Parliament permits to revoke marketing authorizations of medicines held by companies that are related to pharmaceutical manufacturing in Russia / Belarus
On 22 May 2022, the Parliament passed the law aiming to limit the circulation of medicines produced or marketed by companies that are related to pharmaceutical manufacturing in Russia / Belarus (the "Law"). Pursuant to the Law:
- Pharmaceuticals produced by companies having manufacturing facilities in Russia / Belarus
The Ministry of Health ("MOH") may reject marketing authorization ("MA") application or cancel an existing MA for a medicinal product (by way of its termination or reduction of its validity period) in case data in the MA file shows that one or more stage of its manufacturing is performed by a company with manufacturing capacities in Russia / Belarus.
This is expected to fully close the Ukrainian market for pharmaceuticals manufactured with any direct involvement of Russian / Belarus companies (including, e.g., at the stage of final packaging).
- Pharmaceuticals with MA holders ("MAH") related to manufacturing in Russia / Belarus
The MOH may temporarily suspend or terminate MAs for medicinal products in case the fact is established that their MAH or its authorized representative:
- is directly or indirectly related to entities (including their representatives, branches, representative offices, licensees, MAHs, manufacturers and suppliers) that directly or indirectly carry out manufacturing of medicinal products in Russia / Belarus; or
- after 23 February 2022:
- performed legal actions aimed at participating in at least one stage of manufacturing of any medicinal product or API by an entity located in Russia / Belarus; or
- provided, rented or transferred title to (directly or indirectly) pharmaceutical tangible or intangible assets or related patents, authorizations, licenses, MAs, rights or documents required for manufacturing of pharmaceutical products (including APIs) to residents of Russia / Belarus.
If the MOH decides to exercise the above authority, it should temporarily suspend the MA first. Termination of the MA may follow not earlier than 3 months after that in case MAH continues activities as summarized above. The termination decision has to be approved by the Cabinet of Ministers of Ukraine.
The above may potentially affect pharmaceuticals marketed in Ukraine by multinational pharmaceutical groups that have manufacturing facilities in Russia / Belarus, irrespective of whether such facilities are involved into manufacturing for Ukraine.
- Process, expected further developments and timeline
The Law needs to be signed by the President and promulgated to become effective.
The Law does not per se trigger or require the suspension or termination of MAs. Instead, it grants to the MOH a discretional authority to do that. Details would need to be set out in subordinate regulations. The Law gives 2 weeks to the Government to have them developed and approved. It will remain in effect for the period of martial law and 3 months after that.
As the Law lacks clarity on many important issues (e.g., the criteria for choosing products for MA suspension / termination or how the relationship with Russian / Belarus entities will be established), subordinate regulations will be essential to determine its specific effect on, and risks for, the pharmaceutical industry.
