FSI «SID & GP»
The Ministry of industry and trade of the Russian Federation
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Never get far on your own. How the healthcare system is addressing the issue of access to medicines

Moscow, November 23th. – Within the framework of the International Exhibition Pharmtech & Ingredients, a plenary session was held on the access to medicines for the national healthcare system. Vladislav Shestakov, Director of the State Institute of Drugs and Good Practices of the Ministry of Industry and Trade of Russia took part in the discussion and raised the issues of organizing remote inspections during border closures.

 

 

A lively discussion was generated. After all, the issues of the access to medicines, national drug safety and healthcare in general are now the hottest, most sensitive and vital.

At the beginning of his speech, Vladislav Shestakov emphasized that no matter what interests, needs, difficulties and complications of market participants are on the one side of the scale, the patient’s health is always on the other side, which will outweigh everything else. The adopted amendments to the Federal laws “On the Circulation of Medicines”, “On Licensing”, “On the Basics of Health Protection of Citizens”, the 441st and 789th Decrees of the Government of the Russian Federation allowed the Russian healthcare system to withstand the pressure and workload that pandemic of a new coronavirus infection has maintained its pressure on, close the emerging shortage of necessary drugs and medical devices, conducting urgent purchases and delivering them throughout the country.

«In such conditions, one remembers the proverb, known to everyone since childhood, «Never get far on your own» (literally from Russian, «One is not a warrior in the field»), – said the director of FSI «SID & GP». – Indeed, the crisis situation that has arisen in the world has led to the unification of efforts of all departments and authorities involved in the process of drug provision, and the joint coordinated work of each of the participant in this process allowed making the necessary decisions that can currently guarantee the national drug safety and health of citizens of the country».

Specifically Vladislav Shestakov highlighted as he is the Deputy Head of the Russian GMP Inspectorate, the topic of remote inspections, which have become a real tool to reduce the risk of drug shortages during border closings.

«From May 2020 to the present day, we have carried out about 600 remote inspections, – Vladislav Shestkov cited factual data. – Specifically, I would like to note that we give priority to those sites where we have already carried out face-to-face inspections, which we have already seen and at which we have been personally. The utility of a risk-based approach allows us to minimize risks when conducting a remote inspection, since it still differs from a face-to-face inspection in the inability to inspect the entire site in person».

Dmitry Galkin, Director of the Department of Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of Russia, also emphasized the importance of remote inspections and the readiness of colleagues from the Eurasian Economic Commission to amend legal acts to introduce remote inspection into the practice of the Eurasian Economic Union.