Draft Law of Ukraine “On Amendments to the Law of Ukraine“ On Public Procurement ”and other laws of Ukraine on procurement of medicines, medical devices and their aids by a person authorized to procure in the field of health care and with the involvement of specialized organizations, who procure ”(hereinafter – the Bill) is designed to successfully continue the experience of providing patients of Ukraine with vital effective, safe and high-quality medicines and medical devices at the expense of the state budget with the involvement of international specialized organizations that procure.
The draft law was developed by the Ministry of Health of Ukraine (hereinafter – the Ministry of Health) on its own initiative.
Since 2015, the Ministry of Health has been procuring medicines and medical devices with the participation of specialized procurement organizations (such as the United Nations Development Program (UNDP), Crown Agencies Limited, the United Nations Children’s Fund in Ukraine (UNICEF)).
Such international procurement organizations have many years of experience in implementing projects for the procurement of goods and services on behalf of individual states or organizations, and their activities are strictly regulated in terms of the control system, procurement processes, and procedures.
World experience shows that the involvement of international procurement organizations in the process of purchasing medicines and medical devices at public expense provides a number of benefits for both patients and health care in general, as well as provides significant budget savings. In particular, such advantages are:
- reduction of the supply chain of medicines and medical devices (in particular, many medicines and medical devices are purchased by international procurement organizations under direct agreements with manufacturers, which allows obtaining the best price and quality guarantees);
- ensuring the procurement of high-quality medicines and medical devices due to the strict requirements for medicines;
- ensuring the speed of procurement through procurement from suppliers qualified by international procurement organizations (ie suppliers that have been tested by an international procurement organization for financial viability, as well as compliance with ethical requirements and applicable law);
- conducting procurement in accordance with transparent and open rules and procedures of international procurement organizations;
- the possibility of purchasing medicines and medical devices at low prices due to the large volumes of procurement carried out by international procurement organizations, as well as due to the conclusion of long-term framework agreements with suppliers by international procurement organizations.
The experience of procurement of these organizations has proven its success, providing the population for many years with the supply of quality and safe medicines and medical devices while significantly saving budget funds.
It should be noted that procurement with the involvement of specialized organizations since 2015 has been forced to strengthen the Ministry of Health’s own institutional capacity to procure medicines and medical devices through a national strategic purchaser.
This is due to the fact that the procurement of medicines and medical devices must be carried out within the deadlines set by law and are urgent, and the current system of centralized public procurement proved ineffective and posed risks of restricting patients’ access to essential medicines. temporary mechanism (for the period of reforming this area) with the involvement of proven world experience in the procurement of medicines and medical devices for budget funds.
Such a national strategic purchaser was the state enterprise “Medical Procurement of Ukraine”, which applies the leading practices and mechanisms of specialized organizations and continues the successful experience of specialized organizations.
According to each year, the list of medicines and medical devices procured with the involvement of international specialized organizations decreases, and the relevant areas of procurement are procured by the state enterprise “Medical Procurement of Ukraine” as a person authorized to procure health care for programs and implementation of centralized health care measures.
However, as the practice of procurement of medicines and medical devices by the state enterprise “Medical Procurement of Ukraine” in the period
2020-2021, there is a need to continue the temporarily introduced mechanism of parallel use for procurement of both international specialized organizations and the person authorized to conduct procurement in the field of health to implement programs and implement centralized health measures for another year.
Continuing to engage specialized organizations is also in line with the Sustainable Development Goals, including Goal 3, “Strong Health and Well-Being”, which is a bold commitment to tackling AIDS, tuberculosis, malaria, and other communicable diseases by 2030 by universal health coverage and providing access to safe and affordable medicines and vaccines.
In addition, the need to continue to involve specialized organizations in procurement procured to ensure the purchase of COVID-19 vaccines and COVID-19 vaccines from leading manufacturers of drugs with which specialized organizations have long-term contracts in 2022-2023.
At present, the conditions for the involvement of the Ministry of Health of international specialized organizations for the procurement of medicines and medical devices for budget funds are limited in time, namely:
– The Law of Ukraine “On Amendments to Certain Laws of Ukraine on Ensuring Timely Access of Patients to Necessary Medicines and Medical Devices through Public Procurement with the Involvement of Specialized Procurement Organizations” is valid until April 30, 2022;
Part 7 of Article 33 of the Law of Ukraine “On Ensuring the Functioning of the Ukrainian Language as the State Language” health, with specialized organizations that carry out procurement, valid until April 30, 2022;
– paragraph 19 of the fifth part of Article 3 of the Law of Ukraine “On Public Procurement”, which states that this Law does not apply to cases where the subject of procurement are goods and services to be procured in accordance with procurement agreements concluded by the central executive body the authorities of Ukraine, which ensures the formation and implementation of state policy in the field of health care, with specialized organizations that carry out procurement, valid until March 31, 2022;
– the validity of registration certificates for medicinal products subject to procurement as a result of a procurement procedure conducted by a specialized procurement organization for the implementation of a procurement agreement between the central executive body that ensures the formation and implementation of state health policy, and the relevant specialized organization conducting procurement valid until March 31, 2020, extended until March 31, 2022, and the fifth paragraph, the third sentence of the tenth paragraph of subparagraph 2, subparagraph 3, paragraphs five and seven of subparagraph 4, paragraphs two – the fourth sub-item 5, sub-item 6 of item 2, item 3, the third paragraph of item 4 of section I of the Law of Ukraine “On Amendments to Certain Laws of Ukraine Aimed at Improving the Availability of Medicines, Medical Devices and Auxiliaries for procurement in the field of health care “are in force until March 31, 2022.
The draft law proposes to extend the validity of the listed norms, which are in a systemic connection with the involvement of international specialized organizations in procurement, until April 30, 2023.
Adoption of the amendments proposed by this Bill will create favorable conditions for the further functioning of the procurement system in the field of health care, taking into account the unique specifics of international specialized organizations, and increase the availability of medicines and medical devices to patients.