Bulgarian President vetoes amendments to drugs law

Written by on January 29, 2014 in Bulgaria - No comments

Bulgaria’s President Rossen Plevneliev said on January 29 that he vetoed amendments passed by Parliament earlier this month, which restricted drug exports.

Plevneliev said that all efforts to ensure that Bulgaria had sufficient amounts of medicine to meet domestic demand should be welcomed, but said that such efforts should be in line with both Bulgaria’s constitution and EU law.

The key provision in the amended law that the presidency objected to was the requirement for drug wholesalers to receive the approval for export from the government’s Medicines Agency. Such a request has to be filed for each individual export shipment and the agency would have up to 30 days to give or withhold its approval.

Plevneliev said that the amendments did not include any provisions to ensure that potential exporters were treated equally: “Could a refusal by the director of the Medicines Agency of one export request serve as the grounds for tacit approval for another request on the ‘grounds’ that sufficient amounts have been secured [for domestic demand]?”

In the absence of clear rules how the new export approval framework is to work, the situation “has the potential to induce corruption practices”, Plevneliev said.

Furthermore, the amendments breached EU law because export approval was required even if the drugs were to be shipped to another EU member state – and EU law explicitly bans export restrictions within the bloc, Plevneliev said.

Once again, the President criticised the lack of detailed motives explaining the goals of the bill and arguments why it was necessary, as well as an impact analysis that would allow an objective assessment of whether the proposed changes would accomplish the stated goals.

“The practice of bills being prepared without motives, which would contain a preliminary impact assessment, or with ostensive motives, is not line with the principles of the rule of law,” he said. “It is unacceptable for the weaknesses of the law to become evident only as it is being implemented.”

 

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