Contents
• Promotion and sampling of pharmaceuticals to be prohibited
• Legal liability for adulteration and illegal distribution of pharmaceuticals to be toughened
• Licensing of activity pertaining to import of pharmaceuticals to be implemented
• Ban on pharmaceutical advertisement and certain restrictionsproposed

Promotion and sampling of pharmaceuticals to beprohibited

On 5 June 2012 Draft Law “On Amendment of Fundamental Ukrainian Legislation on Healthcare Related to Imposing estrictions for Officials and Employees of Medical and Pharmaceutical Institutions” was registered at the Ukrainian Parliament (registration No. 10560). The Draft Law proposes to divest medical and pharmaceutical institutions’ officials and employees of the right to accept rewards (fees) and samples of pharmaceutical goods (pharmaceuticals and medical purpose goods) fromlegal entities engaged in the production and/or sale of them.

The Draft Law also proposes to ban (i) mentioning (defining) the name of a pharmaceutical goods producer (their trademarks) during prescription and (ii) prescription of pharmaceuticals using prescription forms that bearadvertising information.

On 14 June 2012 the Committee on Healthcare discussed the Draft andamended it for a second reading.

If adopted, the law will take effect on 1 August 2012.

Legal liability for adulteration and illegal distribution of pharmaceuticals to be toughened

On 7 June 2012, the Ukrainian Parliament adopted in the first reading a Draft Law “On the Introduction of Changes to Certain Legislative Acts of Ukraine to Toughen Liability for Adulteration and Illegal Distribution of Pharmaceuticals” (registrationNo. 10561).

The Draft provides for:
• administrative liability for violation of restrictions on employees and officers of medical and pharmaceutical institutions
• criminal liability for violation of the prescribed procedure for carrying out preclinical or clinical trials and stateregistration of pharmaceuticals.

Additionally, the amendments proposed by the Draft toughen criminal liability for crimes related to executing transactions with adulteratedpharmaceuticals.

If passed, the law will take force on the daysubsequent to the day of its publication.

Licensing of activity pertaining to import of pharmaceuticals to be implemented

On 5 June 2012 the Draft Law “On Amendment of Certain Laws of Ukraine on Licensing Activity for Import of Pharmaceuticals and Defining ‘Active Pharmaceutical Ingredient’” was registered at the Ukrainian Parliament (No. 10562). On 19 June 2012 the Committee on Industrial and Regulatory Policy and Entrepreneurship discussed the draft. It recommended that Parliament adopt the law in the second reading and take into account certainamendments.

The Draft proposes to amend article 9 of the Law of Ukraine “On Licensing Certain Types of Economic Activities” and to implement licensing of activity pertaining to pharmaceutical import. Additionally, the Draft provides definitions for “active pharmaceutical ingredient,” dosage forms andproducts “in bulk.”

If passed, the law will take force on the day subsequent to the day of its publication, save for certain provisions taking effect on 18 October2012 or 1 March 2013.

Ban on pharmaceutical advertisement and certainrestrictions proposed

The government has developed the Draft Law “On Amendment of Certain Laws of Ukraine on Banning Pharmaceutical Advertisement.” It was registered at the Ukrainian Parliament on 5 June 2012 as No. 10563. The Draft envisages that advertising will be (i) allowed solely in specialized publications intended for medical institutions and doctors and (ii) provided and distributed at seminars, conferences and symposiums on medical subjects. However, the Draft allows the advertising for medical equipment, prevention methods, diagnostics, medical treatment and aftertreatments that are allowed in Ukraine by the specially authorized central executive authority in charge of healthcare. Such advertising should not contain references to therapeutic effects on diseases that cannot be treated or that can be cured only with difficulty. In addition, doctors and other professional medical employees and persons whose appearance imitates that of doctors areforbidden from participation.

If adopted, the law will take force on the daysubsequent to the day of its publication.

We will follow the changes to legislation and keep you informed on further developments in thepharmaceutical industry.