On 19 July 2022, the Ministry of Health of Ukraine (MOH) approved Order No. 1251 (“Order”). The Order enables the implementation of Law No. 2271-IX (“Law”) aimed at preventing 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. On 29 July 2022, the Order became effective. Thus, from 29 July 2022, the Law became applicable.
We expect that the Law will affect many international pharmaceutical companies that have a presence in Russia and/or Belarus and in Ukraine. This includes not only companies that operate manufacturing facilities in Russia and/or Belarus, but also companies that fall under the broad and vague criteria set forth below.
In more detail
The Law: criteria for suspension/withdrawal
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 meets/has met the following conditions:
- “Directly or indirectly” carries out manufacturing of pharmaceuticals in Russia or Belarus
- Carried out the following 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 of 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
- Is a representative, representative office, branch, licensee, marketing authorization holder, manufacturer or supplier of an entity listed in (A) or (B) above
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 Order: products that will not be affected by the Law
The products whose marketing authorizations will not be suspended/withdrawn include the following:
- Pharmaceuticals with less than two analogues (based on ATC-5 and NFC-1 classification) registered and supplied to Ukraine within the preceding year, provided that, for each of the analogues, the marketing authorization holder provides a letter guaranteeing the capacity to fulfill 100% of the country’s demand for such a product. In the absence of such letters, the minimum quantity of analogues must be three.
- Biological products
- Innovative products
- Products included in protocols for treating orphan diseases as listed at https://www.orpha.net
- Products in a dosage/form that have no generic substitutes registered and sold in Ukraine
- Products covered by the procurement agreements entered into before 24 February 2022
- Products included in the list of medicines prequalified by the World Health Organization
Products approved by the US FDA within the United States’ President’s Emergency Plan for AIDS Relief (i.e., products holding PEPFAR US FDA Tentative approval)
The Order: procedure for suspension/withdrawal
The MOH is authorized to take decisions on suspending/withdrawing marketing authorizations only after the six month suspension. A decision on suspension may be triggered by the information provided by e.g., the State Service of Ukraine on Pharmaceuticals and Control of Narcotics and the State Expert Center of the MOH and State Intelligence Service. The marketing authorization holder has the right to provide a written objection that should be considered by the MOH before taking the decision on the suspension.
Upon the expiry of the six-month period, the MOH is authorized to permanently withdraw the suspended marketing authorization, upon the approval of the Cabinet of Ministers of Ukraine, unless within six months of the suspension date, the MOH is provided with information to its satisfaction setting out the following:
- That the grounds that gave rise to the initial suspension have been eliminated
- The termination of the manufacture of nonexempt pharmaceutical products in Russia or Belarus and “confirmation of initiating” such termination
- The marketing authorization holder’s confirmation that they will terminate their investments in Russia and/or Belarus and/or exit Russia and/or Belarus within one year
The Order does not provide clarity on how the relation to a business entity engaged in/enabling manufacturing in Russia and/or Belarus will be determined, how the MOH will decide what specific marketing authorizations will be challenged and what the procedure for renewing the suspended/terminated marketing authorizations would be.