Upharmacia October 2017
REGULATORY UPDATES
The Parliament Has Adopted the Healthcare Reform
On Oct 19, 2017, Ukrainian Parliament voted for 3 Draft Laws that are part of the medical reform:
1. The Draft Law " On State Financial Guarantees for the Provision of Medical Services and Medicines " No. 6327( adopted wholly);
2. The draft law " On Amendments to the Budget Code of Ukraine on Providing State Financial Guarantees for the Provision of Medical Services and Medicines” No. 6604 as of Jun 21, 2017( adopted in the first reading)
3. The draft law " On Increasing Accessibility and Quality of Medical Care in Rural Areas "( adopted in the first reading) No. 7117 as of Sep 18, 2017.
These draft laws concern the spheres of financing of medical care, in particular, the introduction of a state guaranteed package of medical services and medicines, the creation of the National Healthcare Service of Ukraine as the only customer for medical services, the reform of the primary healthcare system and the introduction of electronic patient records.
Primary healthcare system reform provides that patients will exercise their right to choose a family doctor by submitting to the medical services provider a declaration on the choice of a doctor who provides first medical aid.
The ideology of the medical reform is that the healthcare will be financed on a contractual basis. That is, healthcare institutions will receive money for specific services provided to specific patients. Financing the number of places in hospitals now will be substituted by the principle“ money follows the patient”.
The draft law introduces the concept of the program of state guarantees for medical services to the population, according to which the state pays fully from the state budget of Ukraine. Such a list includes primary, emergency and palliative care. It is worth noting that when reviewing the draft, the Parliament excluded option of copayment for medical services by patients.
Special attention is paid to reforming rural medicine- this is the focus of the draft law initiated by the President of Ukraine. The document envisages the introduction of telemedicine in Ukraine, which is intended to simplify the diagnosis in those cases when not a personal examination is needed, but rather an evaluation of the examination data.
In addition, the draft addresses the social issues of healthcare professionals. Thus, local authorities are recommended to develop and approve programs to provide healthcare professionals working in rural areas with official housing and office vehicles. The government is invited to take measures to ensure access of healthcare institutions in rural areas to the Internet. Commenting on this draft law, President P. Poroshenko said that the budget has at least UAH 5 bn of additional funding for medicine in rural areas for 2 years.
Provided by
Members of Parliament Proposed to Introduce a License for Manufacturing, Trade and Import of Medical Products
On October 6th, 2017 the draft Law on amendments to the Law of Ukraine " On Licensing Economic Activities " was registered in the Parliament.
The draft envisages the expansion of the list of types of economic activities subject to licensing. It is proposed to supplement the list with such activities as production, wholesale and retail trade, as well as import of medical products. In addition, the reference to medical products is included in the paragraph on licensing of the activities on manufacture, trade and import of medicines.
The explanatory note to the draft law states that the purpose of amendments is to bring Ukrainian legislation closer to the EU law. However, the EU does not have the practice of licensing production, wholesale and retail trade, as well as import of medical products.
At the same time, in order to unify the approaches to regulating the medical products market in Ukraine and the EU and in order to deregulate business, since July 1st, 2017 the requirement to register medical products has been substituted by the requirement to confirm their compliance with the technical regulations. Technical regulations provide only a register
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