{"id":12122,"date":"2016-05-12T22:19:13","date_gmt":"2016-05-12T22:19:13","guid":{"rendered":"https:\/\/patients.org.ua\/?p=12122"},"modified":"2024-04-18T12:57:50","modified_gmt":"2024-04-18T12:57:50","slug":"moh-intends-to-annul-pharmaceutical-market-deregulation-initiated-by-groysman","status":"publish","type":"post","link":"https:\/\/patients.org.ua\/en\/news\/moh-intends-to-annul-pharmaceutical-market-deregulation-initiated-by-groysman\/","title":{"rendered":"MoH Intends to Annul Pharmaceutical Market Deregulation Initiated by Groysman"},"content":{"rendered":"

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\nThe Ministry of\u00a0Health intends to\u00a0annul the simplified authorization of\u00a0medicines introduced by\u00a0the Cabinet of\u00a0Ministers of\u00a0Ukraine a\u00a0few weeks ago. These provisions submitted by\u00a0the MoH sit in\u00a0the amendments to\u00a0the government bill No\u00a04484\u00a0on the deregulation of\u00a0the pharmaceutical market in\u00a0Ukraine.<\/p>\n

\u00abThe bill as\u00a0revised by\u00a0the MoH does not deregulate, but, on\u00a0the contrary, overregulates the pharmaceutical market. In\u00a0fact, it\u00a0creates opportunities for micromanagement of\u00a0the medicines market authorization. The most terrible thing is\u00a0that under the pretext of\u00a0simplification the MoH actually complicates the simplified authorization procedure, which is\u00a0currently in\u00a0place for some most important illness categories, such as\u00a0HIV\/AIDS, TB, oncology, hepatitis and orphan diseases. That will never\u00a0do<\/em>\u00bb, indicates Lana Sinichkina<\/strong>, a\u00a0partner at\u00a0Arzinger Law Firm.<\/p>\n

The point is\u00a0that the Ministry of\u00a0Health introduced amendments to\u00a0the government bill aimed at\u00a0the deregulation of\u00a0the pharmaceutical market. By\u00a0doing this it\u00a0actually annuls all reformatory standards initiated by\u00a0the Prime Minister and downplays the very idea of\u00a0deregulation. In\u00a0particular, the MoH proposes to\u00a0restrict a\u00a0list of\u00a0medicines with fast track down to\u00a0those, which have no\u00a0branded equivalents in\u00a0Ukraine<\/strong>. In\u00a0fact, it\u00a0means holding of\u00a0the current pharmaceutical market monopoly<\/strong> and entire restriction of\u00a0the competition. In\u00a0addition, a\u00a0patient will be\u00a0deprived of\u00a0the right to\u00a0choose the medicines he\/she wants to\u00a0buy. This means that the main idea of\u00a0increasing competition in\u00a0the pharmaceutical market of\u00a0Ukraine, which would reduce the prices for medicines, was completely annulled by\u00a0this norm.<\/p>\n

Moreover, as\u00a0against the government bill, the MoH is\u00a0willing to\u00a0implement micromanagement for authorization of\u00a0the medicines from the developed countries, such as\u00a0the\u00a0EU and the USA, in\u00a0the Ukrainian market. It\u00a0means that in\u00a0order to\u00a0apply the simplified procedure the applicant has to\u00a0submit information and the documents according to\u00a0the list, which is\u00a0not specified. In\u00a0this situation the applicant may be\u00a0rejected just because his\/her package of\u00a0documents is\u00a0incomplete!<\/p>\n

Additionally, the applicant has to\u00a0prove to\u00a0the Ukrainian bureaucrats that the said medicine is\u00a0included to\u00a0the regulations and formularies of\u00a0the developed countries. All this creates freedom for fiddling and additional barriers for the medicine authorization as\u00a0well as\u00a0procrastinates the whole procedure.<\/p>\n

\u00abAs\u00a0a\u00a0member of\u00a0the Okhmatdit Board of\u00a0Trustees I\u00a0see with my\u00a0own eyes how parents and volunteers are desperately searching for the needed medications. In\u00a0order to\u00a0provide Ukrainians with access to\u00a0the medicines we\u00a0need to\u00a0simplify the procedures, remove the unnecessary barriers and consequently ruin the monopoly in\u00a0the pharmaceutical market<\/em>\u00bb, indicates Hanna Hopko<\/strong>, the Head of\u00a0the VR\u00a0Committee for Foreign Affairs.<\/p>\n

It\u00a0is\u00a0noteworthy that on\u00a0April 20\u00a0the Cabinet of\u00a0Ministers of\u00a0Ukraine approved Resolution No\u00a0312, by\u00a0which implemented the simplified authorization procedure for the medicines from the states with strict regulatory norms, such as\u00a0USA, Switzerland, Austria, Japan and the\u00a0EU states. The MoH will annul all achievements of\u00a0the Cabinet of\u00a0Ministers. Moreover, this will lead to\u00a0overregulation of\u00a0the pharmaceutical market and micromanagement of\u00a0the entire pharmaceutical sector.<\/p>\n

Now serious patients, their relatives and volunteers have to\u00a0become smugglers. In\u00a0order to\u00a0save lives they are forced to\u00a0illegally import the medicines not registered in\u00a0Ukraine. The bill initiated by\u00a0Groisman was really progressive and raised hopes in\u00a0these people that they would receive an\u00a0opportunity to\u00a0buy the necessary medicines in\u00a0Ukraine for affordable prices. However the MoH amended the bill in\u00a0a\u00a0way that it\u00a0changed its very idea: instead of\u00a0deregulation it\u00a0overregulates the pharmaceutical market. In\u00a0such conditions it\u00a0is\u00a0impossible to\u00a0ruin the monopoly and provide access to\u00a0the medicines for the Ukrainian patients. Instead of\u00a0the reformation initiated by\u00a0the Government we\u00a0have a\u00a0rollback, indicates Olga Stefanyshyna<\/strong>, the Executive Director of\u00a0the Charitable Foundation Patients of\u00a0Ukraine.<\/p>\n

The patients\u2019 organizations and the professional community call on\u00a0the Prime Minister of\u00a0Ukraine to\u00a0renounce the lobbying proposals of\u00a0the Ministry of\u00a0Health and return to\u00a0the initial reformatory version of\u00a0the bill No\u00a04484.<\/p>\n

For your information<\/strong>:<\/p>\n