On 19 July 2022, the Ministry of Health ("MOH") approved its order No. 1251 ("Order") to implement the law No. 2271-IX dated 22 May 2022 ("Pharmaceutical Sanctions Law"). Pharmaceutical Sanctions Law permits to suspend or terminate marketing authorizations ("MA") for medicinal products of companies that are related to pharmaceutical manufacturing in Russia / Belarus.
The Order establishes the following: (i) criteria for suspension / termination of MAs, (ii) types of products that qualify for exemption, and (iii) decision-making process of the MOH.
The Order sets out a very broad list of criteria for suspension / termination of MAs. If an international group of companies has pharmaceutical manufacturing facilities in Russia / Belarus (irrespective of whether such facilities are involved into manufacturing of products for Ukraine), it may be captured by the Order. Any other type of relationship (direct or indirect) with pharmaceutical manufacturing in Russia / Belarus, including at the above Ukraine level, may also present a risk.
Pursuant to the Order, the MOH will not take decisions to temporarily suspend / terminate MAs if relevant medicinal product:
- has less than 2 alternatives based on ATC-5 and NFC-1 classification that are registered in Ukraine and were supplied to Ukrainian market within the last calendar year. Each MAH (or its authorized representative) of such alternative product should provide a letter to the MOH confirming its readiness to cover Ukraine's 100% need for such product. In the lack of such letters, exemption should be granted if less than 3 alternatives are available;
- is a biological, immunobiological (immunological) medicinal product;
- is an original (innovative), reference medicinal product;
- is included into treatment protocols for orphan diseases according to the list at https://www.orpha.net;
- has pharmaceutical and dosage form for which no generic alternatives are registered and actually supplied in Ukrainian market;
- is covered by a valid agreement for its purchase out of public funds (state or local budgets) that was entered into before 24 February 2022;
- has gone through the procedure of prequalification by the WHO and is included into the WHO Prequalified List or is approved by US FDA within the framework of the United States President's Emergency Plan for AIDS Relief (PEPFAR).
The MOH should not approve decisions on suspension / termination of MAs in the above instances. Arguably, this does not prevent Ukrainian agencies to initiate relevant proposals with the MOH even with respect to companies / products that qualify for exemptions. Final decision on availability of exemptions is to be taken by the MOH.
The Order establishes the following decision-making process:
- Several groups of state entities, including the Security Service of Ukraine and the Foreign Intelligence Service of Ukraine, may approach the MOH with proposals to suspend or terminate MAs, referring to identified facts and violations. The MOH should inform the marketing authorization holder ("MAH ") accordingly within 5 business days;
- Proposals are considered by the Commission of the MOH. The Commission should inform MAH (or its representative) in writing of potential suspension / termination of MA based on the established criteria (see subsection "Criteria" above) and propose MAH to provide its comments. MAH has 10 business days to respond;
- Both proposals from state agencies and comments from MAH (if any) are considered by the Commission which then provides its recommendations to the MOH;
- The MOH takes the decision on temporary suspension of MA within 14 days following consideration of the matter by the Commission. Products brought into circulation before the temporary suspension of MA may continue to be used until their expiry date;
- Termination of MA may be imposed not earlier than 6 months following the temporary suspension. During such 6 months, MAH may provide (i) evidence that the grounds for temporary suspension were removed, or (ii) guarantee obligations that it will exit Russian / Belarus market within a year. If such satisfactory evidence / guarantee obligations are not provided, the MOH takes decision on termination of MA, subject to prior approval by the Cabinet of Ministers of Ukraine;
- Arguably, even if guarantee obligations are provided by MAH, they may only postpone the termination of MA, while the temporary suspension will remain in effect. Full exit from manufacturing in Russia / Belarus may be required for the temporary suspension to be lifted;
- The decision of the MOH to terminate MA will remain in effect for the period of martial law and 3 months after that.
At the stage of its public discussion, draft Order was criticized for deficiencies in legal drafting and risks related to excessive discretionary powers granted to the MOH. Those issues were not addressed in the final version of the Order and remain relevant.
Several other subordinate regulations are still required to make the Pharmaceutical Sanctions Law fully operational. However, it cannot be ruled out that state authorities may be launching the mechanisms under the Pharmaceutical Sanctions Law based on the Order and in the lack of the complete set of other regulations.