New National List of Medicines: Change in Rules For a Patient’s Sake
Dmytro Aleshko, partner with Legal Alliance Company
This autumn great and tangible changes to healthcare sector in Ukraine will be made.
Starting from September 1st, 2017 healthcare institutions funded from the state and local budgets will start public procurement of the medicines included in the new National List of Essential Medicines.
For patients it means that effective, high-quality and safe essential (that is key) medicines from all diseases recognized internationally as Ukraine’s priority should be provided free of charge starting from 2018 in inpatient departments.
This means reducing the cost of medicines to be paid by patients and increasing the duration and quality of life of people as a result.
For the state, this means controlled and effective use of resources. This is a guarantee of the help to a greater number of patients, where budget funds will be spent not on vitamins, but on really necessary medicines.
For pharmaceutical manufacturers, this means possibility of predicting the volume of drug consumption and establishing transparent relations with the state.
This means the prospect for new companies to enter Ukrainian market and promote competition.
Let us remind you that laying down the National List is an integral part of national priorities for addressing the main challenges to public health and illnesses that are most threatening to the country.
Like any large-scale reform, at the early stages of its introduction the new National List raises a lot of questions.
Often they are transformed into anxiety and fear. This is normal, since it deals with medicines on which life often depends. However, it is impossible to allow fear to interfere with the reform, the need of which has been brewing over the years.
In a country where 69% of the population do self-treatment, in which 43% of the hospitalized are forced to borrow or sell property to cover the cost of treatment, we simply do not have the right to do so.
As a team member working on the new National List and harmonization of its regulatory framework for its implementation, I will try to answer the most common questions.
Why does the National List include so few medicines? Who and on what basis included them in the List?
The Expert Committee on the Selection and Use of Essential Medicines, an advisory body of the Ministry of Health of Ukraine, has created the new National List based on the WHO Model List and evidence of the effectiveness, safety and economic feasibility of medicines.
Prior to this, the Committee, relying on the international methodology, identified a list of priority diseases and pathological conditions in Ukraine, that is, those that pose the greatest threat to public health and the are greatest burden for the state.
In 2018, the Expert Committee will finalize the second edition of the National List, which will be the basis for the procurement by hospitals in 2019.
I note that the committee has been created on a competitive basis, all its members have declared lack of conflict of interest.
Is the National List a final document, or will it still be amended?
The National List is reviewed annually.
A manufacturer or its authorized representative may file a statement in the prescribed form with the Expert Committee for the inclusion of a medicinal product thereto.
After detailed consideration, the Committee recommends that the Ministry of Health include or not include the medicine in the National List.
If a medicinal product is not on the National List, but is registered in Ukraine, does this mean that it cannot be procured for public funds?
No, it is not true.
After the healthcare institutions provide patients with 100% medication which are on the National List (the need for such drugs is measured independently based on the methodology approved by order of the Ministry of Health of Ukraine No. 782), they can procure any other necessary drugs registered in Ukraine
What will happen to the provision of medicines such as insulin, drugs for the treatment of orphan diseases, medicines that were prescribed on preferential basis at the outpatient level?
The requirement to procure drugs from the National List does not apply to centralized procurement of drugs (including for the treatment of orphan diseases), which is currently carried out through specialized international organizations.
Also, until January 1st, 2019 it does not apply to the pilot project on the reimbursement of cost of insulin medications.
From July 1st, 2017, only those medications that are included in the National List may be prescribed on preferential basis at out-patient level in accordance with Regulation 1303.
The situation with provision of medicines for patients with rare diseases at the expense of local budgets requires separate decisions at the national level.
One of the solutions may be adoption of a separate resolution of the Cabinet of Ministers on the provision of medicines for this category of patients. As far as we know, the Ministry of Health is actively working to resolve this issue.
The WHO Model List was introduced in 1977.
It became the basis for the creation of national lists of essential medicines in 156 of 196 countries.
Now Ukraine is only at the beginning of the path. This transition will definitely be difficult, but it is absolutely necessary to build an effective, fair and transparent healthcare system in our country.
When this system starts to work, every person who will be on in-patient treatment will be 100% provided with the main medicines that are on the National List.
Source: Ukrainska Pravda