The year just ending was a big challenge for all industries. Yet it was the pharmaceutical industry that had to rise to the task like no other. No wonder, it needs to operate cohesively for the sake of people’s lives and health.

The Association of Pharmaceutical Manufacturers of the Eurasian Economic Union (APMEEU) has now decided to take stock of the year and is pleased to share its summary of the most important events for the pharmaceutical market here.

The pharmaceutical industry is one that has always been overly regulated and seen as conservative. This is why this year has been a breakthrough period in terms of legislative incentives. The relevant ministries have been working harder and faster on behalf of the state to take supportive decisions that are both unprecedented and crucial for this period.

1) The Government of the Russian Federation has adopted a procedure for faster registration of medical devices and granting approvals for the use of medicines to treat coronavirus patients and then extended it for a year. The fast-track procedure allows one to have all the necessary documents for the use of medicines or medical devices in as short a time as possible. Specific circulation of medicines intended for use in the threat of an emergency and the prevention and treatment of diseases posing a danger to others have been approved by Government Resolution of the Russian Federation No. 441 of April 3, 2020. The special procedure was approved in April 2020 in the face of the COVID-19 spread. It now extends until January 1, 2022.

2) The Government of the Russian Federation has approved Resolution No. 1771 that establishes a special procedure for the re-registration of prices for the most demanded medicines on the VED list in the event of inventory shortage. Roszdravnadzor (Russian Federal Health Care Supervisory Agency) is now bound by the new rules to monitor current shortages or risks of shortages of certain drugs due to pricing.

3) The Government of the Russian Federation has amended the VED List 

(Decree of the Government of the Russian Federation No. 2626-p of October 12, 2020). The list is for an indefinite period now (the previous lists lasted for one year) and also has 3 coronavirus drugs on it. Today, the companies that are members of the Association produce 223 drugs on the VED list in a variety of nosologies.

The pandemic has shown that immunoprophylaxis issues are coming to the fore. The WHO cites the failure to vaccinate as one of the top 10 threats to humanity. Immunization is lifesaving and cost-effective activity: 1 ruble put into vaccination equals 16 times the budgetary savings over time.

4) The Government of the Russian Federation has approved The Immunoprophylaxis Development Strategy for the next 15 years. The document is commissioned by the President of the Russian Federation and sets out a roadmap until 2035. The strategy targets immunoprophylaxis for an array of infections such as diphtheria, measles, rubella, viral hepatitis B, and seasonal influenza. The actions of the strategy fall into six main areas.

The first calls for the optimization of the national preventive vaccination and disease-specific vaccination schedules. It will list all vaccine-controlled infections exhaustively.

The second is to foster scientific advances and pre-clinical research aimed at the creation of immunobiological medicines.

The third is to localize the full cycle of vaccine production at domestic facilities.

The fourth is to make immunizations safe and to ensure pharmacological follow-up of their results.

The fifth is to perfect the state policy in the area of immunoprophylaxis of infectious diseases.

The sixth is to raise people’s awareness of the good things they can get from vaccination.

5) The world’s first coronavirus vaccine, Sputnik V, has been registered in Russia.

A milestone this year was the full-scale introduction of labeling to help track the movement of medicines and to protect the end consumer while making the market perfectly traceable. APMEEU members are the first to launch drug labeling.

6) Labeling has been made binding for the pharmaceutical industry since July 1, 2020. Some practical difficulties still arose, but now the Government Resolution PP No. 1779 of November 6, 2020, which is valid until February 2021, has put an end to all of them.

7) The implementation of the Pharma 2020 strategy has been summarized and Pharma 2030 has been put into action. The Strategy has proven itself a success over the last 10 years, shaping the industry and paving the way for more than just bringing essential medicines to patients during a pandemic. The industry is better able to rise to the task, meet the challenge, and respond to difficulties as they arise. At the next stage, innovative development should become the main driver of Pharma 2030. This means that Russian companies must learn how to make modern high-tech drugs that will be copyright patented.

8) The Federal Centre for Planning and Organization of Drug Provision to Citizens was established on November 26. Acting as a state customer, the institution will arrange for the procurement or acquisition of pharmaceuticals out of the federal budget funds as stipulated by Presidential Decrees, resolutions, and orders of the Russian Government, place state orders and award contracts, and arrange and hold the procurement of pharmaceuticals out of the federal budget funds, particularly for the treatment of people suffering from orphan diseases, cancer, HIV, tuberculosis. It will also cover immunobiological medicinal products for immunoprophylaxis aimed at giving prophylactic vaccinations listed in the National Calendar of Prophylactic Immunizations. Elena Maksimkina was appointed Acting Head of the Centre.

9) Shifting to the EEU Registration of Medicinal Products. The changeover to common Union rules will let harmonize the standards between countries as well as move towards a more EU-like registration approach. The EEU registration makes the expert report of the regulatory body that contains the findings of the expert examination of registered medicinal products on crucial issues such as efficacy, safety, and quality open to the public. Hence, it is greatly transparent. This approach will bring the quality of the state expert examination of medicinal products to a higher level, which will ultimately have a positive effect on clinical practice.

10) Creation of a state fund to help orphan children. The Russian Ministry of Healthcare has sent a draft list of diseases and medicines for treating them that the newly created fund would be able to finance to the Government.

The Association of Pharmaceutical Manufacturers of the Eurasian Economic Union was registered in 2012.

The Association aims to create the framework for the pharmaceutical market of the Russian Federation and other EEU countries to build up, to reinforce the position and competitive performance of the national pharmaceutical industry.

Members of the Association have the main competence centers, research laboratories, and production facilities among them, in the Russian Federation and other EEU countries. Likewise, they have proprietary know-how and other intellectual property in the development and production of medicines and medical technologies. The Association includes leading full-cycle pharmaceutical companies, namely: Pharmstandart PJSC, Biocad CJSC, GEROPHARM LLC, Nanolek LLC, Polysan, Science and Technology Drug Company, Aktivny Komponent JSC, Generium JSC, ChemRar, High Technology Center, NatiVita, JVLLC.