Currently, the Committee of the Verkhovna Rada of Ukraine on health care has created a working group to develop a new draft law on medicinal products, which will be supported by the specialized committee. The next discussion of the draft law took place on May 15.

REGISTRATION CERTIFICATE OR TRADE LICENSE?

One of the key issues of the draft law on medicinal products is the harmonization of Ukrainian legislation with the requirements of European directives, in particular, Directive 2001/83/EC. This document defines European approaches to regulating the production, sale and use of drugs.

The system of admission of medicinal products to the market in Ukraine provides for the state registration of the drug and the applicant’s receipt of a registration certificate. According to  the Law of Ukraine “On Medicinal Products”,  state registration is a permit for medical use. The law stipulates that medicinal products are allowed to be used in Ukraine after their state registration.

Meanwhile, in the EU, the admission system involves obtaining permission to place on the market, that is, marketing. Accordingly, the document that the applicant receives in the EU is called a trade license — Marketing authorization.

In view of the above, when developing a new draft of the law “On medicinal products”, it should be determined whether this act will change the ideology of the process of admission of medicinal products to the Ukrainian market?

In this regard, Tetyana Kotlyar, head of the board of the All-Ukrainian Pharmaceutical Union “FARMUKRAINA”, head of the Public Council at the State Service of Ukraine for Medicines and Drug Control (State Service of Medicines and Narcotics Control), noted that during the discussion the draft law becomes more and more burdensome and difficult to understand . At the same time, the working group has not decided whether it will focus on Directive 2001/83/EC when drafting the draft law. Will the draft document take into account the requirements of the current legal acts, for example,  Licensing conditions  for conducting economic activities for the production of medicinal products, wholesale and retail trade of medicinal products, import of medicinal products (except for active pharmaceutical ingredients)? T. Kotlyar offered to clearly define these issues.

Nataliya Lytvynenko, head of the expert department of UKRMEDSERT LLC, took part in the meeting of the working group. She previously worked as a consultant in separate WHO projects, and currently works as an expert in an EU project in one of the post-Soviet countries. Regarding the harmonization of Ukrainian legislation in the field of circulation of medicinal products with EU requirements, the expert noted the following: “The draft law that is currently being developed should not freeze the situation that has developed in the pharmaceutical sector. We are not saying that it is difficult or bad, but Ukraine should gradually implement European requirements into national legislation. Therefore, it is extremely important to understand the concept of the drug bill. With this document, we are laying the groundwork for the further development of the pharmaceutical sector for at least 10 years.”

The expert also drew attention to the fact that the national laws of EU countries, developed on the basis of European directives, contain detailed requirements and provisions of direct effect. In Ukraine, the situation is different — laws define general principles and relations in one or another sphere, and provisions of direct effect are contained in by-laws. However, according to N. Lytvynenko, this difference will not interfere with the harmonization of Ukrainian legislation with European legislation.

“Specialists remember how difficult Ukraine’s path to PIC/S (Pharmaceutical Inspection Cooperation Scheme) was.” But international organizations saw Ukraine’s mad desire to become a member of this respectable organization. Currently, our country seeks to become a member of the EU, and the sooner, the better. Therefore, the sooner we implement European requirements into our national legislation, the sooner Ukraine will get the prospect of such membership. Therefore, the draft law on medicinal products should provide for full, but gradual harmonization with EU legislation,” the expert emphasized.

According to the speaker, the issue of mutual recognition of inspection results will also be resolved in the area of ​​harmonization of legislation in the field of circulation of medicinal products with EU requirements. Adoption of the harmonized law by the Parliament will open opportunities for signing relevant agreements, for example, the Agreement on conformity assessment and acceptance of industrial products (АССА). Such an agreement can be concluded in the format of an appendix to the Association Agreement between Ukraine and the EU, provided that the legislation of Ukraine is harmonized with the EU norms in the field of assessment of production compliance with GMP standards, as well as other related norms.

In the context of harmonization, N. Lytvynenko emphasized another important aspect that should be taken into account by developers. It is about the need to create a single regulatory body in the field of circulation of medicinal products. Today in Ukraine, several bodies are involved in the process of state registration. Firstly, it is the Ministry of Health of Ukraine, which grants permission for the medical use of the medicinal product, secondly, it is the State Medical Service, which issues and confirms the certificates of good manufacturing practice submitted by applicants as part of the registration dossier, and thirdly, it is the SE “State expert center of the Ministry of Health of Ukraine”, which carries out examination of registration materials.

Instead, in the EU, a license for the marketing of a medicinal product is issued by a single authorized state body. “In Ukraine, there is a misconception that the European Medicines Agency (EMA) is the body that grants permission for the marketing of a medicinal product, and the European Directorate for the Quality of Medicines (EDQM) is a quality control body. In fact, EDQM is a body of the Council of Europe, and EMA is a supranational body of the EU, which coordinates the activities of national bodies for the admission of drugs to the market and deals with the centralized procedure for granting marketing authorization. And licensing of products, i.e. admission of medicinal products to the domestic market of the country, is handled by national bodies. That is, the centralized procedure starts at EMA and ends at the national body,” the expert emphasized.

Svitlana Bunina, executive director of the Association of Employers of the Medical and Microbiological Industry of Ukraine (OORMMPU), recalled that according to the Association Agreement, Ukraine must ensure the harmonization of national legislation with EU requirements by 2020. Therefore, the answer to the question of whether to take into account the requirements of Directive 2001/83/EC and other European documents when developing a draft law on medicinal products is obvious.

In turn, Volodymyr Rudenko, director of the GS “Pharmacy Professional Association of Ukraine (APAU)”, noted that in the process of implementing the requirements of the directive, it is necessary to take into account the fact that Ukraine is not a member of the EU, has its own national legislation in the field of circulation of medicinal products and peculiarities. “Yes, we are guided by the Directive, but we are not rewriting it,” the APAU director emphasized.

In response, N. Lytvynenko noted that the directive is a regulatory document introduced through national legislation. The directive obliges the member states to take measures aimed at achieving the goals defined in it within the specified period. Therefore, if Ukraine aspires to become a member of the EU, it must gradually implement the provisions of the directives into national legislation.

Returning to the issue of the document that will be issued to the applicant for the admission of the drug to the Ukrainian market, Ihor Kryachok, director of LLC “MORION”, drew attention to the fact that the registration certificate is a permit for medical use. If, in the new law, the content of this document will be brought into line with European legislation, that is, instead of a permit for medical use, the applicant will receive a permit to be placed on the market, this will make it possible to solve a number of problems that market operators constantly face in the process of circulation of medicinal products.

In the EU, only the authorized body can stop the circulation of the drug on the market by canceling the trade license. And in Ukraine, the circulation of a medicinal product or the supply of a substance can be stopped, for example, by customs or the police. It is no secret that there are rare cases when, despite the presence of a registration certificate for a medicinal product, the customs office classifies the product as a dietary supplement. This happens because the Law of Ukraine “On Medicinal Products” regulates only the medical use of medicinal products and does not define other aspects of their circulation, namely, production, supply, etc. The introduction of a trade license instead of a registration certificate will solve these problems forever.

The participants of the discussion agreed that the ideology of the admission of medicinal products needs to be changed, but the introduction of a trade license will require changes not only at the level of the Law of Ukraine “On Medicinal Products”. This amendment provides for amendments to a number of other laws, in particular the laws of Ukraine “On licensing of types of economic activity”, “On the basic principles of state supervision (control) in the sphere of economic activity”, etc. In order to implement this, it is necessary to indicate in the final provisions of the draft law the changes that must be made to other laws and the terms of their entry into force. It should be noted that this was implemented in the draft law  “On specifics of the implementation of certain provisions of the legislation of the European Union regarding the circulation of medicinal products” , registered in the Verkhovna Rada of Ukraine at the initiative of Iryna Sysoenko and other people’s deputies on 04/18/2016 for the register. No. 4465z.

Through an open vote, the members of the working group decided by a majority vote that the term “trade license” will be used instead of “registration certificate” in the new draft law on medicinal products.

DISTANCE TRADE

A heated discussion arose around the issue of normalizing the distance trade of medicinal products. APAU representatives – Volodymyr Rudenko and Nataliya Petrovska, APAU lawyer, as well as Olena Prudnikova, head of the NGO “All-Ukrainian Union” Mykolaiv Pharmaceutical Association “PharmRada” (VOMFAFR) spoke categorically against this.

For his part, Kostyantyn Kosyachenko, head of the department of pharmacy and industrial drug technology of the National Medical University named after O.O. Bogomoletsa, noted that Directive 2001/83/EC has a separate section dedicated to distance trade. Therefore, Ukrainian law can also provide for this type of activity. But the order of such trade will be determined at the level of by-laws. Therefore, according to the scientist, it is advisable to leave the provisions on distance trade in the draft law.

In turn, I. Kryachok reminded that an electronic prescription is currently being introduced in Ukraine. This means that Ukrainians will be able to receive medicines by electronic prescription, which will be sent to the pharmacy via the Internet.

In addition, today so-called Internet pharmacies are a common phenomenon in Ukraine. But there are no legal requirements for them. Therefore, any person is engaged in the sale of medicines via the Internet, and no one understands whether this pharmacy is licensed or not. In order to regulate Internet trade, relevant provisions should be provided in the draft law on medicinal products. There is a public demand for this, because ordering medicines via the Internet is becoming more and more popular in Ukraine. Determining the legal requirements for online shopping is a matter of safety for Ukrainian patients.

After listening to the arguments of the parties, Ruslan Svitliy, general director of KP “Pharmatsia”, deputy chairman of the working group, proposed a compromise solution – to leave the provisions on distance trade of medicinal products in the draft law at the discretion of the people’s deputies.

For our part, we note that insurance medicine will be introduced sooner or later in Ukraine. Insurance companies not only order drugs online for their customers, but also deliver the necessary drugs to the hospital or even to their homes. Therefore, the necessity of normalizing remote trade of medicinal products, including delivery to the final consumer, is one of the conditions for the further development of the health care system.

In addition, the remote trade of medicinal products in the EU was introduced with the aim of increasing competition in the retail segment of the pharmaceutical market and, as a result, reducing retail prices. For Ukraine, where consumers mostly buy medicines at their own expense, the issue of lowering the prices of medicines is no less relevant than for the EU.

IMPORT LICENSING

Import licensing remains a debatable issue. We will remind that on the initiative of I. Sysoenko, People’s Deputy of Ukraine, this type of activity is provided for in the draft law of Ukraine  “On Medicinal Products” , which is currently being developed by a working group. At the time of the discussion, I. Sysoenko proposed the following version of the definition of the term “importer” — it is a business entity registered in Ukraine, in particular, a manufacturer or a person representing a manufacturer of medicinal products, which conducts business activities for the import of medicinal products and has a license to import medicinal products means

T. Kotlyar expressed her own point of view on this issue. “The draft states that the importer is the manufacturer or a person representing the manufacturer. Therefore, it is not clear which business entity it is about. As for a foreign manufacturer, he cannot be a business entity in Ukraine,” said T. Kotlyar. She proposed the following definition of an importer. This is a legal entity or an individual who is a resident of Ukraine and carries out the activity of importing medicinal products and has the appropriate license.

Commenting on this proposal, N. Lytvynenko noted that European legislation contains a definition of the term “importer”. He is equated with the manufacturer and can represent him. In the EU, the manufacturer’s representative is often the owner of the trade license at the same time.

Regarding the license that the importer has in the EU, T. Lytvynenko explained that, in essence, the import license is a part of the production license. But in EU countries, it happens that licenses for production and import are combined into one document, and it happens that they are two documents, for example, as in Poland. According to the expert, when regulations on import licensing were developed in Ukraine, the Polish experience was taken as a basis.

That is, import is not limited to import. This is a set of activities that includes logistics, quality control, etc.

In continuation of the topic, I. Kryachok noted the following. If the draft law stipulates that from the moment of the adoption of the relevant law, only a business entity registered in Ukraine, i.e. a resident, will receive permission to place a medicinal product on the market of Ukraine, then the problem of import licensing will disappear. Of course, it is necessary to provide for a sufficient transition period, for example 5 years, so that representative offices of foreign pharmaceutical companies register in Ukraine as residents.

The participants of the discussion decided that the provisions on import licensing should be finalized. T. Kotlyar and N. Lytvynenko are tasked to do this, they should present the document at the next meeting of the working group, which will be held at the end of May.

Published based on materials from www.apteka.ua