Upcoming 2019 already is awaiting with much change regarding the compulsory labelling and also with the new objectives of health development in the Pharma-2030 program.
According to Dmitry Chagin, the Chairman of the Board of the Association of Pharmaceutical Manufacturers of the EAEU, one of the main problems of the local pharmaceutical market is the abundance of nomenclatures. There are known even the cases when the number of INNs in a single denomination reaches hundreds. In order to avoid such confusion, it is must task to register only drugs with proven efficacy. According to the Dmitry Chagin, it is difficult to register new generics in some countries if there are already several drugs of this group on the market.
The labelling is expected to be mandatory in 2020. Since November of this year (2018), the Center for Development of Promising Technologies (MDGT) has become the operator of the pilot labelling project. Andrei Kirillov, the Operations Director, said that today more than 9000 participants and 1000 drugs are already registered in the system, 575 documents have been created and 12000 packages have been marked. There is an additional measure protection on the packages – a cryptocode, that is of 64 bits in size, the field length is 88 characters. For the additional protection, proving its uniqueness, the cryptocode will be protected by a digital signature, with measures of 12 × 12 or of 10 × 10 mm. To ensure a code for printing on the package, there will be special devices – emission recorders. MDGT plans to complete the delivery of the devices to the medical organisations by the end of 2019.
Liliya Titova, the Executive Director of the Union of Professional Pharmaceutical Organisations, noted that mandatory labelling has another benefit – the manufacturer will be able to obtain information of number of packages sold and reasonably increase production volumes. Marking will also help to avoid a situation where the pharmacies cannot sell the product and pay to the distributor and that – to the pharmacist.
Today, the grown of the pharmaceutical market is largely promoted by expensive drugs. The inflation in the market is now minimal: it was 0.5 % for drugs from the Vital and Essential Drugs List and 1.91 % for other drugs. The hardest – by 7.4 % – increased the price of medicines worth up to 50 RUB, but the drugs that are more expensive than 500 RUB, have fallen to 0.4 %.