Ukraine: Topical legislative changes
Introduction of criminal liability for intentional non-compliance with the procedure of approval and conducting of clinical trials, as well as procedure of market authorization of medicines
The final wording of the Law of Ukraine On Introduction of Amendments to Certain Legislative Acts of Ukraine On Strengthening the Liability For Counterfeit or Circulation of Medicinal Products No. 5065-VI (the “New Law”) was placed on July 30, 2012 on the official web-page of Ukrainian Parliament. The New Law was recently signed by the President (in spite of numerous requests for veto) and enters into force on the day following its official publication which is expected within the next few days. We must admit that the amendments discussed in this newsletter do not actually concern counterfeiting of medicines, but rather set up unexpected and excessive grounds for criminal liability.
Among other amendments to the Criminal Code of Ukraine (hereinafter – the “Criminal Code”) the New Law introduces new article 3212 which stipulates criminal liability for violations in the field of pre-clinical study, clinical trials and market authorization of medicinal products.
In Ukraine only private individuals may bear criminal responsibility. Thus according to the updated Criminal Code (a) top-managers (or other responsible managers) of sponsors of clinical trials, respective CROs contracted by clinical trials sponsors, clinical sites, state experts and investigators, as well as (b) top-managers (or other responsible managers) of pharmaceutical companies and their subsidiaries/representative offices may be held liable for the following actions:
Intentional violation of (a) established procedure of pre-clinical study, clinical trials of medicinal products, fabrication of their results, and violation of (b) established procedure of market authorization of medicinal products entails imprisonment for the term of 3 (three) to 5 (five) years with debarment for the term of 1 (one) to 3 (three) years;
Same actions committed repeatedly or by a group of persons by previous concert entail imprisonment for the term of 5 (five) to 8 (eight) years with debarment for the term of 2 (two) to 3 (three) years;
Aforementioned actions if they caused the death of a victim or other severe consequences entails imprisonment for the term of 8 (eight) to 10 (ten) years with debarment for the term of 2 (two) to 3 (three) years.
Considering the wording of article 3212 there is a risk that responsible management of sponsors, CRO and clinical sites, as well as state experts and investigators will be held liable even for minor violations of procedural requirements in respect of clinical trials even if there is no harm thereof. Accordingly, even higher risk is attached to the violations of procedural requirements in respect of market authorization of medicines, where responsible top-managers of companies (representative offices), regulatory managers or state experts may be held liable without necessity to prove the consciousness of violation.
In order to minimize the abovementioned risks it is highly recommended to make sure that the way the clinical trials projects and internal market authorization application procedures are organized and conducted, is correct and absolutely legally compliant. Moreover, it may be suggested to conduct specific limited due diligence of:
The final wording of the Law of Ukraine On Introduction of Amendments to Certain Legislative Acts of Ukraine On Strengthening the Liability For Counterfeit or Circulation of Medicinal Products No. 5065-VI (the “New Law”) was placed on July 30, 2012 on the official web-page of Ukrainian Parliament. The New Law was recently signed by the President (in spite of numerous requests for veto) and enters into force on the day following its official publication which is expected within the next few days. We must admit that the amendments discussed in this newsletter do not actually concern counterfeiting of medicines, but rather set up unexpected and excessive grounds for criminal liability.
Among other amendments to the Criminal Code of Ukraine (hereinafter – the “Criminal Code”) the New Law introduces new article 3212 which stipulates criminal liability for violations in the field of pre-clinical study, clinical trials and market authorization of medicinal products.
In Ukraine only private individuals may bear criminal responsibility. Thus according to the updated Criminal Code (a) top-managers (or other responsible managers) of sponsors of clinical trials, respective CROs contracted by clinical trials sponsors, clinical sites, state experts and investigators, as well as (b) top-managers (or other responsible managers) of pharmaceutical companies and their subsidiaries/representative offices may be held liable for the following actions:
Intentional violation of (a) established procedure of pre-clinical study, clinical trials of medicinal products, fabrication of their results, and violation of (b) established procedure of market authorization of medicinal products entails imprisonment for the term of 3 (three) to 5 (five) years with debarment for the term of 1 (one) to 3 (three) years;
Same actions committed repeatedly or by a group of persons by previous concert entail imprisonment for the term of 5 (five) to 8 (eight) years with debarment for the term of 2 (two) to 3 (three) years;
Aforementioned actions if they caused the death of a victim or other severe consequences entails imprisonment for the term of 8 (eight) to 10 (ten) years with debarment for the term of 2 (two) to 3 (three) years.
Considering the wording of article 3212 there is a risk that responsible management of sponsors, CRO and clinical sites, as well as state experts and investigators will be held liable even for minor violations of procedural requirements in respect of clinical trials even if there is no harm thereof. Accordingly, even higher risk is attached to the violations of procedural requirements in respect of market authorization of medicines, where responsible top-managers of companies (representative offices), regulatory managers or state experts may be held liable without necessity to prove the consciousness of violation.
In order to minimize the abovementioned risks it is highly recommended to make sure that the way the clinical trials projects and internal market authorization application procedures are organized and conducted, is correct and absolutely legally compliant. Moreover, it may be suggested to conduct specific limited due diligence of:
- respective internal policies which regulate clinical trials conducting/market authorization applications;
- agreements between sponsors/CROs and investigators, clinical sites, the State Expert Center of the Ministry of Healthcare, as well as respective powers of attorney and other related documents.
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