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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