There is just under a month left before the start of one of the key events in the world of pharma — the International Eurasian Pharmaceutical Forum, which will be held for the 15th time this year. The participants of the previous event discussed the most popular and urgent topics, covering a wide range of issues, both at the level of legislative initiatives and in the practical application of existing norms. But what challenges do the EAEU member states face today, what problems do companies face? What risks should we be working on now? Larisa Emelianova, Counsellor at AEQUITAS Law Firm, told us about this and much more.

Larisa Anatolievna, let me thank you for your initiative to participate in this year’s Forum. Will you share your opinion on the upcoming event?
We have participated in the Forum on numerous occasions as attentive listeners, and this year we have decided to speak on the most pressing legal issues in the industry that we face. I would like to note that during our observation we came to the conclusion that the Forum is extremely lively — it brings together professionals from various fields, including public administration, international and non-profit organisations, pharmaceutical business, and of course, what is very pleasant — legal professionals. The Forum boldly raises and discusses topics useful for society and business, and perhaps this is its main value. Moreover, the special benefit of communication between different entities and market participants is that each party can share its opinion on a particular issue. This also determines the appropriate approach to the discussion. For example, a doctor, having met a conditional person, will study the anamnesis from a professional point of view, a lawyer will look for a way to protect his legal rights, a businessman will assess him as a candidate for a job, a journalist will prepare questions for an interview, etc. That is why, in the interests of seeking legal truth, utility and order, we have planned our report.

Please tell us about the topic of your report.
Since one of the key objectives of the legal mechanism is to create a sustainable system of functioning of social relations and to direct the vector of their development towards the common good, we are convinced that law should be a "material" reflection of the eternal "immaterial" principles of justice (in Latin — AEQUITAS — ed). Thus, the topic of my report follows as a consequence of this belief — "Systemic risks of the legal environment within the EAEU and national Kazakhstani legislation affecting the circulation and availability of medicines on the Kazakhstan market".

The word "systemic" in the subject of your report cannot be overlooked. As far as it can be understood, when we speak of some "system", we always imply the existence of certain "constants" in it. In this case, risks. What can you say about this from a lawyer’s point of view?
Yeah, that’s right. A system is a set of elements subordinated to a certain order. For legislation, the ideal system is clear, reasonable, fair, sufficient and structured rules with a clear understanding. These rules must be effective in accomplishing the prospective goal that the state has set. However, reality indicates that this level of rulemaking is very difficult to achieve. It is an ideal to strive for. The legislative process is an extremely complex endeavor, requiring enormous preparation and study of factual and theoretical material, as well as strong forward planning. But we have to pay tribute — a lot of work is being done within the framework of the harmonisation of the legislation of the EAEU countries, as well as the development of local (in our case, Kazakhstan’s) legislation. Basically, the whole system is lined up and still taking shape. At the same time, through the prism of the prospective development of the pharmaceutical industry, the legal risks caused by deficiencies in the legal system, which impede or may impede such development in the future, have recently become increasingly evident. That’s what we plan to talk about.

What aspects of the legal system are affected by these risks?
The main "pillars" of the current legal system of pharmaceutical activities (in the context of the part selected for the report) are the following areas of regulation: 1) access of the wholesale distribution entity to the market. Legally, it is a licence and qualification requirements, i.e. requirements for the given entity and permission to start activities; 2) access of medicines to the market. In other words, it is the state or "above"-state registration as a conventional point of reference for the access of a drug to the market, if exceptions are not taken into account; 3) the processes of circulation of medicines. This may include "state lists", importation, storage, procurement, sales, quality assessment, pharmacovigilance and so on; 4) promotion of medicines, including advertising and non-advertising interactions between different participants in society.

I would also point out such an important aspect as pricing, which affects procurement through the "state channel" (GOBMP, OSMS) and commercial turnover. I am not talking here about patents and trademarks, competition protection tools and much more. A prime example of systemic risk may be insufficiently systemic regulation of drug promotion. For any pharmaceutical company as a business unit — marketing its products is one of the main tasks. However, promotion must be subject to ethical standards. The underlying ethical approaches are proposed by the World Health Organization in the Ethical Criteria for the Marketing of Medicines (Geneva, 1988). Kazakhstan’s legislation has adapted some unconditionally positive WHO recommendations (e.g., the prohibition on providing material "incentives" to medical and pharmaceutical workers for prescribing and dispensing drugs). However, in general, the system of promotion regulation (and it was a progressive step of the legislator in its time), in our opinion, does not reflect the real conditions of development of interests of the society, health care professionals and business environment. Thus, systemic risks affect the pharmaceutical sector in many ways.

Perhaps your company is doing some kind of work to address current challenges and proactively address potential risks?
I will say that out of 31 years on the market, we have spent the last 15 years, among other things, working with international pharmaceutical companies on a wide range of issues. Of course, for a number of reasons, I cannot disclose certain details of this work due to confidentiality. However, in the mentioned report, without disclosing any confidential points, we plan to highlight an aggregated publicly recognized vision of the situation, which we have formed on the basis of our experience. It should be taken into account that pharmaceutical activity is a rather risky area of the economy, with complex legal regulation, numerous prohibitions and restrictions. Despite a good level of normative elaboration, there is a large block of insufficiently clear norms of local legislation and EAEU law, gaps, inconsistency between the literal content and real meaning of certain norms, lagging of legal norms with the development of the economy. Such systemic deficiencies form what we call a legal grey area. Our work is about finding safe legal options to deal fairly with the issues that arise, and this, among other things, will be discussed in the report.

Still, we would be glad to hear directly from you with any details about this work. This data may also be useful for those who are just planning to visit the Forum…
Some points, of course, I will outline. For example, bringing market authorization of medicines in line with supranational EAEU rules has been discussed for many years. The current deadline is 31 December 2025, when all medicines must be registered according to the EAEU rules. But is it all of them? Or not all of them? These are important questions that need to be answered. The expert community is also interested in the answer to the question: "Is it possible to avoid registration under the EAEU rules if a drug is registered under national rules as a "strategically important drug"? If you "dig" into the legal norms, the formally obvious answer becomes not so obvious. Thus, it will inevitably have to refer to the Decision of the Council of the Eurasian Economic Commission of 10 June 2022 № 96 "On temporary measures to establish the peculiarities of circulation of medicines for medical use" (Nur-Sultan). According to this decision, the authorised bodies of the Member States in the field of circulation of medicinal products are entitled to establish a temporary procedure for circulation of medicinal products (including registration of medicinal products and amendments to the registration dossier of medicinal products) valid until 31 December 2023. A literal interpretation of this international document, which is part of EAEU law, leads to the conclusion that the national rules on the circulation of medicines (including sales, storage, transportation, registration, etc.) were temporary and were to expire on 31 December 2023. But we do not see this within the framework of Kazakhstan’s local legal field. We made a number of inquiries to the Ministry of Health of the Republic of Kazakhstan. For the pharmaceutical sector, the opinion of the regulator can be vital. To this point, we have received an answer so far to the question regarding the application of Decision No. 96. The state authority has extended the deadline for providing answers to the other mentioned questions of EAEU law, which shows the really complex nature of the legal issues we have raised. There is some intrigue in this, and we plan to talk about the Ministry’s response in our report, if we receive it by then.

You touched on the topic of ethical criteria for the promotion of medicines. Tell me, to what extent does this area of the pharmaceutical industry correlate with current legislation and objective realities for business?
The basic, but not the single problem in this matter is the absence of a legislative definition of the far from obvious term promotion. This automatically brings a significant part of such activities into the grey legal zone, which dramatically increases the legal and reputational risks for pharmaceutical companies and drug distributors. In preparation for this report we made an enquiry to the Ministry of Health of the Republic of Kazakhstan: we believe that for risk management purposes it would be useful to know the official opinion of the regulator on its understanding of this term. In addition, Kazakhstan’s legislation, in our opinion, does not sufficiently take into account the need of the population and health care professionals for reliable and, I emphasise, non-advertising information on health issues, methods and means of treatment where it is permissible and appropriate from the position of ethics and public interest. We came to this conclusion, among other things, on the basis of our survey of medical and pharmaceutical professionals (the results of the survey are of interest and we plan to report on them in the report). However, the legal line between advertising (regulated and heavily restricted) and non-advertising is very thin and often in a legal grey area. Many other ethical ways of disseminating information about pharmaceutical products (e.g., medical symposia and conferences, webinars, roundtables) that are accepted worldwide and demanded by the medical community also fall into the legal grey area. We definitely think it is advisable to change the system of regulation of promotion issues itself — in fact, to rewrite it from scratch in order to exclude or narrow the grey legal area as much as possible.

Other issues will be addressed at the Forum. For example, accessibility, drug circulation and pricing. Do you see risks in these fundamental areas as well?
Yes, we also observe systemic risks in these areas, as well as those mentioned earlier. The release of a new drug on the market is a complex and lengthy process, and is usually associated not only with the registration itself, but also with the formation of price limits, as well as inclusion in clinical protocols and various "state lists" for procurement, including within the framework of the GOBMP/OSMS. During these processes, pharmaceutical companies face not only technical difficulties but also legislative shortcomings. For example, the current regulations do not provide for a timeframe for the formulary commission to make a decision on inclusion of a drug in the list for procurement by a single distributor, as well as a timeframe for approval of maximum prices for MNNs for GGBMP/OSMS. In addition, the system of price registration itself designed to prevent uncontrolled price increases by suppliers, in our opinion, also prevents their situational decrease. In particular, the manufacturer’s ceiling price for wholesale and retail sales of imported medicinal products must be declared upon registration not higher than the maximum value of the prices stated in the submitted documents confirming the price of the medicinal product (copy of the invoice or invoice) minus the discount. Thus, the granting of various discounts by the supplier of an imported drug, for example, related to the volume of purchases or for social support for certain groups of patients, may result in a generally lower registered price for the drug, which may not be acceptable to the supplier.

We would also like to note the opinion of health care specialists and heads of individual professional associations, who have repeatedly noted in conversation with us that the existing system of creating and applying clinical protocols does not always meet the cause of quality provision of medical care to a particular patient. Many of the physicians we interviewed noted, on the one hand, the undoubted usefulness of the clinical protocol, but on the other hand, the need for a more flexible approach to its preparation and application, with the possibility of reasonable deviation from the protocol in the interests of patients. In the opinion of some medical professionals with whom we had the opportunity to speak, this is due to the fact that the process of preparing clinical protocols in the current realities does not provide for studying and taking into account sufficiently the experience and opinions of a wide range of health professionals and interested professional medical and non-profit organizations, as well as clinical practice "on the ground". In addition, revision of clinical protocols in accordance with the accumulated knowledge and the level of development of the pharmaceutical industry (including when new promising drugs enter the market) may take an indefinite period of time, depending on the prioritization of this work by developers. Finally, a clinical protocol cannot foresee all possible cases and the characteristics of the particular person the physician must care for. Meanwhile, the doctor is essentially bound by the prescriptions of the clinical protocol. These issues, we believe, require serious and careful analysis, involving a wide range of stakeholders and the medical community in an open discussion. For our part, we are prepared to comment upon them from a legislative perspective.

What other issues would you like to highlight?
Separately, we would like to mention potential legal issues related to the global development of artificial intelligence technologies, including the introduction of AI algorithms in healthcare — perhaps this topic will also be raised by our colleagues at the Forum. It is worth emphasizing that these problems may not yet be obvious to a wide range of patients, but their hypothetical consequences could affect the daily lives of citizens.
As for the more pressing issues affecting the accessibility of drug provision for the population, we would like to note that they are not limited to legal issues. In preparation for the report, for the purpose of systematic and versatile coverage of the problems, we spoke with the Director of the Association of Pharmaceutical and Medical Organizations of SKR "Damu" Ms. Alzhanova H.D., who noted such difficulties in the pharmacy segment as a significant shortage of pharmacists with higher education in the regions of Kazakhstan, problems with prescriptions and dispensing of prescription drugs, regulatory pressure and disproportionate fines in the activities of pharmacies. This makes it increasingly difficult for pharmacy organizations to operate, especially in smaller communities. These issues can be addressed, among other things, by adjusting the legislation.

What position does AEQUITAS take on pharmaceutical regulatory issues?
Regardless of a number of circumstances, we are in favor of qualitative positive reform of the legal regulation of pharmaceutical activities, observing ethical standards and balancing the interests of the state, patients, healthcare professionals and business. I would like to emphasize that the President of the Republic of Kazakhstan, the esteemed Kasym-Zhomart Tokaev, recently noted that very soon Kazakhstan will start the most important cardinal reforms that will make our economy more transparent, sustainable and dynamic. We believe that one area for reform could be an audit of existing health care regulations for the potential to improve regulatory impact and remove unnecessary barriers to business, while ensuring the interests of patients and taking into account the views of health care professionals. We believe it is necessary to carefully and thoughtfully fine-tune a legal instrument so that it sounds beautiful and clean. The rules need to become clearer and fairer. It would be much more comfortable for business if the legal regulation answered the questions directly — "Yes" or "No" - eliminating the gray option of depending on the unpredictable interpretation of a regulator or court. Perhaps we need to be proactive here. I’ll give you a simple example: if your child has grown and the coat has become too small, it is wise and efficient to think about new comfortable and neat clothes, sometimes even for growing up.

Can you outline the key objective of your report?
The goal within the report is to activate constructive and useful discussion, exchange of opinions from different sides, to offer possible options to improve the legal environment in the sphere of pharmaceutical activities, drug provision and other topical health care issues.

At Janssen, we are creating a future where disease is a thing of the past. We are the Johnson & Johnson family of pharmaceutical companies, and we are working hard to make this future a reality for patients around the world. We conquer disease with cutting-edge discoveries of science, increase access to therapy with ingenuity, and heal hopelessness with human warmth.
We focus on the areas of medicine where we can provide the most benefit: cardiovascular disease, metabolic and ophthalmic diseases, immune-mediated conditions, infectious diseases and vaccines, neurology, oncology and pulmonary arterial hypertension.

Janssen, the pharmaceutical products division of the Johnson & Johnson LLC branch in the Republic of Kazakhstan is part of Janssen, the Johnson & Johnson group of pharmaceutical companies.

The representative office of AstraZeneca in Kazakhstan was opened in 2007.     
At the moment, the company employs about 200 employees in different regions of the country: Almaty, Nur-Sultan, Karaganda, Shymkent, Aktobe, Ust-Kamenogorsk, Uralsk, etc. Currently, 24 AstraZeneca drugs are registered in Kazakhstan in such therapeutic areas as oncology, respiratory and autoimmune diseases, cardiovascular diseases, metabolic disorders and rare diseases. By 2026, the company plans to introduce more than 15 new products to the Republic market. In September 2023, AstraZeneca Kazakhstan LLP (Limited Liability Partnership) was registered in Kazakhstan.

The AstraZeneca company cooperates with the Ministry of Health (MoH) of the Republic of Kazakhstan (RK) and is implementing a number of large-scale projects that improve the quality and accessibility of innovative medicine for all patients of the Republic. The company is a member of AIPM, Eurobak, and also acts as a regular speaker of the National Chamber of Entrepreneurs of the Republic of Kazakhstan “Atameken”.

AstraZeneca initiates industry discussion platforms in the field of healthcare. With the support of AstraZeneca, Business Sweden Round Tables are regularly held with the participation of the Ministry of Health of Kazakhstan and the Embassy of Sweden in Kazakhstan. Being an Anglo-Swedish company, AstraZeneca intends to initiate the development of discussion platforms, including those with the British Embassy.

AstraZeneca pays special attention to projects to improve the diagnosis of diseases and develop clinical trials in the Republic of Kazakhstan. Visit the company's global website https://www.astrazeneca.com/

Clinical Trial Support (Kazakhstan) provides a range of services to support clinical trials and manage study sites.
Our team consists of experts in the field of clinical research with relevant experience in providing similar services in the Russian Federation.
The range of Clinical Trial Support services includes:

• organization of work and management of study sites,
• stuff training,
• leasing of medical equipment for study sites,
• organizing transfers for study subjects,
• organizing payments to study subjects and study sites.

Our mission is to make the clinical study process convenient, fast, and efficient.
We are creating a developed clinical study infrastructure in the EAEU and CIS countries.

The Nextons team, formerly part of Dentons' Russian practice, provides a full range of legal services, following the best practices and traditions created over more than 30 years of work in the CIS countries. Nextons is an official partner of the international law firm Dentons and successfully supports client projects all over the world.

Nextons' pharmaceutical, medical and biotechnology practice has been supporting complex projects in the pharmaceutical and medical industries for many years, aimed at bringing new products to the market, localizing production, technology transfer and partnership with the government. Our specialists have unique experience in structuring technology transfer, contract manufacturing, experience in consulting on legal issues regarding the strategy for introducing medicines and medical devices to the CIS market, legal support for local manufacturers in the development of new foreign markets, and support for innovative drug supply projects.

Nextons' pharmaceutical, medical and biotechnology practice is included in the first group of legal ratings of Chambers Europe, Pravo-300, Kommersant. In 2021, the Nextons team was recognized as the winner of the LMG Life Sciences Europe Awards in the “Law Firm of the Year in Russia” category.

Sartorius German concern is a leading global manufacturer and supplier of technological solutions, equipment, and services for Bioprocesses and Laboratories
The most important areas of activity of the Sartorius concern in Bioprocesses are equipment and materials that help our customers obtain end-to-end solutions, be efficient and reliable in the production of vaccines, monoclonal antibodies, recombinant proteins, gene therapy, blood products, as well as classical pharmaceutical industry associated with the production of sterile liquid forms.
The company produces and supplies bioreactors, culture media, purification systems (UF/DF), filters for a wide range of applications (depth, sterilizing liquid/gas, antiviral), disposable sterile systems for storing and handling liquids, chromatographic equipment, sorbents, freezing systems , as well as peripheral equipment and consumables. It provides full equipment maintenance and also offers services such as: development and characterization of cell lines, research in the field of validation of disposable systems and sterilizing filters, and much more.
Sartorius laboratory equipment and expertise enable customers around the world to work with maximum efficiency and convenience, implementing modern standards in applications such as pipetting, laboratory weighing, water treatment, filtration, microbiological control, and cell processing. Our goal is to help scientists and engineers make progress in the development and production of medicines faster and easier, in order to make medicine accessible to as many people as possible.
Over the past decade, Sartorius has been advising and equipping customers to produce vaccines against infectious disease outbreaks and pandemics such as Ebola, Zika, H1N1 and COVID-19, and it is a global leader in cell and microbial culture-based drug manufacturing solutions.

Statandocs company is a diversified, dynamically developing company that provides a wide range of services in the field of circulation of medicines and medical devices.
Established in 2016 as an independent expert and consulting agency, Statandocs has completed over 7 years of work more than 2,600 projects (of which 799 in 2022) for 94 clients in Russia and the EAEU, including large international ones (Pfizer, AstraZeneca, Bayer, Takeda, Stada , Gilead, etc.) and local (R-Pharm, Geropharm, Alium group, Valenta Pharm, Santo, Minskintercaps, Yuria-Pharm, etc.) pharmaceutical companies and CROs, and our staff today includes 82 employees who are experts in their field.
For clinical and observational studies (including RWE), we prepare a full set of necessary documents and support the submission process, develop and support eCRF and IWRS, conduct validation and statistical analysis of data with the preparation of statistical and clinical reports.
For registration dossiers, we prepare all CTD modules, including the formation of a CTD summary (module 2), independently carry out or support the submission of an application, plan and conduct user testing of the BPI(PL), provide our own cloud service for the EAEU XML eCDT (dossier preparation and life cycle maintenance).
We provide pharmacovigilance services during clinical trials and post-market launch (including QPPV services), including the development of SOPs, master files, RMPs, literature monitoring and preparation of PSURs and DSURs.
We actively work in the field of scientific medical writing, preparing materials for doctors and patients, articles (including systematic reviews and meta-analysis), posters and presentations.
The documents and materials we offer are successfully accepted by the authorized bodies of the member countries of the EAEU, the EU, the USA, as well as Vietnam, Georgia, Moldova, Tajikistan and Uzbekistan.

Sciencefiles has been specializing in comprehensive support for the development and registration of medicines and medical devices for more than 13 years. Sciencefiles develops documentation, processes data and conducts statistical analysis for clinical studies of any phase, any specialty and any nosology. The company's portfolio includes support for over 500 clinical trials, including those in rare specialties and dosage forms.
Since its establishment in 2009, Sciencefiles has successfully completed over 950 projects for more than 130 Russian and foreign pharmaceutical companies and contract research organizations, including 8 companies from the TOP 20 Global Pharma. The company's quality management system is certified according to the international standard ISO 9001:2015.
The highly professional Sciencefiles team includes more than 70 experts - doctors and candidates of medical, pharmaceutical and biological sciences. Documents are prepared in Russian and English, with the possibility of medical translation into more than 80 languages of the world. Deep expertise, guaranteed quality and caring service are the key advantages of Sciencefiles.
Read feedback from our clients on the website.

Aston Health today provides modern technologies and proven data to solve business problems of pharmaceutical manufacturers, distributors, pharmacy chains, medical and patient communities, government agencies and professional associations operating in the healthcare market.
Since 1999, the company's activities have been devoted to the study, systematization and development of this market. We understand its mechanisms well, evaluate all components and foresee development trends.


Main areas of work:

• Patient monitoring programs
• Diagnostic programs and patient selection
• Marketing, GR and Market Access programs
• Patient support programs
• Educational programs for doctors and patients
• Analysis and examination of the pharmaceutical market

Algimed is a dynamically developing group of companies; for 18 years we have been providing comprehensive equipment for laboratories and have won the status of an international supplier. We offer our clients a wide choice of: analytical equipment, chemical agents and reagents, pharmacopoeial standards, consumables, products for cellular molecular biology, as well as solutions for the determination of bacterial endotoxins and pyrogens, veterinary medicine and food safety.
Algimed provides prompt technical support, service and personnel training.
Our offices are located in Kazakhstan and Uzbekistan. You can find more information about the products supplied and services of the company on our website

GRATA International is a dynamically developing international law firm serving projects in the countries of the former USSR and Eastern Europe: the most complete coverage of the region with a network of offices, the presence of a highly professional team trained to conduct cross-border projects. The company's reputation and experience are confirmed by reviews from transnational clients and leading international ratings.
250 specialists in 22 countries around the world advise the largest international and local firms, funds, banks, insurance, construction, mining companies, airlines, heavy and light industry enterprises, telecommunications organizations, pharmaceutical companies, etc.
GRATA International is annually recognized as the best company by leading international ratings: The Legal 500, Chambers Global, Chambers AsiaPacific, IFLR1000, Who's Who Legal, Asialaw Profiles.
The client can receive quality services in 8 industries and 16 specializations.

The AEQUITAS law firm was founded in 1993 and is one of the leading Kazakh firms recognized in the global legal services market. The largest rating publications Chambers & Partners, The Legal 500, Who's Who Legal and others classify AEQUITAS and the firm's lawyers as the most recommended Kazakhstani professionals.
In 2021, 2022 and 2023, AEQUITAS received the Firm of the Year in Kazakhstan award according to the results of a study conducted by the international rating agency Who is Who Legal.
AEQUITAS is one of the few law firms in Kazakhstan that has an active specialized practice in the field of healthcare, medicine, and pharmaceuticals.
AEQUITAS clients are companies from leading economic sectors from more than 50 countries. More than 20 international, foreign and Kazakh companies manufacturing medical and pharmaceutical products, as well as the largest international corporations, companies representing world-famous brands, banks and financial institutions are among them.
The firm's main values are high quality services, honesty, transparency, and efficiency.

Velpharm LLC is a modern pharmaceutical high-tech research and production full cycle complex for the development and production of medicines
The company's portfolio includes more than 300 types of drugs from various pharmacotherapeutic groups.
The production of finished medicinal products is also carried out from in-house pharmaceutical substances
Today, Velpharm LLC consists of:
1. An integrated quality management system for compliance with GMP and ISO 9001:2015 requirements.
The quality management system includes a set of measures at all stages of the product life cycle, which, if carried out regularly, can guarantee quality, efficacy, and safety of manufactured drugs.
An stablished system of internal and external audits ensures constant monitoring of the processes for compliance with GMP requirements in order to eliminate customer risks during technology transfer.
2. A team of highly professional specialists with extensive experience in registration, development of medicines, technological processes, and analytical control.
3. Own pilot production workshop for the production of pilot batches.
4. Quality control laboratory and microbiological laboratory.
5. Well-equipped warehouses.
6. Contract manufacturing and licensed production at the Velpharm site.
7. Approved procedure for transfer of pharmaceutical production technologies.

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