Alexander Bondar, senior associate at Legal Alliance Company
Zoia Zamikhovska, associate at Legal Alliance Company
For more than a year the medical (pharmaceutical) sphere has been confidently holding the first place in terms of the number of media occasions and the intensity of professional public discussions. In many respects this is due to fundamental changes at the level of legislative regulation of the pharmaceutical sector that have been initiated or implemented for the past 3 years.
The catalyst for such changes was, on the one hand, the critical condition of the pharmaceutical sector, and on the other hand, official commitments undertaken by the government to bring the regulatory framework of Ukraine and the European Union closer. The post-revolutionary period only strengthened the European integration moods and the work on the analysis and implementation of the positive experience of the developed European countries. Changes in the procedure of public procurement of medicines and medical products with the involvement of specialized international organizations, the launch of a program for reimbursement of the cost of medicines, the development of the National List of Medicines and the system of selection to it have become key within the outlined pool.
The Ministry of Health of Ukraine has temporarily "ceded" change in the mechanism of centralized government procurement of medicines and medical products to the authority to conduct public procurement of medicines and medical products since 2015. It was assumed that during the period of the Ministry's transformations and healthcare reform to establish transparent processes and timely provision of patients with the necessary pharmaceutical products, the authority to conduct procurement will be transferred to authoritative international specialized organizations.
The Ministry of Health of Ukraine should update its approaches to the organization of processes and establish a central procurement organization for all public procurements of medicines and medical products by March 31st, 2019. By that time, public procurement should be conducted by medical institutions in Ukraine with the involvement of selected specialized organizations that carry out procurement based on appropriate contracts. Now, such specialized international organizations are UNDP, UNICEF and Crown Agents.
The launch of the innovative mechanism required the development and implementation of a number of legal acts. Lawyers of Legal Alliance made a significant intellectual contribution to the preparation of drafts of most by-laws adopted in pursuance of Law of Ukraine "On Amending Certain Laws of Ukraine on Ensuring Timely Patient Access to Essential Medicines and Medical Products through the Implementation of Public Procurement with the Involvement of Specialized Organizations" No. 269-VIII as of March 19th, 2015
Of course, only the Ministry of Health of Ukraine can account responsibly for real results of such a procurement mechanism. But despite the active position of opponents of international procurement, which is replicated in the media, the figures published in open sources allow us to speak about significant savings in budget resources thanks to a new procurement mechanism.
Together with the latest legislative changes that allow using the saved funds to procure additional medicines in the relevant areas, this undoubtedly improves the situation of patients. Analysis of international procurement would be incomplete without taking into account the problems that still exist in the international procurement procedure. They include an annual delay in signing contracts with international organizations, old approaches to the formation of nomenclature, long terms of delivery of goods can also be caused by a low level of material and technical support of public medical institutions in Ukraine that support the procurement of medicines and medical products purchased by international specialized organizations on the whole territory of Ukraine on the basis of relevant contracts, and the like.
Thus, given the viability of this procurement mechanism, issues that have been discovered in practice require urgent refinement and correction.
Unification of the List of Medicinal Products For Procurement
The National List of Essential Medicines (hereinafter - the National List) should be formed taking into account the world experience of rational pharmacotherapy and the implementation of the pharmacoeconomic approach to diagnosis and treatment of patients with priority pathological conditions, taking into account the level of morbidity and mortality from diseases, as well as industry standards in the field of healthcare.
In most countries, this function is performed by the WHO Model List of Essential Medicines which is a basic document to provide the public with medical assistance financed from public funds. Essential medicines taking into account the prevalence of diseases, evidence of comparative effectiveness and safety, economic efficiency". Such medicines should be available in in-patient and outpatient conditions at any time in sufficient quantities in appropriate dosage forms and of guaranteed quality, taking into account the features of the health care system.
Guided by these principles, the international non-governmental organization Management Sciences for Health (MSH), which is implementing the international technical assistance project "Systems for Improved Access to Medicines and Pharmaceutical Services" (SIAPS) in Ukraine sponsored by the United States Agency for International Development (USAID) has launched jointly with the Ministry of Health of Ukraine the project on the development of the National List in Ukraine.
From a practical point of view, this meant the creation of a consultative body under the Ministry’s of Health of Ukraine guidance to determine the criteria for the formation of the National List and the grounds and frequency of its viewing. Within the SIAPS, the team of Legal Alliance was also involved in the work of the expert committee to develop a package of documents on the National List of Essential Medicines.
Based on the results of the joint work on the basis of the 19th edition of the WHO Model List of Essential Medicines, the first version of the National List was developed (approved by Resolution of the Cabinet of Ministers of Ukraine 180 as of March 16th, 2017). As of the time of preparation of this publication, applications were received from concerned business representatives to include medicines in the National List. This list will be used from 2019 to conduct all state procurement of medicines. In addition, procurement will be conducted at the same time by international organizations in accordance with the nomenclature of medicines and procurement in the hospital segment based on the National List.
We have described only a part of the projects of Legal Alliance, as well as state initiatives on reforming the medical sphere. It is a difficult task to live in the time of reforms, but to be able to join in the creation of new processes is an invaluable experience. Now, given almost 20 years of experience in this field, we can guarantee that the Legal Alliance will continue to render its professional expertise to public initiatives on the implementation of leading European practices taking into account the realities of the modern pharmaceutical market in Ukraine.
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