On March 20th, the Cabinet of Ministers published Resolution of the Cabinet of Ministers "On Ensuring Affordability/Accessibility of Medicinal Products" No. 152 as of March 17th, 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 April 1st, 2017.
The resolution of the Cabinet of Ministers, in particular, amends resolutions of the Cabinet of Ministers No. 862 as of November 9th, 2016, No. 863 as of November 9th, 2016, No. 955 as of October 17th, 2008 and No. 240 as of July 2nd, 2014.
The main aspects are the following:
1) Resolution of the Cabinet of Ministers No. 862 as of November 9th, 2016 will not govern free market. That is, 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:
4) Determination of the lowest ex-factory price for a particular INPN 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 Ministry of Health.
Lawyers of Legal Alliance Company will talk about all aspects and pitfalls of the adopted resolution of the Cabinet of Ministers at the seminar "Reform of Pricing for Medicinal Products. Saga. Episode 4: A New Hope" which will be held on March 27th, 2017.
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