On 22 May 2022, the Parliament of Ukraine adopted draft law No. 7313 (“Draft Law“) aiming to prevent the turnover of pharmaceuticals manufactured in Russia or Belarus, or marketed by marketing authorization holders affiliated or otherwise related to companies with pharmaceutical manufacturing in these countries. To become effective, the Draft Law would need to be signed by the president of Ukraine and published in the official gazette. The Draft Law will come into force on the next day after it is published and will remain effective for three months after the termination or cancellation of martial law.
The pharmaceutical industry in Ukraine is deeply concerned about the absence of straightforward criteria in the Draft Law to determine which specific marketing authorizations would be suspended or canceled.
We recommend that companies monitor the status of the Draft Law. We also recommend that pharmaceutical companies test their current operations against the potential changes to identify their level of exposure.
In more detail
The Ministry of Health of Ukraine (MOH) is authorized to perform either of the following actions:
- Cancel or refuse a marketing authorization, if at least one stage of the manufacturing process is carried out by an entity with manufacturing facilities in Russia or Belarus
- Cancel or suspend a marketing authorization, if its holder or holder’s representative in Ukraine is directly or indirectly affiliated to an entity that:
- “Directly or indirectly” carries out manufacturing of pharmaceuticals in Russia or Belarus
- Is a representative, a representative office, a branch, licensee, marketing authorization holder, manufacturer or supplier of an entity listed in (i) above
- After 23 February 2022:
- Concluded transactions on taking part in at least one stage of manufacturing a pharmaceutical or an active pharmaceutical ingredient (API) by an entity located in Russia or Belarus
- Provided for the use by an entity located in Russia or Belarus “pharmaceutical tangible or intangible assets” or related patents, authorizations, licenses, marketing authorizations, rights and other documents required for the manufacturing of pharmaceuticals or APIs, or lent, rented out, licensed out or sold such assets, rights or documents directly or indirectly to a Russian or Belarusian resident for manufacturing pharmaceutical products
The MOH would be able to cancel a marketing authorization only after suspending it for three months and if the marketing authorization holder continues to carry out the activities set forth in item 2 above after the expiry of the three-month period. The Cabinet of Ministers of Ukraine must agree upon the cancellation of the marketing authorization.
The adoption of the Draft Law does not immediately trigger a refusal, cancellation or suspension of any of the impacted marketing authorizations. Instead, the Draft Law provides the MOH with the authority to decide on the refusal, cancellation or suspension of marketing authorizations on a case-by-case basis. The MOH must approve the bylaws detailing the procedures for refusal, cancellation or suspension of marketing authorizations within two weeks after the Draft Law becomes effective.
Issues to be further clarified
There are still many uncertainties 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 suspended or canceled
- How the affiliation of a marketing authorization holder to an entity related to pharmaceutical manufacturing in Russia or Belarus would be determined
- The meaning of the terms “indirect manufacturing of pharmaceuticals” and “pharmaceutical tangible or intangible assets”