Amendments to the License Conditions of Carrying out Economic Activity on Producing Medicinal Products, Wholesale, Retail Trade of Medicinal Products
On May 3rd, 2012 the Draft Order of the Ministry of Health of Ukraine "On Amendments to the License Conditions of Carrying out Economic Activity on Producing Medicinal Products, Wholesale, Retail Trade of Medicinal Products" was placed at the official web site of the Ministry of Health of Ukraine for public consideration.
According to the Explanatory Note, the Draft Order aims to define the content, volume and value of terms "domestic producer of medicinal products" and "in bulk products".
Definition of Terms of "Small", "Large" and "Exceptionally Large" Size of Counterfeit Medicinal Products
On May 3rd, 2012 the Draft Order "On Definition of Terms of "Small", "Large" and "Exceptionally Large" Size of Counterfeit Medicinal Products" was placed at the official web site of the Ministry of Health of Ukraine for public consideration.
According to the Explanatory Note, the Draft Order aims to determine the terms of "small", "large" and "exceptionally large" size of counterfeit medicinal products.
On Amendments to the Cabinet of Ministers Resolution #536
On May 4th, 2012 the Draft Resolution of the Cabinet of Ministers "On Amendments to the Cabinet of Ministers Resolution #536 dated June 11th, 2008" was placed at the official web site of the Ministry of Health of Ukraine for public consideration.
According to the Explanatory Note, the Draft Resolution aims to amend the Technical Regulation on Medical Devices in compliance with the CMU Resolution #920 and European Standards.
Amendments to the Price Registration Procedure
On April 28th, 2012 the Ministry of Health of Ukraine held the meeting devoted to the discussion of the proposals from the Ministry of Economic Development and Trade of Ukraine on amendments to the Resolution of the Cabinet of Ministers of Ukraine #932 "On Improvement of Government Regulation of Prices for Medicines and Medicinal Products Procured from the State and Local Budgets" as well as actual issues in the price registration procedure.
As a result of the meeting it was agreed that the current Resolution #932 should be replaced with the new one establishing the prices declaration model instead of prices registration mechanism. According to the Ministry of Health of Ukraine, the abovementioned model should be similar to the previous prices declaration model stipulated in the CMU Resolution #1012.
Also the following points were recommended to be taken into account:
1) the new procedure should cover all products being purchased
in the course of public procurement procedures (not only medicines,
but also medical devices);
2) the procedure should be as simple as possible;
3) the procedure of prices declaration should allow the applicant
to submit any level of price, provided it does not exceed the
previous year price for a product (being proposed for public
tenders) for more than e.g. certain % over the previous year price.
This rule would not be applied if:
a) the product is new on Ukrainian market (prices in certain
reference countries may be taken into account instead of the
previous year prices in this case);
b) the applicant provides certain (to be clearly defined in the
regulation) grounds justifying the price increase.
4) it should clearly define whether the already registered prices
(based on the Resolution #932) should be taken into account.
The Resolution of the Cabinet of Ministers of Ukraine #
340 "On Realization of the Pilot Project on Introduction of
State Regulation of Prices of Medicines for Patients with
Hypertension"
On April 25th the updated draft Resolution of the Cabinet of
Ministers of Ukraine "On the Pilot Project on Introduction of
State Regulation of Prices of Medicines for Patients with
Hypertension" was adopted by the Ministry of Health of
Ukraine.
The Resolution stipulates the realization of the pilot project on
introduction of state regulation of prices of medicines for
patients with hypertension from June 1st till December 31st 2012 by
introducing marginal wholesale prices for these medicinal products
with use of reference prices mechanism (first stage) and partial
reimbursement of their costs by state and local budgets (second
stage).
A Draft Order of the Ministry of Health of Ukraine "On Introduction of Special Labeling of Medicinal Products including Immunobiological Medicines Purchased by State Budgets"
On April 13th, 2012 the Draft Order of the Ministry of Health of
Ukraine "On Introduction of Special Labeling of Medicinal
Products including Immunobiological Medicines Purchased by State
Budgets" was placed at the official web site of the Ministry
of Health of Ukraine.
The Draft Order aims to strengthen control over circulation of
medicinal products, including immunobiological medicines purchased
by state budgets.
The Draft Order "On Certain Issues regarding Ban on
Advertising of Medicinal Products"
The Draft Order of the Ministry of Health of Ukraine "On Certain Issues regarding Ban on Advertising of Medicinal Products" was placed at the official web site of the Ministry of Health of Ukraine on March 30th, 2012.
The Draft Order determines the criteria for certain OTC medicinal product, which will be prohibited for advertising and will come into force on July 13th, 2012.
It was proposed to amend the wording of the Draft Order regarding medicinal products containing substance, which is attributed to narcotic drugs as well as medicines, that can cause addiction syndrome and to exclude from the list medicinal products used for treatment of children under the age of 12.
Ministry of Health of Ukraine Intervenes in the Situation with Customs Clearance of Medicinal Products Containing Ethanol
The State Customs Service did not allow medicinal products containing ethanol to be imported to Ukraine asking to transfer all the medicinal products containing ethanol to alcoholic drinks category, i.e. the products for which the excise duty must be paid.
The Ministry of Health of Ukraine addressed the State Customs Service with a letter regarding this issue.
According to the available information, at the present moment
the State Customs Service has discontinued the transfer of all the
medicinal products containing ethanol to alcoholic drinks
category.
Criminal liability for IP related violations
On February 16, 2012the new Draft Law on criminal responsibility for IPR violations
was submitted to the VerkhovnaRada of Ukraine. As infringement
of intellectual property rights is sensitive for pharmaceutical
sector, new rules for criminal liability in IP may have an impact
for the industry.
In order to humanize criminal responsibility for a number of law
violations, at the end of 2011 respective changes were introduced
into the Criminal Code, in particular imprisonment and corrective
works were substituted by fine. Article 229 (violation of rights
for trademark, company name, appellation of origin) was amended as
well: its sanctions provide for fine instead of imprisonment and
corrective works. Articles 176 and 177 were not changed and still
provide imprisonment/corrective works for violation of copyright
and related rights, as well as rights for invention, utility model,
industrial design, plant variety, etc.
It is generally recognized that there is a big number of IPR
infringements in Ukraine. Thus it is questionable whether such
humanization of criminal liability is reasonable.
Implementation of the Pharmacists Ethic Code of Ukraine
The draft order of the MOH of Ukraine On a Mechanism of Implementation of the Pharmacists Ethic Code of Ukrainewas published on the web-site of the MOH for public hearings.
Novelties of the Order:
- To establish Ethics commissions within public services, pharmacy establishments, higher educational establishments, research institutions, professional public organizations, which would be responsible for supporting and monitoring the implementation of the Pharmacists Ethic Code of Ukraine by pharmacists and chemists of the above establishments, institutions, and organizations;
- To acquaint with the Pharmacists Ethic Code of Ukraine (the Code) in establishments, institutions, and organizationsup to 01.09.2012;
- To introduce amendments to the programs and curricula of students of pharmaceutical faculties, pharmacist interns and students in order to acquaint them with the Code;
- To establish an Ethics Commission of the MOH of Ukraine (the Commission) composed of 30 members: 17 appointed and 13 approved by the Minister of the MOH;
- To approve a Model Regulations of the Commission on the basis of which respective regulations of Ethics commissions would be elaborated;
- To define the main activities of the
Commission with thefollowing provisions:
- Establishing the priorities in the development of pharmaceutical ethics, justification of the introduction of modern scientific pharmaceutical innovations;
- Controlling over the compliance with the Code;
- Guiding the work of ethics commissions;
- Consideration together with the departments of MOH of Ukraine the proposals on the ways of development of pharmaceutical ethics, amending to the Code, drafting relevant decisions of the Minister;
- Consideration of draft legal acts of the MOH of Ukraine on strategic issues of the pharmaceutical sector development and making appropriate proposals for their improvement, taking into account the principles of pharmaceutical ethics;
- Cooperation with agencies, institutions and organizations in developing proposals for improving the Code and other issues in the sphere of pharmaceutical ethics.
- To establish the following about the
Commission:
- Term of participation – 3 years, but not more than 2 consecutive terms;
- Commission meetings – are to be held in accordance with need, but not less than 1 time in 6 months;
- Commission decisions – are to be adopted by consensus.
Recommendation to the draft Order:
- To amend preamble with the reference to the respective law of Ukraine, act or instruction of the President of Ukraine, act of the Cabinet of Ministers of Ukraine;
- To amend the composition of the Commission with the Minister (head of the Commission) and deputies of the Minister;
- To amend the Model Regulations of the
Commission with thefollowing provisions:
- To include the procedure of appealing to theCommission concerning all issues connected with the implementation of the Code;
- To include the procedure of controlling over compliance with the Code;
- To add provisions concerning the principles of activity of the Commission, legislative basis to be guided by, procedure of controlling over compliance by the Commission with the entrusted responsibilities;
- To eliminate clerical errors and inconsistence of some words in the text.
Approval of Provisions on the Electronic Register op Patients
On May 10th, 2012 the Draft Resolution of the Cabinet of Ministers of Ukraine "On Approval of Provisions on the Electronic Register of Patients" was posted on the official web site of the Ministry of Health of Ukraine.
According to the Explanatory Note, the Draft Resolution aims to establish Electronic Register of Patients, improve efficiency and quality of medical care and its acceleration, and increase the reliability of statistical information.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
