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Health Care

12/ 10/ 2012

State authorities officially supported EBA’s call to cancel criminal liability for the violations in preclinical, clinical trials and medical drugs registration procedures.

Background: On 5 June 2012 the Draft Law No 10561 “On Amending Certain Legislative Acts regarding Increased Liability for the Falsification or Circulation of Falsified Medical Drugs” was registered in the Verkhovna Rada of Ukraine. The Draft Law added, inter alia, the new Article 321-2 to the Criminal Code of Ukraine and  established the criminal liability for the violations in preclinical, clinical trials and medical drugs registration procedures.

The European Business Association (hereinafter – the EBA) send out a number of appeals concerning the unacceptability of approval and adoption of this Draft Law pointing out its controversy with international and European legislation and practices. Moreover, the EBA stressed the risk of subjective abuses caused by the novelty which can bring difficulties to the pharmaceutical companies’ operational activity in both medical drugs registration and clinical trials areas.

The relevant appeals were addressed to Mykola Azarov , the Prime Minister of Ukraine, Valeriy Khoroshkovsky, the First Vice Prime Minister of Ukraine, Raisa Bohatyryova, the Vice Prime Minister of Ukraine/Minister of Health of Ukraine, Petro Poroshenko, the Minister of Economic Development and Trade of Ukraine, Volodymyr Lytvyn, Head of the Verkhovna Rada of Ukraine,  Tetyana Bakhteyeva, Head of the Committee on Public Health of the Verkhovna Rada of Ukraine, Nataliya Korolevska, Head of the Committee on Industrial & Regulatory Policy and Entrepreneurship of the Verkhovna Rada of Ukraine, Iryna Akimova, First Deputy Head of the Presidential Administration, Andriy Klyuev, Secretary of National Security and Defence Council, and Jose Manuel Pinto Teixeira, Head of Delegation of the European Union to Ukraine.

However, on 5 July 2012 the Draft Law was adopted by the Verkhovna Rada of Ukraine in the second hearing. The EBA immediately appealed to Victor Yanukovych, the President of Ukraine, calling for presidential veto of this Draft Law.

Moreover, on 19 July 2012 the EBA held the press-conference “Double Risk for the Pharmaceutical Market” and reiterated the inexpediency of the proposed changes and their negative impact on the overall investment attractiveness of Ukraine.

On 26 July the President of Ukraine signed the Law.

On 31 August 2012 The Draft Law No 11129 “On Amending the Criminal Code of Ukraine via Cancelling the Criminal Liability for the Violations in the Preclinical, Clinical Trials and Medical Drugs Registration Procedures” was registered in the Verkhovna Rada of Ukraine. The Draft Law presumes the cancellation of the Article 321-2 of the Criminal Code of Ukraine. The EBA fully supports this legislative initiative and already made it known to the relevant Committees of the Verkhovna Rada of Ukraine, and also to Volodymyr Lytvyn, Head of the Verkhovna Rada of Ukraine, and Raisa Bohatyryova, the Vice Prime Minister of Ukraine/Minister of Health.

We are glad to inform you that the EBA received official responses from the VRU Committee on Legislative Support of Law Enforcement (the major Committee responsible for the mentioned Draft Law) and the Ministry of Health of Ukraine supporting our position and the need to adopt this Draft Law as soon as possible.

We hope for the successful approval and adoption of the Draft Law No 11129 by the Verkhovna Rada of Ukraine in the nearest future.

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