On 8 June 2022, law No. 2271-IX (“Law“) became effective. This Law expects 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. For more details on the draft of this law, please refer to our dedicated legal alert.
As a next step, to enable the implementation of the Law, the Ministry of Health of Ukraine (MOH) should approve an order detailing the procedures for refusal, cancellation or suspension of marketing authorizations. The deadline for approval of the order is 22 June 2022. The MOH has published the draft order detailing the procedure for suspending and terminating marketing authorizations for public discussion. While the draft order provides clarity on the list of pharmaceuticals whose marketing authorizations will not be challenged, it still lacks clarity on the criteria for challenging marketing authorizations of a specific marketing authorization holder and the detailed and transparent procedures around these suspensions and terminations, giving rise to concerns about taking potentially arbitrary decisions.
We expect that the Law will affect many international pharmaceutical companies that operate manufacturing facilities in Russia and/or Belarus and those that have presence in Ukraine. We recommend that companies provide their comments on the draft of the MOH order and test their current operations against the upcoming changes to identify their level of exposure. The summary of the key provisions of the draft order of the MOH is set out below.
In more detail
Based on the Law, the 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 only be able to cancel a marketing authorization 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 Law does not immediately trigger a refusal, cancellation or suspension of any of the impacted marketing authorizations. Instead, the 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 Law will remain effective for three months after the termination or cancellation of martial law.
The draft order
The current version of the draft order is under public discussion and may still change. The current version of the draft order, among other things, sets forth the list of products whose marketing authorizations will not be suspended/terminated, including:
- Pharmaceuticals with less than two analogues (based on ATC-5 ad NFC-1 classification) registered and supplied to Ukraine
- Biological products
- Innovative products
- Products with no generic substitutes registered and used in Ukraine
- Products covered by the procurement agreements entered into before 24 February 2022
At the same time, the draft order does not provide clarity on how the relation to a business entity engaged in/enabling manufacturing in Russia or Belarus be determined, how the MOH will decide what specific marketing authorizations will be challenged, what the procedure for renewal of the suspended/terminated marketing authorizations would be etc.