Monday, 25 March 2019

Government approves regulation of drug export

ČTK |
14 January 2016

Prague, Jan 13 (CTK) - The Czech government approved an amendment to regulate exports of sensitive medicines to prevent their re-export yesterday, Health Minister Svatopluk Nemecek (Social Democrats, CSSD) has told reporters during the government meeting.
The draft legislation is yet to be approved by both houses of parliament and signed by President Milos Zeman into law.
Experts will make the list of these drugs on the basis of reports from pharmacies. It is to include, for instance, anticancer drugs, medicines to treat heart and circulation diseased and neurological products the shortage of which might harm Czech patients.
Medicines for 70 billion crowns are annually distributed in the Czech Republic, of which products worth up to five billion crowns end up abroad. They are re-exported since they rank among the cheapest in Europe thanks to the price regulation.
The Health Ministry expects the amendment to take effect later this year.
In cooperation with the State Institute for Drug Control (SUKL), the ministry will create the list of key medicines, the shortage of which could threaten the patients' health and lives that were re-exported in the past. Their export will be prohibited.
The Health Ministry will publish the list, which will be regularly updated, in its gazette.
The firms that plan to export a medicine from the list will have to ask the ministry for consent 15 days ahead.
The amendment will introduce a fine of up to 20 million crowns and a maximum two-year ban on business activities to be imposed on distributors, which would actually liquidate them.
The ministry will be able to immediately react to a threatening lack of medicines. The existing law enables it to interfere only if the medicines are not available.
The Health Ministry dealt with the unavailability of some medicines several times in the past and it banned their re-export then.
According to the Pharmacists' Chamber, the regulation of the export of cheap medicines will not solve the problem of their shortage on the Czech market.
The amendment is also to facilitate the procedure of the approval of clinical studies that annually bring up to two billion crowns to the Czech health care sector.
The rules will be modified in accordance with the EU requirements.
In the case of underage patients, for instance, an informed consent not only of their legal representatives (mostly a parent), but also of the underage patient alone will be needed. The amendment will also set conditions of testing medicines on prisoners and inmates of social care facilities.
($1=24.937 crowns)

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