Analysis of the Main Remarks to the Draft Law On Amendments to Some Laws of Ukraine on Protection of Public Health from Harmful Effects of Tobacco (No2820)

December 14, 2015

15 May 2015 the members of parliament OlhaBohomolets, Hanna Hopko, OlehMusiy, Pavlo Unhurian, IhorLutsenko, and Oksana Korchynska registered the Draft Law No2820 On Amendments to Some Laws of Ukraine on Protection of Public Health from Harmful Effects of Tobacco.

The legislation reflects the recognized practice of tobacco control based on scientific facts, which demonstrates a reduction in smoking prevalence. As it was stated in the explanatory memorandum, the main purpose of the draft law is “to ensure a high-level protection of human health, especially young people, and Ukraine’s commitments under the WHO Framework Convention on Tobacco Control (FCTC)”.

With this aim, the project introduces the legislation of Ukraine in accordance with the EU Directive 2014/40/ECOn the approximation of laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37 / EC.”

In particular, the legislation proposes:

  • Combination of warnings with the pictures placed at the top of both sides of a pack occupying 65% of a total area and rotate on an annual basis;
  • New definitions and additions to labeling and production of tobacco;
  • The rules of selling and labeling of herbal smoking mixtures;
  • The rules on selling and labeling electro cigarettes and refilled containers, and their content;
  • Advertising and promotion of cigarettes are forbidden;
  • An introduction of the requirements to the content of the harmful to human health liquids and ingredients that tobacco products contain and are evaporated during smoking;
  • New mechanisms of tobacco control.


Even though the Directive 2001/37/EC is formally a part of the Association Agreement with the EU, for Ukraine this Directive is not up-to-date since it was developed and adopted for more than 15 years ago, and even it is the one that weakens an anti-tobacco legislation. Adjacent to this, it is relevant to remind that the authors of the draft law reason its necessity referring to the articles 9, 10, 11 of the Framework Convention of Tobacco Control aiming “to protect current and future generation from harmful effects to human health and social, ecological and economic consequences of tobacco consumption and effects of tobacco smoke.”

Hence, the legislation No2820, on the one hand, aims at reducing tobacco consumption, especially among young people, which consequently would lead to improving human health, and, on the other hand, it is a progressive euro-integration step in the sphere of public health. Thus, the further adoption of the legislation shall be a firm signal of Ukraine’s readiness to implement not only the legislative norms of the EU, foreseen by the Association Agreement, and also the further norms acquis communautaire.

Detailed key remarks to the legislation

1. Suggested in the draft law No2820 definitions of terms do not fully reveal their main characteristics.

The article No428 of the Association Agreement between Ukraine and the EU stated that “Ukraine gradually brings its legislation and practice closer to the principles of the acquis EU, particularly in the field of infectious diseases, blood services, transplantation of tissues and cells and tobacco. The list of relevant acts with the acquis EU, defined in Annex XLI of this Agreement.” In Annex XLI noted that within 2 years, starting from the date of the Agreement entering into force, in Ukraine there should be legally implemented provisions: 1) of the Directive №2001 / 37 / EC of the European Parliament and of the Council from 5 June 2001 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products.

It should be noted that on 3 April 2014 28 Member States of the EU adopted a new Directive 2014/40 / EC on tobacco products. The article No31 of this directive provides the abolition of the previous Directive 2001/37 / EC starting from 20 May 2016. At the same time, the article No29 states that the state must change the necessary legislation and administrative regulations until 20 May 2016.

When developing the draft law No2820, its authors took rightly the Directive 2014/40 / EC as a basis,  because firstly, it covers a much broader range of issues related to tobacco control based on scientific evidence, and secondly, it automatically cancels the effect of the previous Directive 2001/37 / EC. For this reason, all incorporated in the legislation definitions were borrowed from the article No2 of the Directive 2014/40/EC. However, taking into consideration the technical component of the remarks proposed definitions could be clarified during the preparation of the legislation before the second reading.

  1. Revision of certain norms of the draft law No2820 is characterized by excessive detailization

According to the preamble of the WHO Framework Convention on Tobacco Control, the spread of the tobacco epidemic is a global problem with serious consequences for human health.Worldwide the consumption and production of cigarettes and other tobacco products are increasing, particularly in developing countries, and scientific evidence explicitly confirm that tobacco consumption and exposure to tobacco smoke causes death, diseases and disability.

The article 4.1 of the WHO Framework Convention on Tobacco Control emphasized that “everyone should be informed about the health effects of a deadly threat and the threat of addiction, as a result of tobacco consumption and exposure to tobacco smoke.”

Taking into consideration the fact that the main purpose of the legislation is to ensure a high level protection of human health, especially young people, and the fact that tobacco is a deadly harmful product, which requires a clear state regulation, the detailization of the draft law No2820 is apparently the only right decision.

  1. The legislation No2820 should be considered as an alternative one to the draft law No2430-1

On 3 April 2015 the Verkhovna Rada of Ukraine registered the legislation No2430-1 On Amendments to some laws of Ukraine concerning Ukraine’s obligations under the Association Agreement between Ukraine, on the one hand, and the European Union, the European Atomic Energy Community and their Member States (concerning the manufacture, presentation and sale of tobacco products advertising and sponsorship). According to the conclusion of the Committee on Bylaws and organizational work of the Verkhovna Rada of Ukraine, “the legislation No2430-1 and the legislation No2820 are practically the alternative ones.”

Moreover, it is relevant to note that even though the draft laws No2430-1 and No2820 regulate the same range of issues, at its essence they are completely different. The legislation No2430-1 provides only minimal changes that regulates the norms of nicotine and tar in cigarettes and determines a definition of tobacco for peroral use. In its turn, the draft law No2820 is significantly broader and more effective, which implements a new progressive EU directive, which was approved in April 2014 by the 28 EU Member States after 5 years of consultations and debate.

Additionally, it should be mentioned that the alternative legislations should have the same main committees, like for example, the article No110 of the Rules provides that the alternative draft laws are usually tabled in accordance with their registrations, and the main committee may recommend to Verkhovna Rada take one of them as a basis, or prepare another legislation. Herewith, it should be noted that the Committee on taxation and customs policy was defined as a primary one in preparation of the draft law No2430-1, in return, the Committee on public health is the main one in preparing the legislation No2820.

  1. The Draft law No2820 defines that health warnings on tobacco products shall be approved by Ministry of Health

According to the paragraph 4 of the article No12 of the Law of Ukraine On Measures to Prevent and Reduce Tobacco Use and its Harmful Effects on Health; “an image (images) and / or symbol (icon) approved by the Cabinet of Ministers of Ukraine on the proposal of the central body of the executive power in the sphere of health care and are subjects to review (re-approval) by the Cabinet of Ministers of Ukraine in the same order every five years.

The draft law proposes the amendments to the article No12 of the Law of Ukraine On Measures to Prevent and Reduce Tobacco Use and its Harmful Impact on Public Health, and envisages that “the combined text and photo of health warnings – text to curb tobacco use, as well as technical requirements for layout, design and forms of combined health warnings – are approved by the central executive body in health care.”

We believe that the authorization of the Ministry of Health to approve a layout, design and a form of composed health warnings on tobacco products, is a conceptually correct solution, which meets the requirements of the article No11 of the Framework Convention, which provides that such warnings should be approved by a competent authority. In the legislative system of Ukraine, the Ministry of Health is exactly such an authority, which is the main body in the central authorities system of executive power that ensures the formation and implementation of the national policy in the field of public health. In this case, it is necessary to emphasize that any question concerning tobacco products is directly linked to the health of the population.

  1. The legislation No2820 set unrealistic terms of transition period

The article No29 of Directive 2014/40 / EC states that the governments have to change the necessary legislation, administrative and regulatory acts until 20 May 2016. That is why when preparing the draft law, it was taken as a basis. Adjacent to this, it is meaningful to add that the European Commission developed the detailed technical recommendations for the implementation of a new EU Directive 2014/40 / EC and Member States are actively adapting their legislations to the requirements of the new directive. In addition, the Republic of Moldova, as a signatory of the Association Agreement, on 31 May 2015 has already adopted the law on tobacco on the basis of the Directive 2014/40 / EC, the norms of which will come into force at different periods of 2016-2017.

However, such a quick period of time is not sufficient for a transition to print new packs of cigarettes. Therefore, it is relevant to set a transition period of 1-2 years from the moment the law come into force.