On November 29-30, 2021, the seventh meeting of the Association Committee between Ukraine and the European Union took place in Brussels to discuss the progress made in the implementation of the Association Agreement and further prospects for reforms in Ukraine.

The Ukrainian delegation was headed by Natalia Forsyuk, Director General of the Government Office for Coordination of European and Euro-Atlantic Integration, and the EU delegation was headed by the Managing Director for Russia, Eastern Partnership, Central Asia, Regional Cooperation, and the OSCE.

Opening the meeting of the Committee, Michael Siebert stressed the timeliness of its holding against the background of Russia’s aggravated security situation. In his introductory remarks, he stressed the progress and importance of continuing reforms.

According to him, the Association Agreement between Ukraine and the European Union is the most ambitious agreement that the European Union has with any third partner, and the European side is interested in its full implementation.

The head of the Ukrainian delegation Natalia Forsyuk thanked the European partners for their unwavering support of the reform process and assured of the sustainability of further reform steps. In her speech, she stressed the readiness of the Ukrainian side to update a number of Annexes to the Association Agreement.

“We hope that the joint assessment of the achievement of the goals of the Association Agreement will be an important driving force for its further renewal in accordance with the realities of today,” said Natalia Forsyuk.

During the meeting, the parties discussed in detail the progress and prospects of reforms, issues of political association and development of the situation in Ukraine, strengthening cooperation in the field of justice, freedom and security, economic cooperation, and other aspects of sectoral cooperation between Ukraine and the EU.

The head of the Ukrainian delegation informed her European colleagues about the current state of implementation of the Association Agreement. According to her, the greatest progress during the implementation of the Agreement has been made in the following areas:

• “Political dialogue, national security and defense” – 89%;

• “Justice, freedom, security, human rights” – 87%;

• “Humanitarian policy” – 87%;

• “Technical barriers to trade” – 86%;

• “Public procurement” – 85%;

• “Statistics and information exchange” – 84%;

• “Entrepreneurship” – 83%;

• “Taxation” – 81%;

• “Education, training and youth” – 79%;

• Public Finance Management – 74%.

According to the results of the Committee, the parties expressed satisfaction with the constructive approach to the issues considered during the joint meeting.

For reference

The Association Committee between Ukraine and the European Union is the highest body of the association at the expert level. It consists of representatives of ministries, mainly at the level of Deputy Ministers for European Integration. The Committee shall assist the Council of the Association in the performance of its duties and functions and shall carry out the tasks provided for in the Agreement and entrusted to it by the Council of the Association.

JERELO opened access to another market in November – the company’s office in Moldova at MD 2024, or. Chisinau, str. Pietrariei nr. 19 A

We will be glad to cooperate and communicate.

The Verkhovna Rada of Ukraine registered a draft Law of Ukraine dated 21 5547 dated 21.05.2021, which proposes to restate the Law of Ukraine dated 04.04.1996 № 123 “On Medicinal Products” (hereinafter – the Draft Law).

If adopted, it will take effect in 12 months. after its official publication.

The bill with accompanying documents is posted at the link.

The bill was adopted as the basis on 09.09.2021.

The document is currently being prepared for the second reading, the wording of which has not been made public at the time of writing.

Therefore, for the analysis of the existence of certain provisions on the market of medical devices, the wording of the Draft Law of 21.05.2021 was taken.

Thus, it was established that the Bill provides for a significant change in the approach to advertising, namely, in fact, to establish a ban on the advertising of medical devices.

The draft law proposes a new version of Article 21 “Advertising of Medicines, Medical Equipment, Methods of Prevention, Diagnosis, Treatment and Rehabilitation” of the Law of Ukraine “On Advertising” (Vedomosti Verkhovnoi Rady Ukrainy, 1996, № 39, p. 181 ) provide for the following, in particular:

Advertising is allowed only for such medical devices that are duly permitted by the central executive body implementing the state policy in the field of health care for use in Ukraine (Ministry of Health of Ukraine).

It should be noted that currently, the Ministry of Health of Ukraine does not issue permits for the use of medical devices in Ukraine. In this version of the article of the Bill, there is a risk of banning the advertising of virtually all medical devices.

Mandatory elements of advertising medical devices are defined.

Advertising of medical devices may not contain references to therapeutic effects in relation to diseases that are not amenable or difficult to treat, or materials that are incorrect, alarming, or misleading, refer to recovery with the use of such a product.

Advertising of medical devices is prohibited:

• information that may give the impression that, in the case of a medical device, consultation with a specialist or surgery is not necessary, in particular due to advertising recommendations for diagnosis or offering remote treatment;
• information that the therapeutic effect of the use of a medical device is guaranteed, materials that incorrectly, by alarming or misleading, use images of changes in the human body due to disease, injury or the action of a drug on the human body or part of the body;
• allegations that contribute to the emergence or development of fear of getting sick or deteriorating their health due to non-use of advertised medical devices; this ban does not apply to vaccination campaigns approved by the central executive body that ensures the formation and implementation of state policy in the field of health care (Ministry of Health of Ukraine);
• allegations, materials, which, as a result of describing or demonstrating the history of the disease contribute to the possibility of erroneous self-diagnosis of diseases, pathological human conditions and their self-treatment with the use of advertised medical products;
• references to medical devices as the most effective, safest, exceptional in the absence of side effects;
• references to specific cases of successful use of medical devices;
• recommendations or references to the recommendations of medical, pharmaceutical specialists (employees), scientists, medical institutions and organizations regarding the advertised product or service;
• special expressions of gratitude, appreciation, letters, excerpts from them with recommendations, stories about the use and results of the advertised goods or services from individuals;
• images and mentions of names of popular people, heroes of film, TV and animated films, authoritative organizations;
• information that may mislead the consumer regarding, in particular, the composition, origin, effectiveness, patent protection of the advertised product;
• materials intended exclusively or mainly for children.

In the advertising of medicines is prohibited the participation of medical, pharmaceutical professionals (employees), as well as persons whose appearance mimics the appearance of the latter.

Persons who manufacture and/or sell medical equipment may sponsor television, radio, and program programs by providing information of an advertising nature about the name or designation, a mark for goods and services, except for any reference to medical equipment, the application of which requires special knowledge and training.

Teleshopping of medical equipment, the use of which requires special knowledge and training, is prohibited.

It should be noted that in the draft Law of Ukraine “On Medical Devices” of October 20, 2021, published at https://moz.gov.ua/article/public-discussions/proekt-zakonu-ukraini-pro-medichni-virobi article 10 also establishes rules for the advertising of medical devices, namely, it is provided that the advertising of medical devices of class I, medical devices for self-control.

Requirements for advertising of such medical devices are established by the Law of Ukraine “On Advertising”, the Law of Ukraine “On Medicinal Products”.

Thus, both draft acts on the provisions of advertising of medical devices 1) contradict each other; 2) to some extent, establish a ban on advertising of medical devices, in particular, such a ban may include such medical devices as condoms, which are an indispensable means of contraception to reduce the burden of HIV in Ukraine.

The draft law uses outdated terminology, namely the concept of “medical equipment”, “medical equipment”, which are currently completely absent in the system of legal regulation of the market of medical devices.

In Ukraine, there are three technical regulations in the market of medical devices, namely:

– Technical regulations on medical devices, approved by the resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 № 753;
-Technical regulations on medical devices for in vitro diagnostics, approved by the resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 № 754;
– Technical regulations on active implantable medical devices, approved by the resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 № 755.

Technical regulations establish requirements for medical devices provided on the market of Ukraine, including the rights and obligations of economic entities and other persons to place medical devices on the market and make them available on the market.

The Technical Regulations define the general concept of “medical device” – any instrument, apparatus, device, device, software, material, or other device used alone or in combination with each other (including software provided by the manufacturer for use specifically for diagnostic and/or therapeutic purposes and necessary for the proper functioning of the medical device), intended by the manufacturer for use in diagnosing, preventing, monitoring, treating or alleviating the patient’s disease in case of injury or disability or compensation, research, replacement, modification or maintenance of anatomy or physiological process, control of the fertilization process and the main expected effect of which in the body or on the human body is not achieved by pharmacological, immunological or metabolic means, but which such tools can help.

On November 16, the Resolution of the Cabinet of Ministers of Ukraine of November 10, 2021, № 1172 came into force, which amended the Resolution of the Cabinet of Ministers of Ukraine of December 23, 2020, № 1300 “On Approval of the Procedure for State Assessment of Medical Technologies”.

Thus, the changes postpone the deadline for the introduction of the state assessment of medical technologies (HTA), which are not medicines, from January 1, 2022, to January 1, 2023. Until this date, the deadline provided by the Ministry of Health for:

• creation of a state unitary commercial enterprise, which will be entrusted with the functions of conducting state HTA;
• development and approval of guidelines for state HTA, which are not medicines.

Also, the Procedure for state HTA, approved by Resolution № 1300, is supplemented by a new provision, according to which the Ministry of Health is obliged to approve the Procedure for inclusion (exclusion) of medicinal products in the National List of Essential Medicines and/or nomenclatures of purchased medicinal products. at the expense of the state budget for the implementation of programs and implementation of centralized health care measures, with the use of state HTA.

In addition, the amendments provide for the Ministry of Health to be able to extend the state OMT under the abbreviated procedure for 10 calendar days required for the Ministry of Health to respond to a reasoned request of the authorized body for state assessment of medical technologies (hereinafter – the authorized body).

We will remind, according to the resolution № 1300 the state HTA under the shortened procedure provides the comparative analysis of efficiency (effectiveness), safety and influence on the budget of medical technology on the basis of open information and lasts no more than 30 calendar days from the date of receipt by the authorized body. Ministry of Health.

The Cabinet of Ministers of Ukraine has allocated UAH 86.9 million for the modernization of the equipment of health care facilities of the State Administration of Affairs.

Of them:

• UAH 15.0 million – for the purchase of an X-ray mammography system for the state scientific institution “Scientific and Practical Center for Preventive and Clinical Medicine”.
• UAH 71.9 million for equipment for the Feofania Clinical Hospital, in particular, for the All-Ukrainian Center for Radiosurgery, which is an independent division of the Feofania Clinical Hospital.

The funds were allocated under the program KPKVK 2301220 “Development of the emergency medical care system and modernization and renewal of the material and technical base of health care facilities.”

It will be recalled that in pursuance of the Decree of the President of Ukraine Volodymyr Zelensky, the Ministry opens access to Feofania to all citizens. From January 1, 2022, this hospital will enter the priority package of the Medical Guarantee Program.

On October 20, 2021, the draft Law of Ukraine “On Medical Devices” (hereinafter – the Draft Law) with accompanying documents was posted for public discussion on the official website of the Ministry of Health of Ukraine.

Grounds for drafting the Bill – implementation of the decision of the National Security and Defense Council of Ukraine of July 30, 2021 “On the state of the national health care system and urgent measures to provide Ukrainian citizens with medical care”, enacted by Presidential Decree of August 18, 2021 № 369 / 2021 regarding the submission to the Verkhovna Rada of Ukraine of the draft Law of Ukraine “On Medical Devices” by December 15, 2021, developed in accordance with the norms of European directives.

According to the text of the regulatory impact analysis, the implementation and enforcement of the regulatory act will eliminate the existing legal gap in the absence of sectoral legislation in the field of medical devices and reduce the negative consequences, namely: the presence in the current legislation of Ukraine. and, accordingly, the absence of certain rules of law.

The preamble of the Bill states that it (the Law) regulates legal relations related to the peculiarities of putting into circulation, placing on the market or putting into operation of medical devices, medical devices for in vitro diagnostics, active implantable medical devices, auxiliary means to them.

It is determined that the Law applies to medical devices, medical devices for in vitro diagnostics, active implantable medical devices, aids, products intended for performance evaluation, medical devices intended for clinical trials.

For the purposes of this Law, aids are considered as medical devices.

The Law does not apply to:
1) medicinal products, including medicinal products made from human blood and blood plasma (blood products), which are subject to the Law of Ukraine “On Medicinal Products”;
2) cosmetic products;
3) anatomical materials to which the Law of Ukraine “On the use of transplantation of anatomical materials to humans” applies;
4) food products, including dietary supplements, which are covered by the Law of Ukraine “On Basic Principles and Requirements for Food Safety and Quality”;
5) products of general laboratory purpose, if such products by their characteristics are not intended by the manufacturer specifically for use during in vitro diagnostic testing;
6) products intended only for research work and have appropriate markings.

It is noted that the Bill (in case of its adoption and signing by the President of Ukraine) will enter into force on the day following the day of its publication, and shall enter into force three months after its entry into force.

The bill, among other things, proposes to resolve the existing problem regarding the need for SES conclusions on medical devices by amending the Law of Ukraine “On Ensuring Sanitary and Epidemic Welfare of the Population” with the term “object of state sanitary and epidemiological examination”.

At the same time, the Cabinet of Ministers of Ukraine is instructed to:

– within six months from the day following the day of publication of this Law: bring its regulations in line with this Law; to ensure the review and bringing by the central executive bodies of their normative legal acts in compliance with this Law;
– ensure the entry into force of the relevant regulations from the day following the day of entry into force of this Law.

On November 17, Denis Shmygal chaired a regular meeting of the Government, during which he said that the current statistics on the incidence of COVID-19 show that Ukraine has reached the level of a “plateau”. In almost all oblasts there is a decrease in the number of both new cases and hospitalizations. However, it is too early to raise the issue of abolishing the “red” level of epidemic danger. According to him, the situation with the pandemic was stabilized due to quarantine restrictions and vaccination.

During the meeting, the Resolution of the Cabinet of Ministers of Ukraine № 1201 “On Amendments to the List of Goods (Including Medicines, Medical Devices and / or Medical Equipment) Necessary for Implementing Measures to Prevent the Occurrence and Spread, Localization and Elimination of Outbreaks, Epidemics” was adopted. and pandemics of the acute respiratory disease COVID-19 caused by the coronavirus SARS-CoV-2, the import of which into the customs territory of Ukraine and / or the supply of which in the customs territory of Ukraine are exempt from value added tax. We are talking about the exemption from value added tax (VAT) of equipment for the production of vaccines and medicines needed to overcome the COVID-19 pandemic.

According to the Prime Minister, this will allow Ukrainian companies to intensify the process of building their own production facilities, increase investment in research and development of vaccines and drugs from COVID-19. Instead, for the state it is an opportunity to meet the domestic need for the necessary drugs and not depend on the will of other countries or their supplies.

The Government has also increased payments for the treatment of patients with COVID-19 under agreements concluded between health care facilities and the National Health Service of Ukraine. Thus, from November 1, 2021, the global rate for medical institutions for the treatment of patients with coronavirus will increase to 634 thousand UAH. She will be paid for her medical staff, medical devices and medicines. Thus, the funding of “covi” hospitals increases by almost 15%.

In addition, the Government has allocated UAH 33 million for Donetsk and Odessa regions, of which:

almost UAH 25 million will be allocated for Donetsk region for additional purchase of 535 oxygen concentrators;
UAH 5.5 million will be allocated for the reconstruction and purchase of medical equipment for the infectious diseases department of the Anan’iv Multidisciplinary Hospital in the Odesa Region.
At the same time, D. Shmygal stressed that the main goal of the Government is to vaccinate the majority of the country’s adult population against COVID-19. Currently, this figure is just over 40%. The weekly rate of vaccinations remains at 1.5 million. In order to maintain such a high rate of vaccination and additional motivation of people to get vaccinated, it was decided to pay UAH 1,000 to all vaccinated citizens. This initiative of the President of Ukraine will support small and medium-sized businesses in Ukraine affected by the pandemic. In addition, it supports the sports and cultural development of Ukrainians. After all, these funds will be paid for virtual payment cards through the “Action” service and can be spent on tickets to cinemas, theaters, concerts, sports and travel to Ukraine by train or plane.

According to him, about 6 thousand businesses across the country will be able to participate in this program, which will work from December 19, 2021 and will run until the end of 2022. It is allocated 3 billion UAH in 2021 and 3 billion UAH at the beginning of 2022 with further expansion of funding.

On November 18, the Parliament adopted, in general, the draft law “On Insurance”, registered on March 29, 2021, at № 5315, which takes into account changes to the regulation of insurance in clinical trials.

Thanks to these changes, Ukraine will move to a fully European model of liability insurance in clinical trials.

The law amends the current Law of Ukraine “On Medicinal Products”. In particular, we are talking about changes to Art. 8 to clarify the provisions of the contract of liability insurance of the sponsor of the clinical trial to third parties, as well as to Art. 2 to supplement the list of terms specified in the insurance contract in the clinical trial.

The main achievement was the clear regulation of the provision on insurance in clinical trials, which was a problematic issue for the field of clinical trials in Ukraine and differed from the model operating in the European Union.

Previously, Ukrainian legislation on insurance in clinical trials created opportunities for double interpretations, did not fully comply with international practice, did not cover all aspects of the sponsor’s and researchers’ liability for possible harm to clinical trial subjects, and extended the patient’s overall inclusion in a clinical trial. to become the only chance for him.

This approach was not in line with the main provisions of European law due to the fact that in the Directive 2001/20 / EC of the European Parliament and of the Council on the approximation of laws, regulations and administrative provisions of the Member States relating to good clinical practice in clinical trials of April 4, 2001, the need to provide for “insurance or indemnity insurance to cover the researcher’s or sponsor’s liability” is important, and the transition from personal insurance in clinical trials to a liability insurance system is important.

Making similar changes in Ukrainian legislation will improve the regulation of clinical trials and eliminate current problems that hinder patients’ prompt access to innovative therapies in clinical trials and reduce the attractiveness of Ukraine in the eyes of sponsors of clinical trials.

On November 29, the State Service of Ukraine for Medicines and Drug Control (hereinafter – the State Medical Service) approved the Sectoral Plan of State Market Supervision for 2022 (hereinafter – the Sectoral Plan).

It contains 112 items of medical devices, 17 items of medical devices for in vitro diagnostics, as well as cosmetic products, including 2 items for the oral cavity and 5 – for the face.

In addition, the Product Control Plan was approved, which details the information on 129 items of medical devices included in the Sectoral Plan, according to the codes according to the Ukrainian classification of goods for foreign economic activity.

We will remind that earlier the State Medical Service reported that during the development of the Sectoral plan considered:

• belonging of types of products to the increased degree of risk;
• the results of monitoring the causes and number of cases of harm to human health due to consumption (use) of products;
• analysis of information obtained through international notification systems for products that pose a serious risk;
• appeals received from consumers (users), executive authorities, law enforcement agencies, and the results of the work of territorial bodies of the State Medical Service for the implementation of state market supervision for 2021;
• the epidemiological situation with the spread of coronavirus disease (COVID-19).

During a working visit of the President of Ukraine Volodymyr Zelenskyy to the United States of America, the Ministry of Health signed a Memorandum of Cooperation with the American company MSD. This was announced by Minister of Health Viktor Liashko.

“The Ministry of Health is interested in developing the potential of Ukraine’s healthcare system, and strengthening cooperation with MSD is strategic for Ukraine’s healthcare system, especially amid pandemic,” the Health Minister stressed.

It is a priority for the Ministry of Health to boost the supply of innovative medicines and immunobiological drugs on the Ukrainian market and to create opportunities for localization of their production in Ukraine on the basis of international partnership, which is one of the steps to pharmaceutical independence. The important tool in the localization of production is the adoption of the law on state support of projects with significant investments, the so-called “investment nannies” and the efficiency of the regulatory system in the circulation of medicines.

Cooperation with MSD on a mutually beneficial basis will enable Ukraine to treat patients with COVID-19 by providing innovative medicines.

“Ukraine would become one of the first countries in the world to receive innovative drugs against COVID-19 produced by MSD,” Viktor Liashko underlined. “We have learned lessons on the late signing of contracts for innovative immunobiological drugs from COVID-19, so now the team of the Ministry of Health is staying ahead. ”

MSD also expressed interest in assisting the Ministry of Health in conducting screening programs as part of the implementation of the President’s program “Healthy Ukraine”.