Upharmacia March 2017 | Page 8

Upharmacia March 2017
of Ministers approved the new edition of the National List of essential drugs . The List is updated according to the latest version of the Model List of the World Health Organization ( WHO ). Before developing the List , the government determined prior diseases and conditions , which represent the biggest burden for the country .
The last time the List was reviewed in 2009 , so it had become outdated . The new List included 347 INNs , which all have justification of the WHO experts regarding their effectiveness . The adoption of the new List is intended to provide patients with medicines in the entire hospital segment and for outpatient treatment under the reimbursement program .
Reform of Medicinal Products Pricing Has a Chance of Existence
On Mar 20 , the Cabinet of Ministers published Resolution of the Cabinet of Ministers “ On Ensuring Affordability / Accessibility of Medicinal Products ” No . 152 as of Mar 17 , 2017 designed to relieve the tension that has arisen in the pharmaceutical market in the area of regulation of price for certain drugs used for the treatment of cardiovascular diseases , diabetes of type II and bronchial asthma , as well as to regulate the mechanism of reimbursement of the cost of such drugs for the population , which should come into effect on Apr 1 , 2017 . The main aspects are the following :
1 ) The medicinal products will be subject to state regulation provided they are reimbursed and / or purchased for budgetary funds . However , the inclusion of a specific drug in the reimbursement program will be voluntary .
2 ) Only those drugs , ex-factory price of which will not exceed the threshold set by the Ministry of Health , can be covered by the reimbursement program .
3 ) The state price regulation will be carried out in two directions : limitation of the maximum level of ex-factory prices based on internal and external reference pricing ; limitation of the maximum wholesale and retail mark-ups at 10 % and 15 %, respectively . 4 ) Determination of the lowest ex-factory price for a particular INN on the Ukrainian market ( internal referencing ) will be carried out based on applications of market entities .
5 ) Ex-factory prices for drugs , the cost of which will be reimbursed , will require declaring . At the same time , the declared price cannot exceed the threshold set by the MOH .
Parliamentary Committee endorsed the Bills on the Support of Investment Programs for Pharmaceutical Production
The Parliamentary Committee on Public Health reviewed the list of Draft Law aimed to the development of local production of pharmaceuticals .
The approval of the documents will allow decreasing the tax burden on economic entities that carry out investment projects on production of medicines and medical devices and equipment that is used in their production .
The income tax rate for such projects will amount : 0 % – for the first 5 years of the project ; 8 % – for the next 5 years ; 18 % – after the first 10 years . For this the entities , which carry out such projects should fulfill the following requirements :
• The overall amount of investments in the project should not be less than EUR 15 mio ;
• The number of new workplaces should be more than 200 ;
• The minimum salary of employees engaged in the project should not be less than 2.5 of minimum salaries in Ukraine ;
• The income of the taxpayer earned on investment projects and equipment that is used during their production is at least 75 % of the total amount of its income for the reporting ( tax ) period .
The members of the Committee unanimously supported the Draft Laws .
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