LAW FIRM DIRECTORY

Industry Sectors | Pharmaceutics

LANA SINICHKINA,

She was born in Sevastopol. In 2006 she graduated from the Institute of International Relations of Taras Shevchenko National University of Kyiv with a Degree in "Private International Law".

Since 2004 she had worked at the Yurservis Consulting Company Law Firm. In 2006 she was a Leading Expert of the Antimonopoly Committee of Ukraine, in 2007 – the Head of the Department for Foreign Trade Support and Forensic Claim Work at Nemiroff. In September 2009, she headed the Legal Department of the companies GlaxoSmithKline Pharmaceuticals Ukraine, GlaxoSmithKline Consumers Healthcare Ukraine. In 2012 she joined the team, and from July 2013 has become a Partner, Head of the Health and Pharmacy Industrial Practice of Arzinger JSC.

Specialization: pharmaceuticals, health care, food industry, antitrust and competition law, anti-corruption and compliance.

She is co-chairperson of the Food Manufacturing Industry Committee, an expert of the ACC Health Care Committee in Ukraine, expert of the EBA Health Care and Food Industry Committee, member of the Public Council at the Antimonopoly Committee of Ukraine.

 

Procurement Stage

It is necessary to minimize the engagement of officials from the Ministry of Health in procurement and open our market to producers who previously passed by Ukraine",
— Lana Sinichkina, Partner at Arzinger, suggests

— How did the idea to implement the mechanism of global purchasing of pharmaceutical products in Ukraine emerge, and what is its essence?

— I do not remember who first suggested implementing the system of global purchasing in Ukraine. A group of people driven by a single desire for changes in the health sector had already been formed at that time. Inspired by the achievements of the Revolution of Dignity, we decided to put into execution a reformist project that allows eliminating corrupt practices and improving the provision of medicines in Ukraine. I, as a lawyer in the health sector, took upon myself and my team the development of this idea.

The point is to minimize the engagement of officials from the Ministry of Health in the organization of procurement procedures, to ensure the transparency and fairness of selection of pharmaceutical products, to open our market to producers who previously passed by Ukraine. Simplification of pharmaceutical products, the registration procedure in Ukraine (if purchased through an international tender), of the rules for their import and abolition of VAT have become the important points of these changes. Thanks to engaging more producers in the market the price and quality of competition increases, and this is the most natural and legitimate way to reduce the final price at which the pharmaceuticals of better quality are bought for money from the Ukrainian budget. However, the idea itself was not invented by us. To all intents and purposes it has been borrowed from other countries, including European ones, which at different stages of development attracted independent international organization for the effective conduct of procurement procedures.

 

— How was the process of this project’s implementation formed?

— As an entirely new mechanism for Ukraine was suggested, we started with the development and presentation of the Concept on implementation of international pharmaceuticals purchases. If we had started directly with writing laws, there would be the risk of project failure at the stage of approval. Firstly, the language of the law does not allow to full disclosure of the idea, to inform on the need for its implementation. Secondly, the authors themselves, working on the Concept, imagine the complete picture of the final result better, work through the details more thoughtfully, and take into account the nuances. Thirdly, the documented Concept enables discussion of future rules with stakeholders at an early stage in a convenient form, identifying the weaknesses, attracting allies and ensuring the feasibility of the proposed novations.

So we acted this way, and presented the Concept and every detail was reported to all the persons who can influence its implementation. At this point, we had learned the position of the international organizations, which were then involved in the global purchasing of medicines in Ukraine. And only after that did we start the development of draft laws.

Once the draft bills were registered in the Verkhovna Rada, we felt powerful opposition from the lobbyists of the interests of the Ukrainian pharmaceutical companies, the "monopolistic and corrupt" business of which has been built on the procurement system of the Ministry of Health that we have begun to liquidate. During one night about eight clone draft laws were registered in Parliament, i.e. one of the methods used to ensure failure of the unfavorable project. Then there were others, but due to the fact that at that time the President of Ukraine personally demonstrated political will to implement the changes proposed by us, the "lobbying attempts" were unsuccessful and our package of draft laws was adopted in the first reading.

 

— Then it only remains to apply the law.

— We were under the illusion that our main battle was over, as the transitional provisions of the laws contained the most complete list of implementing regulations necessary for implementation of the proposed initiatives. However, the system has only intensified the confrontation. The Cabinet of Ministers and the Ministry of Health required more than half a year to prepare the necessary package of implementing regulations, although we immediately offered our assistance in their development. The process for the procurement of subject matter approval and signing the contracts with the international organizations, without which the latter could not proceed with the invitation for tenders, in the Ministry of Health, took the same amount of time.

 

— How did you manage to resist the pressure?

— In addition to the confrontation with the obvious opponents of this reform in Parliament, the Government, their information support and fight with discreditation, we faced the clumsy, unintelligent, bureaucratic system of the state authorities. Sometimes we had the feeling that people obtain their salaries for generating destructive ideas, as they did everything in order that the adopted laws never began to work and did it very professionally.

Only thanks to the excellent team did we manage to overcome this wall of sabotage and bureaucracy. First and foremost, these are the members of the public organization "Patients of Ukraine" who undertook the shaping of public opinion on these issues and the search for allies of the reform whom we were able to enlist in our team. These were the experts of the Anti-Corruption Centre, representatives of international institutions, MPs and people in the Ministries, the Cabinet of Ministers, Presidential Administration, who are not indifferent to this problem. Certainly, this is my team of lawyers practicing in the area of pharmaceutics and health care, who have spent a lot of time and effort to implement this project. We all performed not only legal work, but also organized the information support – publications in the media, public events, news conferences, etc.

 

— How is this project being implemented today? Did it justify your expectations?

— It seems incredible, but the confrontation of the system continued at the stage of the very procurements and even supplies. Despite the fact that the procurement procedure has been taken away from the Ministry of Health, the process of forming the subject matter of the purchase, i.e. the order on the basis of which the international organizations hold tenders, remained in the same offices of the Ministry. Delays in the formation of the lists of the procured medicines began, and the unreadiness of the Ministry of Health officials to take responsibility for the relevant, even technical, decisions, appeared.

Information attacks in the media controlled by the Ukrainian pharmaceutical lobbyists continued. They do not cease to manipulate the facts. For example, they assert the lack of savings due to the international procurement by comparing the prices that were exclusively offered in the national currency by some companies during the first year after Maidan (as a non-recurrent "social" initiative) with the prices in foreign currency formed based on the results of international tenders.

However, the greatest surprise for us was the fact that some Ukrainian suppliers won the international tenders only for the purpose of discrediting them by sabotaging the delivery of medicines. Delays in deliveries have caused a lot of negative consequences: decrease in the shelf life of medicines held in warehouses, the lack of socially important medicinal products in the regions and so on, giving a reason for the next wave of discreditation in the media.

Despite the simplicity of the idea, it was a long and winding road to its application. Four Ministers of Health were replaced during this time and the discussion moved far beyond Ukraine. Notwithstanding all of this, we believe that we have chosen the proper direction of development and the ultimate goal – improving the provision of medicines to the Ukrainian people –will not allow reducing the effort made to zero. We hope that the following purchases of medicines will be performed more smoothly and efficiently. Although the international sites are vital today, we hope that after some time has passed the national public procurement system will become transparent and simple and international procurements will not be required.