AIPM consolidates efforts of international pharmaceutical companies to ensure uninterrupted supplies of medicines and support the Russian healthcare system

April 9, 2020, Moscow – The international pharmaceutical industry reaffirms its global and regional commitment to attract the industry expertise and know-how needed to accelerate the development of safe and effective new vaccines, diagnostics and treatments to use in the fight against COVID-19 in collaboration with all stakeholders. In context of the COVID-19 pandemic and unprecedented challenges for public healthcare, companies and leading global industry associations – IFPMA (International Federation of Pharmaceutical Manufacturers & Association) and EFPIA (European Federation of Pharmaceutical Industries and Associations), of which AIPM is a member – have voiced their willingness to support public healthcare systems around the world during these difficult times.

The Association of International Pharmaceutical Manufacturers (AIPM), which unites over 60 leading international pharmaceutical companies in Russia, is doing everything possible to coordinate the efforts of the industry and support the government to tackle the COVID-19 outbreak. In addition to accelerating efforts to develop diagnostic and therapeutic solutions, the Association and its member companies are working hard to prevent drug shortages and supply chain disruptions.

Under current circumstances, we focus on the following key areas:

1. Ensuring continuity and uninterrupted supply of all necessary drugs to the patients that need them;
2. Supporting comprehensive measures by the government and healthcare system in order to respond as quickly as possible to the challenges posed by the COVID-19 outbreak;
3. Accelerating the development of new vaccines, diagnostics and treatment for COVID-19, arranging conditions for fast registration thereof in the Russian Federation once successful therapeutic solutions emerge.

In order to ensure the fast availability of drugs for treating those suffering from COVID-19 and its complications and in order to plan and maintain uninterrupted supplies of all necessary drugs, the Association has come up with proposals to supplement the set of measures and tools developed by the Government, with measures that will allow for flexible monitoring, planning, production, and adaptation of regulatory requirements to minimize risks of shortages in drug provision to patients.

AIPM sent letters of appeal to government bodies: the Government of the Russian Federation, the Ministry of Health, the Ministry of Industry and Trade, Roszdravnadzor (Federal Service for Surveillance in Healthcare), realizing that amid tougher quarantine conditions, additional steps will be required to prevent a shortage of medicines in pharmacies and healthcare facilities, maintain the necessary supply regime, and create opportunities to quickly respond to the emerging needs of relevant government agencies. All this will allow regulators to concentrate as much as possible on solving other paramount tasks in the fight against the novel coronavirus pandemic.

The initiatives proposed by the Association include the following:

• providing of permissions to conduct clinical trials on the indication of COVID-19 in a priority (accelerated) order;
• introducing “conditional registration\ approval on conditions” on the COVID-19 indication and a simplified procedure for granting marketing authorization for COVID-19 medicinal products, vaccines, and diagnostics already approved in countries with strong regulatory systems;
• introducing a temporary moratorium on laboratory examinations and on-site inspections of pharmaceutical production facilities in order to confirm GMP compliance certificates provided that the applicant undertakes all necessary measures to carry out GMP inspections in the post-registration period;
• extending the transition period for the introduction of Trace&Track system for medicines until the COVID-19 pandemic has been taken under control, the quarantine regime both in Russia and abroad has ended, and borders will be reopened so that professionals can travel;
• introducing a simplified procedure for introduction into civil circulation of priority medicinal products deemed essential for the treatment of patients suffering from the novel coronavirus and its complications, as well as for other medicines in high demand during the current pandemic;
• taking into account global restrictions on the supply of API and their auxiliary components, to establish procedure of urgent amendments to the registration dossier for the medicinal product which should be made by notification. This measure will allow for a quick substitution of an API supplier if there are any sudden changes should be adopted to supplying chains or if production facilities have to be changed;
• taking into account the the growing dynamics of the COVID-19 pandemic that requires taking emergency and extraordinary measures on the part of stakeholders and the public healthcare system as a whole, consider giving an authorized federal healthcare executive body special powers to regulate the circulation of medicines;\
• and others.

Understanding the importance of the prompt interaction between government bodies and pharmaceutical companies, the Association has prepared lists of responsible persons in each of the member companies for direct communication on issues related to the supply and clinical trials related to vaccines and therapies that are potentially effective against COVID-19, and submitted the lists to appropriate government agencies in order to facilitate interaction.

“Today, given the extraordinary conditions that we face, it is crucial to work in a united and coordinated way and conduct the direct dialogue between the industry and government bodies,” says Vladimir Shipkov, Executive Director of AIPM. - “This enables all sides to quickly rearrange the resources, take non-standard decisions, and promptly manage emerging risks. We proactively submitted our proposals, and we see that some of them have already been adopted as they are included in the government's decisions, got shapes in the form of legal acts, thus ensuring continuous and efficient medicines supplies. Despite the quarantine measures, reduced opportunities for cargo transportation, and a wide range of other limiting factors, all Association member companies deliver their medicines without disruptions. For our part, we are doing everything possible to ensure that patients and physicians do not experience any shortage of the therapies they need. The industry is prepared to assist in any way possible. We are open to expanding cooperation and strive for uninterrupted supply in any scenario.”

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For information about international pharmaceutical companies’ contribution in the fight against the spread of COVID-19 on global and national level in the Russian Federation, please visit the AIPM website (in Russian).

Or read more on  IFPMA (International Federation of Pharmaceutical Manufacturers & Association) web site via the link,  or EFPIA (European Federation of Pharmaceutical Industries and Associations) web recourses via the link (in English).

About:

The Association of International Pharmaceutical Manufacturers (AIPM) was established in 1994 to represent leading international pharmaceutical companies operating within Russia. Its members produce and develop modern, effective, safe and high-quality medicines. AIPM unites 60 international companies, which account for over 80% of the world's pharmaceutical production and over 60% of the volume of medicines supplied to the Russian Federation.

For more information, please contact

Elena Yankovskaya, Head of Communications, AIPM

Tel.: +7 (495) 933 70 40 (ext. 109), E.Yankovskaya@aipm.org