the inclusion in the existing long-term contracts of new, innovative medicines produced by domestic producers that have evidence-based medical effectiveness;
- development of a mechanism for redistributing the supply of drugs between domestic producers, in case of failure to fulfill the declared obligations under long-term contracts;
- strengthening the position of domestic pharmaceutical companies by stabilizing existing measures of state support (primarily in the framework of the state order);
- development of new mechanisms to stimulate investment in the pharmaceutical industry, which should create conditions for a new qualitative growth in domestic production of pharmaceutical products in the long run;
- monitoring of new categories of diseases that tend to spread in Kazakhstan, as well as in other countries;
- establishment of centers for the development of new medicines for the planned import substitution of medicines;
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- approval of specialties for the development and production of medicines in higher and specialized educational institutions, as well as training specialists taking into account international standards of GMP.
In addition, it is necessary to maintain the level of purchased pharmaceuticals within the guaranteed volume of free medical care because of their great social importance. From the state side, it is necessary to provide support to domestic pharmaceutical enterprises in the form of preferences and benefits. To date, there has been a decline in the purchasing power of pharmaceutical companies, as well as the renewal of a memorandum to contain prices for essential medicines in Kazakhstan. Under the changed market conditions, it is necessary to take measures to stimulate the activities of domestic pharmaceutical manufacturers, which may suffer economic losses due to the containment of prices for medicines in the changed market conditions.
It should also be noted that domestic producers should be actively involved in the existing measures of state support provided for under various development programs, including reimbursement of costs incurred for training and professional development of personnel.