New National List: The Way to Implement. Interview With Dmytro Aleshko, Expert in the Field of Pharmaceutical Regulatory

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From September 1^st, 2017, healthcare facilities and institutions funded from state and local budgets will start public procurement of medicines included in the new National List of Essential Medicines (hereinafter - the National List). We discussed significance of these innovations for the state and society with Dmytro Aleshko, partner at Legal Alliance Company and a member of the team that was working on the new National List and harmonization of the regulatory framework for the implementation of the project.

- We know that in 2015 Legal Alliance Company won tender for the development of regulatory documents for the project “Systems for Improved Access to Medicines and Pharmaceutical Services” (SIAPS). What were the requirements to the contest participants and how did you manage to win?

- In recent years our company has implemented a lot of rulemaking projects. In particular, in cooperation with the United Nations Development Program (UNDP) we provided legal support for the preparation of regulatory and legal acts in the field of public procurement of medicines and medical products by the Ministry of Health of Ukraine with the involvement of international specialized organizations; interacting with the WHO, our experts participated in the development of the draft State Strategy for the Implementation of the State Policy in the Sphere of Providing the Population with Medicines in 2017-2025; we engaged in development and provision of legal support to create the necessary prerequisites for effective implementation of the programs of the Global Fund to fight AIDS, tuberculosis and malaria in Ukraine. In addition, during 2014-2015 our team did extensive work to draft the Law of Ukraine “On Medicines”. Given such a significant standard-setting experience in the healthcare sector, it is difficult to compete in this area with us.

- Why are there so few medicines on the National List? Who and on what principle included them?

- The Expert Committee on the Selection and Use of Essential Medicines, which is an advisory body of the Ministry of Health of Ukraine, has made a new National List of Essential Medicines based on the World Health Organization's Model List and evidence of the efficacy, safety and economic feasibility of medicines, that also includes assessment of the state’s ability to pay for them. Before that, the Committee determined a list of priority diseases and pathological conditions for Ukraine, namely those that pose the greatest threat to public health and are the greatest burden for the state. This approach to the creation of such lists is used in both developed and developing countries. In Ukraine this approach was used for the first time.

Now the Expert Committee has reviewed the first edition of the National List, taking into account the nomenclature of medicines procured for budgetary funds under state programs, and the results of the analysis of impact on the budget (so-called fast track procedure). Relevant information was published on its website on August 1^st, 2017.

In 2018, the Expert Committee will finalize the second edition of the National List, which will form the basis for regional procurement in 2019.

- What will the introduction of the new National List mean for citizens?

- First of all I want to say that the introduction of the National List is not a question of the number of medicines on the list and the inclusion or non-inclusion of any specific articles to it. This is the issue of providing 100% of patients undergoing inpatient treatment with at least all basic essential drugs. This concerns every Ukrainian.

Let me remind you that the formation of the National List is an integral part of national priorities for combating the main challenges to public health and diseases that pose the greatest threat to the country. The Agreement on the Coalition of Members of Parliament of Ukraine and the Government's Priority Action Plan provide for relevant changes.

For citizens, the introduction of the National List means that quality and safe basic, that is, key medicines with proven effectiveness, that have been recognized as a priority for Ukraine, should be provided free of charge from the beginning of 2018. This means reducing costs from the “pocket” of consumers and improving the quality of medical care.

It should be noted that the prospects of creating an independent call centre, where patients could receive information in case they did not receive the necessary medicines from the National List in inpatient departments in 2018, were preliminarily discussed with the representatives of international projects.

Like any significant changes, at the first stages of the introduction, the new National List raises many questions, as it concerns medicines on which life of people depends largely. Now the Ministry receives messages from the regions about cases of violation of continuous treatment of patients. These problems are not ignored, they are seen, understood and appropriate solutions are being prepared.

- Changes were made to the National List three months following its approval, including changes in the dosage form and doses of some drugs. Although in accordance with the Regulation on the National List, amendments are made to it once a year.

How do you generally assess the latest changes to Resolution of the Cabinet Resolution No. 333 as of March 25^th, 2009?

- For the first time Ukraine is passing the stage of forming the National List based on international experience. Like any large-scale reform, this process is not perfect. Therefore, unfortunately, there were inaccuracies in the text of the approved document regarding dosage forms, doses and the like. So, in order that patients could receive necessary medicines free of charge, a decision was made to correct such mistakes. I will note that no drug was excluded or added to the National List at this stage.

- Recently, representatives of pharmacy institutions have asked us what to do with the remnants of medicines dealt with in Resolution of the Cabinet of Ministers No. 1071 as of September 5^th, 1996, since in accordance with Resolution of the Cabinet of Ministers No. 1303 as of August 17, 1998, only medicines included in the National List can be prescribed using free and preferential prescriptions from July 1^st.

- Everyone understood that the issue of providing the population with medicines in accordance with Resolution of Cabinet of Ministers of Ukraine No. 1303 will be one of the main painful. Indeed, from July 1^st, 2017, only those medicines that are included in the National List can be prescribed for outpatient treatment using preferential prescriptions.

There are a number of circumstances that caused this situation. However, if we focus on them, this will not lead to reasonable results. Decisions aimed at solving the situation should be made.

The issue of postponing the introduction of the National List till January 1^st, 2018 was discussed.

After July 1^st, 2017, it became obvious that as a result of the introduction of the National List, it is not possible to avoid limiting patients' access to preferential drugs. With thin in mind and in order to stabilize the situation a number of meetings were held with patient organizations, heads of the Ministry of Health of Ukraine and some healthcare departments in the regions. As a result, issue of postponing the introduction of the National List till January 1^st, 2018 was discussed.

After hearing the explanations of the parties, Uliana Suprun, Acting Minister of Health, supported this idea and signed relevant documents that had already been submitted to the Cabinet of Ministers. Thus, in case of adoption of the corresponding resolution by the Cabinet of Ministers, patients will be able to receive medicines on preferential prescriptions in accordance with Resolution of Cabinet of Ministers of Ukraine No. 1303.

- How will healthcare institutions determine what quantity of medicines included in the National List must be procured?

- Inpatient department calculate the need for such medicines independently based on the methodology approved by Order of the Ministry of Health of Ukraine No. 782 as of July 1^st, 2017. This methodology was developed based on international experience with a view to unify approaches to calculation. This technique does not work for medicines requiring a special approach, for example, such as medications for patients who have undergone or are preparing for organ transplantation, drugs for substitution maintenance therapy, etc. Legislation provides for other methods to calculate necessary quantity of such medicines.

Healthcare institutions, wholly or partly funded from the state and local budgets, by this time have been calculating the quantity of needed medicines. The approved Procedure provides for the application of two methods for the quantification of needs: the method of morbidity and the method of consumption. The first one is based on the use of data on the number of people asking for medical care, including cases of hospitalization, and the second one - on the data on the quantity of medicines consumption in previous years.

According to preliminary data, on September 15^th, 2017 the Ministry of Health of Ukraine is planning to hold a workshop for healthcare institutions on the application of the adopted Procedure for Calculating the Needed Quantity. It will consist of two parts: theoretical and practical. Based on the results of the latter, representatives of the regions that will participate in the event will have to receive ready-made calculations of the needed quantities of medicines of their establishments.

- What will happen to the provision of such drugs as insulin, drugs for the treatment of orphan diseases, etc.?

- Most of these medicines are procured by the specialized ministry centrally through international specialized organizations, including drugs for the treatment of orphan diseases. Such procurement is not limited to the National List.

The rest of the drugs were provided by procurement at the local level. According to Resolution of the Cabinet of Ministers No. 333 as of March 25^th, 2009, (as amended by Resolution of the Cabinet of Ministers No. 547 as of July 4^th, 2017), from January 1^st, 2018, provided that 100% of the needed medicines included in the National List have been supplied, customers will be able to purchase any other medicines registered in Ukraine, the need for which they determine themselves.

In this case, preference should be given to medicines included in industry standards in the field of healthcare.

In addition, the Ministry of Health plans to develop approaches to the application of Resolution of Cabinet of Ministers No. 1303 after January 1^st, 2018.

With regard to the provision of insulin, it should be noted that by January 1^st, 2019, the National List does not apply to the corresponding pilot project for the reimbursement of insulin costs, which is implemented in accordance with Resolution of the Cabinet of Ministers No. 73 as of March 5^th, 2014.

- Will the experts of Legal Alliance take part in the processes related to the revision of the National List?

- The last document regarding the introduction of the new National List is the Order of the Ministry of Health “On Amendments to Order of the Ministry of Health of Ukraine No. 84 as of February 11^th, 2016 and Order No. 1050 as of October 7^th, 2016”, which is now registered with the Ministry of Justice of Ukraine. We hope that its state registration will take place next week. This is our last task.

I believe that we have done our best in order to establish in Ukraine a progressive world model for the creation and functioning of the National List for the benefit of patients in Ukraine.