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Will Eurasia be a new single drugs market?
Earlier this month it was reported that the working group of the Eurasian Economic Commission (EEC) prepared three further documents for the introduction of a single drugs market within the Eurasian Economic Union (EEU).
The documents include requirements for labelling of medicinal products, the procedure for forming and maintaining the register of entities authorized to manufacture drugs, and general requirements for the quality of pharmaceutical inspectorates. The preparation of these documents represents a step closer towards implementation of a single drugs market which, no doubt, is likely to prove a challenging endeavour.
EEU and the single drugs market
The EEU was put in place on 1 January this year, initially including Kazakhstan, Belarus, and Russia, while Armenia joined on 2 January. More recently, at the end of May, Kyrgyzstan also entered the union. As part of the EEU, a single drugs market is planned to be put in place from 1 January 2016. This implies that a number of regulations of the individual member states would have to be harmonised for the purpose of the introduction of the single market. It was stated last year by Yury Kalinin, president of RosMedProm, the Russian Association of Drug Manufacturers and Suppliers, quoted by RIA AMI news agency, that legislation containing 25 documents pertaining to the circulation of drugs would have been approved by the beginning of next year. These would include:
- Harmonisation of pharmacopoeias
- Regulations for the registration of medications
- Good manufacturing practice (GMP) and good laboratory practice guidelines
- Guidelines for conducting pharmaceutical inspections, wholesale distribution transportation, and storage of medicines
- General rules for conducting research for bioanalogue (biosimilar) drugs
Furthermore, a single information system is to be created, which will include a single registry of drugs, and also an information database containing data on safety and quality. At the same time, however, certain regulations for medications, such as pricing, are to remain within the scope of national level jurisdiction.
Implications for pharma companies
The harmonisation of the legislations is likely to present significant challenges. With the single drugs market, some of the countries within the union would have to either relax or tighten their regulations, representing a change in the operating environment for a company exporting its products to a given member country. On the other hand, the single market between the countries would mean expansion of access to the other EEU member states within the union for a company's products. The same would hold for domestic companies of the EEU countries, which would now see the geographical footprint of their products increase as well. At the same time, the domestic companies from the countries of the EEU would benefit from a preference within the individual countries' tendering system, which would add an additional challenge for foreign manufacturers.
Similarly, while having a mixed impact on the pharmaceutical firms operating within these markets, the implementation of a single drugs market would also, unsurprisingly, have a varying impact on the individual country's market. For instance, while Kazakhstan is expecting the single drugs market to have a positive impact on the expansion of its pharmaceutical industry, certain officials in Kyrgyzstan, on the other hand, have expressed concerns over the population's access to medications. According to a member of Kyrgystan's Supreme Council (Jogorku Kenesh), Ravshan Jeenbekov, a number of studies suggested that since most of medicines suppliers to the country tend to be imported from outside the EEU, drugs may become more expensive as a result of higher customs duties.
Although the single drugs market has yet to be implemented and the required regulations to be approved, it seems that the impact of the creation of the single market for pharmaceuticals may be mixed for countries. The impact on pharmaceutical companies would likewise be mixed.
Kavita Rainova is a life sciences analyst for IHS
Posted 16 July 2015
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