EAEU countries expect new drugs registration order

EAEU countries expect new drugs registration order

Starting this year, the EAEU pharmaceutical market must register medicines according to uniform rules. The decision was made in order to make medicines more affordable, safe and of high quality.

It was planned to legalize the uniform rules for drugs’ registration in EAEU countries since 1.01.2021. However, it is only the Russian Federation that has been affected by the innovation, since the country was considered to be the most prepared for the update. For other countries, e.g., Kyrgyzstan, Armenia, Kazakhstan and Belarus, new drugs’ registration will be amended by 30. 06. 2021. So, new system implementation should be completed by 1.07.21.

United pharmaceutical market was announced in 2017. Since that time, countries started to harmonize their national laws in the drug field in accordance with this idea. In the future, EAEU countries should harmonize the rules for drugs’ manufacture and sale by 2025. It is assumed to help to eliminate counterfeit and fake products from the market. Another advantage is that the quality control will be monitored by special control laboratories. This will eliminate barriers for quality medicines to access the market. The competitive advantages of drug manufacturers will also be favored that will allow them to easily enter international markets.

Expected benefits

Drug manufacturers recognize EAEU market as attractive. According to 2019 statistics, the GDP of the EAEU made  $1.9 billion, and the population was equal to 184 million. As for the volume of the drugs manufactures, in the Union member states, it made $9.243 billion in 2018. According to analysts' forecasts CIS and EEC pharmaceutical market growth in 2019 will make about 11%. By 2024, it will reach $46 billion level.

Oleg Berezin (Deloitte industry enterprises Head) states that innovations will benefit for both Russian and foreign companies. In the future no mutual rechecks or drug registration in 5 countries will be required. Harmonized standards will be applied for all.

Ekaterina Loskutova (Head of the RUDN Economics and Management Chair) states that EAEU operating pharmaceutical companies are interested in the international market. That is why they strive to improve the quality of their own products. The potential of medicinal products and the competitiveness of companies should increase since the updated registration requirements are close to international ones.

Vladimir Shipkov (AIPM CEO) notes that EAEU products competitiveness will increase due Union's legislation uniformity to international standards, including ICH. These are exactly the standards required for the study, development, production and circulation of medicines implemented in absolutely all regulatory systems all over the worls.

Artur Valiev, Sun Pharma CEO in Russia, notes that the national and Eurasian regulator have signed and now implement the Eurasian GMP standards for any new registrations. At the same time, the Eurasian standards somewhat resemble the Russian GMP standards. They clearly and definitely describe the requirements imposed by the regulator for the drugs manufacture. If such standards are followed, it will be possible to harmonize the drug manufacture for the Eurasian market.

Andrey Kolesnikov, Director of Market Access at Teva, confirms all of the above. He believes EAEU regulation to be the right way since it is based on the best international practices. Moreover, when registering a particular drug, the company must documentally support the production site compliance with the EAEU requirements.

Consumer health and safety

Vasily Ryazhenov, Head of the Drug Regulatory Relations Chair at Sechenov University, claims that the digitization of all the approvals will improve the products quality. Digital EAEU registries publish expert reports and conclusions on drugs efficacy, quality and safety. This is the first time such publicity has been introduced at the Union level. Before that, countries did not publicly provide such information. Registers will allow databases access to companies, pharmacovigilance services, and people.

Speaking of counterfeit products, Artur Valiev declares Russia succeeded in the field, e.g., introduced in Russia drug labeling system practically excluded counterfeit. Eurasian market should also stick to such practice. Labeling will make it possible to fully trace products since their production to market release. Consumers can confirm that the drug is original all by themselves. These measures will eliminate counterfeit fully.

Consumers are also interested in the availability of medicines.

Victoria Samsonova, KPMG Head of Healthcare Companies Interaction, says that market integrity is critical to the consumer. It enables people to gain access to new drugs without waiting for the local approval.

Oleg Berezin, in turn, notes that several factors affect the drugs availability. These are price regulation, state programs and their effectiveness. Such rules are established at the national level. However, if the drug’s price manufactured in Kazakhstan or Belarus is lower than Russian, the final price may be lower than that of analogues in the Russian Federation.

What problems can arise?

After July 1, 2021 there still will be a lot of issues to be resolved. Sergey Lut, "Lut, Kuroshin and Partners" lawer believes that it is not enough to remove the customs declaration to have harmonized market. Legislation also need amendment. The laws should not only regulate the drugs manufacture and import, but market circulation as well. Otherwise, current regulatory standards may be mutually contradictive or redundant.

The lawyer also notes that currently the parties are working on unified patents register. Its main function will be protecting the manufacturers intellectual property. Sergey Lut believes that such a register will help to solve the problems with patent infringement that manufacturers face in Russia these years. Also, registry will be aimed to create single drug’s market and to attract investors. Please mind that we are talking about the possibility to apply a patent or an invention without patent holder consent, and to produce the drugs generics.

Setting prices within the EAEU pharmaceutical market remains unresolved. Olga Pentegova, Deputy CEO of the Russian Drug Manufacturers Association, guesses  that the issues of price formation depends on the countries pricing policies. Currently, it is too early to consider harmonization. Each country sets prices at its own discretion. The policy of setting prices depends on the programs of a particular state concerning the provision of medicines to people, as well as on the state budget. In fact, common EAEU denominator will be difficult to reach.