Regulatory Developments in Ukrainian Pharmaceutical and Medical Device Sectors under Martial Law
On 24 February 2022, in response to Russia's military aggression, the state of martial war was declared in Ukraine. The Government further introduced various measures in the pharmaceuticals and medical device sectors required to address the critical humanitarian and defense challenges. Below we present a brief description of such measures most of which will remain in effect for the period of martial law. As at the date of this update, the state of martial law is declared through 25 April 2022, but could be further extended if required.
1. CLINIAL TRIALS
On 14 March 2022, State Enterprise "State Expert Center of the Ministry of Health of Ukraine" ("SEC") released recommendations related to holding of clinical trials in Ukraine. The key points include, among other things, as follows:
- Suspend initiation of new clinical trials, inclusion of additional sites and enrolment of new subjects for ongoing trials;
- If continuation of the trial at a site is not possible, ensure withdrawal of patients from the trial or their transfer to another approved site (including abroad, should subjects be leaving Ukraine for other countries). SEC and the relevant local ethics commission should be notified of such transfer as soon as practicable;
- Take all possible efforts to ensure the continuity of treatment with IMPs and compliance with trial protocols;
- Notify on breaches of the protocol in line with applicable regulations. No separate notifications to SEC and local ethics commissions are required with respect to the launch of the military aggression by the Russian Federation;
- Notifications to SEC and local ethics commissions, including with respect to substantial amendments to clinical trial materials, may be provided via email. Submissions for approval of substantial amendments will be processed by SEC in accordance with the established regular procedure, subject to SEC being able to maintain its operations;
- In case subjects' ability to attend trial sites is limited, consider implementing the following measures:
- Replace physical visits with telephone or video contacts, reschedule or cancel visits if necessary;
- In case it is impossible to obtain a regular written informed consent from a subject, an oral consent may be obtained instead in the presence of an impartial witness. In addition, it is permissible for the investigator and the subject to each sign a separate copy of the informed consent. Properly signed consent should further be obtained from the subject as soon practicable;
- Consider alternative options of IMPs' delivery to patients, subject to compliance with storage requirements established by the manufacturer. IMPs may be delivered by an independent distributor on the basis of an agreement entered into with the sponsor (to the extent permitted by the protocol and sponsor instructions).
In addition, SEC informed that scheduled audits of clinical trials are suspended.
Source: SEC official website https://www.dec.gov.ua/news/vazhlyvo-do-uvagy-sponsoriv-klinichnyh-vyprobuvan-predstavnykiv-sponsoriv-doslidnykiv-kerivnykiv-pidpryyemstv-ustanov-ta-organizaczij-zadiyanyh-u-provedenni-klinichnyh-vyprobuvan/.
2. STATE REGISTRATION OF MEDICINAL PRODUCTS AND CONFORMITY ASSESSMENT OF MEDICAL DEVICES
- State registration of medicinal products developed and/or manufactured in the Russian Federation is prohibited. The Ministry of Health of Ukraine ("MOH") terminated existing marketing authorizations for medicinal products that are manufactured, or for which marketing authorizations are held, by companies registered in or with registered place of operations in the Russian Federation and Belarus.
Basis: (i) Order of the MOH "On Prohibition of Use of Certain Medicinal Products in the Territory of Ukraine" No. 394 dated 2 March 2022, (ii) Order of the MOH "Certain Issues of Emergency State Registration of Medicinal Products under Martial Law" No. 384 dated 26 February 2022 ("MOH Order 384"), (iii) Order of the MOH "On Prohibition of Use in the Territory of Ukraine of Medicinal Products Originating from the Republic of Belarus" No. 503 dated 19 March 2022.
- Conformity assessment and Ukrainian language labelling requirements are temporarily waived for medical devices, active implantable medical devices and in vitro diagnostic medical devices. The MOH does not object to medical devices being imported, commissioned and used in Ukraine in the lack of compliance with applicable Ukrainian technical regulations.
Basis: Letter of the MOH No. 24-04/5396/2-22 dated 25 February 2022.
- Fast-track emergency use marketing authorization procedure has been approved for medicinal products and biologicals supplied to Ukraine during the period of martial law. Products so authorized may only be used by healthcare providers in medical practice and do not quality for retail sales.
Basis: MOH Order 384.
3. IMPORT OF MEDICINAL PRODUCTS AND MEDICAL DEVICES
- Pharmaceuticals and medical devices are included into the list of critical imports exempted from the general moratorium on cross-border payments and FX transactions. However, this is not a capture-all exemption, and some groups of products may not be covered by it. Furthermore, a number of formalities need to be complied with to effect the payments.
Basis: (i) Resolution of the Cabinet of Ministers of Ukraine "On the List of Products of Critical Imports" No. 153 dated 24 February 2022 (as amended); (ii) Resolution of the Board of the National Bank of Ukraine "On Activities of the Banking System in the Period of Martial Law" No. 18 dated 24 February 2022 (as amended).
- Import of medicinal products that (i) have marketing authorizations in Ukraine, but are supplied in foreign packaging, or (ii) have no marketing authorizations in Ukraine is temporarily permitted to cover the needs of Ukrainian healthcare institutions, to the extent supplies are accompanied by the certificate of analysis for each batch. Evidence of GMP compliance issued by Ukrainian authorities is not mandatorily required for import purposes. Similarly to some other measures described in this update, this change has been only reflected in clarificatory "no objection" letters of the MOH rather than in regulations.
Basis: (i) Letter of the MOH No. 24-04/5397/2-22 dated 25 February 2022, (ii) Letter of the MOH No. 24-04/5426/2-22 dated 1 March 2022.
- Mandatory minimum shelf-life requirements for medicinal products imported to Ukraine are waived. Import is permitted to the extent shelf life has not expired.
Basis: Order of the MOH "On Circulation of Certain Medicinal Products under Martial Law in Ukraine" No. 406 dated 3 March 2022 ("MOH Order 406").
4. PHARMACEUTICAL WHOLESALING
- Pharmaceutical wholesalers are permitted to supply medicinal products (other than those containing controlled substances) to entities that do not have pharmaceutical or medical licenses, including military administrations, units of armed forces and entities involved in volunteering and humanitarian activities.
Basis: Letter of the State Service of Ukraine for Medicinal Products and Drug Control ("SSUMP") No. 1655-001.1/004.0/17-22 dated 1 March 2022.
5. RETAIL SALES OF MEDICINAL PRODUCTS
- Pharmacies are permitted to sell and otherwise provide Rx medicinal products (other than those containing controlled substances) without prescriptions. This does not extend to products that are subject to reimbursement.
Basis: Order of the MOH "Certain Issues of Circulation and Sale of Medicinal Products under Martial Law" No. 413 dated 4 March 2022.
6. STORAGE AND TRANSPORTATION OF MEDICINAL PRODUCTS
- Transportation of medicinal products by non-dedicated vehicles (including public transport), as well as via post is permitted, subject to compliance with storage conditions established by the manufacturer;
- Holders of pharmaceutical licenses are allowed to store medicinal products in warehouse facilities not covered by their licenses, subject to compliance with storage conditions established by the manufacturer.
Basis: MOH Order 406.
7. HUMANITARIAN AID
- State Institution "Public Health Center of the Ministry of Health of Ukraine" is defined as an authorized recipient of medicinal products, medical devices, personal protective equipment and other products supplied as humanitarian aid or on charity basis for the needs of Ukrainian healthcare sector under martial law.
Basis: Order of the MOH "Certain Issues of Receipt of Humanitarian Aid and Charitable Supplies Under Martial Law" No. 474 dated 12 March 2022.
8. PUBLIC PROCUREMENT
- State Enterprise "Medical Procurement of Ukraine" and public hospitals may purchase medicinal products and medical devices directly from suppliers rather than through generally mandatory e-tendering process. They will still be required to further report publicly on the terms of such direct purchases.
Basis: (i) Resolution of the Cabinet of Ministers of Ukraine "Certain Issues of Holding Defense and Public Procurements of Goods, Works and Services Under Martial Law" No. 169 dated 28 February 2022 (as amended), and (ii) Order of the MOH "On Certain Issues of Holding Public Procurements to Cover the Needs of Healthcare Sector Under Martial Law" No. 408 dated 4 March 2022 (as amended).
- JSC "Ukrainian Railways" is authorized to make payments to suppliers for medical products ordered by Ukrainian military administrations. Ukrainian Railways is also permitted to transport and temporarily store medicinal products, subject to compliance with relevant requirements established by the manufacturer, including in terms of cold chain.
Basis: (i) Resolution of the Cabinet of Ministers of Ukraine "Certain Issues of Public Procurements of Goods, Works and Services to Satisfy the Urgent Needs of State Functioning under Martial Law" No. 185 dated 2 March 2022, and (ii) Order of the MOH "On Implementation of the Resolution of the Cabinet of Ministers of Ukraine No. 185 dated 2 March 2022" No. 416 dated 5 March 2022.
9. ADMINISTRATIVE PROCEDURES
- Statutory deadlines for various administrative procedures in pharmaceutical and medical device sectors are suspended. This affects, among other things, timings for marketing authorization procedures, approval of clinical trials, health technology assessment and obtaining of pharmaceutical licenses. Licenses for operations with controlled substances that expire after 24 February 2022, are deemed to be automatically extended. Ukrainian state authorities are performing their operations to the extent possible, however, significant delays in administrative procedures and/or temporary unavailability of some of administrative services should still be expected.
Basis: (i) Resolution of the Cabinet of Ministers of Ukraine "Certain Issues of Implementation of Rights, Freedoms and Legitimate Interests of Individuals and Legal Entities" No. 165 dated 28 February 2022; (ii) Letter of the State Regulatory Service of Ukraine dated 10 March 2022.
- SSUMP will generally not be performing scheduled and unscheduled inspections, as well as other market surveillance measures, in pharmaceutical and medical device markets. However, unscheduled market surveillance is still possible in limited circumstances, in particular to prevent unreasonable growth of prices for socially significant products. The Government has already instructed SSUMP to control retail prices for certain groups of locally produced pharmaceuticals.
Basis: (i) Resolution of the Cabinet of Ministers of Ukraine "On Termination of State Surveillance (Control) and State Market Surveillance Under Martial Law" No. 303 dated 13 March 2022, and (ii) Resolution of the Cabinet of Minister of Ukraine "On Introduction of Amendments to the Resolution of the Cabinet of Ministers of Ukraine dated 25 December 1996 No. 1548" No. 223 dated 6 March 2022.