{"id":11447,"date":"2016-05-23T06:57:32","date_gmt":"2016-05-23T06:57:32","guid":{"rendered":"https:\/\/patients.org.ua\/?p=11447"},"modified":"2024-04-17T08:27:07","modified_gmt":"2024-04-17T08:27:07","slug":"patients-ruined-pharmaceutical-lobbyist-wall-in-front-of-the-cabinet-of-ministers","status":"publish","type":"post","link":"https:\/\/patients.org.ua\/en\/news\/patients-ruined-pharmaceutical-lobbyist-wall-in-front-of-the-cabinet-of-ministers\/","title":{"rendered":"Patients Ruined Pharmaceutical Lobbyist Wall in Front of the Cabinet of Ministers"},"content":{"rendered":"

\"article
\nActivists of\u00a0the patients and public organizations came to\u00a0the building of\u00a0the Cabinet of\u00a0Ministers protesting against micromanagement of\u00a0the pharmaceutical market regulation. The patients who have to\u00a0illegally import the medications not authorized in\u00a0Ukraine ruined a\u00a0brick wall with an\u00a0inscription \u00abPharmaceutical Barrier\u00bb in\u00a0front of\u00a0the Cabinet of\u00a0Ministers. By\u00a0doing this they wanted to\u00a0show the need to\u00a0destroy the artificially created barriers due to\u00a0which thousand of\u00a0Ukrainians have limited access to\u00a0quality medications.<\/p>\n

\u00abIn\u00a0order to\u00a0save lives of\u00a0the oncology children the doctors prescribe medications, which have no\u00a0alternatives in\u00a0Ukraine. As\u00a0a\u00a0charity foundation we\u00a0have two options. The first one is\u00a0to\u00a0purchase them in\u00a0the black market with no\u00a0guarantee what the package contains; therefore we\u00a0will never use his option. The second option is\u00a0to\u00a0find someone abroad, who can sell these medications legally. For already half year we\u00a0are looking for one medicine in\u00a0various clinics abroad. This is\u00a0the longest legislative and bureaucratic red tape, so\u00a0children may not wait till it\u2019s over<\/em>\u00bb, said Natalia Onipko, the Head of\u00a0the Charity Foundation Zaporuka.<\/p>\n

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. Further simplification of\u00a0the authorization procedure, annulment of\u00a0the unnecessary licenses and permits created for micromanagement of\u00a0the pharmaceutical market and bribing of\u00a0the officials were going to\u00a0become the next steps. The Government bill No\u00a04484<\/a>, which specified deregulation of\u00a0the pharmaceutical market, was registered in\u00a0the Verkhovna Rada on\u00a0April\u00a020, 2016. However, during one week the Health Ministry amended this bill so\u00a0that it\u00a0actually limited any competition on\u00a0the pharmaceutical market downplaying the very idea of\u00a0deregulation . Further some MPs submitted alternative draft laws aimed at\u00a0protecting the current situation in\u00a0the pharmaceutical market and creating even more barriers for supply of\u00a0the medicines to\u00a0Ukraine. Particularly, Ms\u00a0T. Bakhteeva by\u00a0her remarks at\u00a0the latest meeting of\u00a0the relevant committee actually shelved the urgent idea of\u00a0the Prime Minister of\u00a0Ukraine.<\/p>\n

\u00abWe\u00a0are sick and tired of\u00a0listening to\u00a0the arguments of\u00a0MoH and some MPs that we\u00a0will heap Ukraine with low quality medicines authorized in\u00a0Europe. This and some other myths are permanently communicated by\u00a0those MPs and officials, who under the pretext of\u00a0deregulation are actually tightening the screws on\u00a0supplying the medicines that were authorized in\u00a0the regulatory authorities of\u00a0the states trusted by\u00a0the whole world. The whole patient community supports the idea of\u00a0the pharmaceutical market deregulation. That is\u00a0why today we\u00a0submitted to\u00a0Volodymyr Groisman a\u00a0progressive draft law supported by\u00a0the public and the professionals and aimed at\u00a0real deregulation of\u00a0the market and its supply with quality medicines<\/em>\u00bb, indicates Olga Stefanyshyna, the Executive Director of\u00a0the Charitable Foundation Patients of\u00a0Ukraine<\/p>\n

Different variants of\u00a0the bill No\u00a04484, actively discussed in\u00a0the\u00a0VR and in\u00a0MoH, contain a\u00a0number of\u00a0artificial limiting factors. For example, one of\u00a0the obligatory requirements for access of\u00a0the medicine to\u00a0the simplified authorization procedure is\u00a0its manufacturing in\u00a0the USA, Australia, Canada, Japan or\u00a0in\u00a0the\u00a0EU member states. However, all medicines authorized in\u00a0these countries are quality, effective and safe irrespective of\u00a0the manufacturing country\u00a0\u2014 either the\u00a0EU member state or\u00a0another country of\u00a0the world. Moreover, some companies locate their production facilities outside the\u00a0EU for economic reasons, however manufacturing standards for the medicines authorized in\u00a0strict regulatory jurisdictions guarantee quality and safety of\u00a0the product.<\/p>\n

Another artificial restriction is\u00a0the requirement that throws Ukraine back for 20\u00a0years in\u00a0authorization of\u00a0the medicines in\u00a0comparison with other countries. This key requirement is\u00a0the use of\u00a0the medicine in\u00a0the clinical practice of\u00a0the authorization country according to\u00a0the guidelines or\u00a0formularies of\u00a0these countries<\/strong>. However, an\u00a0average period between commercial distribution of\u00a0the medicine and its inclusion into formularies and guidelines is\u00a0from a\u00a0couple to\u00a020\u00a0years. Is\u00a0there a\u00a0sense for Ukrainians to\u00a0wait for so\u00a0long in\u00a0order to\u00a0receive an\u00a0access to\u00a0the novel medications, which were tested for quality and safety according to\u00a0the strictest rules in\u00a0the world? Moreover, the clinical guidelines of\u00a0the most developed countries include only those medicines that are subject to\u00a0reimbursement from the state budget, and this is\u00a0a\u00a0limited range of\u00a0medicines. Therefore, the Ukrainian pharmaceutical market will be\u00a0closed for the medicines sold at\u00a0the European pharmacies.<\/p>\n

\u00abThe largest threat of\u00a0the deregulation is\u00a0authorization of\u00a0those medicines that are used in\u00a0the indicated countries. The point is\u00a0that it\u00a0is\u00a0very difficult to\u00a0prove the fact of\u00a0usage because it\u00a0will be\u00a0exclusively at\u00a0the disposal of\u00a0the Ukrainian authorization body to\u00a0recognize the document certifying the fact of\u00a0usage. As\u00a0a\u00a0lawyer\u00a0I would say that there is\u00a0no\u00a0such document of\u00a0the prescribed form. This will cause legal uncertainty and micromanagement of\u00a0the pharmaceutical market<\/em>\u00bb, indicates Olga Svyatenka, lawyer of\u00a0the Law Firm Arzinger.<\/p>\n

The patients\u2019 organizations and the professional community call on\u00a0the Prime Minister of\u00a0Ukraine to\u00a0renounce the lobbying proposals and to\u00a0take into consideration the draft law developed by\u00a0the experts.<\/p>\n

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