On 3 May 2022, the parliament of Ukraine adopted in the first reading the draft law No. 7313 (“Draft Law“), aiming to prevent the turnover of pharmaceuticals manufactured in Russia or Belarus, or marketed by marketing authorization holders with ties to pharmaceutical manufacturing in these countries. The restrictions set forth in the Draft Law are discussed below.
Cancellation or refusal in marketing authorization
Based on the current wording of the Draft Law, the Ministry of Health of Ukraine (MOH) would be authorized to cancel or refuse a marketing authorization, if at least one stage of the manufacturing process is carried out by an entity having manufacturing facilities in Russia or Belarus.
Temporary cancellation of marketing authorization
The MOH would also be authorized to “temporarily cancel” a marketing authorization, if its holder or holder’s representative in Ukraine is directly or indirectly related to an entity that:
- “Directly or indirectly” carries out manufacturing of pharmaceuticals in Russia or Belarus
- Is a representative, a representative office, licensee, marketing authorization holder, manufacturer or supplier of an entity listed in (i) above
- After 23 February 2022:
- Performed obligations in taking part in at least one stage of manufacturing a pharmaceutical or an active pharmaceutical ingredient (API) in Russia or Belarus
- Provided, licensed out, rented out or sold directly or indirectly “pharmaceutical tangible or intangible assets” or related patents, authorizations, licenses, marketing authorizations, rights and other documents required for the manufacturing of pharmaceuticals and APIs to a Russian or Belarusian resident.
Issues to be further clarified
There are still many issues around the provisions of the Draft Law, including the following:
- The criteria to determine which specific marketing authorizations of a certain marketing authorization holder would be temporarily cancelled
- How the relation to an entity with ties to pharmaceutical manufacturing in Russia or Belarus would be determined
- The mechanism of temporary cancellation and the subsequent renewal of a marketing authorization
- The meaning of terms “indirect manufacturing of pharmaceuticals” and “pharmaceutical tangible or intangible assets”
Current status of the Draft Law
The Draft Law was approved in the first reading. Currently, the proposals to revise the text of the Draft Law are being developed in preparation of the Draft Law to the second reading in parliament. To become effective, the Draft Law would need to be adopted by parliament and signed by the president. Once effective, the relevant law would be valid for the duration of the martial law and three months thereafter.